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  1. Medical Devices

January 2022 510(K) Clearances

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


DEVICE: e-Throne Folding Wheelchair, Model: ET-12F22
Golden Motor Technology Co., Ltd. 510(k) NO: K191105(Traditional)
ATTN: Philip  Yao                 PHONE NO : 86 519 81004118 
Room 1401-1405, Tower 5 No. 18-50 SE DECISION MADE: 21-JAN-22
Changzhou  CN 213164              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i3 Foldable Mobility Scooter
PUC Perfect Union Co., LTD.       510(k) NO: K191356(Traditional)
ATTN: Anita  Chen                 PHONE NO : 886 02 29993690 
8F-4, No.20, Lane 609, Sec. 5, ChuSE DECISION MADE: 11-JAN-22
New Taipei City  TW 241           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CHIRANA Insulin Syringes
CHIRANA T. Injecta                510(k) NO: K201044(Traditional)
ATTN: Zdenka  Klbeckova           PHONE NO : 42 132 7709972 
Nàm. Dr. Schweitzera 194          SE DECISION MADE: 18-JAN-22
Starà Turà  SK 916 01             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bio-Medicus Life Support Catheter and Introducer
Medtronic Inc.                    510(k) NO: K201057(Traditional)
ATTN: Juli  Rubin                 PHONE NO : 763 5262357 
8200 Coral Sea St. NE             SE DECISION MADE: 14-JAN-22
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INNO SLA Submerged Implant System
Cowellmedi Co., Ltd.              510(k) NO: K201323(Traditional)
ATTN: Minjin  Park                PHONE NO : 82 51314 2028 
48, Hakgam-daero 221beon-gil, SasaSE DECISION MADE: 25-JAN-22
Busan  KR 46986                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardiovascular Suite 4.2.1
Quipu S.R.L                       510(k) NO: K202094(Traditional)
ATTN: Vincenzo  Gemignani         PHONE NO : 39 328 3074229 
Moruzzi 1 56124                   SE DECISION MADE: 11-JAN-22
Pisa  IT 56124                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing
Smith & Nephew Medical Limited    510(k) NO: K202783(Traditional)
ATTN: Steeve  Lamvohee            PHONE NO : 44 7583 048727 
101 Hessle Road                   SE DECISION MADE: 14-JAN-22
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SternaFuse Fixation System
Fusion Innovations, LLC           510(k) NO: K202914(Traditional)
ATTN: Mark  Schumacher            PHONE NO : 407 6171440 
116 E Main Street Suite 201       SE DECISION MADE: 26-JAN-22
Rock Hill SC  29732               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InnoClip Disposable Clip Applier, InnoClip Clip Applier
Taiwan Surgical Corporation       510(k) NO: K202994(Traditional)
ATTN: Ken  Chen                   PHONE NO : 886 365 88129 
3F., No.12, Sec.2, ShengYi Rd.    SE DECISION MADE: 04-JAN-22
Zhubei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Franz Zirconia Dental Crown
Franz Biotech Inc.                510(k) NO: K203072(Traditional)
ATTN: Anita  Chen                 PHONE NO : 886 939 855759 
5F.-3, No. 56, Ln. 258, Ruiguang RSE DECISION MADE: 19-JAN-22
Taipei City  TW 114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Wuhan Raytex Protection CO., LTD  510(k) NO: K203161(Traditional)
ATTN: Maggie  Yao                 PHONE NO : 86 27 87263395 
RM1201,Mingchuang Building,GreenlaSE DECISION MADE: 20-JAN-22
Wuhan  CN 430060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterisystem Dry-Base Instrument Tray
O&M Halyard, Inc                  510(k) NO: K203177(Traditional)
ATTN: Steven  Dowdley             PHONE NO : 678 4518062 
1 Edison Drive                    SE DECISION MADE: 02-JAN-22
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Brain Hemorrhage
Siemens Medical Solutions USA, Inc510(k) NO: K203260(Traditional)
ATTN: Tabitha  Estes              PHONE NO : 865 8044553 
810 Innovation Drive              SE DECISION MADE: 28-JAN-22
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alltest Pregnancy Rapid Combo Test Cassette
Hangzhou AllTest Biotech Co., Ltd 510(k) NO: K203272(Traditional)
ATTN: Rosa  Wu                    PHONE NO : 86 571 56267891 
No. 550, Yinhai Street            SE DECISION MADE: 31-JAN-22
Hangzhou  CN 310018               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Abbott Medical Grounding Pad, model RF-DGP-IS
Abbott Medical                    510(k) NO: K203293(Traditional)
ATTN: Jordan  Hanson              PHONE NO : 972 3092113 
5050 Nathan Lane                  SE DECISION MADE: 21-JAN-22
Plymouth MN  55442                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EK Implants and Abutments System
Hiossen, Inc.                     510(k) NO: K203360(Traditional)
ATTN: Peter  Lee                  PHONE NO : 888 6780001 
85 Ben Fairless Drive             SE DECISION MADE: 07-JAN-22
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Platform treatment system
Shanghai Apolo Medical Technology 510(k) NO: K203395(Traditional)
ATTN: Felix  Li                   PHONE NO : 86 13 849190618 
Room 301-310, Building 11, No.388,SE DECISION MADE: 28-JAN-22
Shanghai  CN 200231               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynaFuse Fixation System
MedShape, Inc.                    510(k) NO: K203595(Traditional)
ATTN: Ryan  O'Flaherty            PHONE NO : 240 2853189 
1575 Northside Drive NW, Suite 440SE DECISION MADE: 04-JAN-22
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Electric Motor
Guilin Woodpecker Medical Instrume510(k) NO: K203706(Traditional)
ATTN: Jiakang  Ning               PHONE NO : 86 773 2350532 
Information Industrial Park, GuiliSE DECISION MADE: 13-JAN-22
Guilin  CN 541004                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ParaMotion
PowerBaseTec GmbH                 510(k) NO: K203761(Traditional)
ATTN: Niclas  Nachtwey            PHONE NO : 49 5507 9194797 
Hauptstrasse 8                    SE DECISION MADE: 21-JAN-22
Bodensee  DE 37434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnipod 5 ACE Pump (Pod)
Insulet Corporation               510(k) NO: K203768(Traditional)
ATTN: Alexander  Hamad            PHONE NO : 978 6002432 
100 Nagog Park                    SE DECISION MADE: 27-JAN-22
Acton MA  01720                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnipod 5 SmartBolus Calculator
Insulet Corporation               510(k) NO: K203772(Traditional)
ATTN: Julie  Perkins              PHONE NO : 978 6007951 
100 Nagog Park                    SE DECISION MADE: 27-JAN-22
Acton MA  01720                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRM TOOL Screws
BRM Extremities Srl               510(k) NO: K203773(Traditional)
ATTN: Andrea De Maglio            PHONE NO : 389 19 38034 
Via Papa Giovanni XXIII, 9        SE DECISION MADE: 14-JAN-22
Civate  IT 23862                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartAdjust technology
Insulet Corporation               510(k) NO: K203774(Traditional)
ATTN: Alexander  Hamad            PHONE NO : 978 6002432 
100 Nagog Park                    SE DECISION MADE: 27-JAN-22
Acton MA  01720                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CORE1 Implant System
Cybermed Inc.                     510(k) NO: K210039(Traditional)
ATTN: Han Seul Kim                PHONE NO : 82 70 51187131 
6-26, Yuseong-daero 1205 beon-gil SE DECISION MADE: 07-JAN-22
Yuseong-gu  KR 34104              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: American-Made Surgical Mask
Armbrust Inc.                     510(k) NO: K210101(Abbreviated)
ATTN: Landon  Morales             PHONE NO : 561 8091586 
3813 Helios Way Building B, Suite SE DECISION MADE: 26-JAN-22
Pflugerville TX  78660            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive
GPC Medical Limited               510(k) NO: K210198(Traditional)
ATTN: Vikas  Narang               PHONE NO : 91 11 43222600 
GPC Square, M-Block, DDA LSC, VikaSE DECISION MADE: 07-JAN-22
New Delhi  IN 110018              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parkell Self-Adhesive Cement
Parkell, Inc                      510(k) NO: K210259(Traditional)
ATTN: La-Shaunda  Joseph          PHONE NO : 631 3891134 
300 Executive Drive               SE DECISION MADE: 20-JAN-22
Edgewood NY  11717                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)
Osteonic Co., Ltd                 510(k) NO: K210360(Traditional)
ATTN: Na Young  Kang              PHONE NO : 82 2 69028415 
1206Ho, 38, Digital-ro 29-gil, GurSE DECISION MADE: 27-JAN-22
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermoplastic Elastomer (TPE) Hybrid Examination Glove
Xuzhou Full Sun Medical Products L510(k) NO: K210463(Traditional)
ATTN: Hsun-Hui  Huang             PHONE NO : 86 516 67680555 
Bihe Industry Area, Yitang Town   SE DECISION MADE: 23-JAN-22
Pizhou  CN 221316                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silver Gelling Fiber Dressing
Winner Medical Co., Ltd.          510(k) NO: K210466(Traditional)
ATTN: Haoyuan  He                 PHONE NO : 86 7552 8138888653 
Winner Industrial Park, No. 660 BuSE DECISION MADE: 14-JAN-22
Shenzhen  CN 51809                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Alicn Medical Shenzhen, Inc       510(k) NO: K210564(Traditional)
ATTN: Fang  Meisong               PHONE NO : 86 755 26501548 
Room 410, Building A, 3rd Sub-parkSE DECISION MADE: 07-JAN-22
Shenzhen  CN 518118               510(k) STATEMENT
                                                    

DEVICE: Medical Face Mask
Wuxi Yushou Medical Appliances Co.510(k) NO: K210679(Traditional)
ATTN: Xiaoling  Dai               PHONE NO : 86 510 83777555 
No.115 Nongxinhe Road, Xishan DistSE DECISION MADE: 18-JAN-22
Wuxi  CN 214200                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caption Interpretation Automated Ejection Fraction Software
Caption Health                    510(k) NO: K210747(Traditional)
ATTN: Sam  Surette                PHONE NO : 571 3356532 
2000 Sierra Point Pkwy            SE DECISION MADE: 19-JAN-22
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precise Image
Philips Medical Systems Nederland,510(k) NO: K210760(Traditional)
ATTN: Michael  Chilbert           PHONE NO : 440 8694576 
Veenpluis 4-6                     SE DECISION MADE: 14-JAN-22
Best Noord-Brabant  NL 5684 PC    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steiking Packaging for Medical Devices
Wipak OY                          510(k) NO: K210810(Traditional)
ATTN: Mira  Santala               PHONE NO : 35 40 8360602 
Wipaktie 2                        SE DECISION MADE: 23-JAN-22
Nastola  FI FI-15560              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VUZE System
VUZE Medical Ltd.                 510(k) NO: K210830(Traditional)
ATTN: David  Tolkowsky            PHONE NO : 972 0 733983000 
13 Zarhin St.                     SE DECISION MADE: 03-JAN-22
Ra'anana  IL 4366241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc.            510(k) NO: K211003(Traditional)
ATTN: Jeffrey  Richardson         PHONE NO : 706 8626740 
579 Edison Street                 SE DECISION MADE: 19-JAN-22
Menlo GA  30731                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optiflow Oxygen Kit
Fisher &Paykel Healthcare Ltd.    510(k) NO: K211096(Traditional)
ATTN: Reena  Daken                PHONE NO : 64 9 5740100 
15 Maurice Paykel Place, East TamaSE DECISION MADE: 28-JAN-22
Auckland  NZ 2013                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Agile Devices Angler Steerable, Deflectable Microcatheter
Agile Devices, Inc.               510(k) NO: K211110(Traditional)
ATTN: Stephen  Tully              PHONE NO : 617 4165495 
69 Fox Hill Road                  SE DECISION MADE: 07-JAN-22
Wellesley MA  02481               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enlight 2100
Timpel S.A.                       510(k) NO: K211135(Traditional)
ATTN: Rafael  Holzhacker          PHONE NO : 55 11 30880305 
R. Simao Alvares, 356 cj. 41/42 - SE DECISION MADE: 06-JAN-22
Sao Paulo  BR 05417-020           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Urethral Warming Catheter Kit
Varian Medical Systems, Inc.      510(k) NO: K211149(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4245728 
9825 Spectrum Drive, Building 2, SSE DECISION MADE: 05-JAN-22
Austin TX  78717                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Auto-Disable Syringes with/without Needle for Single Use
Azur Medical Company Inc.         510(k) NO: K211210(Traditional)
ATTN: Di  Zhao                    PHONE NO : 928 5922380 
6710 Everglades Dr.               SE DECISION MADE: 27-JAN-22
Richmond VA  23838                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LASSOSTAR NAV Circular Mapping Catheter
Biosense Webster, Inc.            510(k) NO: K211219(Traditional)
ATTN: Michelle  Wheeler           PHONE NO : 949 9234793 
31 Technology Drive Suite 200     SE DECISION MADE: 26-JAN-22
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARAI Surgical Navigation System
Surgalign Spine Technologies      510(k) NO: K211254(Traditional)
ATTN: Cristian  Luciano           PHONE NO : 630 2273809 
520 Lake Cook Road, Suite 315     SE DECISION MADE: 14-JAN-22
Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sheng Jing Tang Surgical Mask
Liaoning Shengjingtang Biotechnolo510(k) NO: K211260(Traditional)
ATTN: Ke  Li                      PHONE NO : 86 135 91461018 
123-11 Huishan St, Shenbei New DisSE DECISION MADE: 10-JAN-22
Shenyang  CN 110141               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visualase MRI-Guided Laser Ablation System (SW 3.4)
Medtronic Navigation, Inc.        510(k) NO: K211269(Traditional)
ATTN: Sharon  McDermott           PHONE NO : 720 8903461 
826 Coal Creek Circle             SE DECISION MADE: 07-JAN-22
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iQ 2 Nasal Mask, Phantom 2 Nasal Mask
Sleepnet Corporation              510(k) NO: K211274(Traditional)
ATTN: Jennifer  Kennedy           PHONE NO : 603 7586625 
5 Merrill Industrial Drive        SE DECISION MADE: 10-JAN-22
Hampton NH  03842                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
Smith Nephew Medical Limited      510(k) NO: K211318(Traditional)
ATTN: Steeve  Lamvohee            PHONE NO : 44 7583 048727 
101 Hessle Road                   SE DECISION MADE: 05-JAN-22
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R3 Large Head Liners
Smith & Nephew, Inc.              510(k) NO: K211330(Traditional)
ATTN: Kayla  Franklin             PHONE NO : 
7135 Goodlett Farms Parkway       SE DECISION MADE: 19-JAN-22
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KIDNEY ASSIST-transport
XVIVO Perfusion AB                510(k) NO: K211333(Traditional)
ATTN: Arjan  van der Plaats       PHONE NO : 31 682 982106 
Mässans Gata 10                   SE DECISION MADE: 20-JAN-22
Goteborg  SE 41251                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Selebrek PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd. 510(k) NO: K211349(Traditional)
ATTN: Zane  Wang                  PHONE NO : 86 512 87174080 
F2-F3, BLDG 6, No. 8, Jinfeng RoadSE DECISION MADE: 07-JAN-22
Suzhou  CN 215163                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iCare HOME2
Icare Finland Oy                  510(k) NO: K211355(Traditional)
ATTN: Hannes  Hyvönen             PHONE NO : 358 9 87751150 
Ayritie 22                        SE DECISION MADE: 25-JAN-22
Vantaa  FI 01510                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Powder Free Examination Gloves (Non-sterile)
Pt. Universal Gloves              510(k) NO: K211360(Traditional)
ATTN: Sutopo  Sutopo              PHONE NO : 62 61 7883055 
Jl. Patumbak No.17 Patumbak       SE DECISION MADE: 15-JAN-22
Medan  ID 20361                   510(k) STATEMENT
                                                    

DEVICE: 3N Contact Lenses Adjunct Cleaner
Suzhou 3N Biological Technology Co510(k) NO: K211361(Traditional)
ATTN: Yang  Bai                   PHONE NO : 86 132 70127262 
NO.218  Xinghu Street             SE DECISION MADE: 13-JAN-22
Suzhou  CN 215000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gingi-Aid Gel
Belport Company, Inc., Gingi-Pak  510(k) NO: K211419(Traditional)
ATTN: Mohammed  Islam             PHONE NO : 805 7644468 
4825 Calle Alto                   SE DECISION MADE: 10-JAN-22
Camarillo CA  93012               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intermittent Catheter (Not Finalized)
Hollister Incorporated            510(k) NO: K211436(Traditional)
ATTN: Michelle  Schiltz-Taing     PHONE NO : 224 8640431 
2000 Hollister Drive              SE DECISION MADE: 27-JAN-22
Libertyville IL  60048            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIBOLIT 3D+
AIbolit Technologies, LLC         510(k) NO: K211443(Traditional)
ATTN: Howard  Schrayer            PHONE NO : 609 2737350 
9616 Moritz Way                   SE DECISION MADE: 07-JAN-22
Delray Beach FL  33446            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Syringe with Needle
Shandong Qinkai Medical Industry C510(k) NO: K211482(Traditional)
ATTN: Ou Kai Jiang                PHONE NO : 86 0530 6112108 
South Section of Quancheng Road, MSE DECISION MADE: 24-JAN-22
Heze City  CN 274200              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)
23andMe, Inc.                     510(k) NO: K211499(Traditional)
ATTN: Marianna  Frendo            PHONE NO : 650 6869288 
349 Oyster Point Blvd.            SE DECISION MADE: 06-JAN-22
South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
Yibin Junxin Electronics Technolog510(k) NO: K211532(Traditional)
ATTN: Guan  Chaoze                PHONE NO : 86 0831 3602202 
Building B2, No. 136, West SectionSE DECISION MADE: 19-JAN-22
Yibin  CN 644000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
Remington Medical, Inc.           510(k) NO: K211589(Traditional)
ATTN: Caitlin  Senter             PHONE NO : 770 8888520 
6830 Meadowridge Court            SE DECISION MADE: 27-JAN-22
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stern Fix Sternal Stabilization System
Neoss Surgery SL                  510(k) NO: K211613(Traditional)
ATTN: Eduard Garcia Puig          PHONE NO : 
Parc Technologic del Valles       SE DECISION MADE: 19-JAN-22
Barcelona  ES 08290               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS Precision Chevron Bunion System
RELJA Innovations, LLC            510(k) NO: K211628(Traditional)
ATTN: David  Pancratz             PHONE NO : 210 3833907 
17145 W. Bluemound Rd., Suite #J-2SE DECISION MADE: 31-JAN-22
Brookfield WI  53005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
Shenzhen Narig Bio-Medical Technol510(k) NO: K211632(Traditional)
ATTN: Fei  Han                    PHONE NO : 86 755 86566930 
1106 Room, East Tower, Digital CulSE DECISION MADE: 14-JAN-22
Shenzhen  CN 518052               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HP358EA Electrically Powered Wheelchair
Kunshan Hi-Fortune Health Products510(k) NO: K211647(Traditional)
ATTN: Jianjiang  Fan              PHONE NO : 86 512 55195100 
No. 625, Juxiang Road, Zhangpu TowSE DECISION MADE: 04-JAN-22
Kunshan  CN 215321                510(k) STATEMENT
                                                    

DEVICE: Powder Free Nitrile Examination Gloves, Blue Chemotest
Careglove Global SDN. BHD.        510(k) NO: K211666(Traditional)
ATTN: Siti Khatijah Ahmad         PHONE NO : 60 6 6782377 
Lot 17479, Lorong Senawang 2/3, OfSE DECISION MADE: 09-JAN-22
Seremban  MY 70450                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biotres
Biotricity                        510(k) NO: K211709(Traditional)
ATTN: Spencer  LaDow              PHONE NO : 585 4147407 
275 Shoreline Drive, Suite 150    SE DECISION MADE: 19-JAN-22
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DropSafe Safety Pen Needles
HTL STREFA SA                     510(k) NO: K211716(Traditional)
ATTN: Justyna  Zemigala           PHONE NO : 48 42 2700010 
ul. Adamówek 7                    SE DECISION MADE: 07-JAN-22
Ozorków  PL 95-035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SignaSure Dual Mobility System
Signature Orthopaedics Pty Ltd.   510(k) NO: K211742(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 07-JAN-22
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Beijing Choice Electronic Technolo510(k) NO: K211752(Traditional)
ATTN: Haiying  Zhao               PHONE NO : 86 10 88794631 
2nd Floor 3rd Floor and Room 410-4SE DECISION MADE: 21-JAN-22
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: restor3d Pin Implants
restor3d                          510(k) NO: K211789(Traditional)
ATTN: Lexi  Lewis                 PHONE NO : 317 2874311 
311 W. Corporation St.            SE DECISION MADE: 04-JAN-22
Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wellead Endoscopic Seal
Well Lead Medical CO., LTD.       510(k) NO: K211814(Traditional)
ATTN: Caroline  Gong              PHONE NO : 86 20 84758878 
No. 47 Guomao Avenue South, HualonSE DECISION MADE: 14-JAN-22
Guangzhou  CN 511434              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical  Face Mask
Zhejiang The Purples Protective Pr510(k) NO: K211833(Traditional)
ATTN: Lihui  Jiang                PHONE NO : 86 579 85178961 
No.45, Suhua Street, Suxi Town    SE DECISION MADE: 16-JAN-22
Yiwu  CN 312000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ora-Aid
TBM Corporation                   510(k) NO: K211851(Traditional)
ATTN: Jaewoong  Jung              PHONE NO : 82 62 9712845 
B-301, 313 Cheomadangwagi-ro, Buk-SE DECISION MADE: 11-JAN-22
Gwangju  KR 61008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
Siyang Jaysun Medtech Co., Ltd.   510(k) NO: K211864(Traditional)
ATTN: Chen  Fang                  PHONE NO : 86 527 85552002 
No.26 Changjiang Rd, Siyang EconomSE DECISION MADE: 21-JAN-22
Suqian  CN 223700                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fetal Doppler
Shenzhen Taikang Medical Equipment510(k) NO: K211940(Traditional)
ATTN: Shigui  Du                  PHONE NO : 86 755 89664986 
3F East, Building 4, Lanzhu East RSE DECISION MADE: 07-JAN-22
Shenzhen  CN 518015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 9Line
Energetic Designs, Inc.           510(k) NO: K211941(Traditional)
ATTN: Kathy  Fortin               PHONE NO : 303 9311344 
3037 Grizzly Peak Dr.             SE DECISION MADE: 27-JAN-22
Broomfield CO  80023              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jplant
JJ Medical Co., Ltd.              510(k) NO: K211978(Traditional)
ATTN: Sun Jae Lee                 PHONE NO : 82 2 69334897 
Daeryung Techno Town 3 409 Gasan-DSE DECISION MADE: 05-JAN-22
Seoul  KR 08505                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNA Prime
GE Healthcare (Tianjin) Company Li510(k) NO: K211980(Traditional)
ATTN: Huande  Li                  PHONE NO : 86 181 01131237 
No. 266 Jingsan Road, Tianjin AirpSE DECISION MADE: 16-JAN-22
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNiD Spine Analyzer
MEDICREA International, Inc.      510(k) NO: K212005(Traditional)
ATTN: David  Ryan                 PHONE NO : 0033 472 018787 
5389 Route de Strasbourg - Vancia SE DECISION MADE: 12-JAN-22
Rilleux La Pape  FR 69140         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Follicle Clarity
Cycle Clarity                     510(k) NO: K212012(Traditional)
ATTN: John  Schnorr               PHONE NO : 843 8836200 
1209 Fifteen Mile Landing Rd.     SE DECISION MADE: 19-JAN-22
Awendaw SC  29429                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Universal Grounding Pad
Medline Industries, Inc           510(k) NO: K212093(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 14-JAN-22
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: Myflon Surgical Mask Level 3
Feliks Plastik Laminasyon Ve Ambal510(k) NO: K212111(Traditional)
ATTN: Ali Serdar Serteser         PHONE NO : 90 222 2362353 
Ve TIC A.S. Eskisehir Industrial ZSE DECISION MADE: 23-JAN-22
Eskisehir  TR 26100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
JOYTECH HEALTHCARE CO.,LTD        510(k) NO: K212115(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 05-JAN-22
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Masks
Hubei Xinxin Non-woven Co.,Ltd.   510(k) NO: K212120(Traditional)
ATTN: Nicole  Jin                 PHONE NO : 86 728 2618155 
Taizihu Industrial Park, PengchangSE DECISION MADE: 28-JAN-22
Xiantao  CN 433018                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Picocaremajesty
Won Tech Co., Ltd.                510(k) NO: K212127(Traditional)
ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346 
64 Techno 8-ro                    SE DECISION MADE: 07-JAN-22
Yuseong-gu  KR 34028              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prelude IDeal 9F Hydrophilic Sheath Introducer
Merit Medical Systems             510(k) NO: K212152(Traditional)
ATTN: David  Thomas               PHONE NO : 801 3164956 
1600 West Merit Parkway           SE DECISION MADE: 07-JAN-22
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
inomed Medizintechnik GmbH        510(k) NO: K212166(Traditional)
ATTN: Tomasz  Moszkowski          PHONE NO : 49 7641 9414583 
Im Hausgruen 29                   SE DECISION MADE: 07-JAN-22
Emmendingen  DE 79312             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HDH Treatment Planning System
CDB Corporation                   510(k) NO: K212173(Traditional)
ATTN: Leah M Lehman               PHONE NO : 910 3536464 
9201 Industrial Park Boulevard    SE DECISION MADE: 25-JAN-22
Leland NC  28451                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Surgical Mask
Wepon Medical Technology Co., Ltd.510(k) NO: K212299(Traditional)
ATTN: Yongxian  Sun               PHONE NO : 86 135 86268021 
West side of North Baizhang Road, SE DECISION MADE: 04-JAN-22
Wenling  CN 317500                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RA-T59 Wrist blood pressure monitor
LotusNine Medical Limited         510(k) NO: K212312(Traditional)
ATTN: Yating  Chang               PHONE NO : 886 49 2316379 
No. 2, Ln. 223, Sec. 1, Taiping RdSE DECISION MADE: 27-JAN-22
Nantou County  TW 524007          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal
Dongguan Define Beauty Electronic 510(k) NO: K212318(Traditional)
ATTN: Shaowu  Wang                PHONE NO : 0086 0769 89367468 
No.10 Xiangya Road, Chicken wing rSE DECISION MADE: 14-JAN-22
Dongguan  CN 523821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5
Canon Medical Systems Corporation 510(k) NO: K212333(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 24-JAN-22
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U
Qura S.r.l.                       510(k) NO: K212341(Traditional)
ATTN: Raffaella  Tommasini        PHONE NO : 39 0535 1803050 
Via di Mezzo, 23                  SE DECISION MADE: 28-JAN-22
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical isolation gown
Wuhan Zonsen Medical Products Co.,510(k) NO: K212357(Traditional)
ATTN: Cynthia  Ye                 PHONE NO : 86 027 82737771 
No 8 Jinchao Road, Zhucheng StreetSE DECISION MADE: 20-JAN-22
Wuhan  CN 431000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Romero Cervical Cage
SpineUp Inc.                      510(k) NO: K212358(Traditional)
ATTN: Philippe  Laurito           PHONE NO : 
100 North Biscayne Blvd. Suite 307SE DECISION MADE: 10-JAN-22
Miami FL  33132                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sim&Size
Sim&Cure                          510(k) NO: K212373(Traditional)
ATTN: Caroline  Oziel             PHONE NO : 33 95 3438809 
95 rue Pierre Flourens Bâtiment H SE DECISION MADE: 27-JAN-22
Montpellier  FR 34090             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Surgical Mask
Jiangxi Bestgrand Health Technolog510(k) NO: K212375(Traditional)
ATTN: Jian long Chen              PHONE NO : 86 181 79908058 
BeGrand Industrial Park, PingxiangSE DECISION MADE: 04-JAN-22
Pingxiang  CN 337000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible Video-Uretero-Renoscope SSU System
KARL STORZ Endoscopy America      510(k) NO: K212458(Traditional)
ATTN: Mario  Trujillo             PHONE NO : 424 2188184 
2151 E. Grand Avenue              SE DECISION MADE: 20-JAN-22
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tigereye CTO-Crossing Catheter
Avinger, Inc.                     510(k) NO: K212468(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 650 2417900 
400 Chesapeake Drive              SE DECISION MADE: 06-JAN-22
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dermatological diode laser system
Beijing Stelle Laser Technology Co510(k) NO: K212478(Traditional)
ATTN: Zhao  Changcheng            PHONE NO : 86 139 11687160 
Rm.502-1, Tower B, Building 1, YarSE DECISION MADE: 14-JAN-22
Beijing  CN 102600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HP458E Electrically Powered Wheelchair
Kunshan Hi-Fortune Health Products510(k) NO: K212503(Traditional)
ATTN: Jianjiang  Fan              PHONE NO : 86 512 5519510 
No. 625, Juxiang Road, Zhangpu TowSE DECISION MADE: 18-JAN-22
Kunshan  CN 215321                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DUMI ManipulatOR
The O R Company Pty Ltd           510(k) NO: K212505(Traditional)
ATTN: Amesha  Silva               PHONE NO : 61 3 94135555 
1/32 Silkwood Place               SE DECISION MADE: 10-JAN-22
Carrum Downs  AU 3201             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants
Institut Straumann AG             510(k) NO: K212533(Traditional)
ATTN: Corinne  Arimatea           PHONE NO : 41 61 9651128 
Peter Merian Weg 12               SE DECISION MADE: 28-JAN-22
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix
DeltaMed GmbH                     510(k) NO: K212541(Traditional)
ATTN: Michael  Zimmermann         PHONE NO : 0049 603 1728317 
Raiffeisenstrasse 8a              SE DECISION MADE: 10-JAN-22
Friedberg  DE 61169               510(k) STATEMENT
                                                    

DEVICE: Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Materialise NV                    510(k) NO: K212569(Traditional)
ATTN: Simona  Beri                PHONE NO : 32 167 45471 
Technologielaan 15                SE DECISION MADE: 12-JAN-22
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MDx-Chex for BCID2
Streck, Inc                       510(k) NO: K212576(Traditional)
ATTN: Deborah S. Kipp             PHONE NO : 402 5375215 
7002 S. 109th Street              SE DECISION MADE: 19-JAN-22
La Vista NE  68128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
Stryker GmbH                      510(k) NO: K212581(Traditional)
ATTN: Keith  Neligan              PHONE NO : 00 353 877995645 
 325 Corporate Drive              SE DECISION MADE: 19-JAN-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Surgical Gown
Suzhou JaneE Medical Technology Co510(k) NO: K212591(Traditional)
ATTN: Chen  Ke                    PHONE NO : 86 139 14506197 
No.339 HuaFeng Road, New District SE DECISION MADE: 11-JAN-22
Suzhou  CN 215129                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gas-Chex Indicator
Propper Manufacturing Co., Inc.   510(k) NO: K212592(Abbreviated)
ATTN: Andrew  Sharavara           PHONE NO : 1 718 8691252 
36-04 Skillman Avenue             SE DECISION MADE: 20-JAN-22
Long Island City NY  11101        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSIOfiber® Staple
OSSIO Ltd.                        510(k) NO: K212594(Traditional)
ATTN: Taly  Linder                PHONE NO : 972 4 9986600 
8 HaTochen St.                    SE DECISION MADE: 21-JAN-22
Caesarea  IL 3079861              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iHealth infrared Ear thermometer PT5
Andon Health Co., Ltd.            510(k) NO: K212598(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 87611660 9223
No. 3 Jin Ping Street,Ya An Road, SE DECISION MADE: 28-JAN-22
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BHA100 Series Braun Clear Hearing Aid
Kaz USA, Inc., a Helen of Troy Com510(k) NO: K212609(Traditional)
ATTN: Matt J. Baun                PHONE NO : 508 4907240 
400 Donald Lynch Boulevard, Suite SE DECISION MADE: 05-JAN-22
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Foshan Nanhai Plus Medical CO LTD 510(k) NO: K212610(Traditional)
ATTN: Suyi  Li                    PHONE NO : 86 757 86914198 
Shijiang Industrial Zone, Shatou, SE DECISION MADE: 26-JAN-22
Foshan  CN 528208                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Immunodiagnostic Products CK-MB Reagent Pack
Ortho Clinical Diagnostics        510(k) NO: K212648(Traditional)
ATTN: Declan  Hynes               PHONE NO : 44 656 778032 
Felindre Meadows                  SE DECISION MADE: 28-JAN-22
Pencoed  GB CF35 5PZ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celeris, Disposable Sinus Debrider
Gyrus ACMI, Inc.                  510(k) NO: K212650(Traditional)
ATTN: Dolan  Mills                PHONE NO : 901 3550007 
800 West Park Drive               SE DECISION MADE: 19-JAN-22
Westborough MA  01581             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLOBAL ICON Stemless Shoulder System
DePuy (Ireland)                   510(k) NO: K212683(Traditional)
ATTN: Kathy  Harris               PHONE NO : 574 3727020 
Loughbeg Ringaskiddy              SE DECISION MADE: 19-JAN-22
Co. Cork Munster  IE              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger
Qura S.r.l.                       510(k) NO: K212688(Traditional)
ATTN: Raffaella  Tommasini        PHONE NO : 39 0535 1803050 
Via di Mezzo, 23                  SE DECISION MADE: 10-JAN-22
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Air compression leg massager HY-1117A
Xiamen High Top Electronic Technol510(k) NO: K212713(Traditional)
ATTN: Liangsan  Zhao              PHONE NO : 86 153 59228717 
F2-5 No. 118 Siming Park, Tong'an SE DECISION MADE: 18-JAN-22
Xiamen  CN 361000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical gowns
Xiantao Dingcheng Non-Woven Produc510(k) NO: K212718(Traditional)
ATTN: Cheng  Qin                  PHONE NO : 86 180 07229722 
Liukou Industrial Park            SE DECISION MADE: 12-JAN-22
Xiantao  CN 433099                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
Xingyu Medical Tech Co., Ltd.     510(k) NO: K212735(Traditional)
ATTN: Cathrine  Luan              PHONE NO : 0086 182 63618867 
No. 2189 Yaoqian Road, Gaomi EconoSE DECISION MADE: 11-JAN-22
Weifang  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Dual Action Tissue Clip
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K212748(Traditional)
ATTN: Cecilia  Sun                PHONE NO : 86 25 58646395 
No.10 Gaoke Third Road, Nanjing NaSE DECISION MADE: 20-JAN-22
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightStim Elipsa
LED Intellectual Properties LLC   510(k) NO: K212771(Traditional)
ATTN: Chase  Marchese             PHONE NO : 949 5024088 
16552 Von Karman Ave              SE DECISION MADE: 26-JAN-22
Irvine CA  92606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Align
Precision Align LLC.              510(k) NO: K212772(Traditional)
ATTN: Chris  Freeman              PHONE NO : 954 8378367___ 
1825 NE 45th Street Suite A       SE DECISION MADE: 15-JAN-22
Fort Lauderdale FL  33308         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iPrime Viscodelivery System
Glaukos                           510(k) NO: K212797(Traditional)
ATTN: Alex  Bhaskarla             PHONE NO : 949 4810672 
229 Avenida Fabricante            SE DECISION MADE: 06-JAN-22
San Clemente CA  92672            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder free nitrile examination glove- black, non sterile
Hong Seng Gloves Sdn Bhd          510(k) NO: K212801(Traditional)
ATTN: Ho Chia  Yao                PHONE NO : 604 4211555 
LOT 97, Jalan 10, Kawasan PerusahaSE DECISION MADE: 09-JAN-22
Sungai Petani  MY 08000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Mask
Jiangsu Nanfang Medical Co., Ltd. 510(k) NO: K212826(Traditional)
ATTN: Li  Xia                     PHONE NO : 86 519 86362198 
No. 1 Guoxiang Road, Wujin EconomiSE DECISION MADE: 19-JAN-22
Changzhou  CN 213149              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pectus Blu Support Bar System
Biomet Micofixation               510(k) NO: K212841(Traditional)
ATTN: Mark  Wladowski             PHONE NO : 904 7414400 
1520 Tradeport Drive              SE DECISION MADE: 07-JAN-22
Jacksonville FL  32218            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microvolume Luer Access Device
B. Braun Medical Inc.             510(k) NO: K212842(Traditional)
ATTN: Kimberly  Smith             PHONE NO : 610 5962326 
901 Marcon Blvd.                  SE DECISION MADE: 18-JAN-22
Allentown PA  18109-9341          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penta Glove
Pentavest Holdings Sdn Bhd        510(k) NO: K212847(Traditional)
ATTN: Teng Boon Joo               PHONE NO : 601 22332689 
No. 9574-9578, Jalan PTB 2 , KawasSE DECISION MADE: 06-JAN-22
Batu  MY 76400                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powered Wheelchair
Zhejiang Qianxi Vehicle Co., Ltd. 510(k) NO: K212854(Traditional)
ATTN: Ada  Zhang                  PHONE NO : 86 579 87153722 
No.366, Kechuang Road             SE DECISION MADE: 10-JAN-22
Yongkang City  CN 322000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
Rocamed SAM                       510(k) NO: K212868(Traditional)
ATTN: Tahiana  Rasolofoniaina     PHONE NO : 377 979 84244 
9 Avenue Albert II                SE DECISION MADE: 26-JAN-22
Monaco  MC 98000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Blood Pressure Monitor
Alicn Medical Shenzhen,Inc        510(k) NO: K212877(Traditional)
ATTN: Fang  Meisong               PHONE NO : 86 755 26501548 
Room 410, Building A, 3rd Sub-parkSE DECISION MADE: 12-JAN-22
Shenzhen  CN 518118               510(k) STATEMENT
                                                    

DEVICE: Electric breast pump
Dongguan Rongfeng Medical Co., Ltd510(k) NO: K212884(Traditional)
ATTN: Qianqian  Yu                PHONE NO : 86 158 55474815 
Room 201, No. 7 Xiangyuan Road, ShSE DECISION MADE: 20-JAN-22
Dongguan  CN 523570               510(k) STATEMENT
                                                    

DEVICE: Surgical Face Mask
Jiangxi Ganlong Pharmaceutical Co.510(k) NO: K212913(Traditional)
ATTN: Niansheng  Liao             PHONE NO : 86 189 07977486 
No. 164 Xiangjiang Ave. Ganzhou EcSE DECISION MADE: 14-JAN-22
Ganzhou  CN 341000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitalograph Model 6000 Alpha
Vitalograph Ireland Ltd.          510(k) NO: K212938(Traditional)
ATTN: Tony  O'Hanlon              PHONE NO : 353 656 864100 
Gort Road Business Park           SE DECISION MADE: 26-JAN-22
Ennis Co Clare  IE V95 HFT4       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Porous Patella
Encore Medical, L.P. dba DJO Surgi510(k) NO: K212941(Traditional)
ATTN: Michael A Siano             PHONE NO : 737 2074857 
9800 Metric Boulevard             SE DECISION MADE: 20-JAN-22
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyntheCel Dura Repair
Synthes (USA) products, LLC       510(k) NO: K212943(Traditional)
ATTN: Doug  Steinberger           PHONE NO : 419 3070674 
1230 Wilson Dr.                   SE DECISION MADE: 28-JAN-22
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G-Tech Wireless Patch System (WPS)
G-Tech Medical                    510(k) NO: K212954(Traditional)
ATTN: Steve  Axelrod              PHONE NO : 650 2691479 
2495 Hospital Drive, Suite 300    SE DECISION MADE: 10-JAN-22
Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tesera-k ALIF System
Kyocera Medical Technologies, Inc.510(k) NO: K212980(Traditional)
ATTN: Scott  Rucker               PHONE NO : 1 909 5572360 456
1200 California Street, Ste. 210  SE DECISION MADE: 07-JAN-22
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acumed Ankle Syndesmosis Repair System
Acumed LLC                        510(k) NO: K212990(Traditional)
ATTN: Janki  Bhatt                PHONE NO : 503 7188753 
5885 NE Cornelius Pass Road       SE DECISION MADE: 07-JAN-22
Hillsboro OR  97124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Osteorevive
Bone Solutions, Inc.              510(k) NO: K212991(Traditional)
ATTN: Drew  Diaz                  PHONE NO : 817 8098850 
5712 Colleyville Boulevard, Suite SE DECISION MADE: 21-JAN-22
Colleyville TX  76034             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medical Face Mask
Guangzhou Quantum Laser Intelligen510(k) NO: K212994(Traditional)
ATTN: Hao  Zheng                  PHONE NO : 86 20 39969520 
Building B27 Huachuang Animation ISE DECISION MADE: 17-JAN-22
Guangzhou  CN 511450              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Mask
Guangdong Zhizhen Biological Medic510(k) NO: K212997(Traditional)
ATTN: Caiyun  Zhou                PHONE NO : 86 20 37713902 
3rd and 4th floors of building 2 &SE DECISION MADE: 14-JAN-22
Guangzhou  CN 510820              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Exam Gloves
Hebei Astro Medical Supply Co., Lt510(k) NO: K213019(Traditional)
ATTN: Ning  Zheng                 PHONE NO : 86 186 17965639 
East of Xiaoxixian, West of JingsaSE DECISION MADE: 05-JAN-22
Jinzhou  CN 052260                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iASSIST Knee System
Orthosoft d/b/a Zimmer CAS        510(k) NO: K213033(Traditional)
ATTN: Paul  Hardy                 PHONE NO : 571 4536739 
75 Queen Street, Suite 3300       SE DECISION MADE: 14-JAN-22
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Gloves
Jiangsu Huayuan Medical Technology510(k) NO: K213044(Traditional)
ATTN: Yun  Gao                    PHONE NO : 86 182 52909158 
No. 36 Nanzhuang Road, High-Tech ISE DECISION MADE: 21-JAN-22
Dongtai City  CN 224299           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gold Anchor
Naslund Medical AB                510(k) NO: K213053(Traditional)
ATTN: Tomas  Näslund              PHONE NO : 46 73 2620717 
Avagen 40 B                       SE DECISION MADE: 06-JAN-22
Huddinge  SE 14130                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Smoke Evacuation Shroud
Medline Industries, Inc.          510(k) NO: K213068(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 03-JAN-22
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: Goody Gloves, Wincare, TBG Gloves
Thai Rubber Gloves Co., Ltd.      510(k) NO: K213075(Abbreviated)
ATTN: Chalongkwan  Wongsasuthikul PHONE NO : 66 2 1306356 
680 Moo 2 Banbueng-Klaeng Rd.     SE DECISION MADE: 20-JAN-22
Nongyai  TH 20190                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-Edge 10, T-Edge 11
Tuttnauer Ltd.                    510(k) NO: K213080(Traditional)
ATTN: Robert  Basile              PHONE NO : 631 9300437 
Har-Tuv  Industrial Zone          SE DECISION MADE: 04-JAN-22
Beit-Shemesh  IL 9910101          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311
Guangzhou Berrcom Medical Device C510(k) NO: K213082(Traditional)
ATTN: Zhigang  Du                 PHONE NO : 86 020 34938449 
No.38 Huanzhen Xi Road, Dagang TowSE DECISION MADE: 28-JAN-22
Guangzhou  CN 51147               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STEP-1 PumEtch
Rounding Third LLC                510(k) NO: K213093(Traditional)
ATTN: Thomas  Macari              PHONE NO : 720 7131613 
9750 East Easter Avenue #155      SE DECISION MADE: 28-JAN-22
Centennial CO  80112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: andorate Suction Valve, andorate Air/Water Valve
GA Health Company Limited         510(k) NO: K213095(Traditional)
ATTN: Cindy  Ye                   PHONE NO : 852 28339010 
Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 12-JAN-22
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ES1 System
E-Scopics                         510(k) NO: K213102(Traditional)
ATTN: Claude  Cohen-Bacrie        PHONE NO : 33 684 323275 
931 Chemin De La Bosque D'AntonellSE DECISION MADE: 11-JAN-22
Aix-en-Provence  FR 13090         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MagnetOs granules
Kuros Biosciences BV              510(k) NO: K213111(Traditional)
ATTN: Sonja van der Meer          PHONE NO : 31 30 2297280 
Professor Bronkhorstlaan 10, buildSE DECISION MADE: 10-JAN-22
Bilthoven  NL 3723 MB             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
Shen Wei USA Inc.                 510(k) NO: K213142(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave Ste 102         SE DECISION MADE: 28-JAN-22
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: Medical Examination Gloves
Shandong Huiwosheng Health Technol510(k) NO: K213168(Traditional)
ATTN: Haitao  Wu                  PHONE NO : 86 188 65233273 
50m East Of Chaoyang Road, ZhanqiaSE DECISION MADE: 11-JAN-22
Dezhou  CN 250000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Nitrile Medical Powder-free Glove
Fujian Chunhui Medical Supply Co.,510(k) NO: K213187(Traditional)
ATTN: Jing  Cai                   PHONE NO : 86 180 60003170 
No.179, Shanggeteng Ping, Shifang SE DECISION MADE: 03-JAN-22
Longyan City  CN 364301           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Primary Relief
DyAnsys, Inc.                     510(k) NO: K213188(Traditional)
ATTN: Srini  Nageshwar            PHONE NO : 408 4804700 
300, North Bayshore Boulevard     SE DECISION MADE: 31-JAN-22
San Mateo CA  94401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System
Stryker GmbH                      510(k) NO: K213199(Traditional)
ATTN: Danielle Jannuzzi Madureira PHONE NO : 004 1 798900289 
325 Corporate Drive               SE DECISION MADE: 11-JAN-22
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
Carolina Liquid Chemistries, Corp.510(k) NO: K213211(Traditional)
ATTN: Patricia A Shugart          PHONE NO : 1 877 7228910 
313 Gallimore Dairy Road          SE DECISION MADE: 27-JAN-22
Greensboro NC  27409              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Unicon Optical Co., Ltd           510(k) NO: K213216(Traditional)
ATTN: Nick  Liao                  PHONE NO : 886 4 23551233 
No. 16 Gongye E. 9th Rd, Hsinchu SSE DECISION MADE: 18-JAN-22
Baoshan Township  TW 30075        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs)
Uweport LLC.                      510(k) NO: K213227(Traditional)
ATTN: Mike  Wang                  PHONE NO : 314 4350587 
3623 Latrobe Drive Suite 201      SE DECISION MADE: 19-JAN-22
Charlotte NC  28211               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CELERITY HP Chemical Indicator
Steris Corporation                510(k) NO: K213262(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd                   SE DECISION MADE: 07-JAN-22
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASS LP™ Spinal System, CD Horizon™ Spinal System
Medicrea International SA         510(k) NO: K213281(Traditional)
ATTN: Karine  Trogneux            PHONE NO : 33 472 018787 
5389 Route De Strasbourg - Vancia SE DECISION MADE: 05-JAN-22
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse II with Smart Noise Cancellation
Carestream Health, Inc.           510(k) NO: K213307(Traditional)
ATTN: Gina  Maiolo                PHONE NO : 585 6276543 
150 Verona St                     SE DECISION MADE: 14-JAN-22
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venus BlissMAX
Venus Concept USA Inc.            510(k) NO: K213308(Traditional)
ATTN: Nadav  Reuben               PHONE NO : 972 524211666 
1880 N Commerce Pkwy, Suite 2     SE DECISION MADE: 12-JAN-22
Weston FL  33326                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ShinEvac Smoke Evacuation Pencil
Shining World Health Care Co., Ltd510(k) NO: K213317(Traditional)
ATTN: Anita  Chen                 PHONE NO : 886 0 939855759 
No.22, Ln. 116, Wugong 2nd Rd., WuSE DECISION MADE: 28-JAN-22
New Taipei City  TW 248           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
Anhui Xinyisheng Medical Technolog510(k) NO: K213325(Traditional)
ATTN: Wei Wei  Tang               PHONE NO : 86 180 12883846 
No.999 North Of The Intersection OSE DECISION MADE: 28-JAN-22
Suzhou  CN 234300                 510(k) STATEMENT
                                                    

DEVICE: Capsule Surveillance System
Capsule Surveillance Technologies,510(k) NO: K213335(Traditional)
ATTN: Peter  Kelley               PHONE NO : 978 6974364 
300 Brickstone Square Suite 203   SE DECISION MADE: 14-JAN-22
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRO-DENSE LoVisc Bone Graft Substitute
Wright Medical Technology, Inc.   510(k) NO: K213342(Traditional)
ATTN: Leslie  Fitch               PHONE NO : 901 8674120 
1023 Cherry Road                  SE DECISION MADE: 05-JAN-22
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Saremco Print CROWNTEC
Saremco Dental AG                 510(k) NO: K213343(Abbreviated)
ATTN: Franca  Schmid              PHONE NO : 41 71 7758090 
Gewerbestrasse 4                  SE DECISION MADE: 21-JAN-22
Rebstein  CH CH-9445              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTL-899A
BTL Industries Inc.               510(k) NO: K213344(Traditional)
ATTN: David  Chmel                PHONE NO : 1 866 2851656 
362 Elm Street                    SE DECISION MADE: 05-JAN-22
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADI Medical Surgical Face Mask
Asia Dynamics Inc., d/b/a ADI Medi510(k) NO: K213347(Traditional)
ATTN: Jonathan  Zhu               PHONE NO : 847 6889968 
1565 South Shields Drive          SE DECISION MADE: 25-JAN-22
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Entuit PEG, Entuit PEGJ
Wilson-Cook Medical, Inc.         510(k) NO: K213356(Special)
ATTN: Tiffanny A. Thomas          PHONE NO : 336 7440157 396680
4900 Bethania Station Road        SE DECISION MADE: 20-JAN-22
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 360CAS
Kico Knee Innovation Company Pty L510(k) NO: K213380(Traditional)
ATTN: Stefanie Auf Der Mauer      PHONE NO : 00 614 16177123 
Suite 3, Building 1, 20 Bridge StrSE DECISION MADE: 11-JAN-22
Pymble  AU 2073                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: High Retention Attachment System
Zest Anchors, LLC                 510(k) NO: K213391(Traditional)
ATTN: Mark  Stavro                PHONE NO : 1 442 2444835 
2875 Loker Avenue East            SE DECISION MADE: 11-JAN-22
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIAPLUS Universal
Diadent Group International       510(k) NO: K213401(Traditional)
ATTN: Kab Sun Lee                 PHONE NO : 82 43 2662315 
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 31-JAN-22
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM
STERIS Corparation                510(k) NO: K213412(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 21-JAN-22
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jabra Enhance Plus
GN Hearing A/S                    510(k) NO: K213424(Traditional)
ATTN: Lars  Hagander              PHONE NO : 45 4575 1111 
Lautrupbjerg 7                    SE DECISION MADE: 19-JAN-22
Ballerup  DK DK-2750              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
Adaptiiv                          510(k) NO: K213438(Traditional)
ATTN: Anastasiia  Mereshchuk      PHONE NO : 1902 329 9713 
1344 Summer Street Suite 406      SE DECISION MADE: 19-JAN-22
Halifax  CA B3H 0A8               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
Shenzhen CosBeauty Technology Co.,510(k) NO: K213447(Traditional)
ATTN: Ares  Zou                   PHONE NO : 86 755 86271293 
UnitA-3F, Qiao De Industrial Park,SE DECISION MADE: 19-JAN-22
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PERLA® TL Posterior Osteosynthesis System
Spineart                          510(k) NO: K213470(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 Chemin du Pré Fleuri            SE DECISION MADE: 21-JAN-22
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elevo Snoring Intervention Set
Zelegent, Inc.                    510(k) NO: K213475(Traditional)
ATTN: David C. Humbert            PHONE NO : 650 7638282 102
4250 Executive Square, Suite 675  SE DECISION MADE: 27-JAN-22
La Jolla CA  92037                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate
WishBone Medical, Inc.            510(k) NO: K213489(Traditional)
ATTN: Ramakrishna  Bajaj          PHONE NO : 574 3064006 427
100 Capital Drive                 SE DECISION MADE: 27-JAN-22
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortilink with TiPlus Technology
Paradigm Spine                    510(k) NO: K213493(Traditional)
ATTN: Jessica  Jho                PHONE NO : 1 801 4559267 
Eisenbahnstrabe 84                SE DECISION MADE: 27-JAN-22
Wurmlingen Baden-Wurttemberg  DE 7510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-CUBE i8, X-CUBE i9
Alpinion Medical Systems Co., Ltd.510(k) NO: K213523(Traditional)
ATTN: Boyeon  Cho                 PHONE NO : 82 70 74652104 
5FL, I dong, 77, heungan-daero 81bSE DECISION MADE: 28-JAN-22
Anyang-si  KR 14117               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOMTEC-ARENA
TOMTEC Imaging Systems GmbH       510(k) NO: K213544(Traditional)
ATTN: Marc  Bergenthal            PHONE NO : 49 89 32175555 
Freisinger Strasse 9              SE DECISION MADE: 06-JAN-22
Unterschleissheim  DE 85716       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExactechGPS Total Shoulder Application, Equinoxe Planning Software
Blue Ortho                        510(k) NO: K213546(Traditional)
ATTN: Matthieu  Coic              PHONE NO : 33 4 58003525 
22 Chemin du Vieux Chene          SE DECISION MADE: 06-JAN-22
Meylan  FR 38240                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co510(k) NO: K213570(Traditional)
ATTN: Wang  Lili                  PHONE NO : 86 335 8587198 
No.9 Dushan Road,Economic and TechSE DECISION MADE: 07-JAN-22
Qinhuangdao  CN 066004            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JuniOrtho Plating System™
Orthofix Srl                      510(k) NO: K213572(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via delle Nazioni, 9              SE DECISION MADE: 18-JAN-22
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANTHEM® Fracture System
Globus Medical Inc.               510(k) NO: K213591(Traditional)
ATTN: Jennifer  Antonacci         PHONE NO : 610 9301800 1861
2560 General Armistead Ave.       SE DECISION MADE: 26-JAN-22
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
Boston Scientific Corporation     510(k) NO: K213593(Special)
ATTN: Cassie  Clark               PHONE NO : 763 4941425 
1 Scimed Place                    SE DECISION MADE: 14-JAN-22
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
Covidien, llc                     510(k) NO: K213602(Traditional)
ATTN: Carol S Ming                PHONE NO : 508 4521443 
15 Hampshore Street               SE DECISION MADE: 14-JAN-22
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revaclear 500, Revaclear 400, Revaclear 300
Baxter Healthcare Corporation     510(k) NO: K213639(Traditional)
ATTN: Jesse  Seidman              PHONE NO : 224 2706467 
32650 N Wilson Road               SE DECISION MADE: 24-JAN-22
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
GE Healthcare                     510(k) NO: K213642(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation DRive             SE DECISION MADE: 13-JAN-22
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraPrint-Dental Temp C&B UV
Guangzhou Heygears Imc. Inc       510(k) NO: K213643(Traditional)
ATTN: Lin  Liu                    PHONE NO : 86 176 12078809 
Block B2, 501, 601, Enterprise AccSE DECISION MADE: 14-JAN-22
Guangzhou  CN 510700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNA Hero
GE Healthcare (GE Medical Systems,510(k) NO: K213668(Traditional)
ATTN: Sandra  Westphal            PHONE NO : 262 7208872 
3200 N Grandview Blvd.            SE DECISION MADE: 20-JAN-22
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: b-ONE MOBIO Total Knee System
b-ONE ORTHO, Corp.                510(k) NO: K213673(Traditional)
ATTN: Allison  Gecik              PHONE NO : 973 9658940 
3 Wing Drive Suite #259           SE DECISION MADE: 21-JAN-22
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmoothSkin Pure Mini
CyDen Limited                     510(k) NO: K213692(Special)
ATTN: Adam  Stephens              PHONE NO : 44 0 1792274009 
Block A, Bay Studios Business ParkSE DECISION MADE: 26-JAN-22
Swansea  GB SA1 8QB               510(k) STATEMENT
                                                    

DEVICE: ETHICON Megadyne Electrosurgical Generator
Megadyne Medical Products, Inc.   510(k) NO: K213696(Traditional)
ATTN: Sharon  Sussex              PHONE NO : 904 7423723 
11506 South State Street          SE DECISION MADE: 21-JAN-22
Draper UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNA PET/MR
GE Medical Systems, LLC           510(k) NO: K213709(Traditional)
ATTN: Brian R Zielski             PHONE NO : 262 2273596 
3200 N Grandview Blvd             SE DECISION MADE: 20-JAN-22
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vital Navigation System
ZimVie (Zimmer Biomet Spine, Inc.)510(k) NO: K213720(Special)
ATTN: Hanna  Aucoin               PHONE NO : 816 5622948 
10225 Westmoor Drive              SE DECISION MADE: 07-JAN-22
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantib ND
Quantib B.V.                      510(k) NO: K213737(Special)
ATTN: Floor  van Leeuwen          PHONE NO : 31 108 411749 
Westblaak 106                     SE DECISION MADE: 14-JAN-22
Rotterdam  NL 3012KM              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merlin Aspiration System
MIVI Neurovascular, Inc.          510(k) NO: K213771(Traditional)
ATTN: Janel  Hurtado              PHONE NO : 612 5185800 
6545 City West Parkway            SE DECISION MADE: 27-JAN-22
Eden Prairie MN  55443            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
Canon Inc.                        510(k) NO: K213780(Traditional)
ATTN: Akira  Hirai                PHONE NO : 81 33 7582111 
9-1 Imaikami-Cho, Nakahara-Ku     SE DECISION MADE: 24-JAN-22
Kawasaki  JP 211-8501             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP
DePuy Ireland UC                  510(k) NO: K213781(Special)
ATTN: Erin  Combs                 PHONE NO : 574 4048348 
Loughbeg                          SE DECISION MADE: 18-JAN-22
Ringaskiddy  IE                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPO Hip Instruments
MicroPort Orthopedics Inc.        510(k) NO: K213816(Special)
ATTN: Gillen  Gonzales            PHONE NO : 901 8674400 
5677 Airline Road                 SE DECISION MADE: 05-JAN-22
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPO Knee Instruments; MPO PROPHECY Knee Instruments
MicroPort Orthopedics Inc.        510(k) NO: K213817(Special)
ATTN: Gillen  Gonzales            PHONE NO : 901 8674400 
5677 Airline Road                 SE DECISION MADE: 05-JAN-22
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
Gyrus ACMI, Inc.                  510(k) NO: K213831(Special)
ATTN: Dolan  Mills                PHONE NO : 901 3550007 
800 West Park Drive               SE DECISION MADE: 04-JAN-22
Westborough MA  01581             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCOPE BUDDY PLUS Endoscope Flushing Aid
Medivators Inc                    510(k) NO: K213833(Special)
ATTN: Mark  Arnold                PHONE NO : 416 5715637 
14605 28th Ave North              SE DECISION MADE: 14-JAN-22
Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Corail AMT Hip Prosthesis
DePuy Orthopaedics Inc.           510(k) NO: K213839(Special)
ATTN: Erin  Combs                 PHONE NO : 574 4048348 
700 Orthopaedic Drive             SE DECISION MADE: 06-JAN-22
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENEO TOTALE (Model: ENEOT947)
Premier North America Inc.        510(k) NO: K213841(Special)
ATTN: Ellis  Tamari               PHONE NO : 404 492813311 
3301 SW 42nd Street               SE DECISION MADE: 06-JAN-22
Ft Lauderdale FL  33312           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stronghold Group Nitrile Examination Glove, Powder Free
Stronghold Group LLC              510(k) NO: K213859(Third Party - Traditional)
ATTN: David  Henderson            PHONE NO : 215 3508855 
98 Foxfire Lane                   SE DECISION MADE: 13-JAN-22
Lewisberry PA  17339              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Self-adhesive Electrode
Bozhou Rongjian Medical Appliance 510(k) NO: K213879(Traditional)
ATTN: Zhifang  Wu                 PHONE NO : 86 558 7963368 
Jianghuai Supply Base, Zhongkai GrSE DECISION MADE: 05-JAN-22
Bozhou  CN 233500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Custom Stable Rigid Gas Permeable Scleral Contact Lens
Valley Contax, Inc.               510(k) NO: K213880(Special)
ATTN: Josh  Adams                 PHONE NO : 800 5478815 
200 South Mill St.                SE DECISION MADE: 07-JAN-22
Springfield OR  97477             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Distal Humerus Plating System
Skeletal Dynamics, Inc.           510(k) NO: K213895(Special)
ATTN: Alexandra  Rodriguez        PHONE NO : 305 5967585 7121
7300 N. Kendall Drive, Suite 400  SE DECISION MADE: 13-JAN-22
Miami FL  33156                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cyclops™ Anterior Cervical Plate System
DeGen Medical                     510(k) NO: K213901(Special)
ATTN: Craig  Black                PHONE NO : 843 9924551 
1321-C North Cashua Drive         SE DECISION MADE: 07-JAN-22
Florence SC  29501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SKR 3000
Konica Minolta, INC.              510(k) NO: K213908(Traditional)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 31-JAN-22
Hino-shi  JP 191-8511             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIB Stent Placement Catheter
NuMED Inc.                        510(k) NO: K213915(Special)
ATTN: Nichelle  LaFlesh           PHONE NO : 315 3284491 
2880 Main St.                     SE DECISION MADE: 12-JAN-22
Hopkinton NY  12965               510(k) STATEMENT
                                                    

DEVICE: Kangbeier Surgical Mask (Model: KBR-1001)
Xinxiang Kangbeier Medical Technol510(k) NO: K213920(Third Party - Traditional)
ATTN: Shaoju  Tian                PHONE NO : 86 133 41254319 
East Mancun Industrial District   SE DECISION MADE: 16-JAN-22
Changyuan  CN 48105               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Respiratory Gating for Scanners v2.0
Varian Medical Systems, Inc.      510(k) NO: K213927(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 14-JAN-22
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esteya
Nucletron B.V.                    510(k) NO: K213942(Traditional)
ATTN: Kiran  Jose                 PHONE NO : 31 318 557133 
3900 Ax Veenendaal, P.O. Box 930, SE DECISION MADE: 11-JAN-22
Veenendaal  NL 3905 TH            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORZA XP Expandable Spacer System
Orthofix US LLC                   510(k) NO: K213951(Special)
ATTN: Natalia  Volosen            PHONE NO : 214 9372145 
3451 Plano Parkway                SE DECISION MADE: 05-JAN-22
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
Danameco Medical Joint Stock Corpo510(k) NO: K213970(Third Party - Traditional)
ATTN: Huynh Thi Li Li             PHONE NO : 84 236 3849833 
No 12, Trinh Cong Son Street      SE DECISION MADE: 23-JAN-22
Da Nang  VN 550000                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Straight Arm DDR
Konica Minolta Healthcare Americas510(k) NO: K214012(Special)
ATTN: Jan  Maniscalco             PHONE NO : 973 6331500 
2217 US Highway 70 East           SE DECISION MADE: 12-JAN-22
Garner NC  27529                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc510(k) NO: K214019(Special)
ATTN: Alaine  Medio               PHONE NO : 865 2060337 
810 Innovation Drive              SE DECISION MADE: 20-JAN-22
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Universal DR 1748
Konica Minolta Healthcare Americas510(k) NO: K214030(Traditional)
ATTN: Jan  Maniscalco             PHONE NO : 973 6331500 
2217 US Highway 70 East           SE DECISION MADE: 21-JAN-22
Garner NC  27529                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreLink Navigation Instruments
CoreLink, LLC                     510(k) NO: K214059(Special)
ATTN: Steven  Mounts              PHONE NO : 888 3497808 
2072 Fenton Logistics Park        SE DECISION MADE: 19-JAN-22
St. Louis MO  63026               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
CEFLA S.C.                        510(k) NO: K214084(Special)
ATTN: Lorenzo  Bortolotti         PHONE NO : 39 0542 653441 
Via Selice Provinciale 23/A       SE DECISION MADE: 20-JAN-22
Imola  IT 40026                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QuikPass Catheter
Traverse Vascular, Inc.           510(k) NO: K214106(Third Party - Traditional)
ATTN: Greg  Geissinger            PHONE NO : 858 3498839 
535 Stevens Ave. West             SE DECISION MADE: 28-JAN-22
Solana Beach CA  92075            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 8mm Monopolar Curved Scissors
Intuitive Surgical, Inc.          510(k) NO: K220023(Special)
ATTN: Gayle  Perry                PHONE NO : 650 8679347 
1266 Kifer Road                   SE DECISION MADE: 31-JAN-22
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRESIDENT The Original
Coltène/Whaledent AG              510(k) NO: K220097(Third Party - Traditional)
ATTN: Katrin  Ader                PHONE NO : 41 71 7575325 
Feldwiesenstrasse 20              SE DECISION MADE: 13-JAN-22
Altstätten  CH 9450               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


        TOTAL 510(k)s THIS PERIOD   235                                     
        TOTAL WITH SUMMARIES        223                                     
        TOTAL WITH STATEMENTS        12
                                      
 
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