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June 2021 510(K) Clearances

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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