U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. July 2021 510(K) Clearances
  1. 510(k) Clearances

July 2021 510(K) Clearances

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
                                      
 
Back to Top