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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2022
DEVICE: RoughRider Aurora Manual Wheelchair
RoughRider America LLC 510(k) NO: K200715(Traditional)
ATTN: Marc Krizack PHONE NO : 510 2049333
2233 California Street SE DECISION MADE: 24-JUN-22
Berkley CA 94703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemosure Accu-Reader A100
W.H.P.M., Inc 510(k) NO: K200754(Traditional)
ATTN: Farokh Etemedieh PHONE NO : 626 4438480
5358 North Irwindale Avenue SE DECISION MADE: 02-JUN-22
Irwindale CA 91706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
TaiDoc Technology Corporation 510(k) NO: K201037(Traditional)
ATTN: Jacky Chou PHONE NO : 886 2662 58188
6F, No. 127, Wugong 2nd Rd., Wugu SE DECISION MADE: 16-JUN-22
New Taipei City TW 24888 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy 3D Additive TriFlange Acetabular Cup
DePuy International, Ltd 510(k) NO: K201348(Traditional)
ATTN: Erin Combs PHONE NO : 574 3727211
St. Anthony's Road SE DECISION MADE: 16-JUN-22
Leeds GB LS11 8DT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDEN Spinal Fixation System
JMT Co., Ltd 510(k) NO: K201788(Traditional)
ATTN: Sang-Ok Nam PHONE NO : 82 31 8680951
70-39, Gwonyul-ro 1203 beon-gile, SE DECISION MADE: 23-JUN-22
Yangju-si KR 11517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Tech510(k) NO: K203208(Traditional)
ATTN: Paul Liu PHONE NO : 886 2 26557297
Rm. 1052, Bldg. H, 10F., No.3-2, YSE DECISION MADE: 12-JUN-22
Taipei TW 115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4CIS Chiron Spinal Fixation System
Solco Biomedical Co., Ltd. 510(k) NO: K203233(Special)
ATTN: Hee-Hoon Kim PHONE NO : 82 31 6104079
154 Seotan-ro, Seotan-myeon SE DECISION MADE: 01-JUN-22
Pyeongtaek KR 17704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity Gateway Suite
Draeger Medical Systems, Inc. 510(k) NO: K203579(Traditional)
ATTN: Eileen M Boyle PHONE NO : 781 4398120___
6 Tech Drive SE DECISION MADE: 07-JUN-22
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cholesterol2
Abbott Ireland Diagnostics Divisio510(k) NO: K203597(Traditional)
ATTN: Tracy Schmidt PHONE NO : 224 668 2833
Lisnamuck SE DECISION MADE: 30-JUN-22
Longford IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technolo510(k) NO: K203624(Traditional)
ATTN: Hangli Chen PHONE NO : 86 1502 4335314
North 4F, Building 1, No. 239 YataSE DECISION MADE: 16-JUN-22
Jiaxing CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys AMH
Roche Diagnostics 510(k) NO: K203757(Traditional)
ATTN: Edie Eads PHONE NO : 317 7348046
9115 Hague Road SE DECISION MADE: 10-JUN-22
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stainless Turbine
NAKANISHI INC. 510(k) NO: K203791(Traditional)
ATTN: Masaaki Kikuchi PHONE NO : 81 289 647277
700 Shimohinata SE DECISION MADE: 21-JUN-22
Kanuma JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILKRO
Hironic Co., Ltd 510(k) NO: K210084(Traditional)
ATTN: Ji Yeong Seo PHONE NO : 82 31 5257000
19F, 767, Sinsu-Ro, Suji-Gu SE DECISION MADE: 03-JUN-22
Yongin-Si KR 16827 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc. 510(k) NO: K210107(Traditional)
ATTN: Saiken Ho PHONE NO : 516 8788787 118
16 Midland Ave SE DECISION MADE: 01-JUN-22
Hicksville NY 11801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable Oxygen Concentrator, model: P2-E6
Qingdao Kingon Medical Science and510(k) NO: K210371(Traditional)
ATTN: Zhang Benrong PHONE NO : 86 185 65833539
Room 301-302, No.15 HanchengRoad SE DECISION MADE: 03-JUN-22
Qingdao Free Trade Zone CN 266555510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyClip® and EasyClip® Xpress
Stryker GmbH 510(k) NO: K210582(Traditional)
ATTN: Danielle Jannuzzi Madureira PHONE NO : 41 79 8900289
325 Corporate Drive SE DECISION MADE: 10-JUN-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Neuro Rongeurs
KLS-MARTIN L.P. 510(k) NO: K210741(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial ParkwSE DECISION MADE: 03-JUN-22
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q Patch
Medicalgorithmics S.A. 510(k) NO: K210758(Traditional)
ATTN: Maciej Gamrot PHONE NO : 48 22 8251249
Aleje Jerozolimskie 81 SE DECISION MADE: 02-JUN-22
Warsaw PL 02-001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap 3D Imaging and Mapping Catheter, Model 900009
Acutus Medical, Inc. 510(k) NO: K210766(Traditional)
ATTN: Karla Schaffner PHONE NO : 1 442 2326161
2210 Faraday Ave, Suite 100 SE DECISION MADE: 21-JUN-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adhese Universal DC, Cention Primer
Ivoclar Vivadent, AG 510(k) NO: K210804(Traditional)
ATTN: Sandra Cakebread PHONE NO : 423 2353535
Bendererstrasse 2 SE DECISION MADE: 07-JUN-22
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Noris Medical Dental Implants System - Cortical
Noris Medical Ltd 510(k) NO: K210852(Traditional)
ATTN: Simha Sibony PHONE NO : 972 73 7964477
8 Hataasia SE DECISION MADE: 24-JUN-22
Nesher IL 3688808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navident
ClaroNav Inc 510(k) NO: K210947(Traditional)
ATTN: Tal Bresler Stramer PHONE NO : 647 5442911
1140 Sheppard Avenue West Unit 10 SE DECISION MADE: 27-JUN-22
Toronto CA M3K 2A2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUTRON
ILOODA Co., Ltd 510(k) NO: K211000(Traditional)
ATTN: Yun-Jung Ha PHONE NO : 82 31 2101622
120, Jangan-ro 458 Beon-gil, JangaSE DECISION MADE: 09-JUN-22
Suwon-si KR 16200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powered Breast Pump (Models 7V and 7X)
Haenim Co., Ltd. 510(k) NO: K211016(Traditional)
ATTN: Dae Won Kim PHONE NO : 82 32 3246614
15, Saryeom-ro 21beon-gil, Seo-gu SE DECISION MADE: 29-JUN-22
Incheon KR 22742 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eCareManager 4.5
Visicu, Inc. 510(k) NO: K211046(Traditional)
ATTN: Janine Treter PHONE NO : 55 41 996865600
217 East Redwood Street SE DECISION MADE: 03-JUN-22
Baltimore MD 21202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Specific Marking Guides
Additive Orthopaedics, LLC 510(k) NO: K211076(Traditional)
ATTN: Greg Kowalczyk PHONE NO : 732 8826633
44 Riverdale Ave SE DECISION MADE: 28-JUN-22
Monmouth Beach NJ 07750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Freeze’n Clear Skin Clinic Warts & Tags
CryoConcepts LP 510(k) NO: K211099(Traditional)
ATTN: Sam Niedbala PHONE NO : 855 3552796
205 Webster St SE DECISION MADE: 17-JUN-22
Bethlehem PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORE-Trocar
Incore CO., LTD. 510(k) NO: K211148(Traditional)
ATTN: Jae-Hun Lee PHONE NO : 82 2 8663514
11, Hyeoksin-daero, 78-gil, Dong-gSE DECISION MADE: 21-JUN-22
Daegu KR 41072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: maxmorespine Bipolar Electrodes
Hoogland Spine Products, GmbH 510(k) NO: K211173(Traditional)
ATTN: Jaap Hoogland PHONE NO : 49 069 300883027
Feringastrasse 4 SE DECISION MADE: 23-JUN-22
Munich DE D-85774 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diacare 7000
Globus Sport and Health Technologi510(k) NO: K211207(Traditional)
ATTN: Jorge Millan PHONE NO : 855 4562875
7280 NW 7th St # 109 SE DECISION MADE: 06-JUN-22
Miami FL 33126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yomi Robotic System with YomiPlan Go
Neocis Inc. 510(k) NO: K211466(Traditional)
ATTN: William Tapia PHONE NO : 305 7532742
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 14-JUN-22
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BiMobile Instruments (for BiMobile Dual Mobility System)
Waldemar Link GmbH & Co. KG 510(k) NO: K211567(Special)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53575530
Oststraße 4-10 SE DECISION MADE: 03-JUN-22
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Rapid Readout Biological Indicator, 1295
3M Company 510(k) NO: K211705(Special)
ATTN: Mary Fretland PHONE NO : 651 4612734
3M Center, Building 275-5W-06 SE DECISION MADE: 28-JUN-22
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venus Cervical Plate System
ArtFx Medical LLC 510(k) NO: K211718(Traditional)
ATTN: Ozgen Ozfidan PHONE NO : 1 917 4452085
50 Laura Street #2524 SE DECISION MADE: 28-JUN-22
Jacksonville FL 32202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic Knee System
Total Joint Orthopedics, Inc. 510(k) NO: K211877(Traditional)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 22-JUN-22
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cysto-Gastro-Sets
G-Flex Europe SPRL 510(k) NO: K211909(Traditional)
ATTN: Thierry Cremer PHONE NO : 32 67 883665
20, Rue de l’industrie SE DECISION MADE: 09-JUN-22
Nivelles BE 1400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumenis Y&R Laser System
Lumenis Inc. 510(k) NO: K211979(Traditional)
ATTN: Karen Smith PHONE NO : 650 2796242
1870 S Milestone Dr SE DECISION MADE: 21-JUN-22
Salt Lake City UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KHEIRON® Spinal Fixation System
S.M.A.I.O. 510(k) NO: K211981(Traditional)
ATTN: Jean-Charles Roussouly PHONE NO : 33 670 165171
2, Place Berthe Morisot Parc TechnSE DECISION MADE: 09-JUN-22
Saint-Priest FR 69800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAL System
MicroAire Surgical Instruments, LL510(k) NO: K212024(Traditional)
ATTN: Glenn Gerstenfeld PHONE NO : 434 9758344
3590 Grand Forks Blvd SE DECISION MADE: 10-JUN-22
Charlottesville VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRAUS ENDO
Saeshin Precision Co., Ltd. 510(k) NO: K212043(Special)
ATTN: Nam-Gung San PHONE NO : 82 53 5872345
# 52, Secheon-ro 1-gil, Dasa-eup, SE DECISION MADE: 24-JUN-22
Daegu KR 711-814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Minjie Catheter System
Kai Medtech, LLC 510(k) NO: K212288(Traditional)
ATTN: Stephanie Rallis PHONE NO : 1 949 7678960 103
22651 Lambert Street, Suite 107 SE DECISION MADE: 02-JUN-22
Lake Forest CA 92630 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEG-acp
SOMNOmedics GmbH 510(k) NO: K212325(Traditional)
ATTN: Sabrina Forster PHONE NO : 49 931 35909462
Am Sonnenstuhl 63 SE DECISION MADE: 15-JUN-22
Randersacker DE 97236 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hCG One Step Pregnancy Test
Healstone Biotech Inc. 510(k) NO: K212418(Traditional)
ATTN: Guang Gao PHONE NO : 86 159 95714296
Unit 650, 655 West Kent Ave. N., SE DECISION MADE: 30-JUN-22
Vancouver CA V6P 6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
DonneVie Medical Technology (Shang510(k) NO: K212426(Traditional)
ATTN: Hannah Hang Yin PHONE NO :
Suite 201, Bld 1, 138 Xinjun Ring SE DECISION MADE: 16-JUN-22
Shanghai CN 201114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: freeflex+ Transfer Adapter
Fresenius Kabi AG 510(k) NO: K212445(Traditional)
ATTN: Keith Dunn PHONE NO : 224 8172430
SE DECISION MADE: 01-JUN-22
Bad Homburg DE 61346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Keos Anterior Cervical Interbody Fusion Device System
Keos 510(k) NO: K212450(Traditional)
ATTN: Scott Peterson PHONE NO : 239 2591491
1824 Colonial Village Lane SE DECISION MADE: 06-JUN-22
Lancaster PA 17601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELIOS IV 785
Laseroptek Co., Ltd. 510(k) NO: K212663(Traditional)
ATTN: Hong Chu PHONE NO : 82 31 80235150
#203 & #204 Hyundai I valley, 31, SE DECISION MADE: 09-JUN-22
Seongnam-si KR 13212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)
Huizhou Xiaoou Technology Co., Ltd510(k) NO: K212665(Traditional)
ATTN: Xia Wang PHONE NO : 86 752 3302188
3rd Floor, No.113 (Building D), XiSE DECISION MADE: 22-JUN-22
Huizhou CN 516000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZYPOR
FCI (France Chirurgie Instrumentat510(k) NO: K212741(Traditional)
ATTN: Thierry Fetick PHONE NO : 33 153 989898
20-22 rue Louis Armand SE DECISION MADE: 24-JUN-22
Paris FR 75015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
Blue Sky Bio, LLC 510(k) NO: K212785(Traditional)
ATTN: Albert Zickmann PHONE NO :
800 Liberty Dr. SE DECISION MADE: 30-JUN-22
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Seer Home
Seer Medical Pty Ltd 510(k) NO: K212788(Traditional)
ATTN: David Mitchell PHONE NO : 613 70355736
SE DECISION MADE: 16-JUN-22
Melbourne AU 3133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Logic Hd camera head green, System green
Richard Wolf Medical Instruments C510(k) NO: K212808(Traditional)
ATTN: Michael Loiterman PHONE NO : 847 9131113
353 Corporate Woods Parkway SE DECISION MADE: 14-JUN-22
Vernon Hills IL 60061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TLC Unicompartmental Knee System
Signature Orthopaedics Pty Ltd. 510(k) NO: K212870(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 16-JUN-22
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
Galvanize Therapeutics, Inc. 510(k) NO: K212871(Traditional)
ATTN: Deborah Sheffield PHONE NO : 206 8536398
1531 Industrial Road SE DECISION MADE: 17-JUN-22
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INHANCETM Hybrid Anatomic Glenoid Implant
Depuy Ireland UC 510(k) NO: K212933(Traditional)
ATTN: Yayoi Fujimaki PHONE NO : 508 8283541
Loughbeg SE DECISION MADE: 08-JUN-22
Ringaskiddy IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDx-DR v2.3
Digital Diagnostics Inc. 510(k) NO: K213037(Traditional)
ATTN: Ashley Miller PHONE NO : 319 2485620
2300 Oakdale Blvd SE DECISION MADE: 17-JUN-22
Coralville IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natural Rubber Latex Ultrasound Transducer Probe Covers
Global Protection Corp. 510(k) NO: K213087(Traditional)
ATTN: Christina Cataldo PHONE NO : 617 9462800
12 Channel Street SE DECISION MADE: 07-JUN-22
Boston MA 02210 510(k) STATEMENT
DEVICE: ZQuiet Advance
Sleeping Well, LLC 510(k) NO: K213088(Traditional)
ATTN: Daniel Webster PHONE NO : 802 9853013
138 Steeplebush Rd. SE DECISION MADE: 15-JUN-22
Shelburne VT 05482 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Armory Motion
Pain Management Technologies, Inc.510(k) NO: K213097(Traditional)
ATTN: Joshua A. Lefkovitz PHONE NO : 614 9378236
1760 Wadsworth Rd. SE DECISION MADE: 10-JUN-22
Akron OH 44320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BentrioTM Allergy Blocker
Altamira Therapeutics, Inc. 510(k) NO: K213114(Traditional)
ATTN: Elena Cavallini PHONE NO : 41 612 012348
8 The Green, Ste B SE DECISION MADE: 24-JUN-22
Dover, County Of Kent DE 19901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FX V135 Shoulder Prosthesis
FX Shoulder USA, Inc. 510(k) NO: K213117(Traditional)
ATTN: Kathy Trier PHONE NO : 800 2800775
13465 Midway Road, Suite 101 SE DECISION MADE: 07-JUN-22
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrabEx Pro
MicroSurgical Technologies Inc 510(k) NO: K213173(Traditional)
ATTN: Angela Mallery PHONE NO : 651 2104766
8415 154th Ave NE SE DECISION MADE: 08-JUN-22
Redmond WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
Coloplast Corp 510(k) NO: K213185(Traditional)
ATTN: Gayatri Ghadge PHONE NO : 612 4223206
1601 West River Road North SE DECISION MADE: 08-JUN-22
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD Mediastinoscope
Karl Storz Endoscopy America, Inc.510(k) NO: K213194(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Ave SE DECISION MADE: 23-JUN-22
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyOnyx System
Thought Technology Ltd. 510(k) NO: K213197(Traditional)
ATTN: Suresh Sugirtharaja PHONE NO : 1 514 4898251
5250 Ferrier, Suite 812 SE DECISION MADE: 17-JUN-22
Montreal CA H4P 1L3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeltaFil, DeltaFil Conditioner
DMG Chemisch-Pharmazeutische Fabri510(k) NO: K213201(Traditional)
ATTN: Stephan Schaefer PHONE NO : 011 4940 840060
Elbgaustrasse 248 SE DECISION MADE: 01-JUN-22
Hamburg DE 22547 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revaree Plus Vaginal Suppositories
Farma-Derma S.R.L. 510(k) NO: K213220(Traditional)
ATTN: Mara Calzolari PHONE NO : 39 051 6814181
Via Dell'artigiano 6-8 SE DECISION MADE: 21-JUN-22
Sala Bolognese IT 40010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Polypectomy Snare
Beijing ZKSK Technology Co.,Ltd 510(k) NO: K213222(Traditional)
ATTN: Ma Li PHONE NO : 86 138 11778090
Building 9, 6 & No.6 Yuan Hengye NSE DECISION MADE: 06-JUN-22
Beijing CN 101105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Band Ligator
Beijing ZKSK Technology Co.,Ltd 510(k) NO: K213223(Traditional)
ATTN: Ma Li PHONE NO : 86 138 11778090
Building 9, 6 & No.6 Yuan Hengye NSE DECISION MADE: 06-JUN-22
Beijing CN 101105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeuroLine Disposable Cranial Perforator with Hudson end
EMD Endoszkop Muszer Gyarto es Ker510(k) NO: K213228(Traditional)
ATTN: Gyula Ujvari PHONE NO : 36 52 486034
Bartok Bela u. 113/B SE DECISION MADE: 20-JUN-22
Debrecen HU 4031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 Platform Software
Etiometry, Inc. 510(k) NO: K213230(Traditional)
ATTN: Tim Hanson PHONE NO : 857 3669333
280 Summer St, 4th Floor SE DECISION MADE: 22-JUN-22
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kerecis Silicone
Kerecis Limited 510(k) NO: K213231(Traditional)
ATTN: Gudmundur Fertram SigurjonssPHONE NO : 354 562 2601
Eyrargata 2 SE DECISION MADE: 29-JUN-22
Isafjordur IS 400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZYPRO ECG Recorder (Model: UG02)
Sigknow Biomedical Co.,Ltd. 510(k) NO: K213233(Traditional)
ATTN: Hsiao-Fan Liu PHONE NO : 886 227 612577
6F., No. 760, Sec. 4, Bade Rd., SoSE DECISION MADE: 23-JUN-22
Taipei City TW 105412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscopic Injection Needle
Beijing ZKSK Technology Co.,Ltd 510(k) NO: K213239(Traditional)
ATTN: Ma Li PHONE NO : 86 138 11778090
Building 9, 6 & No.6 Yuan Hengye NSE DECISION MADE: 02-JUN-22
Beijing CN 101105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Secret Duo
Ilooda Co Ltd 510(k) NO: K213250(Traditional)
ATTN: Moon Mason PHONE NO : 031 2101628
120, Jangan-Ro 458 Beon-Gil JanganSE DECISION MADE: 24-JUN-22
Suwon-Si KR 16200 510(k) STATEMENT
DEVICE: CipherOx CRI Tablet
Flashback Technologies, Inc. 510(k) NO: K213255(Traditional)
ATTN: John Jedziniak PHONE NO :
208 Lenox Ave #307 SE DECISION MADE: 17-JUN-22
Westfield NJ 07090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nasogastric Feeding Tubes - ENFit Port - PVC
Cair Lgl 510(k) NO: K213258(Traditional)
ATTN: Irving L. Wiesen PHONE NO : 212 3818774
Parc Tertiaire De Bois Dieu, 1 AllSE DECISION MADE: 09-JUN-22
Lissieu FR 69380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpilME
Neauvia North America 510(k) NO: K213261(Traditional)
ATTN: Joy Willard PHONE NO : 984 7775296
8480 Honeycutt Road SE DECISION MADE: 02-JUN-22
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Qlicksmart BladeFlask UNIVERSAL
Qlicksmart Pty Ltd. 510(k) NO: K213274(Abbreviated)
ATTN: Michael Sinnott PHONE NO : 61 7 38441182
Level 1, 148 Boundary Street, WestSE DECISION MADE: 22-JUN-22
Brisbane AU 4101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
ConvaTec Limited 510(k) NO: K213283(Traditional)
ATTN: Louise Hollywood PHONE NO : 44 0 7776662499
GDC, First Avenue, Deeside industrSE DECISION MADE: 22-JUN-22
Deeside GB CH5 2NU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multifrax Laser System
Paradigm Medical Corporation 510(k) NO: K213332(Traditional)
ATTN: Nikolai Tankovich PHONE NO :
7371 Los Brazos SE DECISION MADE: 03-JUN-22
San Diego CA 92127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORE-CLIP
Incore Co., Ltd. 510(k) NO: K213338(Traditional)
ATTN: Jae-Hun Lee PHONE NO : 82 2 8663514
11, Hyeoksin-daero, 78-gil, Dong-gSE DECISION MADE: 23-JUN-22
Daegu KR 41072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
Path Medical GmbH 510(k) NO: K213345(Traditional)
ATTN: Johann Oswald PHONE NO : 49 89 80076502
Landsberger Strasse 65 SE DECISION MADE: 22-JUN-22
Germering DE 82110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst R1 Reverse Shoulder System
Catalyst OrthoScience, Inc 510(k) NO: K213349(Traditional)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail North, Suite 1SE DECISION MADE: 23-JUN-22
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlexBoardTM, EagleBoardTM, BreastBoard SXTM
MacroMedics BV 510(k) NO: K213439(Traditional)
ATTN: Elizabeth Hajos PHONE NO : 31 182 389777____
Oostbaan 670 SE DECISION MADE: 24-JUN-22
Moordrecht NL 2841 ML 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Extroducer Infusion Catheter System
Smartwise Sweden AB 510(k) NO: K213442(Traditional)
ATTN: Maria Nordlinder PHONE NO : 46 73 9635368
Alfred Nobels allé 150 SE DECISION MADE: 10-JUN-22
Tullinge SE SE-146 48 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Gloves
St Future International Limited 510(k) NO: K213448(Traditional)
ATTN: Ivan Tan PHONE NO : 852 23 180170
Flat/Rm 08 9/F Chevalier CommerciaSE DECISION MADE: 06-JUN-22
Hongkong CN 999077 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA NEXUS Ophthalmic Surgical System
D.O.R.C. Dutch Ophthalmic Research510(k) NO: K213467(Traditional)
ATTN: Linda van Leeuwen PHONE NO : 31 181 458080
B.V. Scheijdelveweg 2 SE DECISION MADE: 14-JUN-22
Zuidland NL 3214 VN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Pen Needle
Becton, Dickinson and Company 510(k) NO: K213478(Traditional)
ATTN: Karen Immanuel PHONE NO : 917 7050933
1 Becton Drive SE DECISION MADE: 28-JUN-22
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation 510(k) NO: K213504(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 16-JUN-22
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WesperO2
Wesper Inc. 510(k) NO: K213515(Traditional)
ATTN: Amir Reuveny PHONE NO : 917 8414830
234 5th Ave SE DECISION MADE: 10-JUN-22
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rune Labs Tremor Transducer System
Rune Labs, Inc. 510(k) NO: K213519(Traditional)
ATTN: Brian Pepin PHONE NO : 360 6062929
649 Iriving Street SE DECISION MADE: 10-JUN-22
San Francisco CA 94122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VenAir, Sequential Compression System
Apex Medical Corp. 510(k) NO: K213577(Traditional)
ATTN: Chieh Yang PHONE NO : 886 2 22685568
No. 9, Min Sheng St., Tu-Cheng, SE DECISION MADE: 28-JUN-22
New Taipei City TW 23679 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Epicardial Access System
Baylis Medical Company Inc. 510(k) NO: K213582(Special)
ATTN: May Tsai PHONE NO : 905 6024875
5825 Explorer Dr. SE DECISION MADE: 30-JUN-22
Mississauga CA L4W 5P6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MyCRO Band
Otto Bock Healthcare LP 510(k) NO: K213587(Traditional)
ATTN: Caleb Beck PHONE NO : 801 9746647
3820 West Great Lakes Drive SE DECISION MADE: 09-JUN-22
Salt Lake City UT 84120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q2 IV Administration Sets
Quest Medical, Inc. 510(k) NO: K213588(Traditional)
ATTN: Tosan Eweka PHONE NO : 972 3326338
One Allentown Parkway SE DECISION MADE: 02-JUN-22
Allen TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYLFIRM X
VIOL Co., Ltd. 510(k) NO: K213612(Traditional)
ATTN: Chai Kyoung Woo PHONE NO : 82 31 80177893
C-808, 809, Bundang Technopark C, SE DECISION MADE: 23-JUN-22
Seongnam-si KR 13510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS AFP
Ortho Clinical Diagnostics 510(k) NO: K213626(Traditional)
ATTN: Declan Hynes PHONE NO : 44 0165 6778032
Felindre Meadows SE DECISION MADE: 15-JUN-22
Pencoed GB CF35 5PZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syngo Carbon Space VA20A
Siemens Healthcare GmbH 510(k) NO: K213665(Traditional)
ATTN: Vijay Ramadas PHONE NO : 49 172 4324369
Siemensstr. 1 SE DECISION MADE: 21-JUN-22
Forchheim DE 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iFuse-TORQ® Implant System
SI-BONE, Inc. 510(k) NO: K213667(Traditional)
ATTN: Meirav Harsat PHONE NO : 650 8624942
471 El Camino Real, Suite 101 SE DECISION MADE: 10-JUN-22
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HemoSphere Advanced Monitor Viewfinder Remote, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index software feature, Acumen Assisted Fluid Management software feature with Acumen AFM Cable
Edwards Lifesciences, LLC 510(k) NO: K213682(Traditional)
ATTN: Manthan Damani PHONE NO : 949 2507853
One Edwards Way SE DECISION MADE: 22-JUN-22
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurgiCase Viewer
Materialise NV 510(k) NO: K213684(Traditional)
ATTN: Aya Nishikawa PHONE NO : 32 16745471
Technologielaan 15 SE DECISION MADE: 15-JUN-22
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIR Recon DL
GE Medical Systems,LLC (GE Healthc510(k) NO: K213717(Traditional)
ATTN: Glen Sabin PHONE NO : 262 8944968
3200 N Grandview Blvd SE DECISION MADE: 08-JUN-22
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PL-1 Skin Treatment System
Avava, Inc 510(k) NO: K213726(Traditional)
ATTN: Jay Bhawalkar PHONE NO : 617 816 2060
275 Second Avenue, Floor 3 SE DECISION MADE: 28-JUN-22
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Hangzhou Runheng Medical Co., Ltd.510(k) NO: K213739(Traditional)
ATTN: Yaya Lu PHONE NO : 86 182 85158974
Room 201, Shunfeng Building, NO.10SE DECISION MADE: 22-JUN-22
Hangzhou CN 311215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Purgo
AeroClean Technologies, LLC 510(k) NO: K213753(Traditional)
ATTN: Riachard Foster PHONE NO : 773 7916198
10455 Riverside Drive, Ste. 100 SE DECISION MADE: 01-JUN-22
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Glidewell 3DP Denture Base Resin
Prismatik Dentalcraft, Inc. 510(k) NO: K213765(Traditional)
ATTN: Jiahe Li PHONE NO : 949 2223516
2144 Michelson Drive SE DECISION MADE: 22-JUN-22
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CiRX Single use electrosurgical pencil with non-coated and coated electrode
Ningbo Shun Ye Medical Company, Lt510(k) NO: K213786(Traditional)
ATTN: Ding Feng Yu PHONE NO : 0574 63778018
No.5 Industry Road, Zhangqi IndustSE DECISION MADE: 27-JUN-22
Ningbo CN 31500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intelligence LaserComb
Yibin Yingtong Intelligent Technol510(k) NO: K213789(Traditional)
ATTN: Pengcheng Pan PHONE NO : 86 0831 2020866
3F, Building 1, Area A, IntelligenSE DECISION MADE: 24-JUN-22
Yibin CN 644000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eko Murmur Analysis Software (EMAS)
Eko Devices, Inc. 510(k) NO: K213794(Traditional)
ATTN: Sam Huang PHONE NO : 1 844 3563384
1212 Broadway, Suite 100 SE DECISION MADE: 29-JUN-22
Oakland CA 94612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
Covidien 510(k) NO: K213818(Traditional)
ATTN: Michael Mach PHONE NO : 320 4931411
60 Middletown Avenue SE DECISION MADE: 27-JUN-22
North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AneuGuide
ArteryFlow Technology Co., Ltd. 510(k) NO: K213838(Traditional)
ATTN: Jianping Xiang PHONE NO : 86 571 86772567
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 01-JUN-22
Hangzhou CN 310051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q2 Blood Administration Sets
Quest Medical, Inc. 510(k) NO: K213846(Traditional)
ATTN: Tosan Eweka PHONE NO : 972 3326338
One Allentown Parkway SE DECISION MADE: 05-JUN-22
Allen TX 75002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD60 Series Ultrasound Diagnostic System
Qingdao Hisense Medical Equipment 510(k) NO: K213862(Traditional)
ATTN: Yalan Wu PHONE NO : 86 180 51581382
No. 399 Songling Road, Laoshan DisSE DECISION MADE: 08-JUN-22
Qingdao CN 266100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EarliPoint System
EarliTec Diagnostics, Inc. 510(k) NO: K213882(Traditional)
ATTN: Thomas Ressemann PHONE NO : 833 5049937
755 Commerce Drive, Suite 700 SE DECISION MADE: 08-JUN-22
Decatur GA 30030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: leva Pelvic Health System
Renovia Inc. 510(k) NO: K213913(Traditional)
ATTN: Jim O'Connor PHONE NO : 860 5103026
263 Summer St, 5th Floor SE DECISION MADE: 30-JUN-22
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gastric Alimetry System
Alimetry Ltd. 510(k) NO: K213924(Traditional)
ATTN: Yaara Yarmut PHONE NO : 64 276 091886
70 Symonds Street SE DECISION MADE: 03-JUN-22
Grafton NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
bioMerieux, Inc. 510(k) NO: K213931(Traditional)
ATTN: Debra Broyles PHONE NO : 314 7318805
595 Anglum Road SE DECISION MADE: 03-JUN-22
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSALLO GT 018 Floppy
Filmecc Co., Ltd. 510(k) NO: K213949(Traditional)
ATTN: Toshiya Osawa PHONE NO : 81 52 7681212
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 30-JUN-22
Nagoya JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atrial Fibrillation History Feature
Apple Inc. 510(k) NO: K213971(Traditional)
ATTN: Luke Olson PHONE NO : 408 6092001
1 Apple Park Way SE DECISION MADE: 03-JUN-22
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc. 510(k) NO: K213977(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 03-JUN-22
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
Oasis Medical, Inc 510(k) NO: K213988(Traditional)
ATTN: James Christensen PHONE NO : 626 8525156
514 S Vermont Avenue SE DECISION MADE: 03-JUN-22
Glendora CA 91741 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Leaseir MHR Xcell
Leaseir Technologies S.L.U. 510(k) NO: K214049(Traditional)
ATTN: Pablo Boto PHONE NO : 34 666 577507
C/ Jimena Fernández de la Vega, 14SE DECISION MADE: 02-JUN-22
Gijón ES 33203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
Guangzhou Shengwei Medical Devices510(k) NO: K214063(Traditional)
ATTN: Xiaojun Cai PHONE NO : 86 136 60308085
No. 126, Guangshao Road, Aotou TowSE DECISION MADE: 03-JUN-22
Conghua city CN 510900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
Fujifilm Corporation 510(k) NO: K214089(Traditional)
ATTN: Randy Vader PHONE NO :
798 Miyanodai Kaisei-Machi SE DECISION MADE: 03-JUN-22
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T-FIX® 3DSI Joint Fusion System
Cutting Edge Spine, LLC 510(k) NO: K214123(Traditional)
ATTN: Kyle Kuntz PHONE NO : 704 2430892
6012 Waxhaw Hwy SE DECISION MADE: 24-JUN-22
Mineral Springs NC 28108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zsquare ENT-Flex Endoscope
Zsquare, Ltd 510(k) NO: K220004(Traditional)
ATTN: Asaf Shahmoon PHONE NO : 972 369 87600
43 Hasivim Street SE DECISION MADE: 14-JUN-22
Petah Tikva IL 4959501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
ZOLL Circulation, Inc 510(k) NO: K220008(Traditional)
ATTN: Elizabeth Haines PHONE NO : 978 4219291
2000 Ringwood Avenue SE DECISION MADE: 02-JUN-22
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coloring Liquid
Dongguan Xiangtong Co., Ltd. 510(k) NO: K220017(Traditional)
ATTN: Charles Shen PHONE NO : 608 2179358
No.4, Tech 9th Rd, Hi-Tech IndustrSE DECISION MADE: 29-JUN-22
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K220058(Traditional)
ATTN: Li Lei PHONE NO : 86 755 81885953
Mindray Building, Keji 12th Road SSE DECISION MADE: 01-JUN-22
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pre-filled Syringe with Saline
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K220060(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510868 666668027
No.23, Huanxi Rd, Zhutang Town SE DECISION MADE: 10-JUN-22
Jiangyin CN 214415 510(k) STATEMENT
DEVICE: QardioArm 2
Qardio Inc 510(k) NO: K220106(Traditional)
ATTN: Rosario Iannella PHONE NO : 415 6709613
345 California Street, Suite 600 &SE DECISION MADE: 15-JUN-22
San Francisco CA 94104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Hemostatic Closure Clip Device
Micro-Tech (Nanjing) Co., Ltd. 510(k) NO: K220157(Traditional)
ATTN: Sally He PHONE NO : 86 25 58646395
No. 10 Gaoke Third Road, Nanjing NSE DECISION MADE: 13-JUN-22
Nanjing CN 210032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rayvolve
AZmed SAS 510(k) NO: K220164(Traditional)
ATTN: Patricia Massako PHONE NO : 0033 6 25846988
6 rue Leonard de Vinci SE DECISION MADE: 02-JUN-22
Laval FR 53000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D Anatomic Models
Ricoh USA, Inc. 510(k) NO: K220205(Traditional)
ATTN: Gary Turner PHONE NO : 1 954 6485680
5575 Venture Drive Unit A SE DECISION MADE: 03-JUN-22
Parma OH 44130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscopy Adapter Set
Yangzhou Fartley Medical Instrumen510(k) NO: K220210(Traditional)
ATTN: Tina Han PHONE NO : 0086 1505 1101225
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 17-JUN-22
Yangzhou CN 225106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLY Adaptive Cataract Treatment System
Lensar, Inc. 510(k) NO: K220259(Traditional)
ATTN: Keith Peck PHONE NO : 888 5756412
2800 Discovery Drive, Suite 100 SE DECISION MADE: 09-JUN-22
Orlando FL 32826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspirex Thrombectomy System
C.R. Bard, Inc. 510(k) NO: K220270(Traditional)
ATTN: Aaron Conovaloff PHONE NO : 602 8305453
1625 West 3rd St SE DECISION MADE: 21-JUN-22
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FridaMom Anti-Nausea Bands
FridaBaby LLC 510(k) NO: K220289(Traditional)
ATTN: Jeffrey Davidson PHONE NO : 305 6737535
82 NE 26th St Suite 101 SE DECISION MADE: 29-JUN-22
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc. 510(k) NO: K220299(Traditional)
ATTN: Jyoti Singh PHONE NO : 408 4313527
1266 Kifer Road SE DECISION MADE: 16-JUN-22
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTOPLAN
Cascination AG 510(k) NO: K220300(Traditional)
ATTN: Jean-Francois Clemence PHONE NO : 41 31 3062626
Steigerhubelstrasse 3 SE DECISION MADE: 24-JUN-22
Bern CH 3008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wearable Breast Pump (Model S10)
Shenzhen Lutejiacheng Technology C510(k) NO: K220309(Traditional)
ATTN: Johnny Dai PHONE NO : 867 558 4861362
Rm 903 Jiangnan BLDG, No.l BantianSE DECISION MADE: 27-JUN-22
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
Stryker GmbH 510(k) NO: K220319(Traditional)
ATTN: Danielle Jannuzzi Madureira PHONE NO : 0041 798 900289
325 Corporate Drive SE DECISION MADE: 10-JUN-22
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
Hologic, Inc. 510(k) NO: K220321(Special)
ATTN: Jill Wyland PHONE NO : 858 4104487
10210 Genetic Center Drive SE DECISION MADE: 03-JUN-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and 510(k) NO: K220358(Traditional)
ATTN: Bryan Behn PHONE NO : 262 2475502
LLC 9900 Innovation Dr. SE DECISION MADE: 06-JUN-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Procedure Mask
Little Rapids Corporation 510(k) NO: K220377(Traditional)
ATTN: Tom Diedrich PHONE NO : 920 4905302
2273 Larsen Road SE DECISION MADE: 24-JUN-22
Green Bay WI 54303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sparta 3-Ply Surgical Disposable Face Mask
Sparta East, LLC 510(k) NO: K220378(Traditional)
ATTN: Ricardo Samayoa PHONE NO : 305 9243610
8830 NW 102 Street SE DECISION MADE: 30-JUN-22
Medley FL 33178 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
OTU Medical Inc. 510(k) NO: K220399(Traditional)
ATTN: Geping Liu PHONE NO : 408 7977313
2231 A Fortune Drive SE DECISION MADE: 16-JUN-22
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTIS pheno (VE21) System
Siemens Medical Solutions USA, Inc510(k) NO: K220409(Traditional)
ATTN: Patricia D. Jones PHONE NO : 678 5758832
40 Liberty Boulevard SE DECISION MADE: 29-JUN-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ebony HP PTA OTW 0.035" Catheter
Natec Medical Ltd. 510(k) NO: K220410(Traditional)
ATTN: Roy Devassy Pallippatt PHONE NO : 230 466 3054
Maeva Centre Building, Silicon AveSE DECISION MADE: 29-JUN-22
Reduit MU 72201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Canary Medical USA LLC 510(k) NO: K220413(Traditional)
ATTN: Nora C.R. York PHONE NO : 760 4976115
2710 Loker Ave. West, Suite 350 SE DECISION MADE: 22-JUN-22
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Saffron Fixation System
Coloplast A/S 510(k) NO: K220420(Traditional)
ATTN: Gayatri Ghadge PHONE NO : 612 4223206
1601 West River Road North SE DECISION MADE: 10-JUN-22
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd 510(k) NO: K220431(Traditional)
ATTN: Marcus Low PHONE NO : 605 80 52166
24, 1st Floor, Kompleks Kota MuliaSE DECISION MADE: 17-JUN-22
Taiping MY 34000 510(k) STATEMENT
DEVICE: ARTIS icono (VE21) System
Siemens Medical Solutions USA, Inc510(k) NO: K220432(Traditional)
ATTN: Patricia D. Jones PHONE NO : 678 5758832
40 Liberty Boulevard SE DECISION MADE: 29-JUN-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis s-Clean Abutment Mini
Dentis Co., Ltd. 510(k) NO: K220440(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 16-JUN-22
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Med-link Disposable ECG Cable and Leadwires
Shenzhen Med-link Electronics Tech510(k) NO: K220447(Traditional)
ATTN: Yi Liu PHONE NO : 0086 755 61568825 884
4th and 5th Floor, Building Two, HSE DECISION MADE: 28-JUN-22
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy CONDUIT LLIF SQUID Inserter
Enztec Limited 510(k) NO: K220449(Traditional)
ATTN: Claire Mai PHONE NO : 64 27 8292440
3/17 Print Place SE DECISION MADE: 28-JUN-22
Middleton NZ 8024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lap-Band System Calibration Tube
ReShape Lifesciences 510(k) NO: K220455(Traditional)
ATTN: Michelle Ravert PHONE NO : 949 4817851
1001 Calle Amanecer SE DECISION MADE: 07-JUN-22
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Examination Glove
Chifeng Huawei Medical Science&Tec510(k) NO: K220469(Traditional)
ATTN: Li Xiaohong PHONE NO : 86 1824 80565694
No. 2-4, Second-stage StandardizedSE DECISION MADE: 16-JUN-22
Chifeng CN 024023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System
NuVasive, Incorporated 510(k) NO: K220478(Traditional)
ATTN: Krunal Shah PHONE NO : 732 7633277
7475 Lusk Blvd. SE DECISION MADE: 21-JUN-22
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sherlock
Open Implants, LLC 510(k) NO: K220482(Traditional)
ATTN: Gregg Gellman PHONE NO : 1 781 5873242
800 West Cummings Ave, Suite 4900 SE DECISION MADE: 21-JUN-22
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Anhui Zhong Lian Latex Gloves Manu510(k) NO: K220488(Traditional)
ATTN: Kitty xu PHONE NO : 86 1385 3370291
Guzhen Economic Development Zone SE DECISION MADE: 01-JUN-22
Bengbu CN 233799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BreathID Hp Lab System, BreathID Smart System
Meridian Bioscience Israel Ltd. 510(k) NO: K220494(Special)
ATTN: Raffi Werner PHONE NO : 972 8 9737502
4 Ha'Maayan st, SE DECISION MADE: 23-JUN-22
Modiin IL 7177872 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLumbo
Smart Soft Healthcare AD 510(k) NO: K220497(Traditional)
ATTN: Yoana Ivanova PHONE NO : 359 883 448962
113 General Kolev Str. Primorski DSE DECISION MADE: 23-JUN-22
Varna BG 9002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: bite away neo
MibeTec, GmbH 510(k) NO: K220514(Traditional)
ATTN: Oliver Grunert PHONE NO : 49 349 54247489
Munchener Strasse 15 SE DECISION MADE: 23-JUN-22
Brehna DE D-06796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: restor3d TiDAL Lumbar Interbody Fusion Device
Restor3d 510(k) NO: K220523(Traditional)
ATTN: Shyam Patel PHONE NO : 704 3514342
404 Hunt St. Suite 500 SE DECISION MADE: 17-JUN-22
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Isolation Cover Gown
Wuhan Dymex Healthcare Co., Ltd. 510(k) NO: K220528(Traditional)
ATTN: Lynn Wu PHONE NO : 86 27 85827780
Room 1701, Unit 2, Building 5, JinSE DECISION MADE: 10-JUN-22
Wuhan CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc. 510(k) NO: K220541(Special)
ATTN: Angela L. Bunn PHONE NO : 470 3647417
1 Edison Drive SE DECISION MADE: 02-JUN-22
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
Ra Medical Systems, Inc. 510(k) NO: K220544(Traditional)
ATTN: Jami Miller PHONE NO : 442 2444672
2070 Las Palmas Drive SE DECISION MADE: 29-JUN-22
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc. 510(k) NO: K220547(Special)
ATTN: Angela L. Bunn PHONE NO : 470 3647417
1 Edison Drive SE DECISION MADE: 02-JUN-22
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask (M663BE,M663BT)
MAKRITE INDUSTRIES, INC. 510(k) NO: K220550(Traditional)
ATTN: Bob Wen PHONE NO : 886 2 26982419
11F-5., NO.79, Sec.1, Xintai 5th RSE DECISION MADE: 14-JUN-22
New Taipei TW 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
CERAGEM Co, Ltd. 510(k) NO: K220572(Traditional)
ATTN: Hyeonggeun Hwang PHONE NO : 82 41 5294359
10, Jeongja 1-gil, Seonggeo-eup, SSE DECISION MADE: 17-JUN-22
Cheonan-si KR 31045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Free.Max, MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc510(k) NO: K220575(Traditional)
ATTN: Alina Goodman PHONE NO : 1 224 5261404
40 Liberty Boulevard SE DECISION MADE: 24-JUN-22
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation eZspand Interbody System
Zavation Medical Products, LLC 510(k) NO: K220581(Traditional)
ATTN: Matt Jones PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 02-JUN-22
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
Sofradim Production 510(k) NO: K220586(Special)
ATTN: Paula Paz PHONE NO : 33 4740 89000
116, Avenue du Formans SE DECISION MADE: 22-JUN-22
Trevoux FR 01600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PrimeLOC Attachment System
Innovative Product Brands, Inc. 510(k) NO: K220612(Traditional)
ATTN: Chris Gervais PHONE NO : 1 760 5223126
7045 Palm Avenue SE DECISION MADE: 06-JUN-22
Highland CA 92346 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDOJECT fine Pen Needles
Chirana T. Injecta 510(k) NO: K220614(Traditional)
ATTN: Zdenka Klbeckova PHONE NO : 421 327709972
Nám. Dr. Schweitzera 194 SE DECISION MADE: 15-JUN-22
Stará Turá SK 916 01 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Boss Crossing Support Catheter
Marvao Medical Devices Ltd 510(k) NO: K220632(Traditional)
ATTN: Chris Davey PHONE NO : 353 091 759301
Unit 1 Galway Business Park, DangaSE DECISION MADE: 02-JUN-22
Galway IE H91A3EF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLET NEXT lancing device, MICROLET Lancet
Ascensia Diabetes Care US Inc 510(k) NO: K220633(Traditional)
ATTN: Sangram Yadav PHONE NO : 201 9368856
5 Wood Hollow Road SE DECISION MADE: 03-JUN-22
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NC TREK NEO Coronary Dilatation Catheter
Abbott Vascular 510(k) NO: K220634(Traditional)
ATTN: Nishi Singh PHONE NO : 408 8450892
3200 Lakeside Drive SE DECISION MADE: 30-JUN-22
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriMed Ripcord Device
TriMed, Inc. 510(k) NO: K220650(Traditional)
ATTN: David Medoff PHONE NO : 661 2557406
27533 Avenue Hopkins SE DECISION MADE: 01-JUN-22
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Type Blood Pressure Monitor
Shenzhen Jamr Medical Technology C510(k) NO: K220651(Traditional)
ATTN: Luo Fusheng PHONE NO : 86 755 85292057
A101-301,D101-201, Jamr Science & SE DECISION MADE: 30-JUN-22
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Knee 3
Brainlab AG 510(k) NO: K220652(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 899 915680____
Olof-Palme-Str. 9 SE DECISION MADE: 03-JUN-22
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
Excellent Medical Technology Group510(k) NO: K220665(Traditional)
ATTN: Kenney Song PHONE NO : 086 512 69398826
Room# 2301, Decheng Jiayuan Plaza,SE DECISION MADE: 03-JUN-22
Suzhou CN 215131 510(k) STATEMENT
DEVICE: Magnum
Magnum Health And Safety Pvt Ltd 510(k) NO: K220670(Traditional)
ATTN: Rakesh Bhagat PHONE NO : 91 982 0050482
Unit No. 21, 22, 23, Supreme IndusSE DECISION MADE: 28-JUN-22
Taluka - Vasai, Dist - Palghar IN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
Riverstone Resources Sdn Bhd 510(k) NO: K220672(Traditional)
ATTN: Suresh Kumar PHONE NO : 60 5 8912777
Lot 20852, No.119, Jalan Logam 7 KSE DECISION MADE: 03-JUN-22
Taiping MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zoupure Nitrile Powder Free Examination glove
Thai Rayong Product Glove Zoupure 510(k) NO: K220693(Traditional)
ATTN: Rattiya Pitutacha PHONE NO : 66 6322 13906
168 moo.1 Nongbua SE DECISION MADE: 07-JUN-22
Bankhai TH 21120 510(k) STATEMENT
DEVICE: RedPoint Medical's Better Bunion System
Redpoint Medical, LLC 510(k) NO: K220717(Traditional)
ATTN: James Spitler PHONE NO : 407 6083208
13326 West Road SE DECISION MADE: 09-JUN-22
Carmel IN 46074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Luminance RED Acne Device
Luminance Medical Ventures, Inc. 510(k) NO: K220729(Traditional)
ATTN: Troy Stites PHONE NO : 619 3413848
2310 Henderson Avenue #1297 SE DECISION MADE: 09-JUN-22
Dallas TX 75201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mural Perinatal Surveillance
GE Medical Systems Information Tec510(k) NO: K220732(Traditional)
ATTN: Brandon O'Shea PHONE NO : 414 3233147
9900 Innovation Drive SE DECISION MADE: 23-JUN-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
Institut Straumann AG 510(k) NO: K220751(Traditional)
ATTN: Viviana Horhoiu PHONE NO : 41 619 651512
Peter Merian Weg 12 SE DECISION MADE: 02-JUN-22
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Introcan Safety 2 IV Catheter
B.Braun Medical Inc. 510(k) NO: K220756(Special)
ATTN: Tracy Larish PHONE NO : 484 3759064
901 Marcon Blvd. SE DECISION MADE: 23-JUN-22
Allentown PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIRCUL8 Connect DVT Prevention Device
Ortho8, Inc. 510(k) NO: K220761(Special)
ATTN: Jeff Culhane PHONE NO : 916 2894002
2217 Plaza Drive SE DECISION MADE: 03-JUN-22
Rocklin CA 95765 510(k) STATEMENT
DEVICE: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System
Alphatec Spine, Inc. 510(k) NO: K220782(Traditional)
ATTN: Andrew Zhang PHONE NO : 760 4946860
1950 Camino Vida Roble SE DECISION MADE: 09-JUN-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
Yangzhou Fartley Medical Instrumen510(k) NO: K220790(Traditional)
ATTN: Tina Han PHONE NO : 0086 150 51101225
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 27-JUN-22
Yangzhou CN 225106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntellaMap Orion High Resolution Mapping Catheter
Boston Scientific Corporation 510(k) NO: K220796(Special)
ATTN: Melissa Schneider PHONE NO : 651 5826935
4100 Hamline Ave North SE DECISION MADE: 10-JUN-22
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venue Go
GE Medical Systems Ultrasound and 510(k) NO: K220800(Traditional)
ATTN: Lee Bush PHONE NO : 262 3099429
LLC 9900 W. Innovation Drive SE DECISION MADE: 21-JUN-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Abbott Diagnostics Scarborough, In510(k) NO: K220801(Special)
ATTN: Jessica Stahle PHONE NO : 207 7306353
10 Southgate Road SE DECISION MADE: 24-JUN-22
Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dia-X Bond Universal
Diadent Group International 510(k) NO: K220804(Special)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 15-JUN-22
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ART-PLAN
TheraPanacea 510(k) NO: K220813(Traditional)
ATTN: Edwin Lindsay PHONE NO : 33 962 527819
Pépinière Cochin Paris Santé, 29 rSE DECISION MADE: 17-JUN-22
Paris FR 75014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Glove
DAXWELL, LLC 510(k) NO: K220834(Traditional)
ATTN: Frank Zhang PHONE NO : 01 281 6990622
2825 Wilcrest Dr #500 SE DECISION MADE: 29-JUN-22
Houston TX 77042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venue Fit
GE Medical Systems 510(k) NO: K220848(Traditional)
ATTN: Lee Bush PHONE NO : 262 3099429
Ultrasound and Primary Care DiagnoSE DECISION MADE: 27-JUN-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Venue
GE Medical Systems 510(k) NO: K220851(Traditional)
ATTN: Lee Bush PHONE NO : 262 3099429
Ultrasound and Primary Care DiagnoSE DECISION MADE: 27-JUN-22
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vial Adapter Ø13mm
Avenir Performance Européenne Medi510(k) NO: K220856(Traditional)
ATTN: Bruno Bertholet PHONE NO : 00334 716 17534
ZI Route de Souppes SE DECISION MADE: 21-JUN-22
Château-Landon FR 77570 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M6-C Artificial Cervical Disc Instruments AS
Spinal Kinetics LLC 510(k) NO: K220861(Traditional)
ATTN: Joyce Zhong PHONE NO : 408 6362524
501 Mercury Drive SE DECISION MADE: 02-JUN-22
Sunnyvale CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann TLX Variobase C
Institut Straumann AG 510(k) NO: K220878(Traditional)
ATTN: Gordon Dodds PHONE NO : 49 89 309075291
Peter Merian Weg 12 SE DECISION MADE: 16-JUN-22
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmileGuard
EnvisionTEC GmbH 510(k) NO: K220894(Traditional)
ATTN: Ruediger Van Bernum PHONE NO : 49 2043 987545
Brusseler Straße 51 SE DECISION MADE: 10-JUN-22
Gladbeck DE D-45968 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal
Shenzhen Qiaochengli Technology Co510(k) NO: K220927(Special)
ATTN: Guoming Zhou PHONE NO : 86 0755 23072580
501-5, rujun building, 105 ZhongxiSE DECISION MADE: 02-JUN-22
Shenzhen CN 510(k) STATEMENT
DEVICE: Restoris Multi-Compartmental Knee System
Mako Surgical Corp. 510(k) NO: K220930(Traditional)
ATTN: Emily DiMambro PHONE NO : 201 8315140
3365 Enterprise Ave SE DECISION MADE: 02-JUN-22
Weston FL 33331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIFOCUS Torque Device
Terumo Medical Products (Hangzhou)510(k) NO: K220934(Traditional)
ATTN: Qing Liu PHONE NO : 908 8429016
M4-9-5, Economic & Technological DSE DECISION MADE: 29-JUN-22
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Mini Fragment System
Arthrex Inc. 510(k) NO: K220937(Traditional)
ATTN: Stacy Valdez PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard SE DECISION MADE: 29-JUN-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
3M Company 510(k) NO: K220942(Special)
ATTN: Yumi Wackerfuss PHONE NO : 1 651 7373556
2510 Conway Avenue, Bldg. 275-5W-0SE DECISION MADE: 24-JUN-22
Saint Paul MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Knotless AC Repair Devices
Arthrex Inc. 510(k) NO: K220947(Traditional)
ATTN: Ivette Galmez PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 06-JUN-22
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BruxZir Opaque Coloring Liquid
Prismatik Dentalcraft, Inc. 510(k) NO: K220960(Traditional)
ATTN: So Hyun Park PHONE NO : 949 8635479
2144 Michelson Drive SE DECISION MADE: 29-JUN-22
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLink Navigation Instruments
CoreLink, LLC 510(k) NO: K220973(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park SE DECISION MADE: 01-JUN-22
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K220975(Traditional)
ATTN: Jee Young Ju PHONE NO : 82 2 21940861
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 29-JUN-22
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EksoNR
Ekso Bionics, Inc. 510(k) NO: K220988(Traditional)
ATTN: Scott Davis PHONE NO : 1 603 8312980
1414 Harbour Way South, Suite 1201SE DECISION MADE: 09-JUN-22
Richmond CA 94804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasound System SONIMAGE MX1
Konica Minolta, INC. 510(k) NO: K220993(Traditional)
ATTN: Tsutomu Fukui PHONE NO : 81 42 5898429
1 Sakura-machi SE DECISION MADE: 23-JUN-22
Hino-shi JP 191-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
Shenzhen Ulike Smart Electronics C510(k) NO: K221002(Traditional)
ATTN: Xiaoming Lin PHONE NO : 86 1591 5373017
No.8, Keyuan Road, Yuehai Subb-disSE DECISION MADE: 01-JUN-22
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
Shanghai Handy Medical Equipment C510(k) NO: K221008(Traditional)
ATTN: Marcia Qiu PHONE NO : 86 21 56766108__
Floor 2, Building No. 11, Lane177,SE DECISION MADE: 22-JUN-22
Baoshan District CN 201906 510(k) STATEMENT
DEVICE: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
Aegis Spine, Inc. 510(k) NO: K221050(Special)
ATTN: Kihyang Kim PHONE NO : 1 303 7414123
9781 S. Meridian Blvd, Ste 300 SE DECISION MADE: 30-JUN-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21HQ613D
LG Electronics Inc. 510(k) NO: K221061(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
77, Sanho-daero SE DECISION MADE: 03-JUN-22
Gumi-si KR 39381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MediLab
Sigma Scientific Services LLC 510(k) NO: K221065(Traditional)
ATTN: Jorge Millan PHONE NO : 786 4165587
7737 N University Drive, Suite 101SE DECISION MADE: 10-JUN-22
Tamarac FL 33321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Niti-S Biliary Slim M Stent
Taewoong Medical Co., Ltd 510(k) NO: K221071(Traditional)
ATTN: Jangsoo Lee PHONE NO : 82 70 46491515
14 Gojeong-ro, Wolgot-myeon SE DECISION MADE: 09-JUN-22
Gimpo-si KR 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Auryon Atherectomy System
Eximo Medical Ltd. 510(k) NO: K221077(Traditional)
ATTN: Yoel Zabar PHONE NO : 972 8 6307639
Pekeris St 3 SE DECISION MADE: 09-JUN-22
Rehovot IL 7670203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
First Source Inc. 510(k) NO: K221081(Traditional)
ATTN: Ronald Viola PHONE NO : 585 2721690
3495 Winton Place Building E SuiteSE DECISION MADE: 13-JUN-22
Rochester NY 14623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
Medtronic Navigation, Inc. 510(k) NO: K221087(Traditional)
ATTN: Silver Wirth PHONE NO : 707 3676521
826 Coal Creek Circle SE DECISION MADE: 10-JUN-22
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd. 510(k) NO: K221117(Traditional)
ATTN: Jee Young Ju PHONE NO : 82 2 21941312
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 17-JUN-22
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
Cepheid 510(k) NO: K221160(Special)
ATTN: Suzette Chance PHONE NO : 262 6231175
904 Caribbean Drive SE DECISION MADE: 07-JUN-22
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TC Gloves
Thanh Cong Pharmaceutical and Trad510(k) NO: K221185(Traditional)
ATTN: Nguyen Thi Tu Anh PHONE NO : 098 171 2992
KM6+ 200 National Road No. 38, HapSE DECISION MADE: 22-JUN-22
Bac Ninh City VN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TC Gloves
Thanh Cong Pharmaceutical and Trad510(k) NO: K221186(Traditional)
ATTN: Nguyen Thi Tu Anh PHONE NO : 098 171 2992
KM6+ 200 National Road No. 38, HapSE DECISION MADE: 16-JUN-22
Bac Ninh City VN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEPTO Precision Capsulotomy System
Centricity Vision, Inc. 510(k) NO: K221188(Traditional)
ATTN: Neal Hartman PHONE NO : 858 3826550
1939 Palomar Oaks Way, Suite A SE DECISION MADE: 23-JUN-22
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Powder-Free Examination Gloves
Shandong Maida Medical Technology 510(k) NO: K221192(Traditional)
ATTN: Kitty Xu PHONE NO : 86 1385 3370291
Room 102, Eastern building, No.166SE DECISION MADE: 22-JUN-22
Dongying CN 257000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoProbe
Active Life Scientific, Inc. 510(k) NO: K221195(Special)
ATTN: Alexander Proctor PHONE NO : 805 7702600
1027 Garden Street SE DECISION MADE: 28-JUN-22
Santa Barbara CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Excipio SV Thrombectomy Device
Contego Medical Inc. 510(k) NO: K221204(Traditional)
ATTN: Jim Clossick PHONE NO : 1 305 6071708
3801 Lake Boone Trail, Suite 100 SE DECISION MADE: 23-JUN-22
Raleigh NC 27607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY Laparoscope
Stryker 510(k) NO: K221217(Traditional)
ATTN: Christie Samsa PHONE NO : 978 5001303
5900 Optical Court SE DECISION MADE: 17-JUN-22
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask (HNFM0304)
Shanghai Hua En Industrial CO LTD 510(k) NO: K221222(Traditional)
ATTN: Lisa Zhao PHONE NO : 86 1561 8875177
#30, NO988 Hui Ji Road, Xuanqiao TSE DECISION MADE: 06-JUN-22
Shanghai CN 201314 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "1st Glove" Blue Nitrile Examination Gloves Powder Free
Koove Iot Pvt. Ltd. 510(k) NO: K221226(Abbreviated)
ATTN: Sudarsan Mohapatra PHONE NO : 773 55 63300
Gokulpur, PO:Shyamraipur SE DECISION MADE: 16-JUN-22
Paschim Midnapur IN 721305 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Drug Relief v1
DyAnsys, Inc. 510(k) NO: K221231(Special)
ATTN: Srini Nageshwar PHONE NO : 408 4804700
300, North Bayshore Boulevard SE DECISION MADE: 06-JUN-22
San Mateo CA 94401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DT-703
ECOTRON Co., Ltd 510(k) NO: K221233(Traditional)
ATTN: Sang Bong Lee PHONE NO : 02 2025 3760
404, 504, 505Ho, Hanshin IT Tower SE DECISION MADE: 27-JUN-22
Seoul KR 08511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mg OSTEOINJECT
Bone Solutions, Inc. 510(k) NO: K221256(Traditional)
ATTN: Drew Diaz PHONE NO : 1 817 8098850___
5712 Colleyville Boulevard, Suite SE DECISION MADE: 28-JUN-22
Colleyville TX 76034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FROG Forceps Valve (VAL1-F1-100)
FUJIFILM medwork GmbH 510(k) NO: K221264(Special)
ATTN: Randy Vader PHONE NO : 360 356 6821
Medworkring 1 SE DECISION MADE: 01-JUN-22
Hochstadt DE 91315 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask (M001)
Shandong Xingyu Gloves Co., Ltd. 510(k) NO: K221272(Traditional)
ATTN: Carrie Li PHONE NO : 86 18263 618867
No. 2189 Yaoqian Road, Gaomi EconoSE DECISION MADE: 28-JUN-22
Weifang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask (M001)
Xingyu Medical Tech Co., Ltd 510(k) NO: K221273(Traditional)
ATTN: Carrie Li PHONE NO : 86 182636 18867
No. 2189 Yaoqian Road, Gaomi EconoSE DECISION MADE: 28-JUN-22
Weifang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAROX
VSI Co., Ltd. 510(k) NO: K221286(Traditional)
ATTN: Jake Yu PHONE NO : 82 43 2679039
151-33, Namseok-ro Nami-myeon, SeoSE DECISION MADE: 29-JUN-22
Cheongju-si KR 28182 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Hair Removal Device
Guangzhou CHUANG ZAO MEI Technolog510(k) NO: K221312(Traditional)
ATTN: Karpov Aleksandr PHONE NO : 086 0131 47561925
Dehe international A505, No.2, QixSE DECISION MADE: 29-JUN-22
Guangzhou CN 510440 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K221314(Special)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminadav St. SE DECISION MADE: 03-JUN-22
Tel Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D²RS and D²RS 9090
Stephanix 510(k) NO: K221335(Special)
ATTN: Sandie Perret PHONE NO : 33 477 478160
10, rue Jean Moulin Z.I du Bayon SE DECISION MADE: 07-JUN-22
La Ricamarie FR 42150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
Contego Medical Inc. 510(k) NO: K221339(Special)
ATTN: Jim Clossick PHONE NO : 1 305 6071708
3801 Lake Boone Trail, Suite 100 SE DECISION MADE: 09-JUN-22
Raleigh NC 27607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd. 510(k) NO: K221345(Special)
ATTN: Junjie Qian PHONE NO : 86 0512 53690872
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 16-JUN-22
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omni Foot and Ankle Plating System
Exremity Medical, LLC. 510(k) NO: K221362(Special)
ATTN: Mary Hoffman PHONE NO : 973 5888980
300 Interpace Parkway, Suite 410 SE DECISION MADE: 10-JUN-22
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Correction System Rings and Compatible HA-Coated Half Pins
WishBone Medical, Inc. 510(k) NO: K221366(Special)
ATTN: Ramakrishna Bajaj PHONE NO : 574 3064006 427
100 Capital Drive SE DECISION MADE: 06-JUN-22
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K221368(Special)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 09-JUN-22
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Heel Blood Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K221371(Special)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 08-JUN-22
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nalu Neurostimulation System
Nalu Medical, Inc. 510(k) NO: K221376(Special)
ATTN: Chelsea Gutierrez PHONE NO : 714 4010608
2320 Faraday Avenue, Suite 100 SE DECISION MADE: 10-JUN-22
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Hivox Biotek Inc. 510(k) NO: K221384(Special)
ATTN: Aaron Huang PHONE NO : 886 285 112668 320
5F., No. 123, Xingde Rd., SanchongSE DECISION MADE: 11-JUN-22
New Taipei City TW 24158 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERF-GEN Pulsatile Perfusion Solution
Institut Georges Lopez 510(k) NO: K221386(Traditional)
ATTN: Matthieu Prouteau PHONE NO : 33 437 646332
Parc Tertiaire du Bois Dieu, 1 AllSE DECISION MADE: 14-JUN-22
Lissieu FR 69380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEL-GEN Cold Storage Solution
Institut Georges Lopez 510(k) NO: K221387(Traditional)
ATTN: Matthieu Porteau PHONE NO : 33 437 646332
Parc Tertiaire du Bois Dieu, 1 AllSE DECISION MADE: 14-JUN-22
Lissieu FR 69380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FairFix AM Adjustable Button FairFix PSP Adjustable Button
Medacta International S.A. 510(k) NO: K221389(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 08-JUN-22
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swoop Portable MR Imaging System
Hyperfine, Inc. 510(k) NO: K221393(Special)
ATTN: Christine Kupchick PHONE NO : 203 3433404
351 New Whitfield Street SE DECISION MADE: 10-JUN-22
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIA Radiation Therapy Management (v16.1 MR3)
Varian Medical Systems, Inc 510(k) NO: K221408(Special)
ATTN: Peter J. Coronado PHONE NO : 1 650 4246320
3100 Hansen Way SE DECISION MADE: 17-JUN-22
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHILL Model F
Whill, Inc. 510(k) NO: K221438(Third Party - Traditional)
ATTN: Tsuyoshi Iriyama PHONE NO : 81 9025 672984
2-1-11 Higashi-Shinagawa; Harbor PSE DECISION MADE: 07-JUN-22
Shinagawa-ku JP 140-0002 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
Varian Medical Systems, Inc 510(k) NO: K221448(Special)
ATTN: Peter J. Coronado PHONE NO : 1 650 4246320
3100 Hansen Way SE DECISION MADE: 15-JUN-22
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ElucidVivo A.3
Elucid Bioimaging Inc. 510(k) NO: K221463(Special)
ATTN: Doug Shufelt PHONE NO : 617 3049520
2 Park Plaza, Suite 700 SE DECISION MADE: 17-JUN-22
Boston MA 02116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Baby Gorilla/Gorilla Plating System
Paragon 28, Inc. 510(k) NO: K221465(Special)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 17-JUN-22
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Langston dual lumen catheter
Vascular Solutions LLC 510(k) NO: K221470(Special)
ATTN: Becky Astrup PHONE NO : 763 7622601___
6464 Sycamore Court North SE DECISION MADE: 17-JUN-22
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Esophageal TTS Stent
Taewoong Medical Co., Ltd. 510(k) NO: K221482(Special)
ATTN: Jangsoo Lee PHONE NO : 82 70 46491515
14 Gojeong-Ro, Wolgot-Myeon SE DECISION MADE: 22-JUN-22
Gimpo-Si KR 10022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K221500(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 South East 51st Street SE DECISION MADE: 14-JUN-22
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Axial3D Cloud Segmentation Service
Axial Medical Printing Limited 510(k) NO: K221511(Third Party - Traditional)
ATTN: Jenna McGarry PHONE NO : 44 774 9147256
17A Ormeau Avenue SE DECISION MADE: 23-JUN-22
Belfast GB BT2 8HD 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Sugita AVM Microclip Applier
Mizuho America, Inc. 510(k) NO: K221524(Special)
ATTN: Richard Chadwick PHONE NO : 510 3244500 150
30057 Ahern Avenue SE DECISION MADE: 24-JUN-22
Union City CA 94587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Shenzhen Fansizhe Science And Tech510(k) NO: K221569(Special)
ATTN: Endang Cheng PHONE NO : 86 0755 85275266
2nd and 3rd floors, No. 17, Xinfa SE DECISION MADE: 30-JUN-22
Shenzhen CN 518125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode Multi-system
InMode Ltd. 510(k) NO: K221571(Special)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 30-JUN-22
Yokneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 780 nm L11 LED Light Source with AIM
Stryker 510(k) NO: K221611(Special)
ATTN: Michelle Hughes PHONE NO : 904 6081262
5900 Optical Court SE DECISION MADE: 29-JUN-22
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Radiography CXDI-Elite, Digital Radiography E1
Canon Inc. 510(k) NO: K221620(Special)
ATTN: Akira Hirai PHONE NO : 81 33 7582111
9-1 Imaikami-Cho, Nakahara-KU SE DECISION MADE: 14-JUN-22
Kawasaki JP 211-8501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Pr510(k) NO: K221658(Traditional)
ATTN: Julie Villanueva, PhD PHONE NO : 404 6393851
1600 Clifton Road NE, MS: H24-11 SE DECISION MADE: 10-JUN-22
Atlanta GA 30329 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Filtek Supreme Flowable Restorative
3M Company ESPE Dental Products 510(k) NO: K221695(Third Party - Traditional)
ATTN: Regina Feferman-Savvateev PHONE NO : 1 651 4673869
2510 Conway Avenue SE DECISION MADE: 13-JUN-22
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Flat Panel Detector
iRay Technology Taicang Ltd. 510(k) NO: K221714(Special)
ATTN: Guo Wu PHONE NO : 86 0512 53690872
No. 33 Xinggang Rd. Taicang Port ESE DECISION MADE: 29-JUN-22
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS AIM Universal II Slittable Inner Catheter
Abbott Medical 510(k) NO: K221750(Special)
ATTN: Indira Verdekel PHONE NO : 1818 4933360
15900 Valley View Court SE DECISION MADE: 30-JUN-22
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers For Disease Control And Pr510(k) NO: K221834(Special)
ATTN: Julie Villanueva, PhD PHONE NO : 404 6393851
1600 Clifton Rd, NE MS H24-11 SE DECISION MADE: 24-JUN-22
ATLANTA GA 30329 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 279
TOTAL WITH SUMMARIES 270
TOTAL WITH STATEMENTS 9
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