U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. January 2021 510(K) Clearances
  1. 510(k) Clearances

January 2021 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2021


DEVICE: EndoClot
EndoClot Plus Co., Ltd.           510(k) NO: K190677(Traditional)
ATTN: Huihui  Xie                 PHONE NO : 086 512 62605550 
101 Room, B8 Building, 218 Xinghu SE DECISION MADE: 29-JAN-21
SuZhou  CN 215000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEX Device
Dex Surgical                      510(k) NO: K191878(Traditional)
ATTN: Guillaume  Noury            PHONE NO : 33 1 69206969 
3 Rue Des Petits Ruisseaux        SE DECISION MADE: 29-JAN-21
Verrieres Le Buisson  FR 91370    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i_Space 1.5T Superconducting Magnetic Resonance Imaging System
MRI Division, Beijing Wandong Medi510(k) NO: K192650(Traditional)
ATTN: Zhou  Lu                    PHONE NO : 86 10 65794660 
No.7 Sanjianfang Nanli, Chaoyang DSE DECISION MADE: 29-JAN-21
Beijing  CN 100024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K192913(Traditional)
ATTN: Muhammed Hulusi Sonmez      PHONE NO : 90 542372 2723 
Fetih Mahallesi Mahir Sokak No:5/2SE DECISION MADE: 19-JAN-21
Konya  TR 42030                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyisoprene Powder Free, Black Colour Surgical Gloves
Emerson & Co. Srl                 510(k) NO: K192933(Special)
ATTN: Laura  Figliomeni           PHONE NO : 39 0105 386400 
Piazza Della Vittoria 10          SE DECISION MADE: 13-JAN-21
Genoa  IT 16121                   510(k) STATEMENT
                                                    

DEVICE: ICE COMPRESSION FIRST, DUO, & MOOVE Systems
mks paris                         510(k) NO: K193079(Traditional)
ATTN: Cervilla  Stanislas         PHONE NO : 0033  497642105 
Zone Ecoparc 27 Rue Meziere       SE DECISION MADE: 11-JAN-21
Fabregues  FR 34690               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIIN
Medico USA Inc.                   510(k) NO: K193266(Traditional)
ATTN: Peter  Son                  PHONE NO : 1 213 7031223 
3407 W 6th St Suite 507           SE DECISION MADE: 22-JAN-21
Los Angeles CA  90020             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uAI EasyTriage-Rib
Shanghai United Imaging Intelligen510(k) NO: K193271(Traditional)
ATTN: Zhao  Xiaojing              PHONE NO : 86 021 67076888 
No. 199, Huanke Road              SE DECISION MADE: 15-JAN-21
Shanghai  CN 201210               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulin Syringe
Prominsemed Hangzhou Meditech Co.,510(k) NO: K193273(Traditional)
ATTN: Liqing  Yang                PHONE NO : 86 0571 88772985 
No. 12, Longtan Road, Cangqian StrSE DECISION MADE: 05-JAN-21
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Electronic Sphygmomanometer
Shenzhen Changkun Technology Co., 510(k) NO: K193386(Traditional)
ATTN: Steve  Li                   PHONE NO : 86 0755 29100487 
801, 3 Floor, 4 Floor, 5 Floor, 6 SE DECISION MADE: 27-JAN-21
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Electronic Sphygmomanometer
ShenZhen Changkun Technology CO.,L510(k) NO: K193387(Traditional)
ATTN: Steve  Li                   PHONE NO : 86 0755 29100487 
801, 3 floor 4floor 5floor 6floor SE DECISION MADE: 27-JAN-21
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fixone Biocomposite Interference Screw
AJU Pharm Co., Ltd.               510(k) NO: K193497(Traditional)
ATTN: Kim Joong Kil               PHONE NO : 82 31 7654420 
A-207, 697, Pangyo-ro             SE DECISION MADE: 05-JAN-21
Seongnam-si  KR 13511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivo 45 LS
Breas Medical AB                  510(k) NO: K193586(Traditional)
ATTN: Ari  Sobel                  PHONE NO : 617 3566289 
Foretagsvagen 1                   SE DECISION MADE: 27-JAN-21
Molnlyeke  SE SE-453 33           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EBERLE Shaver System C3 and Accessories
Eberle GmbH & Co. KG              510(k) NO: K193608(Traditional)
ATTN: Udo  Schniebs               PHONE NO : 49 7044 96110 
Glassbronnenstrasse 6             SE DECISION MADE: 15-JAN-21
Wurmberg  DE 75449                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Applied Medical Anoscope
Applied Medical Resources         510(k) NO: K200021(Traditional)
ATTN: Frans  VandenBroek          PHONE NO : 949 7138369 
22872 Avenida Empresa             SE DECISION MADE: 06-JAN-21
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piccolo Medical SmartPICC System
Piccolo Medical, Inc              510(k) NO: K200037(Traditional)
ATTN: Alexey  Salamini            PHONE NO : 617 4071026 
101 Mississippi St                SE DECISION MADE: 22-JAN-21
San Fransico CA  94107            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-contact Infrared Body Thermometer, model:HTD8823US
HeTaiDa Technology Co., Ltd.      510(k) NO: K200159(Traditional)
ATTN: Tom  Chen                   PHONE NO : 86 769 82658050 
4F, BaiShiDa High-Tech Park, XiangSE DECISION MADE: 05-JAN-21
DongGuan City  CN 523820          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ava Fertility Tracker
Ava AG                            510(k) NO: K200163(Traditional)
ATTN: Blathnaid  Feldman          PHONE NO : 011 41 764431686 
Gustrasse 73                      SE DECISION MADE: 19-JAN-21
Zurich  CH 8055                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Michler-Kapp Cardiovascular Vent Catheter
Kapp Surgical Instrument, Inc.    510(k) NO: K200289(Traditional)
ATTN: Nicole  Merrifield          PHONE NO : 216 5874400 
4919 Warrensville Center Rd       SE DECISION MADE: 28-JAN-21
Cleveland OH  44128               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABI Instrument, Creo Electrosurgical System
Creo Medical Ltd.                 510(k) NO: K200298(Traditional)
ATTN: Patrick  Burn               PHONE NO : 44 129 1643926 
Creo House, Unit 2, Beaufort Park SE DECISION MADE: 05-JAN-21
Chepstow  GB NP16 5UH             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTL-703-2
BTL                               510(k) NO: K200382(Traditional)
ATTN: David  Chmel                PHONE NO : 1 866 2851656 
362 Elm Street                    SE DECISION MADE: 06-JAN-21
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HipXpert 3D Display and Anchoring Application
Surgical Planning Associates, Inc 510(k) NO: K200384(Traditional)
ATTN: Stephen B Murphy            PHONE NO : 617 2774434 
New England Baptist Hospital, 125 SE DECISION MADE: 28-JAN-21
Boston MA  02120                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEE Cages
NGMedical GmbH                    510(k) NO: K200429(Traditional)
ATTN: Stella  Hahn                PHONE NO : 49 06873 999970 
Talsperrenblick 5                 SE DECISION MADE: 29-JAN-21
Nonnweiler  DE 66620              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bfix Orthopedic External Fixator Systems
Aike (Shanghai) Medical Instrument510(k) NO: K200491(Traditional)
ATTN: Gu  Hongying                PHONE NO : 
B320, B321, B322, B323, No. 1128, SE DECISION MADE: 05-JAN-21
Shanghai  CN 201801               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InBody
InBody Co. Ltd.                   510(k) NO: K200560(Abbreviated)
ATTN: Koeun  Jung                 PHONE NO : 82 02 5013939 
InBody Bldg., 625, Eonju-ro, GangnSE DECISION MADE: 06-JAN-21
Seoul  KR 06106                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Galapogos
ResMed Corp                       510(k) NO: K200565(Traditional)
ATTN: Rose  Malonzo               PHONE NO : 858 8366727 
9001 Spectrum Center Blvd         SE DECISION MADE: 17-JAN-21
San Diego CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENTity WiFi Video Nasopharyngoscope System
Optim, LLC                        510(k) NO: K200609(Traditional)
ATTN: Jenna  Lipka                PHONE NO : 508 5565159 
64 Technology Park Rd.            SE DECISION MADE: 13-JAN-21
Sturbridge MA  01566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyPath RF Introducer Sheath
Broncus Medical, Inc              510(k) NO: K200702(Traditional)
ATTN: Robin  Bush                 PHONE NO : 650 4281600 
125 Nicholson Lane                SE DECISION MADE: 14-JAN-21
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLEWICU System (ClewICUServer and ClewICUnitor)
CLEW Medical Ltd.                 510(k) NO: K200717(Traditional)
ATTN: Avigdor  Faians             PHONE NO : 972 9 7795995 
5 Hamelacha St.                   SE DECISION MADE: 09-JAN-21
Netanya  IL 4206002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5
pjur group Luxembourg SA          510(k) NO: K200731(Traditional)
ATTN: Andrea  Giebel              PHONE NO : 352 74 8989 
87 esplanade de la Moselle        SE DECISION MADE: 21-JAN-21
Wasserbillig  LU L-6637           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B
Wilson Instruments (SHA) Co., LTD 510(k) NO: K200769(Traditional)
ATTN: Juan  Wu                    PHONE NO : 86 21 39290696 8027
Building 5, No. 258 Shuangbang Rd.SE DECISION MADE: 06-JAN-21
Shanghai  CN 201702               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiWrap FROST
MAST Biosurgery                   510(k) NO: K200918(Traditional)
ATTN: Roel  Trip                  PHONE NO : 858 5508050 
6749 Top Gun St. Suite 108        SE DECISION MADE: 07-JAN-21
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine HA Pedicle Screw System
Altus Partners, LLC               510(k) NO: K200922(Special)
ATTN: Mark  Melton                PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 26-JAN-21
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halo Single-Loop Microsnare Kit
Argon Medical Devices, Inc.       510(k) NO: K200963(Traditional)
ATTN: Ana  Jimenez-Hughes         PHONE NO : 903 6764276 
1445 Flat Creek Road              SE DECISION MADE: 05-JAN-21
Athens TX  75751                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermidas IR System (ThIR-A615)
Thermidas Americas, Inc.          510(k) NO: K200999(Traditional)
ATTN: Karo  Kujanpaa              PHONE NO : 727 4602507 
7912 Sailboat Key Blvd., Suite 508SE DECISION MADE: 06-JAN-21
South Pasadena FL  33707          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyOnyx System
Thought Technology LTD.           510(k) NO: K201014(Traditional)
ATTN: Zena  Butris                PHONE NO : 1 514 4898251 
5250 Ferrier, Suite 812           SE DECISION MADE: 13-JAN-21
Montreal  CA H4P 1L3              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use)
Huizhou Foryou Medical Devices Co.510(k) NO: K201016(Traditional)
ATTN: Guosheng  Tan               PHONE NO : 86 0752 5302185 
No. 1 Shangxia North Road, DongjiaSE DECISION MADE: 28-JAN-21
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
Ethicon Endo-Surgery, LLC         510(k) NO: K201066(Traditional)
ATTN: Nathan  Anderson            PHONE NO : 787 2726500 
475 Calle C                       SE DECISION MADE: 22-JAN-21
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeVa PV Thrombectomy Device
Vesalio                           510(k) NO: K201085(Traditional)
ATTN: Gustavo  Prado              PHONE NO : 615 2067788 
3200 West End Ave, Ste 500        SE DECISION MADE: 15-JAN-21
Nashville TN  37203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bidop 7
Koven Technology, Inc.            510(k) NO: K201114(Traditional)
ATTN: Heather  Bell               PHONE NO : 314 5422101 
477 N. Lindbergh Blvd., Ste.220   SE DECISION MADE: 05-JAN-21
St. Louis MO  63141               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cytoplast Titanium-Reinforced PTFE Membranes
Osteogenics Biomedical, Inc.      510(k) NO: K201187(Traditional)
ATTN: Shane  Shuttlesworth        PHONE NO : 806 7961923 
4620 71st St. Bldg. 78-79         SE DECISION MADE: 23-JAN-21
Lubbock TX  79424                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biocore9 Femoral Head Resurfacing Component
BioCore9 LLC                      510(k) NO: K201219(Traditional)
ATTN: Stan  Matlak                PHONE NO : 973 5854281 
9 Whippany Road, BLDG A1, Unit 12 SE DECISION MADE: 19-JAN-21
Whippany NJ  07981                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Striate+™
Orthocell Ltd                     510(k) NO: K201241(Traditional)
ATTN: Alison  Carleton            PHONE NO : 61 8936 02888 
Building 191 Murdoch University, SSE DECISION MADE: 11-JAN-21
Perth  AU 6150                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System
Wright Medical Technology, Inc.   510(k) NO: K201259(Traditional)
ATTN: Anna  Hinton                PHONE NO : 901 4516362 
1023 Cherry Road                  SE DECISION MADE: 08-JAN-21
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Airway Mobilescope
Olympus Medical Systems Corp.     510(k) NO: K201300(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 26-JAN-21
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Forwarts
Pronova Laboratories BV           510(k) NO: K201366(Traditional)
ATTN: Diede  Klever               PHONE NO : 31 2944 66611 
Kruitpad 16                       SE DECISION MADE: 21-JAN-21
Muiden  NL 1398 CP                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visage Breast Density
Visage Imaging GmbH               510(k) NO: K201411(Traditional)
ATTN: Stefan  Strowich            PHONE NO : 49 30 70096841 
Lepsiusstrasse 70                 SE DECISION MADE: 29-JAN-21
Berlin  DE 12163                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunset Heated CPAP Tube
Sunset Healthcare Solutions, Inc. 510(k) NO: K201418(Traditional)
ATTN: N. (Nazree)  Williams       PHONE NO : 312 9979980 
180 N. Michigan Ave, Suite 2000   SE DECISION MADE: 29-JAN-21
Chicago IL  60601                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Shenzhen Creative Industry Co., Lt510(k) NO: K201468(Traditional)
ATTN: Jia  Wang                   PHONE NO : 86 755264 33325 
Floor 5, BLD 9 Baiwangxin High-TecSE DECISION MADE: 25-JAN-21
Shenzhen  CN 518110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M-Vizion Femoral Revision System Extension
Medacta International SA          510(k) NO: K201471(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91696 6060
Strada Regina                     SE DECISION MADE: 11-JAN-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simply Iconic Implants
Implant Direct Sybron Manufacturin510(k) NO: K201553(Traditional)
ATTN: Reina  Choi                 PHONE NO : 818 4443306 
3050 East Hillcrest Drive         SE DECISION MADE: 22-JAN-21
Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MatriDerm
MedSkin Solutions Dr. Suwelack AG 510(k) NO: K201577(Traditional)
ATTN: Zuzana  Hülsbusch           PHONE NO : 0049 2543 2182202 
Josef-Suwelack-Strasse 2          SE DECISION MADE: 07-JAN-21
Billerbeck  DE 48727              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shenzhen Xunwei Industrial Co., Lt510(k) NO: K201579(Traditional)
ATTN: Liu  Shengcai               PHONE NO : 86 755 86191210 
First floor to fourth, Upper SmallSE DECISION MADE: 15-JAN-21
Shenzhen  CN 518102               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-contact Electronic Forehead Infrared Thermometer
Zhongshan Jinli Electronic Weighin510(k) NO: K201582(Traditional)
ATTN: Jerry  Liang                PHONE NO : 86 0760 28133793 
283rd South Min’an Road, Xiaolan TSE DECISION MADE: 15-JAN-21
Zhongshan  CN 528416              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenesisZr UHT700 Zirconia
United Dental Resources Corporatio510(k) NO: K201608(Traditional)
ATTN: John Von Thaden             PHONE NO : 1 708 7465730 
70 Towncenter Drive               SE DECISION MADE: 28-JAN-21
University Park IL  60417         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luna® G3 BPAP 25A
3B Medical, Inc.                  510(k) NO: K201620(Traditional)
ATTN: Yasser  Estafanous          PHONE NO : 863 2266285 
203 Avenue A NW, Suite 300        SE DECISION MADE: 29-JAN-21
Winter Haven FL  33881            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Surgical Mask
Tianjin Saiyuan Technology CO., LT510(k) NO: K201625(Abbreviated)
ATTN: Hong  Cai                   PHONE NO : 86 22 60406905 
8 DongJiu Street, Zhongxin Road, PSE DECISION MADE: 12-JAN-21
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VMCore Biopsy Needle
URO-1, Inc.                       510(k) NO: K201650(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 510 2061794 
111 North Chestnut Street Suite 10SE DECISION MADE: 15-JAN-21
Winston Salem NC  27101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Potenza
Jeisys Medical, Inc.              510(k) NO: K201685(Traditional)
ATTN: Do Hyun  Kim                PHONE NO : 82 07 74354930 
307, Daeryung Techno Town 8th, GamSE DECISION MADE: 19-JAN-21
Seoul  KR 08501                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length
Ethicon Endo-Surgery, LLC         510(k) NO: K201696(Traditional)
ATTN: Nathan  Anderson            PHONE NO : 787 2726500 
475 Calle C                       SE DECISION MADE: 22-JAN-21
Guaynabo PR  00696                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEGO Semados® RS/RSX Implant System
BEGO Implant Systems GmbH & Co. KG510(k) NO: K201700(Traditional)
ATTN: Bertrand  Lecointe          PHONE NO : 49 421 2028230 
Wilhelm-Herbst-Str. 1             SE DECISION MADE: 13-JAN-21
Bremen  DE 28359                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vital Sleep
The Snore Reliever Company, LLC   510(k) NO: K201719(Abbreviated)
ATTN: David  Hernandez            PHONE NO : 646 3160918 
4201 Tonnelle Avenue; Unit 202    SE DECISION MADE: 14-JAN-21
North Bergen NJ  07047            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Pre-calibrated Suction
Brainlab AG                       510(k) NO: K201752(Traditional)
ATTN: Chiara  Cunico              PHONE NO : 49 899 915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 29-JAN-21
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190
Olympus Medical Systems Corp.     510(k) NO: K201758(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 21-JAN-21
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT TBI Plasma cartridge with the i-STAT Alinity System
Abbott Laboratories               510(k) NO: K201778(Traditional)
ATTN: Brian  Ma                   PHONE NO : 609 4549360 
400 College Road East             SE DECISION MADE: 08-JAN-21
Princeton NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuFace Trinity Plus Device
Carol Cole Company dba NuFACE     510(k) NO: K201782(Traditional)
ATTN: Danielle Barker Fernandes   PHONE NO : 760 5091236 
1325 Sycamore Avenue, Suite A     SE DECISION MADE: 22-JAN-21
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid Acoustic Pulse Device
Soliton Inc.                      510(k) NO: K201801(Traditional)
ATTN: Leslie  Honda               PHONE NO : 206 3758586 
5304 Ashbrook Drive               SE DECISION MADE: 29-JAN-21
Houston TX  77081                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i
Canon Medical Systems Corporation 510(k) NO: K201836(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 12-JAN-21
Otawara-Shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PediFlex Flexible Nail System
OrthoPediatrics Corp.             510(k) NO: K201838(Traditional)
ATTN: Yan  Li                     PHONE NO : 574 2670864 
2850 Frontier Drive               SE DECISION MADE: 29-JAN-21
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeutrArt
Asset Medikal Tasarim AS.         510(k) NO: K201872(Traditional)
ATTN: Ebru  Sirali                PHONE NO : 902 124942727 
Ikitelli OSB Mahallesi, 17. Cadde,SE DECISION MADE: 05-JAN-21
Istanbul  TR 34490                510(k) STATEMENT
                                                    

DEVICE: Sparrow Therapy System
Spark Biomedical, Inc.            510(k) NO: K201873(Traditional)
ATTN: Daniel  Powell              PHONE NO : 877 5467727 
18208 Preston Road, Suite D9-531  SE DECISION MADE: 02-JAN-21
Dallas TX  75252                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525
Richard Wolf Medical Instruments C510(k) NO: K201897(Traditional)
ATTN: Michael  Loiterman          PHONE NO : 847 9131113 
353 Corporate Woods Parkway       SE DECISION MADE: 15-JAN-21
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trophikos Vaginal Moisturizer
Trophikos, LLC                    510(k) NO: K201922(Traditional)
ATTN: Terri Jackson Wade          PHONE NO : 404 7362595 
1212 Collier Rd NW                SE DECISION MADE: 14-JAN-21
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nanum Syringe
Nanum Company Co., Ltd            510(k) NO: K201930(Traditional)
ATTN: Jeong Ung Jong              PHONE NO : 82 53 7957076 
4th floor, 40, Siji-ro            SE DECISION MADE: 17-JAN-21
Daegu  KR 42251                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-connect S Endo Motor with built-in Apex Locator
Changzhou Sifary Medical Technolog510(k) NO: K201993(Traditional)
ATTN: Amanda  Zhu                 PHONE NO : 86 0519 85962691 
No. 99, Qingyang Road, Xuejia CounSE DECISION MADE: 29-JAN-21
Changzhou City  CN 213000         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Passion Natural Water Based Lubricant
XR LLC                            510(k) NO: K202017(Traditional)
ATTN: Louie  Goryoka              PHONE NO : 714 9071034 
5251 Pipeline Lane                SE DECISION MADE: 08-JAN-21
Huntington Beach CA  92649        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maven Patient-Specific Instrumentation
Paragon 28, Inc.                  510(k) NO: K202019(Traditional)
ATTN: Haylie  Hertz               PHONE NO : 303 7200017 
14445 Grasslands Dr.              SE DECISION MADE: 14-JAN-21
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioGuard EUS Air/Water and Suction Valves
Steris Corporation                510(k) NO: K202104(Traditional)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 14-JAN-21
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Protective Mask
Guangdong Kingfa Sci.&Tech.Co., Lt510(k) NO: K202107(Traditional)
ATTN: Yu  Xiaoge                  PHONE NO : 86 1357 0952157 
28 Delong Avenue, Shijiao Town, QiSE DECISION MADE: 15-JAN-21
Qingyuan  CN 511500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set
Argon Medical Devices, Inc.       510(k) NO: K202141(Traditional)
ATTN: Amy  Clendening-Wheeler     PHONE NO : 469 7311413 
1445 Flat Creek Road              SE DECISION MADE: 15-JAN-21
Athens TX  75751                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTL-899ST
BTL                               510(k) NO: K202199(Traditional)
ATTN: David  Chmel                PHONE NO : 1 866 2851656 
362 Elm Street                    SE DECISION MADE: 26-JAN-21
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VX650
Luneau Technology Operations      510(k) NO: K202221(Traditional)
ATTN: Yossi  Constantinis         PHONE NO : 972 546 535299 
2 rue Roger Bonnet                SE DECISION MADE: 29-JAN-21
Pont-de-l'Arche  FR 27340         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OBS Anchorage Screw, Biokey Anchorage Screw
Bomei Co, Ltd.                    510(k) NO: K202278(Special)
ATTN: Steven  Pan                 PHONE NO : 886 3 3554989 
4F., No.1492-2, Chunrih Rd., TaoyuSE DECISION MADE: 08-JAN-21
Taoyuan City  TW 33051            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System - Zirconia Implant System
JJGC Industria e Comercio de Mater510(k) NO: K202282(Traditional)
ATTN: Mariana  Soares Hartmann    PHONE NO : 55 41 21694000 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 29-JAN-21
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Button Loop
Yunyi (Beijing) Medical Device Co.510(k) NO: K202291(Traditional)
ATTN: Xiaowei  Liu                PHONE NO : 86 10 57234533 
Floor 1-4, Building 4, No. 9 TianfSE DECISION MADE: 08-JAN-21
Beijing  CN 102600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back
Wildcat PPE, LLC                  510(k) NO: K202310(Traditional)
ATTN: Matthew  McFarlane          PHONE NO : 346 3674299 
301 S. Trade Center Pkwy          SE DECISION MADE: 29-JAN-21
Conroe TX  77385                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Procedure face mask (Model: KKF-2A)
Han Zhaoqing Sporting Goods Compan510(k) NO: K202314(Traditional)
ATTN: Zhang  Ming                 PHONE NO : 86 138 25518595 
NO.2-1, Kang tai Street, High-techSE DECISION MADE: 13-JAN-21
Zhaoqing  CN 526238               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lockado Repositionable Hemostasis Clip
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K202333(Traditional)
ATTN: Sally  He                   PHONE NO : 86 25 58646395 
No.10 Gaoke Third Road            SE DECISION MADE: 14-JAN-21
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Monitor
Edan Instruments, Inc.            510(k) NO: K202336(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 26858736 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 23-JAN-21
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System
Shantou Institute of Ultrasonic In510(k) NO: K202350(Traditional)
ATTN: Flower  Cai                 PHONE NO : 86 754 88250150 
77 Jinsha Road                    SE DECISION MADE: 06-JAN-21
Shantou  CN 515041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protective Face Mask for Medical Use
Hunan Heng Chang Pharmaceutical Co510(k) NO: K202358(Traditional)
ATTN: Tao  Jingfeng               PHONE NO : 86 0731 86670066 
Floor 2,3, 102 of Building 16, StaSE DECISION MADE: 29-JAN-21
Changsha  CN 410000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HBP7 Settable Hemostatic Bone Putty
Orthocon, Inc.                    510(k) NO: K202363(Traditional)
ATTN: Howard  Schrayer            PHONE NO : 914 3572600 
1 Bridge Street, Suite 121        SE DECISION MADE: 19-JAN-21
Irvington NY  10533               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGIC Infusion Catheter
Balt USA, LLC                     510(k) NO: K202366(Traditional)
ATTN: Corina  Pierson             PHONE NO : 949 7881443 770
29 Parker                         SE DECISION MADE: 29-JAN-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIR 800
Aesculap, Inc.                    510(k) NO: K202391(Traditional)
ATTN: Kathy A. Racosky            PHONE NO : 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 21-JAN-21
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ti3Z Cervical Interbody System
Zavation Medical Products, LLC    510(k) NO: K202398(Traditional)
ATTN: Katie  Motley               PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 29-JAN-21
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1
Shenzhen Mindray Bio-medical Elect510(k) NO: K202405(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81888998 
Mindray Building, Keji 12th Road SSE DECISION MADE: 07-JAN-21
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas CTNG for use on cobas 6800/8800 systems
Roche Molecular Systems, Inc.     510(k) NO: K202408(Traditional)
ATTN: Aradhana  Karthikeyan       PHONE NO : 925 3537713 
4300 Hacienda Drive               SE DECISION MADE: 21-JAN-21
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrainInsight
Hyperfine Research, Inc           510(k) NO: K202414(Traditional)
ATTN: Robert  Fasciano            PHONE NO : 617 4359098 
530 Old Whitfield St.             SE DECISION MADE: 07-JAN-21
Guilford CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VirtueRF
ShenB Co Ltd                      510(k) NO: K202415(Traditional)
ATTN: Oskar  Lee                  PHONE NO : 82 70 49122702 
ShenB Bldg 148 Seongsui-ro        SE DECISION MADE: 22-JAN-21
Seoul  KR 04796                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZSFab Cervical Interbody System
ZSFab Inc.                        510(k) NO: K202488(Traditional)
ATTN: Kai  Xu                     PHONE NO : 213 8804966 
705 Cambridge Street STE 1        SE DECISION MADE: 07-JAN-21
Cambridge MA  02141               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Face Mask
Jiangsu NewValue Medical Products 510(k) NO: K202491(Traditional)
ATTN: Zhou  Zhengguo              PHONE NO : 86 0523 86867878 
Building G35, No. I Avenue, China SE DECISION MADE: 06-JAN-21
Taizhou  CN 225300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIRION Lateral Lumbar Interbody Fusion
Astura Medical, LLC               510(k) NO: K202495(Traditional)
ATTN: Parker  Kelch               PHONE NO : 469 5015530 
4949 W Royal Ln                   SE DECISION MADE: 06-JAN-21
Irving TX  75063                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GetSet Surgical GoPLF! Posterior Lateral Fusion System
GetSet Surgical, SA               510(k) NO: K202505(Traditional)
ATTN: Ole  Stoklund               PHONE NO : 41 79 2861486 
Route de la Corniche 4            SE DECISION MADE: 11-JAN-21
Epalinges  CH 1066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EEA Circular Stapler with Tri-Staple Technology
Covidien                          510(k) NO: K202507(Traditional)
ATTN: Leo  Chen                   PHONE NO : 86 21 33230182 
Rooms 501, 502, 601, 602 No.3 builSE DECISION MADE: 21-JAN-21
Min Hang District, Shanghai  CN 20510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standard Sterilizable Tray
Implant Direct Sybron Manufacturin510(k) NO: K202524(Traditional)
ATTN: Reina  Choi                 PHONE NO : 818 3073132 
3050 East Hillcrest Drive         SE DECISION MADE: 28-JAN-21
Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instylla Delivery Kit
Instylla, Inc.                    510(k) NO: K202544(Special)
ATTN: Jennifer  Greer             PHONE NO : 781 7904861 
201 Burlington Rd, North Building SE DECISION MADE: 07-JAN-21
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPoint Array System
ClearPoint Neuro, Inc.            510(k) NO: K202575(Traditional)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 22-JAN-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Mask-Model MP002-5, MP002-6
Jiangmen Sure&Me Medical Product C510(k) NO: K202577(Traditional)
ATTN: Liang  Meixia               PHONE NO : 86 181 38977291 
Jingshuiwan, Chakeng Village CommiSE DECISION MADE: 11-JAN-21
Jiangmen  CN 529000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Masks-Non Sterile
Shandong T&F Nonwoven Co., LTD    510(k) NO: K202594(Traditional)
ATTN: Minsheng  Zhao              PHONE NO : 86 1800 5326009 
South of Shuangyong Road, ChengyanSE DECISION MADE: 06-JAN-21
Qingdao  CN 266100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask
Premier Guard USA LLC             510(k) NO: K202595(Traditional)
ATTN: Howard  Sherman             PHONE NO : 310 7177542 
406 Briarwood Drive Suite 400     SE DECISION MADE: 21-JAN-21
Jackson MS  39206                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate
O & M Halyard, Inc.               510(k) NO: K202622(Abbreviated)
ATTN: Steven  Dowdley             PHONE NO : 678 4518062 
1 Edison Drive                    SE DECISION MADE: 07-JAN-21
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentsply Sirona Universal Spray Glazes
Dentsply Sirona                   510(k) NO: K202629(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 20-JAN-21
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Jiangsu Medpure Biological Technol510(k) NO: K202640(Traditional)
ATTN: Jianwen  Fei                PHONE NO : 86 183 06118002 
No. 1 Beiyang Road, Hexi Village, SE DECISION MADE: 22-JAN-21
ChangZhou  CN 213144              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gymform Total ABS
Well Brain International Ltd.     510(k) NO: K202653(Traditional)
ATTN: Victor K. Wai               PHONE NO : 86 852 26190833 
Room 1403 Fook Yip Building, 53-57SE DECISION MADE: 15-JAN-21
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPRINT PNS System
SPR Therapeutics, Inc.            510(k) NO: K202660(Traditional)
ATTN: Kathryn  Stager             PHONE NO : 216 3789108 
22901 Millcreek Blvd. Suite 110   SE DECISION MADE: 22-JAN-21
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Delivery Infusion Set
Quest Medical, Inc.               510(k) NO: K202672(Traditional)
ATTN: Tosan  Eweka                PHONE NO : 972 3326338 
One Allentown Parkway             SE DECISION MADE: 21-JAN-21
Allen TX  75002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
Vycor Medical INC.                510(k) NO: K202694(Traditional)
ATTN: Theo  Novak                 PHONE NO : 631 4634608 
951 Broken Sound Parkway, STE 320 SE DECISION MADE: 14-JAN-21
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ART-Plan
TheraPanacea                      510(k) NO: K202700(Traditional)
ATTN: Edwin  Lindsay              PHONE NO : 33 9 62527819 
Pepiniere Cochin Paris Sante 29 RuSE DECISION MADE: 14-JAN-21
Paris  FR 75014                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Face Masks
Jiangxi Sanxin Medtec Co., Ltd.   510(k) NO: K202719(Traditional)
ATTN: Shuiqing  Sun               PHONE NO : 86 791 85988111 
No. 999, Fushan Road, Xiaolan EconSE DECISION MADE: 04-JAN-21
Nanchang  CN 330200               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity 20 Steam Biological Indicator for IUSS
STERIS Corporation                510(k) NO: K202721(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5976 Heisley Rd                   SE DECISION MADE: 08-JAN-21
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
Viasonix Ltd.                     510(k) NO: K202742(Traditional)
ATTN: Dan  Manor                  PHONE NO : 972 9 7441692 
10 Hamelacha Street               SE DECISION MADE: 25-JAN-21
Raananna  IL 4366105              510(k) STATEMENT
                                                    

DEVICE: MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
eResearchTechnology GmbH          510(k) NO: K202754(Traditional)
ATTN: Margit  Kohlen              PHONE NO : 0049 93 0572060 
Sieboldstrasse 3                  SE DECISION MADE: 28-JAN-21
Estenfeld  DE 97230               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation 510(k) NO: K202767(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 15-JAN-21
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VELYS™ Robotic-Assisted Solution
DePuy Ireland UC                  510(k) NO: K202769(Traditional)
ATTN: Erin  Combs                 PHONE NO : 574 3727211 
Loughbeg                          SE DECISION MADE: 14-JAN-21
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iHealth Clinical Digital Thermometer
Andon Health Co., Ltd.            510(k) NO: K202791(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 05-JAN-21
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRIUS Clear Aligners
Brius Technologies, Inc           510(k) NO: K202792(Traditional)
ATTN: Kate  Garrett               PHONE NO : 
2611 Westgrove Dr Ste 109         SE DECISION MADE: 22-JAN-21
Carrollton TX  75006              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AutoStrut G2
OrthoSpin Ltd                     510(k) NO: K202810(Traditional)
ATTN: Oren  Cohen                 PHONE NO : 972 54 3342651 
13 Hayezira St.                   SE DECISION MADE: 06-JAN-21
Yokneam  IL 2066720               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMMULITE® 2000 Cortisol
Siemens Healthcare Diagnostics Pro510(k) NO: K202826(Traditional)
ATTN: Malgorzata  Robak           PHONE NO : 0044 7921 882559 
Glyn Rhonwy, Llanberis            SE DECISION MADE: 15-JAN-21
Caernarfon  GB LL55 4EL           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sequel External Fixation Device
Sequel Medical Inc.               510(k) NO: K202833(Traditional)
ATTN: Valentina  Kamysheva        PHONE NO : 305 8148299 
12550 Biscayne Blvd Ste 110       SE DECISION MADE: 19-JAN-21
North Miami FL  33181-2536        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Overlapped Compression Therapy
JKH HEALTH CO., LTD.              510(k) NO: K202839(Traditional)
ATTN: Pu  Jiang                   PHONE NO : 86 755 27926589 
4-5F, Building 12, Hengmingzhu IndSE DECISION MADE: 21-JAN-21
Shenzhen  CN 518104               510(k) STATEMENT
                                                    

DEVICE: Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile)
B.J.ZH.F.Panther Medical Equipment510(k) NO: K202843(Traditional)
ATTN: Jiahui  Li                  PHONE NO : 86 10 8078905861 07
Floor 3, Building 1, 28 Huoju StreSE DECISION MADE: 12-JAN-21
Beijing  CN 102200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Gowns
Beijing Biosis Healing Biological 510(k) NO: K202844(Traditional)
ATTN: Ting  Jiang                 PHONE NO : 86 10 61252030 
No.6 plant west, Valley No.1 Bio-mSE DECISION MADE: 06-JAN-21
Beijing  CN 102600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuBrain
BrainNow Medical Technology Limite510(k) NO: K202847(Traditional)
ATTN: Junbing  Huang              PHONE NO : 86 13 416183887 
Unit 201, 2/F, Lakeside 2, No. 10 SE DECISION MADE: 15-JAN-21
Hong Kong  CN 999077              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28
Edan Instruments, Inc.            510(k) NO: K202856(Traditional)
ATTN: Ying  Dai                   PHONE NO : 86 15 221873029 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 25-JAN-21
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPath Aligner
ClearPath Orthodontics Ltd        510(k) NO: K202857(Traditional)
ATTN: Waqas  Wahab                PHONE NO : 92 42 111333276 
6-N, Main Boulevard               SE DECISION MADE: 05-JAN-21
Johar Town  PK 54000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flex-ThreadTM Distal Fibula Intramedullary Nail System
Conventus Orthopaedics, LLC       510(k) NO: K202858(Traditional)
ATTN: Amanda  Pentecost           PHONE NO : 215 3234029 
10200 73rd Ave N. Suite 122       SE DECISION MADE: 22-JAN-21
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puritan Bennett Cuff Pressure Manager
Covidien llc                      510(k) NO: K202874(Traditional)
ATTN: Jenny  Liu                  PHONE NO : 86 21 33230131 
6F, Building 3, 2388 Chenhang RoadSE DECISION MADE: 09-JAN-21
Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prase-AP Anterior Cervical Plate System
GBS Commonwealth Co., Ltd.        510(k) NO: K202878(Traditional)
ATTN: Jimmy  Kim                  PHONE NO : 82 2 69254469 
C-309, Woolim Lion's Valley, 168, SE DECISION MADE: 29-JAN-21
Geumcheon-gu  KR 08507            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: J-Plasma Precise FLEX Handpiece
Apyx Medical Corporation (formerly510(k) NO: K202880(Traditional)
ATTN: Lauren  Tiller              PHONE NO : 727 8038550 
5115 Ulmerton Road                SE DECISION MADE: 04-JAN-21
Clearwater FL  33760-4004         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
Edan Instruments, Inc.            510(k) NO: K202892(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 75 526858736 
#15 Jinhui Road, jinsha Community,SE DECISION MADE: 28-JAN-21
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Jiangxi Feilikang Medical Technolo510(k) NO: K202904(Traditional)
ATTN: Shijun  Zhang               PHONE NO : 86 799 2181777 
Building 8, Anyuan Electronic InfoSE DECISION MADE: 21-JAN-21
Pingxiang  CN 337000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Pressure Monitor
Bioland Technology Ltd.           510(k) NO: K202934(Traditional)
ATTN: Yiqing  Feng                PHONE NO : 86 755 36900999 
No. A6B7 (Block G), ShangRong InduSE DECISION MADE: 26-JAN-21
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ventway Sparrow
Inovytech Medical Solutions Ltd.  510(k) NO: K202970(Traditional)
ATTN: Dana  Hofeller              PHONE NO : 972 9 7794134 
3 Hanagar Street                  SE DECISION MADE: 29-JAN-21
Hod Hasharon Tel-Aviv  IL 4501306 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Platinum dRF Imaging System
Apelem-DMS Group                  510(k) NO: K203010(Special)
ATTN: Samuel  Sancerni            PHONE NO : 330 467504900 
Parc Scientifique Georges Besse 17SE DECISION MADE: 22-JAN-21
Nimes  FR 30005                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IBM iConnect Access
Merge Healthcare Incorporated     510(k) NO: K203104(Traditional)
ATTN: Carol  Nakagawa             PHONE NO : 905 3162579 
900 Walnut Ridge Drive            SE DECISION MADE: 26-JAN-21
Hartland WI  53029                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inion CompressOn Screw
Inion Oy                          510(k) NO: K203105(Traditional)
ATTN: Kati  Marttinen             PHONE NO : 358 10 8306600 
Laakarinkatu 2                    SE DECISION MADE: 13-JAN-21
Tampere  FI 33520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ P10, LOGIQ P9, LOGIQ P8
GE Medical Systems Ultrasound and 510(k) NO: K203114(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
,LLC 9900  Innovation Dr.         SE DECISION MADE: 08-JAN-21
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TissueTak device
Via Surgical Ltd.                 510(k) NO: K203117(Traditional)
ATTN: Ofek  Levin                 PHONE NO : 972 52 6395765 
Mitzpe Kineret Street 22/1        SE DECISION MADE: 07-JAN-21
Amirim  IL 2011500                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
Precision Spine, Inc.             510(k) NO: K203129(Traditional)
ATTN: Michael  Dawson             PHONE NO : 601 4204244 
2050 Executive Drive              SE DECISION MADE: 12-JAN-21
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform
Edwards Lifesciences, LLC         510(k) NO: K203131(Traditional)
ATTN: Christine  Chun             PHONE NO : 949 2502773 
One Edwards Way                   SE DECISION MADE: 22-JAN-21
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veuron-Brain-pAb
Heuron Co., Ltd.                  510(k) NO: K203142(Traditional)
ATTN: Dong Hoon Shin              PHONE NO : 82 32 4298508 
10th Floor, 7, Mirae-ro, Namdong-gSE DECISION MADE: 15-JAN-21
lncheon  KR 21558                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
Globus Medical Inc.               510(k) NO: K203153(Traditional)
ATTN: Jennifer  Antonacci         PHONE NO : 610 9301800 1861
2560 General Armstead Ave.        SE DECISION MADE: 19-JAN-21
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nerivio, FGD000075-4.7
Theranica Bioelectronics ltd      510(k) NO: K203181(Traditional)
ATTN: Alon  Ironi                 PHONE NO : 972 72 3909763 
4 Ha-Omanutst. Poleg Industrial PaSE DECISION MADE: 22-JAN-21
Netanya  IL 4250574               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEROCURE-MD
Aerobiotix, Inc.                  510(k) NO: K203189(Third Party - Traditional)
ATTN: David  Kirschman            PHONE NO : 888 9787087 
444 Alexandersville Rd.           SE DECISION MADE: 21-JAN-21
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
NuVasive, Incorporated            510(k) NO: K203201(Traditional)
ATTN: Sali  Gully                 PHONE NO : 858 4582285 
7475 Lusk Blvd.                   SE DECISION MADE: 12-JAN-21
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirPhysio Positive Expiratory (PEP) Device
AirPhysio Pty Ltd                 510(k) NO: K203209(Third Party - Traditional)
ATTN: Paul  O’Brien               PHONE NO : 61 7 35350640 
Unit 1, 43 Greenway Drive         SE DECISION MADE: 15-JAN-21
Tweed Heads South  AU NSW 2486    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: cobas BKV
Roche Molecular Systems, Inc.     510(k) NO: K203220(Traditional)
ATTN: Raji  Grewal                PHONE NO : 925 3680246 
4300 Hacienda Drive               SE DECISION MADE: 29-JAN-21
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
STERIS                            510(k) NO: K203223(Traditional)
ATTN: Marcia L. Benedict          PHONE NO : 440 3927063 
5960 Heisley Rd                   SE DECISION MADE: 28-JAN-21
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Switched Internal Paddles
Philips North America LLC         510(k) NO: K203231(Special)
ATTN: Neha  Hardiya               PHONE NO : 425 9082569 
22100 Bothell Everett Hwy         SE DECISION MADE: 11-JAN-21
Bothell WA  98021                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OmniGuide BeamPath OTO-U Fiber
OmniGuide, Inc.                   510(k) NO: K203241(Special)
ATTN: David  Johnson              PHONE NO : 617 5518410 
4 Maguire Road                    SE DECISION MADE: 14-JAN-21
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMMULITE/IMMULITE® 1000 Cortisol
Siemens Healthcare Diagnostics Pro510(k) NO: K203270(Traditional)
ATTN: Malgorzata  Robak           PHONE NO : 0044 7921 882559 
Glyn Rhonwy                       SE DECISION MADE: 15-JAN-21
Llanberis  GB LL55 4EL            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hepatica v1 (Hepatica v1.0.0)
Perspectum Ltd.                   510(k) NO: K203280(Traditional)
ATTN: Jaco  Jacobs                PHONE NO : 44 0 1865655329 
5520 John Smith Drive             SE DECISION MADE: 12-JAN-21
Oxford  GB OX4 2LL                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ali Interbody Fusion System
Raed M. Ali, M.D., Inc.           510(k) NO: K203308(Special)
ATTN: Raed  Ali                   PHONE NO : 714 4743367 
6 Starcatcher Circle              SE DECISION MADE: 15-JAN-21
Newport Coast CA  92657           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERTACONNECT TLIF Cage
SIGNUS Medizintechnik             510(k) NO: K203327(Traditional)
ATTN: Antje  Schmidt              PHONE NO : 49 6023 9166 
Industriestrasse 2                SE DECISION MADE: 25-JAN-21
Alzenau  DE 63755                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeartFlow Analysis
HeartFlow, Inc.                   510(k) NO: K203329(Traditional)
ATTN: Windi  Hary                 PHONE NO : 415 5313435 
1400 Seaport Boulevard, Building BSE DECISION MADE: 08-JAN-21
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEOLab Clear Aligners
New England Ortho Lab, Inc        510(k) NO: K203339(Special)
ATTN: Christian  Saurman          PHONE NO : 800 9226365 123
3 Riverside Drive                 SE DECISION MADE: 06-JAN-21
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MULTIX Impact C
Siemens Medical Solutions USA, Inc510(k) NO: K203340(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 484 4734209 
40 Liberty Blvd Mail code: 65-1A  SE DECISION MADE: 06-JAN-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACS LD Uni FB Knee System
Implantcast GmbH                  510(k) NO: K203341(Traditional)
ATTN: Juliane  Hoeppner           PHONE NO : 00049 4161 744135 
Lueneburger Schanze 26            SE DECISION MADE: 08-JAN-21
Buxtehude  DE 21614               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MULTIX Impact
Siemens Medical Solutions USA, Inc510(k) NO: K203345(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 484 4734209 
40 Liberty Blvd Mail code: 65-1A  SE DECISION MADE: 07-JAN-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Research Medical Trident SI Screw System
Advanced Research Medical, LLC    510(k) NO: K203373(Traditional)
ATTN: John D. Siegel              PHONE NO : 610 4575324 
1515 Hwy 13 East                  SE DECISION MADE: 22-JAN-21
Burnsville MN  55337              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynanail Mini Hybrid
MedShape Inc                      510(k) NO: K203381(Traditional)
ATTN: Akhilesh  Gokhale           PHONE NO : 678 2353311 
1575 Northside Drive, Suite 440   SE DECISION MADE: 15-JAN-21
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm,  Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
Biopsybell s.r.l.                 510(k) NO: K203397(Traditional)
ATTN: Carlo Ricca Prandi Bellini  PHONE NO : 39 0535 27850 
Via A. Manuzio, 24                SE DECISION MADE: 11-JAN-21
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOS Large Fragment Plating System
Smith & Nephew, Inc.              510(k) NO: K203405(Traditional)
ATTN: Thomas  Fearnley            PHONE NO : 901 3991224 
1450 E Brooks Rd                  SE DECISION MADE: 27-JAN-21
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Hypodermic Syringe
Becton Dickinson and Company      510(k) NO: K203453(Traditional)
ATTN: Charlton  Foo               PHONE NO : 1 857 2701395 
1 Becton Drive                    SE DECISION MADE: 25-JAN-21
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
OSSIO Ltd.                        510(k) NO: K203465(Traditional)
ATTN: Taly  Lindner               PHONE NO : 972 4 9986600 
8 HaTochen St.                    SE DECISION MADE: 06-JAN-21
Caesarea  IL 3079861              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomet Microfixation RibFix Advantage System
Biomet Micofixation               510(k) NO: K203474(Traditional)
ATTN: Lauren  Jasper              PHONE NO : 904 7419259 
1520 Tradeport Drive              SE DECISION MADE: 28-JAN-21
Jacksonville FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Pedicle Screw Extension and Long Tab Implants
Medacta International SA          510(k) NO: K203482(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 26-JAN-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SnugFit All-Suture Anchor
Medacta International SA          510(k) NO: K203485(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 19-JAN-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERLA® TL posterior osteosynthesis system
SPINEART                          510(k) NO: K203506(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pré Fleuri            SE DECISION MADE: 15-JAN-21
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitality® Spinal Fixation System
Zimmer Biomet Spine, Inc.         510(k) NO: K203507(Traditional)
ATTN: Alex  Pawlowski             PHONE NO : 303 2648255 
10225 Westmoor Drive              SE DECISION MADE: 28-JAN-21
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C Scope Visualization System
CIT Ortho                         510(k) NO: K203526(Third Party - Traditional)
ATTN: Megan  Lecavalier           PHONE NO : 440 7721421 
26202 Detroit Road Ste 340        SE DECISION MADE: 12-JAN-21
Westlake OH  44145                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: XYPAN Expandable Lumbar Cage System
Aegis Spine, Inc.                 510(k) NO: K203531(Traditional)
ATTN: Woo Joong Kwon              PHONE NO : 
9781 S. Meridian Blvd, Ste 300    SE DECISION MADE: 29-JAN-21
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChoiceSpine Navigation System
ChoiceSpine, LLC                  510(k) NO: K203561(Special)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 04-JAN-21
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioGuard Air/Water and Suction Valves
STERIS Corporations               510(k) NO: K203630(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 08-JAN-21
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StealthStation Cranial Software v1.3.2
Medtronic Navigation, Inc.        510(k) NO: K203639(Special)
ATTN: Taylor Gold West            PHONE NO : 720 8902322 
826 Coal Creek Circle             SE DECISION MADE: 13-JAN-21
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
JKH USA, LLC                      510(k) NO: K203652(Traditional)
ATTN: Bill Quanqin Dai            PHONE NO : 909 9299896 
20505 Valley Blvd. Suite 108      SE DECISION MADE: 06-JAN-21
Walnut CA  91789                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Contact Forehead Thermometer (UT30H)
Uni-Trend Technology(CHINA) CO.,LT510(k) NO: K203656(Third Party - Traditional)
ATTN: Mike  Mao                   PHONE NO : 86 769 85723888 
No 6, Gong Ye Bei 1st Road, SongshSE DECISION MADE: 22-JAN-21
Dongguan  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Micro C Medical Imaging System, M01
OXOS Medical, Inc.                510(k) NO: K203658(Third Party - Traditional)
ATTN: Evan  Ruff                  PHONE NO : 855 7339729 
1230 Peachtree Street NE Suite 300SE DECISION MADE: 12-JAN-21
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Mobius3D
Varian Medical Systems, Inc.      510(k) NO: K203669(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 14-JAN-21
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
Medacta International SA          510(k) NO: K203671(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 13-JAN-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViewPoint 6
GE Medical Systems Ultrasound & Pr510(k) NO: K203677(Special)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W. Innovation Drive          SE DECISION MADE: 15-JAN-21
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON™ Spinal System
Medtronic Sofamor Danek USA, INC. 510(k) NO: K203678(Special)
ATTN: Madhuvanthi  Soundirarajan  PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 15-JAN-21
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CarboClear Lumbar Cage System
CarboFix Orthpedics Ltd.          510(k) NO: K203683(Special)
ATTN: Hila  Wachsler-Avrahami     PHONE NO : 972 9 9511511 
11 Ha'Hoshlim Street              SE DECISION MADE: 15-JAN-21
Herzeliya  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntraSight Mobile
Volcano Corporation               510(k) NO: K203719(Special)
ATTN: Linda  Schulz               PHONE NO : 425 9081362 
3721 Valley Centre Dr Ste 500     SE DECISION MADE: 19-JAN-21
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K203726(Special)
ATTN: HyunJung  Lee               PHONE NO : 425 2815061 
22010 S.E. 51st Street            SE DECISION MADE: 19-JAN-21
Issaquah WA  98029                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Contact Forehead Thermometer (Models UT306H & UT308H)
Uni-Trend Technology (China) Co., 510(k) NO: K203747(Third Party - Traditional)
ATTN: Mike  Mao                   PHONE NO : 86 769 85723888 
No 6, Gong Ye Bei 1st Road, SongshSE DECISION MADE: 25-JAN-21
Guangzhou  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: vatech A9 (Model : PHT-30CSS)
Vatech Co., Ltd                   510(k) NO: K203797(Special)
ATTN: Daniel  Kim                 PHONE NO : 82 31 3799492 
13, Samsung 1-ro 2-gil            SE DECISION MADE: 25-JAN-21
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VASOBand Vascular Compression Device
VASOInnovations, Inc              510(k) NO: K203803(Third Party - Traditional)
ATTN: Rajendra  Gurudas Sardesai  PHONE NO : 626 6882568 
1260 Huntington Drive Suite 208   SE DECISION MADE: 26-JAN-21
South Pasadena CA  91030          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: BOSS 8F Balloon Guide Catheter
Marblehead Medical LLC            510(k) NO: K203840(Special)
ATTN: Kristin M. Mortenson        PHONE NO : 612 2021142 
753 Fox Chase Rd SW               SE DECISION MADE: 28-JAN-21
Rochester MN MN  55902-8749       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: General Radiography CXDI-CS01
CANON INC.                        510(k) NO: K203849(Special)
ATTN: Akira  Hirai                PHONE NO : 81 33 7582111 
9-1 Imaikami-Cho, Nakahara-Ku     SE DECISION MADE: 26-JAN-21
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    


      TOTAL 510(k)s THIS PERIOD   200                                     
      TOTAL WITH SUMMARIES        196                                     
      TOTAL WITH STATEMENTS        4
                                       
 
Back to Top