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  1. 510(k) Clearances

June 2022 510(K) Clearances

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


DEVICE: RoughRider Aurora Manual Wheelchair
RoughRider America LLC            510(k) NO: K200715(Traditional)
ATTN: Marc  Krizack               PHONE NO : 510 2049333 
2233 California Street            SE DECISION MADE: 24-JUN-22
Berkley CA  94703                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hemosure Accu-Reader A100
W.H.P.M., Inc                     510(k) NO: K200754(Traditional)
ATTN: Farokh  Etemedieh           PHONE NO : 626 4438480 
5358 North Irwindale Avenue       SE DECISION MADE: 02-JUN-22
Irwindale CA  91706               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
TaiDoc Technology Corporation     510(k) NO: K201037(Traditional)
ATTN: Jacky  Chou                 PHONE NO : 886 2662 58188 
6F, No. 127, Wugong 2nd Rd., Wugu SE DECISION MADE: 16-JUN-22
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy 3D Additive TriFlange Acetabular Cup
DePuy International, Ltd          510(k) NO: K201348(Traditional)
ATTN: Erin  Combs                 PHONE NO : 574 3727211 
St. Anthony's Road                SE DECISION MADE: 16-JUN-22
Leeds  GB LS11 8DT                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EDEN Spinal Fixation System
JMT Co., Ltd                      510(k) NO: K201788(Traditional)
ATTN: Sang-Ok  Nam                PHONE NO : 82 31 8680951 
70-39, Gwonyul-ro 1203 beon-gile, SE DECISION MADE: 23-JUN-22
Yangju-si  KR 11517               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
Taiwan Aulisa Medical Devices Tech510(k) NO: K203208(Traditional)
ATTN: Paul  Liu                   PHONE NO : 886 2 26557297 
Rm. 1052, Bldg. H, 10F., No.3-2, YSE DECISION MADE: 12-JUN-22
Taipei  TW 115                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4CIS Chiron Spinal Fixation System
Solco Biomedical Co., Ltd.        510(k) NO: K203233(Special)
ATTN: Hee-Hoon  Kim               PHONE NO : 82 31 6104079 
154 Seotan-ro, Seotan-myeon       SE DECISION MADE: 01-JUN-22
Pyeongtaek  KR 17704              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinity Gateway Suite
Draeger Medical Systems, Inc.     510(k) NO: K203579(Traditional)
ATTN: Eileen M Boyle              PHONE NO : 781 4398120___ 
6 Tech Drive                      SE DECISION MADE: 07-JUN-22
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cholesterol2
Abbott Ireland Diagnostics Divisio510(k) NO: K203597(Traditional)
ATTN: Tracy  Schmidt              PHONE NO : 224 668 2833 
Lisnamuck                         SE DECISION MADE: 30-JUN-22
Longford  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technolo510(k) NO: K203624(Traditional)
ATTN: Hangli  Chen                PHONE NO : 86 1502 4335314 
North 4F, Building 1, No. 239 YataSE DECISION MADE: 16-JUN-22
Jiaxing  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys AMH
Roche Diagnostics                 510(k) NO: K203757(Traditional)
ATTN: Edie  Eads                  PHONE NO : 317 7348046 
9115 Hague Road                   SE DECISION MADE: 10-JUN-22
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stainless Turbine
NAKANISHI INC.                    510(k) NO: K203791(Traditional)
ATTN: Masaaki  Kikuchi            PHONE NO : 81 289 647277 
700 Shimohinata                   SE DECISION MADE: 21-JUN-22
Kanuma  JP 322-8666               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SILKRO
Hironic Co., Ltd                  510(k) NO: K210084(Traditional)
ATTN: Ji Yeong Seo                PHONE NO : 82 31 5257000 
19F, 767, Sinsu-Ro, Suji-Gu       SE DECISION MADE: 03-JUN-22
Yongin-Si  KR 16827               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.    510(k) NO: K210107(Traditional)
ATTN: Saiken  Ho                  PHONE NO : 516 8788787 118
16 Midland Ave                    SE DECISION MADE: 01-JUN-22
Hicksville NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portable Oxygen Concentrator, model: P2-E6
Qingdao Kingon Medical Science and510(k) NO: K210371(Traditional)
ATTN: Zhang  Benrong              PHONE NO : 86 185 65833539 
Room 301-302, No.15 HanchengRoad  SE DECISION MADE: 03-JUN-22
Qingdao Free Trade Zone  CN 266555510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyClip® and EasyClip® Xpress
Stryker GmbH                      510(k) NO: K210582(Traditional)
ATTN: Danielle Jannuzzi Madureira PHONE NO : 41 79 8900289 
325 Corporate Drive               SE DECISION MADE: 10-JUN-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin Neuro Rongeurs
KLS-MARTIN L.P.                   510(k) NO: K210741(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial ParkwSE DECISION MADE: 03-JUN-22
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q Patch
Medicalgorithmics S.A.            510(k) NO: K210758(Traditional)
ATTN: Maciej  Gamrot              PHONE NO : 48 22 8251249 
Aleje Jerozolimskie 81            SE DECISION MADE: 02-JUN-22
Warsaw  PL 02-001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap 3D Imaging and Mapping Catheter, Model 900009
Acutus Medical, Inc.              510(k) NO: K210766(Traditional)
ATTN: Karla  Schaffner            PHONE NO : 1 442 2326161 
2210 Faraday Ave, Suite 100       SE DECISION MADE: 21-JUN-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adhese Universal DC, Cention Primer
Ivoclar Vivadent, AG              510(k) NO: K210804(Traditional)
ATTN: Sandra  Cakebread           PHONE NO : 423 2353535 
Bendererstrasse 2                 SE DECISION MADE: 07-JUN-22
Schaan  LI FL-9494                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Noris Medical Dental Implants System - Cortical
Noris Medical Ltd                 510(k) NO: K210852(Traditional)
ATTN: Simha  Sibony               PHONE NO : 972 73 7964477 
8 Hataasia                        SE DECISION MADE: 24-JUN-22
Nesher  IL 3688808                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navident
ClaroNav Inc                      510(k) NO: K210947(Traditional)
ATTN: Tal Bresler Stramer         PHONE NO : 647 5442911 
1140 Sheppard Avenue West Unit 10 SE DECISION MADE: 27-JUN-22
Toronto  CA M3K 2A2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUTRON
ILOODA Co., Ltd                   510(k) NO: K211000(Traditional)
ATTN: Yun-Jung  Ha                PHONE NO : 82 31 2101622 
120, Jangan-ro 458 Beon-gil, JangaSE DECISION MADE: 09-JUN-22
Suwon-si  KR 16200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powered Breast Pump (Models 7V and 7X)
Haenim Co., Ltd.                  510(k) NO: K211016(Traditional)
ATTN: Dae Won Kim                 PHONE NO : 82 32 3246614 
15, Saryeom-ro 21beon-gil, Seo-gu SE DECISION MADE: 29-JUN-22
Incheon  KR 22742                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eCareManager 4.5
Visicu, Inc.                      510(k) NO: K211046(Traditional)
ATTN: Janine  Treter              PHONE NO : 55 41 996865600 
217 East Redwood Street           SE DECISION MADE: 03-JUN-22
Baltimore MD  21202               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Specific Marking Guides
Additive Orthopaedics, LLC        510(k) NO: K211076(Traditional)
ATTN: Greg  Kowalczyk             PHONE NO : 732 8826633 
44 Riverdale Ave                  SE DECISION MADE: 28-JUN-22
Monmouth Beach NJ  07750          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freeze’n Clear Skin Clinic Warts & Tags
CryoConcepts LP                   510(k) NO: K211099(Traditional)
ATTN: Sam  Niedbala               PHONE NO : 855 3552796 
205 Webster St                    SE DECISION MADE: 17-JUN-22
Bethlehem PA  18015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORE-Trocar
Incore CO., LTD.                  510(k) NO: K211148(Traditional)
ATTN: Jae-Hun  Lee                PHONE NO : 82 2 8663514 
11, Hyeoksin-daero, 78-gil, Dong-gSE DECISION MADE: 21-JUN-22
Daegu  KR 41072                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: maxmorespine Bipolar Electrodes
Hoogland Spine Products, GmbH     510(k) NO: K211173(Traditional)
ATTN: Jaap  Hoogland              PHONE NO : 49 069 300883027 
Feringastrasse 4                  SE DECISION MADE: 23-JUN-22
Munich  DE D-85774                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diacare 7000
Globus Sport and Health Technologi510(k) NO: K211207(Traditional)
ATTN: Jorge  Millan               PHONE NO : 855 4562875 
7280 NW 7th St # 109              SE DECISION MADE: 06-JUN-22
Miami FL  33126                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yomi Robotic System with YomiPlan Go
Neocis Inc.                       510(k) NO: K211466(Traditional)
ATTN: William  Tapia              PHONE NO : 305 7532742 
2800 Biscayne Blvd Suite 600      SE DECISION MADE: 14-JUN-22
Miami FL  33137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BiMobile Instruments (for BiMobile Dual Mobility System)
Waldemar Link GmbH & Co. KG       510(k) NO: K211567(Special)
ATTN: Stefanie  Fuchs             PHONE NO : 49 40 53575530 
Oststraße 4-10                    SE DECISION MADE: 03-JUN-22
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Rapid Readout Biological Indicator, 1295
3M Company                        510(k) NO: K211705(Special)
ATTN: Mary  Fretland              PHONE NO : 651 4612734 
3M Center, Building 275-5W-06     SE DECISION MADE: 28-JUN-22
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus Cervical Plate System
ArtFx Medical LLC                 510(k) NO: K211718(Traditional)
ATTN: Ozgen  Ozfidan              PHONE NO : 1 917 4452085 
50 Laura Street #2524             SE DECISION MADE: 28-JUN-22
Jacksonville FL  32202            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic Knee System
Total Joint Orthopedics, Inc.     510(k) NO: K211877(Traditional)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 22-JUN-22
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cysto-Gastro-Sets
G-Flex Europe SPRL                510(k) NO: K211909(Traditional)
ATTN: Thierry  Cremer             PHONE NO : 32 67 883665 
20, Rue de l’industrie            SE DECISION MADE: 09-JUN-22
Nivelles  BE 1400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumenis Y&R Laser System
Lumenis Inc.                      510(k) NO: K211979(Traditional)
ATTN: Karen  Smith                PHONE NO : 650 2796242 
1870 S Milestone Dr               SE DECISION MADE: 21-JUN-22
Salt Lake City UT  84104          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KHEIRON® Spinal Fixation System
S.M.A.I.O.                        510(k) NO: K211981(Traditional)
ATTN: Jean-Charles  Roussouly     PHONE NO : 33 670 165171 
2, Place Berthe Morisot Parc TechnSE DECISION MADE: 09-JUN-22
Saint-Priest  FR 69800            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PAL System
MicroAire Surgical Instruments, LL510(k) NO: K212024(Traditional)
ATTN: Glenn  Gerstenfeld          PHONE NO : 434 9758344 
3590 Grand Forks Blvd             SE DECISION MADE: 10-JUN-22
Charlottesville VA  22911         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRAUS ENDO
Saeshin Precision Co., Ltd.       510(k) NO: K212043(Special)
ATTN: Nam-Gung  San               PHONE NO : 82 53 5872345 
# 52, Secheon-ro 1-gil, Dasa-eup, SE DECISION MADE: 24-JUN-22
Daegu  KR 711-814                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Minjie Catheter System
Kai Medtech, LLC                  510(k) NO: K212288(Traditional)
ATTN: Stephanie  Rallis           PHONE NO : 1 949 7678960 103
22651 Lambert Street, Suite 107   SE DECISION MADE: 02-JUN-22
Lake Forest CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EEG-acp
SOMNOmedics GmbH                  510(k) NO: K212325(Traditional)
ATTN: Sabrina  Forster            PHONE NO : 49 931 35909462 
Am Sonnenstuhl 63                 SE DECISION MADE: 15-JUN-22
Randersacker  DE 97236            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: hCG One Step Pregnancy Test
Healstone Biotech Inc.            510(k) NO: K212418(Traditional)
ATTN: Guang  Gao                  PHONE NO : 86 159 95714296 
Unit 650, 655 West Kent Ave. N.,  SE DECISION MADE: 30-JUN-22
Vancouver  CA V6P 6               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA])
DonneVie Medical Technology (Shang510(k) NO: K212426(Traditional)
ATTN: Hannah Hang Yin             PHONE NO : 
Suite 201, Bld 1, 138 Xinjun Ring SE DECISION MADE: 16-JUN-22
Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: freeflex+ Transfer Adapter
Fresenius Kabi AG                 510(k) NO: K212445(Traditional)
ATTN: Keith  Dunn                 PHONE NO : 224 8172430 
                                  SE DECISION MADE: 01-JUN-22
Bad Homburg  DE 61346             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Keos Anterior Cervical Interbody Fusion Device System
Keos                              510(k) NO: K212450(Traditional)
ATTN: Scott  Peterson             PHONE NO : 239 2591491 
1824 Colonial Village Lane        SE DECISION MADE: 06-JUN-22
Lancaster PA  17601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HELIOS IV 785
Laseroptek Co., Ltd.              510(k) NO: K212663(Traditional)
ATTN: Hong  Chu                   PHONE NO : 82 31 80235150 
#203 & #204 Hyundai I valley, 31, SE DECISION MADE: 09-JUN-22
Seongnam-si  KR 13212             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911)
Huizhou Xiaoou Technology Co., Ltd510(k) NO: K212665(Traditional)
ATTN: Xia  Wang                   PHONE NO : 86 752 3302188 
3rd Floor, No.113 (Building D), XiSE DECISION MADE: 22-JUN-22
Huizhou  CN 516000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZYPOR
FCI (France Chirurgie Instrumentat510(k) NO: K212741(Traditional)
ATTN: Thierry  Fetick             PHONE NO : 33 153 989898 
20-22 rue Louis Armand            SE DECISION MADE: 24-JUN-22
Paris  FR 75015                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments
Blue Sky Bio, LLC                 510(k) NO: K212785(Traditional)
ATTN: Albert  Zickmann            PHONE NO : 
800 Liberty Dr.                   SE DECISION MADE: 30-JUN-22
Libertyville IL  60048            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Seer Home
Seer Medical Pty Ltd              510(k) NO: K212788(Traditional)
ATTN: David  Mitchell             PHONE NO : 613  70355736 
                                  SE DECISION MADE: 16-JUN-22
Melbourne  AU 3133                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Logic Hd camera head green, System green
Richard Wolf Medical Instruments C510(k) NO: K212808(Traditional)
ATTN: Michael  Loiterman          PHONE NO : 847 9131113 
353 Corporate Woods Parkway       SE DECISION MADE: 14-JUN-22
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TLC Unicompartmental Knee System
Signature Orthopaedics Pty Ltd.   510(k) NO: K212870(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 16-JUN-22
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
Galvanize Therapeutics, Inc.      510(k) NO: K212871(Traditional)
ATTN: Deborah  Sheffield          PHONE NO : 206 8536398 
1531 Industrial Road              SE DECISION MADE: 17-JUN-22
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INHANCETM Hybrid Anatomic Glenoid Implant
Depuy Ireland UC                  510(k) NO: K212933(Traditional)
ATTN: Yayoi  Fujimaki             PHONE NO : 508 8283541 
Loughbeg                          SE DECISION MADE: 08-JUN-22
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IDx-DR v2.3
Digital Diagnostics Inc.          510(k) NO: K213037(Traditional)
ATTN: Ashley  Miller              PHONE NO : 319 2485620 
2300 Oakdale Blvd                 SE DECISION MADE: 17-JUN-22
Coralville IA  52241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Natural Rubber Latex Ultrasound Transducer Probe Covers
Global Protection Corp.           510(k) NO: K213087(Traditional)
ATTN: Christina  Cataldo          PHONE NO : 617 9462800 
12 Channel Street                 SE DECISION MADE: 07-JUN-22
Boston MA  02210                  510(k) STATEMENT
                                                    

DEVICE: ZQuiet Advance
Sleeping Well, LLC                510(k) NO: K213088(Traditional)
ATTN: Daniel  Webster             PHONE NO : 802 9853013 
138 Steeplebush Rd.               SE DECISION MADE: 15-JUN-22
Shelburne VT  05482               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Armory Motion
Pain Management Technologies, Inc.510(k) NO: K213097(Traditional)
ATTN: Joshua A. Lefkovitz         PHONE NO : 614 9378236 
1760 Wadsworth Rd.                SE DECISION MADE: 10-JUN-22
Akron OH  44320                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BentrioTM Allergy Blocker
Altamira Therapeutics, Inc.       510(k) NO: K213114(Traditional)
ATTN: Elena  Cavallini            PHONE NO : 41 612 012348 
8 The Green, Ste B                SE DECISION MADE: 24-JUN-22
Dover, County Of Kent DE  19901   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FX V135 Shoulder Prosthesis
FX Shoulder USA, Inc.             510(k) NO: K213117(Traditional)
ATTN: Kathy  Trier                PHONE NO : 800 2800775 
13465 Midway Road, Suite 101      SE DECISION MADE: 07-JUN-22
Dallas TX  75244                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrabEx Pro
MicroSurgical Technologies Inc    510(k) NO: K213173(Traditional)
ATTN: Angela  Mallery             PHONE NO : 651 2104766 
8415 154th Ave NE                 SE DECISION MADE: 08-JUN-22
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
Coloplast Corp                    510(k) NO: K213185(Traditional)
ATTN: Gayatri  Ghadge             PHONE NO : 612 4223206 
1601 West River Road North        SE DECISION MADE: 08-JUN-22
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HD Mediastinoscope
Karl Storz Endoscopy America, Inc.510(k) NO: K213194(Traditional)
ATTN: Alita  McElroy              PHONE NO : 424 2188376 
2151 E. Grand Ave                 SE DECISION MADE: 23-JUN-22
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyOnyx System
Thought Technology Ltd.           510(k) NO: K213197(Traditional)
ATTN: Suresh  Sugirtharaja        PHONE NO : 1 514 4898251 
5250 Ferrier, Suite 812           SE DECISION MADE: 17-JUN-22
Montreal  CA H4P 1L3              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DeltaFil, DeltaFil Conditioner
DMG Chemisch-Pharmazeutische Fabri510(k) NO: K213201(Traditional)
ATTN: Stephan  Schaefer           PHONE NO : 011 4940 840060 
Elbgaustrasse 248                 SE DECISION MADE: 01-JUN-22
Hamburg  DE 22547                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revaree Plus Vaginal Suppositories
Farma-Derma S.R.L.                510(k) NO: K213220(Traditional)
ATTN: Mara  Calzolari             PHONE NO : 39 051 6814181 
Via Dell'artigiano 6-8            SE DECISION MADE: 21-JUN-22
Sala Bolognese  IT 40010          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Polypectomy Snare
Beijing ZKSK Technology Co.,Ltd   510(k) NO: K213222(Traditional)
ATTN: Ma  Li                      PHONE NO : 86 138 11778090 
Building 9, 6 & No.6 Yuan Hengye NSE DECISION MADE: 06-JUN-22
Beijing  CN 101105                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi-Band Ligator
Beijing ZKSK Technology Co.,Ltd   510(k) NO: K213223(Traditional)
ATTN: Ma  Li                      PHONE NO : 86 138 11778090 
Building 9, 6 & No.6 Yuan Hengye NSE DECISION MADE: 06-JUN-22
Beijing  CN 101105                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroLine Disposable Cranial Perforator with Hudson end
EMD Endoszkop Muszer Gyarto es Ker510(k) NO: K213228(Traditional)
ATTN: Gyula  Ujvari               PHONE NO : 36 52 486034 
Bartok Bela u. 113/B              SE DECISION MADE: 20-JUN-22
Debrecen  HU 4031                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T3 Platform Software
Etiometry, Inc.                   510(k) NO: K213230(Traditional)
ATTN: Tim  Hanson                 PHONE NO : 857 3669333 
280 Summer St, 4th Floor          SE DECISION MADE: 22-JUN-22
Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kerecis Silicone
Kerecis Limited                   510(k) NO: K213231(Traditional)
ATTN: Gudmundur Fertram SigurjonssPHONE NO : 354 562 2601 
Eyrargata 2                       SE DECISION MADE: 29-JUN-22
Isafjordur  IS 400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZYPRO ECG Recorder (Model: UG02)
Sigknow Biomedical Co.,Ltd.       510(k) NO: K213233(Traditional)
ATTN: Hsiao-Fan  Liu              PHONE NO : 886 227 612577 
6F., No. 760, Sec. 4, Bade Rd., SoSE DECISION MADE: 23-JUN-22
Taipei City  TW 105412            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscopic Injection Needle
Beijing ZKSK Technology Co.,Ltd   510(k) NO: K213239(Traditional)
ATTN: Ma  Li                      PHONE NO : 86 138 11778090 
Building 9, 6 & No.6 Yuan Hengye NSE DECISION MADE: 02-JUN-22
Beijing  CN 101105                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Secret Duo
Ilooda Co Ltd                     510(k) NO: K213250(Traditional)
ATTN: Moon  Mason                 PHONE NO : 031 2101628 
120, Jangan-Ro 458 Beon-Gil JanganSE DECISION MADE: 24-JUN-22
Suwon-Si  KR 16200                510(k) STATEMENT
                                                    

DEVICE: CipherOx CRI Tablet
Flashback Technologies, Inc.      510(k) NO: K213255(Traditional)
ATTN: John  Jedziniak             PHONE NO : 
208 Lenox Ave #307                SE DECISION MADE: 17-JUN-22
Westfield NJ  07090               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nasogastric Feeding Tubes - ENFit Port - PVC
Cair Lgl                          510(k) NO: K213258(Traditional)
ATTN: Irving L. Wiesen            PHONE NO : 212 3818774 
Parc Tertiaire De Bois Dieu, 1 AllSE DECISION MADE: 09-JUN-22
Lissieu  FR 69380                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EpilME
Neauvia North America             510(k) NO: K213261(Traditional)
ATTN: Joy  Willard                PHONE NO : 984 7775296 
8480 Honeycutt Road               SE DECISION MADE: 02-JUN-22
Raleigh NC  27615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Qlicksmart BladeFlask UNIVERSAL
Qlicksmart Pty Ltd.               510(k) NO: K213274(Abbreviated)
ATTN: Michael  Sinnott            PHONE NO : 61 7 38441182 
Level 1, 148 Boundary Street, WestSE DECISION MADE: 22-JUN-22
Brisbane  AU 4101                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
ConvaTec Limited                  510(k) NO: K213283(Traditional)
ATTN: Louise  Hollywood           PHONE NO : 44 0 7776662499 
GDC, First Avenue, Deeside industrSE DECISION MADE: 22-JUN-22
Deeside  GB CH5 2NU               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multifrax Laser System
Paradigm Medical Corporation      510(k) NO: K213332(Traditional)
ATTN: Nikolai  Tankovich          PHONE NO : 
7371 Los Brazos                   SE DECISION MADE: 03-JUN-22
San Diego CA  92127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORE-CLIP
Incore Co., Ltd.                  510(k) NO: K213338(Traditional)
ATTN: Jae-Hun  Lee                PHONE NO : 82 2 8663514 
11, Hyeoksin-daero, 78-gil, Dong-gSE DECISION MADE: 23-JUN-22
Daegu  KR 41072                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
Path Medical GmbH                 510(k) NO: K213345(Traditional)
ATTN: Johann  Oswald              PHONE NO : 49 89 80076502 
Landsberger Strasse 65            SE DECISION MADE: 22-JUN-22
Germering  DE 82110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyst R1 Reverse Shoulder System
Catalyst OrthoScience, Inc        510(k) NO: K213349(Traditional)
ATTN: Dale  Davison               PHONE NO : 239 3259976 102
14710 Tamiami Trail North, Suite 1SE DECISION MADE: 23-JUN-22
Naples FL  34110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexBoardTM, EagleBoardTM, BreastBoard SXTM
MacroMedics BV                    510(k) NO: K213439(Traditional)
ATTN: Elizabeth  Hajos            PHONE NO : 31 182 389777____ 
Oostbaan 670                      SE DECISION MADE: 24-JUN-22
Moordrecht  NL 2841 ML            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Extroducer Infusion Catheter System
Smartwise Sweden AB               510(k) NO: K213442(Traditional)
ATTN: Maria  Nordlinder           PHONE NO : 46 73 9635368 
Alfred Nobels allé 150            SE DECISION MADE: 10-JUN-22
Tullinge  SE SE-146 48            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Gloves
St Future International Limited   510(k) NO: K213448(Traditional)
ATTN: Ivan  Tan                   PHONE NO : 852 23 180170 
Flat/Rm 08 9/F Chevalier CommerciaSE DECISION MADE: 06-JUN-22
Hongkong  CN 999077               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVA NEXUS Ophthalmic Surgical System
D.O.R.C. Dutch Ophthalmic Research510(k) NO: K213467(Traditional)
ATTN: Linda van Leeuwen           PHONE NO : 31 181 458080 
B.V. Scheijdelveweg 2             SE DECISION MADE: 14-JUN-22
Zuidland  NL 3214 VN              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Pen Needle
Becton, Dickinson and Company     510(k) NO: K213478(Traditional)
ATTN: Karen  Immanuel             PHONE NO : 917 7050933 
1 Becton Drive                    SE DECISION MADE: 28-JUN-22
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation 510(k) NO: K213504(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 16-JUN-22
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WesperO2
Wesper Inc.                       510(k) NO: K213515(Traditional)
ATTN: Amir  Reuveny               PHONE NO : 917 8414830 
234 5th Ave                       SE DECISION MADE: 10-JUN-22
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rune Labs Tremor Transducer System
Rune Labs, Inc.                   510(k) NO: K213519(Traditional)
ATTN: Brian  Pepin                PHONE NO : 360 6062929 
649 Iriving Street                SE DECISION MADE: 10-JUN-22
San Francisco CA  94122           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VenAir, Sequential Compression System
Apex Medical Corp.                510(k) NO: K213577(Traditional)
ATTN: Chieh  Yang                 PHONE NO : 886 2 22685568 
No. 9, Min Sheng St., Tu-Cheng,   SE DECISION MADE: 28-JUN-22
New Taipei City  TW 23679         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epicardial Access System
Baylis Medical Company Inc.       510(k) NO: K213582(Special)
ATTN: May  Tsai                   PHONE NO : 905 6024875 
5825 Explorer Dr.                 SE DECISION MADE: 30-JUN-22
Mississauga  CA L4W 5P6           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyCRO Band
Otto Bock Healthcare LP           510(k) NO: K213587(Traditional)
ATTN: Caleb  Beck                 PHONE NO : 801 9746647 
3820 West Great Lakes Drive       SE DECISION MADE: 09-JUN-22
Salt Lake City UT  84120          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q2 IV Administration Sets
Quest Medical, Inc.               510(k) NO: K213588(Traditional)
ATTN: Tosan  Eweka                PHONE NO : 972 3326338 
One Allentown Parkway             SE DECISION MADE: 02-JUN-22
Allen TX  75002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYLFIRM X
VIOL Co., Ltd.                    510(k) NO: K213612(Traditional)
ATTN: Chai Kyoung Woo             PHONE NO : 82 31 80177893 
C-808, 809, Bundang Technopark C, SE DECISION MADE: 23-JUN-22
Seongnam-si  KR 13510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS AFP
Ortho Clinical Diagnostics        510(k) NO: K213626(Traditional)
ATTN: Declan  Hynes               PHONE NO : 44 0165 6778032 
Felindre Meadows                  SE DECISION MADE: 15-JUN-22
Pencoed  GB CF35 5PZ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Syngo Carbon Space VA20A
Siemens Healthcare GmbH           510(k) NO: K213665(Traditional)
ATTN: Vijay  Ramadas              PHONE NO : 49 172 4324369 
Siemensstr. 1                     SE DECISION MADE: 21-JUN-22
Forchheim  DE 91301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iFuse-TORQ® Implant System
SI-BONE, Inc.                     510(k) NO: K213667(Traditional)
ATTN: Meirav  Harsat              PHONE NO : 650 8624942 
471 El Camino Real, Suite 101     SE DECISION MADE: 10-JUN-22
Santa Clara CA  95050             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoSphere Advanced Monitor Viewfinder Remote, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index software feature, Acumen Assisted Fluid Management software feature with Acumen AFM Cable
Edwards Lifesciences, LLC         510(k) NO: K213682(Traditional)
ATTN: Manthan  Damani             PHONE NO : 949 2507853 
One Edwards Way                   SE DECISION MADE: 22-JUN-22
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiCase Viewer
Materialise NV                    510(k) NO: K213684(Traditional)
ATTN: Aya  Nishikawa              PHONE NO : 32 16745471 
Technologielaan 15                SE DECISION MADE: 15-JUN-22
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIR Recon DL
GE Medical Systems,LLC (GE Healthc510(k) NO: K213717(Traditional)
ATTN: Glen  Sabin                 PHONE NO : 262 8944968 
3200 N Grandview Blvd             SE DECISION MADE: 08-JUN-22
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PL-1 Skin Treatment System
Avava, Inc                        510(k) NO: K213726(Traditional)
ATTN: Jay  Bhawalkar              PHONE NO : 617 816 2060
275 Second Avenue, Floor 3        SE DECISION MADE: 28-JUN-22
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves
Hangzhou Runheng Medical Co., Ltd.510(k) NO: K213739(Traditional)
ATTN: Yaya  Lu                    PHONE NO : 86 182 85158974 
Room 201, Shunfeng Building, NO.10SE DECISION MADE: 22-JUN-22
Hangzhou  CN 311215               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Purgo
AeroClean Technologies, LLC       510(k) NO: K213753(Traditional)
ATTN: Riachard  Foster            PHONE NO : 773 7916198 
10455 Riverside Drive, Ste. 100   SE DECISION MADE: 01-JUN-22
Palm Beach Gardens FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glidewell 3DP Denture Base Resin
Prismatik Dentalcraft, Inc.       510(k) NO: K213765(Traditional)
ATTN: Jiahe  Li                   PHONE NO : 949 2223516 
2144 Michelson Drive              SE DECISION MADE: 22-JUN-22
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CiRX Single use electrosurgical pencil with non-coated and coated electrode
Ningbo Shun Ye Medical Company, Lt510(k) NO: K213786(Traditional)
ATTN: Ding Feng Yu                PHONE NO : 0574 63778018 
No.5 Industry Road, Zhangqi IndustSE DECISION MADE: 27-JUN-22
Ningbo  CN 31500                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intelligence LaserComb
Yibin Yingtong Intelligent Technol510(k) NO: K213789(Traditional)
ATTN: Pengcheng  Pan              PHONE NO : 86 0831 2020866 
3F, Building 1, Area A, IntelligenSE DECISION MADE: 24-JUN-22
Yibin  CN 644000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eko Murmur Analysis Software (EMAS)
Eko Devices, Inc.                 510(k) NO: K213794(Traditional)
ATTN: Sam  Huang                  PHONE NO : 1 844 3563384 
1212 Broadway, Suite 100          SE DECISION MADE: 29-JUN-22
Oakland CA  94612                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula
Covidien                          510(k) NO: K213818(Traditional)
ATTN: Michael  Mach               PHONE NO : 320 4931411 
60 Middletown Avenue              SE DECISION MADE: 27-JUN-22
North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AneuGuide
ArteryFlow Technology Co., Ltd.   510(k) NO: K213838(Traditional)
ATTN: Jianping  Xiang             PHONE NO : 86 571 86772567 
459 Qianmo Road, Suite C1-501, BinSE DECISION MADE: 01-JUN-22
Hangzhou  CN 310051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q2 Blood Administration Sets
Quest Medical, Inc.               510(k) NO: K213846(Traditional)
ATTN: Tosan  Eweka                PHONE NO : 972 3326338 
One Allentown Parkway             SE DECISION MADE: 05-JUN-22
Allen TX  75002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HD60 Series Ultrasound Diagnostic System
Qingdao Hisense Medical Equipment 510(k) NO: K213862(Traditional)
ATTN: Yalan  Wu                   PHONE NO : 86 180 51581382 
No. 399 Songling Road, Laoshan DisSE DECISION MADE: 08-JUN-22
Qingdao  CN 266100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EarliPoint System
EarliTec Diagnostics, Inc.        510(k) NO: K213882(Traditional)
ATTN: Thomas  Ressemann           PHONE NO : 833 5049937 
755 Commerce Drive, Suite 700     SE DECISION MADE: 08-JUN-22
Decatur GA  30030                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: leva Pelvic Health System
Renovia Inc.                      510(k) NO: K213913(Traditional)
ATTN: Jim  O'Connor               PHONE NO : 860 5103026 
263 Summer St, 5th Floor          SE DECISION MADE: 30-JUN-22
Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gastric Alimetry System
Alimetry Ltd.                     510(k) NO: K213924(Traditional)
ATTN: Yaara  Yarmut               PHONE NO : 64 276 091886 
70 Symonds Street                 SE DECISION MADE: 03-JUN-22
Grafton  NZ 1010                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
bioMerieux, Inc.                  510(k) NO: K213931(Traditional)
ATTN: Debra  Broyles              PHONE NO : 314 7318805 
595 Anglum Road                   SE DECISION MADE: 03-JUN-22
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VASSALLO GT 018 Floppy
Filmecc Co., Ltd.                 510(k) NO: K213949(Traditional)
ATTN: Toshiya  Osawa              PHONE NO : 81 52 7681212 
1703 Wakita-cho, Moriyama-ku      SE DECISION MADE: 30-JUN-22
Nagoya  JP 463-0024               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atrial Fibrillation History Feature
Apple Inc.                        510(k) NO: K213971(Traditional)
ATTN: Luke  Olson                 PHONE NO : 408 6092001 
1 Apple Park Way                  SE DECISION MADE: 03-JUN-22
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrueBeam, TrueBeam STx, Edge, VitalBeam
Varian Medical Systems, Inc.      510(k) NO: K213977(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 03-JUN-22
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
Oasis Medical, Inc                510(k) NO: K213988(Traditional)
ATTN: James  Christensen          PHONE NO : 626 8525156 
514 S Vermont Avenue              SE DECISION MADE: 03-JUN-22
Glendora CA  91741                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leaseir MHR Xcell
Leaseir Technologies S.L.U.       510(k) NO: K214049(Traditional)
ATTN: Pablo  Boto                 PHONE NO : 34 666 577507 
C/ Jimena Fernández de la Vega, 14SE DECISION MADE: 02-JUN-22
Gijón  ES 33203                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
Guangzhou Shengwei Medical Devices510(k) NO: K214063(Traditional)
ATTN: Xiaojun  Cai                PHONE NO : 86 136 60308085 
No. 126, Guangshao Road, Aotou TowSE DECISION MADE: 03-JUN-22
Conghua city  CN 510900           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
Fujifilm Corporation              510(k) NO: K214089(Traditional)
ATTN: Randy  Vader                PHONE NO : 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 03-JUN-22
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-FIX® 3DSI Joint Fusion System
Cutting Edge Spine, LLC           510(k) NO: K214123(Traditional)
ATTN: Kyle  Kuntz                 PHONE NO : 704 2430892 
6012 Waxhaw Hwy                   SE DECISION MADE: 24-JUN-22
Mineral Springs NC  28108         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zsquare ENT-Flex Endoscope
Zsquare, Ltd                      510(k) NO: K220004(Traditional)
ATTN: Asaf  Shahmoon              PHONE NO : 972 369 87600 
43 Hasivim Street                 SE DECISION MADE: 14-JUN-22
Petah Tikva  IL 4959501           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
ZOLL Circulation, Inc             510(k) NO: K220008(Traditional)
ATTN: Elizabeth  Haines           PHONE NO : 978 4219291 
2000 Ringwood Avenue              SE DECISION MADE: 02-JUN-22
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coloring Liquid
Dongguan Xiangtong Co., Ltd.      510(k) NO: K220017(Traditional)
ATTN: Charles  Shen               PHONE NO : 608 2179358 
No.4, Tech 9th Rd, Hi-Tech IndustrSE DECISION MADE: 29-JUN-22
Dongguan  CN 523808               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeneVision Central Monitoring System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K220058(Traditional)
ATTN: Li  Lei                     PHONE NO : 86 755 81885953 
Mindray Building, Keji 12th Road SSE DECISION MADE: 01-JUN-22
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pre-filled Syringe with Saline
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K220060(Traditional)
ATTN: Jianwei  Pan                PHONE NO : 86 510868 666668027 
No.23, Huanxi Rd, Zhutang Town    SE DECISION MADE: 10-JUN-22
Jiangyin  CN 214415               510(k) STATEMENT
                                                    

DEVICE: QardioArm 2
Qardio Inc                        510(k) NO: K220106(Traditional)
ATTN: Rosario  Iannella           PHONE NO : 415 6709613 
345 California Street, Suite 600 &SE DECISION MADE: 15-JUN-22
San Francisco CA  94104           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Hemostatic Closure Clip Device
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K220157(Traditional)
ATTN: Sally  He                   PHONE NO : 86 25 58646395 
No. 10 Gaoke Third Road, Nanjing NSE DECISION MADE: 13-JUN-22
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rayvolve
AZmed SAS                         510(k) NO: K220164(Traditional)
ATTN: Patricia  Massako           PHONE NO : 0033 6 25846988 
6 rue Leonard de Vinci            SE DECISION MADE: 02-JUN-22
Laval  FR 53000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D Anatomic Models
Ricoh USA, Inc.                   510(k) NO: K220205(Traditional)
ATTN: Gary  Turner                PHONE NO : 1 954 6485680 
5575 Venture Drive Unit A         SE DECISION MADE: 03-JUN-22
Parma OH  44130                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Endoscopy Adapter Set
Yangzhou Fartley Medical Instrumen510(k) NO: K220210(Traditional)
ATTN: Tina  Han                   PHONE NO : 0086 1505 1101225 
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 17-JUN-22
Yangzhou  CN 225106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALLY Adaptive Cataract Treatment System
Lensar, Inc.                      510(k) NO: K220259(Traditional)
ATTN: Keith  Peck                 PHONE NO : 888 5756412 
2800 Discovery Drive, Suite 100   SE DECISION MADE: 09-JUN-22
Orlando FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aspirex Thrombectomy System
C.R. Bard, Inc.                   510(k) NO: K220270(Traditional)
ATTN: Aaron  Conovaloff           PHONE NO : 602 8305453 
1625 West 3rd St                  SE DECISION MADE: 21-JUN-22
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FridaMom Anti-Nausea Bands
FridaBaby LLC                     510(k) NO: K220289(Traditional)
ATTN: Jeffrey  Davidson           PHONE NO : 305 6737535 
82 NE 26th St Suite 101           SE DECISION MADE: 29-JUN-22
Miami FL  33137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.          510(k) NO: K220299(Traditional)
ATTN: Jyoti  Singh                PHONE NO : 408 4313527 
1266 Kifer Road                   SE DECISION MADE: 16-JUN-22
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTOPLAN
Cascination AG                    510(k) NO: K220300(Traditional)
ATTN: Jean-Francois  Clemence     PHONE NO : 41 31 3062626 
Steigerhubelstrasse 3             SE DECISION MADE: 24-JUN-22
Bern  CH 3008                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wearable Breast Pump (Model S10)
Shenzhen Lutejiacheng Technology C510(k) NO: K220309(Traditional)
ATTN: Johnny  Dai                 PHONE NO : 867 558 4861362 
Rm 903 Jiangnan BLDG, No.l BantianSE DECISION MADE: 27-JUN-22
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System
Stryker GmbH                      510(k) NO: K220319(Traditional)
ATTN: Danielle Jannuzzi Madureira PHONE NO : 0041 798 900289 
 325 Corporate Drive              SE DECISION MADE: 10-JUN-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
Hologic, Inc.                     510(k) NO: K220321(Special)
ATTN: Jill  Wyland                PHONE NO : 858 4104487 
10210 Genetic Center Drive        SE DECISION MADE: 03-JUN-22
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and 510(k) NO: K220358(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
LLC 9900 Innovation Dr.           SE DECISION MADE: 06-JUN-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Procedure Mask
Little Rapids Corporation         510(k) NO: K220377(Traditional)
ATTN: Tom  Diedrich               PHONE NO : 920 4905302 
2273 Larsen Road                  SE DECISION MADE: 24-JUN-22
Green Bay WI  54303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sparta 3-Ply Surgical Disposable Face Mask
Sparta East, LLC                  510(k) NO: K220378(Traditional)
ATTN: Ricardo  Samayoa            PHONE NO : 305 9243610 
8830 NW 102 Street                SE DECISION MADE: 30-JUN-22
Medley FL  33178                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
OTU Medical Inc.                  510(k) NO: K220399(Traditional)
ATTN: Geping  Liu                 PHONE NO : 408 7977313 
2231 A Fortune Drive              SE DECISION MADE: 16-JUN-22
San Jose CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTIS pheno (VE21) System
Siemens Medical Solutions USA, Inc510(k) NO: K220409(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 678 5758832 
40 Liberty Boulevard              SE DECISION MADE: 29-JUN-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ebony HP PTA OTW 0.035" Catheter
Natec Medical Ltd.                510(k) NO: K220410(Traditional)
ATTN: Roy Devassy Pallippatt      PHONE NO : 230 466 3054 
Maeva Centre Building, Silicon AveSE DECISION MADE: 29-JUN-22
Reduit  MU 72201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System
Canary Medical USA LLC            510(k) NO: K220413(Traditional)
ATTN: Nora C.R. York              PHONE NO : 760 4976115 
2710 Loker Ave. West, Suite 350   SE DECISION MADE: 22-JUN-22
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saffron Fixation System
Coloplast A/S                     510(k) NO: K220420(Traditional)
ATTN: Gayatri  Ghadge             PHONE NO : 612 4223206 
1601 West River Road North        SE DECISION MADE: 10-JUN-22
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
One Glove Industrial Sdn Bhd      510(k) NO: K220431(Traditional)
ATTN: Marcus  Low                 PHONE NO : 605 80 52166 
24, 1st Floor, Kompleks Kota MuliaSE DECISION MADE: 17-JUN-22
Taiping  MY 34000                 510(k) STATEMENT
                                                    

DEVICE: ARTIS icono (VE21) System
Siemens Medical Solutions USA, Inc510(k) NO: K220432(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 678 5758832 
40 Liberty Boulevard              SE DECISION MADE: 29-JUN-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentis s-Clean Abutment Mini
Dentis Co., Ltd.                  510(k) NO: K220440(Traditional)
ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 16-JUN-22
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med-link Disposable ECG Cable and Leadwires
Shenzhen Med-link Electronics Tech510(k) NO: K220447(Traditional)
ATTN: Yi  Liu                     PHONE NO : 0086 755 61568825 884
4th and 5th Floor, Building Two, HSE DECISION MADE: 28-JUN-22
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy CONDUIT LLIF SQUID Inserter
Enztec Limited                    510(k) NO: K220449(Traditional)
ATTN: Claire  Mai                 PHONE NO : 64 27 8292440 
3/17 Print Place                  SE DECISION MADE: 28-JUN-22
Middleton  NZ 8024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lap-Band System Calibration Tube
ReShape Lifesciences              510(k) NO: K220455(Traditional)
ATTN: Michelle  Ravert            PHONE NO : 949 4817851 
1001 Calle Amanecer               SE DECISION MADE: 07-JUN-22
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Vinyl Examination Glove
Chifeng Huawei Medical Science&Tec510(k) NO: K220469(Traditional)
ATTN: Li  Xiaohong                PHONE NO : 86 1824 80565694 
No. 2-4, Second-stage StandardizedSE DECISION MADE: 16-JUN-22
Chifeng  CN 024023                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System
NuVasive, Incorporated            510(k) NO: K220478(Traditional)
ATTN: Krunal  Shah                PHONE NO : 732 7633277 
7475 Lusk Blvd.                   SE DECISION MADE: 21-JUN-22
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sherlock
Open Implants, LLC                510(k) NO: K220482(Traditional)
ATTN: Gregg  Gellman              PHONE NO : 1 781 5873242 
800 West Cummings Ave, Suite 4900 SE DECISION MADE: 21-JUN-22
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs)
Anhui Zhong Lian Latex Gloves Manu510(k) NO: K220488(Traditional)
ATTN: Kitty  xu                   PHONE NO : 86 1385 3370291 
Guzhen Economic Development Zone  SE DECISION MADE: 01-JUN-22
Bengbu  CN 233799                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BreathID Hp Lab System, BreathID Smart System
Meridian Bioscience Israel Ltd.   510(k) NO: K220494(Special)
ATTN: Raffi  Werner               PHONE NO : 972 8 9737502 
4 Ha'Maayan st,                   SE DECISION MADE: 23-JUN-22
Modiin  IL 7177872                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoLumbo
Smart Soft Healthcare AD          510(k) NO: K220497(Traditional)
ATTN: Yoana  Ivanova              PHONE NO : 359 883 448962 
113 General Kolev Str. Primorski DSE DECISION MADE: 23-JUN-22
Varna  BG 9002                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: bite away neo
MibeTec, GmbH                     510(k) NO: K220514(Traditional)
ATTN: Oliver  Grunert             PHONE NO : 49 349 54247489 
Munchener Strasse 15              SE DECISION MADE: 23-JUN-22
Brehna  DE D-06796                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: restor3d TiDAL Lumbar Interbody Fusion Device
Restor3d                          510(k) NO: K220523(Traditional)
ATTN: Shyam  Patel                PHONE NO : 704 3514342 
404 Hunt St. Suite 500            SE DECISION MADE: 17-JUN-22
Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Isolation Cover Gown
Wuhan Dymex Healthcare Co., Ltd.  510(k) NO: K220528(Traditional)
ATTN: Lynn  Wu                    PHONE NO : 86 27 85827780 
Room 1701, Unit 2, Building 5, JinSE DECISION MADE: 10-JUN-22
Wuhan  CN 430000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.                 510(k) NO: K220541(Special)
ATTN: Angela L. Bunn              PHONE NO : 470 3647417 
1 Edison Drive                    SE DECISION MADE: 02-JUN-22
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
Ra Medical Systems, Inc.          510(k) NO: K220544(Traditional)
ATTN: Jami  Miller                PHONE NO : 442 2444672 
2070 Las Palmas Drive             SE DECISION MADE: 29-JUN-22
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves
O&M Halyard, Inc.                 510(k) NO: K220547(Special)
ATTN: Angela L. Bunn              PHONE NO : 470 3647417 
1 Edison Drive                    SE DECISION MADE: 02-JUN-22
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Face Mask (M663BE,M663BT)
MAKRITE INDUSTRIES, INC.          510(k) NO: K220550(Traditional)
ATTN: Bob  Wen                    PHONE NO : 886 2 26982419 
11F-5., NO.79, Sec.1, Xintai 5th RSE DECISION MADE: 14-JUN-22
New Taipei  TW                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702
CERAGEM Co, Ltd.                  510(k) NO: K220572(Traditional)
ATTN: Hyeonggeun  Hwang           PHONE NO : 82 41 5294359 
10, Jeongja 1-gil, Seonggeo-eup, SSE DECISION MADE: 17-JUN-22
Cheonan-si  KR 31045              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Free.Max, MAGNETOM Free.Star
Siemens Medical Solutions USA, Inc510(k) NO: K220575(Traditional)
ATTN: Alina  Goodman              PHONE NO : 1 224 5261404 
40 Liberty Boulevard              SE DECISION MADE: 24-JUN-22
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zavation eZspand Interbody System
Zavation Medical Products, LLC    510(k) NO: K220581(Traditional)
ATTN: Matt  Jones                 PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 02-JUN-22
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
Sofradim Production               510(k) NO: K220586(Special)
ATTN: Paula  Paz                  PHONE NO : 33 4740 89000 
116, Avenue du Formans            SE DECISION MADE: 22-JUN-22
Trevoux  FR 01600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PrimeLOC Attachment System
Innovative Product Brands, Inc.   510(k) NO: K220612(Traditional)
ATTN: Chris  Gervais              PHONE NO : 1 760 5223126 
7045 Palm Avenue                  SE DECISION MADE: 06-JUN-22
Highland CA  92346                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDOJECT fine Pen Needles
Chirana T. Injecta                510(k) NO: K220614(Traditional)
ATTN: Zdenka  Klbeckova           PHONE NO : 421 327709972 
Nám. Dr. Schweitzera 194          SE DECISION MADE: 15-JUN-22
Stará Turá  SK 916 01             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Boss Crossing Support Catheter
Marvao Medical Devices Ltd        510(k) NO: K220632(Traditional)
ATTN: Chris  Davey                PHONE NO : 353 091 759301 
Unit 1 Galway Business Park, DangaSE DECISION MADE: 02-JUN-22
Galway  IE H91A3EF                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MICROLET NEXT lancing device, MICROLET Lancet
Ascensia Diabetes Care US Inc     510(k) NO: K220633(Traditional)
ATTN: Sangram  Yadav              PHONE NO : 201 9368856 
5 Wood Hollow Road                SE DECISION MADE: 03-JUN-22
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NC TREK NEO Coronary Dilatation Catheter
Abbott Vascular                   510(k) NO: K220634(Traditional)
ATTN: Nishi  Singh                PHONE NO : 408 8450892 
3200 Lakeside Drive               SE DECISION MADE: 30-JUN-22
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TriMed Ripcord Device
TriMed, Inc.                      510(k) NO: K220650(Traditional)
ATTN: David  Medoff               PHONE NO : 661 2557406 
27533 Avenue Hopkins              SE DECISION MADE: 01-JUN-22
Santa Clarita CA  91355           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Type Blood Pressure Monitor
Shenzhen Jamr Medical Technology C510(k) NO: K220651(Traditional)
ATTN: Luo  Fusheng                PHONE NO : 86 755 85292057 
A101-301,D101-201, Jamr Science & SE DECISION MADE: 30-JUN-22
Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Knee 3
Brainlab AG                       510(k) NO: K220652(Traditional)
ATTN: Chiara  Cunico              PHONE NO : 49 899 915680____ 
Olof-Palme-Str. 9                 SE DECISION MADE: 03-JUN-22
Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile
Excellent Medical Technology Group510(k) NO: K220665(Traditional)
ATTN: Kenney  Song                PHONE NO : 086 512 69398826 
Room# 2301, Decheng Jiayuan Plaza,SE DECISION MADE: 03-JUN-22
Suzhou  CN 215131                 510(k) STATEMENT
                                                    

DEVICE: Magnum
Magnum Health And Safety Pvt Ltd  510(k) NO: K220670(Traditional)
ATTN: Rakesh  Bhagat              PHONE NO : 91 982 0050482 
Unit No. 21, 22, 23, Supreme IndusSE DECISION MADE: 28-JUN-22
Taluka - Vasai, Dist - Palghar  IN510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
Riverstone Resources Sdn Bhd      510(k) NO: K220672(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 60 5 8912777 
Lot 20852, No.119, Jalan Logam 7 KSE DECISION MADE: 03-JUN-22
Taiping  MY 34600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zoupure Nitrile Powder Free Examination glove
Thai Rayong Product Glove Zoupure 510(k) NO: K220693(Traditional)
ATTN: Rattiya  Pitutacha          PHONE NO : 66 6322 13906 
168 moo.1 Nongbua                 SE DECISION MADE: 07-JUN-22
Bankhai  TH 21120                 510(k) STATEMENT
                                                    

DEVICE: RedPoint Medical's Better Bunion System
Redpoint Medical, LLC             510(k) NO: K220717(Traditional)
ATTN: James  Spitler              PHONE NO : 407 6083208 
13326 West Road                   SE DECISION MADE: 09-JUN-22
Carmel IN  46074                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Luminance RED Acne Device
Luminance Medical Ventures, Inc.  510(k) NO: K220729(Traditional)
ATTN: Troy  Stites                PHONE NO : 619 3413848 
2310 Henderson Avenue #1297       SE DECISION MADE: 09-JUN-22
Dallas TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mural Perinatal Surveillance
GE Medical Systems Information Tec510(k) NO: K220732(Traditional)
ATTN: Brandon  O'Shea             PHONE NO : 414 3233147 
9900 Innovation Drive             SE DECISION MADE: 23-JUN-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
Institut Straumann AG             510(k) NO: K220751(Traditional)
ATTN: Viviana  Horhoiu            PHONE NO : 41 619 651512 
Peter Merian Weg 12               SE DECISION MADE: 02-JUN-22
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Introcan Safety 2 IV Catheter
B.Braun Medical Inc.              510(k) NO: K220756(Special)
ATTN: Tracy  Larish               PHONE NO : 484 3759064 
901 Marcon Blvd.                  SE DECISION MADE: 23-JUN-22
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CIRCUL8 Connect DVT Prevention Device
Ortho8, Inc.                      510(k) NO: K220761(Special)
ATTN: Jeff  Culhane               PHONE NO : 916 2894002 
2217 Plaza Drive                  SE DECISION MADE: 03-JUN-22
Rocklin CA  95765                 510(k) STATEMENT
                                                    

DEVICE: IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System
Alphatec Spine, Inc.              510(k) NO: K220782(Traditional)
ATTN: Andrew  Zhang               PHONE NO : 760 4946860 
1950 Camino Vida Roble            SE DECISION MADE: 09-JUN-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
Yangzhou Fartley Medical Instrumen510(k) NO: K220790(Traditional)
ATTN: Tina  Han                   PHONE NO : 0086 150 51101225 
Beizhou Road, Lidian Town, GuangliSE DECISION MADE: 27-JUN-22
Yangzhou  CN 225106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntellaMap Orion High Resolution Mapping Catheter
Boston Scientific Corporation     510(k) NO: K220796(Special)
ATTN: Melissa  Schneider          PHONE NO : 651 5826935 
4100 Hamline Ave North            SE DECISION MADE: 10-JUN-22
St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venue Go
GE Medical Systems Ultrasound and 510(k) NO: K220800(Traditional)
ATTN: Lee  Bush                   PHONE NO : 262 3099429 
LLC 9900 W. Innovation Drive      SE DECISION MADE: 21-JUN-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Abbott Diagnostics Scarborough, In510(k) NO: K220801(Special)
ATTN: Jessica  Stahle             PHONE NO : 207 7306353 
10 Southgate Road                 SE DECISION MADE: 24-JUN-22
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dia-X Bond Universal
Diadent Group International       510(k) NO: K220804(Special)
ATTN: Kab Sun Lee                 PHONE NO : 82 43 2662315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 15-JUN-22
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ART-PLAN
TheraPanacea                      510(k) NO: K220813(Traditional)
ATTN: Edwin  Lindsay              PHONE NO : 33 962 527819 
Pépinière Cochin Paris Santé, 29 rSE DECISION MADE: 17-JUN-22
Paris  FR 75014                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Glove
DAXWELL, LLC                      510(k) NO: K220834(Traditional)
ATTN: Frank  Zhang                PHONE NO : 01 281 6990622 
2825 Wilcrest Dr #500             SE DECISION MADE: 29-JUN-22
Houston TX  77042                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venue Fit
GE Medical Systems                510(k) NO: K220848(Traditional)
ATTN: Lee  Bush                   PHONE NO : 262 3099429 
Ultrasound and Primary Care DiagnoSE DECISION MADE: 27-JUN-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venue
GE Medical Systems                510(k) NO: K220851(Traditional)
ATTN: Lee  Bush                   PHONE NO : 262 3099429 
Ultrasound and Primary Care DiagnoSE DECISION MADE: 27-JUN-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vial Adapter Ø13mm
Avenir Performance Européenne Medi510(k) NO: K220856(Traditional)
ATTN: Bruno  Bertholet            PHONE NO : 00334 716 17534 
ZI Route de Souppes               SE DECISION MADE: 21-JUN-22
Château-Landon  FR 77570          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M6-C Artificial Cervical Disc Instruments AS
Spinal Kinetics LLC               510(k) NO: K220861(Traditional)
ATTN: Joyce  Zhong                PHONE NO : 408 6362524 
501 Mercury Drive                 SE DECISION MADE: 02-JUN-22
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann TLX Variobase C
Institut Straumann AG             510(k) NO: K220878(Traditional)
ATTN: Gordon  Dodds               PHONE NO : 49 89 309075291 
Peter Merian Weg 12               SE DECISION MADE: 16-JUN-22
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmileGuard
EnvisionTEC GmbH                  510(k) NO: K220894(Traditional)
ATTN: Ruediger Van Bernum         PHONE NO : 49 2043 987545 
Brusseler Straße 51               SE DECISION MADE: 10-JUN-22
Gladbeck  DE D-45968              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal
Shenzhen Qiaochengli Technology Co510(k) NO: K220927(Special)
ATTN: Guoming  Zhou               PHONE NO : 86 0755 23072580 
501-5, rujun building, 105 ZhongxiSE DECISION MADE: 02-JUN-22
Shenzhen  CN                      510(k) STATEMENT
                                                    

DEVICE: Restoris Multi-Compartmental Knee System
Mako Surgical Corp.               510(k) NO: K220930(Traditional)
ATTN: Emily  DiMambro             PHONE NO : 201 8315140 
3365 Enterprise Ave               SE DECISION MADE: 02-JUN-22
Weston FL  33331                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RADIFOCUS Torque Device
Terumo Medical Products (Hangzhou)510(k) NO: K220934(Traditional)
ATTN: Qing  Liu                   PHONE NO : 908 8429016 
M4-9-5, Economic & Technological DSE DECISION MADE: 29-JUN-22
Hangzhou  CN 310018               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Mini Fragment System
Arthrex Inc.                      510(k) NO: K220937(Traditional)
ATTN: Stacy  Valdez               PHONE NO : 1 239 6435553 72010
1370 Creekside Boulevard          SE DECISION MADE: 29-JUN-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES)
3M Company                        510(k) NO: K220942(Special)
ATTN: Yumi  Wackerfuss            PHONE NO : 1 651 7373556 
2510 Conway Avenue, Bldg. 275-5W-0SE DECISION MADE: 24-JUN-22
Saint Paul MN  55144-1000         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Knotless AC Repair Devices
Arthrex Inc.                      510(k) NO: K220947(Traditional)
ATTN: Ivette  Galmez              PHONE NO : 1 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 06-JUN-22
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BruxZir Opaque Coloring Liquid
Prismatik Dentalcraft, Inc.       510(k) NO: K220960(Traditional)
ATTN: So Hyun Park                PHONE NO : 949 8635479 
2144 Michelson Drive              SE DECISION MADE: 29-JUN-22
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreLink Navigation Instruments
CoreLink, LLC                     510(k) NO: K220973(Traditional)
ATTN: Steven  Mounts              PHONE NO : 888 3497808 
2072 Fenton Logistics Park        SE DECISION MADE: 01-JUN-22
St. Louis MO  63026               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K220975(Traditional)
ATTN: Jee Young Ju                PHONE NO : 82 2 21940861 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 29-JUN-22
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EksoNR
Ekso Bionics, Inc.                510(k) NO: K220988(Traditional)
ATTN: Scott  Davis                PHONE NO : 1 603 8312980 
1414 Harbour Way South, Suite 1201SE DECISION MADE: 09-JUN-22
Richmond CA  94804                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasound System SONIMAGE MX1
Konica Minolta, INC.              510(k) NO: K220993(Traditional)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 23-JUN-22
Hino-shi  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
Shenzhen Ulike Smart Electronics C510(k) NO: K221002(Traditional)
ATTN: Xiaoming  Lin               PHONE NO : 86 1591 5373017 
No.8, Keyuan Road, Yuehai Subb-disSE DECISION MADE: 01-JUN-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
Shanghai Handy Medical Equipment C510(k) NO: K221008(Traditional)
ATTN: Marcia  Qiu                 PHONE NO : 86 21 56766108__ 
Floor 2, Building No. 11, Lane177,SE DECISION MADE: 22-JUN-22
Baoshan District  CN 201906       510(k) STATEMENT
                                                    

DEVICE: ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
Aegis Spine, Inc.                 510(k) NO: K221050(Special)
ATTN: Kihyang  Kim                PHONE NO : 1 303 7414123 
9781 S. Meridian Blvd, Ste 300    SE DECISION MADE: 30-JUN-22
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 21HQ613D
LG Electronics Inc.               510(k) NO: K221061(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
77, Sanho-daero                   SE DECISION MADE: 03-JUN-22
Gumi-si  KR 39381                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MediLab
Sigma Scientific Services LLC     510(k) NO: K221065(Traditional)
ATTN: Jorge  Millan               PHONE NO : 786 4165587 
7737 N University Drive, Suite 101SE DECISION MADE: 10-JUN-22
Tamarac FL  33321                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Niti-S Biliary Slim M Stent
Taewoong Medical Co., Ltd         510(k) NO: K221071(Traditional)
ATTN: Jangsoo  Lee                PHONE NO : 82 70 46491515 
14 Gojeong-ro, Wolgot-myeon       SE DECISION MADE: 09-JUN-22
Gimpo-si  KR 10022                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Auryon Atherectomy System
Eximo Medical Ltd.                510(k) NO: K221077(Traditional)
ATTN: Yoel  Zabar                 PHONE NO : 972 8 6307639 
Pekeris St 3                      SE DECISION MADE: 09-JUN-22
Rehovot  IL 7670203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
First Source Inc.                 510(k) NO: K221081(Traditional)
ATTN: Ronald  Viola               PHONE NO : 585 2721690 
3495 Winton Place Building E SuiteSE DECISION MADE: 13-JUN-22
Rochester NY  14623               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
Medtronic Navigation, Inc.        510(k) NO: K221087(Traditional)
ATTN: Silver  Wirth               PHONE NO : 707 3676521 
826 Coal Creek Circle             SE DECISION MADE: 10-JUN-22
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K221117(Traditional)
ATTN: Jee Young Ju                PHONE NO : 82 2 21941312 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 17-JUN-22
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
Cepheid                           510(k) NO: K221160(Special)
ATTN: Suzette  Chance             PHONE NO : 262 6231175 
904 Caribbean Drive               SE DECISION MADE: 07-JUN-22
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TC Gloves
Thanh Cong Pharmaceutical and Trad510(k) NO: K221185(Traditional)
ATTN: Nguyen Thi Tu Anh           PHONE NO : 098 171 2992 
KM6+ 200 National Road No. 38, HapSE DECISION MADE: 22-JUN-22
Bac Ninh City  VN                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TC Gloves
Thanh Cong Pharmaceutical and Trad510(k) NO: K221186(Traditional)
ATTN: Nguyen Thi Tu Anh           PHONE NO : 098 171 2992 
KM6+ 200 National Road No. 38, HapSE DECISION MADE: 16-JUN-22
Bac Ninh City  VN                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZEPTO Precision Capsulotomy System
Centricity Vision, Inc.           510(k) NO: K221188(Traditional)
ATTN: Neal  Hartman               PHONE NO : 858 3826550 
1939 Palomar Oaks Way, Suite A    SE DECISION MADE: 23-JUN-22
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Powder-Free Examination Gloves
Shandong Maida Medical Technology 510(k) NO: K221192(Traditional)
ATTN: Kitty  Xu                   PHONE NO : 86 1385 3370291 
Room 102, Eastern building, No.166SE DECISION MADE: 22-JUN-22
Dongying  CN 257000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoProbe
Active Life Scientific, Inc.      510(k) NO: K221195(Special)
ATTN: Alexander  Proctor          PHONE NO : 805 7702600 
1027 Garden Street                SE DECISION MADE: 28-JUN-22
Santa Barbara CA  93101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Excipio SV Thrombectomy Device
Contego Medical Inc.              510(k) NO: K221204(Traditional)
ATTN: Jim  Clossick               PHONE NO : 1 305 6071708 
3801 Lake Boone Trail, Suite 100  SE DECISION MADE: 23-JUN-22
Raleigh NC  27607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPY Laparoscope
Stryker                           510(k) NO: K221217(Traditional)
ATTN: Christie  Samsa             PHONE NO : 978 5001303 
5900 Optical Court                SE DECISION MADE: 17-JUN-22
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask (HNFM0304)
Shanghai Hua En Industrial CO LTD 510(k) NO: K221222(Traditional)
ATTN: Lisa  Zhao                  PHONE NO : 86 1561 8875177 
#30, NO988 Hui Ji Road, Xuanqiao TSE DECISION MADE: 06-JUN-22
Shanghai  CN 201314               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: "1st Glove" Blue Nitrile Examination Gloves Powder Free
Koove Iot Pvt. Ltd.               510(k) NO: K221226(Abbreviated)
ATTN: Sudarsan  Mohapatra         PHONE NO : 773 55 63300 
Gokulpur, PO:Shyamraipur          SE DECISION MADE: 16-JUN-22
Paschim Midnapur  IN 721305       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Drug Relief v1
DyAnsys, Inc.                     510(k) NO: K221231(Special)
ATTN: Srini  Nageshwar            PHONE NO : 408 4804700 
300, North Bayshore Boulevard     SE DECISION MADE: 06-JUN-22
San Mateo CA  94401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DT-703
ECOTRON Co., Ltd                  510(k) NO: K221233(Traditional)
ATTN: Sang  Bong Lee              PHONE NO : 02 2025 3760 
404, 504, 505Ho, Hanshin IT Tower SE DECISION MADE: 27-JUN-22
Seoul  KR 08511                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mg OSTEOINJECT
Bone Solutions, Inc.              510(k) NO: K221256(Traditional)
ATTN: Drew  Diaz                  PHONE NO : 1 817 8098850___ 
5712 Colleyville Boulevard, Suite SE DECISION MADE: 28-JUN-22
Colleyville TX  76034             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FROG Forceps Valve (VAL1-F1-100)
FUJIFILM medwork GmbH             510(k) NO: K221264(Special)
ATTN: Randy  Vader                PHONE NO : 360 356 6821 
Medworkring 1                     SE DECISION MADE: 01-JUN-22
Hochstadt  DE 91315               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Mask (M001)
Shandong Xingyu Gloves Co., Ltd.  510(k) NO: K221272(Traditional)
ATTN: Carrie  Li                  PHONE NO : 86 18263 618867 
No. 2189 Yaoqian Road, Gaomi EconoSE DECISION MADE: 28-JUN-22
Weifang  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Mask (M001)
Xingyu Medical Tech Co., Ltd      510(k) NO: K221273(Traditional)
ATTN: Carrie  Li                  PHONE NO : 86 182636 18867 
No. 2189 Yaoqian Road, Gaomi EconoSE DECISION MADE: 28-JUN-22
Weifang  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLAROX
VSI Co., Ltd.                     510(k) NO: K221286(Traditional)
ATTN: Jake  Yu                    PHONE NO : 82 43 2679039 
151-33, Namseok-ro Nami-myeon, SeoSE DECISION MADE: 29-JUN-22
Cheongju-si  KR 28182             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode Laser Hair Removal Device
Guangzhou CHUANG ZAO MEI Technolog510(k) NO: K221312(Traditional)
ATTN: Karpov  Aleksandr           PHONE NO : 086 0131 47561925 
Dehe international A505, No.2, QixSE DECISION MADE: 29-JUN-22
Guangzhou  CN 510440              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K221314(Special)
ATTN: Nimrod  Epstein             PHONE NO : 972 73 7946870 
3 Aminadav St.                    SE DECISION MADE: 03-JUN-22
Tel Aviv  IL 6706703              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D²RS and D²RS 9090
Stephanix                         510(k) NO: K221335(Special)
ATTN: Sandie  Perret              PHONE NO : 33 477 478160 
10, rue Jean Moulin Z.I du Bayon  SE DECISION MADE: 07-JUN-22
La Ricamarie  FR 42150            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
Contego Medical Inc.              510(k) NO: K221339(Special)
ATTN: Jim  Clossick               PHONE NO : 1 305 6071708 
3801 Lake Boone Trail, Suite 100  SE DECISION MADE: 09-JUN-22
Raleigh NC  27607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K221345(Special)
ATTN: Junjie  Qian                PHONE NO : 86 0512 53690872 
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 16-JUN-22
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omni Foot and Ankle Plating System
Exremity Medical, LLC.            510(k) NO: K221362(Special)
ATTN: Mary  Hoffman               PHONE NO : 973 5888980 
300 Interpace Parkway, Suite 410  SE DECISION MADE: 10-JUN-22
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Correction System Rings and Compatible HA-Coated Half Pins
WishBone Medical, Inc.            510(k) NO: K221366(Special)
ATTN: Ramakrishna  Bajaj          PHONE NO : 574 3064006 427
100 Capital Drive                 SE DECISION MADE: 06-JUN-22
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Promisemed Blood Lancet,  VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K221368(Special)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 09-JUN-22
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Promisemed Heel Blood Lancet
Promisemed Hangzhou Meditech Co., 510(k) NO: K221371(Special)
ATTN: Zearou  Yang                PHONE NO : 86 571 88772985 
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 08-JUN-22
Hangzhou City  CN 311121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nalu Neurostimulation System
Nalu Medical, Inc.                510(k) NO: K221376(Special)
ATTN: Chelsea  Gutierrez          PHONE NO : 714 4010608 
2320 Faraday Avenue, Suite 100    SE DECISION MADE: 10-JUN-22
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2
Hivox Biotek Inc.                 510(k) NO: K221384(Special)
ATTN: Aaron  Huang                PHONE NO : 886 285 112668 320
5F., No. 123, Xingde Rd., SanchongSE DECISION MADE: 11-JUN-22
New Taipei City  TW 24158         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERF-GEN Pulsatile Perfusion Solution
Institut Georges Lopez            510(k) NO: K221386(Traditional)
ATTN: Matthieu  Prouteau          PHONE NO : 33 437 646332 
Parc Tertiaire du Bois Dieu, 1 AllSE DECISION MADE: 14-JUN-22
Lissieu  FR 69380                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEL-GEN Cold Storage Solution
Institut Georges Lopez            510(k) NO: K221387(Traditional)
ATTN: Matthieu  Porteau           PHONE NO : 33 437 646332 
Parc Tertiaire du Bois Dieu, 1 AllSE DECISION MADE: 14-JUN-22
Lissieu  FR 69380                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FairFix AM Adjustable Button  FairFix PSP Adjustable Button
Medacta International S.A.        510(k) NO: K221389(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 08-JUN-22
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swoop Portable MR Imaging System
Hyperfine, Inc.                   510(k) NO: K221393(Special)
ATTN: Christine  Kupchick         PHONE NO : 203 3433404 
351 New Whitfield Street          SE DECISION MADE: 10-JUN-22
Guilford CT  06437                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIA Radiation Therapy Management (v16.1 MR3)
Varian Medical Systems, Inc       510(k) NO: K221408(Special)
ATTN: Peter J. Coronado           PHONE NO : 1 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 17-JUN-22
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WHILL Model F
Whill, Inc.                       510(k) NO: K221438(Third Party - Traditional)
ATTN: Tsuyoshi  Iriyama           PHONE NO : 81 9025 672984 
2-1-11 Higashi-Shinagawa; Harbor PSE DECISION MADE: 07-JUN-22
Shinagawa-ku  JP 140-0002         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)
Varian Medical Systems, Inc       510(k) NO: K221448(Special)
ATTN: Peter J. Coronado           PHONE NO : 1 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 15-JUN-22
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ElucidVivo A.3
Elucid Bioimaging Inc.            510(k) NO: K221463(Special)
ATTN: Doug  Shufelt               PHONE NO : 617 3049520 
2 Park Plaza, Suite 700           SE DECISION MADE: 17-JUN-22
Boston MA  02116                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.                  510(k) NO: K221465(Special)
ATTN: Haylie  Hertz               PHONE NO : 303 7200017 
14445 Grasslands Dr.              SE DECISION MADE: 17-JUN-22
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Langston dual lumen catheter
Vascular Solutions LLC            510(k) NO: K221470(Special)
ATTN: Becky  Astrup               PHONE NO : 763 7622601___ 
6464 Sycamore Court North         SE DECISION MADE: 17-JUN-22
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esophageal TTS Stent
Taewoong Medical Co., Ltd.        510(k) NO: K221482(Special)
ATTN: Jangsoo  Lee                PHONE NO : 82 70 46491515 
14 Gojeong-Ro, Wolgot-Myeon       SE DECISION MADE: 22-JUN-22
Gimpo-Si  KR 10022                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON Sequoia Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K221500(Third Party - Traditional)
ATTN: Sulgue  Choi                PHONE NO : 425 2819898 
22010 South East 51st Street      SE DECISION MADE: 14-JUN-22
Issaquah WA  98029                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Axial3D Cloud Segmentation Service
Axial Medical Printing Limited    510(k) NO: K221511(Third Party - Traditional)
ATTN: Jenna  McGarry              PHONE NO : 44 774 9147256 
17A Ormeau Avenue                 SE DECISION MADE: 23-JUN-22
Belfast  GB BT2 8HD               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Sugita AVM Microclip Applier
Mizuho America, Inc.              510(k) NO: K221524(Special)
ATTN: Richard  Chadwick           PHONE NO : 510 3244500 150
30057 Ahern Avenue                SE DECISION MADE: 24-JUN-22
Union City CA  94587              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Shenzhen Fansizhe Science And Tech510(k) NO: K221569(Special)
ATTN: Endang  Cheng               PHONE NO : 86 0755 85275266 
2nd and 3rd floors, No. 17, Xinfa SE DECISION MADE: 30-JUN-22
Shenzhen  CN 518125               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode Multi-system
InMode Ltd.                       510(k) NO: K221571(Special)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 30-JUN-22
Yokneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 780 nm L11 LED Light Source with AIM
Stryker                           510(k) NO: K221611(Special)
ATTN: Michelle  Hughes            PHONE NO : 904 6081262 
5900 Optical Court                SE DECISION MADE: 29-JUN-22
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Radiography CXDI-Elite, Digital Radiography E1
Canon Inc.                        510(k) NO: K221620(Special)
ATTN: Akira  Hirai                PHONE NO : 81 33 7582111 
9-1 Imaikami-Cho, Nakahara-KU     SE DECISION MADE: 14-JUN-22
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Pr510(k) NO: K221658(Traditional)
ATTN: Julie  Villanueva, PhD      PHONE NO : 404 6393851 
1600 Clifton Road NE, MS: H24-11  SE DECISION MADE: 10-JUN-22
Atlanta GA  30329                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Filtek Supreme Flowable Restorative
3M Company ESPE Dental Products   510(k) NO: K221695(Third Party - Traditional)
ATTN: Regina  Feferman-Savvateev  PHONE NO : 1 651 4673869 
2510 Conway Avenue                SE DECISION MADE: 13-JUN-22
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K221714(Special)
ATTN: Guo  Wu                     PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd. Taicang Port ESE DECISION MADE: 29-JUN-22
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CPS AIM Universal II Slittable Inner Catheter
Abbott Medical                    510(k) NO: K221750(Special)
ATTN: Indira  Verdekel            PHONE NO : 1818 4933360 
15900 Valley View Court           SE DECISION MADE: 30-JUN-22
Sylmar CA  91342                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers For Disease Control And Pr510(k) NO: K221834(Special)
ATTN: Julie  Villanueva, PhD      PHONE NO : 404 6393851 
1600 Clifton Rd, NE MS H24-11     SE DECISION MADE: 24-JUN-22
ATLANTA GA  30329                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

                TOTAL 510(k)s THIS PERIOD   279                                     
                TOTAL WITH SUMMARIES        270                                     
                TOTAL WITH STATEMENTS        9
                                       
 
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