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  1. 510(k) Clearances

September 2021 510(K) Clearances

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


DEVICE: Acuitas AMR Gene Panel
OpGen, Inc.                       510(k) NO: K191288(Traditional)
ATTN: Autumn  Collasius           PHONE NO : 301 8699683 
9717 Key West Avenue Suite 100    SE DECISION MADE: 30-SEP-21
Rockville MD  20850               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON Ferritin
DiaSorin Inc                      510(k) NO: K193650(Traditional)
ATTN: John C. Walter              PHONE NO : 651 4399710 
1951 Northwestern Ave             SE DECISION MADE: 14-SEP-21
Stillwater MN  55082              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Wheelchair (XW-LY001)
Yongkang Dingchang Industry & Trad510(k) NO: K200423(Traditional)
ATTN: Tony  Chen                  PHONE NO : 86 134 29055889 
NO.99 Huaxi road, Xicheng street  SE DECISION MADE: 22-SEP-21
Yongkang  CN 321300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LAP-iX
Sejong Medical Co., Ltd.          510(k) NO: K200639(Traditional)
ATTN: Yoojung  Choi               PHONE NO : 
11, Sinchon 2-ro                  SE DECISION MADE: 29-SEP-21
Paju-si  CN 10880                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
Medicon Hellas, S.A               510(k) NO: K200898(Traditional)
ATTN: Frank  Matuszak             PHONE NO : 302 1 06606000 
Melitona 5-7                      SE DECISION MADE: 21-SEP-21
Gerakas  GR 15344                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EASYMAX Tag Self-Monitoring Blood Glucose System
EPS Bio Technology Corp.          510(k) NO: K201258(Special)
ATTN: Iden  Chen                  PHONE NO : 886 36686 868 
No. 8 R&D RD.III Hsinchu Science PSE DECISION MADE: 01-SEP-21
Hsinchu City  TW 30077            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
Atrium Medical Corporation        510(k) NO: K201305(Traditional)
ATTN: Robin  Mulvey               PHONE NO : 603 8645352 
40 Continental Blvd.              SE DECISION MADE: 03-SEP-21
Merrimack NH  03054               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Troponin T Gen 5
Roche Diagnostics                 510(k) NO: K201441(Traditional)
ATTN: Jane  Phillips              PHONE NO : 317 5213338 
9115 Hague Road                   SE DECISION MADE: 21-SEP-21
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MultiCath, AcQRate Dx Fixed Curve Catheter
Biotronik, Inc                    510(k) NO: K201445(Traditional)
ATTN: Jon  Brumbaugh              PHONE NO : 888 3450374 
6024 Jean Road                    SE DECISION MADE: 02-SEP-21
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
Cardinal Health 200, LLC          510(k) NO: K201592(Traditional)
ATTN: Padmini  Sahoo              PHONE NO : 847 7854959 
3651 Birchwood Drive              SE DECISION MADE: 26-SEP-21
Waukegan IL  60085                510(k) STATEMENT
                                                    

DEVICE: Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
Viramal Limited                   510(k) NO: K201612(Traditional)
ATTN: Simona  Fiore               PHONE NO : 44 0207 4953052 
106 New Bond Street               SE DECISION MADE: 02-SEP-21
London  GB W1S 1DN                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIEN Dental Cleanser
EPIEN Medical, Inc.               510(k) NO: K201785(Traditional)
ATTN: Reginald  Dupre             PHONE NO : 651 6533380 
4225 White Bear Parkway Suite 600 SE DECISION MADE: 09-SEP-21
St. Paul MN  55110                510(k) STATEMENT
                                                    

DEVICE: CT-STOR
Energy Delivery Solutions         510(k) NO: K201789(Traditional)
ATTN: William  Ehringer           PHONE NO : 812 9200596 
3315 Industrial Parkway           SE DECISION MADE: 20-SEP-21
Jeffersonville IN  47130          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EDEN Peek Cage
JMT Co., Ltd                      510(k) NO: K201793(Traditional)
ATTN: Sang-Ok  Nam                PHONE NO : 82 31 8680951 
70-39, Gwonyul-ro 1203 beon-gile, SE DECISION MADE: 13-SEP-21
Yangju-si  KR 11517               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
Olympus Medical Systems Corp.     510(k) NO: K201832(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 17-SEP-21
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrically Powered Wheelchair -Model HP358E
Kunshan Hi-Fortune Health Products510(k) NO: K201855(Traditional)
ATTN: Jianjiang  Fan              PHONE NO : 86 512 55195100 
No. 625, Juxiang Road, Zhangpu TowSE DECISION MADE: 28-SEP-21
Kunshan  CN 215321                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
Applied Medical Resources Corporat510(k) NO: K202049(Special)
ATTN: Andrew  Powers Davis        PHONE NO : 949 5474136 
22872 Avenida Empresa             SE DECISION MADE: 07-SEP-21
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kinepict Medical Imaging Tool 4.0
Kinepict Health Ltd               510(k) NO: K202056(Traditional)
ATTN: Lilla  Strobel              PHONE NO : 36 317 852260 
Kelta k z                         SE DECISION MADE: 10-SEP-21
Budakeszi  HU 2092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABC Dental Implant System
Abracadabra Implants Ltd          510(k) NO: K202092(Traditional)
ATTN: Daniel  Younisian           PHONE NO : 972 54 4778556 
12 Hacharoshet St                 SE DECISION MADE: 23-SEP-21
Or Yehuda  IL 6037580             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tracheal Stent System
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K202204(Traditional)
ATTN: Sally  He                   PHONE NO : 86 25 58646395 
No.10 Gaoke Third Road            SE DECISION MADE: 01-SEP-21
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RXS 1000
Rolence Enterprise Inc.           510(k) NO: K202369(Traditional)
ATTN: Ben  Chang                  PHONE NO : 886 3 4631999 
18-3 Lane 231 Pu Chung Rd., ChunglSE DECISION MADE: 15-SEP-21
Taoyuan  TW 32083                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SP-1000, SP-2000
DaeSung Maref Co., Ltd            510(k) NO: K202395(Traditional)
ATTN: Hyoung Ju  Cho              PHONE NO : 82 31 4597211 
298-24, Gongdan-ro                SE DECISION MADE: 01-SEP-21
Gunpo-si  KR 15809                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
bioMerieux, Inc.                  510(k) NO: K202396(Traditional)
ATTN: Debra  Broyles              PHONE NO : 314 7318805 
595 Anglum Road                   SE DECISION MADE: 14-SEP-21
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
Pharma System AB                  510(k) NO: K202459(Traditional)
ATTN: Viljar  Salumaa             PHONE NO : 46 18 349500 
Rubanksgatan 9                    SE DECISION MADE: 26-SEP-21
Knivsta  SE 74171                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermArt (Model IR-EFT)
Comper Chuangxiang (Beijing) techn510(k) NO: K202481(Traditional)
ATTN: Han  Du                     PHONE NO : 86 10 57480968 
Building 1, Unit 4, Room 102, 103 SE DECISION MADE: 28-SEP-21
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA Rib-P
Phadia AB                         510(k) NO: K202540(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 13-SEP-21
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA RNA Pol III
Phadia AB                         510(k) NO: K202541(Traditional)
ATTN: Sheryl  Skinner             PHONE NO : 269 5683603 
Rapsgatan 7P P.O. Box 6460        SE DECISION MADE: 13-SEP-21
Uppsala  SE 751 37                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IV Administration Sets
B. Braun Medical Inc.             510(k) NO: K202618(Traditional)
ATTN: Kimberly  Smith             PHONE NO : 610 2660500 
901 Marcon Blvd.                  SE DECISION MADE: 24-SEP-21
Allentown PA  18109-9341          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentilube Spray
Oxy2plus, LLC                     510(k) NO: K202689(Traditional)
ATTN: Chun nan Lin                PHONE NO : 626 8728550 
4120 Rosemead Blvd                SE DECISION MADE: 03-SEP-21
Rosemead CA  91770                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Low-speed Handpieces and Accessories
MicroP Technology (Taiwan), Inc.  510(k) NO: K202786(Traditional)
ATTN: Ina  Lin                    PHONE NO : 886 527 68238 
No.50, Zhongxiao 2nd St., East DisSE DECISION MADE: 03-SEP-21
Chiayi City  TW 600               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Syntec Orthodontic Mini Screw Extended System
Syntec Scientific Corporation     510(k) NO: K202790(Special)
ATTN: Nicole  Tseng               PHONE NO : 886 4 7987099 
No.2, Kung San Road Chuan Shing InSE DECISION MADE: 17-SEP-21
Chang Hua  TW 50971               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SANSIN Tubing Sets for Hemodialysis
Jiangxi Sanxin Medtec Co., Ltd.   510(k) NO: K202796(Traditional)
ATTN: Shuiqing  Sun               PHONE NO : 86 791 85950238 
No. 999, Fushan Road, Xiaolan EconSE DECISION MADE: 06-SEP-21
Nanchang  CN 330200               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlucoSure HT Plus Blood Glucose Monitoring System
Apex BioTechnology Corp.          510(k) NO: K202885(Special)
ATTN: Lisa  Liu                   PHONE NO : 011 886 35641952 
No. 7, Li-Hsin Road V, Hsinchu SciSE DECISION MADE: 15-SEP-21
Hsinchu  CN 30078                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoLIF Delta-Cage and DoubleWedge-Cage
joimax GmbH                       510(k) NO: K203014(Traditional)
ATTN: Gary  Mocnik                PHONE NO : 949 4330413 
Amalienbadstrasse 41              SE DECISION MADE: 01-SEP-21
RaumFabrik 61  DE 76227           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Medtronic                         510(k) NO: K203111(Traditional)
ATTN: Kaitlin  Cady               PHONE NO : 763 2918500 
7611 Northland Drive              SE DECISION MADE: 16-SEP-21
Minneapolis MN  55428             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Mask
Yangzhou Runyi Arts & Crafts CO., 510(k) NO: K203112(Traditional)
ATTN: Li  Yu                      PHONE NO : 086 0514 82082789 
4. NO.87 West Heye Road HanJiang DSE DECISION MADE: 16-SEP-21
Yangzhou  CN 225008               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uramix CuraWay Biopsy Needle
Uramix, Inc.                      510(k) NO: K203141(Traditional)
ATTN: Michael  Mooreville         PHONE NO : 1 610 3949850 
272 N. Lansdowne Ave.             SE DECISION MADE: 17-SEP-21
Lansdowne PA  19050               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BreatheSuite MDI V1
BreatheSuite Inc                  510(k) NO: K203155(Traditional)
ATTN: Brett  Vokey                PHONE NO : 709 7651002 
29 Rowan Street Unit 2            SE DECISION MADE: 17-SEP-21
St. John's  CA A1B2X2             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENDOtube
Nissha Medical Technologies SAS   510(k) NO: K203350(Traditional)
ATTN: Roch  Mignot                PHONE NO : 00 33 139721177 
ZA Des Boutries 12 Rue Des CayenneSE DECISION MADE: 29-SEP-21
Conflans STE Honorine  FR 78700   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage))
Ningbo Ouhan Medical Device Co., L510(k) NO: K203418(Traditional)
ATTN: Annie  Annie                PHONE NO : 86 574 62137999 
No.16, West Ruhu Road, Simen Town SE DECISION MADE: 17-SEP-21
Yuyao City  CN 315470             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BlueStar Rx
WellDoc, Inc                      510(k) NO: K203434(Traditional)
ATTN: Sabyasachi  Roy             PHONE NO : 443 6923100 
10221 Wincopin Circle, Suite 150  SE DECISION MADE: 08-SEP-21
Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TorrentX Wound Wash
Next Science, LLC                 510(k) NO: K203446(Traditional)
ATTN: Courtney  Narain            PHONE NO : 855 5642762 
10550 Deerwood Park Blvd Ste 300  SE DECISION MADE: 23-SEP-21
Jacksonville FL  32256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Mask
Fujian Kang Chen Daily Necessities510(k) NO: K203455(Traditional)
ATTN: Shuyan  Wang                PHONE NO : 86 595 28892058 
No.55 Houdun Road, houmao IndustriSE DECISION MADE: 13-SEP-21
Quanzhou  CN 362000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instrument tray, for semi-rigid ureteroscope
Olympus Winter & Ibe GmbH         510(k) NO: K203492(Traditional)
ATTN: Jan-Oliver  Upmeier         PHONE NO : 49 40 669662098 
Kuehnstr, 61                      SE DECISION MADE: 15-SEP-21
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Male Latex Condom
Global Protection Corp.           510(k) NO: K203536(Abbreviated)
ATTN: Christina  Cataldo          PHONE NO : 617 9462800 
12 Channel Street                 SE DECISION MADE: 03-SEP-21
Boston MA  02210                  510(k) STATEMENT
                                                    

DEVICE: AmCAD-UT
AmCad BioMed Corporation          510(k) NO: K203555(Traditional)
ATTN: Nathan  Liu                 PHONE NO : 866 2 27136227 
FL. 5-2, No.167, Fu Hsing N. RD.  SE DECISION MADE: 08-SEP-21
Taipei  TW 105                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intravascular Administration Sets
Baxter Healthcare Corporation     510(k) NO: K203609(Traditional)
ATTN: Jeffrey E. Thompson         PHONE NO : 224 2703806 
25212 West Illinois Route 120     SE DECISION MADE: 30-SEP-21
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Numen Coil Embolization System; NumenFR Detachment System
MicroPort NeuroTech (Shanghai) Co.510(k) NO: K203625(Traditional)
ATTN: Qiuhua  Zou                 PHONE NO : 86 21 38954600 3959
16th Building, 222 Guangdan Road, SE DECISION MADE: 01-SEP-21
Shanghai  CN 201318               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruAbutment DS, TruBase
TruAbutment Inc.                  510(k) NO: K203649(Traditional)
ATTN: Eunjin  Jang                PHONE NO : 714 9561488 
17666 Fitch                       SE DECISION MADE: 15-SEP-21
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11
Yibin Junxin Electronics Technolog510(k) NO: K203662(Traditional)
ATTN: Chaoze  Guan                PHONE NO : 86 135 30731921 
Building B2, No. 136, West SectionSE DECISION MADE: 23-SEP-21
Yibin  CN 644000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
MYCO Medical Supplies, Inc.       510(k) NO: K203668(Traditional)
ATTN: Sanjiv  Krumar              PHONE NO : 919 4602535 
2015 Production Drive             SE DECISION MADE: 29-SEP-21
Apex NC  27539                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B Dispensing Line
AEA srl                           510(k) NO: K203674(Traditional)
ATTN: Michele  Mengoni            PHONE NO : 003 907 31816689 
Via Fiume 16                      SE DECISION MADE: 27-SEP-21
Angeli de Rosora  IT 60030        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RayPilot System
Micropos Medical AB               510(k) NO: K203722(Traditional)
ATTN: Thomas  Lindstrom           PHONE NO : 46 31 7608005 
Adolf Edelsvards gata 11          SE DECISION MADE: 02-SEP-21
Gothenburg  SE SE414 51           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DT100 Digital Thermometer
Smart Technology Co., Ltd.        510(k) NO: K203731(Traditional)
ATTN: Meg  Mei                    PHONE NO : 086 020 62321333 
No. 8 Xingcheng East Road, Fuwan ISE DECISION MADE: 26-SEP-21
Foshan  CN 528500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
Covidien                          510(k) NO: K203762(Traditional)
ATTN: Ashley  Johnston            PHONE NO : 720 4401057 
6135 Gunbarrel Ave                SE DECISION MADE: 17-SEP-21
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClariSIGMAM
ClariPi Inc.                      510(k) NO: K203785(Traditional)
ATTN: Hyun-Sook  Park             PHONE NO : 82 8 7413014 
3F, 70-15, Ihwajang-gil           SE DECISION MADE: 10-SEP-21
Seoul  KR 03088                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProFlex CO2 Laser Fiber
InnovaQuartz LLC                  510(k) NO: K203799(Traditional)
ATTN: Stephen  Griffin            PHONE NO : 623 4341895 101
23030 N. 15th Ave                 SE DECISION MADE: 20-SEP-21
Phoenix AZ  85027                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips IntelliSite Pathology Solution
Philips Medical Systems Nederland 510(k) NO: K203845(Abbreviated)
ATTN: Liselotte  Kornmann         PHONE NO : 31 611 621238 
Veenpluis 6                       SE DECISION MADE: 17-SEP-21
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless)
Leadtek Research Inc.             510(k) NO: K210032(Special)
ATTN: Kun-Shan  Lu                PHONE NO : 886 2 82265800 
18F, No. 166, Jian-Yi Rd., Chung HSE DECISION MADE: 01-SEP-21
New Taipei City  TW 23511         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACTIVA PRESTO PACK
Pulpdent Corporation              510(k) NO: K210045(Traditional)
ATTN: Lewis  Berk                 PHONE NO : 617 9266666 
80 Oakland Street                 SE DECISION MADE: 22-SEP-21
Watertown MA  02472               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthCCSng
Zebra Medical Vision Ltd.         510(k) NO: K210085(Traditional)
ATTN: Shlomit  Cymbalista         PHONE NO : 972 52 2574837 
Shefayim Commercial Center, PO BoxSE DECISION MADE: 15-SEP-21
Shefayim  IL 6099000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuFFRangio
ArteryFlow Technology Co., Ltd.   510(k) NO: K210093(Traditional)
ATTN: Jianping  Xiang             PHONE NO : 86 571 86772567 
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 10-SEP-21
Hangzhou  CN 310051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFRARED BODY THERMOMETER (Model: YK-001)
Longnan RenZhong Medical Equipment510(k) NO: K210118(Traditional)
ATTN: Liangping  Liao             PHONE NO : 86 13 715212441 
Information Industry Technology CiSE DECISION MADE: 15-SEP-21
Ganzhou  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Current Health Monitoring System Gen 2 (G2)
Current Health                    510(k) NO: K210133(Traditional)
ATTN: Phil  Bromley               PHONE NO : 44 131 2858101 
Playfair House, 6 Broughton StreetSE DECISION MADE: 03-SEP-21
Edinburgh  GB EH 1 3LY            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Digital Blood Pressure Monitor
AVICHE Shandong Medical Technology510(k) NO: K210152(Traditional)
ATTN: Zhike  Song                 PHONE NO : 86 15 689734848 
Floor 26, Building A, A2-1 Jinan PSE DECISION MADE: 23-SEP-21
Jinan  CN                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlertWatch:AC
AlertWatch, Inc.                  510(k) NO: K210160(Traditional)
ATTN: Justin  Adams               PHONE NO : 734 9988344 
330 East Liberty St., Fourth FloorSE DECISION MADE: 10-SEP-21
Ann Arbor MI  48104               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wilson Tech Disposable Medical Face Mask
Wilson Tech (International) Limite510(k) NO: K210184(Traditional)
ATTN: Ho Hang Terry Ting          PHONE NO : 852 231 25136 
RM B, 7 Floor Joy Fat Factory BuilSE DECISION MADE: 14-SEP-21
Kowloon  HK 999077                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile syringe for single use with/without needle
Zhejiang Kangkang Medical-Devices 510(k) NO: K210227(Traditional)
ATTN: Chun  Guo                   PHONE NO : 1358 6180908 
Longwang Industrial District, ChumSE DECISION MADE: 10-SEP-21
Yuhuan  CN 317605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Needles for Single Use
Zhejiang Kangkang Medical-Devices 510(k) NO: K210232(Traditional)
ATTN: Chun  Guo                   PHONE NO : 
Longwang Industrial District, ChumSE DECISION MADE: 23-SEP-21
Yuhuan  CN 317605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MeMed BV
MeMed Diagnostics Ltd.            510(k) NO: K210254(Traditional)
ATTN: Efrat  Hartog-David         PHONE NO : 972 4 8500302 
Nahum Heth 5                      SE DECISION MADE: 01-SEP-21
Tirat Carmel  IL 3508504          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mpres Neck Preserving Stem
MEDACTA INTERNATIONAL, SA         510(k) NO: K210263(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91696 6060
Strada Regina                     SE DECISION MADE: 22-SEP-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: One Touch Spiral Condom
Thai Nippon Rubber Industry Public510(k) NO: K210294(Traditional)
ATTN: Ryosuke  Takamiya           PHONE NO : 66 38 317999 
789/139 Pinthong Industrial EstateSE DECISION MADE: 23-SEP-21
Sriracha  TH 20230                510(k) STATEMENT
                                                    

DEVICE: BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor
STERIS Corporation                510(k) NO: K210342(Traditional)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Rd                   SE DECISION MADE: 03-SEP-21
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Cdiff nucleic acid test for use on the cobas Liat System
Roche Molecular Systems, Inc.     510(k) NO: K210385(Special)
ATTN: Gaila  Balniene             PHONE NO : 510 3056980 
4300 Hacienda Drive               SE DECISION MADE: 09-SEP-21
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Harmony Referral System
Topcon Healthcare Solutions EMEA O510(k) NO: K210396(Traditional)
ATTN: Ramya  Sundaram             PHONE NO : 201 5995553 
Makelininkatu 43                  SE DECISION MADE: 13-SEP-21
Oulu  FI 90100                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unifine SafeControl
Owen Mumford Ltd                  510(k) NO: K210399(Special)
ATTN: Darren  Mansell             PHONE NO : 440 1993 812021 
Brook Hill                        SE DECISION MADE: 17-SEP-21
Woodstock  GB OX20 1TU            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Curiteva Sacroiliac Joint Fusion System
Curiteva, Inc.                    510(k) NO: K210402(Traditional)
ATTN: Eric  Linder                PHONE NO : 256 2131057 
25127 Will McComb Drive           SE DECISION MADE: 09-SEP-21
Tanner AL  35671                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: s-Clean Pre-Milled Abutment Mini
Dentis Co., Ltd.                  510(k) NO: K210410(Traditional)
ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 10-SEP-21
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Versana Premier
GE Medical Systems Ultrasound and 510(k) NO: K210438(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W Innovation Drive           SE DECISION MADE: 10-SEP-21
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Sampler Inactivated Transport Media, Nest ITM
Wuxi Nest Biotechnology Co., Ltd. 510(k) NO: K210440(Traditional)
ATTN: Cheng  Zhiwei               PHONE NO : 86 510 68006788 
No. 530 Xida Road, New District   SE DECISION MADE: 20-SEP-21
Wuxi  CN 214012                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Incontinence Probe
Shenzhen Med-link Electronics Tech510(k) NO: K210441(Traditional)
ATTN: Yongfen  Yang               PHONE NO : 0086 755 61568825 887
4th And 5th Floor, Building Two, HSE DECISION MADE: 17-SEP-21
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: End Cap
Medical Components Inc. (Medcomp) 510(k) NO: K210461(Traditional)
ATTN: Patrick  McDonald           PHONE NO : 215 8590995 
1499 Delp Drive                   SE DECISION MADE: 14-SEP-21
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C-CURVE Interbody Fusion Device
Medicrea International S. A.      510(k) NO: K210470(Traditional)
ATTN: Karine  Trogneux            PHONE NO : 00 334 72018787 
5389 Route De Strasbourg - Vancia SE DECISION MADE: 03-SEP-21
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rocket Platinum Cured Cathter
Rocket Medical Plc                510(k) NO: K210509(Traditional)
ATTN: Tracy  Charlton             PHONE NO : 00 44 1914194488 4067
2-4 Sedling Road                  SE DECISION MADE: 09-SEP-21
Washington  GB NE38 9BZ           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2
Universal Incorporation           510(k) NO: K210513(Traditional)
ATTN: Mei-Hui  Huang              PHONE NO : 886 2 25119161 
10F., No.372 Linsen N. Rd.,ZhongshSE DECISION MADE: 29-SEP-21
Taipei City  TW 10446             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Implanova
Dental Evolutions Inc.            510(k) NO: K210523(Traditional)
ATTN: Matthew  Mineros            PHONE NO : 310 2732819 
9100 Wilshire Blvd Ste 448W       SE DECISION MADE: 30-SEP-21
Beverly Hills CA  90212           510(k) STATEMENT
                                                    

DEVICE: Advisor Pro Platform
DreaMed Diabetes Ltd.             510(k) NO: K210561(Traditional)
ATTN: Inbal  Beinglass Peled      PHONE NO : 972 52 3642760 
5 Mota Gur St.                    SE DECISION MADE: 28-SEP-21
Petah Tikva  IL 4952701           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system
Cardiovascular Systems Inc.       510(k) NO: K210586(Special)
ATTN: Kris  Miller                PHONE NO : 612 9993749 
1225 Old Highway 8 NW             SE DECISION MADE: 14-SEP-21
New Brighton MN  55112            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axis Spine Technologies ALIF
Axis Spine Technologies Ltd       510(k) NO: K210590(Traditional)
ATTN: Edwin  Lindsay              PHONE NO : 44 791 7134922 
Suite 204, 54-56 Victoria Street, SE DECISION MADE: 29-SEP-21
St. Albans  GB AL1 3HZ            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve
FUJIFILM medwork GmbH             510(k) NO: K210625(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
Medworkring 1                     SE DECISION MADE: 10-SEP-21
Hochstadt  DE 91315               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OnGuard2 Chemfort Closed Administration (CADM)
Simplivia Healthcare LTD.         510(k) NO: K210707(Traditional)
ATTN: Shay  Shaham                PHONE NO : 972 4 6908826 
North Industrial Zone             SE DECISION MADE: 23-SEP-21
Kiryat Shmona  IL 1101801         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Verifine Mechanical Safety Insulin Syringe
Promisemed Hangzhou Meditech Co., 510(k) NO: K210712(Traditional)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 08-SEP-21
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmersiveTouch
ImmersiveTouch, Inc.              510(k) NO: K210726(Traditional)
ATTN: P. Pat Banerjee             PHONE NO : 1 630 5705943 
910 W Van Buren St, Suite 715     SE DECISION MADE: 29-SEP-21
Chicago IL  60607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inman Digital Clear Aligners
Inman Orthodontic Laboratories, In510(k) NO: K210763(Traditional)
ATTN: Donal P. Inman              PHONE NO : 800 2890118 
3953 NW 126th Avenue              SE DECISION MADE: 29-SEP-21
Coral Springs FL  33065           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)
VR Vertical LLC dba XRGO          510(k) NO: K210772(Traditional)
ATTN: Matthew  DiPalma            PHONE NO : 716 6729904 
10645 Freeport Drive              SE DECISION MADE: 22-SEP-21
Louisville KY  40258              510(k) STATEMENT
                                                    

DEVICE: TrueCare Biomedix Tamper Evident Cap
US Infusion Inc. D/B/A Truecare Bi510(k) NO: K210818(Traditional)
ATTN: Abbey  Kramarz              PHONE NO : 866 5938444 206
6356 Manor Ln Ste 101             SE DECISION MADE: 15-SEP-21
South Miami FL  33143             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Personal Lubricant
Shenzhen Huanqiu Xuebao Technology510(k) NO: K210857(Traditional)
ATTN: Jiao  Li                    PHONE NO : 
Room 303, Building 2, Lane 2, JinjSE DECISION MADE: 24-SEP-21
Bao'an District Shenzhen  CN 51810510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Stryker GmbH                      510(k) NO: K210861(Traditional)
ATTN: Jonathan  Schell            PHONE NO : 484 8895804 
325 Corporate Drive               SE DECISION MADE: 03-SEP-21
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves Powder Free (Blue)
Great Eco Glove Sdn. Bhd.         510(k) NO: K210868(Traditional)
ATTN: Soh Wei Li                  PHONE NO : 601 62641024 
Lot 1675, Jalan Makmur, Batu 28, ISE DECISION MADE: 02-SEP-21
Bestari Jaya  MY 45600            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask (Model: CM2006, CM2008, A88)
Shenzhen RealTone Medical Applianc510(k) NO: K210878(Traditional)
ATTN: Wei  Zhou                   PHONE NO : 86 13 480838587 
Flat B, 5 Floor, Yaoxiang IndustriSE DECISION MADE: 28-SEP-21
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIDDHARTH-II; IMPACT
Panacea Medical Technologies Pvt.L510(k) NO: K210894(Traditional)
ATTN: Valli  G                    PHONE NO : 80 4394 4602 
Plot No.35, 4th Phase, Malur KIADBSE DECISION MADE: 28-SEP-21
Malur, Kolar District  IN 563130  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Vitamin D total III
Roche Diagnostics                 510(k) NO: K210901(Traditional)
ATTN: Jamie  Ferguson             PHONE NO : 317 2707402 
9115 Hague Road PO Box 50416      SE DECISION MADE: 01-SEP-21
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Sichuan Prius Biotechnology Co., L510(k) NO: K210908(Traditional)
ATTN: Yan  Liu                    PHONE NO : 86 831 3839889 
No.2 Prius Road, Luo Long IndustriSE DECISION MADE: 26-SEP-21
Yibin  CN 644104                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LuxaPrint Ortho Plus
DMG Digital Enterprises SE        510(k) NO: K210940(Traditional)
ATTN: Stephan  Schafer            PHONE NO : 4940 84006 
Elbgaustrasse 248                 SE DECISION MADE: 03-SEP-21
Hamburg  DE 22547                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leonardo Mini Blue
CeramOptec GmbH                   510(k) NO: K210951(Abbreviated)
ATTN: Roland  Dreschau            PHONE NO : 49 228 979670 
Siemensstrabe 44                  SE DECISION MADE: 01-SEP-21
Bonn  DE D-53121                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kubtec Mozart Supra (XPERT 84) Radiography System
KUB Technologies, Inc.            510(k) NO: K210955(Special)
ATTN: Chester  Lowe               PHONE NO : 203 3648544 
111 Research Drive                SE DECISION MADE: 20-SEP-21
Stratford CT  06615               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PreferX Delivery System
MD3 LLC                           510(k) NO: K210997(Traditional)
ATTN: Mary Ann  Greenawalt        PHONE NO : 503 3187722 
3650 Coral Ridge Drive Suite 107  SE DECISION MADE: 07-SEP-21
Coral Springs FL  33065           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Examination Gloves
Foshan Kangkang Biotechnology Co.,510(k) NO: K211073(Traditional)
ATTN: Yico  Xie                   PHONE NO : 86 1370 2554142 
2nd Floor, Building 4, Dongfang InSE DECISION MADE: 21-SEP-21
Foshan City  CN 528225            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Univers Revers Modular Glenoid System, Standard Augment Baseplates
Arthrex Inc.                      510(k) NO: K211074(Traditional)
ATTN: Ivette  Galmez              PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 02-SEP-21
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Banyan USA Surgical Mask Level 3
Banyan USA LLC                    510(k) NO: K211097(Traditional)
ATTN: Ricardo  Ryan               PHONE NO : 631 4565447 
390 Oser Avenue                   SE DECISION MADE: 22-SEP-21
Hauppauge NY  11788               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM
Health & Life Co., Ltd            510(k) NO: K211127(Traditional)
ATTN: Peggy  Su                   PHONE NO : 
9F, No. 186, Jian Yi Road, ZhongheSE DECISION MADE: 08-SEP-21
New Taipei City  TW 23553         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NTI ClenchGuard
Boyd Research, Inc.               510(k) NO: K211158(Traditional)
ATTN: James  Boyd                 PHONE NO : 858 3429802 
5820 Bali Way S                   SE DECISION MADE: 17-SEP-21
St. Pete Beach FL  33706          510(k) STATEMENT
                                                    

DEVICE: IPL Hair Removal
Shenzhen Qiaochengli Technology Co510(k) NO: K211174(Traditional)
ATTN: LiPing  Zhou                PHONE NO : 86 0755 23072580 
501-5, rujun building, 105 ZhongxiSE DECISION MADE: 01-SEP-21
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WoundExpress
Huntleigh Healthcare Ltd          510(k) NO: K211200(Traditional)
ATTN: Steve  Monks                PHONE NO : 44 2920 485885 
35 Portmanmoor Road               SE DECISION MADE: 03-SEP-21
Cardiff  GB CF24 5HN              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagnetOs Easypack Putty
Kuros Biosciences B.V.            510(k) NO: K211201(Traditional)
ATTN: Marcel  Borger              PHONE NO : 31 30 2297280 
Professor Bronkhorstlaan 10, buildSE DECISION MADE: 02-SEP-21
Bilthoven  NL 3723MB              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HTx Disposable Hysteroscope System
AcuVu Inc.                        510(k) NO: K211227(Traditional)
ATTN: Sam  Mostafavi              PHONE NO : 650 6706972 
4546 El Camino Real #211          SE DECISION MADE: 15-SEP-21
Los Altos CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RedEx
Advanced Surgical Concepts ltd    510(k) NO: K211234(Traditional)
ATTN: Edward  Hyland              PHONE NO : 353 1 2864777 
Unit 4, Sunnybank Center, Upper DaSE DECISION MADE: 17-SEP-21
Bray  IE A98 E339                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CIRCUL8 Luxe DVT Prevention Device
Ortho8 Inc.                       510(k) NO: K211235(Traditional)
ATTN: Taylor  Nordeen             PHONE NO : 1 916 2894002 
2217 Plaza Drive                  SE DECISION MADE: 08-SEP-21
Rocklin CA  95765                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Vinyl Examination Gloves
Tangshan Hongyun Healthcare Produc510(k) NO: K211236(Traditional)
ATTN: Suying  Le                  PHONE NO : 86 139 33365259 
South Shenggezhuang Village, PachiSE DECISION MADE: 27-SEP-21
Tangshan  CN 063500               510(k) STATEMENT
                                                    

DEVICE: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
Promisemed Hangzhou Meditech Co., 510(k) NO: K211242(Traditional)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 09-SEP-21
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EFAI PACS Picture Archiving and Communication System
Ever Fortune.AI Co., Ltd.         510(k) NO: K211257(Traditional)
ATTN: Chen  Ming-Fong             PHONE NO : 886 4 23213838 
Rm. D, 8F., NO. 573, Sec. 2, TaiwaSE DECISION MADE: 10-SEP-21
Taichung City  TW 403020          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CIV-Clear cover
CIVCO Medical Instruments Co., Inc510(k) NO: K211270(Traditional)
ATTN: Jim  Leong                  PHONE NO : 319 4002577 
102 First Street South            SE DECISION MADE: 13-SEP-21
Kalona IA  52247                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
Innovative Health, LLC.           510(k) NO: K211276(Traditional)
ATTN: Rick  Ferreira              PHONE NO : 877 4003740 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 15-SEP-21
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compressible Limb and Circulation Therapy System, Model POWER-Q2300
Wonjin Mulsan Co., Ltd.           510(k) NO: K211283(Traditional)
ATTN: Ha Yong Jung                PHONE NO : 82 32 8160552 
89, Geomdan-ro, Seo-gu            SE DECISION MADE: 14-SEP-21
Incheon  KR 22653                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical face mask
Sunsmed Protective Products Ltd.  510(k) NO: K211296(Traditional)
ATTN: Joyce  Lee                  PHONE NO : 86 152 71236397 
No.18, Industrial park, Maozui TowSE DECISION MADE: 11-SEP-21
Xinatao  CN 433000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANNE One
Sibel Inc.                        510(k) NO: K211305(Third Party - Traditional)
ATTN: Peter  Xu                   PHONE NO : 224 2518859 
6650 W Touhy Ave                  SE DECISION MADE: 14-SEP-21
Niles IL  60714                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Iovera System
Pacira Pharmaceuticals Inc.       510(k) NO: K211334(Special)
ATTN: Kent  Jones                 PHONE NO : 510 9331513 
46400 Fremont Blvd                SE DECISION MADE: 10-SEP-21
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Thermometer (XHF2001, XHF2002)
Putian Hanjiang Huafeng Plastic Co510(k) NO: K211352(Traditional)
ATTN: Yiqian  Deng                PHONE NO : 86 15396 155566 
40M road, Jiangkou Town, Hanjiang SE DECISION MADE: 09-SEP-21
Putian  CN 351111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evo sEEG System
NeuroOne Medical Technologies Corp510(k) NO: K211367(Traditional)
ATTN: Joseph  Ostendorf           PHONE NO : 503 7846756 
7599 Anagram Drive                SE DECISION MADE: 01-SEP-21
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Boston Scientific Corporation     510(k) NO: K211375(Traditional)
ATTN: Donall  Hosna               PHONE NO : 651 5826323 
4100 Hamline Ave North            SE DECISION MADE: 10-SEP-21
St. Paul MN  55112-5798           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation
Magstim Company Ltd.              510(k) NO: K211389(Traditional)
ATTN: Tom  Campbell               PHONE NO : 44 0 1994240798 
Spring Gardens                    SE DECISION MADE: 14-SEP-21
Whitland  GB SA34 0HR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Small Bone Nailing System
Skeletal Dynamics, Inc.           510(k) NO: K211439(Traditional)
ATTN: Ana M Escagedo              PHONE NO : 305 5967585 
7300 N. Kendall Drive, Suite 400  SE DECISION MADE: 30-SEP-21
Miami FL  33156                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Playboy 3 Contour Condom
Thai Nippon Rubber Industry Public510(k) NO: K211450(Traditional)
ATTN: Tossaporn  Nilkhamhang      PHONE NO : 66 38 317999 
789/139 Pinthong Industrial EstateSE DECISION MADE: 30-SEP-21
Sriracha  TH 20230                510(k) STATEMENT
                                                    

DEVICE: Nitta M&T Safety Box
Nitta M&T (Thailand) Co., Ltd.    510(k) NO: K211464(Traditional)
ATTN: Takumi  Moro                PHONE NO : 66 2 5204803 
19/52 Unit G5, Phaholyothin Rd., MSE DECISION MADE: 14-SEP-21
Khlong Luang  TH 12120            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kleiner KG2 System
Baat Medical Products BV          510(k) NO: K211474(Traditional)
ATTN: Kelsey van Abbema           PHONE NO : 31 088 5656600 
F. Hazemeijerstraat 800, Building SE DECISION MADE: 14-SEP-21
Hengelo  NL 7555RJ                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Latex Examination Powder Free Gloves
Aspen Glove Sdn. Bhd.             510(k) NO: K211477(Abbreviated)
ATTN: Iskandar Basha bin Abdul KadPHONE NO : 604 227 5000 
Aspen House, 300, JLN Macalister  SE DECISION MADE: 20-SEP-21
Georgetown  MY 10450              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Latex Surgical Gloves Powder Free
Aspen Glove Sdn. Bhd.             510(k) NO: K211478(Abbreviated)
ATTN: Iskandar Basha bin Abdul KadPHONE NO : 604 2275000 
Aspen House, 300, JLN Macalister  SE DECISION MADE: 16-SEP-21
Georgetown  MY 10450              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Nitrile Examination Glove Powder Free
Aspen Glove Sdn. Bhd.             510(k) NO: K211479(Abbreviated)
ATTN: Iskandar Basha bin Abdul KadPHONE NO : 604 2275000 
Aspen House, 300, JLN Macalister, SE DECISION MADE: 16-SEP-21
Georgetown  MY 10450              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ E10
GE Healthcare                     510(k) NO: K211488(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 10-SEP-21
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polaris X Unidirectional Steerable Diagnostic Catheter
Boston Scientific Corporation     510(k) NO: K211494(Traditional)
ATTN: Donall  Hosna               PHONE NO : 612 5826323 
4100 Hamline Ave North            SE DECISION MADE: 14-SEP-21
St. Paul MN  55112-5798           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Encore Hip Stem
Signature Orthopaedics Pty Ltd.   510(k) NO: K211505(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 24-SEP-21
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VISIONAIRE UK Patient Matched Cutting Guides
Smith & Nephew, Inc.              510(k) NO: K211512(Traditional)
ATTN: Leah  Hawkins               PHONE NO : 901 4638447 
7135 Goodlett Farms Parkway       SE DECISION MADE: 16-SEP-21
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Welspun Health Surgical Mask
Welspun India Limited             510(k) NO: K211536(Traditional)
ATTN: Satyapriya  Dash            PHONE NO : 91 735 9072111 
Survey No. 719, Village: VersamediSE DECISION MADE: 01-SEP-21
District:Kutch  IN 370 110        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
Bolder Surgical, LLC.             510(k) NO: K211579(Traditional)
ATTN: Nicholas  Wong              PHONE NO : 720 2877130 
331 S. 104th Street, Suite 200    SE DECISION MADE: 07-SEP-21
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer, Model: HW-1
Dongguan SIMZO Electronic Technolo510(k) NO: K211583(Traditional)
ATTN: Jinlong  Wang               PHONE NO : 86 769 22988335 
No. 6 Zhangzhou Road, Daojiao TownSE DECISION MADE: 03-SEP-21
Dongguan  CN 523187               510(k) STATEMENT
                                                    

DEVICE: NAEOTOM Alpha, Scan&GO
Siemens Medical Solutions USA, Inc510(k) NO: K211591(Traditional)
ATTN: Tabitha  Estes              PHONE NO : 865 8044553 
810 Innovation Drive              SE DECISION MADE: 30-SEP-21
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enteral Pump Syringe
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K211593(Traditional)
ATTN: Jianwei  Pan                PHONE NO : 86 510 86205183 
No.23, Huanxi Road, Zhutang Town  SE DECISION MADE: 30-SEP-21
Jiangyin  CN 214415               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Philips Medical Systems           510(k) NO: K211597(Traditional)
ATTN: Brenna  Loufek              PHONE NO : 651 2471503 
22100 Bothell Everett HWY         SE DECISION MADE: 08-SEP-21
Bothell WA  98021                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate
STERIS Corporation                510(k) NO: K211607(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 07-SEP-21
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AROMA GRAND
Daeju Meditech Engineering Co., Lt510(k) NO: K211637(Traditional)
ATTN: Seongun  Kim                PHONE NO : 82 2 22080905 
#501-504, HausD Sejong Tower, 26, SE DECISION MADE: 03-SEP-21
Seoul  KR 04793                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
Changzhou Universal Medical Equipm510(k) NO: K211667(Traditional)
ATTN: Jerry  Gao                  PHONE NO : 86 133 82802871 
No. 6, Xinxi Road, Xinbei DistrictSE DECISION MADE: 23-SEP-21
Changzhou  CN 213000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Gloves
Changzhou Yihua Sanitation Materia510(k) NO: K211673(Traditional)
ATTN: Ding  Jie                   PHONE NO : 614 01589995 
Sanhekou Village, Zhenglu Town, TiSE DECISION MADE: 01-SEP-21
Changzhou  CN 213000              510(k) STATEMENT
                                                    

DEVICE: KEYSTONE PEEK Cage System
Shanghai Sanyou Medical Co, LTD   510(k) NO: K211689(Traditional)
ATTN: David  Fan                  PHONE NO : 86 21 58389980 
385 Huirong Road                  SE DECISION MADE: 21-SEP-21
Jiading District  CN 201815       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzDent Web
Ewoosoft Co., Ltd                 510(k) NO: K211700(Traditional)
ATTN: Young Seok Kim              PHONE NO : 82 31 80156172 
801-ho, Vatechnetworks Bldg., 13, SE DECISION MADE: 28-SEP-21
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)
Shenzhen OSTO Technology Company L510(k) NO: K211736(Traditional)
ATTN: Li  Yang                    PHONE NO : 86 755 29769546 
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 05-SEP-21
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rotarex Atherectomy System
C.R. Bard, Inc.                   510(k) NO: K211738(Traditional)
ATTN: Aaron  Conovaloff           PHONE NO : 602 8305453 
1625 West 3rd St                  SE DECISION MADE: 14-SEP-21
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DualX
Amplify Surgical, Inc.            510(k) NO: K211740(Special)
ATTN: Andy  Choi                  PHONE NO : 949 6984854 
9272 Jeronimo Rd Suite 107B       SE DECISION MADE: 29-SEP-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable NIBP Cuff
Shenzhen Coreray Technology Co., L510(k) NO: K211747(Traditional)
ATTN: Simon  Fan                  PHONE NO : 86 755 21010817 
Floor 5, Building 10, HuangbeilingSE DECISION MADE: 23-SEP-21
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WELLTRUST WT-III Mask with Flat Earloop
Lonestar Meadows LLC              510(k) NO: K211751(Traditional)
ATTN: Karthik  Sundaram           PHONE NO : 479 2955820 
8585 Commerce Park Dr., Suite 500 SE DECISION MADE: 17-SEP-21
Houston TX  77036                 510(k) STATEMENT
                                                    

DEVICE: Panther OIS
Prowess Inc.                      510(k) NO: K211760(Traditional)
ATTN: Rachel  Scarano             PHONE NO : 925 3560360 
1844 Clayton Road                 SE DECISION MADE: 28-SEP-21
Concord CA  94520                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altor Safety 4-Ply Surgical Mask (Model:62232)
Altor Safety LLC                  510(k) NO: K211762(Traditional)
ATTN: Jared  Scott                PHONE NO : 1 845 4228320 
711 Executive Boulevard Suite C   SE DECISION MADE: 03-SEP-21
Valley Cottage NY  10989          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OneLIF Intervertebral Body Replacement System
NovApproach Spine                 510(k) NO: K211769(Traditional)
ATTN: Ronald P. Green             PHONE NO : 352 3182584 
13900 Tech City Circle, Suite 300 SE DECISION MADE: 07-SEP-21
Alachua FL  32615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves, Green/ Blue/ Black Color
Zhenjiang SuHui Latex Products Co.510(k) NO: K211778(Traditional)
ATTN: Zhengfu  Sun                PHONE NO : 86 138 05299882 
Lianhe Village, Xinba Town        SE DECISION MADE: 02-SEP-21
Yangzhong  CN 212212              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Gloves
Jiangsu Jinke Protective Equipment510(k) NO: K211781(Traditional)
ATTN: Mia  Lai                    PHONE NO : 86 180 58186617 
West Shuangyang Road(South Side), SE DECISION MADE: 29-SEP-21
Suqian  CN 223900                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable surgical mask
Shanghai No.9 Knitting Mill Co., L510(k) NO: K211794(Traditional)
ATTN: Wang  Yipei                 PHONE NO : 021 58128888 
No.555 Kangwu Road, Pudong New DisSE DECISION MADE: 28-SEP-21
Shanghai  CN 201315               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System
Alphatec Spine, Inc.              510(k) NO: K211805(Traditional)
ATTN: Sandy  Gill                 PHONE NO : 760 4946633 
1950 Camino Vida Roble            SE DECISION MADE: 22-SEP-21
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bonine Acupressure Bands
WellSpring Pharmaceutical Corporat510(k) NO: K211823(Traditional)
ATTN: Renee Davis Grandchamp      PHONE NO : 412 9445501 
5911 North Honore Avenue, Suite 21SE DECISION MADE: 01-SEP-21
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HERA W9, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K211824(Traditional)
ATTN: Scully  Kim                 PHONE NO : 82 2 21941312 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 09-SEP-21
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)
Zhejiang Lanhine Medical Products 510(k) NO: K211827(Traditional)
ATTN: Jerry  Gu                   PHONE NO : 86 0574 63970705 
1989 Cidong Road, Cidongbinhai DisSE DECISION MADE: 23-SEP-21
Cixi  CN 315300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion Exceed LB
Canon Medical Systems Corporation 510(k) NO: K211828(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 10-SEP-21
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask
Zhejiang Lanhine Medical Products 510(k) NO: K211832(Traditional)
ATTN: Jerry  Gu                   PHONE NO : 86 0574 63970705 
1989 Cidong Road, Cidongbinhai DisSE DECISION MADE: 08-SEP-21
Cixi  CN 315300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore Sapphire
Electrocore, Inc.                 510(k) NO: K211856(Traditional)
ATTN: Mike  Romaniw               PHONE NO : 973 3556702 
200 Forge Way, Suite 205          SE DECISION MADE: 10-SEP-21
Rockaway NJ  07866                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RayStation 11.0
RaySearch Laboratories AB (publ)  510(k) NO: K211867(Traditional)
ATTN: David  Hedfors              PHONE NO : 46 8 51053000 
Sveavägen 44                      SE DECISION MADE: 08-SEP-21
Stockholm  SE 111 34              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI Segmentation
Varian Medical Systems, Inc.      510(k) NO: K211881(Traditional)
ATTN: Peter  Coronado             PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 02-SEP-21
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Glove
Jiangsu Dihong Industry and Trade 510(k) NO: K211904(Traditional)
ATTN: Sue  Chen                   PHONE NO : 86 187 61104047 
Dongxiaodian Industrial Park      SE DECISION MADE: 17-SEP-21
Shuyang  CN 223616                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Home Use Hair Removal Device
Shenzhen Beauty Every Moment intel510(k) NO: K211922(Traditional)
ATTN: Luo  Huajun                 PHONE NO : 86 0755 33253598 
Rm. 501, Bldg. 4, Haoer Jiashitai SE DECISION MADE: 20-SEP-21
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Digital Thermometer Non-Lubricated Probe Sheath
Medline Industries, Inc.          510(k) NO: K211931(Traditional)
ATTN: Kelsey  Closen              PHONE NO : 847 9482283 
Three Lakes Drive                 SE DECISION MADE: 20-SEP-21
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORIO-Ti Intervertebral Body Fusion Cage System
SpineCraft, LLC                   510(k) NO: K211935(Traditional)
ATTN: Ami  Akallal-Asaad          PHONE NO : 630 9207300 
777 Oakmont Lane, Suite 200       SE DECISION MADE: 30-SEP-21
Westmont IL  60559                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V8 Diagnostic Ultrasound System
Samsung Medison CO., LTD.         510(k) NO: K211945(Traditional)
ATTN: Scully  KIM                 PHONE NO : 82 2 21941312 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 08-SEP-21
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SubtlePET
Subtle Medical, Inc.              510(k) NO: K211964(Traditional)
ATTN: Ajit  Shankaranarayanan     PHONE NO : 650 3978709 
883 Santa Cruz Ave, Suite 205     SE DECISION MADE: 28-SEP-21
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omeza Collagen Matrix
Omeza, LLC                        510(k) NO: K211972(Traditional)
ATTN: Thomas  Gardner             PHONE NO : 941 7805274 
25 South Osprey Avenue            SE DECISION MADE: 01-SEP-21
Sarasota FL  34236                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRI Cocaine Metabolite Assay
Microgenics Corporation           510(k) NO: K211973(Traditional)
ATTN: Nikhita  Tandon             PHONE NO : 510 9795000 
46500 Kato Road                   SE DECISION MADE: 24-SEP-21
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LED PHOTIC System
Micromed S.p.A.                   510(k) NO: K211974(Traditional)
ATTN: Nicola  Rizzo               PHONE NO : 39 041 5937000 
Via Giotto 2                      SE DECISION MADE: 23-SEP-21
Mogliano Veneto  IT 31021         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexta PEEK Hammertoe Correction System
Nextremity Solutions, Inc.        510(k) NO: K211996(Traditional)
ATTN: Elise  Fox                  PHONE NO : 574 3762062 
1195 Polk Drive                   SE DECISION MADE: 23-SEP-21
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synthetic Vinyl Examination Gloves
Yunnan Huazhiyuan Medical Technolo510(k) NO: K212002(Traditional)
ATTN: Yun  Gao                    PHONE NO : 86 182 52909158 
Yangjie Industrial Park,Jianshui CSE DECISION MADE: 23-SEP-21
Honghe Hani and Yi Autonomous Pref510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Gloves
Jiangsu Shenglijie Safety Products510(k) NO: K212009(Traditional)
ATTN: Andy  Jiang                 PHONE NO : 86 138 13628939 
No.88 SI Road                     SE DECISION MADE: 15-SEP-21
Nantong  CN 226401                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6430 MyLabX75, 6430 MyLab XPro75
Esaote S.p.A.                     510(k) NO: K212021(Traditional)
ATTN: Alberto  Carcagni           PHONE NO : 39 055 4229365 
Via Enrico Melen 77               SE DECISION MADE: 16-SEP-21
Genoa  IT 16152                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplatzer Steerable Delivery Sheath
Abbott Medical                    510(k) NO: K212026(Traditional)
ATTN: Dan  Gapp                   PHONE NO : 612 2898887 
5050 Nathan Lane North            SE DECISION MADE: 27-SEP-21
Plymouth MN  55442                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dark Star Navigation Instrument System
Republic Spine, LLC               510(k) NO: K212028(Traditional)
ATTN: James  Doulgeris            PHONE NO : 561 3628094 
2424 N Federal HW, Suite 257      SE DECISION MADE: 27-SEP-21
Boca Raton FL  33431              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SoftSpot
PediaMetrix, Inc.                 510(k) NO: K212045(Traditional)
ATTN: Joshua D Levin              PHONE NO : 301 2192712 
155 Gibbs Street, Suite 537       SE DECISION MADE: 28-SEP-21
Rockville MD  20850               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Longeviti ClearFit™ OTS Cranial Implants
Longeviti Neuro Solutions, LLC    510(k) NO: K212058(Traditional)
ATTN: Heather  Hourihan           PHONE NO : 410 5271803 
303 International Circle Suite 190SE DECISION MADE: 08-SEP-21
Hunt Valley MD  21030             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deep Learning Image Reconstruction
GE Healthcare Japan Corporation   510(k) NO: K212067(Traditional)
ATTN: Katelyn  Rowley             PHONE NO : 2 623 095888 
7-127, 4-Chome, Asahigaoka,       SE DECISION MADE: 17-SEP-21
Hino  JP 191-8503                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Imaging Plate Scanner, i-Scan
Guilin Woodpecker Medical Instrume510(k) NO: K212080(Traditional)
ATTN: Xunxian  Wu                 PHONE NO : 86 773 2350532 
Information Industrial Park, GuiliSE DECISION MADE: 27-SEP-21
Guilin City  CN 541004            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228
3M Company                        510(k) NO: K212081(Special)
ATTN: Mary  Fretland              PHONE NO : 651 4612734 
3M Center, Building 275-5W-06     SE DECISION MADE: 05-SEP-21
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Red Wave Hair Removal
Shenzhen Accompany Technology Co.,510(k) NO: K212099(Traditional)
ATTN: Yourong  Lai                PHONE NO : 0086 0755 22674547 
Unit. 375, Xiangnan Ruifeng GradanSE DECISION MADE: 24-SEP-21
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynamic TiBase
Talladium España, SL              510(k) NO: K212108(Traditional)
ATTN: Xavier Soca Filella         PHONE NO : 34 973 289580 
C/ Virginia Woolf, 17             SE DECISION MADE: 24-SEP-21
Lleida  ES 25005                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nobel Biocare Dental Implant Systems Portfolio - MR Conditional
Nobel Biocare AG                  510(k) NO: K212125(Traditional)
ATTN: Bernice  Jim                PHONE NO : 41 79 8550073 
P.O. Box, 8058 Zurich - Airport   SE DECISION MADE: 24-SEP-21
Balsberg, Balz Zimmermann-Str. 7  510(k) STATEMENT
                                                    

DEVICE: Persona® Personalized Knee System
Zimmer Switzerland Manufacturing G510(k) NO: K212129(Traditional)
ATTN: Thomas  Lincoln             PHONE NO : 0041 58 8548257 
Sulzerallee 8                     SE DECISION MADE: 28-SEP-21
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
Cochlear Americas                 510(k) NO: K212136(Traditional)
ATTN: Whitney  Alexander          PHONE NO : 303 2642123 
10350 Park Meadows Dr             SE DECISION MADE: 29-SEP-21
Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Admiral ACP System
SeaSpine Orthopedics Corporation  510(k) NO: K212139(Traditional)
ATTN: Cindy  Fong                 PHONE NO : 949 8557175 
5770 Armada Drive                 SE DECISION MADE: 01-SEP-21
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SimpleSENSE Platform
Nanowear Inc.                     510(k) NO: K212160(Special)
ATTN: Venkatesh  Varadan          PHONE NO : 718 6374815 
53 Boerum Place, Suite 3F         SE DECISION MADE: 22-SEP-21
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips IntelliVue GuardianSoftware (Rev. E.0X)
Philips Medizin Systeme Boeblingen510(k) NO: K212208(Third Party - Traditional)
ATTN: Johannes  Schmid            PHONE NO : 0049 175 5177024 
Hewlett-Packard Str. 2            SE DECISION MADE: 30-SEP-21
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HandX
Human Xtensions Ltd.              510(k) NO: K212214(Traditional)
ATTN: Maija  Wallenstein          PHONE NO : 972 77 3630316 
4 Meir Ariel St.                  SE DECISION MADE: 13-SEP-21
Netanya  IL 4250574               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform
Imperative Care Inc.              510(k) NO: K212224(Special)
ATTN: Kristin  Ellis              PHONE NO : 408 8570934 
1359 Dell Avenue                  SE DECISION MADE: 20-SEP-21
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DR Safety Syringe, Sterile Hypodermic needle for Single use
Zhuhai DR Medical Instruments Co.,510(k) NO: K212226(Third Party - Traditional)
ATTN: Xu  Jianhai                 PHONE NO : 086 0756 7770668 
Floor 4, Factory Building A, No.28SE DECISION MADE: 29-SEP-21
Zhuhai  CN                        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Philips MR Patient Care Portal
Invivo Corporation                510(k) NO: K212227(Traditional)
ATTN: Maria  Keelan               PHONE NO : 407 4735510 
12151 Research Parkway            SE DECISION MADE: 30-SEP-21
Orlando FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TheraFace Microcurrent
Theragun, Inc.                    510(k) NO: K212238(Traditional)
ATTN: Jaime  Sanchez              PHONE NO : 310 5708341 
6100 Wilshire Blvd, Suite 200     SE DECISION MADE: 29-SEP-21
Los Angeles CA  90048             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exofin Precision Pen
Chemence Medical, Inc.            510(k) NO: K212246(Special)
ATTN: Charnelle  Thomas           PHONE NO : 678 7890760 
200 Technology Drive              SE DECISION MADE: 09-SEP-21
Alpharetta GA  30115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intelligent NR
Canon Inc.                        510(k) NO: K212269(Traditional)
ATTN: Akira  Hirai                PHONE NO : 81 33 7582111 
9-1 Imaikami-cho, Nakahara-ku     SE DECISION MADE: 17-SEP-21
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tempo Natural Tampon
Dong-A Pharmaceutical Co., Ltd.   510(k) NO: K212272(Traditional)
ATTN: Hyunjeong  Jang             PHONE NO : 82 2 9208289___ 
64 Cheonho-daero, Dongdaemun-gu   SE DECISION MADE: 17-SEP-21
Seoul  KR 02587                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioRoot Flow 0.5g, BioRoot Flow 2g
Septodont                         510(k) NO: K212283(Traditional)
ATTN: Kimty  Bui Van              PHONE NO : 33 149 767116 
58, rue du Pont De Creteil        SE DECISION MADE: 16-SEP-21
Saint-Maur des Fosses Cedex  FR 94510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dayspring Lite
Koya Medical, Inc.                510(k) NO: K212287(Special)
ATTN: Jarren  Baldwin             PHONE NO : 1 773 9541371 
2461 Peralta St.                  SE DECISION MADE: 21-SEP-21
Oakland CA  94607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PHOENIX
Sedecal SA                        510(k) NO: K212291(Traditional)
ATTN: Mª Luisa  Gómez de Agüero   PHONE NO : 34 91 6280544 
C/ Pelaya, 9 - 13 Pol. Ind. Río DeSE DECISION MADE: 14-SEP-21
Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2
Osstem Implant Co., Ltd.          510(k) NO: K212303(Traditional)
ATTN: Jinwoo  Bae                 PHONE NO : 82 70 46260701 
2 Floor, B-dong, 51, Mayu-ro 238beSE DECISION MADE: 21-SEP-21
Siheung-si  KR 15079              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-  Large (10 pack)
3M Health Care Business Group     510(k) NO: K212320(Traditional)
ATTN: Teri  Feeley                PHONE NO : 210 4591952 
6203 Farinon Dr.                  SE DECISION MADE: 28-SEP-21
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JiveX (Model Number / Release: 5.3)
Visus Health IT GmbH              510(k) NO: K212321(Traditional)
ATTN: Axel  Schreiber             PHONE NO : 49 234 93693337 
Gesundheitscampus-Sued 15-17      SE DECISION MADE: 23-SEP-21
Bochum  DE 44801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiscCath Needle Set
DiscCath LLC                      510(k) NO: K212328(Traditional)
ATTN: Gregory E. Lutz             PHONE NO : 609 3562449 
62 E 88th Street                  SE DECISION MADE: 26-SEP-21
New York NY  10128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEO Extremity and Ankle Plating System
Gramercy Extremity Orthopedics, LL510(k) NO: K212334(Traditional)
ATTN: Michael P. Simpson          PHONE NO : 855 4392278 
1239 N. Glenville Dr.             SE DECISION MADE: 21-SEP-21
Richardson TX  75081              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZIIP+ Device
ZIIP, Inc                         510(k) NO: K212342(Traditional)
ATTN: David  Mason                PHONE NO : 415 3193639 
1425 Leimert Blvd, Suite 202      SE DECISION MADE: 23-SEP-21
Oakland CA  94062                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DB-EZ Bone Void Filler
Dimensional Bioceramics, LLC.     510(k) NO: K212353(Traditional)
ATTN: Duran N. Yetkinliner        PHONE NO : 408 7576603 
2161 Delaware Avenue, Suite A     SE DECISION MADE: 22-SEP-21
Santa Cruz CA  95060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AngioVac F18 85
AngioDynamics, Inc.               510(k) NO: K212386(Traditional)
ATTN: Kasey E. Newcomb            PHONE NO : 508 6587813 
603 Queensbury Ave                SE DECISION MADE: 30-SEP-21
Queensbury NY  12804              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMERGE™ Anterior Cervical Plate System
Evolution Spine                   510(k) NO: K212405(Abbreviated)
ATTN: Todd  Wallenstein           PHONE NO : 571 5947409 
2300 N. Haskell Ave               SE DECISION MADE: 30-SEP-21
Dallas TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS)
Conformis Inc.                    510(k) NO: K212411(Traditional)
ATTN: Kara  Johnson               PHONE NO : 781 3459122 
600 Technology Park Drive, 4th FloSE DECISION MADE: 23-SEP-21
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRIS-XP
Medicore Co., Ltd.                510(k) NO: K212412(Traditional)
ATTN: Kyo-bum  Kim                PHONE NO : 82 2 20562600 
                                  SE DECISION MADE: 13-SEP-21
Seongnam-si  KR 13207             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADAS 3D
Adas3D Medical S.L                510(k) NO: K212421(Special)
ATTN: Antonio  Riu                PHONE NO : 0034 93 3283964 
Paris 179, 2-2                    SE DECISION MADE: 03-SEP-21
Barcelona  ES 08036               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
ReMade USA LLC                    510(k) NO: K212451(Third Party - Traditional)
ATTN: David  Durst                PHONE NO : 323 5785448 
2915 E Washington Blvd            SE DECISION MADE: 10-SEP-21
Los Angeles CA  90023             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KARL STORZ Flexible HD Cysto-Urethroscope System
KARL STORZ Endoscopy America, Inc.510(k) NO: K212476(Special)
ATTN: Winkie  Wong                PHONE NO : 310 6583427 
2151 E. Grand Ave                 SE DECISION MADE: 03-SEP-21
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air Relax Pro Model AR-4.0
Diode Art Engineering doing busine510(k) NO: K212491(Third Party - Traditional)
ATTN: Beomjoon  Lee               PHONE NO : 1 323 2854231 
9535 Brasher St                   SE DECISION MADE: 02-SEP-21
Pico Rivera CA  90660             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Lung Image Analysis
Pulmonx Corporation               510(k) NO: K212494(Third Party - Traditional)
ATTN: Terry  Solomon              PHONE NO : 650 2160195 
700 Chesapeake Drive              SE DECISION MADE: 02-SEP-21
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Leva Pelvic Health System
Renovia Inc.                      510(k) NO: K212495(Special)
ATTN: Jim  O'Connor               PHONE NO : 860 5103026 
263 Summer St. 5th Floor          SE DECISION MADE: 08-SEP-21
Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Explorer TO System
SeaSpine Orthopedics Corporation  510(k) NO: K212540(Special)
ATTN: Aly  Alvarez                PHONE NO : 619 8844342 
5770 Armada Drive                 SE DECISION MADE: 10-SEP-21
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIGITAL RADIOGRAPHY CXDI-Pro, D1
Canon Inc.                        510(k) NO: K212553(Special)
ATTN: Akira  Hirai                PHONE NO : 81 33 7582111 
9-1 Imaikami-cho, Nakahara-ku     SE DECISION MADE: 09-SEP-21
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: mi-eye 3 needlescope with cannula, mi-tablet 3
Trice Medical, Inc.               510(k) NO: K212556(Special)
ATTN: David  Vancelette           PHONE NO : 949 2388220 
40 General Warren Blvd, Suite 100 SE DECISION MADE: 15-SEP-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Virtual C DRF-NEO Digital Imaging System
Portavision Medical LLC           510(k) NO: K212557(Traditional)
ATTN: Terry  Ancar                PHONE NO : 866 7834133 
800 Central Avenue                SE DECISION MADE: 24-SEP-21
Jefferson LA  70121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symbia VA10A Family
Siemens Medical Solutions USA, Inc510(k) NO: K212604(Special)
ATTN: Tabitha  Estes              PHONE NO : 865 8044553 
810 Innovation Drive              SE DECISION MADE: 16-SEP-21
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeamSite
DoseOptics LLC                    510(k) NO: K212606(Special)
ATTN: Venkat  Krishnaswamy        PHONE NO : 802 7270123 
16 Cavendish Ct                   SE DECISION MADE: 15-SEP-21
Lebanon NH  03766                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StrataMR II Valves and Shunts
Medtronic Neurosurgery            510(k) NO: K212641(Special)
ATTN: Swara  Vashi                PHONE NO : 267 6388778 
5290 California Avenue            SE DECISION MADE: 16-SEP-21
Irvine CA  92617                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POWERSEAL Curved Jaw Sealer and Divider, Double Action
Olympus Surgical Technologies Amer510(k) NO: K212643(Special)
ATTN: Christina  Flores           PHONE NO : 508 8083341 
9600 Louisiana Blvd North         SE DECISION MADE: 27-SEP-21
Brooklyn Park MN  55455           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flyte
Pelvital USA, Inc.                510(k) NO: K212655(Special)
ATTN: Dale  Wahlstrom             PHONE NO : 612 8041319 
1000 LaSalle Avenue, SCH 435      SE DECISION MADE: 21-SEP-21
Minneapolis MN  55403             510(k) STATEMENT
                                                    

DEVICE: Smylio Invisible Clear Aligners
Smylio, Inc                       510(k) NO: K212660(Special)
ATTN: Ren  Menon                  PHONE NO : 510 8682184 
48890 Milmont Dr.                 SE DECISION MADE: 22-SEP-21
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Guide Sheath Kit-401, K-402
Olympus Medical Systems Corp.     510(k) NO: K212667(Special)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 22-SEP-21
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viveve System, Viveve 2.0 System
Viveve Medical, Inc.              510(k) NO: K212678(Special)
ATTN: Kevin  Robison              PHONE NO : 317 4358898 
345 Inverness Drive South, BuildinSE DECISION MADE: 14-SEP-21
Englewood CO  80109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KONICAMINOLTA DI-X1
Konica Minolta, Inc.              510(k) NO: K212685(Special)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 13-SEP-21
Hino-shi  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mariner Pedicle Screw System
SeaSpine Orthopedics Corporation  510(k) NO: K212692(Special)
ATTN: Jesse  Albright             PHONE NO : 760 2165176 
5770 Armada Drive                 SE DECISION MADE: 21-SEP-21
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
Philips Medical Systems           510(k) NO: K212704(Third Party - Traditional)
ATTN: Brenna  Loufek              PHONE NO : 651 2471503 
22100 Bothell Everett HWY         SE DECISION MADE: 24-SEP-21
Bothell WA  98021                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Halo One Thin-Walled Guiding Sheath
C.R.Bard, Inc                     510(k) NO: K212708(Special)
ATTN: Annmarie  Fitzgerald        PHONE NO : 353 53 9237111 
Moyne Upper                       SE DECISION MADE: 23-SEP-21
Enniscorthy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLOBAL UNITE™ Platform Shoulder System
DePuy Ireland UC                  510(k) NO: K212710(Special)
ATTN: Yayoi  Fujimaki             PHONE NO : 508 8283541 
Loughbeg Ringaskiddy              SE DECISION MADE: 15-SEP-21
Co. Cork Munster  IE              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViperCross Support Catheters
Cardiovascular Systems, Inc.      510(k) NO: K212725(Special)
ATTN: Erika  Huffman              PHONE NO : 651 2591608 
1225 Old Highway 8 NW             SE DECISION MADE: 24-SEP-21
St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Pneumonia Panel
BioFire Diagnostics, LLC          510(k) NO: K212727(Special)
ATTN: Kevin  Bourzac              PHONE NO : 801 7366354 1358
515 Colorow Drive                 SE DECISION MADE: 22-SEP-21
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Standard Bougie, 38 Fr. and Hand Pump
Standard Bariatrics               510(k) NO: K212728(Special)
ATTN: Michelle  Schnell           PHONE NO : 1 513 7026083 
4362 Glendale Milford Rd.         SE DECISION MADE: 23-SEP-21
Cincinnati OH  45242              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amplatzer Talisman Delivery Sheath
Abbott Medical                    510(k) NO: K212738(Special)
ATTN: Daniel  Gapp                PHONE NO : 651 7563329 
177 East County Road B            SE DECISION MADE: 27-SEP-21
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating
Waldemar Link GmbH & Co. KG       510(k) NO: K212742(Special)
ATTN: Lydia  Ditter               PHONE NO : 49 40 53575 530
Oststraße 4-10                    SE DECISION MADE: 16-SEP-21
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Da Vinci SP Surgical System
Intuitive Surgical, Inc.          510(k) NO: K212747(Special)
ATTN: Connor  McCarty             PHONE NO : 805 7984205 
1266 Kifer Road                   SE DECISION MADE: 29-SEP-21
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasonic Surgical Aspirator System, Model: XD880B
SMTP Technology Co., Ltd.         510(k) NO: K212750(Special)
ATTN: Songtao  Zhan               PHONE NO : 86 010 88572898 
1F&4F, Building A, Emerging IndustSE DECISION MADE: 27-SEP-21
Zhangjiagang  CN 215634           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jada System
Alydia Health                     510(k) NO: K212757(Special)
ATTN: Colby  Holtshouse           PHONE NO : 650 2753772 
3495 Edison Way                   SE DECISION MADE: 30-SEP-21
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Collaboration Live
Philips Ultrasound, Inc.          510(k) NO: K212777(Special)
ATTN: Courtney  Nix               PHONE NO : 203 2136862 
22100 Bothell Everett Highway     SE DECISION MADE: 24-SEP-21
Bothell WA  98201-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage
Medynus Inc.                      510(k) NO: K212792(Traditional)
ATTN: David  Shin                 PHONE NO : 949 9320847 
18 Technology Dr. Ste 109         SE DECISION MADE: 23-SEP-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accuray Precision Treatment Planning System
Accuray Incorporated              510(k) NO: K212794(Special)
ATTN: Lizhi  Yu                   PHONE NO : 608 8242885 
1209 Deming Way                   SE DECISION MADE: 30-SEP-21
Madison WI  53717                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SteriCap Mini Needle and Standard Needles
OcuJect, LLC                      510(k) NO: K212805(Special)
ATTN: Rebecca K. Pine             PHONE NO : 760 8095178 
1441 Avocado Ave, Suite 204       SE DECISION MADE: 30-SEP-21
Newport Beach CA  92660           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProxiDiagnost N90
Philips Medical Systems DMC GmbH  510(k) NO: K212837(Special)
ATTN: Supriya  Dalvi              PHONE NO : 49 405 0782425 
Roentgenstrasse 24-26             SE DECISION MADE: 21-SEP-21
Hamburg  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMILERS
Biotech Dental Smilers, SAS       510(k) NO: K212961(Third Party - Traditional)
ATTN: Delphine  Mercier           PHONE NO : 33 04 90446060 
305, Allée de craponne            SE DECISION MADE: 20-SEP-21
Salon de Provence  FR 13300       510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


               TOTAL 510(k)s THIS PERIOD   261                                     
               TOTAL WITH SUMMARIES        247                                     
               TOTAL WITH STATEMENTS        14
                                      
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