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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2023
DEVICE: DD Solid Connect® CAD/CAM Abutments
Dental Direkt GmbH 510(k) NO: K191111(Traditional)
ATTN: Gerhard de Boer PHONE NO : 49 5225 863190
Industriezentrum 106-108 SE DECISION MADE: 11-JAN-23
Spenge DE 32139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Shandong Pop Jeans Intelligent Man510(k) NO: K203380(Traditional)
ATTN: Wang Jing PHONE NO : 86 18 678168199
No. 188, Gengjiao Road, Huantai SE DECISION MADE: 06-JAN-23
Zibo CN 256400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tidepool Loop
Tidepool Project 510(k) NO: K203689(Traditional)
ATTN: Howard Look PHONE NO : 650 3532352
3340 Hillview Ave SE DECISION MADE: 23-JAN-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
Pikdare S.p.A 510(k) NO: K203792(Abbreviated)
ATTN: Roberta Zanoni PHONE NO :
Via Saldarini Catelli 10 SE DECISION MADE: 20-JAN-23
Casnate con Bernate IT 22070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tacrolimus Assay Kit
Shanghai Genext Medical Technology510(k) NO: K203833(Traditional)
ATTN: Kimmy Zong PHONE NO : 86 021 61763507
Rm1101, 11th Floor, Bldg 2, PujianSE DECISION MADE: 27-JAN-23
Shanghai CN 201114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XChange Device, XChange System
Pneuma Therapeutics, Inc. 510(k) NO: K210112(Traditional)
ATTN: William Densel PHONE NO : 978 4601469
4090 E Bujia Primera SE DECISION MADE: 30-JAN-23
Tucson AZ 85718-6164 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnispec ED1000
Medispec Ltd. 510(k) NO: K210166(Traditional)
ATTN: Avner Spector PHONE NO : 301 9441575
203 Perry Parkway, Suite 6 SE DECISION MADE: 27-JAN-23
Gaithersburg MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoCr Head
Zimmer GmbH 510(k) NO: K211047(Traditional)
ATTN: Roberto Tommasini PHONE NO : 0041 058 8548264
Sulzerallee 8 SE DECISION MADE: 10-JAN-23
Winterthur CH 8404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bone Cement Genta, Bone Cement HV, Bone Cement LV
Tecres S.p.A. 510(k) NO: K211163(Traditional)
ATTN: Massimo Grazioli PHONE NO : 39 045 9217311
Via Andrea Doria 6 SE DECISION MADE: 09-JAN-23
Sommacampagna IT 37066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscopic Cutter Stapler and Cartridge
Changzhou Waston Medical Appliance510(k) NO: K211197(Traditional)
ATTN: Ning Mao PHONE NO : 86 519 86302873
9 Xihu Road, Wujin Hi-Tech IndustrSE DECISION MADE: 19-JAN-23
Changzhou CN 213164 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyStat 300
Medica Corporation 510(k) NO: K211559(Traditional)
ATTN: Photios Makris PHONE NO : 781 5417443
5 Oak Park Drive SE DECISION MADE: 27-JAN-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Selux AST System; Model AST Gen 1.0
Selux Diagnostics, Inc. 510(k) NO: K211759(Traditional)
ATTN: Eric Stern PHONE NO :
56 Roland Street Suite 206 SE DECISION MADE: 18-JAN-23
Charlestown MA 02129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUEDIAMOND IMPLANT, Abutment Screw
MegaGen Implant Co., Ltd. 510(k) NO: K211812(Traditional)
ATTN: Hyo Eun Lee PHONE NO : 82 53 2472262
45, Secheon-ro, 7-gil SE DECISION MADE: 06-JAN-23
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BrainView QEEG Software
Medeia, Inc. 510(k) NO: K212684(Traditional)
ATTN: Slav Danev PHONE NO : 800 4334609
7 W Figueroa St, Suite 300 SE DECISION MADE: 28-JAN-23
Santa Barbara CA 93101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tibia and Fibula System
Auxein Medical Private Limited 510(k) NO: K213059(Traditional)
ATTN: Rahul Luthra PHONE NO : 91 971 7586969
Plot No.168,169,170 Phase-IV, SectSE DECISION MADE: 27-JAN-23
Sonipat IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: No Stress Impress
No Stress Impress LLC 510(k) NO: K213175(Traditional)
ATTN: Misael Otero PHONE NO : 917 3047010
2012 Scrimshaw PL SE DECISION MADE: 19-JAN-23
Wilmington NC 28405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ax-Surgi Surgical Hemostat
Advamedica Inc. 510(k) NO: K213198(Traditional)
ATTN: Leo Mavely PHONE NO : 973 7187575
Harvard Square, 1 Mifflin Place, SSE DECISION MADE: 05-JAN-23
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OnyxCeph
Image Instruments GmbH 510(k) NO: K213263(Traditional)
ATTN: Greg Holland PHONE NO : 949 2620411
Niederwaldstr. 3 SE DECISION MADE: 04-JAN-23
09123 Chemnitz DE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T3 Platform software
Etiometry. Inc. 510(k) NO: K213423(Traditional)
ATTN: Tim Hanson PHONE NO : 857 3669333
280 Summer St. 4th Floor SE DECISION MADE: 06-JAN-23
Boston MA 02210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectricept Skin and Wound Cleanser
Spectrum Antimicrobials, Inc. (Sub510(k) NO: K213514(Traditional)
ATTN: Hoji Alimi PHONE NO : 707 2065326
1770 Corporate Circle SE DECISION MADE: 13-JAN-23
Petaluma CA 94954 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MultiCut Solo
Asclepion Laser Technologies GmbH 510(k) NO: K213597(Traditional)
ATTN: Tom Gruender PHONE NO : 49 3641 7700201
Bruesseler Strasse 10 SE DECISION MADE: 18-JAN-23
Jena DE 07747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)
HillTek LLC 510(k) NO: K213655(Traditional)
ATTN: Mohammadali Nezakati PHONE NO : 1 206 4069390
421 S Brookhurst Street; Ste#142 SE DECISION MADE: 17-JAN-23
Anaheim CA 92804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LM-9300 Plus Lithotripter
Lite-Med Inc. 510(k) NO: K213772(Traditional)
ATTN: Walt Hsu PHONE NO : 886 2 87681316
9th Floor, 49 Dongxing Road, XinyiSE DECISION MADE: 19-JAN-23
Taipei TW 11070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Thermometer, Model: DT007, DT008
Guangzhou Berrcom Medical Device C510(k) NO: K214077(Traditional)
ATTN: Zhigang Du PHONE NO : 86 020 34938449
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 20-JAN-23
Guangzhou CN 511470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silk’n Toothwave
Home Skinovations Ltd. 510(k) NO: K214078(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 13-JAN-23
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biosci™ Inactivated Transport Medium, Biosci™ ITM
Shenzhen Dakewe Bio-engineering Co510(k) NO: K220059(Traditional)
ATTN: Wei Jiang PHONE NO : 86 755 86235300
No.14 Jinhui Road, Kengzi Street, SE DECISION MADE: 19-JAN-23
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RMF-2000
DRTECH Corporation 510(k) NO: K220073(Traditional)
ATTN: Suyeon Back PHONE NO : 82 31 7797727
Suite No.1, 2 Floor / Suite No. 2,SE DECISION MADE: 26-JAN-23
Jungwon-gu, Seongnam-si, KR 13216510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerPAK Syringe
Vault Paragon Group, Inc. 510(k) NO: K220114(Traditional)
ATTN: Sari Luciano PHONE NO : 858 9453651
189 3rd Street A101 SE DECISION MADE: 25-JAN-23
Oakland CA 94607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Non-invasive EEG Sensor
Shenzhen Med-link Electronics Tech510(k) NO: K220448(Traditional)
ATTN: Yi Liu PHONE NO : 0086 755 61568825 884
4th and 5th Floor, Building Two, HSE DECISION MADE: 19-JAN-23
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SignaSure Dual Mobility System
Signature Orthopaedics Pty Ltd. 510(k) NO: K220495(Traditional)
ATTN: Declan Brazil PHONE NO : 61 2 94285181
7 Sirius Road SE DECISION MADE: 13-JAN-23
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elucis
Realize Medical Inc. 510(k) NO: K220649(Traditional)
ATTN: Dan La Russa PHONE NO : 613 8833461
405-2197 Riverside Drive SE DECISION MADE: 17-JAN-23
Ottawa CA K1H 7X3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
bioMerieux, Inc 510(k) NO: K220803(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 27-JAN-23
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AETOS Shoulder System
Smith & Nephew, Inc. 510(k) NO: K220847(Traditional)
ATTN: Cassidy Lemkau PHONE NO : 512 4661130
7135 Goodlett Farms Parkway SE DECISION MADE: 03-JAN-23
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Endoscope Valve Sets
SML Med-Tech Solutions Limited 510(k) NO: K220884(Traditional)
ATTN: Mark Ko PHONE NO : 86 138 23022407
Rm 406, Wah Yiu Indl Ctr, 30-32 AuSE DECISION MADE: 17-JAN-23
Fo Tan, N.T. CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F
Potrero Medical, Inc. 510(k) NO: K221020(Traditional)
ATTN: Priscila Tapia PHONE NO : 510 8262033
26142 Eden Landing Road SE DECISION MADE: 13-JAN-23
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anatomic Bone Plate
Double Medical Technology Inc. 510(k) NO: K221088(Traditional)
ATTN: Yan Zuo PHONE NO : 86 592 6885068
No.18, Shanbianhong East Road, HaiSE DECISION MADE: 18-JAN-23
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Metal Cannulated Screw
Double Medical Technology Inc. 510(k) NO: K221090(Traditional)
ATTN: Yan Zuo PHONE NO : 86 592 6885068
No.18, Shanbianhong East Road, HaiSE DECISION MADE: 10-JAN-23
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SilentCloud
Aureliym GmBH 510(k) NO: K221125(Traditional)
ATTN: Markus Haller PHONE NO : 49 151 11768646
Hauptstrasse 96 SE DECISION MADE: 04-JAN-23
Bad Neuenahr-Ahrweiler DE D-53474510(k) STATEMENT
DEVICE: U-Motion II Acetabular System-Extension line
United Orthopedic Corporation 510(k) NO: K221149(Traditional)
ATTN: Lois Ho PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park SE DECISION MADE: 05-JAN-23
Hsinchu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced Bone Plate
Double Medical Technology Inc. 510(k) NO: K221150(Traditional)
ATTN: Yan Zuo PHONE NO : 86 592 6885068
No.18, Shanbianhong East Road, HaiSE DECISION MADE: 25-JAN-23
Xiamen CN 361026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tunnel Crossing Catheter
Tractus Vascular, LLC 510(k) NO: K221163(Traditional)
ATTN: Janet Burpee PHONE NO : 732 9968513
20 Meridian Road Unit 9B SE DECISION MADE: 19-JAN-23
Eatontown NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts Inc. 510(k) NO: K221181(Traditional)
ATTN: Melissa Coloroso PHONE NO : 303 6418592
203 Fort Wade Road, Suite 150 SE DECISION MADE: 05-JAN-23
Ponte Vedra FL 32081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XBody Go USA, XBody Pro USA
XBody Hungary Kft. 510(k) NO: K221200(Traditional)
ATTN: R. William Soller PHONE NO : 713 3807146
György Aladár u. 35-39 SE DECISION MADE: 31-JAN-23
Budapest HU 1125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scivita 4KINSIGHT ICG Imaging System
Scivita Medical Technology Co., Lt510(k) NO: K221252(Traditional)
ATTN: Ruqin Wu PHONE NO : 86 512 81877788
No.8, Zhong Tian Xiang, Suzhou IndSE DECISION MADE: 13-JAN-23
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CSF-3
CardiacSense 510(k) NO: K221260(Traditional)
ATTN: Benita Lanzer PHONE NO : 330 2857222
Leshem 6-8 North Industrial Park SE DECISION MADE: 06-JAN-23
Caesarea IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cervical Spine Truss System (CSTS) Interbody Fusion Device
4WEB Medical, Inc. 510(k) NO: K221266(Traditional)
ATTN: Lewis Harrison PHONE NO : 800 2857090
2801 Network Blvd., Suite 620 SE DECISION MADE: 05-JAN-23
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transducer Probe Cover
Hony Medical Co., Ltd. 510(k) NO: K221278(Traditional)
ATTN: Zhu Huina PHONE NO : 86 159 16327827
No.12,9Road,Changlong Ind.Zone, SE DECISION MADE: 11-JAN-23
Taishan CN 529222 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
Gyrus ACMI, Inc. 510(k) NO: K221306(Traditional)
ATTN: Jon Gilber PHONE NO : 1 906 3613237
800 West Park Drive SE DECISION MADE: 27-JAN-23
Westborough MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-Mono
Shinhung MST Co., Ltd. 510(k) NO: K221317(Traditional)
ATTN: Sun Ho Lee PHONE NO : 82 33 7301901
110-2, Donghwagongdan-Ro Munmak-euSE DECISION MADE: 13-JAN-23
Wonju Si KR 26365 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Airvo 3
Fisher & Paykel Healthcare 510(k) NO: K221338(Traditional)
ATTN: Reena Daken PHONE NO : 64 9 5740100
15 Maurice Paykel Place SE DECISION MADE: 27-JAN-23
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steriking LT-Blueline Pouches with Tyvek
Wipak OY 510(k) NO: K221379(Traditional)
ATTN: Hanna Marttila PHONE NO : 358 040 1240290
Wipaktie 2 SE DECISION MADE: 04-JAN-23
Nastola FI FI-15560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TD-5010 Lancing Device and TD-5084 Sterile Lancets
GOSTAR Co., Ltd. 510(k) NO: K221419(Traditional)
ATTN: Pei-Fen Yang PHONE NO : 886 2 22981927
2F, No.65, Wuquan 7nd Rd. SE DECISION MADE: 20-JAN-23
New Taipei City TW 248020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sterile Surgical Powder Free Latex Glove
New Era Medicare Sdn. Bhd. 510(k) NO: K221424(Traditional)
ATTN: Fatin Nor Irdina binti AhmadPHONE NO : 60 14 9072860
Plot 2621-2624 SE DECISION MADE: 26-JAN-23
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: Quality Mix Blender, Oxymixer
DEHAS Medical Systems GmbH 510(k) NO: K221494(Traditional)
ATTN: Jens Mittendorf PHONE NO : 49 451 80904200
Wesloer Strabe 112 SE DECISION MADE: 23-JAN-23
Luebeck DE 23568 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HF-cables (resusable)
Olympus Winter & Ibe Gmbh 510(k) NO: K221522(Traditional)
ATTN: Lilly Omland PHONE NO : 49 40 669663932
Kuehnstr. 61 SE DECISION MADE: 19-JAN-23
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHMB Wound Dressing
Winner Medical Co., Ltd. 510(k) NO: K221532(Traditional)
ATTN: Yi Fu PHONE NO : 86 755 28138888 8717
660 Bulong Road, Longhua District SE DECISION MADE: 30-JAN-23
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Galileo Vertebral Body Replacement Device
Bright Spine 510(k) NO: K221542(Special)
ATTN: Robert Simonson PHONE NO : 561 2899378
834 NE 33rd Street SE DECISION MADE: 13-JAN-23
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Endoscope Model EI-740D/S
FUJIFILM Corporaton 510(k) NO: K221551(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 27-JAN-23
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON Oval V6.2 MRI System
Fujifilm Healthcare Corporation 510(k) NO: K221619(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
2-1, Shintoyofuta SE DECISION MADE: 26-JAN-23
Kashiwa-Shi JP 277-0804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PerfusionGo Plus
Yukun (Beijing) Technology Co., Lt510(k) NO: K221627(Traditional)
ATTN: Qi Wang PHONE NO : 86 10 89735152
Room 313, 315, Building 3, No.11 CSE DECISION MADE: 19-JAN-23
Beijing CN 102200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ideal Med Pro 3-Ply Disposable Face Mask
JSN Holdings, LLC 510(k) NO: K221682(Traditional)
ATTN: Brian Tedesco PHONE NO : 1 201 2475838
1735 Dilworth Road East SE DECISION MADE: 13-JAN-23
Matthews NC 28203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
Olympus Medical Systems Corporatio510(k) NO: K221683(Traditional)
ATTN: Shinichiro Kawachi PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 20-JAN-23
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Anti-HCV II (08837031190)
Roche Diagnostics 510(k) NO: K221693(Traditional)
ATTN: Bin Sun PHONE NO : 317 2923781
9115 Hague Road SE DECISION MADE: 04-JAN-23
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advanced MyHip Planner
Medacta International S.A. 510(k) NO: K221725(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 20-JAN-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uni-FuZe-C Bone Strip
Zavation Medical Products, LLC 510(k) NO: K221726(Traditional)
ATTN: Elke Carter PHONE NO : 601 9191119 332
3670 Flowood Drive SE DECISION MADE: 18-JAN-23
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam Dressing (OTC); Silicone Ag Foam Dressing with Border (OTC)
Winner Medical Co., Ltd. 510(k) NO: K221754(Special)
ATTN: Zhiqin Liang PHONE NO : 86 755 28138888__
Winner Industrial Park, No. 660 BuSE DECISION MADE: 17-JAN-23
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial non-woven sponge dressing
Winner Medical Co., Ltd. 510(k) NO: K221755(Special)
ATTN: Zhiqin Liang PHONE NO : 86 755 28138888__
Winner Industrial Park, No. 660 BuSE DECISION MADE: 13-JAN-23
Shenzhen CN 518109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Garmin ECG App
Garmin International, Inc. 510(k) NO: K221774(Traditional)
ATTN: Travis Johnson PHONE NO : 913 4402624
1200 East 151st Street SE DECISION MADE: 12-JAN-23
Olathe KS 66062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QOCA image Smart CXR Image Processing System
Quanta Computer Inc. 510(k) NO: K221868(Traditional)
ATTN: Joe Wang PHONE NO : 886 3 3272345___
No. 188, Wenhua 2nd Rd., Guishan DSE DECISION MADE: 27-JAN-23
Taoyuan City TW 33383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoGen PSR System
Energist Limited 510(k) NO: K221873(Special)
ATTN: Graham Booth PHONE NO : 440 1792 798768
2 Park Pavilions, Clos Llyn Cwm EnSE DECISION MADE: 12-JAN-23
Swansea GB SA6 8QY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
Thermo Fisher Scientific 510(k) NO: K221899(Traditional)
ATTN: Cynthia Knapp PHONE NO : 800 8718909
1 Thermo Fisher Way SE DECISION MADE: 20-JAN-23
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: MONTAGE Settable, Resorbable Bone Putty
Orthocon, Inc. 510(k) NO: K221933(Traditional)
ATTN: Aniq Darr PHONE NO : 914 3572600
1 Bridge Street - Suite 121 SE DECISION MADE: 13-JAN-23
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ortho Device, ADAPTIX 3D Orthopedic Imaging System
Pausch Medical GmbH 510(k) NO: K221949(Traditional)
ATTN: Christian Stoian PHONE NO : 49 09131 99920
Graf-Zeppelin-Strabe 1 SE DECISION MADE: 26-JAN-23
Erlangen DE D-91056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transit-Pellets
Medifactia AB 510(k) NO: K222000(Traditional)
ATTN: Diana Nystrom PHONE NO : 46 8 46007206
C/O IOffice Buisness Center KungsgSE DECISION MADE: 18-JAN-23
Stockholm SE 11122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HandX Instrument - Monopolar Spatula
Human Xtensions Ltd. 510(k) NO: K222011(Special)
ATTN: Maija Wallenstein PHONE NO : 972 77 3630316
4 Meir Ariel St. SE DECISION MADE: 12-JAN-23
Netanya IL 4250574 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wearable Breast Pump (Model S1DW)
Shenzhen TPH Technology Co.,Ltd. 510(k) NO: K222045(Traditional)
ATTN: Peter Chen PHONE NO : 86 400 7889005
5th floor, Building NO.29 EastsideSE DECISION MADE: 04-JAN-23
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
Howmedica Osteonics Corp., dba Str510(k) NO: K222056(Traditional)
ATTN: Margaret Klippel PHONE NO : 201 835559
325 Corporate Drive SE DECISION MADE: 26-JAN-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISAAC Neurovascular Navigation Catheter
MicroVention, Inc. 510(k) NO: K222115(Traditional)
ATTN: Sona Manickam PHONE NO : 313 6570776
33 Enterprise SE DECISION MADE: 10-JAN-23
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PreXion3D Expedition
PreXion Corporation 510(k) NO: K222150(Traditional)
ATTN: Hiroaki Takahashi PHONE NO : 81 3 52977551
1-14-1, Kandasuda-cho SE DECISION MADE: 12-JAN-23
Chiyoda-ku JP 101-0041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Capiflo 5001
K&L Distributing, Inc. 510(k) NO: K222158(Special)
ATTN: Mark Julian PHONE NO : 813 3219551
7425 Sailfish Drive SE DECISION MADE: 20-JAN-23
Hudson FL 34667 510(k) STATEMENT
DEVICE: Power Acute Triple Lumen Hemodialysis Catheter
Health Line International Corporat510(k) NO: K222170(Traditional)
ATTN: Aaron G Faulkner PHONE NO : 801 7737798 109
260 North Ace Yeager Court, Unit DSE DECISION MADE: 13-JAN-23
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
Magstim Company Ltd 510(k) NO: K222171(Traditional)
ATTN: Tom Campbell PHONE NO : 44 0 1994240798
Spring Gardens SE DECISION MADE: 13-JAN-23
Whitland GB SA340HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
Iconic medicare sdn bhd 510(k) NO: K222181(Traditional)
ATTN: Tan Cho Chia PHONE NO : 60 4 504159
PMT 798, Lingkaran Cassia Selatan,SE DECISION MADE: 11-JAN-23
Bandar Cassia, Pulau Pinang MY 14510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radial Artery Compression Tourniquets
Beijing Demax Medical Technology C510(k) NO: K222182(Traditional)
ATTN: Anny Zhang PHONE NO : 86 010 59771799
101, Floor 1-3, 13-7A JingshengnanSE DECISION MADE: 04-JAN-23
Beijing CN 101102 510(k) STATEMENT
DEVICE: DEKA HELIX
El.En Electronic Engineering Spa 510(k) NO: K222221(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 04-JAN-23
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Self-adhesive Electrode
Shenzhen Roundwhale Technology Co.510(k) NO: K222252(Traditional)
ATTN: Zeng Chunming PHONE NO : 86 755 23212776
202,2/F, Building 27, Dafa IndustrSE DECISION MADE: 19-JAN-23
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTICUL/EZE Ceramic Heads
Depuy Ireland UC 510(k) NO: K222296(Traditional)
ATTN: Paige Myers PHONE NO : 44 7795 389956
Loughbeg, Ringaskiddy SE DECISION MADE: 06-JAN-23
Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gown
Guangzhou Fuzelong Hygiene Materia510(k) NO: K222403(Traditional)
ATTN: Yuehua Zhou PHONE NO : 86 020 87993188
12, Guancun Road, Jiangpu Street, SE DECISION MADE: 26-JAN-23
Guangzhou CN 510900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clarius AI
Clarius Mobile Health Corp. 510(k) NO: K222406(Traditional)
ATTN: Agatha Szeliga PHONE NO : 416 7071707
130-2985 Virtual Way SE DECISION MADE: 23-JAN-23
Vancouver CA V5M 4X7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aristotle Colossus Guidewire
Scientia Vascular Inc 510(k) NO: K222437(Traditional)
ATTN: Max Alfonso PHONE NO : 888 3859016
3487 West 2100 South Suite 100 SE DECISION MADE: 26-JAN-23
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIBOLIT 3D+
Aibolit Technologies, LLC 510(k) NO: K222458(Traditional)
ATTN: Gregory Piskun PHONE NO : 848 4596929
9616 Moritz Way SE DECISION MADE: 12-JAN-23
Delray Beach FL 33446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)
ITP Innovative Tomography Products510(k) NO: K222462(Traditional)
ATTN: Dr. Heinz-Werner Henke PHONE NO : 49 2345 4621940___
Universitaetsstr. 136 SE DECISION MADE: 20-JAN-23
Bochum DE 44799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Hubei Woozon Healthcare Co.,Ltd. 510(k) NO: K222483(Traditional)
ATTN: Li Chunlin PHONE NO : 86____ 728 3280667
Nongfeng Road, Nonwoven Fabric IndSE DECISION MADE: 04-JAN-23
Xiantao City CN 433018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blueprint Mixed Reality system
Tornier SAS 510(k) NO: K222510(Traditional)
ATTN: Moyees Kamara PHONE NO : 1 651 5292969
161 rue LAVOISIER SE DECISION MADE: 20-JAN-23
Montbonnot Saint Martin FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Polymer Glove - Polyethylene (Black)
UR Industry SDN BHD 510(k) NO: K222531(Traditional)
ATTN: Chua Song Han PHONE NO : 607 595 5512______
180, Jalan Murni 9, Taman PerindusSE DECISION MADE: 22-JAN-23
Senai MY 81400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EL CAPITAN Anterior Lumbar Interbody Fusion
Astura Medical 510(k) NO: K222554(Traditional)
ATTN: Parker Kelch PHONE NO : 469 5015530 503
4949 W Royal Ln. SE DECISION MADE: 19-JAN-23
Irving TX 75063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Playground For All Love Sesh
Playground For All 510(k) NO: K222567(Traditional)
ATTN: Sandy Vukovic PHONE NO : 650 2469653
4645 California Street SE DECISION MADE: 30-JAN-23
San Francisco CA 94118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TECHFIT Diagnostic Models
TECHFIT Digital Surgery Inc. 510(k) NO: K222577(Third Party - Traditional)
ATTN: David Garcia-Patino PHONE NO : 57 604 3223375 165
1511 Aviation Center Pkwy, Suite 2SE DECISION MADE: 06-JAN-23
Daytona Beach FL 32114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Flexible Suturing System with Anchors (FSSA)
Integrity Orthopaedics, Inc. 510(k) NO: K222589(Traditional)
ATTN: Jeff Sims PHONE NO : 952 5942795
5565 Pioneer Creek Drive SE DECISION MADE: 26-JAN-23
Maple Plain MN 55359 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruPlan Computed Tomography (CT) Imaging Software
Circle Cardiovascular Imaging, Inc510(k) NO: K222593(Traditional)
ATTN: Sydney Toutant PHONE NO : 1403 200 7706
Suite 110 - 800 5th Ave SW SE DECISION MADE: 18-JAN-23
Calgary CA T2P 3T6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sim&Size
Sim&Cure 510(k) NO: K222664(Traditional)
ATTN: Colette Maurin PHONE NO : 33 9534 38809
95 Rue Pierre Flourens - Bâtiment SE DECISION MADE: 27-JAN-23
Montpellier FR 34090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE® Ankle Fusion Plating System
Medline Industries, Inc. 510(k) NO: K222665(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 25-JAN-23
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS186B Scooter
Suzhou Master Machinery Manufactur510(k) NO: K222711(Traditional)
ATTN: Siqi Shangguan PHONE NO : 86 512 57452882
No.48, Binjiang Road, Zhangpu TownSE DECISION MADE: 09-JAN-23
Kunshan City CN 215321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revogene
Meridian Bioscience, Inc 510(k) NO: K222779(Special)
ATTN: Jack Rogers PHONE NO : 513 9912319
3471 River Hills Drive SE DECISION MADE: 26-JAN-23
Cincinnati OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199;YD-1193S,YD-1195S,YD-1196S,YD-1198S,YD-1199S)
Zhejiang Carebao Co., Ltd. 510(k) NO: K222782(Traditional)
ATTN: Xie Yan PHONE NO : 86 574 87902421
3, No.1, Chuangye 4th Road, NingboSE DECISION MADE: 13-JAN-23
Ningbo CN 325400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P
Chongqing Sunkingdom Medical Instr510(k) NO: K222787(Traditional)
ATTN: Shulin Guo PHONE NO : 8623 68643990
1010, Block A of China Resource CeSE DECISION MADE: 09-JAN-23
Chongqing CN 400050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VADER® Pedicle System, G21 Cement
icotec ag 510(k) NO: K222789(Traditional)
ATTN: Marina Hess PHONE NO :
Industriestrasse 12 SE DECISION MADE: 09-JAN-23
9450 Alstatten (SG) CH 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Haymaker® Screw System
OrthoCircle Spine d.b.a. OC Medica510(k) NO: K222799(Traditional)
ATTN: Jack Matthews PHONE NO : 888___ 4635803___
15 East Montgomery Crossroads SuitSE DECISION MADE: 10-JAN-23
Savannah GA 31406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Lancet
Sarstedt AG & CO KG 510(k) NO: K222801(Traditional)
ATTN: Jochen Hoffman PHONE NO : 49 2293 3054100
Sarstedtstrasse 1 SE DECISION MADE: 25-JAN-23
Nuembrecht DE 51588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Disposable Face Masks
Anqing Mayfield Medical Limited 510(k) NO: K222809(Traditional)
ATTN: Minghan Zhou PHONE NO : 86 1860 1137753
Jingwu Road, Tongcheng Economic anSE DECISION MADE: 03-JAN-23
Anqing CN 231400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpedition ™ Powered Stair Chair (625700000000)
Stryker Medical 510(k) NO: K222818(Traditional)
ATTN: Rachel Stallworth PHONE NO : 269 2136493
3800 E. Centre Ave. SE DECISION MADE: 24-JAN-23
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rainbow 360
Kerr Corporation 510(k) NO: K222830(Traditional)
ATTN: Viviana Lai PHONE NO : 714 5167760
1889 W Mission Blvd SE DECISION MADE: 12-JAN-23
Pomona CA 91766 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sentimag System
Endomagnetics Ltd 510(k) NO: K222832(Traditional)
ATTN: Mehryar Behizad PHONE NO : 44 1223 652540
330 Cambridge Science Park, MiltonSE DECISION MADE: 21-JAN-23
Cambridge GB CB4 0WN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Push Button Blood Collection Set
Jiangsu Caina Medical Co.,Ltd 510(k) NO: K222834(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 510 86205183
No.23, Huanxi Rd, Zhutang Town SE DECISION MADE: 05-JAN-23
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prophecy Preoperative Navigation Alignment System
Wright Medical Technology, Inc. 510(k) NO: K222835(Traditional)
ATTN: Paxia Her PHONE NO : 612 7236163
10801 Nesbitt Ave S. SE DECISION MADE: 27-JAN-23
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: pRESET Thrombectomy Device
phenox Limited 510(k) NO: K222848(Traditional)
ATTN: Catriona Lynch PHONE NO : 353 891 740100
Kamrick Court, Ballybrit Business SE DECISION MADE: 20-JAN-23
Galway IE H91XY38 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)
Wuxi Jiajian Medical Instrument Co510(k) NO: K222879(Traditional)
ATTN: Wu Zhifang PHONE NO : 86____ 558 7662968
No.35 Baiqiao Rd., Ehu Town, XishaSE DECISION MADE: 24-JAN-23
WuXi CN 214116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowArt® Needle-Free Split Septum Valve
Asset Medikal Tasarim San Tic As. 510(k) NO: K222889(Traditional)
ATTN: Ebru Sirali PHONE NO : 902 124 942727
Ikitelli OSB Mahallesi, 17. Cadde,SE DECISION MADE: 20-JAN-23
Istanbul TR 34490 510(k) STATEMENT
DEVICE: EVA15 insufflator
Palliare Ltd. 510(k) NO: K222901(Traditional)
ATTN: John O'Dea PHONE NO : 353 91 516362
Galway Business Park, Dangan SE DECISION MADE: 27-JAN-23
Galway IE H91 P2DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
RMKH Glove (Cambodia) Co., Ltd. 510(k) NO: K222907(Traditional)
ATTN: Yang Clement KC PHONE NO : 86 1521 2555271
Manhattan Special Economic Zone, BSE DECISION MADE: 04-JAN-23
Bavet City KH 120407 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: s-Clean Link Abutment
Dentis Co., Ltd. 510(k) NO: K222913(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 13-JAN-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halcyon, Ethos Radiotherapy System
Varian Medical Systems, Inc 510(k) NO: K222941(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 17-JAN-23
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MU System
Dentis Co., Ltd 510(k) NO: K222976(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 12-JAN-23
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artix BG
Inari Medical 510(k) NO: K223000(Traditional)
ATTN: Ellen Nguyen PHONE NO : 949 4184127
6001 Oak Canyon Suite 100 SE DECISION MADE: 11-JAN-23
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable X-ray System
iRay Technology Taicang Ltd. 510(k) NO: K223010(Traditional)
ATTN: Wei Pan PHONE NO : 86 021 50720560 8222
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 17-JAN-23
Taicang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
BD 510(k) NO: K223016(Traditional)
ATTN: Dung Nguyen PHONE NO : 424 4528128
7 Loveton Cir SE DECISION MADE: 27-JAN-23
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vibrant System
Vibrant Ltd. 510(k) NO: K223031(Traditional)
ATTN: Martha Bezalel PHONE NO : 972 4 6663322
Hakochav P.O. Box 516 SE DECISION MADE: 13-JAN-23
Yokneam IL 2069206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEM Premier ChemSTAT
Instrumentation Laboratory Co 510(k) NO: K223090(Special)
ATTN: Gabriella Erdosy PHONE NO : 781 8614571
180 Hartwell Road SE DECISION MADE: 27-JAN-23
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOLLI 2
MOLLI Surgical, Inc 510(k) NO: K223107(Traditional)
ATTN: Joseph De Croos PHONE NO : 519 8976654
50 Wellington Street East Suite 40SE DECISION MADE: 18-JAN-23
Toronto CA M5E 1C8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear)
Medos International, SARL 510(k) NO: K223108(Traditional)
ATTN: Karin McDonough PHONE NO : 1 508 9773851___
Chemin-Blanc 38 SE DECISION MADE: 19-JAN-23
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-SPERM WASH
Vitromed GmbH 510(k) NO: K223117(Traditional)
ATTN: Greg Holland PHONE NO : 949 2620411
Raiffeisenstr. 15a SE DECISION MADE: 31-JAN-23
Langenfeld DE 40764 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIC Variable Angle Small Fragment Locking Plate System
Orthopaedic Implant Company 510(k) NO: K223118(Traditional)
ATTN: Douglas Fulton PHONE NO : 775 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 21-JAN-23
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LigaSure™ XP Maryland Jaw Sealer/Divider
Covidien, llc 510(k) NO: K223158(Traditional)
ATTN: Miranda Miles PHONE NO : 303 5306205
5920 Longbow Dr. SE DECISION MADE: 23-JAN-23
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medaica M1 Telehealth Stethoscope
Medaica Inc. 510(k) NO: K223166(Third Party - Traditional)
ATTN: Stephen Randall PHONE NO : 1 917 4809995
170 S. Green Valley Pkwy Ste 300 SE DECISION MADE: 19-JAN-23
Henderson NV 89012 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Highlander™ 014 PTA Balloon Dilatation Catheter
C.R. Bard, Inc. 510(k) NO: K223177(Traditional)
ATTN: Andrew Quach PHONE NO : 602 8305680
1625 West 3rd St SE DECISION MADE: 20-JAN-23
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Reline System
NuVasive, Incorporated 510(k) NO: K223181(Traditional)
ATTN: Bland Tanesha PHONE NO : 323 6835714___
7475 Lusk Blvd SE DECISION MADE: 11-JAN-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Light-Guide Cables
Olympus Winter & Ibe GmbH 510(k) NO: K223183(Traditional)
ATTN: Ali Sayad PHONE NO : 49 40 669662997
Kuehnstr. 61 SE DECISION MADE: 13-JAN-23
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Curiteva Navigation System
Curiteva, Inc. 510(k) NO: K223200(Traditional)
ATTN: Eric Linder PHONE NO : 256 2131057
25127 Will McComb Drive SE DECISION MADE: 06-JAN-23
Tanner AL 35671 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile Powder Free Nitrile Examination Gloves
Dynacare Sdn Bhd 510(k) NO: K223221(Traditional)
ATTN: Chow Choong Keong PHONE NO : 601 245 97496
Lot 15528 (PT 5001), Kawasan PerusSE DECISION MADE: 13-JAN-23
Sitiawan MY 32000 510(k) STATEMENT
DEVICE: Plasma IQ
Neauvia North America, Inc 510(k) NO: K223222(Special)
ATTN: Joy Willard PHONE NO : 984 7775296
8480 Honeycutt Road SE DECISION MADE: 17-JAN-23
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Glove
Yangzhou Saraguard Medical Supplie510(k) NO: K223250(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
Standard Workshop No. 1, Phase I, SE DECISION MADE: 19-JAN-23
Yangzhou CN 225009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C2 Xplore
Inomed Medizintechnik GmbH 510(k) NO: K223254(Traditional)
ATTN: Maximilian Wimmer PHONE NO : 49 7641 9414545
Im Hausgruen 29 SE DECISION MADE: 27-JAN-23
Emmendingen DE 79312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D
FUJIFILM Corporaton 510(k) NO: K223295(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 11-JAN-23
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPRINT Peripheral Nerve Stimulation (PNS) System
SPR Therapeutics, Inc. 510(k) NO: K223306(Traditional)
ATTN: Kathryn Stager PHONE NO : 216 3789067
22901 Millcreek Blvd. Suite 500 SE DECISION MADE: 25-JAN-23
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Safety Lancets
HUAIAN HENING MEDICAL INSTRUMENTS 510(k) NO: K223313(Traditional)
ATTN: Zhengcan Da PHONE NO : 86 139 52318668
No. 6 West Hongdou Road Economic DSE DECISION MADE: 23-JAN-23
Huaian CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Blood Lancets
HUAIAN HENING MEDICAL INSTRUMENTS 510(k) NO: K223314(Traditional)
ATTN: Zhengcan Da PHONE NO : 86 139 52318668
No. 6 West Hongdou Road Economic DSE DECISION MADE: 25-JAN-23
Huaian CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitrea Software Package, VSTP-002A
Canon Medical Systems Corporation 510(k) NO: K223336(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 09-JAN-23
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: My3D® Personalized Pelvic Reconstruction
Onkos Surgical, Inc. 510(k) NO: K223348(Traditional)
ATTN: Matthew Vernak PHONE NO : 551 5791081
77 East Halsey Road SE DECISION MADE: 30-JAN-23
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Naviswiss Knee
Naviswiss AG 510(k) NO: K223351(Traditional)
ATTN: Domenico Romeo PHONE NO : 41 617 618537
Stahlrain 2 SE DECISION MADE: 31-JAN-23
Brugg CH 5200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOVISTA B.smart (VB70)
Siemens Medical Solutions USA Inc.510(k) NO: K223363(Special)
ATTN: Denise Adams PHONE NO : 610 9442184
40 Liberty Boulevard SE DECISION MADE: 12-JAN-23
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0T 16ch AIR AA
GE Healthcare Coils (USA Instrumen510(k) NO: K223378(Abbreviated)
ATTN: Lauren Ross PHONE NO : 262 3995721
1515 Danner Drive SE DECISION MADE: 03-JAN-23
Aurora OH 44202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Quanta System, S.p.A. 510(k) NO: K223404(Special)
ATTN: Dario Bandiera PHONE NO : 39 0331 376797
Via Acquedotto 109 SE DECISION MADE: 20-JAN-23
Samarate IT 21017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access Testosterone
Beckman Coulter, Inc. 510(k) NO: K223405(Traditional)
ATTN: Kuljeet Kaur PHONE NO : 952 4651914
1000 Lake Hazeltine Drive SE DECISION MADE: 13-JAN-23
Chaska MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)
Xiamen Probtain Medical Techology 510(k) NO: K223411(Traditional)
ATTN: Jianli Kang PHONE NO : 86 592 7557106
4th Floor, No.1 Building, No.6 Ji'SE DECISION MADE: 04-JAN-23
Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LumiVy™ Lumbar IBF System
Vy Spine, LLC 510(k) NO: K223412(Special)
ATTN: Jordan Hendrickson PHONE NO : 866 4897746
2236 Capital Circle NE, Suite 103-SE DECISION MADE: 06-JAN-23
Tallahassee FL 32308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Mah Sing Healthcare Sdn Bhd 510(k) NO: K223415(Traditional)
ATTN: Ivan Tan Chee Wei PHONE NO : 603 3396 2288
Wisma Mah Sing, Penthouse Suite 1,SE DECISION MADE: 26-JAN-23
Kuala Lumpur MY 57100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Contour Knee
Quality Electrodynamics, LLC 510(k) NO: K223429(Traditional)
ATTN: Eric Yeh PHONE NO : 440 4842940
6655 Beta Drive Suite 100 SE DECISION MADE: 13-JAN-23
Mayfield Village OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Signifier Medical Technologies Ltd510(k) NO: K223446(Special)
ATTN: Yasser Zayni PHONE NO : 442 0709__ 60586
5-17 Hammersmith Grove SE DECISION MADE: 18-JAN-23
London GB W6 0LG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadianceTx Radionuclide Brachytherapy Source
Radiance Therapeutics Inc. 510(k) NO: K223465(Traditional)
ATTN: Laurence Marsteller PHONE NO : 510 2033483
7440 N Oracle Rd., Building #1 SE DECISION MADE: 11-JAN-23
Tucson AZ 85718 510(k) STATEMENT
DEVICE: PathLoc-TA Expandable Lumbar Cage System
L&K Biomed Co., Ltd. 510(k) NO: K223474(Traditional)
ATTN: Katherine Kim PHONE NO : 82 10 54770325
101, 201, 202 16-25, DongbaekjungaSE DECISION MADE: 13-JAN-23
Yongin-si KR 17015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medipoint Blood Lancets
Medipoint Holdings, LLC 510(k) NO: K223480(Traditional)
ATTN: Rochelle Stern PHONE NO : 516 2948822
72 East 2nd St. SE DECISION MADE: 13-JAN-23
Mineola NY 11501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon Spinal System
Medtronic 510(k) NO: K223494(Traditional)
ATTN: Madhuvanthi Soundirarajan PHONE NO : 352 4339130
1800 Pyramid Place SE DECISION MADE: 23-JAN-23
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MR Diffusion Perfusion Mismatch V1.0
Olea Medical 510(k) NO: K223502(Traditional)
ATTN: Nathalie Palumbo PHONE NO : 33 442 712420
93 Avenue des Sorbiers, ZI ATHELIASE DECISION MADE: 13-JAN-23
La Ciotat FR 13600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access 25(OH) Vitamin D Total
Beckman Coulter Inc 510(k) NO: K223503(Traditional)
ATTN: Kate Oelberg PHONE NO : 612 4317315
1000 Lake Hazeltine Drive SE DECISION MADE: 19-JAN-23
Chaska MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VX1+
Volta Medical 510(k) NO: K223516(Traditional)
ATTN: Paola Milpied PHONE NO : 33 7 68025499
65 Avenue Jules Cantini SE DECISION MADE: 21-JAN-23
Marseille FR 13006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZESPIN SI Joint Fusion System
Aegis Spine, Inc. 510(k) NO: K223521(Traditional)
ATTN: KiHyang Kim PHONE NO : 719 3377579
9781 S. Meridian Blvd, Ste 300 SE DECISION MADE: 20-JAN-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triathlon® Hinge Knee System
Howmedica Osteonics Corp. dba Stry510(k) NO: K223528(Traditional)
ATTN: Allison Byrne PHONE NO : 201 8315732
325 Corporate Drive SE DECISION MADE: 20-JAN-23
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AvalancheLase Family
Fotona d.o.o. 510(k) NO: K223540(Traditional)
ATTN: Tina Bartolic PHONE NO : 386 1 5009100
Stegne 7 SE DECISION MADE: 19-JAN-23
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 14HQ721G-B
LG Electronics Inc. 510(k) NO: K223546(Traditional)
ATTN: Jinhwan Jun PHONE NO : 82____ 31 80665641
168, Suchul-daero SE DECISION MADE: 27-JAN-23
Gumi-si KR 39368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK Sphere & GMK SpheriKA Cementless
Medacta International S.A. 510(k) NO: K223548(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 20-JAN-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoCNX
Converg Engineering 510(k) NO: K223563(Traditional)
ATTN: Gustavo R Prado PHONE NO : 404 8254445
2305 Historic Decatur Road SE DECISION MADE: 25-JAN-23
San Diego CA 92106 510(k) STATEMENT
DEVICE: PALLAS Premium
Laseroptek Co., Ltd. 510(k) NO: K223588(Traditional)
ATTN: Hong Chu PHONE NO : 82 31 80235150
#203 & #204 Hyundai I valley, 31, SE DECISION MADE: 26-JAN-23
Seongnam-si KR 13212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
Sienco, Inc. 510(k) NO: K223635(Special)
ATTN: Jennifer Aiken PHONE NO : 303 4201148
5721 Arapahoe Ave, Unit A1-A SE DECISION MADE: 04-JAN-23
Boulder CO 80303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neuronaute with IceCap 2 & IceCap 2 Small
Bioserenity 510(k) NO: K223644(Special)
ATTN: Madubuike Okafor PHONE NO : 347 5076722
47 Boulevard De L Hopital ICM-IPEPSE DECISION MADE: 12-JAN-23
Paris FR 75013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REMEDY Stemmed Knee Spacer
OsteoRemedies, LLC 510(k) NO: K223650(Special)
ATTN: Eric Stookey PHONE NO : 901 7340445___
6800 Poplar Avenue Suite 120 SE DECISION MADE: 05-JAN-23
Memphis TN 38138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONDUIT LLIF Straight Inserters
Enztec Limited 510(k) NO: K223671(Special)
ATTN: James Sheat PHONE NO : 64 3 3480203___
3/17 Print Place SE DECISION MADE: 05-JAN-23
Middleton, Christchurch NZ 8024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WatchPAT ONE (WP1)
Itamar Medical, LTD 510(k) NO: K223675(Special)
ATTN: Efrat Litman PHONE NO : 972 4 6177000
9 Halamish Street SE DECISION MADE: 06-JAN-23
Casearea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmoothCool HR System
Jeisys Medical Inc 510(k) NO: K223685(Special)
ATTN: Sang Hoon Hwang PHONE NO :
307, 308, 401, Daeryung Techno TowSE DECISION MADE: 04-JAN-23
Seoul KR 08501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
Aegis Spine, Inc. 510(k) NO: K223719(Special)
ATTN: Kihyang Kim PHONE NO : 719 3377579
9781 S. Meridian Blvd, Ste 300 SE DECISION MADE: 11-JAN-23
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Modulus-C Interbody System
Nuvasive, Inc. 510(k) NO: K223731(Special)
ATTN: Meet Vaghani PHONE NO : 1 860 5972984
7475 Lusk Blvd. SE DECISION MADE: 12-JAN-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alpha Control Liner System (ACLS)
Coapt 510(k) NO: K223738(Special)
ATTN: Blair Lock PHONE NO : 844 2627800 700
303 W. Institute Pl. Suite 200 SE DECISION MADE: 11-JAN-23
Chicago IL 60610 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 XP Console, Thermogard HQ Console
Zoll Circulation, Inc. 510(k) NO: K223746(Special)
ATTN: Brian Robey PHONE NO : 978 8059015
2000 Ringwood Avenue SE DECISION MADE: 13-JAN-23
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Exam Gloves (Chemotherapy Drug Tested)
US Medical Glove Company LLC 510(k) NO: K223748(Third Party - Traditional)
ATTN: Jorge A. Alcazar PHONE NO : 917 4029898
325 South Illinois Route 31, BuildSE DECISION MADE: 13-JAN-23
Montgomery IL 60538 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: U by Kotex® Click® Unscented Menstrual Tampons
Kimberly-Clark Corporation 510(k) NO: K223749(Third Party - Traditional)
ATTN: Jeremy Paulsen PHONE NO : 921 7212552
2100 Winchester Road SE DECISION MADE: 06-JAN-23
Neenah WI 54956 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INFINITY OCT System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K223764(Special)
ATTN: Laura Beth Parr PHONE NO : 901 3440614
1800 Pyramid Place SE DECISION MADE: 11-JAN-23
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-STIK Electrodes
South Dakota Partners 510(k) NO: K223775(Third Party - Traditional)
ATTN: Mike Plunkett PHONE NO : 617 9219517
205 Hwy 22 E SE DECISION MADE: 03-JAN-23
Clear Lake SD 57226 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set
Ambu A/S 510(k) NO: K223782(Special)
ATTN: Kristian Moltved PHONE NO : 45 7225 2000
Baltorpbakken 13 SE DECISION MADE: 12-JAN-23
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 21HQ513D
LG Electronics Inc. 510(k) NO: K223789(Special)
ATTN: Jinhwan Jun PHONE NO : 82 31 80665641
168, Suchul-daero SE DECISION MADE: 09-JAN-23
Gumi-si KR 39368 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
CEFLA S.C. 510(k) NO: K223794(Special)
ATTN: Lorenzo Bortolotti PHONE NO : 39 0542 653111
Via Selice Provinciale 23/A SE DECISION MADE: 17-JAN-23
Imola IT 40026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FairFix QT Adjustable Button
Medacta International S.A. 510(k) NO: K223795(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 17-JAN-23
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIM – Additional Tracers
MIM Software Inc. 510(k) NO: K223800(Special)
ATTN: Megan Fontanez PHONE NO : 216 4550600
25800 Science Park Drive - Suite 1SE DECISION MADE: 17-JAN-23
Cleveland OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PercuNav Image Fusion and Interventional Navigation System
Philips Ultrasound LLC 510(k) NO: K223804(Third Party - Traditional)
ATTN: Courtney Nix PHONE NO : 570 9162958
22100 Bothell Everett Hwy SE DECISION MADE: 18-JAN-23
Bothell WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SI-Cure Sacroiliac Joint Fusion System
Alevio, LLC 510(k) NO: K223819(Special)
ATTN: Trey Robbins PHONE NO : 205 7835778
200 Cahaba Park, Suite 100 SE DECISION MADE: 18-JAN-23
Birmingham AL 35242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX - Compass
Carestream Health, Inc. 510(k) NO: K223842(Special)
ATTN: Jessica DeRyke PHONE NO : 585 4897627
Building 7, No. 1510 Chuanqiao RoaSE DECISION MADE: 20-JAN-23
China (Shanghai) Pilot Free Trade 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREED™ Cannulated Screws
GLW, Inc. 510(k) NO: K223847(Special)
ATTN: Arundhati Radhakrishnan PHONE NO : 201 2683281
300 Sylvan Avenue SE DECISION MADE: 25-JAN-23
Englewood Cliffs NJ 07632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Carevix™ Suction Cervical Stabilizer
Aspivix SA 510(k) NO: K223866(Special)
ATTN: Mauro Rinaldi PHONE NO : 41 076 3798797
Chemin du Closel, 5 SE DECISION MADE: 25-JAN-23
Renens CH 1020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low Profile Companion Sheath
Merit Medical Systems, Inc. 510(k) NO: K223872(Special)
ATTN: Kirk McIntosh PHONE NO : 801 3163695___
1600 West Merit Parkway SE DECISION MADE: 19-JAN-23
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
Semperit Investments Asia PTE LTD.510(k) NO: K223903(Special)
ATTN: Alexander Weinert PHONE NO : 43 676 8715429___
8 Jurong Town Hall Road, #29-03 ToSE DECISION MADE: 27-JAN-23
Singapore Central SG 609434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 360CAS
Kico Knee Innovation Company Pty L510(k) NO: K223927(Special)
ATTN: Danyon Munro PHONE NO : 61 435 677481
Suite 3, Building 1, 20 Bridge StrSE DECISION MADE: 27-JAN-23
Sydney AU 2073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System
Dexcom, Inc. 510(k) NO: K223931(Special)
ATTN: Brittney Shaver PHONE NO : 858 2036381
6340 Sequence Drive SE DECISION MADE: 11-JAN-23
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 200
TOTAL WITH SUMMARIES 190
TOTAL WITH STATEMENTS 10
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