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510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD June 2021
DEVICE: coDiagnostiX
Dental Wings GmbH 510(k) NO: K193301(Traditional)
ATTN: Angelika Hähnel PHONE NO : 49 371 273903 70
Duesseldorfer Platz 1 SE DECISION MADE: 21-JUN-21
Chemnitz DE 09111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SnugKap
HeadStart, Ltd. 510(k) NO: K193383(Traditional)
ATTN: James McCartney PHONE NO : 844 7443237
1550 E. Higgins Road, Suite 123 SE DECISION MADE: 07-JUN-21
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aptiva Celiac Disease IgA Reagent
Inova Diagnostics, Inc. 510(k) NO: K193604(Traditional)
ATTN: Andrea Seaman PHONE NO : 858 5869900
9900 Old Grove Road SE DECISION MADE: 16-JUN-21
San Diego CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Manual Wheelchair (Model W28)
Jiangsu Jumao X-Care Medical Equip510(k) NO: K200466(Traditional)
ATTN: Weixia Shi PHONE NO : 86 511 86197666
No.36 Danyan Road SE DECISION MADE: 14-JUN-21
Danyang City CN 212300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfect EMS
TensCare Ltd. 510(k) NO: K200694(Traditional)
ATTN: Andrew Brown PHONE NO : 44 01372 723434
9 Blenheim Road, Longmead BusinessSE DECISION MADE: 04-JUN-21
Epsom GB KT19 9BE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCA-C1 series Patient Cable
QT Medical, Inc. 510(k) NO: K200722(Traditional)
ATTN: Ruey-Kang Chang PHONE NO : 909 3230007
1360 Valley Vista Dr., Suite 203 SE DECISION MADE: 03-JUN-21
Diamond Bar CA 91765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System
Becton, Dickinson and Company 510(k) NO: K200891(Traditional)
ATTN: Kimberly Geisler PHONE NO : 1 801 5225703
9450 South State Street SE DECISION MADE: 02-JUN-21
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well-Life Garment Electrodes (GM Series)
Well-Life Healthcare Limited 510(k) NO: K200942(Traditional)
ATTN: Jenny Hsieh PHONE NO :
6F., No, 168, Lide St., Jhonghe DiSE DECISION MADE: 01-JUN-21
New Taipei City TW 235 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scooter (Model: FDB01)
Nanjing Jin Bai He Medical Apparat510(k) NO: K201196(Traditional)
ATTN: Dandan Yang PHONE NO : 86 25 85780899
No. 12, Wuge Rd, Jiangning SE DECISION MADE: 25-JUN-21
Nanjing CN 210000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pivot Breath Sensor
Carrot Inc. 510(k) NO: K201206(Traditional)
ATTN: Sara Lippert PHONE NO : 650 2493959
1400A Seaport Blvd, Suite 501 SE DECISION MADE: 30-JUN-21
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair
Psychemedics Corporation 510(k) NO: K201228(Traditional)
ATTN: Neil Stowe PHONE NO : 301 2167776
5832 Uplander Way SE DECISION MADE: 25-JUN-21
Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium
MECTA Corporation 510(k) NO: K201309(Traditional)
ATTN: Adrian Kettering PHONE NO : 503 6126780
19799 SW 95th Avenue Suite B SE DECISION MADE: 04-JUN-21
Tualatin OR 97062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restor3d Utility Wedge
restor3d, Inc. 510(k) NO: K201314(Traditional)
ATTN: Michaela Pigue PHONE NO : 984 8880593
311 W Corporation St SE DECISION MADE: 17-JUN-21
Durham NC 27701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CenterMed Patient Matched Assisted Surgical Planning (ASP) System
CenterMed, Inc. 510(k) NO: K201353(Traditional)
ATTN: Christine Yu PHONE NO : 855 8408823
226 N Wiget Ln SE DECISION MADE: 28-JUN-21
Walnut Creek CA 94598 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultrasonic Mesh Nebulizer
Shenzhen Ivankaca Technology Co., 510(k) NO: K201397(Traditional)
ATTN: Sam Wong PHONE NO : 0086 755 28510161
3/F, Building B, No. 45 lixin roadSE DECISION MADE: 14-JUN-21
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Black Nitrile Examination Glove
Vietglove Corporation 510(k) NO: K201428(Traditional)
ATTN: Pham Ngoc Thanh PHONE NO : 84 0650 591228
Cau Sat Hamlet, Lai Hung Commune, SE DECISION MADE: 24-JUN-21
Bingh Duong VN 72600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spirometer
MeHow Innovative Ltd 510(k) NO: K201493(Traditional)
ATTN: Gloria Sun PHONE NO : 86 0755 83051518
Block A&B&C, NCBC Industrial Park,SE DECISION MADE: 10-JUN-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Posterior Spinal Fixation System
Shanghai REACH Medical Instrument 510(k) NO: K201737(Traditional)
ATTN: Mingsha Ye PHONE NO : 86 021 54840582
Building 13, No. 999 Jiangyue RoadSE DECISION MADE: 21-JUN-21
Shanghai CN 201112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Su2ura Approximation Device
Anchora Medical, Ltd. 510(k) NO: K201744(Traditional)
ATTN: Yoni Epstein PHONE NO : 972 54 7776615
Beit Tavor, Entrance 2, 3rd floor SE DECISION MADE: 17-JUN-21
I.Z. Yokneam IL 2069202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed PentaRay Nav eco High-Density Mapping Catheter
Sterilmed Inc. (Johnson and Johnso510(k) NO: K201806(Traditional)
ATTN: Jan Flegeau PHONE NO : 786 5755903
5010 Cheshire Parkway N, Suite 2 SE DECISION MADE: 23-JUN-21
Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruBase S
TruAbutment Inc. 510(k) NO: K201842(Traditional)
ATTN: HoSu Lee PHONE NO : 714 9561488
17742 Cowan SE DECISION MADE: 04-JUN-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRVWatch-Mini Wrist Monitor
Taiwan Scientific Corporation 510(k) NO: K201914(Traditional)
ATTN: D.C. Sun PHONE NO : 886 2866 73362
10F, 88-4, Ming-Chiuan Rd., Shin-DSE DECISION MADE: 07-JUN-21
New Taipei TW 23141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Air Pressure Therapy System
Xiamen Weiyou Intelligent Technolo510(k) NO: K201935(Traditional)
ATTN: Yong Sun PHONE NO : 086 0592 6251545
Unit 101-401, No.6 Xianghong Road,SE DECISION MADE: 22-JUN-21
Xiamen CN 361021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green
Shen Wei USA Inc. 510(k) NO: K202085(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 21-JUN-21
Union City CA 94587 510(k) STATEMENT
DEVICE: Disposable Surgical Mask
Shenzhen Peninsula Medical Co. Ltd510(k) NO: K202126(Traditional)
ATTN: Zhang Sudi PHONE NO : 86 150 12578550
B F2, Changfeng Industrial Park, XSE DECISION MADE: 08-JUN-21
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allmed Surgical Face Masks (Ear loops)
Allmed Medical Products Co., LTD 510(k) NO: K202128(Traditional)
ATTN: Vince Tian PHONE NO : 86 717 4215906
No. 180 Gongyuan Road Majiadian ToSE DECISION MADE: 03-JUN-21
Zhijiang CN 443200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioFire RP2.1/RP2.1plus Control Panel M441
Maine Molecular Quality Controls, 510(k) NO: K202196(Traditional)
ATTN: Joan Gordon PHONE NO : 207 8851072
23 Mill Brook Road SE DECISION MADE: 24-JUN-21
Saco ME 04072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kendall NPWT Incision Management Device
Cardinal Health 510(k) NO: K202217(Traditional)
ATTN: Christine Kuntz-Nassif PHONE NO : 508 6183756
3651 Birchwood Drive SE DECISION MADE: 04-JUN-21
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shenzhen Sonida Digital Technology510(k) NO: K202440(Traditional)
ATTN: Vivi Wey PHONE NO : 0755 29607298
6F./3F-B., Building B, ZhengchangdSE DECISION MADE: 17-JUN-21
Shenzhen CN 518103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TMJ Relax
Moonwalker Innovations Inc 510(k) NO: K202523(Traditional)
ATTN: Charles Sutera PHONE NO : 978 3148974
20 Roosevelt Rd SE DECISION MADE: 24-JUN-21
Medford MA 02155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cor-Knot Micro
LSI Solutions, Inc. 510(k) NO: K202551(Traditional)
ATTN: Christopher B. Miller PHONE NO : 585 8696665
7796 Victor-Mendon Road SE DECISION MADE: 24-JUN-21
Victor NY 14564 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Qingdao Likangyuan Medical Device 510(k) NO: K202580(Traditional)
ATTN: Ying Xu PHONE NO : 086 532 89052813
No. 257 Leigongshan Road, HuangdaoSE DECISION MADE: 07-JUN-21
Qingdao CN 266423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulia Diabetes Management Companion
Voluntis, S.A. 510(k) NO: K202596(Special)
ATTN: Kevin Howard PHONE NO : 33 141 383920
22 Quai Gallieni SE DECISION MADE: 04-JUN-21
Suresnes FR 92150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Suture Wing
Osteonic Co., Ltd. 510(k) NO: K202663(Traditional)
ATTN: Dakyung Ham PHONE NO : 82 2 69028456
38 Digital-ro 29-gil SE DECISION MADE: 07-JUN-21
Guro-gu KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Chongqing Chaoke Industry Developm510(k) NO: K202714(Traditional)
ATTN: Liu Xincheng PHONE NO : 86 23 62809222
C31, Yangtze River Industry Park, SE DECISION MADE: 11-JUN-21
Chongqing CN 400067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Qmenta Care Platform Family
Mint Labs, Inc., d/b/a. QMENTA 510(k) NO: K202718(Traditional)
ATTN: Paulo Rodrigues PHONE NO : 34 933282007
One International Place, Suite 370SE DECISION MADE: 16-JUN-21
Boston MA 02110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fix2Lock (PEEK Self Punching)
Osteonic Co., Ltd. 510(k) NO: K202763(Traditional)
ATTN: Da Kyung Ham PHONE NO : 82 2 69028456
38 Digital-ro 29-gil SE DECISION MADE: 04-JUN-21
Guro-gu KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOS Air Cleaner
Guangzhou Ajax Medical Equipment C510(k) NO: K202766(Traditional)
ATTN: Atwood Lee PHONE NO : 86 20 84847938
Building No 2 Dagang industrial zoSE DECISION MADE: 11-JUN-21
Guangzhou CN 511447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
OSTEONIC Co., Ltd. 510(k) NO: K202806(Traditional)
ATTN: Da Kyung Ham PHONE NO : 82 2 69028456
39 Digital-ro 29-gil SE DECISION MADE: 17-JUN-21
Guro-gu KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URO-TOUCH 9 French Probe
Northgate Technologies Inc. 510(k) NO: K202813(Traditional)
ATTN: Todd Gatto PHONE NO : 224 8562250
1591 Scottsdale Court SE DECISION MADE: 14-JUN-21
Elgin IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Green Laser System
Realton (Suzhou) Medical Technolog510(k) NO: K202828(Traditional)
ATTN: Mingzhu Liu PHONE NO : 086 0512 62868599
601 Room, B8 Building, 218 Xinghu SE DECISION MADE: 04-JUN-21
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthodontic Facemask
ITA.O Italian Orthodontic System S510(k) NO: K202855(Traditional)
ATTN: Alessandra Ferroni PHONE NO : 0039 051 6240560
Via Merighi, 30/3 - 30/4 SE DECISION MADE: 21-JUN-21
Villanova di Castenaso IT 40055 510(k) STATEMENT
DEVICE: Transcutaneous Electrical Nerve Stimulator
Wuxi Jiajian Medical Instrument Co510(k) NO: K202893(Special)
ATTN: Caihong Sun PHONE NO : 86 510 88745788
No. 35 Baiqiao Rd., Ehu Town, XishSE DECISION MADE: 18-JUN-21
Wuxi CN 214116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Natural Cycles
Natural Cycles Nordic AB 510(k) NO: K202897(Traditional)
ATTN: Raoul Scherwitzl PHONE NO : 46 70 7174866
St Eriksgatan 63b SE DECISION MADE: 24-JUN-21
Stockholm SE 112 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2430MCA with Xmaru W
Rayence Co., Ltd 510(k) NO: K202902(Traditional)
ATTN: Kee Dock Kim PHONE NO : 82 31 80156459
14, Samsung 1-ro 1-gil SE DECISION MADE: 21-JUN-21
Hwaseong-si KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iBed Wireless with iBed Mobile
Stryker Corporation 510(k) NO: K202964(Traditional)
ATTN: Cathy Friday PHONE NO : 269 3120684
3800 E. Centre Avenue SE DECISION MADE: 18-JUN-21
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fotona XPulse Pro Laser Platform
Fotona d.o.o. 510(k) NO: K202991(Traditional)
ATTN: Marko Berdajs PHONE NO : 386 1 5009119
Stegne 7 SE DECISION MADE: 22-JUN-21
Ljubljana SI 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LF900
DaeSung Maref Co., Ltd 510(k) NO: K203019(Traditional)
ATTN: So Su Hyeon PHONE NO : 82 31 4597211
298-24, Gongdan-ro SE DECISION MADE: 22-JUN-21
Gunpo-si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
WRP ASIA PACIFIC SDN BHD 510(k) NO: K203030(Traditional)
ATTN: Saravanan Ramasamy PHONE NO : 603 870 61557
Lot 1 Jalan 3, Kawasan Perusahaan SE DECISION MADE: 11-JUN-21
Sepang MY 43900 510(k) STATEMENT
DEVICE: Quantum Perfusion Arterial Cannula Graft
Qura S.r.l. 510(k) NO: K203057(Traditional)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 1803050
Via di Mezzo 23 SE DECISION MADE: 30-JUN-21
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
RFX+CARE Manufactoring Co., Ltd. 510(k) NO: K203190(Traditional)
ATTN: Zhou Xiufeng PHONE NO : 86 135 75509137
7 Lanjiang Road, Yuecheng DistrictSE DECISION MADE: 02-JUN-21
Shao Xing CN 312000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Surgical Face Mask
Guangdong Haiou Medical Apparatus 510(k) NO: K203200(Traditional)
ATTN: Zhang Zhuo Xuan PHONE NO : 86 663 2758666
Nanyuan Industrial Zone, North LiuSE DECISION MADE: 16-JUN-21
Puning CN 515300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radius T wearable thermometer
Masimo Corporation 510(k) NO: K203215(Traditional)
ATTN: Sindura Penubarthi PHONE NO : 949 3964041
52 Discovery SE DECISION MADE: 11-JUN-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATRELLE INSPIRA Single Use Sizers for Gel Implants
Allergan 510(k) NO: K203229(Special)
ATTN: Kelly Carty PHONE NO : 714 2466180
2525 Dupont Dr. SE DECISION MADE: 02-JUN-21
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CellChek 20 rc
Konan Medical, Inc. 510(k) NO: K203244(Traditional)
ATTN: Runa Emura PHONE NO : 81 798 363456
10-29, Miyanishicho SE DECISION MADE: 15-JUN-21
Nishinomiya JP 662-0976 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OVOMotion Reverse Shoulder Arthroplasty System
Arthrosurface Inc. 510(k) NO: K203375(Traditional)
ATTN: Dawn J. Wilson PHONE NO : 508 5203003
28 Forge Parkway SE DECISION MADE: 24-JUN-21
Franklin ME 02038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable medical mask
Everwin Toys (Dongguan)., Ltd. 510(k) NO: K203388(Traditional)
ATTN: Huang Zibin PHONE NO : 86 0769 87314418 6118
Xiekeng Village, Qingxi Town SE DECISION MADE: 04-JUN-21
Dongguan CN 523000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corrugated tube with mouthpiece accessory
Trudell Medical International 510(k) NO: K203400(Traditional)
ATTN: Marianne Tanton PHONE NO : 519 4557060
725 Baransway Drive SE DECISION MADE: 14-JUN-21
London CA N5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENFit Disposable Enteral Syringe
Shantou Wealy Medical Instrument C510(k) NO: K203410(Traditional)
ATTN: Yang Songling PHONE NO : 0086 158 16758600
North Jinhuan Road (near Qishan miSE DECISION MADE: 28-JUN-21
Shantou CN 515064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann CARES M-Series CAD/CAM System
Institut Straumann AG 510(k) NO: K203456(Special)
ATTN: Gordon Dodds PHONE NO : 49 89 309075291
Peter Merian-Weg 12 SE DECISION MADE: 23-JUN-21
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precise Position
Philips Healthcare (Suzhou) Co., L510(k) NO: K203514(Traditional)
ATTN: Shiguang An PHONE NO : 86 21 60902504
No. 258, Zhong Yuan, Suzhou IndustSE DECISION MADE: 17-JUN-21
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
FCI (France Chirurgie Instrumentat510(k) NO: K203569(Traditional)
ATTN: Thierry Fetick PHONE NO : 33 1 53989898
20-22 rue Louis Armand SE DECISION MADE: 11-JUN-21
Paris FR 75015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfit FS Dental Zirconia Fully Sintered Block
Vatech Acucera, Inc. 510(k) NO: K203590(Traditional)
ATTN: Kyung Wook Kwon PHONE NO : 82 31 80051821
2544, Nambuk-daero, Idong-eup, CheSE DECISION MADE: 24-JUN-21
Yongin-si KR 17138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureStrip Vitrification Straw, SureLock Vitrification Straw
Allwin Medical Devices, Inc 510(k) NO: K203626(Traditional)
ATTN: Digish Mehta PHONE NO : 714 5721709
3305 E. Miraloma Avenue, Suite 176SE DECISION MADE: 04-JUN-21
Anaheim CA 92806 510(k) STATEMENT
DEVICE: IDx-DR
Digital Diagnostics Inc. 510(k) NO: K203629(Traditional)
ATTN: Ashley Miller PHONE NO : 319 2485620
2300 Oakdale Blvd. SE DECISION MADE: 10-JUN-21
Coralville IA 52241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
SuperSonic Imagine 510(k) NO: K203645(Traditional)
ATTN: Jacques Souquet PHONE NO :
Les Jardins de la Duranne- Bat E eSE DECISION MADE: 29-JUN-21
Aix en Provence FR 13857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vu-Path Ultrasound System
Crystalline Medical 510(k) NO: K203657(Third Party - Traditional)
ATTN: Ivan Ma PHONE NO : 617 7920245
48890 Milmont Drive Suite 106D SE DECISION MADE: 25-JUN-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Surgical face mask
Juntech(Jiaxing)Healthcare Materia510(k) NO: K203704(Traditional)
ATTN: Cam Sun PHONE NO : 86 1386 7356868
No.4 Plant,No1 build of North of YSE DECISION MADE: 04-JUN-21
Jiaxing CN 314009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0
FUJIFILM Corporaton 510(k) NO: K203717(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 30-JUN-21
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROMATE
ISYS Medizintechnik GMBH 510(k) NO: K203720(Traditional)
ATTN: Michael Vogele PHONE NO : 43 0 664241140
Bergwerksweg 21 SE DECISION MADE: 22-JUN-21
Kitzbuehel AT 6370 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S.I.N. Dental Implant System
S.I.N.- Sistema de Implante Nacion510(k) NO: K203725(Traditional)
ATTN: Denise Domiciano PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 23-JUN-21
Sao Paulo BR 03340-000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Zhuhai Gaoge Medical Technology Co510(k) NO: K203732(Traditional)
ATTN: Xiangliang Cheng PHONE NO : 86 0756 8803221
3rd floor, flat 5, No. 6 JinYuan oSE DECISION MADE: 11-JUN-21
Zhuhai CN 519000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 12MP Color Digital Mammography LCD Monitor CL-S1200
JVCKENWOOD Corporation 510(k) NO: K203733(Traditional)
ATTN: Hideki Tengeiji PHONE NO : 81 45 4502715
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 29-JUN-21
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Lucky Textile Industrial(Wuxi) Co.510(k) NO: K203756(Traditional)
ATTN: Grace Tai PHONE NO : 86 510 80192890
No.10 Zhuqiao Road, Yixing EconomiSE DECISION MADE: 10-JUN-21
Yixing CN 214200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symmetric Total Knee System
Signal Medical Corporation 510(k) NO: K203779(Traditional)
ATTN: Dora Culton PHONE NO : 810 3647070
400 Pyramid Dr. SE DECISION MADE: 10-JUN-21
Marysville MI 48040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc 510(k) NO: K203802(Traditional)
ATTN: Robert Jaramillo PHONE NO : 925 8192257
110 Pioneer Way, Ste 1 SE DECISION MADE: 07-JUN-21
Mountain View CA 94041-1519 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEOS Limb Salvage System with BioGrip
Onkos Surgical 510(k) NO: K203815(Traditional)
ATTN: Matthew (Matt) Vernak PHONE NO : 551 5791081
77 East Halsey Rd SE DECISION MADE: 09-JUN-21
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Replens Long-Lasting Vaginal Moisturizer
Church & Dwight Co., Inc 510(k) NO: K203818(Traditional)
ATTN: Supreet Sahota-Bhatti PHONE NO : 609 8067893
500 Charles Ewing Blvd. SE DECISION MADE: 11-JUN-21
Ewing NJ 08628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATS®-D Tonometer Prism
CATS Tonometer LLC 510(k) NO: K203850(Traditional)
ATTN: Nannon Roosa PHONE NO : 520 3704113
1517 N. Wilmot Suite 143 SE DECISION MADE: 14-JUN-21
Tucson AZ 85712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)
Guandong Genial Technology CO., LI510(k) NO: K210014(Traditional)
ATTN: Jun Yu PHONE NO : 86 020 37236838
I-6-05-02, 11th Road, Area B, GuanSE DECISION MADE: 04-JUN-21
Zhaoqing CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Sample King Manufacturing Ltd 510(k) NO: K210015(Traditional)
ATTN: Forest Cao PHONE NO : 0086 0755 33095566 2795
Southwest side of the intersectionSE DECISION MADE: 10-JUN-21
Shenzhen CN 518083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axon Therapy
NeuraLace Medical, Inc. 510(k) NO: K210021(Traditional)
ATTN: Joe Milkovits PHONE NO : 858 2299218
3770 Tansy St #101 SE DECISION MADE: 11-JUN-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EnsoSleep
EnsoData, Inc. 510(k) NO: K210034(Traditional)
ATTN: Sigrid Schoepel PHONE NO : 608 5094704
111 S. Hamilton St. Suite 30 SE DECISION MADE: 16-JUN-21
Madison WI 53703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System
Spinal Elements, Inc. 510(k) NO: K210044(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 30-JUN-21
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Augmented VaultLock Glenoid
Arthrex Inc. 510(k) NO: K210050(Traditional)
ATTN: Ivette Galmez PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 07-JUN-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis s-Clean s-Line Mini
Dentis Co., Ltd. 510(k) NO: K210080(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 04-JUN-21
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuraStat-GI
3-D Matrix, Inc. 510(k) NO: K210098(Traditional)
ATTN: Lisa Spirio PHONE NO : 617 8756204
1234 Chestnut St., Suite 205 SE DECISION MADE: 25-JUN-21
Newton MA 02464 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iTind System
Medi-Tate Ltd. 510(k) NO: K210138(Traditional)
ATTN: Lihi Liviatan PHONE NO : 972 77 7006745
17 Hauman Street SE DECISION MADE: 25-JUN-21
Hadera IL 3850169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical mask
Hubei Wanli Protective Products Co510(k) NO: K210150(Traditional)
ATTN: Andy Wen PHONE NO : 0086 728 3227299
Yuanshi, Ganhe SE DECISION MADE: 02-JUN-21
Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AnyOne Onestage Implant System
MegaGen Implant Co., Ltd. 510(k) NO: K210161(Traditional)
ATTN: You Jung Kim PHONE NO : 82 53 2222828
45, Secheon-ro, 7-gil SE DECISION MADE: 22-JUN-21
Daegu KR 42921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kontact Dental Implant System
BIOTECH DENTAL, SAS 510(k) NO: K210220(Traditional)
ATTN: Delphine Mercier PHONE NO : 33 04 90446060
305 Allées De Craponne SE DECISION MADE: 18-JUN-21
Salon De Provence FR 13300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NovoFine
Novo Nordisk Inc. 510(k) NO: K210258(Traditional)
ATTN: Hiral Palkhiwala Shah PHONE NO : 609 7877603
P.O Box 846 SE DECISION MADE: 23-JUN-21
Plainsboro NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fist Assist Devices Model FA-1
Fist Assist Devices, LLC 510(k) NO: K210281(Traditional)
ATTN: Tej Singh PHONE NO : 1 650 4442599
25599 Fernhill Road SE DECISION MADE: 17-JUN-21
Los Altos CA 94024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Administration Set
Baxter Healthcare Corporation 510(k) NO: K210335(Traditional)
ATTN: James L. Vangeisen PHONE NO : 224 2703308
25212 West Illinois Route 120 SE DECISION MADE: 10-JUN-21
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Migraine Tens Digital Pain Reliever
Shenzhen Dongdixin Technology Co.,510(k) NO: K210364(Traditional)
ATTN: Siping Yuan PHONE NO : 86 755 27652471
Floor 1-2, No.3 Building, Fanshen SE DECISION MADE: 17-JUN-21
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Dongguan Shin Yi Healthcare Produc510(k) NO: K210372(Traditional)
ATTN: Zhao Shuge PHONE NO : 86 769 83361381
No. 17 Ban Hu Road, Huang Jiang ToSE DECISION MADE: 07-JUN-21
Dongguan CN 523750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Glove
Duramitt sdn Bhd 510(k) NO: K210375(Traditional)
ATTN: Terence Lim PHONE NO : 60 12 2811377
No. 3, Jalen Baling Padong Meha InSE DECISION MADE: 21-JUN-21
Kulim MY 09400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker iBur hubs and cutting accessories
Stryker Corporation 510(k) NO: K210377(Traditional)
ATTN: Alison Garrad PHONE NO : 353 87 6164723
1941 Stryker Way SE DECISION MADE: 30-JUN-21
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Ansell Healthcare Products LLC 510(k) NO: K210401(Traditional)
ATTN: Donald Cronk PHONE NO : 1 775 4707106
2301 Robb Drive SE DECISION MADE: 13-JUN-21
Reno NV 89523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transpara 1.7.0
ScreenPoint Medical B.V. 510(k) NO: K210404(Traditional)
ATTN: Umar Waqas PHONE NO : 31 24 3030045
Mercator II, 7th floor, ToernooiveSE DECISION MADE: 02-JUN-21
Nijmegen NL 6525EC 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K210416(Traditional)
ATTN: Shi Jufang PHONE NO : 86 755 81886293
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 10-JUN-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diafil & Diafil Capsule
Diadent Group International 510(k) NO: K210421(Special)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 28-JUN-21
Cheongji-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
Arthrocare Corporation 510(k) NO: K210423(Traditional)
ATTN: Shruthi Bhat PHONE NO : 512 4669296
7000 West William Cannon Drive BuiSE DECISION MADE: 24-JUN-21
Austin TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Jiangxi Heying Pharmaceutical Co.,510(k) NO: K210429(Traditional)
ATTN: Junzheng Liu PHONE NO : 86 793 3273758
Huangjinbu Town, Yugan County SE DECISION MADE: 02-JUN-21
Shangrao CN 335100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intravascular Extension Set
Baxter Healthcare Corporation 510(k) NO: K210430(Traditional)
ATTN: Meaghan Bonn PHONE NO : 224 270 6470
25212 West Illinois Route 120 SE DECISION MADE: 18-JUN-21
Round Lake IL 60073 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask (Ear loops and Tie-on)
Wuhan Dymex Healthcare Co., Ltd. 510(k) NO: K210433(Traditional)
ATTN: Niki Wang PHONE NO : 86 27 84621898
Room1701, Unit2, Building 5, JinseSE DECISION MADE: 07-JUN-21
Wuhan CN 430000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Bougie, 38 Fr.
Standard Bariatrics 510(k) NO: K210437(Traditional)
ATTN: Michelle Schnell PHONE NO : 513 7026083
4362 Glendale Milford Rd. SE DECISION MADE: 29-JUN-21
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nordiwell Surprotect Face Mask
Changzhou Combat Protective Equipm510(k) NO: K210445(Traditional)
ATTN: Yanmei Song PHONE NO : 86 519 85190068
QingSiTang Village, Henglin Town, SE DECISION MADE: 29-JUN-21
Changzhou CN 213101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key
7D Surgical Inc. 510(k) NO: K210457(Traditional)
ATTN: Daniel Zisind PHONE NO : 647 4840079
60 scarsdale road, unit 118 SE DECISION MADE: 21-JUN-21
Toronto CA M3B 2R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott Medical 510(k) NO: K210458(Traditional)
ATTN: Steve Vitale PHONE NO : 612 2149102
4 Robbins Road SE DECISION MADE: 08-JUN-21
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
Medtronic, Inc. 510(k) NO: K210484(Traditional)
ATTN: Dianna L Johannson PHONE NO : 763 5262376
8200 Coral Sea Street NE SE DECISION MADE: 11-JUN-21
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Port Access System
Surgical Innovations Limited 510(k) NO: K210495(Traditional)
ATTN: Stephen Seed PHONE NO : 44 11 32307597
Clayton Wood House, 6 Clayton WoodSE DECISION MADE: 18-JUN-21
Leeds GB LS16 6QZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
Elekta Limited 510(k) NO: K210500(Traditional)
ATTN: Lorenzo Muratori PHONE NO : 1 678 2317791
Linac House, Fleming Way SE DECISION MADE: 11-JUN-21
Crawley GB RH10 9RR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANAVIA Veneer LC
Kuraray Noritake Dental Inc. 510(k) NO: K210504(Traditional)
ATTN: Yasujiro Ohara PHONE NO : 81 3 67011736
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 11-JUN-21
Chiyoda-ku JP 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINELLE DTx System
Uvision360, Inc. 510(k) NO: K210512(Traditional)
ATTN: Allison London Brown PHONE NO : 615 94383698
158 Wind Chime Ct. ,Suite #201 SE DECISION MADE: 30-JUN-21
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Shandong Haidike Medical Products 510(k) NO: K210518(Traditional)
ATTN: Lili Xu PHONE NO : 86 530 4660062
Tianfu Road,Dongcheng District,ShaSE DECISION MADE: 14-JUN-21
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Examination Gloves
Shandong Shengshixincheng Medical 510(k) NO: K210522(Traditional)
ATTN: Ping Wang PHONE NO : 86 155 50323002
No.28 Aluminum Deep Processing IndSE DECISION MADE: 10-JUN-21
Binzhou CN 256200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aprevo Transforaminal IBF
Carlsmed, Inc. 510(k) NO: K210542(Traditional)
ATTN: Karen Liu PHONE NO : 760 7661926
4250 Executive Sq., Ste. 675 SE DECISION MADE: 30-JUN-21
La Jolla CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
Philips Medical Systems 510(k) NO: K210560(Special)
ATTN: Hong Zhu PHONE NO : 86 1850 1616553
Building A2, #718 Lingshi Road, JiSE DECISION MADE: 30-JUN-21
Shanghai CN 200072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine WaveForm™ A Interbody System
SeaSpine Orthopedics Corporation 510(k) NO: K210583(Traditional)
ATTN: Aly Alvarez PHONE NO : 619 8844342
5770 Armada Drive SE DECISION MADE: 02-JUN-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Violet Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx SDN BHD 510(k) NO: K210587(Traditional)
ATTN: Freddy Low PHONE NO : 605 8070666
No 73-86, Jalan Logam 5, PerindustSE DECISION MADE: 28-JUN-21
Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Palm Bladder Scanner - PBSV7.1
Mianyang Meike Electronic Equipmen510(k) NO: K210591(Special)
ATTN: Wenjun Zhao PHONE NO : 0086 0816 6355076
No., 63, Yinping Road, Longmen TowSE DECISION MADE: 09-JUN-21
Mianyang CN 621000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers
Camber Spine Technologies, LLC 510(k) NO: K210595(Traditional)
ATTN: Donald W. Guthner PHONE NO : 1 484 4277060 109
501 Allendale Road SE DECISION MADE: 15-JUN-21
King of Prussia PA 19604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intellihab System
CyMedica Orthopedics, Inc. 510(k) NO: K210604(Traditional)
ATTN: Kereshmeh Shahriari PHONE NO : 480 2398553
19120 N. Pima Rd. SE DECISION MADE: 03-JUN-21
Scottsdale AZ 85331 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIT Clear Aligner
CDB Corporation 510(k) NO: K210613(Special)
ATTN: Leah M Lehman PHONE NO : 910 3536464
9201 Industrial Park Boulevard SE DECISION MADE: 04-JUN-21
Leland NC 28451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Breezeway II
Oscor Inc. 510(k) NO: K210627(Special)
ATTN: Doug Myers PHONE NO : 727 9372511
3816 DeSoto Boulevard SE DECISION MADE: 03-JUN-21
Palm Harbor FL 34683 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Tuosheng Protective Products (Ning510(k) NO: K210641(Traditional)
ATTN: Nanping Yuan PHONE NO : 86 574 63795109
No. 1728 Xiaolin Ave, North IndustSE DECISION MADE: 07-JUN-21
Cixi City CN 315321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation 10.1
RaySearch Laboratories AB (publ) 510(k) NO: K210645(Traditional)
ATTN: David Hedfors PHONE NO : 46 8 51053000
Sveavagen 44 SE DECISION MADE: 29-JUN-21
Stockholm SE 111 34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 6MS Invisible Aligner
SMS OPCO, LLC 510(k) NO: K210652(Traditional)
ATTN: Bruce Page PHONE NO : 866 9577645
672 Morning Star Drive, Suite 120 SE DECISION MADE: 02-JUN-21
The Colony TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Careplus (M) SDN BHD 510(k) NO: K210656(Traditional)
ATTN: Lim Kwee Shyan PHONE NO : 60 6 6772781
Lot 120 & 121, Jalan Senawang 3, SSE DECISION MADE: 24-JUN-21
Seremban MY 70450 510(k) STATEMENT
DEVICE: Silent Nite Sleep Appliance with the Glidewell Hinge
Prismatik Dentalcraft, Inc. 510(k) NO: K210694(Special)
ATTN: Herbert Schoenhoefer PHONE NO : 949 4402632
2144 Michelson Drive SE DECISION MADE: 16-JUN-21
Irvine CA 96212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K210699(Traditional)
ATTN: Hao Yixuan PHONE NO : 86 755 81886129
Mindray Building, Keji 12th Road SSE DECISION MADE: 10-JUN-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NaviNetics D1 Stereotactic System
NaviNetics, Inc 510(k) NO: K210700(Traditional)
ATTN: Patrick Gora PHONE NO : 507 3613570
206 S Broadway, Suite 700 SE DECISION MADE: 17-JUN-21
Rochester MN 55904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KardiaMobile 6L
AliveCor, Inc. 510(k) NO: K210753(Traditional)
ATTN: Saket Bhatt PHONE NO : 650 3968553
444 Castro Street, Suite 600 SE DECISION MADE: 30-JUN-21
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H
Shenzhen OSTO Technology Company L510(k) NO: K210756(Traditional)
ATTN: Li Yang PHONE NO : 86 755 29769546
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 11-JUN-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Masks, Model:FE-1
Hunan Triplex Precision Medical De510(k) NO: K210767(Traditional)
ATTN: Huang Kai PHONE NO : 86 0731 86780069
Room 612 & 613, Building No.5~8, SSE DECISION MADE: 10-JUN-21
Changsha CN 410153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: White Nitrile Powder Free Patient Examination Glove, Non Sterile
Onetexx SDN BHD 510(k) NO: K210775(Traditional)
ATTN: Freddy Low PHONE NO : 605 807 0666
No 73-86, JLN Logam 5, PerindustriSE DECISION MADE: 28-JUN-21
Kamunting MY 34600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coconu Water Based Personal Lubricant
Coconu, LLC. 510(k) NO: K210814(Traditional)
ATTN: Taylor Warnick PHONE NO : 1 801 5508611
1968 E. Ashley Mesa Lane SE DECISION MADE: 14-JUN-21
Sandy UT 84092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smith & Nephew Plates and Screws
Smith & Nephew, Inc. 510(k) NO: K210837(Traditional)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
1450 E Brooks Rd SE DECISION MADE: 29-JUN-21
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Safeway Industry Healthcare. 510(k) NO: K210840(Traditional)
ATTN: Cai Zhimin PHONE NO : 86 138 07179336
#106 Chang'an Road, Changshangkou SE DECISION MADE: 22-JUN-21
Xiantao CN 433024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAGE
SpinTech, Inc. 510(k) NO: K210843(Third Party - Traditional)
ATTN: Kay Fuller PHONE NO : 734 8467852
30200 Telegraph Road, Suite 140 SE DECISION MADE: 29-JUN-21
Bingham Farms MI 48025 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Straumann BLX Implant System
Institut Straumann AG 510(k) NO: K210855(Traditional)
ATTN: Viviana Horhoiu PHONE NO : 41 61 9651259
Peter Merian Weg 12 SE DECISION MADE: 21-JUN-21
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Steri-Dot Process Indicator
Propper Manufacturing Co., Inc. 510(k) NO: K210866(Abbreviated)
ATTN: Andrew Sharavara PHONE NO : 1 718 8691252
36-04 Skillman Avenue SE DECISION MADE: 21-JUN-21
Long Island City NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phantom Hindfoot TTC/TC Nail System
Paragon 28, Inc. 510(k) NO: K210869(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 28-JUN-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M Series Phototherapy Equipment
Daavlin Distributing Co. 510(k) NO: K210881(Traditional)
ATTN: Michele Thiel PHONE NO : 419 6366304 207
205 W. Bement Street SE DECISION MADE: 22-JUN-21
Bryan OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MolecuLight I:X
MolecuLight Inc. 510(k) NO: K210882(Traditional)
ATTN: Jordan John PHONE NO : 416 5425522
Suite 700, 425 University Avenue SE DECISION MADE: 22-JUN-21
Toronto CA M5G 1T6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
Ambu A/S 510(k) NO: K210883(Special)
ATTN: Gurpreet Kaur Rehal PHONE NO : 45 7225 2000
Baltorpbakken 13 SE DECISION MADE: 17-JUN-21
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS Lance+ Conical Connection Dental Implant System
Dentsply Sirona 510(k) NO: K210886(Traditional)
ATTN: Karl J Nittinger PHONE NO : 717 4954286
221 West Philadelphia Street, SuitSE DECISION MADE: 17-JUN-21
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLab Polaris Multi-Modality Guidance System
Boston Scientific Corporation 510(k) NO: K210889(Special)
ATTN: Rochell Aranha PHONE NO : 763 2550017
Three Scimed Place SE DECISION MADE: 25-JUN-21
Maple Grove Hennepin MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK Embrace Shoulder System- Anatomical Configuration
Waldemar Link GmbH & Co. KG 510(k) NO: K210899(Traditional)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53995530
Oststrasse 4-10 SE DECISION MADE: 21-JUN-21
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Metapaste Plus
Meta Biomed Co., Ltd. 510(k) NO: K210904(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308841
270, Osong Saengmyeong 1-ro Osong-SE DECISION MADE: 30-JUN-21
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
Ezisurg Medical Co., Ltd. 510(k) NO: K210909(Traditional)
ATTN: Jingtian Ren PHONE NO : 86 21 50456176 8026
Rm. 103, Bldg. 2, No.1690 Cailun RSE DECISION MADE: 24-JUN-21
Shanghai CN 201203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iBOT Personal Mobility Device ("iBOT PMD")
Mobius Mobility 510(k) NO: K210920(Traditional)
ATTN: Joseph Sullivan PHONE NO : 833 3464268
540 Commercial St. Suite 310 SE DECISION MADE: 16-JUN-21
Manchester NH 03101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omnilux CLEAR
GlobalMed Technologies 510(k) NO: K210948(Traditional)
ATTN: Lisa Thorson PHONE NO : 707 2240200
163 Camino Dorado, Ste B SE DECISION MADE: 24-JUN-21
Napa CA 94558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synergy
YRS Group Inc. 510(k) NO: K210954(Traditional)
ATTN: Doris Dong PHONE NO : 86 21 31261348
4480 Delancey Dr Ste 14 SE DECISION MADE: 29-JUN-21
Las Vegas NV 89103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
Samsung Medison CO., LTD. 510(k) NO: K210959(Traditional)
ATTN: Scully Kim PHONE NO : 82 2 21941312
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 24-JUN-21
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two
CC Wellness LLC 510(k) NO: K210972(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 10-JUN-21
Valencia CA 91344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit
CC Wellness LLC 510(k) NO: K210986(Traditional)
ATTN: Marlent Perez PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 10-JUN-21
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Beveled FT Screws
Arthrex Inc. 510(k) NO: K210994(Traditional)
ATTN: Rebecca R Homan PHONE NO : 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 01-JUN-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral/Enteral Syringe with ENFit connector
Ningbo Tianyi Medical Appliance Co510(k) NO: K211025(Traditional)
ATTN: Wenyu Zhang PHONE NO : 86 574 55011007
No.788, Mozhi North Road, Tourism SE DECISION MADE: 30-JUN-21
Ningbo CN 315121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves
Huayuan Medical Technology(Shangqi510(k) NO: K211028(Traditional)
ATTN: Huamei Wang PHONE NO : 86 137 05111918
In The North Yard of West 1000m RoSE DECISION MADE: 04-JUN-21
Shangqiu CN 476000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biophotas Celluma RESTORE
Biophotas INC 510(k) NO: K211038(Traditional)
ATTN: Patrick Johnson PHONE NO : 714 8381956
1000 E. Howell Ave., Ste A SE DECISION MADE: 29-JUN-21
Anaheim CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sublime Radial Access 018 RX Dilatation Catheter
Creagh Medical Ltd. (a wholly owne510(k) NO: K211044(Special)
ATTN: Holly Ramirez PHONE NO : 763 5007545
Inc) IDA Business Park SE DECISION MADE: 16-JUN-21
Ballinasloe IE H53 HY09 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synthetic Vinyl Examination Gloves
Jiangsu Huayuan Medical Technology510(k) NO: K211045(Traditional)
ATTN: Yun Gao PHONE NO : 86 182 52909158
No. 36 Nanzhuang Road, High-Tech ISE DECISION MADE: 23-JUN-21
Dongtai CN 224299 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)
DePuy Synthes 510(k) NO: K211051(Traditional)
ATTN: Stacey Bonnell PHONE NO : 484 2387519
1301 Goshen Parkway SE DECISION MADE: 02-JUN-21
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240)
Thrombolex, Inc. 510(k) NO: K211061(Traditional)
ATTN: Amy Katsikis PHONE NO : 267 8983986
75 New Britain Dr. SE DECISION MADE: 10-JUN-21
New Britain PA 18901 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
Ammex-Weida (Hubei) Health and Saf510(k) NO: K211062(Traditional)
ATTN: Cai Mingqing PHONE NO : 86 27 85577096
Southern Industrial Zone (XinlirenSE DECISION MADE: 08-JUN-21
Xiantao CN 433011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlphaVac Multipurpose Mechanical Aspiration (MMA) System
AngioDynamics, Inc. 510(k) NO: K211081(Traditional)
ATTN: Kasey E Newcomb PHONE NO : 508 6587813
603 Queensbury Ave SE DECISION MADE: 04-JUN-21
Queensbury NY 12804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: E-Temp
EnvisionTEC GmbH 510(k) NO: K211101(Traditional)
ATTN: Ruediger van Bernum PHONE NO : 49 2043 987545
Bruesseler Straße 51 SE DECISION MADE: 14-JUN-21
Gladbeck DE D-45968 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prudent 1717, Prudent 1417, Prudent 1212
PIXXGEN Corporation 510(k) NO: K211108(Traditional)
ATTN: Young Kim PHONE NO : 824318 70 48468888
5F, SMART BAY, 123, Beolmal-ro, DoSE DECISION MADE: 04-JUN-21
Anyang-si KR 431-804 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
BioMerieux, Inc 510(k) NO: K211136(Traditional)
ATTN: Esther Hernandez PHONE NO : 314 7318841
595 Anglum Rd. SE DECISION MADE: 14-JUN-21
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Virtual C DRF Digital Imaging System
Portavision Medical LLC 510(k) NO: K211191(Traditional)
ATTN: Terry Ancar PHONE NO : 866 7834133
800 Central Avenue SE DECISION MADE: 24-JUN-21
Jefferson LA 70121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Prevue II Peripheral Vascular Vascular Access System
Bard Access Systems, Inc, (C.R. Ba510(k) NO: K211193(Traditional)
ATTN: Fabio De Pasquale PHONE NO : 250 9206501
605 North 5600 West SE DECISION MADE: 25-JUN-21
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SenoBright HD
GE Healthcare 510(k) NO: K211215(Traditional)
ATTN: Florian Akpakpa PHONE NO : 33 130 704040
283 Rue de la Minière SE DECISION MADE: 22-JUN-21
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid S60N / Vivid S70N
GE Medical Systems Ultrasound and 510(k) NO: K211216(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
LLC 9900 W. Innovation Drive SE DECISION MADE: 09-JUN-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apache Ultrasound System
Aco Healthcare Co,. Ltd. 510(k) NO: K211232(Traditional)
ATTN: Henry Huang PHONE NO : 886 3 5820446
Rm. 520, Bldg. 53, No. 195, Sec. 4SE DECISION MADE: 25-JUN-21
Hsinchu TW 31057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement
Stryker Instruments 510(k) NO: K211238(Traditional)
ATTN: Susanne Galin PHONE NO : 812 3457917
1941 Stryker Way SE DECISION MADE: 25-JUN-21
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisionPort System
New View Surgical, Inc. 510(k) NO: K211250(Traditional)
ATTN: Bryce Klontz PHONE NO : 774 2842283
555 Massachusetts Ave., Suite 5 SE DECISION MADE: 21-JUN-21
Boston MA 02118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Glove
Jiangsu Dihong Industry and Trade 510(k) NO: K211252(Traditional)
ATTN: Sue Chen PHONE NO : 86 187 1104047
Dongxiaodian Industrial Park SE DECISION MADE: 25-JUN-21
Shuyang CN 223616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renamel Bulkfill
Cosmedent, Inc 510(k) NO: K211259(Traditional)
ATTN: Gary Chuven PHONE NO : 773 5925604
401 North Michigan Avenue, Suite 2SE DECISION MADE: 24-JUN-21
Chicago IL 60611 510(k) STATEMENT
DEVICE: ICOONE Laser Med (also referred to as ICOONE Medical laser)
I-Tech Industries SRL 510(k) NO: K211272(Traditional)
ATTN: Gianfranco Tudico PHONE NO : 39 051 6259797
Via Casalino 5/H SE DECISION MADE: 22-JUN-21
Bergamo IT 24121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Winged Blood Collection Sets
Promisemed Hangzhou Meditech Co., 510(k) NO: K211293(Traditional)
ATTN: Zearou Yang PHONE NO : 865 7188772985
No. 12 Longtan Road, Cangqian StreSE DECISION MADE: 25-JUN-21
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTRELEASE Endoscopic Soft Tissue Release System
MicroAire Surgical Instruments 510(k) NO: K211297(Traditional)
ATTN: Glenn Gerstenfeld PHONE NO : 434 9758344
3590 Grand Forks Blvd SE DECISION MADE: 24-JUN-21
Charlottesville VA 22911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avon Patello-femoral Joint Prosthesis
Howmedica Osteonics Corp., dba Str510(k) NO: K211303(Traditional)
ATTN: Shraddha More PHONE NO : 201 8315804
325 Corporate Dr. SE DECISION MADE: 04-JUN-21
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LABYRINTH
Zavation Medical Products LLC 510(k) NO: K211306(Traditional)
ATTN: Colby Williams PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 24-JUN-21
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Megine Industries Sdn Bhd 510(k) NO: K211310(Third Party - Traditional)
ATTN: Benjamin Ng Soong Jing PHONE NO : 60 112 6808828
B-05-02, The Vertical Business SuiSE DECISION MADE: 16-JUN-21
Kuala Lumpur MY 59200 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ASTRA Spine System
SpineCraft, LLC 510(k) NO: K211323(Special)
ATTN: Ami Akallal-Asaad PHONE NO : 630 9207300 233
777 Oakmont Lane, Suite 200 SE DECISION MADE: 03-JUN-21
Westmont IL 60559 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Examination Glove
Inner Mongolia Cureguard Medical M510(k) NO: K211336(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
RM 408, Building 5, Block B of BusSE DECISION MADE: 16-JUN-21
Ulanqab CN 012000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
Mahana Therapeutics Inc. 510(k) NO: K211372(Special)
ATTN: Jean-Noel Courvoisier PHONE NO : 415 3358649
One Market, Spear Tower 36th FloorSE DECISION MADE: 02-JUN-21
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
Gyrus ACMI, Inc. 510(k) NO: K211401(Special)
ATTN: Julie Acker PHONE NO : 484 2946981
800 West Park Drive SE DECISION MADE: 03-JUN-21
Westborough MA 01581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CervAlign® Anterior Cervical Plate System
Pioneer Surgical Technology, Inc. 510(k) NO: K211408(Traditional)
ATTN: Jaclyn Holli PHONE NO : 906 2269909
375 River Park Circle SE DECISION MADE: 23-JUN-21
Marquette MI 49855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlidePath 13F Long-Term Hemodialysis Catheter
Bard Peripheral Vascular, Inc 510(k) NO: K211410(Special)
ATTN: Joan Bergstrom PHONE NO : 480 5978425
1625 West 3rd Street SE DECISION MADE: 04-JUN-21
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASM-301 Level 3 Surgical Mask
American Surgical Mask Company LLC510(k) NO: K211440(Third Party - Traditional)
ATTN: Matt Brandman PHONE NO : 850 2282236
5508 N 50th Street Suite 1000 SE DECISION MADE: 02-JUN-21
Tampa FL 33610 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Navigated Anterolateral Disc Prep Instruments
Medtronic Sofamor Danek USA, INC. 510(k) NO: K211441(Special)
ATTN: Alex Underberg PHONE NO : 901 3441443
1800 Pyramid Place SE DECISION MADE: 09-JUN-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via MI WorkFlows, Scenium, syngo MBF
Siemens Medical Solutions USA, Inc510(k) NO: K211459(Special)
ATTN: Clayton Ginn PHONE NO : 865 8982692
810 Innovation Drive SE DECISION MADE: 10-JUN-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Callaly Tampliner
Calla Lily Personal Care, Ltd. 510(k) NO: K211469(Special)
ATTN: Shaun Knights PHONE NO : 44 75 92694078
10 Rose & Crown Yard SE DECISION MADE: 10-JUN-21
London GB SW1Y 6RE 510(k) STATEMENT
DEVICE: Micro C Medical Imaging System, M01
OXOS Medical, Inc. 510(k) NO: K211473(Third Party - Traditional)
ATTN: Evan Ruff PHONE NO : 855 7339729
1230 Peachtree Street NE Suite 300SE DECISION MADE: 04-JUN-21
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing
Imperative Care Inc. 510(k) NO: K211476(Special)
ATTN: Teri Nguyen PHONE NO : 408 8334415
1359 Dell Avenue SE DECISION MADE: 08-JUN-21
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
Stryker Corporation 510(k) NO: K211490(Special)
ATTN: John Chesney PHONE NO : 734 6735624
4100 East Milham Avenue SE DECISION MADE: 09-JUN-21
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System
Volcano AtheroMed, Inc. 510(k) NO: K211518(Special)
ATTN: Jean Chang PHONE NO : 408 5822779
1530 O'Brien Drive, Suite A SE DECISION MADE: 14-JUN-21
Menlo Park CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amerishield Surgical Mask
PremiumEStore, LLC 510(k) NO: K211520(Third Party - Traditional)
ATTN: Brent Dillie PHONE NO : 888 2671801
2601 Reliance Drive Suite 102 SE DECISION MADE: 15-JUN-21
Virginia Beach VA 23452 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Sonata Transcervical Fibroid Ablation System 2.2
Gynesonics, Inc. 510(k) NO: K211535(Special)
ATTN: Christine Ehmann PHONE NO : 585 3156973
600 Chesapeake Drive SE DECISION MADE: 17-JUN-21
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fiducial Marker
Carbon Medical Technologies Inc. 510(k) NO: K211590(Special)
ATTN: Eric Furlich PHONE NO : 651 6538512
1290 Hammond Road SE DECISION MADE: 10-JUN-21
St. Paul MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc. 510(k) NO: K211595(Special)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 23-JUN-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon Spinal System
Medtronic 510(k) NO: K211596(Special)
ATTN: Diamond Wallace PHONE NO : 901 3993133
1800 Pyramid Place SE DECISION MADE: 23-JUN-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mariner Deformity System
SeaSpine Orthopedics Corporation 510(k) NO: K211606(Special)
ATTN: Jesse Albright PHONE NO : 760 2165176
5770 Armada Drive SE DECISION MADE: 23-JUN-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THD Procto Software System
THD SpA 510(k) NO: K211623(Special)
ATTN: Maurizio Pantaleoni PHONE NO : 39 0522 634311
Via dell'Industria, 1 SE DECISION MADE: 24-JUN-21
Correggio IT 42015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D Echo v1.1
JointVue LLC 510(k) NO: K211656(Third Party - Traditional)
ATTN: Maja Ward PHONE NO : 1 865 2351241
2450 E.J. Chapman Drive, Suite 104SE DECISION MADE: 25-JUN-21
Knoxville TN 37996 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Valkyrie Thoracic Fixation System
JM Longyear Manufacturing, LLC d/b510(k) NO: K211695(Special)
ATTN: Wade DePas PHONE NO : 906 3604670
512 4th Street SE DECISION MADE: 23-JUN-21
Gwinn MI 49841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
Waldemar Link GmbH & Co. KG 510(k) NO: K211768(Special)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53575530
Oststraße 4-10 SE DECISION MADE: 30-JUN-21
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 210
TOTAL WITH SUMMARIES 201
TOTAL WITH STATEMENTS 9
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