510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2021
DEVICE: Electric Wheelchair [Models: JRWD6010/JRWD6012]
Jerry Medical Instrument (Shanghai510(k) NO: K192739(Traditional)
ATTN: Jianguo Chen PHONE NO : 86 138 17397985
Building 12, No. 615 Fengdeng Rd, SE DECISION MADE: 13-JUL-21
Shanghai CN 201801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nebulizer Kit
Excellentcare Medical (Huizhou) Lt510(k) NO: K192971(Traditional)
ATTN: Chunyu Zhao PHONE NO : 86 752 6358312
Shatou Industrial Zone. Yuanzhou TSE DECISION MADE: 08-JUL-21
Huizhou CN 516123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Pro510(k) NO: K193047(Traditional)
ATTN: Christine Perkins PHONE NO : 302 6318811
Emil-von-Behring-Str. 76 SE DECISION MADE: 14-JUL-21
Marburg DE 35041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AbutmentCAD
exocad GmbH 510(k) NO: K193352(Traditional)
ATTN: Stefan Walter PHONE NO : 49 6151 629489 0
37, Julius-Reiber-Str. SE DECISION MADE: 21-JUL-21
Darmstadt DE 64293 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur® Digoxin assay
Siemens Healthcare Diagnostics, In510(k) NO: K193397(Traditional)
ATTN: Anoop Joy PHONE NO : 914 5242273
511 Benedict Avenue SE DECISION MADE: 16-JUL-21
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SensiTox C. difficile Toxin Test
First Light Diagnostics, Inc. 510(k) NO: K193490(Traditional)
ATTN: Joanne Spadoro PHONE NO : 781 2710112
2 Omni Way SE DECISION MADE: 08-JUL-21
Chelmsford MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIOCLEAR System
Perfection Aligner System Hong Kon510(k) NO: K193622(Traditional)
ATTN: Alwin Ngai PHONE NO : 852 3766 0737
Flat/Rm 4B, 4/F, Hang Fat IndustriSE DECISION MADE: 06-JUL-21
Kowloon, HongKong HK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Crosstex VH2O2 Chemical Indicators
Crosstex International, Inc. (A Ca510(k) NO: K200096(Special)
ATTN: Pablo Martinez PHONE NO : 800 7221529
6789 W. Henrietta Road SE DECISION MADE: 15-JUL-21
Rush NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OncoMate MSI Dx Analysis System
Promega Corporation 510(k) NO: K200129(Traditional)
ATTN: Ron Wheeler PHONE NO : 608 2744330
2800 Woods Hollow Rd SE DECISION MADE: 26-JUL-21
Madison WI 53711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur® Total hCG assay
Siemens Healthcare Diagnostics, In510(k) NO: K200210(Traditional)
ATTN: Mey Lyn Vasquez PHONE NO : 914 5242458
511 Benedict Ave. SE DECISION MADE: 13-JUL-21
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
Siemens Healthcare Diagnostics, In510(k) NO: K200256(Special)
ATTN: Julie Warren PHONE NO : 302 6318722
511 Benedict Avenue SE DECISION MADE: 02-JUL-21
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM
TRUEMED GROUP LLC 510(k) NO: K200575(Traditional)
ATTN: Nina Galeana Rodriguez PHONE NO : 713 8583189
2002 Timberloch Place Suite 200 SE DECISION MADE: 09-JUL-21
The Woodlands TX 77380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mini PCNL-System
Trokamed GmbH 510(k) NO: K200770(Traditional)
ATTN: Stefan Weiland PHONE NO : 49 07704 924451
Kleine Breite 17 SE DECISION MADE: 30-JUL-21
Geisingen DE 78187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs
GX Corporation Sdn Bhd 510(k) NO: K200915(Traditional)
ATTN: Khon Pu Foo PHONE NO : 60 03 32915788
Lot 6491 Batu 5 3/4, Sementa JalanSE DECISION MADE: 09-JUL-21
Klang MY 42100 510(k) STATEMENT
DEVICE: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
Ningbo Hesi Electric Co., Ltd 510(k) NO: K200983(Traditional)
ATTN: Ma LuLu PHONE NO : 86 158255 67078
No.818-23-156 Qiming Rd, Yinzhou, SE DECISION MADE: 14-JUL-21
Ningbo CN 315000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHIRAVAC Blood Collection Needles
CHIRANA T. Injecta 510(k) NO: K201009(Traditional)
ATTN: Zdenka Klbeckova PHONE NO : 421 32 7709972
Nàm. Dr. Schweitzera 194 SE DECISION MADE: 21-JUL-21
Starà Turà SK 916 01 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio-Medicus Life Support Catheter and Introducer
Medtronic Inc. 510(k) NO: K201100(Traditional)
ATTN: Juli Rubin PHONE NO : 763 5262357
8200 Coral Sea St. NE SE DECISION MADE: 15-JUL-21
Mounds Views MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elos® Intramedullary Nailing System
Intrauma S.p.A. 510(k) NO: K201147(Traditional)
ATTN: Piero Costa PHONE NO : 39 011 9539496
Via Genova 19 SE DECISION MADE: 19-JUL-21
Rivoli (TO) IT 10098 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
M.I. Tech Co., Ltd 510(k) NO: K201160(Traditional)
ATTN: Inae Kim PHONE NO : 82 70 43047450
174, Habuk 2-gil, Jinwi-myeon SE DECISION MADE: 23-JUL-21
Pyeongtaek-si KR 17706 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microwave Therapeutic System
Nanjing ECO Microwave System Co., 510(k) NO: K201262(Traditional)
ATTN: Hong Wei PHONE NO : 86 025 58872663
Third & Fourth Floors, J5 BuildingSE DECISION MADE: 09-JUL-21
Nanjing CN 211800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Microwave Therapeutic Antennas
Nanjing ECO Microwave System Co., 510(k) NO: K201265(Traditional)
ATTN: Hong Wei PHONE NO : 86 25588 72663
Third & Fourth Floors, J5 BuildingSE DECISION MADE: 23-JUL-21
Nanjing CN 211800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair
Psychemedics Corporation 510(k) NO: K201326(Traditional)
ATTN: Neil Stowe PHONE NO : 310 2167776
5832 Uplander Way SE DECISION MADE: 27-JUL-21
Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dexcom G6 Continuous Glucose Monitoring (CGM) System
Dexcom, Inc. 510(k) NO: K201328(Traditional)
ATTN: Maryam Amini PHONE NO : 858 2036715
6310 Sequence Dr. SE DECISION MADE: 15-JUL-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExoAtlet-II
ExoAtlet Asia Co. Ltd. 510(k) NO: K201473(Traditional)
ATTN: Bret Bostock PHONE NO : 720 4751826
4582 S. Ulster Streer, Suite 205 SE DECISION MADE: 16-JUL-21
Denver CO 80237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
Corin Ltd. 510(k) NO: K201657(Traditional)
ATTN: Christina Rovaldi PHONE NO : 800 4486664
480 Paramount Drive SE DECISION MADE: 28-JUL-21
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
bioMerieux, Inc. 510(k) NO: K201675(Traditional)
ATTN: Debra Broyles PHONE NO : 314 7318805
595 Anglum Road SE DECISION MADE: 09-JUL-21
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KDL Micro catheter
Shanghai Kindly Medical Instrument510(k) NO: K201706(Traditional)
ATTN: Xu Jianhai PHONE NO : 86 21591 400568870
No. 925, Jinyuan yi Road SE DECISION MADE: 22-JUL-21
Shanghai CN 201803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arterial Catheter
Haolang Medical USA Corporation 510(k) NO: K201726(Traditional)
ATTN: Lisa Xu PHONE NO : 425 5036325
1100 Bellevue Way NE 8A-533 SE DECISION MADE: 07-JUL-21
Bellevue WA 98004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Provident II Hip Stems
Globus Medical Inc. 510(k) NO: K201733(Special)
ATTN: Jennifer Antonacci PHONE NO : 610 9301800 1861
2560 General Armistead Ave. SE DECISION MADE: 14-JUL-21
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hydrozid
MediLink A/S 510(k) NO: K201740(Traditional)
ATTN: Cristina Teixeira PHONE NO : 45 306 66502
Gammelmosevej 176A SE DECISION MADE: 07-JUL-21
Kgs. Lyngby DK 2800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Abbott Diabetes Care Inc. 510(k) NO: K201761(Traditional)
ATTN: Ono Bacani PHONE NO : 510 2392622
1360 South Loop Road SE DECISION MADE: 30-JUL-21
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-SURE
Lazarus, 3D, Inc 510(k) NO: K201835(Traditional)
ATTN: Smriti Zanevald PHONE NO : 541 7601805
3513 NW Mink Pl SE DECISION MADE: 08-JUL-21
Corvallis OR 97330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask, Surgical Mask
Lear Corporation 510(k) NO: K201844(Abbreviated)
ATTN: Ryan Facer PHONE NO : 336 3418687
1 Penn Dye St SE DECISION MADE: 14-JUL-21
Pine Grove PA 17963 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VS Newborn Heart Rate Monitor
SurePulse Medical Limited 510(k) NO: K201887(Traditional)
ATTN: James Carpenter PHONE NO : 44 0333 5771133
Medicity, D6 Thane Road SE DECISION MADE: 23-JUL-21
Nottingham GB NG90 gbh 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable IV catheter
Shinva Ande Healthcare Apparatus C510(k) NO: K202060(Traditional)
ATTN: Liang Wanjie PHONE NO : 86 533 3917816
No.77 Development Zone North Road SE DECISION MADE: 23-JUL-21
Zibo CN 255086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EliA SmDP-S
Phadia AB 510(k) NO: K202067(Traditional)
ATTN: Carina Magnusson PHONE NO : 46 18 165000
Rapsgatan 7P SE DECISION MADE: 14-JUL-21
Uppsala SE SE 754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulmogine Vibrating Mesh Nebulizer
HCMed Innovations Co., Ltd. 510(k) NO: K202171(Traditional)
ATTN: Yiling Lee PHONE NO : 886 2 27326596 51
Rm.B, 10F, No.319, Sec.2, Dunhua SSE DECISION MADE: 01-JUL-21
Taipei City TW 10669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BeneHold Surgical Incise Drape with CHG antimicrobial
Avery Dennison Belgie BVBA 510(k) NO: K202208(Traditional)
ATTN: Lisa Bartakovics PHONE NO : 1 312 2066159
Tieblokkenlaan, 1 SE DECISION MADE: 30-JUL-21
Turnhout BE 2300 510(k) STATEMENT
DEVICE: LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
Hamilton Thorne, Inc. 510(k) NO: K202241(Traditional)
ATTN: Donald Fournier PHONE NO : 978 9212050
100 Cummings Center, Suite 465E SE DECISION MADE: 02-JUL-21
Beverly MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer, Model BSX976
Shenzhen BSX Technology Electronic510(k) NO: K202296(Traditional)
ATTN: Lijuan Du PHONE NO : 86 755 28719103
Rm301.3F 8th Building, LiHao IndusSE DECISION MADE: 23-JUL-21
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)
NYU Langone Medical Center 510(k) NO: K202304(Third Party - Traditional)
ATTN: Matija Snuderl PHONE NO : 646 5015281
240 E 38th Street SE DECISION MADE: 14-JUL-21
New York NY 10016 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: Aduro Light Beauty Mask
Shenzhen Kaiyan Medical Co Ltd 510(k) NO: K202390(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 135 103787481
40A Fuxin Road, Fuyong SubdistrictSE DECISION MADE: 14-JUL-21
Shenzhen CN 518101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cytrellis Dermal Micro-Coring System
Cytrellis Biosystems, Inc. 510(k) NO: K202517(Traditional)
ATTN: Karen H. Cronholm PHONE NO : 857 2541720
299C Washington St SE DECISION MADE: 09-JUL-21
Woburn MA 01801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insulin Syringe, Insulin Syringe with Safety Retractable
Jiangsu Micsafe Medical Technology510(k) NO: K202570(Traditional)
ATTN: Tony Yang PHONE NO : 086 1365 1929266
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 02-JUL-21
Yancheng CN 224125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruAbutment DS, TruBase
TruAbutment Inc. 510(k) NO: K202579(Traditional)
ATTN: Eunjin Jang PHONE NO : 714 9561488
17742 Cowan SE DECISION MADE: 08-JUL-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SynergyID Endoscopic Imaging System
Arthrex Inc. 510(k) NO: K202582(Traditional)
ATTN: Heli F. Chambi Infantas PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 22-JUL-21
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Temp Pal
iWEECARE Co., Ltd. 510(k) NO: K202603(Traditional)
ATTN: Glen Tseng PHONE NO : 886 2 28213597
2F, No. 121, Sec. 2, Linong St., BSE DECISION MADE: 22-JUL-21
Taipei City TW 112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
Thermo Fisher Scientific 510(k) NO: K202612(Traditional)
ATTN: Cynthia Knapp PHONE NO : 1 800 8718909
One Thermo Fisher Way SE DECISION MADE: 23-JUL-21
Oakwood Village OH 44146 510(k) STATEMENT
DEVICE: Pain Therapy Device
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K202638(Traditional)
ATTN: Sammy Li PHONE NO : 86 20 66393598
No.23 Building, The Second Phase, SE DECISION MADE: 15-JUL-21
Guangzhou CN 511450 510(k) STATEMENT
DEVICE: Peregrine Endoscopy System
3NT Medical Ltd. 510(k) NO: K202727(Traditional)
ATTN: Ehud Bendory PHONE NO : 972 73 7154056
22 HaMelacha St., POB 11384 SE DECISION MADE: 23-JUL-21
Rosh Ha'Ayin IL 4809169 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Forehead Thermometer
Shenzhen Combei Technology Co., Lt510(k) NO: K202741(Traditional)
ATTN: Kevin Fong PHONE NO : 086 755 29588956
No. 105, Huanguan South Road, DaheSE DECISION MADE: 07-JUL-21
Shenzhen CN 518110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sectum
Neauvia North America 510(k) NO: K202780(Traditional)
ATTN: Misty Williams PHONE NO : 984 7775292
8480 Honeycutt Road SE DECISION MADE: 30-JUL-21
Raleigh NC 27615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTI Extra-Short Dental Implant System UnicCa
B.T.I. Biotechnology Institute, S.510(k) NO: K202825(Traditional)
ATTN: Jose Roman Rivero PHONE NO : 34 945 297030
Leonardo da Vinci 14, Parque TecnoSE DECISION MADE: 29-JUL-21
Minano ES 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERA HARZ
Graphy Inc. 510(k) NO: K202846(Traditional)
ATTN: Tae-woo Kim PHONE NO : 82 33 7480433
1607, Gasan SK V1 Center, 171, GasSE DECISION MADE: 15-JUL-21
Seoul KR 08503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeSignals Multi-Parameter Remote Monitoring Platform
LifeSignals, Inc. 510(k) NO: K202868(Traditional)
ATTN: Saravanan Balasubramanian PHONE NO : 510 7706412 4
39355 California Street, Suite 305SE DECISION MADE: 21-JUL-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoSync™ Ti Dental Mesh
Sites Medical, LLC 510(k) NO: K202918(Traditional)
ATTN: Greg Stalcup PHONE NO : 260 6253347
5865 E State Road 14 SE DECISION MADE: 14-JUL-21
Columbia City IN 46725 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: END 200 Endoscopic Tubeset
Palliare Ltd. 510(k) NO: K202922(Traditional)
ATTN: John O’Dea PHONE NO : 353 91 516362
Galway Business Park, Dangan SE DECISION MADE: 08-JUL-21
Galway IE H91 P2DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Xiamen Probtain Medical Techology 510(k) NO: K202954(Traditional)
ATTN: Jianli Kang PHONE NO : 86 592 7557106
4th Floor, No.1 Building, No.6 Ji'SE DECISION MADE: 02-JUL-21
Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Myopia Master
OCULUS Optikgeräte GmbH 510(k) NO: K202989(Traditional)
ATTN: Eckhard Loh PHONE NO : 49 641 20050
Münchholzhäuser Straße 29 SE DECISION MADE: 14-JUL-21
Wetzlar DE 35582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pantheon IBFD
Pantheon Spinal 510(k) NO: K203003(Special)
ATTN: Dave Lamb PHONE NO : 512 3043488
40132 Industrial Park Circle SuiteSE DECISION MADE: 07-JUL-21
Georgetown TX 78626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pisces Spinal System
Ortho Development Corporation 510(k) NO: K203023(Traditional)
ATTN: Divya Palan PHONE NO : 810 6198922
12187 South Business Park Drive SE DECISION MADE: 14-JUL-21
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ignite Stemless Anatomic Shoulder System
Ignite Orthopedics LLC 510(k) NO: K203108(Traditional)
ATTN: Matt Purdy PHONE NO : 612 2145361
700 Park Avenue Suite F SE DECISION MADE: 16-JUL-21
Winona Lake IN 46590 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARVIS Surgical Navigation System
Insight Medical Systems Inc. 510(k) NO: K203115(Traditional)
ATTN: Nicholas R. van der Walt PHONE NO : 858 2259882
25892 La Cuesta Avenue SE DECISION MADE: 14-JUL-21
Laguna Hills CA 92653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030); Bebebao Electric Breast Pump (Model: BB-5020); Yiyadodo Electric Breast Pump (Model: YY-5030)
Ningbo Youhe Electrical Appliance 510(k) NO: K203148(Traditional)
ATTN: Huang Yun Jun PHONE NO : 86 574 63860315
No.567, Xintang Road, Fuhai Town SE DECISION MADE: 08-JUL-21
Cixi CN 315322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BioWave BioWraps
BioWave Corporation 510(k) NO: K203158(Traditional)
ATTN: Bradford Siff PHONE NO : 203 6357175
8 Knight Street, Suite 201 SE DECISION MADE: 08-JUL-21
Norwalk CT 06851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeLens Wireless ECG Monitor
LifeLens Technologies, Inc. 510(k) NO: K203168(Traditional)
ATTN: Landy Toth PHONE NO : 215 6224715
1 Ivybrook Blvd, Suite 115 SE DECISION MADE: 20-JUL-21
Ivyland, Bucks PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARSTEM Cemented Femoral Stem
Smith & Nephew, Inc. 510(k) NO: K203175(Traditional)
ATTN: Brad Sheals PHONE NO : 901 2887141
7135 Goodlett Farms Parkway SE DECISION MADE: 22-JUL-21
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ Metal Sterilization Trays
Karl Storz Endoscopy America Inc 510(k) NO: K203198(Traditional)
ATTN: Leigh Spotten PHONE NO : 424 2188376
2151 E Grand Ave SE DECISION MADE: 06-JUL-21
El Segundo CA 90245-5017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DemarkQ WOW, DemarkQ POP
Shenzhen Kaiyan Medical Co Ltd 510(k) NO: K203214(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 755 82129361
40A Fuxin Road Fuyong Subdistrict SE DECISION MADE: 22-JUL-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
Edwards Lifesciences, LLC 510(k) NO: K203224(Traditional)
ATTN: Lisa Gilman PHONE NO : 949 2501478
One Edwards Way SE DECISION MADE: 30-JUL-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cannula for Organ Perfusion
Bridge to Life Ltd. 510(k) NO: K203262(Traditional)
ATTN: Brett Schultz PHONE NO : 847 7963070
128 Suber Rd., Suite A SE DECISION MADE: 01-JUL-21
Columbia SC 29210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aduro light therapy Handheld
Shenzhen Kaiyan Medical CO LTD 510(k) NO: K203271(Traditional)
ATTN: Alain Dijkstra PHONE NO : 86 755 82129361
40A Fuxin Road, Fuyong SubdistrictSE DECISION MADE: 21-JUL-21
Shenzhen CN 518000 510(k) STATEMENT
DEVICE: NUVO CF Implant System
JJGC Indústria e Comércio de Mater510(k) NO: K203309(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 06-JUL-21
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask
Suzhou Yuyue Medical Technology Co510(k) NO: K203347(Traditional)
ATTN: Sun Wei PHONE NO : 86 512 67373001
No. 9 Jinfeng Road, Suzhou ScienceSE DECISION MADE: 02-JUL-21
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Flu+ Syringe
Becton, Dickinson and Company 510(k) NO: K203359(Traditional)
ATTN: Nikita Abirami Mahendra KumaPHONE NO : 201 8475641
1 Becton Drive SE DECISION MADE: 28-JUL-21
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avance Solo Negative Pressure Wound Therapy (NPWT) System
Molnlycke Health Care US, LLC 510(k) NO: K203369(Traditional)
ATTN: Megan Bevill PHONE NO : 770 5479196
5445 Triangle Parkway Suite 400 SE DECISION MADE: 01-JUL-21
Peachtree Corners GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Summit Patella Plating System
Endeavor Orthopaedics, LLC 510(k) NO: K203408(Traditional)
ATTN: John Alleman PHONE NO : 217 7210758
11601 S Richmond Avenue SE DECISION MADE: 30-JUL-21
Tulsa OK 74137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Skull Unfolding
Siemens Medical Solutions USA, Inc510(k) NO: K203411(Traditional)
ATTN: Tabitha Estes PHONE NO : 865 8044553
810 Innovation Drive SE DECISION MADE: 22-JUL-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Ear Thermometer Probe Cover
Huaian Zhongxin Packing Material C510(k) NO: K203431(Traditional)
ATTN: Feng Zuo PHONE NO : 86 15 751384913
No. 128-5, West Meigao Road, QingpSE DECISION MADE: 28-JUL-21
Huaian CN 223022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axium Detachable Coil; Axium Prime Detachable Coil
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K203432(Traditional)
ATTN: Bhavika Patel PHONE NO : 949 4345030
5290 California Ave SE DECISION MADE: 07-JUL-21
Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System
Nihon Kohden Corporation 510(k) NO: K203435(Traditional)
ATTN: Sandra Gadeyne PHONE NO : 949 3563401
1-31-4 Nishiochiai, Shinjuku-Ku SE DECISION MADE: 16-JUL-21
Tokyo JP 161-8560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The Alma Hybrid Laser System
Alma Lasers, Ltd. 510(k) NO: K203441(Traditional)
ATTN: Avi Hirshnzon PHONE NO : 972 54 3303402
18 Haharash Street, North IndustriSE DECISION MADE: 02-JUL-21
Caesarea Ha Zafon IL 3079895 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SafeCross Transseptal Puncture and Introducer (TSP/I) System
East End Medical I LLC 510(k) NO: K203459(Traditional)
ATTN: Brij Maini PHONE NO : 717 6450809
1157 Sawgrass Corporate Parkway SE DECISION MADE: 06-JUL-21
Sunrise FL 33323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nexo-Gide Bilayer Collagen Membrane
Geistlich Pharma AG 510(k) NO: K203496(Traditional)
ATTN: Marco Steiner PHONE NO : 41 41 4926764
Bahnhofstrasse 40 SE DECISION MADE: 14-JUL-21
Wolhusen CH 6110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LX9max
Daesung Maref CO., LTD. 510(k) NO: K203498(Traditional)
ATTN: Su Hyeon So PHONE NO : 82 31 4597211
298-24, Gongdan-Ro SE DECISION MADE: 02-JUL-21
Gunpo-Si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART FINDER
IMS Giotto S.p.A. 510(k) NO: K203509(Special)
ATTN: Antonella Rossi PHONE NO : 39 051 846851
VIA Sagittario, 5 SE DECISION MADE: 14-JUL-21
Sasso Marconi IT 40037 510(k) STATEMENT
DEVICE: Surgical face mask (Model: Flat Ear Loop/CN102)
Crown Name Disposable Hygiene Prod510(k) NO: K203534(Traditional)
ATTN: Ying Fang PHONE NO : 86 027 82761940
Chengbei Industrial Zone, ZhuchengSE DECISION MADE: 21-JUL-21
Wuhan CN 431400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
Medtronic , Inc. 510(k) NO: K203556(Traditional)
ATTN: Alexandra Theisen PHONE NO : 763 5266758
8200 Coral Sea Street NE SE DECISION MADE: 12-JUL-21
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Finetest Lite Blood Glucose Monitoring System
Osang Healthcare Co., Ltd. 510(k) NO: K203562(Special)
ATTN: Ik-Hyeon Kim PHONE NO : 82 31 4600415
132, Anyangcheondong-Ro, Dongan-GuSE DECISION MADE: 13-JUL-21
Anyang KR 14040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GlidePath Retro Long-Term Hemodialysis Catheter
C.R. Bard, Inc. 510(k) NO: K203575(Traditional)
ATTN: Joan Bergstrom PHONE NO : 480 5978425
1625 W. Third Street SE DECISION MADE: 01-JUL-21
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use Medical Face Mask
Conod Medical Co., Limited 510(k) NO: K203591(Traditional)
ATTN: Carrie Wu PHONE NO : 86 0512 52306320
No.11 Hongfeng Road, Baimao IndustSE DECISION MADE: 02-JUL-21
Changshu CN 215532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iSR'obot Mona Lisa 1.0
Biobot Surgical Pte Ltd 510(k) NO: K203659(Traditional)
ATTN: Lim Yan Shin PHONE NO : 65 97263992
2 Woodlands Spectrum l, #03-10 WooSE DECISION MADE: 08-JUL-21
Singapore SG 738068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAZIC Claro CAD and MAZIC Claro Press
Vericom Co., Ltd. 510(k) NO: K203672(Traditional)
ATTN: Yun Ki Kim PHONE NO : 82 31 4412881
48, Toegyegongdan 1-Gil, SE DECISION MADE: 01-JUL-21
Chuncheon-Si KR 200-944 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DELTA XTEND Reverse Shoulder System
DePuy Ireland UC 510(k) NO: K203694(Traditional)
ATTN: Jaclyn Cincotta PHONE NO :
Loughbeg, Ringaskiddy SE DECISION MADE: 22-JUL-21
Co. Cork Munster IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
Oxoid Limited (Part of Thermo Fish510(k) NO: K203700(Traditional)
ATTN: Philip Brame PHONE NO : 44 0 7884332059
Wade Road SE DECISION MADE: 30-JUL-21
Basingstroke GB RG24 8PW 510(k) STATEMENT
DEVICE: The Slide
Biotex, Inc. 510(k) NO: K203712(Traditional)
ATTN: Wade Munsch PHONE NO : 713 7410111 208
114 Holmes Rd. SE DECISION MADE: 20-JUL-21
Houston TX 77045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Darwin
Luvo Medical Technologies, Inc 510(k) NO: K203728(Traditional)
ATTN: Gregory Berzak PHONE NO : 519 6203900
125 Fleming Drive SE DECISION MADE: 14-JUL-21
Cambridge CA N1T 2B8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann Surgical Cassettes
Straumann USA, LLC 510(k) NO: K203753(Traditional)
ATTN: Chanrasmey White PHONE NO : 978 7472614
60 Minuteman Road SE DECISION MADE: 29-JUL-21
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray
Zirkonzahn SRL 510(k) NO: K203765(Traditional)
ATTN: Julian Steger PHONE NO : 39 0474 066660
Via An der Ahr 7 SE DECISION MADE: 20-JUL-21
Gais IT 39030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Firefly Needleless Connector
PuraCath Medical, Inc 510(k) NO: K203796(Traditional)
ATTN: Julia Rasooly PHONE NO : 415 3054134
37600 Central Court, Suite 210 SE DECISION MADE: 30-JUL-21
Newark CA 94560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SyntrFuge System
Syntr Health Technologies, Inc. 510(k) NO: K203800(Traditional)
ATTN: Ahmed Zobi PHONE NO : 949 7324298
5270 California Ave., Suite #300 SE DECISION MADE: 02-JUL-21
Irvine CA 92617 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JS Dental Lab Mouth Guard
Ampower Dental Laboratories, LLC 510(k) NO: K210011(Traditional)
ATTN: Dylan Hao PHONE NO : 510 7408418
3423 Investment Blvd Suite 11 HaywSE DECISION MADE: 16-JUL-21
Hayward CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tamarin Blue PTCA RX Dilatation Catheter
Natec Medical Ltd. 510(k) NO: K210012(Special)
ATTN: Roy Devassy Pallippatt PHONE NO : 230 466 3065
Maeva Centra Building, Silicon AveSE DECISION MADE: 09-JUL-21
Reduit MU 72201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System
Integra Lifesciences Corporation 510(k) NO: K210016(Traditional)
ATTN: Blesson Abraham PHONE NO : 512 3681423
11101 Metric Blvd SE DECISION MADE: 27-JUL-21
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Promisemed Insulin Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K210059(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 21-JUL-21
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Estar-Z
Osstem Implant Co., Ltd. 510(k) NO: K210097(Traditional)
ATTN: Jungmin Yoo PHONE NO : 82 70 43949670
A-dong, 51, Mayu-ro 238beon-gil SE DECISION MADE: 02-JUL-21
Siheung-si KR 15079 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX
Lifelong Meditech Private Limited 510(k) NO: K210103(Traditional)
ATTN: Hamendra Nath Srivastava PHONE NO : 91 12 44406600
Plot No.18, Sector-5, IMT Manesar SE DECISION MADE: 16-JUL-21
Gurugram IN 122050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SurroundScope System
270Surgical Ltd. 510(k) NO: K210104(Traditional)
ATTN: Avi Levy PHONE NO : 972 779 031100
4 Arie Regev Street SE DECISION MADE: 08-JUL-21
Netanya IL 4250212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FiteBac CC OrthoSeal
Largent Health, LLC 510(k) NO: K210115(Traditional)
ATTN: Kirk Kimmerling PHONE NO : 770 2186221
3698 Largent Way NW, Suite 101 SE DECISION MADE: 29-JUL-21
Marietta GA 30064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iQ200 System, iChemVELOCITY Automated Urine Chemistry System
Beckman Coulter, Inc. 510(k) NO: K210127(Traditional)
ATTN: Marisa Pugliese PHONE NO : 305 3803002
11800 SW 147th Ave SE DECISION MADE: 02-JUL-21
Miami FL 33196 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RF Thermal System
Luvo Medical Technologies, Inc 510(k) NO: K210129(Traditional)
ATTN: Gregory Berzak PHONE NO : 519 6203900
125 Fleming Drive SE DECISION MADE: 20-JUL-21
Cambridge CA N1T 2B8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3)
Foshan Nanhai Plus Medical CO LTD 510(k) NO: K210143(Traditional)
ATTN: Eric Li PHONE NO : 086 757 86914198
Shatou Jiujiang Town, Nanhai DistrSE DECISION MADE: 22-JUL-21
Foshan CN 528200 510(k) STATEMENT
DEVICE: Labat series Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K210154(Traditional)
ATTN: Jiang Xiaosan PHONE NO : 86 755 86007788
1st, 2nd, 5th & 6th Floor, NO.6 BuSE DECISION MADE: 30-JUL-21
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntraLock System
Fusion Orthopedics, LLC 510(k) NO: K210159(Traditional)
ATTN: Whitney Rey PHONE NO : 800 4036876
4135 S. Powder Rd., Suite 110 SE DECISION MADE: 23-JUL-21
Mesa AZ 85212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlowSaver Blood Filter
Inari Medical 510(k) NO: K210176(Traditional)
ATTN: Eben Gordon PHONE NO : 949 4184095
9 Parker, Suite 100 SE DECISION MADE: 22-JUL-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CardioCurve Steerable Sheath
Talon Surgical 510(k) NO: K210185(Traditional)
ATTN: Jay Muse PHONE NO : 801 2102886
6030 West Harold Gatty Drive SE DECISION MADE: 23-JUL-21
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PacBond One
Pac-Dent, Inc. 510(k) NO: K210186(Traditional)
ATTN: Tom Peng PHONE NO : 909 8390888
670 Endeavor Circle SE DECISION MADE: 16-JUL-21
Brea CA 92821 510(k) STATEMENT
DEVICE: Pac-Dent Denture Base Resin
Pac-Dent, Inc. 510(k) NO: K210189(Traditional)
ATTN: Jingtian Peng PHONE NO : 909 8390888 111
670 Endeavor Circle SE DECISION MADE: 28-JUL-21
Brea CA 92821 510(k) STATEMENT
DEVICE: RICOH MEG
Ricoh Company, Ltd. 510(k) NO: K210199(Traditional)
ATTN: Satoshi Yuuki PHONE NO : 81 76 2587012
2-3, Hokuyodai SE DECISION MADE: 02-JUL-21
Kanazawa-shi JP 920-0177 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Gowns
Jiangsu Province Jianerkang Medica510(k) NO: K210215(Traditional)
ATTN: Tang Hongfang PHONE NO : 86 135 85416869
No.1 Jianerkang Road, Zhixi IndustSE DECISION MADE: 07-JUL-21
Changzhou CN 213251 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask
Suzhou Bolisi Medical Technology C510(k) NO: K210244(Traditional)
ATTN: Hong Xu PHONE NO : 86 137 76246881
Baijiaqiao industrial community, YSE DECISION MADE: 12-JUL-21
Zhangjiagang CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lab Bag with Fabric Pouch
Advanced Medical Design Co., Ltd. 510(k) NO: K210248(Traditional)
ATTN: Silvia Yeh PHONE NO : 886 2 22902627 511
4-5F, No 29, Wuquan 5th Rd., Wugu SE DECISION MADE: 30-JUL-21
New Taipei City TW 248018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PowerPiCC Catheter
Bard Access Systems, Inc. 510(k) NO: K210264(Traditional)
ATTN: Mary Strickland PHONE NO : 801 5225000
605 North 5600 West SE DECISION MADE: 30-JUL-21
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Xiamen Eagledon Pharmaceutical Co.510(k) NO: K210267(Traditional)
ATTN: Aggie Zhang PHONE NO : 86 592 7231999
No.220-228, Meihe 3rd Road SE DECISION MADE: 08-JUL-21
Xiamen CN 361100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fingertip Pulse Oximeter
Zhuhai Linte Medical Instrument Co510(k) NO: K210274(Traditional)
ATTN: Kezheng Ma PHONE NO : 86 135 30230360
4th Floor, Building 1, No.66, YongSE DECISION MADE: 30-JUL-21
Zhuhai CN 519090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7.
Shenzhen Mismon Technology Co., Lt510(k) NO: K210311(Traditional)
ATTN: Rain Yip PHONE NO : 86 188 14498433
4th Floor, Building B, Zone A, LonSE DECISION MADE: 23-JUL-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bravo G4 Chamber Autoclave
SciCan Ltd. 510(k) NO: K210326(Abbreviated)
ATTN: Teresa Boyce PHONE NO : 416 4462783
1440 Don Mills Road SE DECISION MADE: 01-JUL-21
Toronto CA M3B 3P9 510(k) STATEMENT
DEVICE: TKO Composite Bite Turbo Gel
Reliance Orthodontic Products, Inc510(k) NO: K210349(Traditional)
ATTN: Christine Cook PHONE NO : 800 3234348
1540 W Thorndale Ave SE DECISION MADE: 20-JUL-21
Itasca IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Broncho Videoscope System
Scivita Medical Technology Co., Lt510(k) NO: K210379(Traditional)
ATTN: Ruqin Wu PHONE NO : 86 512 81877788
No.8, ZhongTian Xiang, Suzhou InduSE DECISION MADE: 28-JUL-21
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical surgical mask
Shantou T&K Medical Equipment Fact510(k) NO: K210380(Traditional)
ATTN: Wan Li PHONE NO : 86 159 92258456
No.8 Workshop, Wanji South Second SE DECISION MADE: 08-JUL-21
Shantou CN 515065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blustone Synergy Diamond SA Cervical System
Blustone Synergy, LLC 510(k) NO: K210382(Traditional)
ATTN: Tom Gentry PHONE NO : 760 9926118
5520 Ventana Ct SE DECISION MADE: 23-JUL-21
Pueblo CO 81005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magneto Nasal Mask
Respironics, Inc. 510(k) NO: K210386(Traditional)
ATTN: Anna Danley PHONE NO : 412 5423513
1740 Golden Mile Highway SE DECISION MADE: 12-JUL-21
Monroeville PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-use medical face mask
Zhuhai Herald Datanetics Limited. 510(k) NO: K210391(Traditional)
ATTN: Jackson Leung PHONE NO : 0756 892 0609
Building#2, No.1 Pingxi Road 6, NaSE DECISION MADE: 22-JUL-21
Zhuhai CN 519060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Shandong Zhushi Pharmaceutical Gro510(k) NO: K210409(Traditional)
ATTN: Junhui Zhu PHONE NO : 86 530 7150111
No.6 Shande Road, Shan County SE DECISION MADE: 28-JUL-21
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pac-Dent Ceramic Nanohybrid Resin
Pac-Dent, Inc. 510(k) NO: K210412(Traditional)
ATTN: Jingtian Peng PHONE NO : 909 8390888 111
670 Endeavor Circle SE DECISION MADE: 26-JUL-21
Brea CA 92821 510(k) STATEMENT
DEVICE: QSM software, QSMetric
Medimagemetric LLC 510(k) NO: K210415(Traditional)
ATTN: Yi Wang PHONE NO : 917 7332285
171 Floral Ave SE DECISION MADE: 22-JUL-21
Johnson City NY 13790 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ReCross
IMDS Operations B.V. 510(k) NO: K210431(Traditional)
ATTN: Edwin Schulting PHONE NO : 315 082 00230
Ceintuurbaan Noord 150 SE DECISION MADE: 15-JUL-21
Roden NL 9301 NZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SC1 Handheld Ultrasound Imaging System (Model: SC1)
FCU Co., Ltd. 510(k) NO: K210468(Traditional)
ATTN: Lee Hee Yeon PHONE NO : 82 42 9369078
B-620/621, Biz Center, 17, Techno SE DECISION MADE: 23-JUL-21
Yuseong-gu KR 34013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Insight Agile DRF
Imaging Engineering, LLC 510(k) NO: K210469(Traditional)
ATTN: George Jachode PHONE NO : 239 2331371
1318 NW 7th Ave SE DECISION MADE: 27-JUL-21
Cape Coral FL 33993 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
AtriCure Inc. 510(k) NO: K210477(Traditional)
ATTN: Melissa Smallwood PHONE NO : 513 6444736
7555 Innovation Way SE DECISION MADE: 26-JUL-21
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuPebble SA
Acurable Limited 510(k) NO: K210480(Traditional)
ATTN: Esther Rodriguez-Villegas PHONE NO : 44 7939 036867____
Finsgate, 5-7 Cranwood Street SE DECISION MADE: 06-JUL-21
London GB EC1V 9EE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InMode RF Pro System
InMode MD Ltd. 510(k) NO: K210492(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 12-JUL-21
Yokneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System
SeaSpine Orthopedics Corporation 510(k) NO: K210497(Special)
ATTN: Aly Alvarez PHONE NO : 619 8844342
5770 Armada Drive SE DECISION MADE: 07-JUL-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Changzhou Holymed Products Co., Lt510(k) NO: K210524(Traditional)
ATTN: Shan Shang PHONE NO : 86 182 51200602
525 Changwu Road South SE DECISION MADE: 07-JUL-21
Changzhou CN 213167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Extended infusion set
Unomedical A/S 510(k) NO: K210544(Traditional)
ATTN: Lone Sylvest Vestergaard JepPHONE NO : 45 6 0775559
Aaholmvej 1-3 SE DECISION MADE: 16-JUL-21
Osted DK 4320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Pulse System
NuVasive, Incorporated 510(k) NO: K210574(Traditional)
ATTN: Manthan Damani PHONE NO : 858 4582272
7475 Lusk Boulevard SE DECISION MADE: 29-JUL-21
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Nitrile Examination Gloves (Power free, Blue)
Jiangxi Hongda Medical Equipment G510(k) NO: K210578(Traditional)
ATTN: Yang Qinghua PHONE NO : 86 189 7009359
39 South Shengli RD. Jinxian CountSE DECISION MADE: 10-JUL-21
Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System
OTU Medical Inc. 510(k) NO: K210579(Traditional)
ATTN: Geping Liu PHONE NO : 408 7977313
2231A Fortune Drive SE DECISION MADE: 22-JUL-21
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AortaSTAT Occlusion Device
RenalPro Medical, Inc. 510(k) NO: K210602(Traditional)
ATTN: James Twitchell PHONE NO : 508 397 6191
2370-B Walsh Avenue SE DECISION MADE: 09-JUL-21
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro
Heraeus Medical GmbH 510(k) NO: K210607(Traditional)
ATTN: Ljuba Jaeckel PHONE NO : 49 6181 353138
Phillipp-Reis-Str. 8/13 SE DECISION MADE: 09-JUL-21
Wehrheim DE 61273 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Free.Max
Siemens Medical Solutions USA, Inc510(k) NO: K210611(Traditional)
ATTN: Andrew Turner PHONE NO : 610 8505627
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 01-JUL-21
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Route 92 Medical Full Length 088 Access System
Route 92 Medical Inc. 510(k) NO: K210635(Special)
ATTN: Kirsten Valley PHONE NO : 650 5811179
155 Bovet Road, Suite 100 SE DECISION MADE: 27-JUL-21
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE Planner Hip
Orthosoft d/b/a Zimmer CAS 510(k) NO: K210653(Traditional)
ATTN: Paul Hardy PHONE NO : 574 4536739
75 Queen Street, Suite 3300 SE DECISION MADE: 07-JUL-21
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
Ra Medical Systems, Inc. 510(k) NO: K210664(Traditional)
ATTN: Jami Miller PHONE NO : 760 8041648
2070 Las Palmas Drive SE DECISION MADE: 27-JUL-21
Carlsbad CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Chest-CAD
Imagen Technologies, Inc 510(k) NO: K210666(Traditional)
ATTN: Robert Lindsey PHONE NO : 917 8304721
151 West 26th Street, Suite 1001 SE DECISION MADE: 20-JUL-21
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Medical Examination Glove
Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K210684(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 20-JUL-21
Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Glove
Yunnan Huazhiyuan Medical Technolo510(k) NO: K210686(Traditional)
ATTN: Yun Gao PHONE NO : 86 182 52909158
Yangjie Industrial Park, Jianshui SE DECISION MADE: 21-JUL-21
Honghe Hani and Yi Autonomous Pref510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown
O&M Halyard, Inc 510(k) NO: K210688(Abbreviated)
ATTN: Kimberly Lewis PHONE NO : 470 4139064
9120 Lockwood Blvd SE DECISION MADE: 21-JUL-21
Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Medical Examination Glove
Jiangsu Cureguard Glove Co., Ltd. 510(k) NO: K210691(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
No. 65 Shenzhen Road, The EconomicSE DECISION MADE: 30-JUL-21
Suqian CN 223800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HM70 EVO Diagnostic Ultrasound System
Samsung Medison CO., LTD. 510(k) NO: K210713(Traditional)
ATTN: Jee Young Ju PHONE NO : 82 2 21940861
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 09-JUL-21
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bone Screws dia. 5,0 mm
LimaCorporate S.p.A. 510(k) NO: K210717(Traditional)
ATTN: Antonia Trevisan PHONE NO :
Via Nazionale 52 SE DECISION MADE: 12-JUL-21
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Change Healthcare Anatomical AI
Change Healthcare Canada Company 510(k) NO: K210719(Traditional)
ATTN: Chester McCoy PHONE NO : 404 3382088
10711 Cambie Road SE DECISION MADE: 20-JUL-21
Richmond CA V6X 3GS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Glove
Jiangxi Zhonghong Pulin Medical Pr510(k) NO: K210723(Traditional)
ATTN: Zhou Ziyu PHONE NO : 86 199 31401105
Yinshawan Park,High-tech IndustriaSE DECISION MADE: 12-JUL-21
Jiujiang CN 332500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: doctorgram Stethoscope DES-I
GV Concepts 510(k) NO: K210736(Traditional)
ATTN: Ching-Kay Chow PHONE NO : 408 7813861
3240 S White Rd #286 SE DECISION MADE: 27-JUL-21
San Jose CA 95148 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acumed Clavicle Hook Plating System
Acumed LLC 510(k) NO: K210750(Traditional)
ATTN: Janki Bhatt PHONE NO : 503 7188753
5885 NE Cornelius Pass Road SE DECISION MADE: 15-JUL-21
Hillsboro OR 97124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Velguard Surgical Face Mask
Estee Exports Health Care Division510(k) NO: K210761(Traditional)
ATTN: Zachary Wilson PHONE NO : 805 3651348
8/3176 A3 & A4, Jothipuram, 2nd StSE DECISION MADE: 16-JUL-21
Tirupur IN 641602 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrist Blood Pressure Monitor, Blood Pressure Monitor
Andon Health Co., Ltd. 510(k) NO: K210768(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 30-JUL-21
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
Andon Health Co., Ltd. 510(k) NO: K210770(Abbreviated)
ATTN: Liu Yi PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 29-JUL-21
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
5R MED Instruments (Chengdu) Co., 510(k) NO: K210776(Traditional)
ATTN: Yuzhang Pan PHONE NO : 86 139 28606563
Building 9, Section 1, No.618 of WSE DECISION MADE: 12-JUL-21
Chengdu CN 611130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Us2.v1
eko.ai Pte. Ltd. d/b/a Us2.ai 510(k) NO: K210791(Traditional)
ATTN: James Hare PHONE NO : 65 62327857
2 College Road, #02-00 SE DECISION MADE: 27-JUL-21
Singapore SG 94080 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical PVC Examination Gloves
Jiangxi Hongda Medical Equipment G510(k) NO: K210821(Traditional)
ATTN: Yang Qinghua PHONE NO : 86 189 70093059
39 South Shengli Road, Jinxian CouSE DECISION MADE: 09-JUL-21
Nanchang CN 331700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Purism Disposable Surgical Mask
Chuzhou Daddy's Choice Science and510(k) NO: K210856(Traditional)
ATTN: Amie Yang PHONE NO : 86 550 30369811
Middle of Nanjing Road, Langya DisSE DECISION MADE: 28-JUL-21
Chuzhou CN 239000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hemafuse System
Sisu Global Health 510(k) NO: K210862(Traditional)
ATTN: Gillian Henker PHONE NO : 412 7219269
2720 Sisson Street SE DECISION MADE: 29-JUL-21
Baltimore MD 21211 510(k) STATEMENT
DEVICE: MEO Med Disposable Medical Face Mask
Fujian MEO Medical Technology Limi510(k) NO: K210870(Traditional)
ATTN: Zhuang Yan PHONE NO : 86 135 99192517
Floor 4th, No. 1 Production BuildiSE DECISION MADE: 30-JUL-21
Ningde CN 352100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Evolve System with the T3 Applicator
InMode Ltd. 510(k) NO: K210877(Traditional)
ATTN: Amit Goren PHONE NO : 972 4 9097470
Tabor Building, Shaar Yokneam SE DECISION MADE: 19-JUL-21
Yoqneam Illit IL 2069200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1Derful HS, 1Derful HT
1Derful, Inc 510(k) NO: K210884(Traditional)
ATTN: Mohamad Alkassab PHONE NO : 346 3319811
38345 Donigan Road SE DECISION MADE: 27-JUL-21
Brookshire TX 77423 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IS Multi Unit Abutment System
Neobiotech Co., Ltd. 510(k) NO: K210903(Traditional)
ATTN: Young-Ku Heo PHONE NO : 82 2 5822885
#204, 36, Digital-ro 27gil, Guro-gSE DECISION MADE: 23-JUL-21
Seoul KR 08381 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Snore Bandit
SnoreBandit LLC 510(k) NO: K210910(Traditional)
ATTN: Garry Thynne PHONE NO : 702 2833557
8176 Merlewood Ave SE DECISION MADE: 01-JUL-21
Las Vegas NV 89117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerDot PD-01MT2 Muscle Stimulator
Smartmissimo Technologies Pte Ltd 510(k) NO: K210938(Special)
ATTN: Alexey Pisarev PHONE NO : 65 832 16256
#28-01, SGX Centre II, 4 Shenton WSE DECISION MADE: 30-JUL-21
Singapore SG 068807 510(k) STATEMENT
DEVICE: Ultra SEP
Reliance Orthodontic Products, Inc510(k) NO: K210945(Traditional)
ATTN: Christine Cook PHONE NO : 800 3234348
1540 W Thorndale Ave SE DECISION MADE: 08-JUL-21
Itasca IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART Taylor Spatial Frame
Smith & Nephew, Inc. 510(k) NO: K210953(Traditional)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
1450 E Brooks Rd SE DECISION MADE: 29-JUL-21
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENNOVATE Spinal System
Aesculap Implant Systems, LLC 510(k) NO: K210963(Traditional)
ATTN: Paul Amudala PHONE NO : 610 4170839
3773 Corporate Parkway SE DECISION MADE: 19-JUL-21
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Surgical Mask Model FE2311B
BYD Precison Manufacturer Co., Ltd510(k) NO: K210970(Traditional)
ATTN: Yubo Guan PHONE NO : 86 77589 8888868765
No.3001 Baohe Road, Baolong IndustSE DECISION MADE: 21-JUL-21
Shenzhen CN 518116 510(k) STATEMENT
DEVICE: Grappler Suture Anchor System
Paragon 28, Inc. 510(k) NO: K211002(Traditional)
ATTN: Haylie Hertz PHONE NO : 303 7200017
14445 Grasslands Dr. SE DECISION MADE: 07-JUL-21
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-TRAXTM Persona Knee Containment Device
K1 Medical LLC 510(k) NO: K211007(Traditional)
ATTN: Walt Oko PHONE NO : 203 9134161
56 Newton Road SE DECISION MADE: 01-JUL-21
Woodbridge CT 06525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves
Huayuan Medical Technology(Shangqi510(k) NO: K211012(Traditional)
ATTN: Huamei Wang PHONE NO : 86 13 705111918
In The North Yard of West 1000m RoSE DECISION MADE: 23-JUL-21
Shangqiu CN 476000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portray
Surround Medical Systems 510(k) NO: K211014(Traditional)
ATTN: Elizabeth Sullivan PHONE NO : 919 4244904
175 Southport Dr, Suite 900 SE DECISION MADE: 28-JUL-21
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Procedural Ear-loop Face Mask
Changzhou DSB Medical Co., LTD 510(k) NO: K211042(Traditional)
ATTN: Sunny Han PHONE NO : 86 519 88363800
No. 98 Fumin Rd, Changzhou EconomiSE DECISION MADE: 15-JUL-21
Changzhou CN 213025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann RidgeFit Implants
Institut Straumann AG 510(k) NO: K211052(Traditional)
ATTN: Viviana Horhoiu PHONE NO : 41 61 9651512
Peter Merian Weg 12 SE DECISION MADE: 08-JUL-21
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grosz Play Feel
RB Health (US) LLC 510(k) NO: K211088(Traditional)
ATTN: Elizabeth Viguerie PHONE NO : 973 4042715
399 Interpace Parkway SE DECISION MADE: 09-JUL-21
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nerve and Muscle Stimulator
Shenzhen XFT Medical Limited 510(k) NO: K211094(Traditional)
ATTN: Cindy Peng PHONE NO : 86 755 29888818
Room 203, Building 1, Biomedicine SE DECISION MADE: 08-JUL-21
Shenzhen CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL-899 FP
BTL Industries Inc. 510(k) NO: K211107(Traditional)
ATTN: David Chmel PHONE NO : 1 866 2851656
362 Elm Street SE DECISION MADE: 09-JUL-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureMAX-SA Cervical Standalone System
Additive Implants, Inc 510(k) NO: K211111(Traditional)
ATTN: Jeff Horn PHONE NO : 602 7958850
3101 E. Shea Blvd, Suite 122 SE DECISION MADE: 16-JUL-21
Phoenix AZ 85028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Spinal System
Zavation Medical Products LLC 510(k) NO: K211113(Traditional)
ATTN: Katie Motley PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 12-JUL-21
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neocis Guidance System (NGS) with Intraoral Fiducial Array
Neocis Inc. 510(k) NO: K211129(Traditional)
ATTN: William Tapia PHONE NO : 305 7532742
2800 Biscayne Blvd Suite 600 SE DECISION MADE: 28-JUL-21
Miami FL 33137 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Medical Examination Glove
Siyang Threeguard Medical Supplies510(k) NO: K211131(Traditional)
ATTN: Guo Hua PHONE NO : 86 134 85097856
East of Nanhai Road and South of GSE DECISION MADE: 29-JUL-21
Suqian CN 223799 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Vinyl Patient Examination Gloves
Shijiazhuang Hongjun Plastic Manuf510(k) NO: K211177(Traditional)
ATTN: Lv Zhanmin PHONE NO : 86 311 66766067
Xinye Industrial Zone, Wangtong ViSE DECISION MADE: 17-JUL-21
Shijiazhuang CN 051330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: xvision Spine system (XVS)
Augmedics Ltd 510(k) NO: K211188(Traditional)
ATTN: Tami Harel PHONE NO : 972 4 3730111
1 Ha-Tsmikha St SE DECISION MADE: 19-JUL-21
Yokneam Illit IL 2069205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Grivamax Family of Lasers, Models 272 and 148
Leana Orders, Inc 510(k) NO: K211192(Traditional)
ATTN: Leonid Krits PHONE NO : 718 4151901
12 Jefferson Boulevard, Suite 1F SE DECISION MADE: 20-JUL-21
Staten Island NY 10312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
Guangdong Kingfa Sci. & Tech. Co.,510(k) NO: K211220(Traditional)
ATTN: Xiaoge Yu PHONE NO : 86 13 570952157
No. 28 Delong Ave., Shijiao Town, SE DECISION MADE: 22-JUL-21
Qingyuan CN 511545 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: qER-Quant
Qure.ai Technologies 510(k) NO: K211222(Traditional)
ATTN: Pooja Rao PHONE NO : 91 22 68505800
Level 7, Commerz II, InternationalSE DECISION MADE: 30-JUL-21
Mumbai IN 400063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Boston Scientific Corporation 510(k) NO: K211223(Traditional)
ATTN: Rachel Nankervis PHONE NO : 508 6834755
300 Boston Scientific Way SE DECISION MADE: 21-JUL-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS Ti-base abutment
Dentsply Sirona 510(k) NO: K211225(Traditional)
ATTN: Rebecca Sporer PHONE NO : 717 8494793
221 West Philadelphia Street, SuitSE DECISION MADE: 28-JUL-21
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl compound examination gloves
Hebei Titans Hongsen Medical Techn510(k) NO: K211229(Traditional)
ATTN: Feng Shuangyan PHONE NO : 86 13 733285059
Eastern Industrial Zone SE DECISION MADE: 29-JUL-21
Nangong CN 051800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraTemp Rez II
Ultradent Products, Inc. 510(k) NO: K211237(Traditional)
ATTN: Shawn L. Quigley PHONE NO : 801 9166567
505 W Ultradent Drive (10200 SouthSE DECISION MADE: 13-JUL-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vinyl Patient Examination Gloves
Jiangxi Shengda Medical Technology510(k) NO: K211239(Traditional)
ATTN: Yun Gao PHONE NO : 86 182 52909158
No.25 Factory, Wencheng Block, HigSE DECISION MADE: 17-JUL-21
Shangrao CN 334711 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PET VCAR
GE Medical Systems SCS 510(k) NO: K211247(Traditional)
ATTN: Elizabeth Mathew PHONE NO : 262 424 7774
283, rue de la Miniere SE DECISION MADE: 27-JUL-21
BUC FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altor Safety 3-Ply Surgical Mask (Model:62222)
Altor Safety LLC 510(k) NO: K211249(Traditional)
ATTN: Jared Scott PHONE NO : 1 845 4228320
711 Executive Boulevard Suite C SE DECISION MADE: 23-JUL-21
Valley Cottage NY 10989 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Nitrile Synthetic Gloves Powder Free
Tangshan Hongyun Healthcare Produc510(k) NO: K211262(Traditional)
ATTN: Suying Le PHONE NO : 86 139 33365259
South Shenggezhuang Village,PachigSE DECISION MADE: 24-JUL-21
Tangshan CN 063500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves
Shenzhen Shiqiao Science and Techn510(k) NO: K211264(Traditional)
ATTN: Mikki Wan PHONE NO : 86 189 22802487
Unit 2105 ,Tower D, Galaxy World pSE DECISION MADE: 30-JUL-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volpara Imaging Software
Volpara Health Technologies Limite510(k) NO: K211279(Special)
ATTN: Ralph Highnam PHONE NO : 64 4 4996029
Level 14-15, Simpl House, 40 MerceSE DECISION MADE: 27-JUL-21
Wellington NZ 6011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
Fiagon GmbH 510(k) NO: K211291(Traditional)
ATTN: Dirk Mucha PHONE NO : 49 3320 2012124
Neuendorfstr. 23b SE DECISION MADE: 19-JUL-21
Hennigsdorf DE 16761 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys Syphilis
Roche Diagnostics 510(k) NO: K211302(Traditional)
ATTN: Bin Sun PHONE NO : 317 5213107
9115 Hague Road SE DECISION MADE: 20-JUL-21
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCS Lung Solution
TransMedics, Inc. 510(k) NO: K211314(Traditional)
ATTN: Miriam Provost PHONE NO : 978 4947897
200 Minuteman Road, Suite 302 SE DECISION MADE: 29-JUL-21
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc. 510(k) NO: K211316(Traditional)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 23-JUL-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRUXVIEW
CRUXELL Corp. 510(k) NO: K211317(Traditional)
ATTN: Boeun Bang PHONE NO : 82 42 9352554
405, Migun techno World II, 187, TSE DECISION MADE: 29-JUL-21
Daejeon KR 34025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
Asensus Surgical, Inc. 510(k) NO: K211325(Traditional)
ATTN: Taylor Fisher PHONE NO : 919 7658400
1 TW Alexander Drive, Suite 160 SE DECISION MADE: 27-JUL-21
Durham NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Machine, Model Number: BM-100
Zhengzhou Bestview St Co., Ltd. 510(k) NO: K211335(Traditional)
ATTN: Yangchun Jia PHONE NO : 86 158 03801506
Room 204, 20F, Lande Center, HuayaSE DECISION MADE: 28-JUL-21
Zhengzhou CN 450000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K211337(Traditional)
ATTN: Zhang Wei PHONE NO : 86 755 81885655
Keji 12th Road South, Hi-Tech InduSE DECISION MADE: 01-JUL-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOTRAP III Revascularization Device
Neuravi Limited 510(k) NO: K211338(Traditional)
ATTN: Niall Fox PHONE NO : 353 86 1730678
Block 3, Ballybrit Business Park SE DECISION MADE: 30-JUL-21
Galway IE H91 K5YD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Nitrile Exam Gloves
Jiangxi Surefine Medical Co., Ltd.510(k) NO: K211341(Traditional)
ATTN: Steve Zhu PHONE NO : 86 1380 5860705
Jinshan Rd., Yugan Hi-tech IndustrSE DECISION MADE: 29-JUL-21
Shangrao CN 335100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Face Mask
HuBei Kangning Protective Products510(k) NO: K211363(Traditional)
ATTN: Zhao Yuxuan PHONE NO : 86 139 07227068
Special No1, Xuefu Road, Xiantao CSE DECISION MADE: 24-JUL-21
Xiantao CN 433000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via RT Image Suite
Siemens Medical Solutions USA Inc.510(k) NO: K211379(Traditional)
ATTN: Clayton Ginn PHONE NO : 865 8982692
810 Innovation Drive SE DECISION MADE: 30-JUL-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elexir
Nu Eyne Co., Ltd. 510(k) NO: K211380(Traditional)
ATTN: Dong Seong Lee PHONE NO : 82 2 69538120
#608, 28, Digital-ro 30-gil, Guro-SE DECISION MADE: 30-JUL-21
Seoul KR 08389 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MySpine WebPlanner & MyBalance
Medacta International SA 510(k) NO: K211386(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 23-JUL-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Selethru(TM) NC PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd. 510(k) NO: K211393(Traditional)
ATTN: Maggie Xu PHONE NO : 86 150 51476125
F2-3, BLDG 6, No. 8, Jinfeng Road,SE DECISION MADE: 02-JUL-21
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO-I
Einstein Works LLC 510(k) NO: K211395(Traditional)
ATTN: Roy Bachrach PHONE NO : 001 713 7236000
5312 Elm St SE DECISION MADE: 28-JUL-21
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powersculp laser lipolysis system
Lotuxs Medtech (Suzhou) Co., Ltd. 510(k) NO: K211402(Traditional)
ATTN: Na Wu PHONE NO : 86 0512 62880553
RM301, NW-06, Nanopolis Suzhou, 99SE DECISION MADE: 30-JUL-21
Suzhou CN 215123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System (RED 68 Reperfusion Catheter)
Penumbra, Inc. 510(k) NO: K211411(Traditional)
ATTN: Micaela Victoria PHONE NO : 510 9902082
One Penumbra Place SE DECISION MADE: 01-JUL-21
Alameda CA 95132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown
Jiangsu Medplus Non-woven Manufact510(k) NO: K211422(Traditional)
ATTN: Shuying An PHONE NO : 86 527 80300123
No.217 East Wencheng Road, EconomiSE DECISION MADE: 02-JUL-21
Siyang CN 223700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation Spinous Process Clamps
Medtronic Navigation 510(k) NO: K211442(Traditional)
ATTN: Victoria Baldock PHONE NO : 423 8635907
826 Coal Creek Circle SE DECISION MADE: 08-JUL-21
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
Shen Wei USA Inc. 510(k) NO: K211455(Traditional)
ATTN: Cheryl Reep PHONE NO : 510 4298692
33278 Central Ave Ste 102 SE DECISION MADE: 28-JUL-21
Union City CA 94587 510(k) STATEMENT
DEVICE: HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
Edwards Lfesciences 510(k) NO: K211465(Traditional)
ATTN: Chirag Shah PHONE NO : 949 2501580
One Edwards Way SE DECISION MADE: 08-JUL-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NubeX
TechHeim Co., Ltd 510(k) NO: K211480(Traditional)
ATTN: Weon Yong Lee PHONE NO : 82 2 20280733
Floor 3.4, 21, Banpo-daero 24-gil SE DECISION MADE: 08-JUL-21
Seoul KR 06648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dental Impression Material
Nanchang Dental Bright Technology 510(k) NO: K211489(Traditional)
ATTN: Justin Qin PHONE NO : 86 15 079010001
Building 182, Jiahai Industrial PaSE DECISION MADE: 28-JUL-21
Nanchang CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RadiForce RX370
EIZO Corporation 510(k) NO: K211491(Abbreviated)
ATTN: Hiroaki Hashimoto PHONE NO : 81 76 2742468
153 Shimokashiwano SE DECISION MADE: 12-JUL-21
Hakusan JP 924-8566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pounce Thrombectomy System
Surmodics, Inc. 510(k) NO: K211492(Traditional)
ATTN: Holly Ramirez PHONE NO : 952 5007545
9924 W 74th Street SE DECISION MADE: 30-JUL-21
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monarch Platform
Auris Health, Inc. 510(k) NO: K211493(Special)
ATTN: Shikha Gola PHONE NO : 201 2403891
150 Shoreline Drive SE DECISION MADE: 09-JUL-21
Redwood CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOS PMP
Sorin Group Italia S.R.L 510(k) NO: K211495(Special)
ATTN: Luigi Vecchi PHONE NO : 39 0535 29957
Via Statale 12 Nord. 86 SE DECISION MADE: 12-JUL-21
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Honeywell Safety Products 510(k) NO: K211497(Traditional)
ATTN: Ivy Pettis PHONE NO : 401 8640496
10 Thurber Boulevard SE DECISION MADE: 28-JUL-21
Smithfield RI 02917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowerLook Density Assessment V4.0
iCAD, Inc. 510(k) NO: K211506(Traditional)
ATTN: Heather Reed PHONE NO : 603 3091945
98 Spit Brook Rd Suite 100 SE DECISION MADE: 12-JUL-21
Nashua NH 03062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: decimal Bolus
.decimal, LLC 510(k) NO: K211511(Traditional)
ATTN: Kevin Erhart PHONE NO : 407 3303300
121 Central Park Place SE DECISION MADE: 01-JUL-21
Sanford FL 32771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Longeviti PorousFit implant
Longeviti Neuro Solutions, LLC 510(k) NO: K211514(Traditional)
ATTN: Heather Hourihan PHONE NO : 410 5271803
303 International Circle Suite 190SE DECISION MADE: 15-JUL-21
Hunt Valley MD 21030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SwiftNINJA Steerable Microcatheter
Merit Medical Systems, Inc. 510(k) NO: K211525(Traditional)
ATTN: Luke Meidell PHONE NO : 801 2084623
1600 West Merit Parkway SE DECISION MADE: 16-JUL-21
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMO S
A.T.S. Applicazione Tecnologie Spe510(k) NO: K211542(Traditional)
ATTN: Livia Pillitteri PHONE NO : 39 035 584311
Via Alessandro Volta, 10 SE DECISION MADE: 09-JUL-21
Torre De Roveri IT 24060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
Edma Group, LLC 510(k) NO: K211547(Traditional)
ATTN: Vio Cretu PHONE NO :
3634 E Piccadilly Rd SE DECISION MADE: 15-JUL-21
Phoenix AZ 85018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLARSTEM Calcar Reamer Guide
Smith & Nephew, Inc. 510(k) NO: K211548(Traditional)
ATTN: Pamela Hopkins PHONE NO : 901 4277303
1450 East Brooks Rd SE DECISION MADE: 19-JUL-21
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Extreme X8
Magic Mobility 510(k) NO: K211574(Traditional)
ATTN: Alex Suen PHONE NO : 61 3 87915600
3 International Court SE DECISION MADE: 09-JUL-21
Scoreby AU 3179 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avanti Orthopaedics Ulnar Shortening System
Avanti Orthopaedics, Inc. 510(k) NO: K211592(Traditional)
ATTN: J. Doug Patterson PHONE NO : 302 5306369
4606 Simon Road SE DECISION MADE: 16-JUL-21
Wilmington DE 19803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Klassic Knee System
Total Joint Orthopedics, Inc. 510(k) NO: K211602(Traditional)
ATTN: Chris Weaber PHONE NO : 801 4866070
1567 E. Stratford Avenue SE DECISION MADE: 23-JUL-21
Salt Lake City UT 84106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K211633(Traditional)
ATTN: Janine F. Reyes PHONE NO : 714 6697853
1385 Shimoshigami SE DECISION MADE: 22-JUL-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vision Monitor - MonpackONE
Metrovision 510(k) NO: K211643(Traditional)
ATTN: Jacques Charlier PHONE NO : 33 3201 71956
4 rue des Platanes SE DECISION MADE: 26-JUL-21
Perenchies FR 59840 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINE Osteotomy
Bodycad Laboratories, Inc. 510(k) NO: K211646(Traditional)
ATTN: Nadine Adia PHONE NO : 418 5271388
2035, rue du Haut-Bord SE DECISION MADE: 28-JUL-21
Quebec City CA G1N 4R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: aPROMISE
EXINI Diagnostics AB 510(k) NO: K211655(Traditional)
ATTN: Aseem Anand PHONE NO : 46 706 604084
Ideon Science Park, Scheelevägen 2SE DECISION MADE: 27-JUL-21
Lund SE SE-223 70 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zap-X Radiosurgical System
Zap Surgical Systems, Inc. 510(k) NO: K211663(Traditional)
ATTN: Jim Talbot PHONE NO : 650 7938250
590 Taylor Way SE DECISION MADE: 29-JUL-21
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK Sphere Revision
Medacta International S.A. 510(k) NO: K211664(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 29-JUL-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELEOS Limb Salvage System
Onkos Surgical 510(k) NO: K211677(Traditional)
ATTN: Matthew (Matt) Vernak PHONE NO : 551 5791081
77 East Halsey Rd SE DECISION MADE: 28-JUL-21
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-Air and Athlos-1 and Athlos-Air
Athlos Oy 510(k) NO: K211688(Third Party - Traditional)
ATTN: Konstantinos Spartiotis PHONE NO : 358 401 362566
Klovinpellontie 1-3, Tower 2 SE DECISION MADE: 22-JUL-21
Espoo FI 02180 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System
Orthofix Inc. 510(k) NO: K211710(Traditional)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 30-JUL-21
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UltraLase Flexible CO2 Laser Waveguide
W & R Investments, LLC dba Laser E510(k) NO: K211761(Special)
ATTN: Robert I Rudko PHONE NO : 508 5202552
113 Cedar Street, SuiteS5 SE DECISION MADE: 30-JUL-21
Milford MA 10757 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9
ControlRad, Inc 510(k) NO: K211782(Special)
ATTN: Chris Fair PHONE NO :
275 Scientific Drive NW #1100 SE DECISION MADE: 01-JUL-21
Norcross GA 30092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO
Nico.Lab B.V. 510(k) NO: K211788(Special)
ATTN: Merel Boers PHONE NO : 31 20 2440852
Paasheuvelweg 25 SE DECISION MADE: 08-JUL-21
Amsterdam NL 1105 BP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DX-D Imaging Package with XD Detectors
Agfa N.V. 510(k) NO: K211790(Traditional)
ATTN: Wim Govaerts PHONE NO : 32 3444 6246
Septestraat 27 SE DECISION MADE: 30-JUL-21
Mortsel BE B-2640 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StitchKit
Origami Surgical Inc . 510(k) NO: K211792(Special)
ATTN: John Gillespie PHONE NO : 774 5670277
42 Main St. SE DECISION MADE: 16-JUL-21
Madison NJ 07940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Hyperfine, Inc. 510(k) NO: K211818(Special)
ATTN: Christine Kupchick PHONE NO : 203 3433404
530 Old Whitfield Street SE DECISION MADE: 07-JUL-21
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEKA Motus AZ
El.En Electronic Engineering SPA 510(k) NO: K211821(Special)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 06-JUL-21
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrode Market Disposable Surface Electrodes
Electrode Market Co.,Ltd. 510(k) NO: K211839(Traditional)
ATTN: Seolmin Jeong PHONE NO : 82 10 20226445
205, Manhae-ro, Danwon-gu, A-dong SE DECISION MADE: 28-JUL-21
Ansan-Si KR 15421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K211859(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 South East 51st Street SE DECISION MADE: 20-JUL-21
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TAIJI Professional Series Level 3 Surgical Face Mask
Taiji Medical Supplies, Inc. 510(k) NO: K211861(Third Party - Abbreviated)
ATTN: Katherine Giannamore PHONE NO : 305 5079843
3211 Progress Drive SE DECISION MADE: 28-JUL-21
Lincolnton NC 28092 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Bencox THR System
Corentec Co., Ltd. 510(k) NO: K211866(Special)
ATTN: Seungri Kim PHONE NO : 82 41 4107117
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 14-JUL-21
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
William Cook Europe ApS 510(k) NO: K211874(Special)
ATTN: Mie Dyrholm PHONE NO : 45 56 868492
Sandet 6 SE DECISION MADE: 28-JUL-21
Bjaeverskov DK 4632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
William Cook Europe ApS 510(k) NO: K211875(Special)
ATTN: Mie Dyrholm PHONE NO : 45 56 868492
Sandet 6 SE DECISION MADE: 28-JUL-21
Bjaeverskov DK 4632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MolecuLightDX
MolecuLight Inc. 510(k) NO: K211901(Special)
ATTN: Jordan John PHONE NO : 416 5425522
Suite 700, 425 University Avenue SE DECISION MADE: 21-JUL-21
Toronto CA M5G 1T6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Signs
Oxehealth Limited 510(k) NO: K211906(Special)
ATTN: Hugh Lloyd-Jukes PHONE NO : 44 186 5900599
Magdalen Centre North, The Oxford SE DECISION MADE: 20-JUL-21
Oxford GB OX4 4GA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Z-6 Atrioseptostomy Catheter
NuMED, Inc. 510(k) NO: K211910(Special)
ATTN: Nichelle LaFlesh PHONE NO : 315 3284491
2880 Main Street SE DECISION MADE: 19-JUL-21
Hopkinton NY 12965 510(k) STATEMENT
DEVICE: Fixxsure Anterior Lumbar Plate and Screw System
Oak Tree Engineering, LLC. 510(k) NO: K211932(Traditional)
ATTN: Douglas W Neary PHONE NO : 805 7973003
419 Main Street, #242 SE DECISION MADE: 27-JUL-21
Huntington Beach CA 92648 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EleVation Breast Biopsy System
Bard Peripheral Vascular 510(k) NO: K211933(Special)
ATTN: Meghan McKelvey PHONE NO : 602 8305063
1625 W. 3rd Street SE DECISION MADE: 15-JUL-21
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Physica LMC Knee System
LimaCorporate 510(k) NO: K211938(Special)
ATTN: Roberto Gabetta PHONE NO : 39 338 6439379
Via Nazionale, 52 SE DECISION MADE: 13-JUL-21
Villanova di San Daniele del Friul510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExacTrac Dynamic
Brainlab AG 510(k) NO: K211939(Special)
ATTN: Chiara Cunico PHONE NO : 49 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 22-JUL-21
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE® Digital Fusion Screw System
Medline Industries, Inc. 510(k) NO: K211944(Special)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three L akes Drive SE DECISION MADE: 22-JUL-21
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Soniquence Reusable Bipolar Cable
Soniquence, LLC 510(k) NO: K211946(Special)
ATTN: Suzanne Lucas PHONE NO : 516 6341370
2477 Grand Avenue SE DECISION MADE: 16-JUL-21
Baldwin NY 11510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GI Genius
Cosmo Artificial Intelligence - AI510(k) NO: K211951(Special)
ATTN: Nhan Ngo Dinh PHONE NO : 39 06 90287198
Riverside II, Sir John Rogerson’s SE DECISION MADE: 23-JUL-21
Dublin IE D02 KV60 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K211958(Special)
ATTN: Kelly McDonnell PHONE NO : 651 2699806
1800 Pyramid Place SE DECISION MADE: 21-JUL-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIO+ Adult
WaisMed Ltd 510(k) NO: K211968(Special)
ATTN: Shifra Hoch PHONE NO : 972 9 9517444
10 Amal St. Afek Industrial Park SE DECISION MADE: 22-JUL-21
Rosh Ha'Ayin IL 4809234 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASC Surgical Mask
Mid-America Safety Corp. 510(k) NO: K211984(Third Party - Traditional)
ATTN: Yunxiang (Phil) Fan PHONE NO : 847 9798606
800 Greenleaf Avenue SE DECISION MADE: 25-JUL-21
Elk Grove Village IL 60007 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Aveir Introducer
Abbott Medical 510(k) NO: K211989(Special)
ATTN: Bijal Jain PHONE NO : 1 818 2825438
15900 Valley View Court SE DECISION MADE: 27-JUL-21
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rist 071 Radial Access Guide Catheter
Micro Therapeutics, Inc., d/b/a ev510(k) NO: K211990(Special)
ATTN: Amnon Talmor PHONE NO : 352 5142339
9775 Toledo Way SE DECISION MADE: 27-JUL-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Catalyst R1 Reverse Shoulder System
Catalyst OrthoScience, Inc. 510(k) NO: K211991(Special)
ATTN: Dale Davison PHONE NO : 239 3259976 102
14710 Tamiami Trail North SE DECISION MADE: 28-JUL-21
Naples FL 34110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Braun Silk.expert Mini
CyDen Limited 510(k) NO: K211994(Special)
ATTN: Adam Stephens PHONE NO : 44 0 1792274009
Block A, Bay Studios Business ParkSE DECISION MADE: 28-JUL-21
Swansea GB SA1 8QB 510(k) STATEMENT
DEVICE: Reveal LINQ Insertable Cardiac Monitor
Medtronic. Inc. 510(k) NO: K212008(Special)
ATTN: Andrea Artman PHONE NO : 419 7084172
8200 Coral Sea Street NE SE DECISION MADE: 22-JUL-21
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flex-Thread™ Distal Fibula lntramedullary Nail System
Flower Orthopedics Corporation DBA510(k) NO: K212030(Special)
ATTN: Amanda Pentecost PHONE NO :
100 Witmer Road SE DECISION MADE: 23-JUL-21
Horsham PA 19044 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FibroScan 230
Echosens 510(k) NO: K212035(Special)
ATTN: Karine Bonenfant PHONE NO : 33 1 44827856
6 rue Ferrus SE DECISION MADE: 30-JUL-21
Paris FR 75014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HMB32 Dialysis Solution
Haemopharm Biofluids S.r.l. 510(k) NO: K212052(Special)
ATTN: Francesca Curti PHONE NO : 39 0342 771019
Via dell'Industria 6 SE DECISION MADE: 23-JUL-21
Tovo di S. Agata IT 23030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClariCT.AI
ClariPi Inc. 510(k) NO: K212074(Special)
ATTN: Hyun-Sook Park PHONE NO : 82 8 7413014
3F, 70-15, Ihwajang-gil SE DECISION MADE: 27-JUL-21
Seoul KR 03088 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 294
TOTAL WITH SUMMARIES 275
TOTAL WITH STATEMENTS 19
