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
