1 year ago510(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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