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  1. 510(k) Clearances

May 2022 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2022


DEVICE: Assure Titanium Blood Glucose Monitoring System
Arkray, Inc.                      510(k) NO: K200788(Dual Track)
ATTN: Yosiharu  Uehata            PHONE NO : 81 50 58300922 
Yousuien-nai, Gansuin-cho         SE DECISION MADE: 23-MAY-22
Kamigyo-ku  JP 602-0008           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiveOne
LiveMetric (Medical) S.A.         510(k) NO: K201302(Traditional)
ATTN: Chen Botvin Moshe           PHONE NO : 972 6703737 
40 Rue Glesener                   SE DECISION MADE: 04-MAY-22
Luxembourg  LU L-1630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: restor3d MTP Implant
Restor3d, Inc.                    510(k) NO: K201393(Traditional)
ATTN: Nathan  Evans               PHONE NO : 984 8880593 
311 W Corporation St              SE DECISION MADE: 25-MAY-22
Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alinity i STAT High Sensitivity Troponin-I
Abbott Laboratories Diagnostics Di510(k) NO: K202525(Traditional)
ATTN: Judi  Wallach               PHONE NO : 224 6671132 
Dept. 9AA, CP01-2 100 Abbott Park SE DECISION MADE: 19-MAY-22
Abbott Park IL  60064-6038        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiComp
Pac-Dent, Inc.                    510(k) NO: K202920(Traditional)
ATTN: Jiahe  Li                   PHONE NO : 909 8390888 
670 Endeavor Circle               SE DECISION MADE: 25-MAY-22
Brea CA  92821                    510(k) STATEMENT
                                                    

DEVICE: Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
Cepheid                           510(k) NO: K203429(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 09-MAY-22
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunalysis Tapentadol Urine HEIA
lmmunalysis Corporation           510(k) NO: K203527(Traditional)
ATTN: Elina  Arroyo               PHONE NO : 224 3617080 
829 Towne Center Drive            SE DECISION MADE: 09-MAY-22
Pomona CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRYO Arctic, CRYO Penguin
CryoScience North America, Inc.   510(k) NO: K203661(Traditional)
ATTN: Greg  Nehrlich              PHONE NO : 800 3924158 
401 Louisuana St, 8th Floor       SE DECISION MADE: 25-MAY-22
Houston TX  77002-1629            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IWL2020 Blood Glucose Monitoring System
Roche Diabetes Care Inc.          510(k) NO: K203711(Traditional)
ATTN: Kelly  Brennan              PHONE NO : 317 3619101 
9115 Hague Road                   SE DECISION MADE: 06-MAY-22
Indianapolis IN  46250-0457       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Urea Nitrogen2
Abbott Ireland Diagnostics Divisio510(k) NO: K203771(Traditional)
ATTN: Tiffini  Jenkins            PHONE NO : 224 6688864 
Lisnamuch                         SE DECISION MADE: 31-MAY-22
Longford  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PosiSep EAR Fragmentable Ear Dressing
Hemostasis LLC                    510(k) NO: K210411(Traditional)
ATTN: Lakshmi  Ganesh Bollina     PHONE NO : 651 8551466 2026
5000 Township Pkwy                SE DECISION MADE: 05-MAY-22
St Paul MN  55110                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clicky Cross
Yomura Technologies Inc.          510(k) NO: K210516(Traditional)
ATTN: David  Lee                  PHONE NO : 886 2 86013839 206
No. 8, Gong 8th Rd., Linkou DistriSE DECISION MADE: 16-MAY-22
New Taipei City  TW 24450         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
Marci Beauty Inc                  510(k) NO: K210545(Traditional)
ATTN: Shaul  Rappaport            PHONE NO : 001 808 3516168 
4290 Cameron St Unit 7            SE DECISION MADE: 20-MAY-22
Las Vegas NV  89103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Integrated Arterial Catheter
Centurion Medical Products        510(k) NO: K210548(Traditional)
ATTN: Amy  Ganton                 PHONE NO : 517 5451159 
100 Centurion Way                 SE DECISION MADE: 17-MAY-22
Williamston MI  48895             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711
Alicn Medical Shenzhen,Inc        510(k) NO: K210565(Traditional)
ATTN: Fang  Meisong               PHONE NO : 86 755 26501548 
Room 410, Building A, 3rd Sub-parkSE DECISION MADE: 05-MAY-22
Shenzhen  CN 518118               510(k) STATEMENT
                                                    

DEVICE: HDF Assist Mudule, HDF Infusion Set and Substitution Filter
Nephros                           510(k) NO: K210575(Traditional)
ATTN: Vashone R Thomas            PHONE NO : 201 3450829 
380 Lackawanna Place              SE DECISION MADE: 13-MAY-22
South Orange NJ  07079            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD CTGCTV2
Becton Dickinson and Company      510(k) NO: K210585(Traditional)
ATTN: Sue  Werner                 PHONE NO : 585 3588098 
7 Loveton Circle                  SE DECISION MADE: 10-MAY-22
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARCHITECT Toxo IgG
Abbott Laboratories               510(k) NO: K210596(Traditional)
ATTN: Linda  Sohn                 PHONE NO : 224 6674846 
Dept 09AA, Bldg. Ap8-1, 100 AbbottSE DECISION MADE: 19-MAY-22
Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BENCOX Mirabo Z Cup Cortinium
Corentec Co.,Ltd.                 510(k) NO: K210614(Traditional)
ATTN: Yoorim  Bae                 PHONE NO : 82 414 107116 
12, Yeongsanhong 1-gil, Ipjang-myeSE DECISION MADE: 24-MAY-22
Chungcheongnam-do  KR 31056       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)
Thompson Surgical Instruments Inc.510(k) NO: K210615(Traditional)
ATTN: Tiffany  Irwin              PHONE NO : 231 6425607 
10341 E Cherry Bend Rd            SE DECISION MADE: 13-MAY-22
Traverse MI  49684                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amylase2
Abbott Ireland Diagnostics Divisio510(k) NO: K210633(Traditional)
ATTN: Magdalena  Suszko           PHONE NO : 224 6679025 
Lisnarnuck                        SE DECISION MADE: 26-MAY-22
Longford  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
Innovative Health, LLC.           510(k) NO: K210655(Traditional)
ATTN: Rick  Ferreira              PHONE NO : 877 4003740 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 25-MAY-22
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Well-life TM Pen Needles, Well-life TM Safety Pen Needles
W. L. Med Co., Ltd.               510(k) NO: K210748(Traditional)
ATTN: Ha Tae  Joo                 PHONE NO : 82 31 80572162 
246, Geumgwangosan-ro, Geumgwang-ySE DECISION MADE: 25-MAY-22
Anseong-si  KR 17535              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241
Alicn Medical Shenzhen, Inc.      510(k) NO: K210937(Traditional)
ATTN: Fang  Meisong               PHONE NO : 86 755 26501548 
Room 410, Building A, 3rd Sub-ParkSE DECISION MADE: 12-MAY-22
Shenzhen  CN 518118               510(k) STATEMENT
                                                    

DEVICE: BD Epilor Syringe
Becton Dickinson and Company      510(k) NO: K210983(Traditional)
ATTN: Huwien  Yang                PHONE NO : 201 8474408 
1 Becton Drive                    SE DECISION MADE: 19-MAY-22
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRRIGO Wound Wash Jet System
Inopro Inc                        510(k) NO: K210987(Traditional)
ATTN: Alain  Lefebvre             PHONE NO : 514 4388481 
800 rue Sud Porte A               SE DECISION MADE: 31-MAY-22
Cowansville  CA J2K 2Y3           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K211021(Traditional)
ATTN: Cecilia  Sun                PHONE NO : 86 25 58646395 
No. 10 Goake Third Road, Nanjig NaSE DECISION MADE: 06-MAY-22
Narijing  CN 210032               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plus Medical Chemotherapy Gown
Foshan Nanhai Plus Medical CO LTD 510(k) NO: K211036(Traditional)
ATTN: Eric  Li                    PHONE NO : 086 757 86914198 
Shatou Jiujiang Town, Nanhai DistrSE DECISION MADE: 04-MAY-22
Foshan  CN 528200                 510(k) STATEMENT
                                                    

DEVICE: Durex Condom with Benzocaine
RB Health (US) LLC                510(k) NO: K211152(Traditional)
ATTN: Kyle  Prince                PHONE NO : 973 4042600 
399 Interpace Parkway             SE DECISION MADE: 11-MAY-22
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liver Suite
GE Medical Systems SCS            510(k) NO: K211180(Traditional)
ATTN: Peter  Uhlir                PHONE NO : 36 70 4369317 
283, rue de la Miniere            SE DECISION MADE: 02-MAY-22
BUC  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Sampler Viral Transport Media
Wuxi Nest Biotechnology Co., Ltd. 510(k) NO: K211256(Traditional)
ATTN: Cheng  Zhiwei               PHONE NO : 0086 510 68006788 
No.530 Xida Road, New District    SE DECISION MADE: 20-MAY-22
Wuxi  CN 214112                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neoss Individual Prosthetics
Neoss Ltd                         510(k) NO: K211396(Traditional)
ATTN: Stellan  Sundstrom          PHONE NO : 46 031 881280 
Windsor House Cornwell Road       SE DECISION MADE: 17-MAY-22
Harrogate  GB HG1 2PW             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAVIRFA Scope
NaviFUS Corporation               510(k) NO: K211529(Traditional)
ATTN: Arthur  Lung                PHONE NO : 886 2586 0560 
12F., No. 246, Sec. 3, Chengde Rd.SE DECISION MADE: 05-MAY-22
Datong Dist., Taipei City  TW 1036510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RevoLix HTL
LISA Laser Products GmbH          510(k) NO: K211534(Traditional)
ATTN: Ralf  Balkenhol             PHONE NO : 49 5556 993851 
Albert-Einstein-Str, 4            SE DECISION MADE: 19-MAY-22
Katlenburg-Lindau  DE 37191       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
Zhejiang Longterm Medical Technolo510(k) NO: K211571(Traditional)
ATTN: Claudia  Zsang              PHONE NO : 416 2769555 
No. 493 North Huancheng Road MoganSE DECISION MADE: 31-MAY-22
Deqing  CN 313200                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renuvion Dermal Handpiece, Renuvion Dermal System
Apyx Medical Corporation (formerly510(k) NO: K211652(Traditional)
ATTN: Topaz  Kirlew               PHONE NO : 727 8038617 
5115 Ulmerton Road                SE DECISION MADE: 25-MAY-22
Clearwater FL  33760-4004         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SONON Ultrasound Imaging System, Model: SONON300C
HEALCERION CO., LTD.              510(k) NO: K211665(Special)
ATTN: Lee  Sooyeol                PHONE NO : 82 70 82170820 
1403-ho, 12, Digital-ro 33-gil, GuSE DECISION MADE: 16-MAY-22
Seoul  KR 08377                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Testosterone II
Roche Diagnostics                 510(k) NO: K211685(Traditional)
ATTN: Adennis N Cora              PHONE NO : 317 3134093 
9115 Hague Road, PO Box 50416     SE DECISION MADE: 06-MAY-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioTeke Sterile Disposable Virus Sampling Kit
BioTeke Corporation (WuXi) Co., Lt510(k) NO: K211707(Traditional)
ATTN: Zhitu  Zhou                 PHONE NO : 86 510 88661198 
4th Floor, D5, No. 1719, Huishan ASE DECISION MADE: 04-MAY-22
Wuxi City  CN 21474               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.
Chip Ideas Electronics S.L.       510(k) NO: K211779(Traditional)
ATTN: Bernardo Plaza Trillo       PHONE NO : 34 961 156738 
Calle Alfareria 3 B               SE DECISION MADE: 26-MAY-22
Burjasot  ES 46100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl)
PT. Shamrock Manufacturing Corpora510(k) NO: K211810(Traditional)
ATTN: Jeni  Chuason               PHONE NO : 909 5918855 
JL. Raya Medan - Namorambe Ps IV  SE DECISION MADE: 23-MAY-22
Kab. Deli Serdang  ID 20356       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sight OLO
S.D. Sight Diagnostics Ltd.       510(k) NO: K211840(Traditional)
ATTN: Sarah  Levy                 PHONE NO : 972 3 5418580 
 23 Menachem Begin Rd.            SE DECISION MADE: 09-MAY-22
Tel Aviv  IL 6618356              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement
Ormed Grup Medikal Turizm Saglik H510(k) NO: K211869(Traditional)
ATTN: Kenan  Kara                 PHONE NO : 90 0312 2110192 
Ticaret Limited S Macun Mahallesi SE DECISION MADE: 19-MAY-22
Ankara  TR 06200                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiquiBand XL
Advanced Medical Solutions Limited510(k) NO: K211878(Traditional)
ATTN: Martin  Mitchell            PHONE NO : 
Western Wood Way , Langage ScienceSE DECISION MADE: 23-MAY-22
Plymouth  GB PL7 5BG              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Sterilized Latex Surgical Gloves
Jiangxi Kemei Medical Apparatus & 510(k) NO: K211953(Traditional)
ATTN: Jenny  Huang                PHONE NO : 86 177 02094798 
No. 316 National road, Xinju, ChanSE DECISION MADE: 25-MAY-22
Nanchang  CN 331724               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Segment 3DPrint
Medviso AB                        510(k) NO: K211966(Traditional)
ATTN: Einar  Heiberg              PHONE NO : 46 0 702788938 
Griffelvägen 3                    SE DECISION MADE: 06-MAY-22
Lund  SE SE-22467                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orchid Safety Release Valve(TM)
Linear Health Sciences, LLC       510(k) NO: K212064(Traditional)
ATTN: Daniel  Clark               PHONE NO : 310 7216222 
5333 Wisteria Drive               SE DECISION MADE: 03-MAY-22
Oklahoma City OK  73142           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portable Folding Electric Wheelchair (Model: DC01)
Anhui JBH Medical Apparatus Co., L510(k) NO: K212092(Traditional)
ATTN: Yang  Dandan                PHONE NO : 86 189 36033123 
No. 116 qicang Road               SE DECISION MADE: 06-MAY-22
Mingguang City, Chuzhou  CN 239400510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FreeStyle Libre 3 Continuous Glucose Monitoring System
Abbott Diabetes Care Inc.         510(k) NO: K212132(Traditional)
ATTN: Naveen  Thuramalla          PHONE NO : 510 2392618 
1360 South Loop Road              SE DECISION MADE: 26-MAY-22
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311
Alicn Medical Shenzhen, Inc.      510(k) NO: K212257(Traditional)
ATTN: Fang  Meisong               PHONE NO : 86 755 26501548 
Room 410, Building A, 3rd Sub-ParkSE DECISION MADE: 04-MAY-22
Shenzhen  CN 518118               510(k) STATEMENT
                                                    

DEVICE: FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
FMD Co., Ltd.                     510(k) NO: K212268(Traditional)
ATTN: Takashi  Higashikubo        PHONE NO : 81 3 33200081 
1-57-7 Sasazuka                   SE DECISION MADE: 27-MAY-22
Shibuya-ku  JP 151-0073           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
Neuronetics, Inc                  510(k) NO: K212289(Traditional)
ATTN: Cory  Anderson              PHONE NO : 610 9814104 
3222 Phoenixville Pike            SE DECISION MADE: 06-MAY-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M-Vizion Monobloc
Medacta International S.A.        510(k) NO: K212327(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 24-MAY-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618
Shenzhen Pango Medical Electronics510(k) NO: K212346(Traditional)
ATTN: Youjian  Xie                PHONE NO : 86 755 33825988 301
No. 25, 1st Industry Zone, FenghuaSE DECISION MADE: 05-MAY-22
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALPHALOK™ Plating System
Vilex LLC                         510(k) NO: K212348(Traditional)
ATTN: Louis  Monaco               PHONE NO : 435 6591880 
111 Moffitt Street                SE DECISION MADE: 02-MAY-22
McMinnville TN  37110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caas Qardia
Pie Medical Imaging B.V.          510(k) NO: K212376(Traditional)
ATTN: Annemiek  Bouts             PHONE NO : 31 43 3281328 
Philipsweg 1                      SE DECISION MADE: 16-MAY-22
Maastricht  NL 6227 AJ            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid)
Pt. Maja Agung Latexindo          510(k) NO: K212408(Traditional)
ATTN: Sivaprakash  S              PHONE NO : 62 61 8459170 
Jl. Utama No. 98, Pujimulyo       SE DECISION MADE: 18-MAY-22
Sunggal, Deli Serdang  ID 20352   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I-Motion
I-Motion Group Global Iberica S.L.510(k) NO: K212413(Traditional)
ATTN: Jose Luis Soto Belloso      PHONE NO : 34 638 455573 
Calle Loeches 66.8 CP             SE DECISION MADE: 26-MAY-22
Alcorcon  ES 28925                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
Wenzhou Xikang Medical Instruments510(k) NO: K212416(Traditional)
ATTN: Wang  Tiance                PHONE NO : 86 577 86876969 
No.1478 Haining Road, Haibin StreeSE DECISION MADE: 18-MAY-22
Wenzhou  CN 325024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neuromuscular Transmission Monitor TOF3D
MIPM Mammendorfer Institut für Phy510(k) NO: K212434(Traditional)
ATTN: Jennifer  Rosenheimer       PHONE NO : 49 8145 92090 
Oskar-von-Miller Str. 6           SE DECISION MADE: 05-MAY-22
Mammendorf  DE 82291              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
Prevest Denpro Limited            510(k) NO: K212475(Traditional)
ATTN: Atul  Modi                  PHONE NO : 941 9194280 
Export Promotion Industrial Park  SE DECISION MADE: 13-MAY-22
Bari Brahmana  IN 181133          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Overjet Caries Assist
Overjet, Inc.                     510(k) NO: K212519(Traditional)
ATTN: Wardah  Inam                PHONE NO : 617 9490380 
560 Harrison Ave, Unit 403        SE DECISION MADE: 10-MAY-22
Boston MA  02118                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Spine Truss System Plating Solution (CSTS-PS)
4WEB Medical, Inc.                510(k) NO: K212527(Traditional)
ATTN: Lewis  Harrison             PHONE NO : 800 2857090 
2801 Network Blvd., Suite 620     SE DECISION MADE: 17-MAY-22
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC
Covidien llc                      510(k) NO: K212555(Traditional)
ATTN: Anushka  Jayaraman          PHONE NO : 303 9029428 
6135 Gunbarrel Avenue             SE DECISION MADE: 06-MAY-22
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
Prevest Denpro Limited            510(k) NO: K212563(Traditional)
ATTN: Atul  Modi                  PHONE NO : 941 9194280 
Export Promotion Industrial Park  SE DECISION MADE: 23-MAY-22
Bari Brahmana  IN 181133          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Breast Pump
Guangdong Horigen Mother & Baby Pr510(k) NO: K212564(Traditional)
ATTN: Changxin  Chen              PHONE NO : 086 0754 83613668 
No. 18, Pingnan Industrial Zone, MSE DECISION MADE: 06-MAY-22
Shantou  CN 515100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoverScan v1
Perspectum Ltd.                   510(k) NO: K212565(Traditional)
ATTN: Ioan  Wigley                PHONE NO : 44 186 5655329 
5520 John Smith Drive             SE DECISION MADE: 19-MAY-22
Oxford  GB OX4 2LL                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpyGlass Discover Balloon Dilation Catheter
Boston Scientific Corporation     510(k) NO: K212582(Traditional)
ATTN: Laura  Kuroski              PHONE NO : 508 3820442 
100 Boston Scientific Way         SE DECISION MADE: 06-MAY-22
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Nitrile Examination Gloves Powder Free
Amazing Rubber Products Pvt Ltd   510(k) NO: K212584(Abbreviated)
ATTN: Jayasankar  S               PHONE NO : 944 7053062 
Plot No 14c, Cochin Special EconomSE DECISION MADE: 28-MAY-22
Cochin  IN 682037                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
C.R. Bard, Inc                    510(k) NO: K212588(Special)
ATTN: Arieona  Boyle              PHONE NO : 602 8305603 
1625 W Third Street               SE DECISION MADE: 04-MAY-22
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amazing+ Latex Examination Powder Free Gloves
Amazing Rubber Products Pvt Ltd   510(k) NO: K212597(Abbreviated)
ATTN: Jayasankar  S               PHONE NO : 94 47 053062 
Plot No 14c, Cochin Special EconomSE DECISION MADE: 28-MAY-22
Cochin  IN 682037                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
Fresenius Medical Care Renal Thera510(k) NO: K212620(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 9969103 
920 Winter Street                 SE DECISION MADE: 12-MAY-22
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PP Care Nitrile Examination Gloves
EG Group Product and Services CO.,510(k) NO: K212629(Traditional)
ATTN: Aristotle  Nafpliotis       PHONE NO : 
168/72 Nakniwat Road, Lat Phrao   SE DECISION MADE: 26-MAY-22
Bangkok  TH 10230                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aura Storm
Invictus Lighting                 510(k) NO: K212644(Traditional)
ATTN: Neeraj  Lal                 PHONE NO : 828 8559324 
1401 Main Ave. SW                 SE DECISION MADE: 26-MAY-22
Hickory NC  28602                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Heater-Cooler
Spectrum Medical Ltd.             510(k) NO: K212657(Traditional)
ATTN: Colleen  Powell             PHONE NO : 44 0 1242387082 
Harrier 4, Meteor Business Park, CSE DECISION MADE: 06-MAY-22
Gloucester  GB GL29QL             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Hemoclip
Zhejiang Chuangxiang Medical Techn510(k) NO: K212669(Traditional)
ATTN: Lucius  Long                PHONE NO : 
301B, No.22, XinYan Road, Yuhang DSE DECISION MADE: 27-MAY-22
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LuxCreo Clear Aligner System
Luxcreo Inc                       510(k) NO: K212680(Traditional)
ATTN: Mike  Yang                  PHONE NO : 1 650 3360888 
940 Old County Road,              SE DECISION MADE: 31-MAY-22
Belmont CA  94002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Polyethylene Examination Gloves
Mastermax Plastic (Huizhou) LTD   510(k) NO: K212699(Traditional)
ATTN: Benson  Xu                  PHONE NO : 86 752 2315076 
No.1, Qingli 3rd Road, Shuikou, HuSE DECISION MADE: 31-MAY-22
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bone Cement-Normal Viscosity
Biomecanica Industria e Comerciode510(k) NO: K212729(Traditional)
ATTN: Thais  Busquim              PHONE NO : 55 14 21047900 
Rua Luiz Pengo 145                SE DECISION MADE: 31-MAY-22
Jau  BR 17212-811                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med-link Pulse Oximeter
Shenzhen Med-link Electronics Tech510(k) NO: K212752(Traditional)
ATTN: Jialing  Zhang              PHONE NO : 0086 755 61568825 884
4th and 5th Floor, Building Two, HSE DECISION MADE: 20-MAY-22
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
MEDOS International SARL          510(k) NO: K212756(Traditional)
ATTN: Nicole  Aeschbacher         PHONE NO : 41 61 9656118 
Chemin-Blanc 38                   SE DECISION MADE: 05-MAY-22
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biocore9 Acetabular Cup System
Biocore9, LLC.                    510(k) NO: K212761(Traditional)
ATTN: Stan  Matlak                PHONE NO : 973 5854281 
9 Whippany Rd, Bldg A1, Unit 12   SE DECISION MADE: 17-MAY-22
Whippany NJ  07981                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SternaLock Sternal Closure System
Biomet Microfixation              510(k) NO: K212782(Traditional)
ATTN: Mark  Wladkowski            PHONE NO : 904 7414400 
1520 Tradeport Dr                 SE DECISION MADE: 17-MAY-22
Jacksonville FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DailyMate Orthodontic Aligner System
3D Global Biotech Inc             510(k) NO: K212803(Traditional)
ATTN: Keng-Liang  Ou              PHONE NO : 886 2 26971272 
21F.-1, No.99, Sec. 1, Xintai 5th SE DECISION MADE: 23-MAY-22
New Taipei City 221  TW           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Benchmark Intracranial Access System
Penumbra, Inc.                    510(k) NO: K212838(Traditional)
ATTN: Buu Buu Ly                  PHONE NO : 510 9952332 
One Penumbra Place                SE DECISION MADE: 27-MAY-22
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aspire Cristalle
FUJIFILM Corporation              510(k) NO: K212873(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 27-MAY-22
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectral CT on Rails
Philips Medical Systems Nederland 510(k) NO: K212875(Traditional)
ATTN: Maya  Tolchinsky            PHONE NO : 972 52 8598223 
Veenpluis 6                       SE DECISION MADE: 13-MAY-22
BEST  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEPS, LEPS FeetSupport (including variations of FeetSupport, KneeSupport, KneeSupport LiftBlock, Shoulder retr. for LEPS, LEPS baseplate, LEPS baseplate short), FeetSupport (various models) ,CouchStrip, VacuumCushion Pos. Strip, MRIdian Rail (various models),VacuumCushions, Vacuum Cushions (various models)
MacroMedics BV                    510(k) NO: K212909(Traditional)
ATTN: Elizabeth  Hajos            PHONE NO : 31 182389777 
Oostbaan 670                      SE DECISION MADE: 11-MAY-22
Moordrecht  NL 2841 ML            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MVision AI Segmentation
MVision AI                        510(k) NO: K212915(Traditional)
ATTN: Kalpana  Jha                PHONE NO : 358 449 214354 
C/O Terkko Health Hub, HaartmaninkSE DECISION MADE: 03-MAY-22
Helsinki  FI 00290                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CalcShift™ Displacement Calcaneal Osteotomy System
Nextremity Solutions, Inc.        510(k) NO: K212979(Traditional)
ATTN: Elise  Fox                  PHONE NO : 574 3762062 
1195 Polk Drive                   SE DECISION MADE: 20-MAY-22
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ONO Retrieval Device
Onocor Vascular LLC               510(k) NO: K212988(Traditional)
ATTN: Tiffini  Wittwer            PHONE NO : 707 7996732 
808 General Sterling Drive        SE DECISION MADE: 23-MAY-22
West Chester PA  19382            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Procedure Mask, Surgical  Mask
A Plus International, Inc.        510(k) NO: K213001(Traditional)
ATTN: Solomon  Chen               PHONE NO : 909 5915168 
5138 Eucalyptus Ave.              SE DECISION MADE: 11-MAY-22
Chino CA  91710                   510(k) STATEMENT
                                                    

DEVICE: Needle Free Connector
Medcaptain Life Science Co., Ltd. 510(k) NO: K213004(Traditional)
ATTN: David  Xia                  PHONE NO : 86 755 28380626 
601, Building C, Jinweiyuan IndustSE DECISION MADE: 10-MAY-22
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
CEFLA S.C.                        510(k) NO: K213022(Traditional)
ATTN: Lorenzo  Bortolotti         PHONE NO : 39 054 2653111 
Via Selice Provinciale 23/A       SE DECISION MADE: 09-MAY-22
Imola  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser hair growth helmet
Kam Yuen Plastic Products Ltd.    510(k) NO: K213025(Traditional)
ATTN: Anna  Dan                   PHONE NO : 86 400 9621668 
No. 2, Hengfeng 2nd Road, Pujin InSE DECISION MADE: 12-MAY-22
Zhongshan  CN 528400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser Hair Growth Comb
Kam Yuen Plastic Products Ltd     510(k) NO: K213027(Traditional)
ATTN: Anna  Dan                   PHONE NO : 86 400 9621668 
No. 2, Heng Feng Two Road, Pu Jin SE DECISION MADE: 26-MAY-22
ZhongShan  CN 528400              510(k) STATEMENT
                                                    

DEVICE: Micro-current facial cold and hot service (model: TPML-100)
Li-Tek Electronics Technology C0.,510(k) NO: K213039(Traditional)
ATTN: Barry  Yuan                 PHONE NO : 86 769 83117755 
No. 8-13, the industrial park of JSE DECISION MADE: 25-MAY-22
Dongguan  CN 523106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Distal Access Catheter
Guangzhou Easycess Medical Co., Lt510(k) NO: K213065(Traditional)
ATTN: Xingcheng  Liu              PHONE NO : 86 18 218806821 
Room 701, Building B4, 11 Kaiyuan SE DECISION MADE: 31-MAY-22
Guangzhou  CN 510530              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Innova Vision Inc.                510(k) NO: K213119(Traditional)
ATTN: Kari  Huang                 PHONE NO : 886 359 27299 
2F., No. 20, Prosperity Rd. 1, HsiSE DECISION MADE: 13-MAY-22
Hsinchu  TW 300091                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTDose
Carina Medical LLC                510(k) NO: K213137(Traditional)
ATTN: Xue  Feng                   PHONE NO : 434 2841073 
1233 Litchfield Ln                SE DECISION MADE: 13-MAY-22
Lexington KY  40513               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution
Shen Wei USA Inc.                 510(k) NO: K213141(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave. Suite 102      SE DECISION MADE: 28-MAY-22
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral)
Meditrina, Inc.                   510(k) NO: K213171(Traditional)
ATTN: Csaba  Truckai              PHONE NO : 404 4714877 
1190 Saratoga Avenue, Suite 180   SE DECISION MADE: 26-MAY-22
San Jose CA  95129                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
Cardinal Health                   510(k) NO: K213174(Traditional)
ATTN: Nivedita  Namjoshi          PHONE NO : 508 6183975 
3651 Birchwood Drive              SE DECISION MADE: 19-MAY-22
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plus Medical Cover Gown
Foshan Nanhai Plus Medical CO LTD 510(k) NO: K213177(Traditional)
ATTN: Eric  Li                    PHONE NO : 086 757 86914198 
Shatou Jiujiang Town, Nanhai DistrSE DECISION MADE: 11-MAY-22
Foshan  CN 528200                 510(k) STATEMENT
                                                    

DEVICE: S-Line
Barkey GmbH & Co. KG              510(k) NO: K213191(Traditional)
ATTN: Thomas  Barkey              PHONE NO : 49 5202 980189 
Gewerbestr. 8                     SE DECISION MADE: 24-MAY-22
Leopoldshoehe  DE 33818           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Provena(TM) Midline Catheter
C. R. Bard, Inc.                  510(k) NO: K213203(Special)
ATTN: Jeremy  Kuyakana            PHONE NO : 801 5225869 
605 North 5600 West               SE DECISION MADE: 13-MAY-22
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMADEO, M-UK1015 (incl. attachments and accessories)
W&H Dentalwerk Buermoss GmbH      510(k) NO: K213221(Traditional)
ATTN: Weidler  Gerhard            PHONE NO : 0043 6274 62369339 
Ignaz-Glaser-Strasse 53           SE DECISION MADE: 26-MAY-22
Buermoos  AT 5111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless EEG System
Pascall Systems Inc               510(k) NO: K213299(Traditional)
ATTN: Tuan Le Mau                 PHONE NO : 857 2254138 
200 Portland St                   SE DECISION MADE: 11-MAY-22
Boston MA  02114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: exoplan
exocad GmbH                       510(k) NO: K213302(Traditional)
ATTN: Tobias  Turba               PHONE NO : 49 615 16294890 
37, Julius-Reiber-Str.            SE DECISION MADE: 03-MAY-22
Darmstadt  DE 64293               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fibrillar Collagen Wound Dressing
Collagen Matrix, Inc.             510(k) NO: K213341(Traditional)
ATTN: Peggy  Hansen               PHONE NO : 201 4051477 304
15 Thornton Road                  SE DECISION MADE: 31-MAY-22
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triever24, Triever20
Inari Medical                     510(k) NO: K213402(Special)
ATTN: Kit  Cariquitan             PHONE NO : 949 4184095 
9 Parker, Suite 100               SE DECISION MADE: 23-MAY-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WaveForm L System, WaveForm TO System, WaveForm TA System
SeaSpine Orthopedics Corporation  510(k) NO: K213420(Traditional)
ATTN: Aly  Alvarez                PHONE NO : 619 8844342 
5770 Armada Drive                 SE DECISION MADE: 04-MAY-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline General Surgery Tray
Medline Industries, Inc.          510(k) NO: K213481(Traditional)
ATTN: Stephanie  Augsburg         PHONE NO : 847 3936552 
Three Lakes Drive                 SE DECISION MADE: 24-MAY-22
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
Shenzhen AOJ Medical Technology Co510(k) NO: K213485(Traditional)
ATTN: Queena  Chen                PHONE NO : 86 755 27786026 
Room 301&4F, Blk A, Building A, JiSE DECISION MADE: 25-MAY-22
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Universal Pilot Guidance Instrument System
CTL Medical Corporation           510(k) NO: K213491(Traditional)
ATTN: Sean  Suh                   PHONE NO : 214 5455820 
4550 Excel Pkwy Ste 300           SE DECISION MADE: 12-MAY-22
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aurora-RT
MagnetTx Oncology Solutions Ltd.  510(k) NO: K213526(Traditional)
ATTN: Michael  Cook               PHONE NO : 587 4581162 
9505 41 Avenue NW                 SE DECISION MADE: 04-MAY-22
Edmonton  CA T6E 5X7              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Safety Hypodermic Needles for Single Use
Zhejiang Kangkang Medical-Devices 510(k) NO: K213535(Traditional)
ATTN: Chun  Guo                   PHONE NO : 135 86180908 
Longwang Industrial District, ChumSE DECISION MADE: 13-MAY-22
Yuhuan  CN 317605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set
Qura S.r.l.                       510(k) NO: K213540(Traditional)
ATTN: Raffaella  Tommasini        PHONE NO : 39 0535 1803050 
Via di Mezzo, 23                  SE DECISION MADE: 20-MAY-22
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HydroPICC 5F Dual Lumen Catheter
Access Vascular Inc               510(k) NO: K213550(Traditional)
ATTN: Brian  Hanley               PHONE NO : 781 5386594 101___
175 Middlesex Trunpike            SE DECISION MADE: 04-MAY-22
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems
Philips Medical Systems Nederland 510(k) NO: K213583(Abbreviated)
ATTN: Jan Van De Kerkhof          PHONE NO : 31 613 300542 
Veenpluis 4-6                     SE DECISION MADE: 16-MAY-22
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHOLASER X4
ELESTA SPA                        510(k) NO: K213594(Traditional)
ATTN: Fabio  Andreola             PHONE NO : 39 055 8826807 
Via Baldanzese 17                 SE DECISION MADE: 03-MAY-22
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaPASS™ 2.0 Ligament Augmentation System
Medicrea International S. A.      510(k) NO: K213659(Traditional)
ATTN: Teal  Bjoraker              PHONE NO : 00 33 472018787 
5389 Route De Strasbourg - Vancia SE DECISION MADE: 24-MAY-22
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoLink PCR Plating System
In2Bones USA, LLC                 510(k) NO: K213698(Traditional)
ATTN: Christine  Scifert          PHONE NO : 901 8318053___ 
6000 Poplar Ave, Suite 115        SE DECISION MADE: 27-MAY-22
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
Ever Fortune.AI Co., Ltd.         510(k) NO: K213731(Traditional)
ATTN: Cheng  Ming-Fong            PHONE NO : 886 4 23226363 
8F., No. 573, Sec. 2, Taiwan Blvd.SE DECISION MADE: 31-MAY-22
Taichung City  TW 403020          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid
LimaCorporate                     510(k) NO: K213785(Special)
ATTN: Roberto  Gabetta            PHONE NO : 39 338 6439379 
Via Nazionale, 52                 SE DECISION MADE: 13-MAY-22
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monaco RTP System
Elekta Solutions AB               510(k) NO: K213787(Traditional)
ATTN: Anju  Kurian                PHONE NO : 1 678 2317791 
Kungstensgatan 18 Box 7593        SE DECISION MADE: 17-MAY-22
Stockholm  SE SE10393             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080)
Dongguan Bohuikang Technology Co.,510(k) NO: K213788(Traditional)
ATTN: Rihua  Meng                 PHONE NO : 86 138 26974835 
5th Floor,No 5, Second Street,HuaiSE DECISION MADE: 06-MAY-22
DongGuan  CN 523165               510(k) STATEMENT
                                                    

DEVICE: Artiglass NRFitTM Tip L.O.R. Glass Syringes
Artiglass Srl                     510(k) NO: K213800(Special)
ATTN: Sabrina  Baccarin           PHONE NO : 39 049 5290442 
Via Piemonte 13                   SE DECISION MADE: 19-MAY-22
Due Carrare  IT 35020             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Syringes for Single Use
Berpu Medical Technology Co., Ltd.510(k) NO: K213811(Traditional)
ATTN: Buxin  Yu                   PHONE NO : 86 577 86651999 
No.14 Xingji Road, Yongxing StreetSE DECISION MADE: 12-MAY-22
Wenzhou  CN 325000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCENARIA View
FUJIFILM Healthcare Corporation   510(k) NO: K213829(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
2-1, Shintoyofuta                 SE DECISION MADE: 23-MAY-22
Kashiwa-Shi  JP 277-0804          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AAMI3 Isolation Gown
Hubei Xinxin Non-woven Co., Ltd.  510(k) NO: K213832(Traditional)
ATTN: Nicole  Jin                 PHONE NO : 86 728 2618155 
Taizihu Industrial Park, PengchangSE DECISION MADE: 16-MAY-22
Xiantao  CN 433018                510(k) STATEMENT
                                                    

DEVICE: Arthrx Fracture Plates
Arthrex Inc.                      510(k) NO: K213837(Traditional)
ATTN: Stacy  Valdez               PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard          SE DECISION MADE: 02-MAY-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MolecuLight I:X
MolecuLight, Inc.                 510(k) NO: K213840(Traditional)
ATTN: Jordan  John                PHONE NO : 416 5425522 
Suite 700, 425 University Avenue  SE DECISION MADE: 18-MAY-22
Toronto  CA M5G 1T6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExactechGPS® System
Blue Ortho                        510(k) NO: K213877(Traditional)
ATTN: Matthieu  Coic              PHONE NO : 33 4 58003525 
22, Chemin du Vieux Chene         SE DECISION MADE: 02-MAY-22
Meylan  FR 38240                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable EEG cable
Shenzhen Changke Connect Electroni510(k) NO: K213884(Abbreviated)
ATTN: Yahui  Zhou                 PHONE NO : 86 136 13012560 
A1-2nd and A2 4th floor of factorySE DECISION MADE: 06-MAY-22
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WAVi SCAN EEG System and Accessories
WAVi Co.                          510(k) NO: K213900(Traditional)
ATTN: David  Oakley               PHONE NO : 720 2036970 
3459 Ringsby Ct. Ste. #305        SE DECISION MADE: 06-MAY-22
Denver CO  80216                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PISCES-SA Standalone ALIF Interbody System
Osseus Fusion Systems             510(k) NO: K213935(Traditional)
ATTN: Jonathan  Rosen             PHONE NO : 888 3305960 
1931 Greenville Ave Suite 200     SE DECISION MADE: 06-MAY-22
Dallas TX  75206                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compass BDS Biliary Stent
Cook Ireland LTD                  510(k) NO: K213946(Traditional)
ATTN: Kieran  Casey               PHONE NO : 353 61 334440 
O'Halloran Road, National TechnoloSE DECISION MADE: 09-MAY-22
Limerick  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KEOPS Balance Analyzer 3D
S.M.A.I.O                         510(k) NO: K213975(Traditional)
ATTN: Jean-Charles  Roussouly     PHONE NO : 33 6 70165171 
2 place Berthe Morisot            SE DECISION MADE: 06-MAY-22
Saint Priest  FR 69800            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FreeStyle Libre 3 Continuous Glucose Monitoring System
Abbott Diabetes Care Inc.         510(k) NO: K213996(Traditional)
ATTN: Rodney  Huang               PHONE NO : 510 2392614 
1360 South Loop Road              SE DECISION MADE: 26-MAY-22
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental diode laser
Shenzhen Soga Technology Co., Ltd.510(k) NO: K214008(Abbreviated)
ATTN: Tse  Adrian                 PHONE NO : 086 159 15873605 
D906, Yinxing Technology Building SE DECISION MADE: 10-MAY-22
Shenzhen  CN 518110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable
Stryker                           510(k) NO: K214046(Traditional)
ATTN: Michelle  Hughes            PHONE NO : 904 6081262 
5900 Optical Court                SE DECISION MADE: 25-MAY-22
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA ONE Brain application
Medtech S.A.S                     510(k) NO: K214065(Traditional)
ATTN: Paul  Hardy                 PHONE NO : 574 373 5011 
432 rue du Rajol                  SE DECISION MADE: 04-MAY-22
Mauguio  FR 34130                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo O3 Regional Oximeter System
Masimo Corporation                510(k) NO: K214072(Traditional)
ATTN: Kertana  Shankar            PHONE NO : 949 2977260 
52 Discovery                      SE DECISION MADE: 06-MAY-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs
Hartalega NGC SDN. BHD.           510(k) NO: K214074(Traditional)
ATTN: Kuan Mun Leong              PHONE NO : 603 6277 1733 
No. 1 Persiaran Tanjung           SE DECISION MADE: 26-MAY-22
Sepang  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: Respire Clear
Respire Medical, LLC              510(k) NO: K214096(Traditional)
ATTN: David  Walton               PHONE NO : 718 6437326 
18 Bridge St.                     SE DECISION MADE: 31-MAY-22
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Orbis Chemo Surgical Gown
Medline Industries LP             510(k) NO: K214108(Traditional)
ATTN: Adam  Ostrower              PHONE NO : 224 9311513 
Three Lakes Drive                 SE DECISION MADE: 06-MAY-22
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GSS610N21 Series Steam Sterilizer
Maquet GmbH                       510(k) NO: K214120(Traditional)
ATTN: Holger  Ullrich             PHONE NO : 49 722 29321550 
Kehler Strasse 31                 SE DECISION MADE: 18-MAY-22
Rastatt  DE 76437                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
Scopio Labs Ltd.                  510(k) NO: K220013(Traditional)
ATTN: Shahar  Karny               PHONE NO : 972 546 542164 
10 Ha’sharon                      SE DECISION MADE: 03-MAY-22
Tel Aviv  IL 6618502              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vista Ophthalmics Vitrectomy Probe
Vista Ophthalmics LLC             510(k) NO: K220030(Traditional)
ATTN: Don  Knowles                PHONE NO : 713 7025707 
23510 Kingsland Blvd. Suite 200   SE DECISION MADE: 04-MAY-22
Katy TX  77494                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HandPICO
Vydence Medical Industria E Comerc510(k) NO: K220041(Traditional)
ATTN: Kathy  Maynor               PHONE NO : 352 5863113 
Rua Aldo Germano Klein, 359 CEP: 1SE DECISION MADE: 05-MAY-22
CEAT - Sao Carlos/SP Sao Paulo  BR510(k) STATEMENT
                                                    

DEVICE: Single Use Ureteral Access Sheath
Zhejiang Chuangxiang Medical Techn510(k) NO: K220065(Traditional)
ATTN: Lucius  Long                PHONE NO : 86 571 89167088 
Room 101,201,301,401,501, BuildingSE DECISION MADE: 25-MAY-22
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LDV((Low Dead Volume )Syringe
Anhui Hongyu Wuzhou Medical Manufa510(k) NO: K220083(Traditional)
ATTN: Bingyi  Xiang               PHONE NO : 86 556 5129666 
No. 2 Guanyin Road, Taihu EconomicSE DECISION MADE: 25-MAY-22
Anqing  CN 246400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saige-Dx
DeepHealth, Inc.                  510(k) NO: K220105(Traditional)
ATTN: B. Nathan Hunt              PHONE NO : 424 8321480 
1000 Massachusetts Avenue         SE DECISION MADE: 12-MAY-22
Cambridge MA  01238               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger
Qura S.r.l.                       510(k) NO: K220110(Traditional)
ATTN: Raffaella  Tommasini        PHONE NO : 39 0535 1803050 
Via di Mezzo, 23                  SE DECISION MADE: 06-MAY-22
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112)
Shenzhen Finicare Co., Ltd.       510(k) NO: K220113(Traditional)
ATTN: Chao  Li                    PHONE NO : 86 755 23013503 
201, No.50, the 3rd Industrial ParSE DECISION MADE: 31-MAY-22
Shenzhen  CN 518104               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
MiRus, LLC                        510(k) NO: K220115(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 404 3458235 
1755 West Oak Parkway, Suite 100  SE DECISION MADE: 13-MAY-22
Marietta GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves
KL-Kepong Rubber Products SDN. BHD510(k) NO: K220118(Traditional)
ATTN: Cheng Phooi Yann            PHONE NO : 60 554 17337 
Lot 134905, ¾ Mile Off Jalan BerchSE DECISION MADE: 12-MAY-22
Ipoh  MY 31400                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisAR
Novarad Corporation               510(k) NO: K220146(Traditional)
ATTN: Doug  Merrill               PHONE NO : 801 6421001 
3152 North University Avenue, SuitSE DECISION MADE: 27-MAY-22
Provo UT  84604                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs
Motex Healthcare (Anhui) Co., Ltd.510(k) NO: K220155(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 86 056 36089888 
Xinhang Economic Development Zone,SE DECISION MADE: 23-MAY-22
Xuancheng City  CN 242234         510(k) STATEMENT
                                                    

DEVICE: Skin Care Beauty Mask (Model: MJ-06)
Shenzhen Kaiyan Medical Co Ltd    510(k) NO: K220168(Traditional)
ATTN: Alain  Dijkstra             PHONE NO : 86 1351 03787481 
40A Fuxin Road Fuyong Subdistrict SE DECISION MADE: 17-MAY-22
Shenzhen  CN 518101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zone Specific AIM
CONMED Corporation                510(k) NO: K220186(Traditional)
ATTN: Orjada  Dervishleri         PHONE NO : 239 6829213 
525 French Road                   SE DECISION MADE: 13-MAY-22
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Face Mask
Jiujiang Taixin Technology Co., Lt510(k) NO: K220191(Traditional)
ATTN: Li  Xiaojie                 PHONE NO : 86 0792 4818315 
Zone A, Ruichang Science and TechnSE DECISION MADE: 24-MAY-22
Jiujiang  CN 332299               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Procedure mask/Surgical mask/Face mask
Winner Medical Co., Ltd.          510(k) NO: K220194(Traditional)
ATTN: Mingni  Liu                 PHONE NO : 86 755 28138888 8822
Winner Industrial Park, No.660 BulSE DECISION MADE: 17-MAY-22
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iFuse Bedrock Granite™ Implant System
SI-BONE, Inc.                     510(k) NO: K220195(Traditional)
ATTN: Meirav  Harsat              PHONE NO : 650 8624942 
471 El Camino Real, Suite 101     SE DECISION MADE: 26-MAY-22
Santa Clara CA  95050             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paltop Conical Implant System
Paltop Advanced Dental Solutions, 510(k) NO: K220200(Traditional)
ATTN: Zina  Gurgov                PHONE NO : 972 4 6271711 
Hashita 5, Industrial Park        SE DECISION MADE: 25-MAY-22
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Gloves
Hebei kangxida Medical Technology 510(k) NO: K220211(Traditional)
ATTN: Xiaomin  Liu                PHONE NO : 15 033 056781 
No. 5, Chuangye Avenue, Weixian EcSE DECISION MADE: 18-MAY-22
Handan  CN 056000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Siren SGT
Tools for Surgery, LLC            510(k) NO: K220218(Traditional)
ATTN: Arnold R. Leiboff           PHONE NO : 631 4444448 
8 Technology Drive, #100          SE DECISION MADE: 18-MAY-22
East Setauket NY  11773-3327      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue)
Grand Work Plastic Products Co., L510(k) NO: K220249(Traditional)
ATTN: Wu  Yuli                    PHONE NO : 86 311 66766067 
Donggao Industrial Zone, Zanhuang SE DECISION MADE: 26-MAY-22
Shijiazhuang  CN 050000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
Grand Work Plastic Products Co., L510(k) NO: K220250(Traditional)
ATTN: Wu  Yuli                    PHONE NO : 86 311 66766067 
Donggao Industrial Zone, Zanhuang SE DECISION MADE: 11-MAY-22
Shijiazhuang  CN 050000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HM70 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K220269(Traditional)
ATTN: Ju Jee Young                PHONE NO : 82 2 21940861 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 06-MAY-22
Hongcheon-gun  KP 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
Hong Qiangxing (Shen Zhen) Electro510(k) NO: K220283(Traditional)
ATTN: Xu  Jianhua                 PHONE NO : 86 755 26423665 
4F, Jingcheng Building, Xicheng InSE DECISION MADE: 02-MAY-22
Shenzhen  CN 518126               510(k) STATEMENT
                                                    

DEVICE: PINE Pedicle Screw System
TDM Co. Ltd.                      510(k) NO: K220285(Traditional)
ATTN: Choi  Jung Wook             PHONE NO : 82 62 9717460 
69, Cheomdan Venture So-ro, 37 beoSE DECISION MADE: 19-MAY-22
Gwangju  KR 61003                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECGenius System
CathVision ApS                    510(k) NO: K220306(Traditional)
ATTN: Mads  Matthiesen            PHONE NO : 45 31 470730 
Titangade 11                      SE DECISION MADE: 03-MAY-22
Copenhagen N  DK 2200             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardiovascular Angiography System
Allengers Medical Systems Limited 510(k) NO: K220311(Traditional)
ATTN: Sanjeev K. Marjara          PHONE NO : 91 1762 282600 
FDA Hall Unit-2, Bhankarpur, MubarSE DECISION MADE: 03-MAY-22
Derabassi, Distt. Mohali  IN 14050510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Orbis LVL 3 Surgical Gown
Medline Industries, LP.           510(k) NO: K220333(Traditional)
ATTN: Adam  Ostrower              PHONE NO : 224 9311513 
Three Lakes Drive                 SE DECISION MADE: 18-MAY-22
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: ARx Modular Spinal System
Life Spine, Inc.                  510(k) NO: K220341(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S. Quality Drive            SE DECISION MADE: 02-MAY-22
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KardiaMobile 6L
AliveCor, Inc.                    510(k) NO: K220350(Traditional)
ATTN: Susan  Noriega              PHONE NO : 650 7931966 
189 N. Bernardo Ave. Suite 100    SE DECISION MADE: 25-MAY-22
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astroglide Ultra Gentle Gel
BioFilm Inc.                      510(k) NO: K220355(Traditional)
ATTN: Kevin  Jamil                PHONE NO : 760 7279030 
3225 Executive Ridge              SE DECISION MADE: 26-MAY-22
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)
Tianjin Huahong Technology Co., Lt510(k) NO: K220370(Traditional)
ATTN: Yuan  Ying                  PHONE NO : 153 021 27671
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 19-MAY-22
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heel Stick Safety Lancet (HHZ-II, HHZ-III)
Tianjin Huahong Technology Co., Lt510(k) NO: K220372(Traditional)
ATTN: Yuan  Ying                  PHONE NO : 153 02127671 
A01, Plant B, No. 278, Hangkong RoSE DECISION MADE: 17-MAY-22
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode Laser Therapy Systems
Beijing LaserTell Medical Co., Ltd510(k) NO: K220381(Traditional)
ATTN: Zeng  Xun                   PHONE NO : 86 138 10934930 
Block1, No.12 Jingsheng South 2nd SE DECISION MADE: 20-MAY-22
Beijing  CN 101149                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PAPAYA 3D & PAPAYA 3D Plus
GENORAY Co., Ltd.                 510(k) NO: K220392(Traditional)
ATTN: Jiyeon  Lee                 PHONE NO : 82 31 51785770 
#512, 560, Dunchon-daero, Jungwon-SE DECISION MADE: 19-MAY-22
Seongnam-si  KR 13230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANSiStim-PP
DyAnsys, Inc.                     510(k) NO: K220397(Traditional)
ATTN: Srini  Nageshwar            PHONE NO : 408 4804700 
300, North Bayshore Boulevard     SE DECISION MADE: 12-MAY-22
San Mateo CA  94401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERRAD NX with ALLClear Technology
Advanced Sterilization Products, I510(k) NO: K220404(Traditional)
ATTN: Katy  Nennig                PHONE NO : 920 2546370 
33 Technology Drive               SE DECISION MADE: 16-MAY-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A)
Stryker Sustainability Solutions  510(k) NO: K220411(Traditional)
ATTN: Scott  English              PHONE NO : 901 4511456 
1810 W Drake Drive                SE DECISION MADE: 13-MAY-22
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaCross Connect Transseptal Dilator
Baylis Medical Company Inc.       510(k) NO: K220414(Special)
ATTN: May  Tsai                   PHONE NO : 905 6024875 
5825 Explorer Dr.                 SE DECISION MADE: 09-MAY-22
Mississauga  CA L4W 5P6           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SwiftMR
AIRS Medical Inc.                 510(k) NO: K220416(Traditional)
ATTN: Jihyeon  Seo                PHONE NO : 82 10 34462636 
8-9F, CS Tower, 1838, NambusunhwanSE DECISION MADE: 25-MAY-22
Seoul  KR 08788                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PAPAYA & PAPAYA Plus
GENORAY Co., Ltd.                 510(k) NO: K220423(Traditional)
ATTN: Jiyeon  Lee                 PHONE NO : 82 31 51785770 
512, 560, Dunchon-daero, Jungwon-gSE DECISION MADE: 19-MAY-22
Seongnam-si  KR 13230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: White Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial SDN BHD      510(k) NO: K220427(Traditional)
ATTN: Marcus  Low                 PHONE NO : 605 80 52166 
24, 1st floor, Kompleks Kota MuliaSE DECISION MADE: 10-MAY-22
Taiping  MY 34000                 510(k) STATEMENT
                                                    

DEVICE: Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial SDN BHD      510(k) NO: K220428(Traditional)
ATTN: Marcus  Low                 PHONE NO : 605 80 52166 
24, 1st floor, Kompleks Kota MuliaSE DECISION MADE: 10-MAY-22
Taiping  MY 34000                 510(k) STATEMENT
                                                    

DEVICE: Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile
One Glove Industrial SDN BHD      510(k) NO: K220429(Traditional)
ATTN: Marcus  Low                 PHONE NO : 605 8052166 
24, 1st floor, Kompleks Kota MuliaSE DECISION MADE: 13-MAY-22
Taiping  MY 34000                 510(k) STATEMENT
                                                    

DEVICE: Capsulo
Quantel Medical                   510(k) NO: K220430(Traditional)
ATTN: Bruno  Pages                PHONE NO : 
1 Rue du Bois Joli-CS40015        SE DECISION MADE: 12-MAY-22
Cournon D'Auvergne-Cedex  FR 63808510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synguard Nitrile Exam Glove
Tianjin Aoshang Outdoor Equipment 510(k) NO: K220442(Traditional)
ATTN: Xiaoning  Zhang             PHONE NO : 86 22 87702678 
C-1-106, No.23 Xiangtan Road, HongSE DECISION MADE: 12-MAY-22
Tianjin  CN 300133                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Versana Balance
GE Medical Systems Ultrasound and 510(k) NO: K220446(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
LLC 9900 W. Innovation Drive      SE DECISION MADE: 11-MAY-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Osteotomy Truss System (OTS)
4WEB Medical, Inc.                510(k) NO: K220463(Traditional)
ATTN: Lewis  Harrison             PHONE NO : 800 2857090 
2801 Network Blvd., Suite 620     SE DECISION MADE: 18-MAY-22
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Lumenis Be, Ltd.                  510(k) NO: K220467(Traditional)
ATTN: Shlomit  Segman             PHONE NO : 972 4 9599230 
6 Hakidma Street PO BOX 240       SE DECISION MADE: 18-MAY-22
Yokneam  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BENCOX Mirabo Cup System
Corentec Co.,Ltd.                 510(k) NO: K220468(Special)
ATTN: Yoorim  Bae                 PHONE NO : 8 241 14107116 
12, Yeongsanhong 1-gil, Ipjang-myeSE DECISION MADE: 18-MAY-22
Cheonan-si  KR 31056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Wireless Stethoscope
Shanghai Hulu Devices Co., Ltd    510(k) NO: K220470(Third Party - Traditional)
ATTN: Junfeng  Zhao               PHONE NO : 86 186 21892190 
No. 509 Caobao Road, Room 101-2 BuSE DECISION MADE: 23-MAY-22
Shanghai  CN 200233               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
Stryker Sustainability Solutions  510(k) NO: K220481(Traditional)
ATTN: Scott  English              PHONE NO : 901 4511456 
1810 W Drake Drive                SE DECISION MADE: 25-MAY-22
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
The Anspach Effort, Inc.          510(k) NO: K220485(Traditional)
ATTN: Marie  Ferrier              PHONE NO : 33 067 5765048 
4500 Riverside Drive              SE DECISION MADE: 19-MAY-22
Palm Beach Gardens FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
Hainan Asther Medical Equipment Co510(k) NO: K220491(Traditional)
ATTN: Viki  Ye                    PHONE NO : 86 1505 8326008 
503 Room, 5th Floor, B03, Hainan ESE DECISION MADE: 14-MAY-22
Chengmai  CN 571900               510(k) STATEMENT
                                                    

DEVICE: Rapid PE Triage and Notification (PETN)
iSchemaView Inc.                  510(k) NO: K220499(Traditional)
ATTN: James  Rosa                 PHONE NO : 303 7043374 
1120 Washington Ave., Ste 200     SE DECISION MADE: 17-MAY-22
Golden CO  80401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
3M Company                        510(k) NO: K220507(Traditional)
ATTN: Hilary  Hovde               PHONE NO : 651 7360364 
2510 Conway Ave. Building 275-5W-0SE DECISION MADE: 23-MAY-22
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CATALYS Precision Laser system
AMO Manufacturing USA, LLC        510(k) NO: K220516(Traditional)
ATTN: Alex  Etlin                 PHONE NO : 415 7979879 
510 Cottonwood Drive              SE DECISION MADE: 17-MAY-22
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7D Surgical System - Percutaneous Application (7D Flash Frame)
7D Surgical                       510(k) NO: K220522(Special)
ATTN: Daniel  Ziskind             PHONE NO : 647 4840079 
60 scarsdale road, unit 118       SE DECISION MADE: 20-MAY-22
Toronto  CA M3B 2R7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable surgical mask
Xiamen Blue Star Enterprise Co., L510(k) NO: K220532(Traditional)
ATTN: Jincong  Zhang              PHONE NO : 86 130 15920500 
Room 201, South Building, No.506, SE DECISION MADE: 23-MAY-22
Xiamen  CN 361000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
HL Rubber Industries Sdn bhd      510(k) NO: K220545(Traditional)
ATTN: Noorzaliza  Ahmad           PHONE NO : 606 4811087 88
Lot 10, Kawasan Perindustrian DiohSE DECISION MADE: 26-MAY-22
Kuala Pilah  MY 72000             510(k) STATEMENT
                                                    

DEVICE: MoistureMeterD Compact, LymphScanner
Delfin Technologies Ltd           510(k) NO: K220557(Traditional)
ATTN: Jouni  Nuutinen             PHONE NO : 358 50 9111199 
Microkatu 1                       SE DECISION MADE: 27-MAY-22
Kuopio  FI 70210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 17HQ901G-B
LG Electronics Inc.               510(k) NO: K220559(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
77, Sanho-daero                   SE DECISION MADE: 05-MAY-22
Gumi-si  KR 39381                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355
3M Company                        510(k) NO: K220564(Traditional)
ATTN: Yumi  Wackerfuss            PHONE NO : 1 651 7373556 
2510 Conway Avenue, Bldg. 275-5W-0SE DECISION MADE: 23-MAY-22
St. Paul MN  55144-1000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Bozhou Rongjian Medical Appliance 510(k) NO: K220578(Traditional)
ATTN: Wu  Zhifang                 PHONE NO : 86 558 7662968 
Jianghuai Supply Base, Zhongkai GrSE DECISION MADE: 25-MAY-22
Bozhou  CN 233500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Evis Exera III Duodenovideoscope Olympus TJF-Q190V
Olympus Medical Systems Corp.     510(k) NO: K220587(Traditional)
ATTN: Toshio  Nakamura            PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 11-MAY-22
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Skyra Fit
Siemens Medical Solutions USA, Inc510(k) NO: K220589(Traditional)
ATTN: Karthik  Pillai             PHONE NO : 317 3718593 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 13-MAY-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine Guidance Software, Stryker Q Guidance System
Stryker Leibinger GmbH & Co. KG   510(k) NO: K220593(Traditional)
ATTN: Andrea  Wallen-Gerding      PHONE NO : 269 4919234 
Bötzinger Straße 41               SE DECISION MADE: 27-MAY-22
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wearable Breast Pump (Model S9)
Shenzhen TPH Technology Co., Ltd. 510(k) NO: K220596(Traditional)
ATTN: Peter  Chen                 PHONE NO : 86 755 82703212 
5th floor, Lianchuang 2nd technoloSE DECISION MADE: 26-MAY-22
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Face Mask (FM-34EE,FM-44EE)
Qingdao Bestex Rubber & Plastic Pr510(k) NO: K220597(Traditional)
ATTN: Lucy  Wang                  PHONE NO : 86 185 62823807 
No.8-5 Guangzhou Road, Pingdu     SE DECISION MADE: 26-MAY-22
Qingdao  CN 266701                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color)
Encompass Industries Sdn. Bhd.    510(k) NO: K220609(Traditional)
ATTN: Nur Atikah binti Muhammad MuPHONE NO : 
Lot 18256, Kawasan Perindustrian LSE DECISION MADE: 27-MAY-22
Kemaman  MY 24300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOLO-L
Aurora Spine Inc                  510(k) NO: K220610(Traditional)
ATTN: Laszlo  Garamszegi          PHONE NO : 1 949 4125428 
1930 Palomar Point Way, Suite #103SE DECISION MADE: 27-MAY-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Introcan Safety IV Catheter
B.Braun Medical Inc.              510(k) NO: K220626(Special)
ATTN: Tracy  Larish               PHONE NO : 610 5965941 
901 Marcon Blvd.                  SE DECISION MADE: 14-MAY-22
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINK Endo-Model EVO Knee System
Waldemar Link GmbH & Co. KG       510(k) NO: K220628(Traditional)
ATTN: Stefanie  Fuchs             PHONE NO : 49 40 53995530 
Oststraße 4-10                    SE DECISION MADE: 03-MAY-22
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Barrigel Injectable Gel
Palette Life Sciences             510(k) NO: K220641(Traditional)
ATTN: David  Goodnough            PHONE NO : 805 8697087 
27 East Cota Street, Suite 402    SE DECISION MADE: 26-MAY-22
Santa Barbara CA  93101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astroglide Glycerin & Paraben Free
BioFilm Inc.                      510(k) NO: K220653(Traditional)
ATTN: Kevin  Jamil                PHONE NO : 760 7279030 
3225 Executive Ridge              SE DECISION MADE: 06-MAY-22
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iovera System
Pacira Biosciences, Inc.          510(k) NO: K220656(Special)
ATTN: Danny  Rivera               PHONE NO : 858 6252414 3175
10450 Science Center Drive        SE DECISION MADE: 20-MAY-22
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Barrier Sleeves
Premium Plus (Dongguan) Limited   510(k) NO: K220662(Traditional)
ATTN: Jessica  Mao                PHONE NO : 86 769 83397277 
No.1 Industrial Area, Tutang, ChanSE DECISION MADE: 11-MAY-22
Dongguan  CN 523581               510(k) STATEMENT
                                                    

DEVICE: NewTom 7G
CEFLA S.C.                        510(k) NO: K220664(Traditional)
ATTN: Lorenzo  Bortolotti         PHONE NO : 39 0542 653441 
Via Selice Prov.le 23/            SE DECISION MADE: 06-MAY-22
Imola  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL HAIR REMOVAL HANDSET, Model: IPL-666
Shenzhen Junbobeauty Technology Co510(k) NO: K220669(Traditional)
ATTN: Jian  Zhan                  PHONE NO : 86 176 65318870 
#522, Jinyuan Business Building A,SE DECISION MADE: 16-MAY-22
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx
Qingdao HIGHTOP Biotech Co., Ltd. 510(k) NO: K220685(Traditional)
ATTN: Ray  Li                     PHONE NO : 86 0532 58710705 
No.369 Hedong Road, Hi-tech IndustSE DECISION MADE: 05-MAY-22
Qingdao  CN 266112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vatech Clismile
Rayence Co.,Ltd                   510(k) NO: K220689(Traditional)
ATTN: Kevin  Kim                  PHONE NO : 82 31 80156459 
14, Samsung 1-ro, 1gil            SE DECISION MADE: 06-MAY-22
Hwaseong-si  KR 445-170           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension
Seigla Medical, Inc.              510(k) NO: K220691(Traditional)
ATTN: Chad J. Kugler              PHONE NO : 763 2346937___ 
7688 5th Street SE                SE DECISION MADE: 05-MAY-22
Buffalo MN  55313                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
Yian Medical Technology (Haining) 510(k) NO: K220700(Traditional)
ATTN: Zhiqin  Yu                  PHONE NO : 86 0573 87217250 
1st Floor Area 1, 2nd Floor Area 1SE DECISION MADE: 04-MAY-22
Jiaxing  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC              510(k) NO: K220704(Traditional)
ATTN: Carol  Burns                PHONE NO : 610 6882006 
150 Strafford Avenue #315         SE DECISION MADE: 04-MAY-22
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyKnee R Pin Positioners
Medacta International S.A.        510(k) NO: K220705(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 04-MAY-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System
SeaSpine Orthopedics Corporation  510(k) NO: K220711(Traditional)
ATTN: Kavita  Chandrashekar       PHONE NO : 858 4051276 
5770 Armada Drive                 SE DECISION MADE: 10-MAY-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spartan SC 069
Spartan Micro, Inc.               510(k) NO: K220716(Traditional)
ATTN: Gary  Avedovech             PHONE NO : 415 6024279 
                                  SE DECISION MADE: 05-MAY-22
Costa Mesa CA  92626              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hand Trauma Screw System
Skeletal Dynamics, Inc.           510(k) NO: K220723(Traditional)
ATTN: Alexandra  Rodriguez        PHONE NO : 305 5967585 7215
7300 N Kendall Drive, Suite 400   SE DECISION MADE: 12-MAY-22
Miami FL  33156                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: inHEART MODELS
inHEART, SAS                      510(k) NO: K220727(Traditional)
ATTN: Audrey  Labèque             PHONE NO : 33 5 35381972 
IHU LIryc – Hôpital Xavier ArnozanSE DECISION MADE: 10-MAY-22
Pessac  FR 33600                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Motive Knee Wrap
CyMedica Orthopedics, Inc.        510(k) NO: K220738(Traditional)
ATTN: Kereshmeh  Shahriari        PHONE NO : 480 2398553___ 
2120 East 6th Street              SE DECISION MADE: 12-MAY-22
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Power Wheelchair, W5907 (Q50 R Carbon)
Zhejiang Innuovo Rehabilitation De510(k) NO: K220740(Traditional)
ATTN: Leo  Zheng                  PHONE NO : 86 183 58936043 
No.196 Industry Road, Hengdian MovSE DECISION MADE: 12-MAY-22
Dongyang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Power Wheelchair (N5515B)
Zhejiang Innuovo Rehabilitation De510(k) NO: K220747(Traditional)
ATTN: Leo  Zheng                  PHONE NO : 86 1835 8936043 
No.196 Industry Road, Hengdian MovSE DECISION MADE: 12-MAY-22
Dongyang  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP
Unimax Medical Products Co., Ltd. 510(k) NO: K220749(Traditional)
ATTN: Haibo  Ning                 PHONE NO : 86 027 82213162 
No.1 Liansai Road, Changshangkou TSE DECISION MADE: 13-MAY-22
Xiantao  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Argo Knotless SP Anchor
CONMED Corporation                510(k) NO: K220757(Traditional)
ATTN: Dionne  Sanders             PHONE NO : 727 5092930 
525 French Road                   SE DECISION MADE: 13-MAY-22
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pre-Formed Penile Silicone Block
International Medical Devices, Inc510(k) NO: K220760(Traditional)
ATTN: James  Elist                PHONE NO : 310 6522600 
717 North Maple Drive             SE DECISION MADE: 13-MAY-22
Beverly Hills CA  90210           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eMurmur Heart AI
CSD Labs GmbH                     510(k) NO: K220766(Special)
ATTN: Andreas  Reinisch           PHONE NO : 43 650 5272666___ 
Nikolaiplatz 4                    SE DECISION MADE: 31-MAY-22
Graz  AT 8020                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical and Prosthetic Trays
Dentsply Sirona                   510(k) NO: K220791(Traditional)
ATTN: Courtney  Clark             PHONE NO : 248 8954379___ 
221 West Philadelphia Street, SuitSE DECISION MADE: 03-MAY-22
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMR Reverse Liner
LimaCorporate S.p.A.              510(k) NO: K220792(Traditional)
ATTN: Michela  Zanotto            PHONE NO : 39 043 2945511 
Via Nazionale 52                  SE DECISION MADE: 19-MAY-22
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InnoVoyce Laser Fiber
InnoVoyce LLC                     510(k) NO: K220793(Traditional)
ATTN: Kent  Johnson               PHONE NO : 678 7088874 
25 Dorchester Avenue, Ste #52318  SE DECISION MADE: 25-MAY-22
Boston MA  02205                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Imperative Care Radial 088 Access System
Imperative Care Inc.              510(k) NO: K220807(Traditional)
ATTN: Kristin  Elis               PHONE NO : 408 8570934 
1359 Dell Avenue                  SE DECISION MADE: 17-MAY-22
Campbell CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Mask (Planar type)
Hunan Chopard Medical Devices Co.,510(k) NO: K220824(Traditional)
ATTN: Hongwei  Wei                PHONE NO : 86 1322 5896000 
88, Tongxin Road, Longfu Town InduSE DECISION MADE: 19-MAY-22
Liuyang  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Dynamics (Version VA40E)
Siemens Medical Solutions USA, Inc510(k) NO: K220832(Third Party - Traditional)
ATTN: Abhineet  Johri             PHONE NO : 1 484 6808723 
400 W. Morgan Road                SE DECISION MADE: 20-MAY-22
Ann Arbor MI  48108               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Artisan Bone Plug, Universal Cement Restrictor
Howmedica Osteonics, dba Stryker O510(k) NO: K220838(Traditional)
ATTN: Margaret  Klippel           PHONE NO : 201 8315559 
325 Corporate Drive               SE DECISION MADE: 20-MAY-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accu-Chek Safe-T-Pro Plus Lancing Device
Roche Diabetes Care, Inc.         510(k) NO: K220849(Traditional)
ATTN: Jason  Lee                  PHONE NO : 1 317 4354782 
9115 Hague Road                   SE DECISION MADE: 19-MAY-22
Indianapolis IN  46256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tapestry Biointegrative Implant
Embody, Inc.                      510(k) NO: K220867(Traditional)
ATTN: Brianna  Schehr             PHONE NO : 236 9947912 
4211 Monarch Way Suite 500        SE DECISION MADE: 23-MAY-22
Norfolk VA  23508                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
Medacta International S.A.        510(k) NO: K220888(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 24-MAY-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senhance Surgical System
Asensus Surgical, Inc.            510(k) NO: K220889(Special)
ATTN: Casey  Hinckley             PHONE NO : 1 801 3105491 
1 TW Alexander Drive, Suite 160   SE DECISION MADE: 27-MAY-22
Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navagio Lumbar Cage
Kalitec Medical, LLC              510(k) NO: K220902(Traditional)
ATTN: Scott  Winn                 PHONE NO : 407 5452063 
618 E. South Street, Suite 500    SE DECISION MADE: 27-MAY-22
Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
GRI-Alleset, Inc.                 510(k) NO: K220917(Traditional)
ATTN: Marty D Paugh               PHONE NO : 678 5238977 
4142 Industry Way                 SE DECISION MADE: 18-MAY-22
Flowery Branch GA  314031         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MULTIX Impact E
Siemens Medical Solutions USA, Inc510(k) NO: K220919(Traditional)
ATTN: Denise  Adams               PHONE NO : 610 9442184 
40 Liberty Boulevard              SE DECISION MADE: 17-MAY-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MY01 Continuous Compartmental Pressure Monitor
MY01 Inc.                         510(k) NO: K220952(Traditional)
ATTN: Charles  Allen              PHONE NO : 1 855 7996901 
400 De Maisonneuve Boulevard West,SE DECISION MADE: 24-MAY-22
Montreal  CA H3A 1L4              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ON3D
3D ONS, Inc.                      510(k) NO: K221000(Traditional)
ATTN: Jeong Rae Cho               PHONE NO : 82 2 5118120 
18, Eonju-ro 171-gil              SE DECISION MADE: 23-MAY-22
Gangnam-gu  KR 06023              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Home Use Hair Removal Device
Shenzhen Beauty Every Moment intel510(k) NO: K221001(Traditional)
ATTN: Luo  Huajun                 PHONE NO : 86 755 33883239 
Rm.101,201,501, Bldg. 4, Haoer JiaSE DECISION MADE: 12-MAY-22
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intra.Ox 2.0 Handheld Tissue Oximeter
ViOptix, Inc.                     510(k) NO: K221010(Special)
ATTN: Scott  Coleridge            PHONE NO : 510 2265860 
39655 Eureka Drive                SE DECISION MADE: 03-MAY-22
Newark CA  94560                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GIA Auto Suture Stapler with DST Series Technology
Covidien                          510(k) NO: K221013(Special)
ATTN: Robert  Zott                PHONE NO : 917 4216878 
60 Middletown Avenue              SE DECISION MADE: 05-MAY-22
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steriking Packaging for Medical Devices
Wipak OY                          510(k) NO: K221016(Special)
ATTN: Hanna  Marttila             PHONE NO : 358 040 1240290___ 
Wipaktie 2                        SE DECISION MADE: 05-MAY-22
Nastola  FI FI-15560              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQGuide® VUE Steerable Sheath
Acutus Medical, Inc.              510(k) NO: K221044(Third Party - Traditional)
ATTN: Sarah  Clay                 PHONE NO : 949 2917811 
2210 Faraday Ave., Suite 100      SE DECISION MADE: 05-MAY-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Invu by Nuvo
Nuvo- Group Ltd.                  510(k) NO: K221046(Special)
ATTN: Chen  Rubinstein            PHONE NO : 972 54 3063996 
Yigal Alon 94. St, Alon Tower 1   SE DECISION MADE: 06-MAY-22
Tel Aviv  IL 6789155              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viatrac 14 Plus Peripheral Dilatation Catheter
Abbott Vascular                   510(k) NO: K221057(Special)
ATTN: Jiyoung  Dang               PHONE NO : 408 8450960 
3200 Lakeside Drive               SE DECISION MADE: 05-MAY-22
Santa Clara CA  95054             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: K221059(Special)
ATTN: Kara  Johnson               PHONE NO : 781 3459122 
600 Technology Park Drive, 4th FloSE DECISION MADE: 10-MAY-22
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Self-Punching PushLock Suture Anchor
Arthrex Inc.                      510(k) NO: K221099(Special)
ATTN: Kelsey  Roberts             PHONE NO : 1 239 5984302 72257
1370 Creekside Boulevard          SE DECISION MADE: 13-MAY-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantib Prostate
Quantib BV                        510(k) NO: K221106(Special)
ATTN: Arnault  Massink            PHONE NO : 31 108 411749 
Westblaak 106                     SE DECISION MADE: 13-MAY-22
Rotterdam  NL 3012 KM             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flow-Nail
Flow-FX, LLC                      510(k) NO: K221115(Special)
ATTN: Patrick J. Sweeney          PHONE NO : 815 5314424 
9301 West 191st Street            SE DECISION MADE: 13-MAY-22
Mokena IL  60448                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XACT ACE Robotic System
XACT Robotics Ltd.                510(k) NO: K221116(Special)
ATTN: Chen  Levin                 PHONE NO : 972 4 7700369 
8 Hatochen Street, PO Box 3097    SE DECISION MADE: 13-MAY-22
Caesarea  IL 3079861              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Procedure Mask with Ear Loops and Surgical Mask with Ties
SafeSource Direct, LLC            510(k) NO: K221134(Third Party - Traditional)
ATTN: Robbie  Wicks               PHONE NO : 337 2107943 
200 St Nazaire Rd.                SE DECISION MADE: 19-MAY-22
Broussard LA  70518               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: X-Twist PEEK Suture Anchor
Parcus Medical LLC                510(k) NO: K221135(Special)
ATTN: Calen  Souther              PHONE NO : 770 6161389 
6423 Parkland Drive               SE DECISION MADE: 19-MAY-22
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadiForce MX243W
EIZO Corporation                  510(k) NO: K221136(Abbreviated)
ATTN: Hiroaki  Hashimoto          PHONE NO : 81 76 2742468 
153 Shimokashiwano                SE DECISION MADE: 10-MAY-22
Hakusan  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
Radisen Co., Ltd                  510(k) NO: K221144(Special)
ATTN: John  Lim                   PHONE NO : 82 31 80849762 
14F, 128, Gongduk B/D, 11, SaechanSE DECISION MADE: 13-MAY-22
Seoul  KR 04168                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Telepack +
KARL STORZ Endoscopy America, Inc 510(k) NO: K221174(Special)
ATTN: Mario  Trujillo             PHONE NO : 424 2188184 
2151 E. Grand Avenue              SE DECISION MADE: 13-MAY-22
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
Medtronic Sofamor Danek USA, INC  510(k) NO: K221180(Special)
ATTN: Elizabeth  Hamilton         PHONE NO : 901 8318017 
1800 Pyramid Place                SE DECISION MADE: 25-MAY-22
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: e-motion M25
Alber GmbH                        510(k) NO: K221215(Special)
ATTN: Christoph  Hauschel         PHONE NO : 49 74 322006370 
Vor dem Weißen Stein 14           SE DECISION MADE: 24-MAY-22
Albstadt-Tailfingen  DE 72461     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT CaScoring
Siemens Medical Solutions USA, Inc510(k) NO: K221219(Special)
ATTN: Monsuru  Bello              PHONE NO : 202 8566099 
810 Innovation Drive              SE DECISION MADE: 17-MAY-22
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Univers Revers Humeral Cup Implant
Arthrex Inc.                      510(k) NO: K221232(Special)
ATTN: Ivette  Galmez              PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 19-MAY-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K221240(Special)
ATTN: Nimrod  Epstein             PHONE NO : 972 73 7946870 
3 Aminadav St.,                   SE DECISION MADE: 17-MAY-22
Tel Aviv  IL 6706703              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD Horizon™ Spinal System
Medtronic                         510(k) NO: K221244(Special)
ATTN: Justin  O'Connor            PHONE NO : 901 3992480 
1800 Pyramid Place                SE DECISION MADE: 25-MAY-22
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid LVO
iSchemaView Inc.                  510(k) NO: K221248(Special)
ATTN: James  Rosa                 PHONE NO : 303 7043374 
1120 Washington Ave., Ste 200     SE DECISION MADE: 31-MAY-22
Golden CO  80401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoNavigator R4.0
Philips Medical Systems Nederland 510(k) NO: K221270(Special)
ATTN: Supriya A. Dalvi            PHONE NO : 31 628 945536 
Veenpluis 6                       SE DECISION MADE: 31-MAY-22
Best  NL 5684 PC                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liverty™ TIPS Access Set
Bard Peripheral Vascular, Inc     510(k) NO: K221440(Third Party - Traditional)
ATTN: Scott  Johnson              PHONE NO : 602 8305517 
1625 West 3rd Street              SE DECISION MADE: 31-MAY-22
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


            TOTAL 510(k)s THIS PERIOD   286                                     
            TOTAL WITH SUMMARIES        263                                     
            TOTAL WITH STATEMENTS        23
                                      
 
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