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  1. 510(k) Clearances

November 2021 510(K) Clearances

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


DEVICE: BD Kiestra IdentifA
Becton, Dickinson and Company     510(k) NO: K191964(Traditional)
ATTN: Janine  Spafford            PHONE NO : 410 3164938 
7 Loveton Circle, MC 964          SE DECISION MADE: 03-NOV-21
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capiox iCP Centrifugal Pump
Terumo Cardiovascular Systems Corp510(k) NO: K200091(Traditional)
ATTN: John  Chesney               PHONE NO : 734 7416410 
6200 Jackson Road                 SE DECISION MADE: 18-NOV-21
Ann Arbor MI  48103               510(k) STATEMENT
                                                    

DEVICE: LTV2 Series Ventilators
Vyaire Medical Inc                510(k) NO: K201082(Traditional)
ATTN: Colleen  Watson             PHONE NO : 872 7570070 
26125 N. Riverwoods Blvd.         SE DECISION MADE: 10-NOV-21
Mettawa IL  60045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
Qura S.r.l.                       510(k) NO: K201320(Traditional)
ATTN: Raffaella  Tommasini        PHONE NO : 39 0535 180305 
Via di Mezzo 23                   SE DECISION MADE: 03-NOV-21
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARROW Short Stem Humeral System
FH Industrie                      510(k) NO: K202024(Traditional)
ATTN: Patricia  Donnard           PHONE NO : 
6 rue Nobel, Zi De Kernevez       SE DECISION MADE: 30-NOV-21
Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIXI Medical Microdeep Micro-Macro Depth Electrodes
Dixi Medical                      510(k) NO: K202087(Traditional)
ATTN: Lucie  Petegnief            PHONE NO : 033 3 81889890 
2A Route de Pouligney             SE DECISION MADE: 18-NOV-21
Chaudefontaine  FR 25640          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MStim Drop Model: LGT-233
Guangzhou Longest Science & Techno510(k) NO: K202110(Traditional)
ATTN: Xiaobing  Luo               PHONE NO : 86 020 66353999 
5&6F, Building B4, No.11, Kaiyuan SE DECISION MADE: 05-NOV-21
Guangzhou  CN 510530              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finebeam
SNJ Co., Ltd.                     510(k) NO: K202288(Traditional)
ATTN: Hyang-Kee  Lee              PHONE NO : 82 2 8669005 
No. 604, Ace-Techno Tower 2, DigitSE DECISION MADE: 19-NOV-21
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
Tianjin Huahong Technology Co., Lt510(k) NO: K202319(Traditional)
ATTN: Yan  Li                     PHONE NO : 86 22 58775333 
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 12-NOV-21
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BESPA Charcot System
Bespa Global, LLC                 510(k) NO: K202326(Traditional)
ATTN: Lisa  Viele                 PHONE NO : 
9 Rand Road                       SE DECISION MADE: 09-NOV-21
Caoe Elizabeth ME  04107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Highspeed Airturbine Handpiece
Beijing Dongbo Dental Handpiece Co510(k) NO: K202371(Traditional)
ATTN: Chao  Hao                   PHONE NO : 86 10 80479758 
3F, Building 3, No. 17, First JinmSE DECISION MADE: 08-NOV-21
Beijing  CN 101318                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hystero-V Hysteroscope
Hysterovue, Inc.                  510(k) NO: K202445(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 650 3975174 
5337 14th Place SE                SE DECISION MADE: 23-NOV-21
Bellevue WA  98006                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALTMS Magnetic Stimulation Therapy System
REMED Co., Ltd                    510(k) NO: K202537(Traditional)
ATTN: Yonsoo  Nam                 PHONE NO : 812 3457485 
#301-#303 Migun Techno World II, 1SE DECISION MADE: 26-NOV-21
Daejeon  KR 34025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K202671(Traditional)
ATTN: Sammy  Li                   PHONE NO : 86 020 66393598 
No.23 Building, The Second Phase, SE DECISION MADE: 12-NOV-21
Guangzhou  CN 511450              510(k) STATEMENT
                                                    

DEVICE: Disposable Medical Face Mask
Zhejiang Senhong Medical&Instrumen510(k) NO: K202676(Traditional)
ATTN: Eric  Jian                  PHONE NO : 86 18 006712375 
Floor 1-2, Building 2, No 889 NortSE DECISION MADE: 05-NOV-21
Huzhou  CN 313200                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOL-CARE IV Bag Safety Connector
Sol-Millennium Medical Group      510(k) NO: K202732(Traditional)
ATTN: Jim  Barley                 PHONE NO : 949 4333058 
315 Shawnee North Drive, Suite 100SE DECISION MADE: 03-NOV-21
Suwanne GA  30024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical surgical mask
Henan Huibo Medical Co.,Ltd.      510(k) NO: K202842(Traditional)
ATTN: Hui  Lu                     PHONE NO : 86 400 6000067 
Weishi Road Central, Nanyang New ESE DECISION MADE: 26-NOV-21
Nanyang  CN 473000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F
Qura S.r.l.                       510(k) NO: K203067(Traditional)
ATTN: Raffaella  Tommasini        PHONE NO : 39 0535 1803050 
Via di Mezzo 23                   SE DECISION MADE: 08-NOV-21
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
PT. Universal Gloves              510(k) NO: K203074(Traditional)
ATTN: Li  I-Feng                  PHONE NO : 62 61 7883055 
Jl. Pertahanan No. 17 Patumbak    SE DECISION MADE: 19-NOV-21
Medan  ID 20361                   510(k) STATEMENT
                                                    

DEVICE: HYDRASHIFT 2/4 isatuximab
Sebia                             510(k) NO: K203184(Traditional)
ATTN: Karen  Anderson             PHONE NO : 1 800 8356497 3704
1705 Corporate Drive Suite 400    SE DECISION MADE: 12-NOV-21
Norcross GA  30096                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Albumin BCG2
Abbott Ireland Diagnostics Divisio510(k) NO: K203248(Traditional)
ATTN: Suzanne  Cheang             PHONE NO : 972 5186617 
Lisnamuck                         SE DECISION MADE: 23-NOV-21
Longford  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyMRI
SyntheticMR AB                    510(k) NO: K203372(Traditional)
ATTN: Lisa  Warnroth              PHONE NO : 46 73 3109915 
Storgatan 11                      SE DECISION MADE: 03-NOV-21
Linkoping  SE 582 23              510(k) STATEMENT
                                                    

DEVICE: Venen-trainer (Model: FM150, SFM90)
Shenzhen Pango Electronic CO., LTD510(k) NO: K203746(Traditional)
ATTN: Guojun  Zeng                PHONE NO : 86 136 32731945 
No.25, 1st Industry Zone, FenghuanSE DECISION MADE: 10-NOV-21
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeptiCyte RAPID
Immunexpress, Inc                 510(k) NO: K203748(Traditional)
ATTN: LaKesha  Hunt-Dickens       PHONE NO : 434 9419951 
425 Pontius Avenue North, Suite 47SE DECISION MADE: 29-NOV-21
Seattle WA  98109                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guiding Catheter
CenterPoint Systems LLC           510(k) NO: K210009(Traditional)
ATTN: Marybeth  Gamber            PHONE NO : 774 2495250 
3338 Parkway Blvd                 SE DECISION MADE: 24-NOV-21
West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Mask
Suzhou Letian Protective Products 510(k) NO: K210042(Traditional)
ATTN: Huang  Qizhi                PHONE NO : 86 137 01567601 
No. 12 Zhenfeng Road, Nanfeng TownSE DECISION MADE: 17-NOV-21
Suzhou  CN 215600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Playboy Premium Silicone Lubricant
Thai Nippon Rubber Industry Public510(k) NO: K210095(Traditional)
ATTN: Ryosuke  Takamiya           PHONE NO : 66 38 317999 
789/139 Pinthong Industrial EstateSE DECISION MADE: 23-NOV-21
Sriracha  TH 20230                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paltop Narrow Implant
Paltop Advanced Dental Solutions, 510(k) NO: K210117(Traditional)
ATTN: Zina  Gurgov                PHONE NO : 972 4 627171 
Hashita 5, Industrial Park        SE DECISION MADE: 30-NOV-21
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Mask
Guangdong Lide Medical Technology 510(k) NO: K210222(Traditional)
ATTN: Zhuang  Shenglin            PHONE NO : 186 645 14268 
HFDB-05-2102 Ecological TechnologySE DECISION MADE: 02-NOV-21
Shanwei  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Best Glove-Latex Powder Free Examination Glove
Bestsafe Glove CO., LTD.          510(k) NO: K210253(Traditional)
ATTN: Piyawat  Chirasakulkarun    PHONE NO : 66 038 949880 
52/43 Wat Khot Hin-Khao Phai Road,SE DECISION MADE: 05-NOV-21
Muang Rayong  TH 21000            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VS3 Iridium Sytem
Visionsense Ltd.                  510(k) NO: K210265(Traditional)
ATTN: Nancy  Sauer                PHONE NO : 720 3615290 
20 Hamagshimim St.                SE DECISION MADE: 22-NOV-21
Petach Tikva, Hamerkaz  IL 4934829510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: inVisionOS
PrecisionOS Technology Inc.       510(k) NO: K210344(Traditional)
ATTN: Danny  Goel                 PHONE NO : 604 3450401 
500-319 West Hastings Street      SE DECISION MADE: 10-NOV-21
Vancouver  CA V6B 1H6             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gemini 2 810+980 Soft Tissue Laser
Azena Medical, LLC                510(k) NO: K210350(Traditional)
ATTN: Lindsay  Tilton             PHONE NO : 925 6999091 
3021 Citrus Circle Suite 180      SE DECISION MADE: 18-NOV-21
Walnut Creek CA  94598            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrap Accessory Electrodes
Hi-Dow International Inc.         510(k) NO: K210383(Traditional)
ATTN: Eric  Chen                  PHONE NO : 314 5692888 
2555 Metro Blvd                   SE DECISION MADE: 12-NOV-21
Maryland Heights MO  63043        510(k) STATEMENT
                                                    

DEVICE: CARESCAPE R860
Datex-Ohmeda, Inc.                510(k) NO: K210384(Traditional)
ATTN: Trishia  Mercier            PHONE NO : 608 6958319 
3030 Ohmeda Drive, PO Box 7550    SE DECISION MADE: 04-NOV-21
Madison WI  53707-7550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LELTEK Ultrasound Imaging System (Model: LU700 Series)
Leltek Inc                        510(k) NO: K210432(Traditional)
ATTN: Jessie  Wang                PHONE NO : 886 2 29137577 
6F-3., No. 293, Sec. 1, Beixin Rd.SE DECISION MADE: 03-NOV-21
New Taipei City  TW 23147         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)
Imicryl Dis Malzemeleri Sanayi Ve 510(k) NO: K210473(Traditional)
ATTN: Hüsamettin  Sonmez          PHONE NO : 0090 44 47130 144
Fetih Mahallesi Mahir Sokak No: 5/SE DECISION MADE: 02-NOV-21
Konya  TR 42030                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alpha Dent Implants Dental Implants System
Alpha Dent Implants GmbH          510(k) NO: K210499(Traditional)
ATTN: Simha  Sibony               PHONE NO : 972 52 6546625 
Hanauer Street 8                  SE DECISION MADE: 01-NOV-21
Pforzheim  DE 75181               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IM007
Implicity, Inc.                   510(k) NO: K210543(Traditional)
ATTN: David  Perlmutter           PHONE NO : 033 6 76731731 
185 Alewife Brook Parkway Suite 21SE DECISION MADE: 03-NOV-21
Cambridge MA  02138               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velofix SA Cervical Cage
U&I Corporation                   510(k) NO: K210573(Traditional)
ATTN: Jee-Ae  Bang                PHONE NO : 82 31 8606846 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 19-NOV-21
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pediatric Nasogastric Feeding Tubes - Single ENFit Port
CAIR LGL                          510(k) NO: K210598(Traditional)
ATTN: Irving L. Wiesen            PHONE NO : 212 3818774 
Parc Tertiaire De Bois Dieu, 1 AllSE DECISION MADE: 02-NOV-21
Lissieu  FR 69380                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-FLO Fluid Management System
Thermedx, LLC                     510(k) NO: K210628(Traditional)
ATTN: Daniel  Marijian            PHONE NO : 440 5420883 
31200 Solon Rd Unit 1             SE DECISION MADE: 04-NOV-21
Solon OH  44139                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETEST Fosfomycin (FO) (0.032-512 µg/mL)
bioMerieux SA                     510(k) NO: K210757(Traditional)
ATTN: Marine  Taravant            PHONE NO : 33 04 78872126 
376, chemin de l’Orme             SE DECISION MADE: 12-NOV-21
Marcy-l’Etoile  FR 69280          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Jieshi Medical Products C510(k) NO: K210777(Traditional)
ATTN: Li  Biao                    PHONE NO : 86 530 2061157 
North Road, Fumin Avenue, Qinghe SSE DECISION MADE: 02-NOV-21
Heze  CN 274400                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
Shandong Shangwei Medical Products510(k) NO: K210779(Traditional)
ATTN: Li  Hua                     PHONE NO : 86 530 2069778 
North Road, Fumin Avenue, Qinghe SSE DECISION MADE: 10-NOV-21
Heze  CN 274400                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tablo Cartridge
Outset Medical, Inc.              510(k) NO: K210782(Traditional)
ATTN: Jennifer  Mascioli-Tudor    PHONE NO : 699 2318200 
3052 Orchard Drive                SE DECISION MADE: 26-NOV-21
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Gowns
Chongqing Litai Fashion Group Limi510(k) NO: K210785(Traditional)
ATTN: David  Ni                   PHONE NO : 0086 15 678607429 
Building D7-1, Chongqing China TexSE DECISION MADE: 13-NOV-21
Chongqing  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OnQ Neuro
CorTechs Labs, Inc                510(k) NO: K210831(Traditional)
ATTN: Kora  Marinkovic            PHONE NO : 1 858 4599703 
5060 Shoreham Place, Suite 240    SE DECISION MADE: 19-NOV-21
San Diego CA  92122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
Smiths Medical ASD, Inc.          510(k) NO: K210833(Traditional)
ATTN: Nancy  DeAngelo             PHONE NO : 1 763 3833059 
6000 Nathan Lane North            SE DECISION MADE: 26-NOV-21
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InstruSafe Instrument Protection System
Summitt Medical LLC               510(k) NO: K210836(Traditional)
ATTN: Debra  Kridner              PHONE NO : 763 4434476 
815 Vikings Pkwy, Suite 100       SE DECISION MADE: 30-NOV-21
St. Paul MN  55121                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enteral Feeding Set
KB Medical (Group) Inc.           510(k) NO: K210854(Traditional)
ATTN: Chunsheng  Sheng            PHONE NO : 1 949 4910797 
9650 Research Dr STE#A            SE DECISION MADE: 16-NOV-21
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NextAR™ Spine Platform
Medacta International, SA         510(k) NO: K210859(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 05-NOV-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TaiChiB
Our United Corporation            510(k) NO: K210921(Traditional)
ATTN: Qi  Liu                     PHONE NO : 86 15 389012257 
Room 10301, 3rd Floor, Unit 1, BloSE DECISION MADE: 02-NOV-21
Xi'an  CN 710018                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
Johnson & Johnson Vision Care, Inc510(k) NO: K210930(Traditional)
ATTN: Jamie  Frenz-Ross           PHONE NO : 561 3737697 
7500 Centurion Parkway, Suite 100 SE DECISION MADE: 29-NOV-21
Jacksonville FL  32256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Abbott Diabetes Care Inc.         510(k) NO: K210943(Traditional)
ATTN: Ono  Bacani                 PHONE NO : 510 2392622 
1360 South Loop Rd.               SE DECISION MADE: 22-NOV-21
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nulife
MRK Healthcare Pvt Ltd            510(k) NO: K210969(Abbreviated)
ATTN: Anil R Dave                 PHONE NO : 91 2766 297206 
S.No.153/P&310,Panch, Pippal, HansSE DECISION MADE: 03-NOV-21
Patan  IN 384265                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System
Brainlab AG                       510(k) NO: K210989(Traditional)
ATTN: Chiara  Cunico              PHONE NO : 49 899 915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 12-NOV-21
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-sterile Powder Free Nitrile Examination Gloves
Rubberex Alliance Sdn Bhd         510(k) NO: K210990(Traditional)
ATTN: Sabri Abd Hamid             PHONE NO : 605 5482723 
Lot 128201 Off 3/4 Mile, Jalan BerSE DECISION MADE: 22-NOV-21
Ipoh  MY 314000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Urinary Catheter 12 Fr, Urinary Catheter 16 Fr
UroGen Pharma Ltd                 510(k) NO: K211032(Traditional)
ATTN: James G. Otinger            PHONE NO : 1 610 7451230 
9 Ha'Ta'asiya Street              SE DECISION MADE: 19-NOV-21
Ra'anana  IL 4365405              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microcurrent device (Model: HBR2-1)
Shenzhen DJ Medical Equipment Co.,510(k) NO: K211055(Traditional)
ATTN: Jet  Li                     PHONE NO : 86 755 85573525 
Room 801, Building A, FirstFlag ScSE DECISION MADE: 05-NOV-21
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HALYARD Flexaprene Green Powder-Free Exam Glove
O & M Halyard, Inc.               510(k) NO: K211063(Abbreviated)
ATTN: Steven  Dowdley             PHONE NO : 678 4518062 
1 Edison Drive                    SE DECISION MADE: 19-NOV-21
Alpharetta GA  30005              510(k) STATEMENT
                                                    

DEVICE: BioFire COVID-19 Test 2
BioFire Defense, LLC              510(k) NO: K211079(Traditional)
ATTN: Cynthia  Phillips           PHONE NO : 801 2623592 1370
79 W 4500 S, Suite 14             SE DECISION MADE: 01-NOV-21
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EkoSonic Endovascular Device
Boston Scientific                 510(k) NO: K211080(Traditional)
ATTN: Joshua  Kim                 PHONE NO : 530 9021194 
Two Scimed Place                  SE DECISION MADE: 19-NOV-21
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Vinyl Examination Gloves
Shanghai Shengda Medical Applicati510(k) NO: K211103(Traditional)
ATTN: Ying  Su                    PHONE NO : 086 21 33517332 
No. 608 Xingwen Road, North DeveloSE DECISION MADE: 04-NOV-21
Shanghai  CN 201815               510(k) STATEMENT
                                                    

DEVICE: CUBE Air Purifier
Samsung Electronics Co., Ltd.     510(k) NO: K211139(Traditional)
ATTN: Hana  Jung                  PHONE NO : 82 10 83070822 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 26-NOV-21
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Masks, Model Name:MY020003
Huizhou Jie Bai Purification Co.,L510(k) NO: K211165(Traditional)
ATTN: Terrance  Huang             PHONE NO : 86 183 12418578 
Dongjiang Road, Liangwu Village, YSE DECISION MADE: 09-NOV-21
Huizhou  CN 516123                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips Incisive CT on Trailer
Philips Healthcare (Suzhou) Co., L510(k) NO: K211168(Traditional)
ATTN: Shiguang  An                PHONE NO : 86 21 60902504 
No. 258, ZhongYuan Road, Suzhou InSE DECISION MADE: 22-NOV-21
Suzhou  CN 215024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bronchoscope System
Shanghai AnQing Medical Instrument510(k) NO: K211169(Traditional)
ATTN: Shuwen  Fan                 PHONE NO : 86 021 61117375 
3&4 Floor, No. 2 Building, 366 HuiSE DECISION MADE: 24-NOV-21
Shanghai  CN 201201               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ST AIA-PACK BNP Assay
Tosoh Bioscience, Inc.            510(k) NO: K211199(Special)
ATTN: Louise  Musante             PHONE NO : 650 2425563 
6000 Shoreline Court, Suite 101   SE DECISION MADE: 08-NOV-21
South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FreedomEdge(R) Syringe Infusion System
Repro-Medical System, Inc., dba Ko510(k) NO: K211206(Traditional)
ATTN: Brian  Schiller             PHONE NO : 845 6105587 
24 Carpenter Road                 SE DECISION MADE: 09-NOV-21
Chester NY  10918                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VSP® Orthopedics System
3D Systems                        510(k) NO: K211244(Traditional)
ATTN: Ben  Johnson                PHONE NO : 720 6431001 
5381 South Alkire Circle          SE DECISION MADE: 10-NOV-21
Littleton CO  80127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Pall Corporation                  510(k) NO: K211286(Traditional)
ATTN: Brian  Goetz                PHONE NO : 516 8019267 
25 Harbor Park Drive              SE DECISION MADE: 16-NOV-21
Port Washington NY  11050         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
Microlife Intellectual Property Gm510(k) NO: K211288(Traditional)
ATTN: Gerhard  Firck              PHONE NO : 41 71 7277000 
Espenstrasse 139                  SE DECISION MADE: 04-NOV-21
Widnau  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RMU-2000 Automated Chest Compression System
Defibtech, LLC                    510(k) NO: K211289(Traditional)
ATTN: Allison  Bohren             PHONE NO : 203 4536652 159
741 Boston Post Road              SE DECISION MADE: 09-NOV-21
Guilford CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask (sterile)
Nanjing 3H Medical Products Co., L510(k) NO: K211295(Traditional)
ATTN: Chun  Yang                  PHONE NO : 86 25 57885555 
No.5 Zhushan Road Gaochun County ESE DECISION MADE: 24-NOV-21
Nanjing  CN 211300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comby EEG Caps
Pamel d.o.o                       510(k) NO: K211315(Traditional)
ATTN: Marko  Pavic                PHONE NO : 00385 1 3473134 
Mesekov Put 16                    SE DECISION MADE: 09-NOV-21
Zagreb  HR 10090                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoScreener
Chengdu Wision Medical Device Co.,510(k) NO: K211326(Traditional)
ATTN: JingJia  Liu                PHONE NO : 86 186 01037373 
Unit 802, Floor 8, Building 17, YiSE DECISION MADE: 19-NOV-21
Chengdu  CN 610041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
Jiangsu Kangbao Medical Equipment 510(k) NO: K211329(Traditional)
ATTN: Rujun  Tang                 PHONE NO : 86 514 88223540 
78#, North Suzhong Road, Baoying  SE DECISION MADE: 15-NOV-21
Yangzhou  CN 225800               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofia 2 Campylobacter FIA
Quidel Corporation                510(k) NO: K211342(Traditional)
ATTN: Michelle  Bodien            PHONE NO : 210 7405756 
10165 McKellar Court              SE DECISION MADE: 23-NOV-21
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C-30 Crown Kit
Perfect Fit Crowns, LLC           510(k) NO: K211345(Traditional)
ATTN: Steve  Ziskind              PHONE NO : 954 4155639 
1128 Royal Palm Beach Blvd, #166  SE DECISION MADE: 24-NOV-21
Royal Palm Beach FL  33411        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uretero1 Ureteroscope System
STERIS Corporation                510(k) NO: K211347(Traditional)
ATTN: Caroll  Martin              PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 23-NOV-21
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GIQuant
Motilent Ltd                      510(k) NO: K211356(Traditional)
ATTN: Ian  Knott                  PHONE NO : 0044 0781 7476978 
IDEALondon, 69 Wilson Street      SE DECISION MADE: 08-NOV-21
London  GB EC2A 2BB               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation
Tornier, Inc.                     510(k) NO: K211359(Traditional)
ATTN: Lisa  Stahl                 PHONE NO : 612 8499970 
10801 Nesbitt Ave South           SE DECISION MADE: 12-NOV-21
Bloomington MN  55437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Breathe Easy Mobile Respiratory Monitor (MRM)
Sound Life Sciences, Inc.         510(k) NO: K211387(Traditional)
ATTN: Kamal  Shah                 PHONE NO : 206 4148667 
Startup Hall, Box 354625, 1100 NE SE DECISION MADE: 23-NOV-21
Seattle WA  98195-4625            510(k) STATEMENT
                                                    

DEVICE: Myomics Q
Phantomics Inc.                   510(k) NO: K211432(Traditional)
ATTN: Sangmin  Cho                PHONE NO : 82 2 63472019 
B-1224, 247, Gonghang-daero, GangsSE DECISION MADE: 23-NOV-21
Seoul  KR 07803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Regulora
metaMe Health, Inc.               510(k) NO: K211463(Traditional)
ATTN: Tim  Rudolphi               PHONE NO : 224 6882057 
222 W. Merchandise Mart Plaza - SuSE DECISION MADE: 24-NOV-21
Chicago IL  60654                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SofWave System
Sofwave Medical Ltd.              510(k) NO: K211483(Traditional)
ATTN: Ruthie  Amir                PHONE NO : 972 25 43003164 
Beit Tavor 2                      SE DECISION MADE: 15-NOV-21
Yokneam Ilit  IL 2069202          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
Convergent Laser Technologies     510(k) NO: K211517(Traditional)
ATTN: Jennifer  Mok               PHONE NO : 510 8322130 
1660 South Loop Road              SE DECISION MADE: 09-NOV-21
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Protect X Level 3 Isolation Gown
AZAC Group                        510(k) NO: K211538(Traditional)
ATTN: Yen Ping Shan               PHONE NO : 937 8309632 
17870 Castleton St. Suite 121     SE DECISION MADE: 17-NOV-21
City of Industry CA  91748        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MammoScreen 2.0
Therapixel                        510(k) NO: K211541(Traditional)
ATTN: Quentin  De Snoeck          PHONE NO : 0033 663 079607 
455 Promenade des Anglais         SE DECISION MADE: 26-NOV-21
Nice  FR 06200                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Brainlab AG                       510(k) NO: K211544(Traditional)
ATTN: Chiara  Cunico              PHONE NO : 49 89 9915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 03-NOV-21
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vektor Computational ECG Mapping System (vMap)
Vektor Medical, Inc.              510(k) NO: K211546(Traditional)
ATTN: Mike  Monko                 PHONE NO : 858 4050094 
7875 Sitio Abeto                  SE DECISION MADE: 09-NOV-21
Carlsbad CA  92009                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Virtue RF
ShenB Co Ltd                      510(k) NO: K211562(Traditional)
ATTN: Sunny  Kang                 PHONE NO : 82 70 49122702 
ShenB Bldg 148 Seongsui-ro        SE DECISION MADE: 23-NOV-21
Seoul  KR 04796                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SoftFix Balloon Trocar
Unimax Medical Systems Inc.       510(k) NO: K211577(Traditional)
ATTN: Monoj Mon Kalita            PHONE NO : 886 2 89191698 202
8F-2, No. 127, Lane 235, Pao ChiaoSE DECISION MADE: 05-NOV-21
New Taipei  TW 23145a             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves (Blue, Violet)
Lyncmed Medical Technology (Beijin510(k) NO: K211586(Traditional)
ATTN: Jiali  Zhou                 PHONE NO : 86 1511 7964608 
Room 1601, Building No. 2, ZhubangSE DECISION MADE: 01-NOV-21
Beijing  CN 100022                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trevo Trak 21 Microcatheter
Stryker Neurovascular             510(k) NO: K211594(Special)
ATTN: Shivani H Patel             PHONE NO : 949 4154982 
47900 Bayside Parkway             SE DECISION MADE: 26-NOV-21
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PCEA Syringe Set
Baxter Healthcare Corporation     510(k) NO: K211649(Traditional)
ATTN: Jeffrey E Thompson          PHONE NO : 224 2703806 
25212 West Illinois Route 120     SE DECISION MADE: 23-NOV-21
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Radian MIS Bunion System
Nvision Biomedical Technologies, I510(k) NO: K211650(Traditional)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4590 Lockhill Selma               SE DECISION MADE: 24-NOV-21
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse PRO
Spacelabs Healthcare Ltd.         510(k) NO: K211651(Traditional)
ATTN: Roger  Moldon               PHONE NO : 011 44 1992507730 
Unit B, Foxholes Centre, John TateSE DECISION MADE: 22-NOV-21
Hertford  GB SG13 7DT             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed IntellaMap Orion High Resolution Mapping Catheter
Innovative Health, LLC.           510(k) NO: K211662(Traditional)
ATTN: Rick  Ferreira              PHONE NO : 877 4003740 
1435 North Hayden Road Suite 100  SE DECISION MADE: 18-NOV-21
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KardiaMobile Card
AliveCor, Inc.                    510(k) NO: K211668(Special)
ATTN: Saket  Bhatt                PHONE NO : 650 3968553 
444 Castro Street, Suite 600      SE DECISION MADE: 30-NOV-21
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lunit INSIGHT MMG
Lunit Inc.                        510(k) NO: K211678(Traditional)
ATTN: Joohee  Lee                 PHONE NO : 82 10 89906329 
15 Floor, 27 Teheran-ro-2-gil, GanSE DECISION MADE: 17-NOV-21
Seoul  KR 06241                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Face Mask
Anhui Cleanpro Pharmpack Co., Ltd.510(k) NO: K211696(Traditional)
ATTN: Chong  Xiuming              PHONE NO : 86 550 7981778 
Yeshan Industrial Zone            SE DECISION MADE: 30-NOV-21
Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esperance Aspiration Catheter System
Wallaby Medical                   510(k) NO: K211697(Traditional)
ATTN: Nathaniel  Knock            PHONE NO : 949 4809466 
22901 Mill Creek Drive            SE DECISION MADE: 16-NOV-21
Laguna Hills CA  92653            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuson SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K211726(Traditional)
ATTN: Christine  Dunbar           PHONE NO : 925 3742045 
685 East Middlefield Road         SE DECISION MADE: 05-NOV-21
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs
Dong Tai City Huayi Gloves Co.,Ltd510(k) NO: K211727(Traditional)
ATTN: Wang  Huamei                PHONE NO : 86 137 05111918 
No.36 Nanzhuang Road, Dongtai HighSE DECISION MADE: 15-NOV-21
Dongtai  CN 224249                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comprehensive® Convertible Glenoid - Vivacit-E Liner
Biomet Manufacturing Corp.        510(k) NO: K211729(Traditional)
ATTN: Patricia Sandborn Beres     PHONE NO : 574 2676639 
56 East Bell Drive                SE DECISION MADE: 04-NOV-21
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lunit INSIGHT CXR Triage
Lunit Inc.                        510(k) NO: K211733(Traditional)
ATTN: Seulhee  Jung               PHONE NO : 82 10 71842481 
15th Floor, 27 Teheran-ro 2-gil   SE DECISION MADE: 10-NOV-21
Seoul  KR 06241                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pre-Formed Extra Support Guidewire
Lake Region Medical               510(k) NO: K211741(Traditional)
ATTN: Deko  Hussein               PHONE NO : 952 6428302 
340 Lake Hazeltine Drive          SE DECISION MADE: 22-NOV-21
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Contact Infrared Thermometer, model HL710H
Health & Life Co., Ltd            510(k) NO: K211744(Traditional)
ATTN: Simon  Lee                  PHONE NO : 886 2 82271300 11205
9F, No. 186, Jian Yi Road Zhonghe SE DECISION MADE: 24-NOV-21
New Taipei  TW 23553              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vital Signs Monitor
Beijing Choice Electronic Technolo510(k) NO: K211754(Traditional)
ATTN: Haiying  Zhao               PHONE NO : 86 10 88794631 
No.9 Shuangyuan road, Badachu Hi-tSE DECISION MADE: 15-NOV-21
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown
Cardinal Health LLC               510(k) NO: K211765(Traditional)
ATTN: Brenda  Gerena              PHONE NO : 312 2702148 
3651 Birchwood Drive              SE DECISION MADE: 23-NOV-21
Waukegan IL  60085                510(k) STATEMENT
                                                    

DEVICE: Anterion
Heidelberg Engineering GmbH       510(k) NO: K211817(Traditional)
ATTN: Arianna Schoess Vargas      PHONE NO : 49 6221 64630 
Max-Jarecki-Strasse 8             SE DECISION MADE: 05-NOV-21
Heidelberg  DE 69115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deploy Expandable Interbody System
Southern Spine LLC                510(k) NO: K211845(Traditional)
ATTN: Calder  Clay                PHONE NO : 478 7450000 
487 Cherry Street - Third Street TSE DECISION MADE: 16-NOV-21
Macon GA  31201                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITA Akzent LC
VITA Zahnfabrik GmbH H Rauter & Co510(k) NO: K211854(Traditional)
ATTN: Bernd  Walker               PHONE NO : 49 7761 562384 
Spitelgasse 3                     SE DECISION MADE: 22-NOV-21
Bad Sackingen  DE D-79713         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FAICO Dental Implant System and CAD/CAM Abutments
Faico Medical LLC                 510(k) NO: K211871(Traditional)
ATTN: Hernan Dario Fernandez      PHONE NO : 561 3346123 
2424 North Federal Highway, Suite SE DECISION MADE: 18-NOV-21
Boca Raton FL  33428              510(k) STATEMENT
                                                    

DEVICE: Intellijoint VIEW
Intellijoint Surgical Inc.        510(k) NO: K211876(Traditional)
ATTN: Katarina  Jugovic           PHONE NO : 519 3423178 2231
809 Wellington Street North , UnitSE DECISION MADE: 12-NOV-21
Kitchener  CA N2H 5L6             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Promisemed Sharps container
Promisemed Hangzhou Meditech Co., 510(k) NO: K211890(Traditional)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 17-NOV-21
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trachealator
DISA Medintec                     510(k) NO: K211894(Traditional)
ATTN: Michelle  Nieuwoudt         PHONE NO : 27 87 3302301 
Stand 171, Northlands Business ParSE DECISION MADE: 24-NOV-21
Johannesburg  ZA 2169             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Jiangsu Synecoun Medical Technolog510(k) NO: K211937(Traditional)
ATTN: Zhheng  Li                  PHONE NO : 86 523 86511020 
1/2F East Side,No. 50, G60, EastsiSE DECISION MADE: 18-NOV-21
Taizhou  CN 225300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlideScope BFlex 2.8 Single-Use Bronchoscope
Verathon Medical (Canada) ULC     510(k) NO: K211947(Traditional)
ATTN: Teresa  Davidson            PHONE NO : 425 6295516 
2227 Douglas Road                 SE DECISION MADE: 03-NOV-21
Burnaby  CA V5C 5A9               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 039 Surgical Face Mask
AOK Tooling Limited               510(k) NO: K211956(Traditional)
ATTN: Francis  Nithyananthan      PHONE NO : 852 0 23101703 
# 101 And 1Building, 2Building, 3BSE DECISION MADE: 23-NOV-21
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Agile Esophageal OTW Stent System
Boston Scientific Corporation     510(k) NO: K211960(Traditional)
ATTN: Inderdeep  Tiwana           PHONE NO : 508 6834005 
100 Boston Scientific Way         SE DECISION MADE: 22-NOV-21
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensual Massage, Ultra Pure
Dreambrands, Inc.                 510(k) NO: K211967(Traditional)
ATTN: Cecile  Kehoe               PHONE NO : 602 3547640 
11645 N. Cave Creek Road          SE DECISION MADE: 09-NOV-21
Phoenix AZ  85020                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Drug Relief v1
DyAnsys, Inc.                     510(k) NO: K211971(Traditional)
ATTN: Srini  Nageshwar            PHONE NO : 408 4804700 
300, North Bayshore Boulevard     SE DECISION MADE: 05-NOV-21
San Mateo CA  94401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
Caldera Medical, Inc.             510(k) NO: K211975(Special)
ATTN: Vicki  Gail                 PHONE NO : 818 4837602 
4360 Park Terrace drive           SE DECISION MADE: 10-NOV-21
Westlake Village CA  91361        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMRA Profiler
AMRA Medical AB                   510(k) NO: K211983(Traditional)
ATTN: Eric  Converse              PHONE NO : 46 13 162600 
Badhusgatan 5                     SE DECISION MADE: 24-NOV-21
Linkoping  SE 582 22              510(k) STATEMENT
                                                    

DEVICE: Desnuda Reflect
Good Clean Love, Inc.             510(k) NO: K211998(Traditional)
ATTN: Wendy  Strgar               PHONE NO : 541 3444483 
207 W 5th Avenue                  SE DECISION MADE: 18-NOV-21
Eugene OR  97401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medley
Good Clean Love, Inc.             510(k) NO: K212000(Traditional)
ATTN: Wendy  Strgar               PHONE NO : 541 3444483 
207 W 5th Avenue                  SE DECISION MADE: 18-NOV-21
Eugene OR  97401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESSENZ Patient Monitor
LivaNova Deutschland GmbH         510(k) NO: K212003(Special)
ATTN: Florian  Goetz              PHONE NO : 
Lindberghstr. 25                  SE DECISION MADE: 10-NOV-21
Munich  DE 80939                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eKuore Pro 4T - REF EP0098
Chip Ideas Electronics S.L.       510(k) NO: K212013(Special)
ATTN: Bernardo Plaza Trillo       PHONE NO : 0034 961 156738 
C/ Alfareria 3 B                  SE DECISION MADE: 10-NOV-21
Burjasot  ES 46100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Nano 2nd Gen Pen Needle
Becton Dickinson and Company      510(k) NO: K212015(Traditional)
ATTN: Charlton  Foo               PHONE NO : 857 2701395 
1 Becton Drive                    SE DECISION MADE: 19-NOV-21
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
Jiangsu Micsafe Medical Technology510(k) NO: K212019(Traditional)
ATTN: Tony  Yang                  PHONE NO : 086 136 51929266 
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 04-NOV-21
Yancheng  CN 224125               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves (non-sterile)
Taizhou Kangjian Medical Equipment510(k) NO: K212029(Traditional)
ATTN: Hua  Cong                   PHONE NO : 86 576 87299799 
The Machine Electricity Zone (HangSE DECISION MADE: 16-NOV-21
Taizhou  CN 317600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrueLok Evo
Orthofix SRL                      510(k) NO: K212044(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via delle Nazioni, 9              SE DECISION MADE: 05-NOV-21
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Impertech Surgical Face Mask
Impertech Industries Ltd.         510(k) NO: K212046(Traditional)
ATTN: Mohamad  Khweis             PHONE NO : 972 3 9367682 
20 Derech Barkan St.              SE DECISION MADE: 18-NOV-21
Barkan  IL 4482000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantheris System
Avinger, Inc.                     510(k) NO: K212047(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 650 2417004 
400 Chesapeake Drive              SE DECISION MADE: 16-NOV-21
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biotech Dental Kits
Biotech Dental, SAS               510(k) NO: K212068(Traditional)
ATTN: Delphine  Mercier           PHONE NO : 33 490 446060 
305 Allées De Craponne            SE DECISION MADE: 08-NOV-21
Salon de Provence  FR 13300       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fetal Doppler
Shenzhen Mericonn Technology Co., 510(k) NO: K212084(Traditional)
ATTN: Jiang  Chuanyuan            PHONE NO : 0086 139 28416535__ 
Room 20203, Building 6, DonglongxiSE DECISION MADE: 03-NOV-21
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci SP Firefly Imaging System
Intuitive Surgical, Inc.          510(k) NO: K212101(Traditional)
ATTN: Connor  McCarty             PHONE NO : 805 7984205 
1266 Kifer Road                   SE DECISION MADE: 23-NOV-21
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Water-soluble Personal Lubricant
Foshan PingChuang Medical Technolo510(k) NO: K212104(Traditional)
ATTN: Huang  Zhiyue               PHONE NO : 86 757 29269896 
Room 301, No. 3, Huaye Road, LingaSE DECISION MADE: 18-NOV-21
Foshan  CN 528312                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reverso
Intelis Instruments Ltd.          510(k) NO: K212107(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 528 701672 
HaOman 12                         SE DECISION MADE: 10-NOV-21
Hadera  IL 3850172                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spin Care Disposable Protective Mask Level 3
SpinTech LLC                      510(k) NO: K212109(Traditional)
ATTN: Jim  Jean                   PHONE NO : 704 9293596 
1920 Flintstone Drive             SE DECISION MADE: 14-NOV-21
Statesville NC  28677             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardiologs Holter Platform
Cardiologs Technologies           510(k) NO: K212112(Traditional)
ATTN: Arezou  Azar                PHONE NO : 1 650 8040285 
136 Rue Saint Denis               SE DECISION MADE: 18-NOV-21
Paris  FR 75002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exablate Prostate System
Insightec, Inc                    510(k) NO: K212150(Traditional)
ATTN: Nadir  Alikacem             PHONE NO : 214 6302000 
4851 LBJ Freeway, Suite 400       SE DECISION MADE: 23-NOV-21
Dallas TX  75244                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLUME catheter
The Flume Catheter Company, Ltd.  510(k) NO: K212151(Traditional)
ATTN: Roger  Holmes               PHONE NO : 44 0207 8089125 
The Granary, Millhouse            SE DECISION MADE: 03-NOV-21
Frensham  GB GU10 3EE             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air compression therapy system FO3002
Foshan Hongfeng Co., Ltd.         510(k) NO: K212169(Traditional)
ATTN: Dongfeng  Cheng             PHONE NO : 86 0757 8392028 
No.4-2 Leqiang Road, Leping SanshuSE DECISION MADE: 23-NOV-21
Foshan  CN 528000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Blood Pressure Monitor
Dongguan Kangweile Electronic Tech510(k) NO: K212171(Traditional)
ATTN: Zhixin  Gao                 PHONE NO : 86 769 82677482 
4th Floor, Building D, Yizhong SciSE DECISION MADE: 01-NOV-21
Dongguan  CN 523770               510(k) STATEMENT
                                                    

DEVICE: ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Merit Medical Systems, Inc.       510(k) NO: K212199(Special)
ATTN: Kirk  McIntosh              PHONE NO : 801 3163695 
1600 West Merit Parkway           SE DECISION MADE: 03-NOV-21
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica CH Enzymatic Creatinine_3 (ECre3)
Siemens Healthcare Diagnostics Inc510(k) NO: K212223(Traditional)
ATTN: Ian  Thompson               PHONE NO : 
511 Benedict Avenue               SE DECISION MADE: 24-NOV-21
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D-Cut
3D-Side SA                        510(k) NO: K212237(Traditional)
ATTN: Laurent  Paul               PHONE NO : 32 0 10813548 
Rue André Dumont 5                SE DECISION MADE: 29-NOV-21
Mont-Saint-Guibert  BE 1435       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Zirdent New Material Co., Ltd     510(k) NO: K212259(Traditional)
ATTN: Jia  Li                     PHONE NO : 86 731 85529297 
No.101,3rd building of Hai Ping InSE DECISION MADE: 12-NOV-21
Changsha  CN 410205               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face mask
Nantong Taiweishi Medical Technolo510(k) NO: K212264(Traditional)
ATTN: Zhang  Xuewen               PHONE NO : 0086 187 61789767 
Taihangshan Road, New District, EcSE DECISION MADE: 13-NOV-21
Nantong  CN 226400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K212265(Traditional)
ATTN: Hao  Yixuan                 PHONE NO : 86 755 81886129 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 16-NOV-21
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dermalux Flex MD
Aesthetic Technology Ltd.         510(k) NO: K212275(Traditional)
ATTN: Dale  Needham               PHONE NO : 44 0845 6891789 
Unit 211 Europa Blvd.             SE DECISION MADE: 18-NOV-21
Warrington  GB WA5 7TN            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Automatic Core Biopsy Instrument
Suzhou Leapmed Healthcare Corporat510(k) NO: K212284(Traditional)
ATTN: Yu  Zhu                     PHONE NO : 86 512 66554498 8043
Wuzhong Science Park, NO.2 & NO.3 SE DECISION MADE: 10-NOV-21
Suzhou  CN 215100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
Covidien, LLC                     510(k) NO: K212301(Traditional)
ATTN: Celso  Duran                PHONE NO : 303 5306445 
5920 Longbow Dr.                  SE DECISION MADE: 15-NOV-21
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tapestry Biointegrative Implant
Embody, Inc.                      510(k) NO: K212306(Traditional)
ATTN: Brianna  Schehr             PHONE NO : 236 9947912 
4211 Monarch Way, Suite 500       SE DECISION MADE: 02-NOV-21
Norfolk VA  23508                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BodySculp
Rohrer Aesthetics, LLC            510(k) NO: K212331(Traditional)
ATTN: Mark  Rohrer                PHONE NO : 205 3561172 
105 Citation Court                SE DECISION MADE: 09-NOV-21
Birmingham AL  35209              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soteria.AI
Omega Medical Imaging, LLC        510(k) NO: K212336(Traditional)
ATTN: John  Newman                PHONE NO : 407 3239400 203
3400 St. Johns Parkway, Suite 1020SE DECISION MADE: 17-NOV-21
Sanford FL  32771                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SterileRight sterilization pouch and roll
SterileRight Packaging Mfg., Inc. 510(k) NO: K212338(Traditional)
ATTN: Thomas  Chou                PHONE NO : 886 2 24555498 
1F, No.33-7, Dahua 2nd Rd., Qidu DSE DECISION MADE: 01-NOV-21
Keelung City  TW 206              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Xiantao Dingcheng Non-woven Produc510(k) NO: K212344(Traditional)
ATTN: Cheng  Qin                  PHONE NO : 86 1800 7229722 
Liukou Industrial Park            SE DECISION MADE: 16-NOV-21
Xiantao  CN 433099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S.I.N. Instrument Kits
S.I.N. - Sistema de Implante Nacio510(k) NO: K212404(Traditional)
ATTN: Denise  Domiciano           PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 03-NOV-21
São Paulo  BR 03340-000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Modular Glenoid System-Titanium Glenosphere
Arthrex Inc.                      510(k) NO: K212415(Traditional)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 
1370 Creekside Boulevard          SE DECISION MADE: 17-NOV-21
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Qora Stool Management Kit
CM Technologies, Inc.             510(k) NO: K212444(Special)
ATTN: Nishith  Chasmawala         PHONE NO : 800 5204714___ 
2165 San Diego Avenue             SE DECISION MADE: 17-NOV-21
San Diego CA  92110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Anterior Cervical Plate Systems
NuVasive, Incorporated            510(k) NO: K212446(Traditional)
ATTN: Priscila  Saraiva           PHONE NO : 858 9091807 
7475 Lusk Blvd.                   SE DECISION MADE: 03-NOV-21
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NightGuard Flex
SprintRay Inc                     510(k) NO: K212448(Traditional)
ATTN: Sara  Moghtadernejad        PHONE NO : 917 9123858 
2705 Media Center Drive, Suite 100SE DECISION MADE: 12-NOV-21
Los Angeles CA  90065             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InZone Detachment System
Stryker Neurovascular             510(k) NO: K212455(Traditional)
ATTN: Breskella  Halteh           PHONE NO : 650 8143781 
47900 Bayside Parkway             SE DECISION MADE: 16-NOV-21
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc.                   510(k) NO: K212456(Traditional)
ATTN: Christine  Kupchick         PHONE NO : 203 3433404 
530 Old Whitfield Street          SE DECISION MADE: 17-NOV-21
Guilford CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
Guangzhou ZhengKang Medical Equipm510(k) NO: K212460(Traditional)
ATTN: Mike  Wu                    PHONE NO : 86 136 00073056 
Room101,No.9Nanling Zhongxin KuangSE DECISION MADE: 05-NOV-21
GuangZhou  CN 510540              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Examination Glove
Inner Mongolia Boming Medical Supp510(k) NO: K212467(Traditional)
ATTN: Guo  Hua                    PHONE NO : 86 134 85097856 
Room 326, New Industrial Park ManaSE DECISION MADE: 04-NOV-21
Baotou  CN 014017                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Mask
Haian Medigauze Co., Ltd          510(k) NO: K212471(Traditional)
ATTN: Weihua  Xu                  PHONE NO : 13 90 1478762 
Jiaoxie Industry Park, Haian      SE DECISION MADE: 04-NOV-21
Nantong  CN 226633                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Examination gloves
Fujian Yuanxin Safety Protection T510(k) NO: K212485(Traditional)
ATTN: Alan  Wu                    PHONE NO : 86 593 8311666 
Xiacun Medical Industry Zone, ZherSE DECISION MADE: 05-NOV-21
Ningde  CN 355300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoLink Vallux Plating System
In2Bones USA, LLC                 510(k) NO: K212487(Traditional)
ATTN: Christine  Scifert          PHONE NO : 
6000 Poplar Ave, Suite 115        SE DECISION MADE: 18-NOV-21
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synthetic Nitrile Examination Gloves
Shandong Hongxin Chemicals Co., Lt510(k) NO: K212488(Traditional)
ATTN: Ping  Wang                  PHONE NO : 86 155 50323002 
No. 10161, Xinhua Road, Zhoucun DiSE DECISION MADE: 26-NOV-21
Zibo  CN 255399                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortho Aligner System
Ortho Lab Services, LLC           510(k) NO: K212496(Traditional)
ATTN: Zuzana  Huelsbusch          PHONE NO : 0049 1573 0655886 
251 Little Falls                  SE DECISION MADE: 04-NOV-21
Wilmington DE  19808              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Glove (Powder free, Blue)
Jiangsu Jinlian Medical Technology510(k) NO: K212497(Traditional)
ATTN: Wu  Min                     PHONE NO : 86 186 41219728 
No. 14 Factory Building, 1st FloorSE DECISION MADE: 11-NOV-21
Suqian  CN 223800                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resonic Rapid Acoustic Pulse Device
Soliton Inc.                      510(k) NO: K212502(Traditional)
ATTN: Leslie  Honda               PHONE NO : 206 3758586 
5304 Ashbrook Drive               SE DECISION MADE: 05-NOV-21
Houston TX  77081                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Isolation Gown AAMI Level 3
Kenpax International Limited      510(k) NO: K212504(Traditional)
ATTN: Solomon  Chen               PHONE NO : 909 4387898 
Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 07-NOV-21
Hong Kong  CN 999077              510(k) STATEMENT
                                                    

DEVICE: Medical Examination Gloves (Tested for Use with Chemotherapy)
GUANGDONG GYMDA MEDICAL TECHNOLOGY510(k) NO: K212506(Traditional)
ATTN: Olivia  Chen                PHONE NO : 86 20 37738661 
No.13, Quan'an Third Road, Phase 2SE DECISION MADE: 07-NOV-21
Shaoguan City  CN 512400          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7 Series Phototherapy Device
Daavlin Distributing Co.          510(k) NO: K212510(Traditional)
ATTN: Michele  Thiel              PHONE NO : 419 6366304 207
205 W. Bement Street              SE DECISION MADE: 04-NOV-21
Bryan OH  43506                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110)
Stryker                           510(k) NO: K212511(Traditional)
ATTN: Marlene  Fraga              PHONE NO : 928 2949043 
5900 Optical Court                SE DECISION MADE: 04-NOV-21
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOVIX DReamy
Stephanix                         510(k) NO: K212515(Abbreviated)
ATTN: Sandie  Perret              PHONE NO : 33 477 478160 
10, rue Jean Moulin Z.I du Bayon  SE DECISION MADE: 03-NOV-21
La Ricamarie  FR 42150            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VFSS Pro Mobile Digital Imaging System
IMAGExRAY, LLC                    510(k) NO: K212523(Traditional)
ATTN: Gary  Korkola               PHONE NO : 973 2350606 
160 Park Avenue                   SE DECISION MADE: 05-NOV-21
Nutley NJ  07110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Suzhou JaneE Medical Technology Co510(k) NO: K212526(Traditional)
ATTN: Chen  Ke                    PHONE NO : 86 139 14506197 
No.339 HuaFeng Road, New District SE DECISION MADE: 09-NOV-21
Suzhou  CN 215129                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hypotension Decision Assist Model HDA-OR2
Directed Systems Ltd              510(k) NO: K212529(Special)
ATTN: Mark S. Leaning             PHONE NO : 011 44 7552747389 
47-51 Norfolk Street              SE DECISION MADE: 23-NOV-21
Cambridge  GB CB1 2LD             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
CRDLight Optoelectronic Technology510(k) NO: K212532(Traditional)
ATTN: Fishy  Liang                PHONE NO : 86 13924 689685 
Floor 1-5 Building No.7 & Floor 1-SE DECISION MADE: 11-NOV-21
Jiangmen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REAL INTELLIGENCE CORI (CORI)
Blue Belt Technologies, Inc.      510(k) NO: K212537(Traditional)
ATTN: Sarah  Plittman             PHONE NO : 423 8384454 
2905 Northwest Blvd., Ste. 40     SE DECISION MADE: 03-NOV-21
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hura CTP v1.0
Hura Imaging, Inc.                510(k) NO: K212550(Traditional)
ATTN: Danny  Wang                 PHONE NO : 310 9483390 
23120 Park Sorrento               SE DECISION MADE: 08-NOV-21
Calabasas CA  91302               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves
Anhui Fine Glove Medical Technolog510(k) NO: K212551(Traditional)
ATTN: Guanghao  Liu               PHONE NO : 86 135 88829369 
Intersection of Feng Xiang Avenue SE DECISION MADE: 05-NOV-21
Chuzhou  CN 233100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroPen EVO
Eclipse Medcorp LLC               510(k) NO: K212558(Traditional)
ATTN: Julie  Summerville          PHONE NO : 972 3802911 2405
5916 Stone Creek Drive            SE DECISION MADE: 24-NOV-21
The Colony TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Hubei Huanfu Plastic Products Co.,510(k) NO: K212575(Traditional)
ATTN: Yan  Zhao                   PHONE NO : 86 137 07291713 
No.188 Wanfu Street, Chenhu Town  SE DECISION MADE: 14-NOV-21
Hanchuan  CN 431608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlignRT Plus
Vision RT Ltd                     510(k) NO: K212583(Traditional)
ATTN: Jade  Dunphy                PHONE NO : 44 208 3464300 
Dove House, Arcadia Avenue        SE DECISION MADE: 10-NOV-21
London  GB N3 2JU                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erchonia FX-405
Erchonia Corporation              510(k) NO: K212595(Traditional)
ATTN: Steven  Shanks              PHONE NO : 888 2420571 
650 Atlantis Road                 SE DECISION MADE: 12-NOV-21
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves (Non-sterile)
Suqian Linglian Medical Technology510(k) NO: K212600(Traditional)
ATTN: Eric  Li                    PHONE NO : 86 137 61053383 
No 1 Rd Wanpi Industrial Park, XinSE DECISION MADE: 18-NOV-21
Suqian  CN 223699                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Darwin
Luvo Medical Technologies, Inc    510(k) NO: K212607(Traditional)
ATTN: Gregory  Berzak             PHONE NO : 519 6203900 
125 Fleming Drive                 SE DECISION MADE: 15-NOV-21
Cambridge  CA N1T 2B8             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAMMOVISTA B.smart
Siemens Medical Solutions USA, Inc510(k) NO: K212621(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 484 4734209 
40 Liberty Boulevard              SE DECISION MADE: 12-NOV-21
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue
String King Lacrosse, LLC         510(k) NO: K212633(Traditional)
ATTN: Thomas  Frasca              PHONE NO : 1 508 6541988 
19100 S Vermont Ave.              SE DECISION MADE: 24-NOV-21
Gardena CA  90248                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stratum® Ankle Fusion Plating System
Nextremity Solutions, Inc.        510(k) NO: K212640(Traditional)
ATTN: Elise  Fox                  PHONE NO : 574 3762062 
1195 Polk Drive                   SE DECISION MADE: 18-NOV-21
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyft LS Expandable Interbody System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K212653(Traditional)
ATTN: Madhuvanthi  Soundirarajan  PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 19-NOV-21
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: More-Cell-System
Agency for Medical Innovations Gmb510(k) NO: K212659(Traditional)
ATTN: Martin  Hohlrieder          PHONE NO : 43 5522 90505 
Im Letten 1                       SE DECISION MADE: 10-NOV-21
Feldkirch  AT 6800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Examination Glove
Inner Mongolia Cureguard Medical T510(k) NO: K212661(Traditional)
ATTN: Guo  Hua                    PHONE NO : 86 134 85097856 
Room 326, Management Committee of SE DECISION MADE: 19-NOV-21
Baotou  CN 014100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sherlock
Open Implants, LLC                510(k) NO: K212664(Traditional)
ATTN: Gregg  Gellman              PHONE NO : 1 781 5873242 
800 West Cummngs Ave, Suite 4900  SE DECISION MADE: 30-NOV-21
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR 5300
Philips Medical Systems Nederland 510(k) NO: K212673(Abbreviated)
ATTN: Jan van de Kerkhof          PHONE NO : 31 613 300542 
Veenpluis 4-6                     SE DECISION MADE: 19-NOV-21
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KARL STORZ ICG Imaging System
KARL STORZ Endoscopy America      510(k) NO: K212695(Traditional)
ATTN: Mario  Trujillo             PHONE NO : 424 2188184 
2151 E. Grand Avenue              SE DECISION MADE: 15-NOV-21
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leaf Smooth
Shenzhen Leaflife Technology Co., 510(k) NO: K212697(Traditional)
ATTN: Cheng  Qiang                PHONE NO : 086 178 75910506 
4 F,Bldg. C, JMD Industrial Park, SE DECISION MADE: 19-NOV-21
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoolSculpting Elite System
Zeltiq Aesthetics, Inc.           510(k) NO: K212707(Special)
ATTN: Vicky  Chai                 PHONE NO : 919 5648811 
4410 Rosewood Drive               SE DECISION MADE: 05-NOV-21
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves
Wuhan Huirui Technology Co., Ltd  510(k) NO: K212722(Traditional)
ATTN: Jing  Li                    PHONE NO : 86 181 86661114 
Building 29-1 and 29-2, wuhan DianSE DECISION MADE: 26-NOV-21
Wuhan  CN 430075                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Circul8 Pro
Ortho8 Inc.                       510(k) NO: K212731(Special)
ATTN: Nordeen  Taylor             PHONE NO : 916 2894002 
2217 Plaza Drive                  SE DECISION MADE: 15-NOV-21
Rocklin CA  95765                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: geko W-2
Firstkind Limited                 510(k) NO: K212762(Traditional)
ATTN: Neil  Buckley               PHONE NO : 44 845 2222921 
Hawk House, Peregrine Business ParSE DECISION MADE: 29-NOV-21
High Wycombe  GB HP13 7DL         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Bloomden Bioceramics (HuNan) Co., 510(k) NO: K212765(Traditional)
ATTN: Shengyong  Liao             PHONE NO : 86 158 74253042 
No.301, 5th Building, Hi-tech Int'SE DECISION MADE: 15-NOV-21
Changsha  CN 410000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GT5 conductive & abrasive gel
Wuhan Greentek Pty Ltd.           510(k) NO: K212787(Traditional)
ATTN: Yarong  Liu                 PHONE NO : 86 27 88185488 
Room 03-2, Floor 3, Dingye BuildinSE DECISION MADE: 08-NOV-21
Wuhan  CN 430074                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C2 CryoBalloon Ablation System
PENTAX of America, Inc.           510(k) NO: K212814(Traditional)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
303 Convention Way, Suite 1       SE DECISION MADE: 29-NOV-21
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy CONDUIT LLIF Angled Inserters
Enztec Limited                    510(k) NO: K212823(Traditional)
ATTN: Claire  Mai                 PHONE NO : 6 427 8292440 
3/17 Print Place                  SE DECISION MADE: 01-NOV-21
Middleton  NZ 8024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Opulent TiNbN Coated Knee
Meril Healthcare Pvt. Ltd.        510(k) NO: K212839(Traditional)
ATTN: Neelam  Desai               PHONE NO : 91 905 4623695 
Survey No. 135/2/B & 174/2, H1-H3,SE DECISION MADE: 16-NOV-21
Vapi  IN 396191                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Stand-Alone System
Eminent Spine, LLC                510(k) NO: K212853(Traditional)
ATTN: Stephen  Courtney           PHONE NO : 972 499 3593
2004 Ventura Drive, Suite 100     SE DECISION MADE: 05-NOV-21
Plano TX  75093                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RTapp
SegAna, Inc.                      510(k) NO: K212887(Traditional)
ATTN: Jennifer  Bosley            PHONE NO : 410___ 2273124 
3259 Progress Drive               SE DECISION MADE: 10-NOV-21
Orlando FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragon 28 External Ring Fixation System
Paragon 28, Inc                   510(k) NO: K212895(Traditional)
ATTN: Haylie  Hertz               PHONE NO : 303 7200017 
14445 Grasslands Dr.              SE DECISION MADE: 08-NOV-21
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visible Patient Suite
Visible Patient, SAS              510(k) NO: K212896(Traditional)
ATTN: Emeline  Degivry            PHONE NO : 33 03 68668181 
8 rue Gustave Adolphe HIRN        SE DECISION MADE: 05-NOV-21
Strasbourg  FR 67000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device, model: AI01
Shenzhen Century Dongyuan Technolo510(k) NO: K212897(Traditional)
ATTN: He  Wang                    PHONE NO : 86 137 98450554 
Floor 2, Building B1, Gonghe FourtSE DECISION MADE: 04-NOV-21
Shenzhen  CN 518104               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K212900(Traditional)
ATTN: Shi  Jufang                 PHONE NO : 86 755 81886293 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 05-NOV-21
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
b-ONE ORTHO, Corp                 510(k) NO: K212912(Traditional)
ATTN: Allison  Gecik              PHONE NO : 973 9658940 
3 Wing Drive Suite #259           SE DECISION MADE: 04-NOV-21
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dakota ALIF Plate System
Precision Spine, Inc.             510(k) NO: K212937(Traditional)
ATTN: Michael  Dawson             PHONE NO : 601 4204244 
2050 Executive Dr.                SE DECISION MADE: 04-NOV-21
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K212948(Traditional)
ATTN: Sammy  Li                   PHONE NO : 86 20 66393598 
No.23 Building, The Second Phase, SE DECISION MADE: 01-NOV-21
Guangzhou  CN 511450              510(k) STATEMENT
                                                    

DEVICE: FDR Cross (DR-XD 3000)
FUJIFILM Corporation              510(k) NO: K212956(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 08-NOV-21
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode laser therapy system
BEIJING UNT Technology Co., Ltd   510(k) NO: K212978(Traditional)
ATTN: Qianwen  Sheng              PHONE NO : 86 106 1960002 
M2-1 Area, Xinggu Development ZoneSE DECISION MADE: 10-NOV-21
Beijing  CN 101200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiPACS HTML5 Web Viewer
LEAD Technologies Inc.            510(k) NO: K212984(Traditional)
ATTN: William  Little             PHONE NO : 704 2740243 
1927 S. Tryon Street, Suite 200   SE DECISION MADE: 12-NOV-21
Charlotte NC  28203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low-frequency Stimulator (Model: AST-645, AST-646)
Shenzhen OSTO Technology Co., Ltd.510(k) NO: K212989(Traditional)
ATTN: Li  Yang                    PHONE NO : 86 755 29769546 
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 22-NOV-21
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINK® Embrace Shoulder System - Reverse Configuration
Waldemar Link GmbH & Co. KG       510(k) NO: K212992(Traditional)
ATTN: Stefanie  Fuchs             PHONE NO : 49 405 3995530 
Ostsraße 4-10                     SE DECISION MADE: 18-NOV-21
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile PHALINX Hammertoe System
Wright Medical Technology, Inc.   510(k) NO: K212996(Traditional)
ATTN: Michael  Mullins            PHONE NO : 901 8674142 
1023 Cherry Road                  SE DECISION MADE: 16-NOV-21
Memphis TN  37117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air Compression Massager (Model LF-FT003)
Wenzhou Lingfeng Electronic Techno510(k) NO: K213000(Traditional)
ATTN: Xiaoqun  Ye                 PHONE NO : 86 577 65436666 
No.9,Jintang Road,Jielu Industry DSE DECISION MADE: 15-NOV-21
Ruian  CN 325200                  510(k) STATEMENT
                                                    

DEVICE: IPL Hair Removal, Model: OBT-02
Glan Electronics Co., Ltd.        510(k) NO: K213041(Traditional)
ATTN: Lisa  Pan                   PHONE NO : 0086 755 28910840 
A4 Building, Huafa Industrial ZoneSE DECISION MADE: 18-NOV-21
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MD-320W Ultrasound Biomicroscope
Meda Co., LTD                     510(k) NO: K213070(Traditional)
ATTN: Linda  Zhang                PHONE NO : 86 22 83713808 812
F2C,F3D,F4C,F5, F6C, Building C2, SE DECISION MADE: 18-NOV-21
Tianjin  CN 300384                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOTOTM Partial Knee & MOTO PFJ Systems Extension
Medacta International S.A.        510(k) NO: K213071(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 916 966060 
Strada Regina                     SE DECISION MADE: 16-NOV-21
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
Ivenix, Inc.                      510(k) NO: K213089(Special)
ATTN: John  Sokolowski            PHONE NO : 978 7758030 
50 High St                        SE DECISION MADE: 10-NOV-21
North Andover MA  01845           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Frontier Series Power Wheelchairs
Magic Mobility                    510(k) NO: K213090(Traditional)
ATTN: Jill  Mckechnie             PHONE NO : 61 387 915600 
3 International Court             SE DECISION MADE: 19-NOV-21
Scoreby  AU 3179                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MZ Skin LightMAX Supercharged LED Mask 2.0
Mz Skin                           510(k) NO: K213184(Traditional)
ATTN: Maryam  Zamani              PHONE NO : 44 020 34091479 
110-112 Kings Road, First floor   SE DECISION MADE: 23-NOV-21
London  GB SW3 4TX                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Vortex Threaded Bone Marrow Recovery Needle
Arthrex Inc.                      510(k) NO: K213213(Traditional)
ATTN: Nick  Moore                 PHONE NO : 1 239 6435553 71883
1370 Creekside Boulevard          SE DECISION MADE: 19-NOV-21
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Wrist
Newclip Technics                  510(k) NO: K213214(Traditional)
ATTN: Gregoire  Larche            PHONE NO : 33 2 28213712 
P.A. de la Lande Saint Martin - 45SE DECISION MADE: 24-NOV-21
Haute-Goulaine  FR F-44115        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RCT700
RAY Co., Ltd                      510(k) NO: K213226(Traditional)
ATTN: Youna  Im                   PHONE NO : 82 31 6051000 
332-7, Samsung 1-ro               SE DECISION MADE: 29-NOV-21
Hwaseong-si  KR 18380             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HANAROSTENT Esophagus Asymmetric (CCC)
M.I.Tech Co., Ltd.                510(k) NO: K213251(Special)
ATTN: Sunyoung  Jo                PHONE NO : 82 10 43047429 
174, Habuk 2-gil, Jinwi-myeon     SE DECISION MADE: 18-NOV-21
Pyeongtaek-si  KR 17706           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axialis Ophthalmic Ultrasound System
Quantel Medical                   510(k) NO: K213254(Traditional)
ATTN: Bruno  Pages                PHONE NO : 
11 Rue du Bois Joli-CS40015       SE DECISION MADE: 15-NOV-21
Cournon D'Auvergne-Cedex  FR 63808510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisionX 3.0
Durr Dental SE                    510(k) NO: K213326(Special)
ATTN: Oliver  Lange               PHONE NO : 49 0 7142705190 
Hopfigheimer Str. 17              SE DECISION MADE: 02-NOV-21
Bietigheim-Bissingen  DE 74321    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnSite X EP System
Abbott Medical                    510(k) NO: K213364(Special)
ATTN: Tabitha  Payne              PHONE NO : 612 2688558 
5050 Nathan Ln N                  SE DECISION MADE: 11-NOV-21
Plymouth MN  55442                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WHILL Model C2
Whill, Inc.                       510(k) NO: K213383(Third Party - Traditional)
ATTN: Tsuyoshi  Iriyama           PHONE NO : 81 90 25672984 
2-1-11 Higashi-Shinagawa; Harbor PSE DECISION MADE: 09-NOV-21
Shinagawa-ku  JP 140-0002         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System
Conformis Inc.                    510(k) NO: K213389(Special)
ATTN: Kara  Johnson               PHONE NO : 781 3459122 
600 Technology Park Drive, 4th FloSE DECISION MADE: 10-NOV-21
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Savvy Mask - Level 3 Surgical Face Mask
Texas MedPlast LLC                510(k) NO: K213406(Third Party - Traditional)
ATTN: Diego  Olmos                PHONE NO : 832 2882106 
6630 Roxburgh Drive #171          SE DECISION MADE: 18-NOV-21
Houston TX  77041                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Vector® Hammertoe Correction System
Nvision Biomedical Technologies, I510(k) NO: K213421(Special)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4590 Lockhill Selma               SE DECISION MADE: 19-NOV-21
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BruxZir Esthetic
Prismatik Dentalcraft, Inc.       510(k) NO: K213425(Special)
ATTN: So Hyun Park                PHONE NO : 949 8635479 
2144 Michelson Drive              SE DECISION MADE: 17-NOV-21
Irvine CA  96212                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarius Ultrasound Scanner
Clarius Mobile Health Corp.       510(k) NO: K213436(Special)
ATTN: Agatha  Szeliga             PHONE NO : 416 7071707 
130-2985 Virtual Way              SE DECISION MADE: 15-NOV-21
Vancouver  CA V5M 4X7             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DS Implants abutments provided with the EV connection
Dentsply Sirona                   510(k) NO: K213449(Special)
ATTN: Courtney  Clark             PHONE NO : 248 8954379 
221 West Philadelphia Street, SuitSE DECISION MADE: 15-NOV-21
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spartan MC 0165
Spartan Micro                     510(k) NO: K213451(Traditional)
ATTN: Gary  Avedovech             PHONE NO : 415 6024279 
3167 Skyway Ct                    SE DECISION MADE: 22-NOV-21
Fremont CA  94539                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
Medtronic Powered Surgical Solutio510(k) NO: K213454(Special)
ATTN: Carrie  Eddings             PHONE NO : 214 3840606 
4620 North Beach Street           SE DECISION MADE: 23-NOV-21
Fort Worth TX  76137              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ControlRad Select Model Z
ControlRad, Inc.                  510(k) NO: K213455(Special)
ATTN: Chris  Fair                 PHONE NO : 1 800 5225148 
275 Scientific Drive NW #1100     SE DECISION MADE: 24-NOV-21
Norcross GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALORY
Agfa N.V.                         510(k) NO: K213469(Traditional)
ATTN: Wim  Govaerts               PHONE NO : 32 34446246 
Septestraat 27                    SE DECISION MADE: 18-NOV-21
Mortsel  BE B-2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
H&abyz Co., Ltd.                  510(k) NO: K213497(Special)
ATTN: Hyunook (David)  Han        PHONE NO : 82 70 46589300 
IF, 2-Dong, 41-16 Cheoinseong-Ro NSE DECISION MADE: 15-NOV-21
Yongin-Si  KR 17118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    


              TOTAL 510(k)s THIS PERIOD   256                                     
              TOTAL WITH SUMMARIES        241                                     
              TOTAL WITH STATEMENTS        15
                                      
 
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