510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2021
DEVICE: Velocity Alpha Highspeed Surgical Drill System
adeor Medical AG 510(k) NO: K191479(Traditional)
ATTN: Viktor Rundel PHONE NO : 0049 089 74442398
Biberger Str. 93 SE DECISION MADE: 11-APR-21
Unterhaching DE 82008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device
Avazzia, Inc 510(k) NO: K191951(Traditional)
ATTN: Tammy Lahutsky PHONE NO : 214 5752820
13140 Coit Road, Suite 515 SE DECISION MADE: 27-APR-21
Dallas TX 75240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solax Electric Scooter
Dongguan Prestige Sporting Goods C510(k) NO: K192190(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 1376 3128800
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 23-APR-21
Dongguan CN 523950 510(k) STATEMENT
DEVICE: VIVACE Electrosurgical Device
ShenB Co Ltd. 510(k) NO: K193070(Traditional)
ATTN: Sun Young Kang PHONE NO : 82 2 4660010
Shenb Bldg 148, Seongsui-ro SE DECISION MADE: 26-APR-21
Seongdong-Gu KR 04796 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hekaDrill
Zethon Ltd 510(k) NO: K193630(Traditional)
ATTN: Faith Green PHONE NO : 44 012966 34090
2 Halton Brook Business Park SE DECISION MADE: 09-APR-21
Aylesbury GB hp22 5wf 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
Boston Scientific Corporation 510(k) NO: K200260(Traditional)
ATTN: Heidi Shearer PHONE NO : 763 2550056
Three Scimed Place SE DECISION MADE: 26-APR-21
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: rainbow MCT
Dentium Co., Ltd (ICT Branch) 510(k) NO: K200270(Traditional)
ATTN: Sangwoo Lee PHONE NO : 82 70 70984027
76, Changnyong-daero 256beon-gil, SE DECISION MADE: 16-APR-21
Suwon-Si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: rainbow CT
Dentium Co., Ltd (ICT Branch) 510(k) NO: K200271(Traditional)
ATTN: Sangwoo Lee PHONE NO : 82 70 70984027
76, Changnyong-daero 256beon-gil, SE DECISION MADE: 16-APR-21
Suwon-Si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDCAM Dental Implants
Implants Diffusion International 510(k) NO: K200329(Traditional)
ATTN: Rony Boukhris PHONE NO : 33 014 8707048
23 rue Emile Zola SE DECISION MADE: 22-APR-21
Montreuil FR 93100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPACT Extension
Medacta International SA 510(k) NO: K200391(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 28-APR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Huber Needle Infusion Set, Safety Huber Needle Infusion Set
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K200463(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 0510 86866666 8027
No.23, Huanxi Rd, Zhutang Town SE DECISION MADE: 07-APR-21
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Idys ALIF 3DTi
CLARIANCE 510(k) NO: K200919(Traditional)
ATTN: Fadwa Bahr PHONE NO : 33 3 21161215
18, rue Robespierre SE DECISION MADE: 12-APR-21
Beaurains FR 62217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Wheelchair (Model: S7110)
Dongguan Prestige Sporting Goods C510(k) NO: K200978(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 137 63128800
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 16-APR-21
Dongguan CN 523950 510(k) STATEMENT
DEVICE: Expandable Titanium PLIF/TLIF System
Spectrum Spine, LLC 510(k) NO: K201024(Traditional)
ATTN: James Robinson PHONE NO : 404 5501335
4020 Stovall Terrace NE SE DECISION MADE: 29-APR-21
Atlanta GA 30342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fusion Taper System
Signature Orthopaedics Pty Ltd. 510(k) NO: K201047(Traditional)
ATTN: Declan Brazil PHONE NO : 61 29428 5181
7 Sirius Road SE DECISION MADE: 16-APR-21
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEFEND Ear-loop Face Masks
Young Dental Manufacturing Co. 1, 510(k) NO: K201127(Abbreviated)
ATTN: Jose Espino PHONE NO : 847 4585829 2829
13705 Shoreline Court East SE DECISION MADE: 14-APR-21
Earth City MO 63045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSure® Single Use Saline Topical Solution
Amsino Medical Inc. 510(k) NO: K201138(Traditional)
ATTN: Torsten Nilson PHONE NO : 847 7721958
700 Enterprise St. Aurora SE DECISION MADE: 14-APR-21
Aurora IL 60504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
LEONI Fiber Optics, Inc. 510(k) NO: K201171(Traditional)
ATTN: Martin Trapp PHONE NO : 757 2584805
209 Bulifants Blvd SE DECISION MADE: 02-APR-21
Williamsburg VA 23188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Arrive Systems Inc 510(k) NO: K201257(Traditional)
ATTN: Aseem Gupta PHONE NO :
113 Brakdale SE DECISION MADE: 06-APR-21
New Ark DE 19711 510(k) STATEMENT
DEVICE: Auxein Brand Vertaux 5.5 mm Pedicle Screw System
Auxein Medical Private Limited|711510(k) NO: K201457(Traditional)
ATTN: Gaurav Luthra PHONE NO : 91 971 7586969
Plot No.168,169,170 Phase-IV, SectSE DECISION MADE: 06-APR-21
Sonipath IN 131028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuRE PMMA Disc
Quest Dental USA Corp. 510(k) NO: K201563(Special)
ATTN: Hirotaka Mori PHONE NO : 949 8703985
17865 Sky Park Circle, Suite L1 SE DECISION MADE: 09-APR-21
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Apex Knee System
OMNIlife science 510(k) NO: K201611(Traditional)
ATTN: Dipti Dharia PHONE NO : 1 732 7545466
480 Paramount Drive SE DECISION MADE: 02-APR-21
Raynham MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GD Disposable Medical Face Mask
Jiangsu Guangda Medical Material G510(k) NO: K201718(Traditional)
ATTN: George Zhang PHONE NO : 86 513 88219002
No. 18 Baochang Road (North) SE DECISION MADE: 15-APR-21
Libao Town CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Naton Disposable Surgical Face Mask
Naton Biotechnology (Beijing) Co.,510(k) NO: K201853(Traditional)
ATTN: Shanshan Zou PHONE NO : 86 010 83022442
No. 9, Chengwan Street, Haidian DiSE DECISION MADE: 23-APR-21
Beijing CN 100094 510(k) STATEMENT
DEVICE: Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
Maquet Critical Care AB 510(k) NO: K201874(Traditional)
ATTN: David Ardanius PHONE NO : 46 10335 7300
Rontgenvagen 2 SE DECISION MADE: 20-APR-21
Solna SE 17154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric breast pump (Models: RH-228 and RH-338)
Cixi Ruihong Electric Appliance Co510(k) NO: K201903(Traditional)
ATTN: Zhangkelong Zhangkelong PHONE NO : 0086 0574 63581761
No. 18, Xiamaojia Road, ShuangqingSE DECISION MADE: 09-APR-21
Ningbo CN 315322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Idys LLIF 3DTi
Clariance, SAS 510(k) NO: K202032(Traditional)
ATTN: Fadwa Bahr PHONE NO : 33 3 21161215
18, rue Robespierre SE DECISION MADE: 01-APR-21
Beaurains FR 62217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Secret Duo
Ilooda Co Ltd 510(k) NO: K202043(Traditional)
ATTN: Kevin Walls PHONE NO : 720 9625412
120, Jangan-Ro 458 Beon-Gil JanganSE DECISION MADE: 23-APR-21
Suwon-Si Gyeonggido KR 16200 510(k) STATEMENT
DEVICE: Looper (Model: ZX-579S)
Heat In A Click LLC 510(k) NO: K202055(Traditional)
ATTN: Guy Levi PHONE NO : 1 954 5189777
1975 Tigertail Blvd Dania SE DECISION MADE: 16-APR-21
Homestead FL 33034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeepLook PRECISE
DeepLook Inc. 510(k) NO: K202084(Traditional)
ATTN: Steven Schwadron PHONE NO : 202 3060808
1220 Burton Street SE DECISION MADE: 09-APR-21
Silver Spring MD 20910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo
Largan Medical Co., Ltd. 510(k) NO: K202129(Traditional)
ATTN: Amy Tien PHONE NO : 886 4 36000203
2F., No. 14, 23rd Rd., Taichung InSE DECISION MADE: 01-APR-21
Taichung TW 40850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Well Lead All Silicone Foley Catheter with Temperature Sensor
Well Lead Medical Co., LTD. 510(k) NO: K202134(Special)
ATTN: Jenny Zhu PHONE NO : 86 20 84758878
C-4# Jinhu Industrial Estate, HualSE DECISION MADE: 08-APR-21
Guangzhou CN 511434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDS Cortisol
Immunodiagnostic Systems Ltd. 510(k) NO: K202136(Traditional)
ATTN: Mick Henderson PHONE NO : 191 51 90660
10 Didcot Way Boldon Business ParkSE DECISION MADE: 13-APR-21
Boldon GB NE35 9PD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B-Capta
LivaNova Deutschland GmbH 510(k) NO: K202154(Traditional)
ATTN: Mattia Ronchetti PHONE NO : 39 342 7621974
Lindberghstr. 25 SE DECISION MADE: 01-APR-21
Munich DE 80939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Porcine Mineral Collagen Composite
Collagen Matrix, Inc. 510(k) NO: K202183(Traditional)
ATTN: Gloria Zuclich PHONE NO : 201 4051477
15 Thornton Road SE DECISION MADE: 02-APR-21
Oakland NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMG PMP Pediatric
Eurosets S.r.l. 510(k) NO: K202206(Traditional)
ATTN: Katia Vescovini PHONE NO : 39 0535 660334
Strada Statale 12, n°143 SE DECISION MADE: 01-APR-21
Medolla IT i-41036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Omron Model BP7900 Blood Pressure Monitor + EKG
Omron Healthcare, Inc. 510(k) NO: K202228(Traditional)
ATTN: Renee Thornborough PHONE NO : 847 2475626
1925 West Field Court, Suite 100 SE DECISION MADE: 01-APR-21
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SkinPen Precision System
Crown Aesthetics 510(k) NO: K202243(Traditional)
ATTN: Marie Fogartie PHONE NO : 423 6302296
5005 Lyndon B. Johnson Frwy., SuitSE DECISION MADE: 02-APR-21
Dallas TX 75244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermatological Diode Laser Systems
Zhuolu Jontelaser Manufacturing Te510(k) NO: K202257(Traditional)
ATTN: Karen Liu PHONE NO : 86 139 11459627
No. 31, Sanguanmiao Alley, Zhuolu SE DECISION MADE: 23-APR-21
Zhangjiakou CN 072750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ERISE Laser handpiece
EL.EN. Electronic Engineering Spa 510(k) NO: K202258(Traditional)
ATTN: Paolo Peruzzi PHONE NO : 39 055 8826807
Via Baldanzese 17 SE DECISION MADE: 26-APR-21
Calenzano IT 50041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EasyPoint Blood Collection Plus
Retractable Technologies, Inc. 510(k) NO: K202325(Traditional)
ATTN: Becky Piroga PHONE NO : 1 972 2941010
511 Lobo Lane SE DECISION MADE: 09-APR-21
Little Elm TX 75068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pentax Medical Video Duodenoscope ED32-i10
Pentax of America, Inc. 510(k) NO: K202365(Traditional)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 01-APR-21
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Face Mask
Guangdong Bida Medical Technology 510(k) NO: K202387(Traditional)
ATTN: Zhang Rong PHONE NO : 86 134 37492306
No.2, Xingfeng Rd, Shangsha ZhenxiSE DECISION MADE: 23-APR-21
Dongguan CN 523843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKORE (Colors & Flavors), SKORE (Colors)
TTK Healthcare Limited 510(k) NO: K202403(Traditional)
ATTN: Daniel J. S. PHONE NO : 9 413 2261401
12, K P Natham Road, Thiruvandar KSE DECISION MADE: 15-APR-21
Puducherry IN 605102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOTECH Nitrile Examination Gloves
TK Hitech Technology Co., Ltd. 510(k) NO: K202419(Traditional)
ATTN: Kanyapadsanan SuppipatthipbPHONE NO : 66 02 0038218
1/221 Venish Irish Iris WatcharaphSE DECISION MADE: 16-APR-21
Tha Rang, Bangkok TH 10220 510(k) STATEMENT
DEVICE: Eclipse II with Smart Noise Cancellation
Carestream Health, Inc. 510(k) NO: K202441(Traditional)
ATTN: Duane Gutowski PHONE NO : 585 6278760
150 Verona Street SE DECISION MADE: 02-APR-21
Rochester NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Orbis Surgical Gown
Medline Industries, Inc. 510(k) NO: K202447(Traditional)
ATTN: Adam Ostrower PHONE NO : 224 9311513
Three Lakes Drive SE DECISION MADE: 02-APR-21
Northfield IL 60093 510(k) STATEMENT
DEVICE: M1 Surgical Face Mask
CHISON Medical Technologies Co., L510(k) NO: K202457(Traditional)
ATTN: Qifei Liu PHONE NO : 0086 510 85311707
No.228, Changjiang East Road, BlocSE DECISION MADE: 29-APR-21
Wuxi CN 214142 510(k) STATEMENT
DEVICE: SIGMA Sterilization Pouch and Roll
Sigma Medical Supplies Corporation510(k) NO: K202462(Abbreviated)
ATTN: Ethan Lin PHONE NO : 886 3 3648880 3572
NO.34, Ding-Ping Road, Rui Fang InSE DECISION MADE: 23-APR-21
New Taipei City TW 224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vital Sign Monitoring Sensor (Model :XK300)
Xandar Kardian Inc. 510(k) NO: K202464(Traditional)
ATTN: Glen (Jeong Woo) Choi PHONE NO : 82 70 88220309
#309, Seongsuil-Ro 10-Gil SeongdonSE DECISION MADE: 26-APR-21
Seoul KR 04793 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
Parker Hannifin 510(k) NO: K202480(Third Party - Traditional)
ATTN: Andrew Ellinger PHONE NO : 215 7234000
245 Township Line Road SE DECISION MADE: 22-APR-21
Hatfield PA 19440 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Karma Powered Wheelchair
Karma Medical Products Co., Ltd. 510(k) NO: K202506(Traditional)
ATTN: Ke-Min Jen PHONE NO : 886 5 2066688
No. 2363, Sec. 2, University Road,SE DECISION MADE: 19-APR-21
Chia Yi CN 62144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask-Model FM-04
Shenzhen Jinko Industrial Co., Ltd510(k) NO: K202513(Traditional)
ATTN: Wang Yinghui PHONE NO : 0086 400 9909777
Building B2 101, Haocheng (Heping)SE DECISION MADE: 09-APR-21
Shenzhen CN 518100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs
String King Lacrosse, LLC 510(k) NO: K202607(Traditional)
ATTN: Thomas Frasca PHONE NO : 1 508 6541988
19100 S Vermont Ave. SE DECISION MADE: 23-APR-21
Gardena CA 90248 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Metapex Plus
Meta Biomed Co., Ltd. 510(k) NO: K202617(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308841
270, Osongsaengmyeong 1-ro, Osong-SE DECISION MADE: 14-APR-21
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KardiFlex PTCA Balloon Dilatation Catheter
Medcaptain Life Science Co., Ltd. 510(k) NO: K202619(Traditional)
ATTN: David Xia PHONE NO : 86 755 28380626
601, Building C, Jinweiyuan IndustSE DECISION MADE: 29-APR-21
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric wheelchair (S7204/S7205)
Dongguan Prestige Sporting Goods C510(k) NO: K202632(Traditional)
ATTN: Zhang Zhao PHONE NO : 86 137 63128800
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 08-APR-21
Dongguan CN 523950 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: si-Mochi
Biostone Ltd 510(k) NO: K202639(Traditional)
ATTN: Wei-Jen Lo PHONE NO : 44 7906 001281
BioCity, Pennyfoot Street SE DECISION MADE: 21-APR-21
Nottingham GB NG1 1GF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Ningbo Green Textile Co., Ltd. 510(k) NO: K202647(Traditional)
ATTN: Carol No Last Name ProvidedPHONE NO : 86 574 63541998
No.498, 3rd Xingci Road, Hangzhou SE DECISION MADE: 26-APR-21
Ningbo CN 315336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Dongguan Runlin Medical Supplies T510(k) NO: K202655(Traditional)
ATTN: Weiming Chen PHONE NO : 0086 138 29181625
No.6, longzhou wei street, liaobu SE DECISION MADE: 05-APR-21
dongguan CN 523145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3
McGovern Medical School 510(k) NO: K202679(Traditional)
ATTN: K. Lance Gould PHONE NO : 713 5006611
6431 Fannin Street, MSB 4.256 SE DECISION MADE: 12-APR-21
Houston TX 77030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vascutek Gelsoft Plus ERS Vascular Graft
Vascutek Ltd 510(k) NO: K202703(Traditional)
ATTN: Chirag Merchant PHONE NO : 44 0141 8125555
Newmains Avenue SE DECISION MADE: 06-APR-21
Inchinnan GB PA4 9RR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K202729(Traditional)
ATTN: Gerhard Frick PHONE NO : 41 717 277000
Espenstrasse 139 SE DECISION MADE: 08-APR-21
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enteral Feeding Catheter
Medcaptain Life Science Co., Ltd. 510(k) NO: K202748(Traditional)
ATTN: David Xia PHONE NO : 86 755 28380626
601, Building C, Jinweiyuan IndustSE DECISION MADE: 09-APR-21
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Knee+
Pixee Medical 510(k) NO: K202750(Traditional)
ATTN: Lucie Pecheur PHONE NO : 33 458 101365
18 rue Alain Savary SE DECISION MADE: 21-APR-21
Besancon FR 25000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor
Contec Medical Systems Co., Ltd. 510(k) NO: K202757(Traditional)
ATTN: Xueyong Li PHONE NO : 86 355 8015490
No.112 Qinhuang West Street, EconoSE DECISION MADE: 28-APR-21
Hebei Province CN 066004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable medical surgical mask
Chongqing COE Display Technology C510(k) NO: K202759(Traditional)
ATTN: Liu Qingjun PHONE NO : 86 023 67849398
No. 3, Tonggui Avenue, Yufengshan SE DECISION MADE: 21-APR-21
Chongqing CN 401120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask (Non-sterile)
Guangdong GoodFeeling Hygiene Mate510(k) NO: K202761(Traditional)
ATTN: Zheng Zhijin PHONE NO : 86 15 860481335
No.10 Phoenix Avenue Eco-industriaSE DECISION MADE: 11-APR-21
Foshan CN 528200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOSMO Femoral Stem
b-One Ortho Corp. 510(k) NO: K202768(Traditional)
ATTN: Allison Gecik PHONE NO : 973 5878431
3 Wing Drive Suite #259 SE DECISION MADE: 01-APR-21
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K202785(Traditional)
ATTN: Ma chao PHONE NO : 86 755 81886573
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 08-APR-21
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Axiostat Patch
Advamedica Inc. 510(k) NO: K202830(Traditional)
ATTN: Leo Mavely PHONE NO : 1 973 7187575
Harvard Square, 1 Mifflin Place, SSE DECISION MADE: 15-APR-21
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SR-1 Skin Treatment System
AVAVA, Inc. 510(k) NO: K202884(Traditional)
ATTN: Lewis Levine PHONE NO : 617 5102194
275 Second Avenue, Floor 3 SE DECISION MADE: 13-APR-21
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EndoPilot2
Schlumbohm GmbH & Co. KG 510(k) NO: K202906(Traditional)
ATTN: Gerald Schlumbohm PHONE NO : 0049 04324 89290
Klein Floyen 8-10 SE DECISION MADE: 13-APR-21
Brokstedt DE D-24616 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CreoDent Solidex Customized Abutment
CreoDent Prosthetics, Ltd. 510(k) NO: K202909(Special)
ATTN: Calvin Shim PHONE NO : 1 212 3023860
29 West 30th Street, 11th Floor SE DECISION MADE: 02-APR-21
New York NY 10001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIS Thermocoagulator and Digital Colposcope
Liger Medical, LLC 510(k) NO: K202915(Traditional)
ATTN: Wm. Dean Wallace PHONE NO : 801 2566576
3300 North Running Creek Way, BuilSE DECISION MADE: 23-APR-21
Lehi UT 84043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DV. Target
Deepvoxel INC 510(k) NO: K202928(Traditional)
ATTN: Jerry Liu PHONE NO : 858 2818029
22 Talisman SE DECISION MADE: 02-APR-21
Irvine CA 92620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rescue Pulmonary Grasping Forceps
Anrei Medical (Hangzhou) Co., Ltd 510(k) NO: K202987(Traditional)
ATTN: Huibing Yang PHONE NO : 011 861 3205812171
No. 3 Ave 8, HEDA SE DECISION MADE: 29-APR-21
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase, RIB Fractures Triage (RibFx)
Aidoc Medical, Ltd. 510(k) NO: K202992(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
3 Aminaday St. SE DECISION MADE: 14-APR-21
Tel-Aviv IL 6706703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KeyPrint KeySplint Hard
Mycone Dental Supply Co. Inc. (DBA510(k) NO: K203000(Traditional)
ATTN: Diamond Bynum PHONE NO : 800 3333131
480 S. Democrat Road SE DECISION MADE: 09-APR-21
Gibbstown NJ 08027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask
Customfab, INC. 510(k) NO: K203012(Abbreviated)
ATTN: Erentia Gillmer PHONE NO : 714 8919119
7345 Orangewood Ave SE DECISION MADE: 11-APR-21
Garden Grove CA 92841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARband, STARlight, St. Louis Band
Orthomerica Products Inc. 510(k) NO: K203098(Traditional)
ATTN: David C. Kerr PHONE NO : 407 2906592
6333 North Orange Blossom Trail SE DECISION MADE: 27-APR-21
Orlando FL 32810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Responsive Arthroscopy Thunderbolt System
Responsive Arthroscopy LLC 510(k) NO: K203121(Traditional)
ATTN: Douglas Kohrs PHONE NO : 952 2509505
701 N 3rd Street, Suite 208 SE DECISION MADE: 27-APR-21
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOS Stent and Electrocautery Enhanced Delivery System
Boston Scientific Corporation 510(k) NO: K203132(Traditional)
ATTN: Aparna Philip PHONE NO : 508 3820259
100 Boston Scientific Way SE DECISION MADE: 15-APR-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Ureteral Access Sheath
Suzhou Beyo Medical Technology Co.510(k) NO: K203165(Traditional)
ATTN: Aline Qin PHONE NO : 86 512 67269209
No. 38 Beiguandu Road SE DECISION MADE: 30-APR-21
Suzhou CN 215000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer Models: DT-8806S, DT-8807S
Shenzhen Everbest Machinery Indust510(k) NO: K203170(Traditional)
ATTN: Deng Aiguo PHONE NO :
19th Building, 5th Region, BaiwangSE DECISION MADE: 16-APR-21
Shenzhen CN 518108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simpleware ScanIP Medical
Synopsys (Northern Europe) Ltd. 510(k) NO: K203195(Traditional)
ATTN: Jessica James PHONE NO : 44 0 1392428750
Bradninch Hall, Castle Street SE DECISION MADE: 01-APR-21
Exeter GB EX4 3PL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Invacare Platinum 5NXG Oxygen Concentrator
Invacare Corporation 510(k) NO: K203210(Traditional)
ATTN: Elijah Wreh PHONE NO : 440 3296840
One Invacare Way SE DECISION MADE: 12-APR-21
Elyria OH 44035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Global Shoulder and Delta CTA systems
DePuy lnc. 510(k) NO: K203230(Traditional)
ATTN: Megan Bernier PHONE NO : 651 3251178
700 Orthopaedic Drive SE DECISION MADE: 02-APR-21
Warsaw IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AccelX Abutments
Integrated Dental Systems LLC 510(k) NO: K203240(Traditional)
ATTN: David Singh PHONE NO : 917 6935595
145 Cedar Lane SE DECISION MADE: 27-APR-21
Englewood NJ 07631 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroDose Injector
MedOne Surgical, Inc. 510(k) NO: K203264(Traditional)
ATTN: Bruce Beckstein PHONE NO : 941 3593129
670 Tallevast Road SE DECISION MADE: 26-APR-21
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The BioBrace Implant
Biorez, Inc. 510(k) NO: K203267(Traditional)
ATTN: Kevin Rocco PHONE NO : 860 3018638
470 James Street, Suite 14 SE DECISION MADE: 30-APR-21
New Haven CT 06513 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
Biocompatibles UK Ltd (part of Bos510(k) NO: K203276(Traditional)
ATTN: Christina Fischer PHONE NO : 49 162 1788391
Chapman House, Weydon Lane SE DECISION MADE: 20-APR-21
Farnham GB GU9 8QL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
Olympus Winter & Ibe GmbH 510(k) NO: K203277(Traditional)
ATTN: Jan-Oliver Upmeier PHONE NO : 49 40 669662098
Kuehnstr. 61 SE DECISION MADE: 28-APR-21
Hamburg DE 22045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System
Jiangsu Synecoun Medical Technolog510(k) NO: K203310(Traditional)
ATTN: Yue Li PHONE NO : 86 523 86868618
East of 1/F. No. 50, G60, EastsideSE DECISION MADE: 02-APR-21
Taizhou CN 225316 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cartesion Prime (PCD-1000A/3) V10.8
Canon Medical Systems Corporation 510(k) NO: K203314(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 23-APR-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUEPRINT™ Patient Specific Instrumentation
Tornier SAS 510(k) NO: K203315(Traditional)
ATTN: Aymen Azaiez PHONE NO : 33 648 381036
161 rue Lavoisier SE DECISION MADE: 15-APR-21
Montbonnot Saint Martin FR 38330 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVT-PRO
Daesung Maref Co., LTD 510(k) NO: K203353(Special)
ATTN: Su Hyeon So PHONE NO : 82 31 4597211
298-24, Gongdan-Ro SE DECISION MADE: 22-APR-21
Gunpo-Si KR 15809 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MDPC-8127
Barco NV 510(k) NO: K203364(Traditional)
ATTN: Lieven De Wandel PHONE NO : 32 56 233459
President Kennedypark 35 SE DECISION MADE: 15-APR-21
Kortrijk BE 8500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter
Shockwave Medical, Inc. 510(k) NO: K203365(Traditional)
ATTN: Danica Van PHONE NO : 408 5804471
5403 Betsy Ross Dr SE DECISION MADE: 22-APR-21
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Artimes pro Balloon Dilatation Catheter
BrosMed Medical Co., Ltd. 510(k) NO: K203390(Traditional)
ATTN: Wade Zhang PHONE NO : 86 769 22892018
15th building, SMEs Venture Park, SE DECISION MADE: 14-APR-21
Dongguan CN 523808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Triathlon AS-1
Conformis Inc. 510(k) NO: K203421(Traditional)
ATTN: Mary Kruitwagen PHONE NO : 781 3459038
600 Technology Park Drive, 4th FloSE DECISION MADE: 19-APR-21
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves
Shandong Zhushi Pharmaceutical Gro510(k) NO: K203436(Traditional)
ATTN: Junhui Zhu PHONE NO : 86 15 764021131
No. 6 Shande Road Shan County SE DECISION MADE: 28-APR-21
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: F&P Visairo NIV Mask Range
Fisher & Paykel Healthcare Ltd 510(k) NO: K203449(Traditional)
ATTN: Reena Daken PHONE NO : 64 5740100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 14-APR-21
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TCL3 Motion Tracking System
Tracinnovations ApS 510(k) NO: K203451(Traditional)
ATTN: Stefan Glimberg PHONE NO : 45 61 668969
World Trade Center Borupvang 3 DK-SE DECISION MADE: 28-APR-21
Ballerup DK 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Thermometer
Shandong Zhushi Pharmaceutical Gro510(k) NO: K203454(Traditional)
ATTN: Junhui Zhu PHONE NO : 86 15 764021131
No.6 Shande Road, Shan Country SE DECISION MADE: 29-APR-21
Heze CN 274300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI Segmentation
Varian Medical Systems, Inc. 510(k) NO: K203469(Traditional)
ATTN: Peter Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 19-APR-21
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KMTI Hip Replacement System
Kyocera Medical Technologies, Inc.510(k) NO: K203472(Special)
ATTN: Anthony DeBenedictis PHONE NO : 909 5572360
1200 California St., Suite 210 SE DECISION MADE: 02-APR-21
Redlands CA 92374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOZO
ImpediMed Limited 510(k) NO: K203473(Traditional)
ATTN: Catherine Kingsford PHONE NO : 61 7 38603700
Unit 1, 50 Parker Court SE DECISION MADE: 19-APR-21
Pinkenba AU 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOUBLEFLO system
Hemodia SAS 510(k) NO: K203480(Traditional)
ATTN: Adeline Theron PHONE NO : 33 561 007181
85 Rue Du Chene Vert SE DECISION MADE: 05-APR-21
Lebege FR 31670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEFRIA PCP Oral Fluid Enzyme Immunoassay
Immunalysis Corporation 510(k) NO: K203489(Traditional)
ATTN: Wenying (Jessica) Zhu PHONE NO : 909 4820480
829 Towne Center Drive SE DECISION MADE: 20-APR-21
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PicoLO Nd: YAG Picosecond Laser System
Laseroptek Co., Ltd. 510(k) NO: K203491(Special)
ATTN: Hong Chu PHONE NO : 82 31 80235151
#203 & #204 Hyundai I valley, 31, SE DECISION MADE: 07-APR-21
Seongnam-si KR 13212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SwiveLock Anchor
Arthrex Inc. 510(k) NO: K203495(Traditional)
ATTN: Kelsey Roberts PHONE NO : 239 5984302 72257
1370 Creekside Boulevard SE DECISION MADE: 19-APR-21
Naples FL 34108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
Vatech acucera, Inc. 510(k) NO: K203499(Traditional)
ATTN: Kyung Wook Kwon PHONE NO : 82 31 80051821
2544, Nambuk-daero, Idong-eup, CheSE DECISION MADE: 05-APR-21
Yongin-si KR 17138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RetCam Envision
Natus Medical Incorporated DBA Exc510(k) NO: K203500(Traditional)
ATTN: Sanjay Mehta PHONE NO : 905 2875055
2568 Bristol Circle SE DECISION MADE: 13-APR-21
Oakville CA L6H 5S1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDO-Thyroid
MEDO DX Pte. Ltd. 510(k) NO: K203502(Traditional)
ATTN: Dornoosh Zonoobi PHONE NO : 780 9919462
4560 TEC Centre, 10230 Jasper AvenSE DECISION MADE: 23-APR-21
Edmonton CA T5J4P6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Glove
VIP Glove SDN BHD 510(k) NO: K203512(Traditional)
ATTN: Terence Lim PHONE NO : 60 387 668191
No 17, Jalan Perusahaan 1, KawasanSE DECISION MADE: 26-APR-21
Beranang MY 43700 510(k) STATEMENT
DEVICE: Saige-Q
DeepHealth, Inc. 510(k) NO: K203517(Traditional)
ATTN: A. Gregory Sorensen PHONE NO : 617 9703817
1000 Massachusetts Ave SE DECISION MADE: 16-APR-21
Cambridge MA 02138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blustone Synergy Interbody Fusion System
Blustone Synergy, LLC 510(k) NO: K203520(Traditional)
ATTN: Tom Gentry PHONE NO : 760 9926118
5520 Ventana Ct SE DECISION MADE: 07-APR-21
Pueblo CO 81005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BI-MENTUM™ ALTRX® Dual Mobility Liner
Depuy Ireland UC 510(k) NO: K203532(Traditional)
ATTN: Erin Combs PHONE NO : 574 40 48348
Loughbeg Ringaskiddy SE DECISION MADE: 28-APR-21
Co. Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASSALLO GT
Filmecc Co., Ltd 510(k) NO: K203533(Traditional)
ATTN: Toshiya Osawa PHONE NO : 81 52 7681212
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 21-APR-21
Nagoya JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trinias
Shimadzu Corporation Medical Syste510(k) NO: K203535(Traditional)
ATTN: Shigeru Naganishi PHONE NO : 81 75 8231305
1, Nishinokyo-Kuwabaracho, NakagyoSE DECISION MADE: 28-APR-21
Kyoto City JP 604-8511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ActivSight Intraoperative Imaging System
Activ Surgical, Inc. 510(k) NO: K203550(Traditional)
ATTN: Matthew King PHONE NO : 603 4599755
840 Summer Street SE DECISION MADE: 08-APR-21
Boston MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral-B Dry Mouth Oral Rinse
The Procter & Gamble Company 510(k) NO: K203567(Traditional)
ATTN: Brenda S. Fuentes PHONE NO : 513 6221384
1 Procter & Gamble Plaza SE DECISION MADE: 05-APR-21
Cincinnati OH 45202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mya Joy PLUS Breast Pump
Ameda, Inc. 510(k) NO: K203570(Traditional)
ATTN: Carolin Archibald PHONE NO : 847 9642620
485 Half Day Road; Suite 320 SE DECISION MADE: 22-APR-21
Buffalo Grove IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc. 510(k) NO: K203571(Traditional)
ATTN: James A. Bonafini PHONE NO : 585 4588409
1667 Lake Avenue, Suite 354 SE DECISION MADE: 09-APR-21
Rochester NY 14615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtiSential Laparoscopic Instruments-Electrodes
LivsMed Inc. 510(k) NO: K203580(Traditional)
ATTN: Dong Wook Lee PHONE NO : 82 70 77094993
#304, D-dong, 700, Pangyo-ro, BundSE DECISION MADE: 30-APR-21
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Panthera Occlusal Appliance
Panthera Dental Inc. 510(k) NO: K203596(Traditional)
ATTN: Martine Fortin PHONE NO : 418 5270388
9105, rue John-Simons SE DECISION MADE: 20-APR-21
Quebec CA G2B 0S6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Innova Nasal Non-Vented Mask
Sleepnet Corporation 510(k) NO: K203601(Traditional)
ATTN: Jennifer Kennedy PHONE NO : 603 7586625
5 Merrill Industrial Drive SE DECISION MADE: 30-APR-21
Hampton NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SteriTrak
Arbutus Medical Inc. 510(k) NO: K203605(Traditional)
ATTN: Michael Cancilla PHONE NO : 778 7736477
828 10th Ave W, Suite 560 SE DECISION MADE: 23-APR-21
Vancouver CA V5Z 1L8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Automatic Anatomy Recognition (AAR)
Quantitative Radiology Solutions, 510(k) NO: K203610(Traditional)
ATTN: Steve Owens PHONE NO : 1 973 5908574
3675 Market Street, Suite 200 SE DECISION MADE: 20-APR-21
Philadelphia PA 19104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainsway Deep (DTMS) System
Brainsway Ltd. 510(k) NO: K203616(Traditional)
ATTN: Ahava Stein PHONE NO : 972 2 5824030
19 Hartom Str. SE DECISION MADE: 16-APR-21
Jerusalem IL 9777518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StentBoost Mobile
Philips India Limited 510(k) NO: K203623(Abbreviated)
ATTN: Shruti Sancheti PHONE NO :
Plot No. B-79, MIDC, Phase-II, ChaSE DECISION MADE: 05-APR-21
Pune IN 410501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solevy Co. LLC Silicone Based Personal Lubricant
Solevy Co. LLC 510(k) NO: K203644(Traditional)
ATTN: Joe Mendoza PHONE NO : 818 6015738
29017 Avenue Penn SE DECISION MADE: 19-APR-21
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask
Guangzhou Mei Yi Kang Medical Tech510(k) NO: K203646(Traditional)
ATTN: Lou Yonghui PHONE NO : 86 20 22682888
No. 43-31 Baofeng East Road, JinShSE DECISION MADE: 22-APR-21
Guangzhou CN 510800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Solevy Co. LLC Water-Based Personal Lubricant
Solevy Co. LLC 510(k) NO: K203654(Traditional)
ATTN: Joe Mendoza PHONE NO : 818 6015738
29017 Avenue Penn SE DECISION MADE: 19-APR-21
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
Medacta International SA 510(k) NO: K203673(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 06-APR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
Brainlab AG 510(k) NO: K203681(Traditional)
ATTN: Chiara Cunico PHONE NO : 49 899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 09-APR-21
Munich DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo. CT Extended Functionalities
Siemens Medical Solutions USA, Inc510(k) NO: K203699(Traditional)
ATTN: Alaine Medio PHONE NO : 865 2060337
810 Innovation Drive SE DECISION MADE: 30-APR-21
Knoxville TN 37932 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Locator Overdenture Implant System
Ivory Super Holdco Inc. / Zest Anc510(k) NO: K203701(Traditional)
ATTN: Marysa Loustalot PHONE NO : 408 3149404
2875 Loker Avenue East SE DECISION MADE: 15-APR-21
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainsway Deep TMS System
Brainsway Ltd. 510(k) NO: K203735(Traditional)
ATTN: Ahava Stein PHONE NO : 972 54 6420642
19 Hartom St. (Bynet Bldg) Har HotSE DECISION MADE: 23-APR-21
Jerusalem IL 9777518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IdentiTi ALIF Standalone Interbody System
Alphatec Spine Inc. 510(k) NO: K203742(Traditional)
ATTN: Cynthia Dorne PHONE NO : 760 4946740
5818 El Camino Real SE DECISION MADE: 09-APR-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNIVision system
Corin USA 510(k) NO: K203751(Traditional)
ATTN: Lucinda Gerber PHONE NO : 440 1285 884357
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 12-APR-21
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pristine Long-Term Hemodialysis Catheter
C B Bard, Inc 510(k) NO: K203767(Traditional)
ATTN: Arieona Boyle PHONE NO : 480 5978260
1625 W Third Street SE DECISION MADE: 02-APR-21
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nanox Cart X-ray System
Nano-x Imaging Ltd. 510(k) NO: K203782(Third Party - Traditional)
ATTN: Yuval Shapiro PHONE NO : 972 2 5746300
Communications Center Building C, SE DECISION MADE: 01-APR-21
Neve Ilan IL 9085000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MAC 7 - Resting ECG Analysis System
GE Medical Systems Information Tec510(k) NO: K203786(Traditional)
ATTN: Lee Bush PHONE NO : 262 3099429
9900 Innovation Drive SE DECISION MADE: 30-APR-21
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Star RF Electrode, VIVA RF Electrode
STARmed Co., Ltd. 510(k) NO: K203795(Traditional)
ATTN: Jun-Young Jung PHONE NO : 82 70 46738657
B-dong, 4F&12F, 158, Haneulmaeul-rSE DECISION MADE: 01-APR-21
Goyang-si KR 10355 510(k) STATEMENT
DEVICE: Disposable Surgical Face Mask
Anhui Jiabao Protective Equipments510(k) NO: K203801(Traditional)
ATTN: Mark Zhang PHONE NO : 86 180 72729283
312 State Road Intersection With DSE DECISION MADE: 06-APR-21
Lu’an CN 237000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Examination Gloves
Jiangsu Yanfang Medical Technology510(k) NO: K203805(Traditional)
ATTN: Wei Kaijian PHONE NO : 186 138 12992152
No.16, Kaiyuan Road, Changjing TowSE DECISION MADE: 20-APR-21
Wuxi CN 214411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeGen Navigated Instrumentation
DeGen Medical 510(k) NO: K203816(Traditional)
ATTN: Craig Black PHONE NO : 843 9924551
1321-C North Cashua Drive SE DECISION MADE: 02-APR-21
Florence SC 29501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VPS Impression Material
Hygedent INC. 510(k) NO: K203824(Traditional)
ATTN: Peng Wang PHONE NO : 010 139 01284956
Room 210C, Building 4, No 5 ChaoqiSE DECISION MADE: 19-APR-21
Beijing CN 102299 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS Solution
Next Science, LLC 510(k) NO: K203835(Traditional)
ATTN: Courtney Narain PHONE NO : 855 5642762 6004
10550 Deerwood Park Blvd Ste 300 SE DECISION MADE: 23-APR-21
Jacksonville FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen Hexin ZONDAN Medical Equi510(k) NO: K203854(Traditional)
ATTN: John Liu PHONE NO : 86 755 26865970
Floor 14, Block D, Dianlian TechnoSE DECISION MADE: 23-APR-21
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPER AiR
Shanghai United Imaging Healthcare510(k) NO: K210001(Traditional)
ATTN: Xin GAO PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 30-APR-21
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Face Mask
Jinhua Jingdi Medical Supplies Co.510(k) NO: K210007(Traditional)
ATTN: Hu Xiaojiang PHONE NO : 86 139 89428215
Building 2, Ditian Function, XiaosSE DECISION MADE: 23-APR-21
Jinhua CN 321000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Mask
Diasia Biomedical Technology Co., 510(k) NO: K210018(Traditional)
ATTN: Jason Luo PHONE NO : 86 150 12999080
2F/3F301/4F (Building A) & 2F (BuiSE DECISION MADE: 11-APR-21
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Mask
Zhende Medical Co., Ltd. 510(k) NO: K210020(Traditional)
ATTN: Chen Ming PHONE NO : 86 575 88770363
Gaobu Town, 312035 SE DECISION MADE: 28-APR-21
Shaoxing CN 312035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Face Mask
Guangdong Winsun Personal Care Pro510(k) NO: K210023(Traditional)
ATTN: Dong Pingping PHONE NO : 86 139 29904428
No.1 Guangxing Road, Xiqiao Sci-TeSE DECISION MADE: 02-APR-21
Foshan CN 528200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medical Surgical Mask
Tianjin Aoshang Outdoor Equipment 510(k) NO: K210030(Traditional)
ATTN: Xiaoning Zhang PHONE NO : 86 22 87702678
C-1-106, No.23 Xiangtan Road, HongSE DECISION MADE: 23-APR-21
Tianjin CN 300133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProLift Lateral HELO Fixated
Life Spine, Inc. 510(k) NO: K210061(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
139541 S. Quality Drive SE DECISION MADE: 30-APR-21
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mectaplug PE II
Medacta International SA 510(k) NO: K210062(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 08-APR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Verifine Safety Type Insulin Pen Needle
Promisemed Hangzhou Meditech Co., 510(k) NO: K210065(Traditional)
ATTN: Zearou Yang PHONE NO : 86 571 88772985
No. 1388 Cangxing Street, CangqianSE DECISION MADE: 22-APR-21
Hangzhou City CN 311121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
Samsung Medison CO., LTD. 510(k) NO: K210068(Traditional)
ATTN: Scully Kim PHONE NO : 82 2 21941312
3366, Hanseo-ro, Nam-myeon SE DECISION MADE: 09-APR-21
Hongcheon-gun KR 25108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Athena Surgical RMUS System
Athena Surgical, LLC 510(k) NO: K210087(Traditional)
ATTN: Greg Slusser PHONE NO : 612 8889394
6110 Blue Circle Drive, Suite 280 SE DECISION MADE: 12-APR-21
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes
Stryker 510(k) NO: K210088(Traditional)
ATTN: Jessie Duong PHONE NO : 408 8217952
5900 Optical Court SE DECISION MADE: 13-APR-21
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Examination Gloves
Zhenjiang Huayang Latex Products C510(k) NO: K210106(Traditional)
ATTN: Han Sheng PHONE NO : 86 511 88427686
Lianhe Village, Xinba Town SE DECISION MADE: 07-APR-21
Yangzhong CN 212212 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROSA Partial Knee System
Orthosoft d/b/a Zimmer CAS 510(k) NO: K210121(Traditional)
ATTN: Kavina Veeren PHONE NO : 514 2458906
75 Queen Street, Suite 3300 SE DECISION MADE: 19-APR-21
Montreal CA H3C 2N6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stockert S5 System
LivaNova Deutschland GmbH 510(k) NO: K210130(Special)
ATTN: Florian Goetz PHONE NO : 49 089 32301236
Lindberghstr. 25 SE DECISION MADE: 05-APR-21
Munich DE 80939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dentis s-Clean s-Line
Dentis Co., Ltd. 510(k) NO: K210134(Traditional)
ATTN: Gyu Ri Kim PHONE NO : 82 53 5893541
99, Seongseoseo-ro, Dalseo-gu SE DECISION MADE: 19-APR-21
Daegu KR 42718 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nitrile Glove Powder Free Blue
Changzhou Universal Medical Equipm510(k) NO: K210145(Traditional)
ATTN: Xiaohai Wan PHONE NO : 312 730 0091
No 6 Xinxi Road SE DECISION MADE: 21-APR-21
Xinbei District CN 213000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLE Medial Column Fusion Plate
Orthofix SRL 510(k) NO: K210157(Traditional)
ATTN: Gianluca Ricadona PHONE NO : 39 045 6719000
Via delle Nazioni, 9 SE DECISION MADE: 20-APR-21
Bussolengo IT 37012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscope Model EI-740D/S
FUJIFILM Corporation 510(k) NO: K210162(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 09-APR-21
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Growth Device
Dongguan Lescolton Intelligent Ele510(k) NO: K210169(Traditional)
ATTN: Liu Jianwen PHONE NO : 86 755 33141373
401, Building 1, #3, Xinxing 3rd RSE DECISION MADE: 16-APR-21
Dongguan CN 523586 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANAMA™ Anterior Cervical Plate (ACP) System
FloSpine 510(k) NO: K210182(Traditional)
ATTN: Peter Harris PHONE NO : 561 7053080
3651 FAU Blvd.., Suite 400 SE DECISION MADE: 07-APR-21
Boca Raton FL 33431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NFC-600 Automated Portable Retinal Camera
Crystalvue Medical Corporation 510(k) NO: K210197(Special)
ATTN: Oliver Lin PHONE NO : 886 3 3607711
No.116, Ln.956, Zhongshan Rd., TaoSE DECISION MADE: 13-APR-21
Taoyuan TW 33072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Verrata PLUS Pressure Guide Wire
Volcano Corporation 510(k) NO: K210235(Special)
ATTN: Leilani Taylor PHONE NO : 858 7204121
3721 Valley Centre Drive, Ste 500 SE DECISION MADE: 15-APR-21
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astroglide X Silicone Personal Lubricant
BioFilm Inc. 510(k) NO: K210242(Traditional)
ATTN: Kevin Jamil PHONE NO : 760 7279030
3225 Executive Ridge SE DECISION MADE: 28-APR-21
Vista CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoCentric Integrated Hip Fastener System
OsteoCentric Technologies d.b.a. O510(k) NO: K210247(Traditional)
ATTN: Todd Evans PHONE NO : 1 800 9690639
75 West 300 North, Suite #150 SE DECISION MADE: 30-APR-21
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClearPath Disposable Introducer
ClearMind Biomedical 510(k) NO: K210251(Traditional)
ATTN: Sheng-Chi (aka Vance Lin) LPHONE NO : 886 2 22697417 106
5F, No. 167, Fuxing N. Rd., SongshSE DECISION MADE: 02-APR-21
Taipei TW 105403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polaris Spinal System
Zimmer Biomet Spine, Inc 510(k) NO: K210275(Special)
ATTN: Anjanet Mort PHONE NO : 720 8397926
10225 Westmoor Drive SE DECISION MADE: 02-APR-21
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Nitrile Gloves
Fujian Ercon Medical Management Co510(k) NO: K210276(Traditional)
ATTN: Lin Ruijin PHONE NO : 86 135 99517229
Unit 701, Xinyi International CentSE DECISION MADE: 16-APR-21
Xiamen CN 361000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Titan SGS
Standard Bariatrics 510(k) NO: K210278(Traditional)
ATTN: Alison Sathe PHONE NO : 513 3047971
4362 Glendale Milford Rd. SE DECISION MADE: 28-APR-21
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JACE Medical Thoracic Plating System
JACE Medical, LLC 510(k) NO: K210290(Traditional)
ATTN: Scott Steffensmeier PHONE NO : 574 5279427
3516 Commerce Drive SE DECISION MADE: 30-APR-21
Warsaw IN 46850 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
VueSonic, LLC 510(k) NO: K210300(Traditional)
ATTN: Sheri Ker PHONE NO : 786 5541887
1234 Washington Ave., #205 SE DECISION MADE: 01-APR-21
Miami Beach FL 33139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PlutoX Digital Intraoral X-Ray Imaging System
iRay Technology Taicang Ltd. 510(k) NO: K210312(Traditional)
ATTN: Wei Pan PHONE NO : 86 0512 53690872
No.33 Xinggang Rd., Taicang Port ESE DECISION MADE: 23-APR-21
Ticang CN 215434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Edge Insulated Blade Electrode
Covidien LLC 510(k) NO: K210338(Traditional)
ATTN: Miranda Miles PHONE NO : 303 9297269
5920 Longbow Drive SE DECISION MADE: 15-APR-21
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR
Canon Medical Systems Corporation 510(k) NO: K210340(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 01-APR-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2MP Monochrome LCD Monitor MS-S200
Jvckenwood Corporation 510(k) NO: K210345(Traditional)
ATTN: Hideki Tengeiji PHONE NO : 81 45 4502715
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 23-APR-21
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VSP System
3D Systems 510(k) NO: K210347(Traditional)
ATTN: Scott Brewer PHONE NO : 720 6431001
5381 South Alkire Circle SE DECISION MADE: 26-APR-21
Littleton CO 80127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Variable Angle Locking Patella Plating System
Synthes (USA) Products, LLC 510(k) NO: K210408(Traditional)
ATTN: Enrico Gindro PHONE NO : 41 79 9127359
1301 Goshen Parkway SE DECISION MADE: 08-APR-21
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPER Focus
Shanghai United Imaging Healthcare510(k) NO: K210418(Traditional)
ATTN: Xin Gao PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 09-APR-21
Shanghai CN 201807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Goblin and Goblin LS Pedicle Screw Systems
Medynus Inc. 510(k) NO: K210420(Traditional)
ATTN: David Shin PHONE NO : 949 9320847
18 Technology Dr. Ste 109 SE DECISION MADE: 19-APR-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. Midline Cortical (MC) Screw System
Medacta International SA 510(k) NO: K210427(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 20-APR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
Alcon Laboratories Inc. 510(k) NO: K210436(Traditional)
ATTN: Alicia Plesnarski PHONE NO : 678 4153924
6201 South Freeway SE DECISION MADE: 12-APR-21
Fort Worth TX 76131-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ligament Staple
Medacta International SA 510(k) NO: K210456(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 12-APR-21
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline UNITE REFLEX Nitinol Staple System
Medline Industries, Inc. 510(k) NO: K210482(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 22-APR-21
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOBIO Total Knee System
b-ONE ORTHO, Corp. 510(k) NO: K210483(Traditional)
ATTN: Allison Gecik PHONE NO : 973 5878431
3 Wing Drive Suite # 259 SE DECISION MADE: 21-APR-21
Cedar Knolls NJ 07927 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CW120N
Wide Corporation 510(k) NO: K210491(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
15F, The First Tower III, 602, DonSE DECISION MADE: 08-APR-21
Hwaseong-Si KR 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CX30N (CX30PQX)
Wide Corporation 510(k) NO: K210493(Traditional)
ATTN: YeoJin Yun PHONE NO : 82 31 2181675
15F, The First Tower III, 602, DonSE DECISION MADE: 14-APR-21
Hwaseong-Si KR 18469 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MY01 Continuous Compartmental Pressure Monitor
MY01 Inc. 510(k) NO: K210525(Traditional)
ATTN: Charles Allan PHONE NO : 85 5 7996901
400 De Maisonneuve Boulevard West,SE DECISION MADE: 22-APR-21
Montreal CA H3A 1LA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoreLink Midline Fixation System
CoreLink, LLC 510(k) NO: K210539(Traditional)
ATTN: Steven Mounts PHONE NO : 888 3497808
2072 Fenton Logistics Park Blvd. SE DECISION MADE: 15-APR-21
St. Louis MO 63026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARx Spinal System
Life Spine, Inc. 510(k) NO: K210549(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S. Quality Drive SE DECISION MADE: 22-APR-21
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Physica system
Limacorporate S.p.A. 510(k) NO: K210554(Traditional)
ATTN: Giuseppe Valenti PHONE NO : 39 04 32945511
Via Nazionale, 52 Villanova di SanSE DECISION MADE: 06-APR-21
Udine IT 33038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Preview Shoulder
Genesis Software Innovations 510(k) NO: K210556(Traditional)
ATTN: Matt Miller PHONE NO : 616 2941026 5
220 Lyon St NW Suite 500 SE DECISION MADE: 21-APR-21
Grand Rapids MI 49503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InnovaMatrix FS
Triad Life Sciences, Inc. 510(k) NO: K210580(Special)
ATTN: Jon G. Hargis PHONE NO : 901 3336000
1770 Moriah Woods Blvd, Suite 18 SE DECISION MADE: 21-APR-21
Memphis TN 38117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOLLI
MOLLI Surgical, Inc. 510(k) NO: K210600(Traditional)
ATTN: Fazila Seker PHONE NO : 833 6655463
22 St. Clair Ave. East, Suite #150SE DECISION MADE: 16-APR-21
Toronto CA M4t 2s3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plato 17 Microcatheter
Scientia Vascular LLC 510(k) NO: K210601(Third Party - Traditional)
ATTN: Amy McManus PHONE NO : 888 3859016
3487 West 2100 South Suite 100 SE DECISION MADE: 28-APR-21
West Valley City UT 84119 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation
3M Company 510(k) NO: K210605(Traditional)
ATTN: Hilary Hovde PHONE NO : 651 7360364
2510 Conway Ave. SE DECISION MADE: 29-APR-21
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens
VP Optics 510(k) NO: K210609(Traditional)
ATTN: Daniel Yoon PHONE NO : 82 507 14041026
D-611, 17, Techno 4-ro SE DECISION MADE: 27-APR-21
Daejeon KR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral/Enteral Syringe
Ningbo Tianyi Medical Appliance Co510(k) NO: K210621(Traditional)
ATTN: Wenyu Zhang PHONE NO : 86 574 55011007
No.788, Mozhi North Road, Tourism SE DECISION MADE: 28-APR-21
Ningbo CN 315121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
Cordis Corporation 510(k) NO: K210626(Traditional)
ATTN: Wai Morgan PHONE NO : 704 5765147
14201 N.W. 60th Avenue SE DECISION MADE: 23-APR-21
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SecurAcath
Interrad Medical Inc 510(k) NO: K210629(Special)
ATTN: Denise Lenz PHONE NO : 1 763 2256699
181 Cheshire Lane, Suite 100 SE DECISION MADE: 12-APR-21
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon™ Spinal System
Medtronic 510(k) NO: K210637(Traditional)
ATTN: Shweta Sharma PHONE NO : 901 3992425
1800 Pyramid Place SE DECISION MADE: 30-APR-21
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter
Vascular Solutions LLC 510(k) NO: K210647(Traditional)
ATTN: Steph Pahl PHONE NO : 763 7622641
6464 Sycamore Court North SE DECISION MADE: 30-APR-21
Minneapolis MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Volition Plating System
Ortho Solutions UK Ltd 510(k) NO: K210658(Special)
ATTN: Andy Leither PHONE NO : 614 5468705
West Station Business Park, SpitalSE DECISION MADE: 13-APR-21
Maldon GB CMF 6FF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stone Retrieval Balloon Catheter
Anrei Medical (Hangzhou) Co., Ltd.510(k) NO: K210660(Traditional)
ATTN: Huibing Yang PHONE NO : 86 571 86913333 8658
No.3 Ave.8, HEDA SE DECISION MADE: 27-APR-21
Hangzhou CN 310018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermatological Diode Laser Systems
Beijing HuaCheng Taike Technology 510(k) NO: K210663(Traditional)
ATTN: Li Yi PHONE NO : 86 158 10861388
5102P, Floor 1, Building 5, No.17 SE DECISION MADE: 26-APR-21
Beijing CN 101113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TSolution One Total Knee Application
THINK Surgical, Inc. 510(k) NO: K210668(Special)
ATTN: Meliha Mulalic PHONE NO : 510 2492337
47201 Lakeview Blvd SE DECISION MADE: 01-APR-21
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SiteSeal SV
Ensite Vascular 510(k) NO: K210681(Special)
ATTN: Thomas Reidy PHONE NO : 816 2608476
10900 S. Clay Blair Blvd. SE DECISION MADE: 06-APR-21
Olathe KS 66061 510(k) STATEMENT
DEVICE: AcQCross Qx Integrated Transseptal Dilator/Needle
Acutus Medical Inc. 510(k) NO: K210685(Third Party - Traditional)
ATTN: Sarah Clay PHONE NO : 949 2917811
2210 Faraday Ave, Suite 100 SE DECISION MADE: 06-APR-21
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DigitalDiagnost
Philips Medical Systems DMC GmbH 510(k) NO: K210692(Special)
ATTN: Supriya Dalvi PHONE NO : 49 40 50782425
Roentgenstrasse 24-26 SE DECISION MADE: 02-APR-21
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CATALYS Precision Laser System
AMO Manufacturing USA, LLC 510(k) NO: K210701(Special)
ATTN: Laarni Ricafort PHONE NO : 408 2734016
510 Cottonwood Drive SE DECISION MADE: 07-APR-21
Milpitas CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTAX Medical Video Duedenoscope ED34-i10T2
PENTAX of America, Inc. 510(k) NO: K210710(Special)
ATTN: William Goeller PHONE NO : 201 5712300 2318
3 Paragon Drive SE DECISION MADE: 09-APR-21
Montvale NJ 07645-1782 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
CarboFix Orthopedics Ltd. 510(k) NO: K210716(Special)
ATTN: Hila Wachsler-Avrahami PHONE NO : 972 9 9511511
11 Ha'hoshlim St. SE DECISION MADE: 06-APR-21
Herzeliya IL 4672411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endovascular Dilator and Sets
Cook Incorporated 510(k) NO: K210734(Special)
ATTN: Michael Venezia PHONE NO : 812 3254172
750 Daniels Way SE DECISION MADE: 06-APR-21
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUSON Redwood Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K210743(Third Party - Traditional)
ATTN: Sulgue Choi PHONE NO : 425 2819898
22010 South East 51st Street SE DECISION MADE: 01-APR-21
Issaquah WA 98029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HydroMARK Breast Biopsy Site Marker
Devicor Medical Products, Inc. 510(k) NO: K210752(Special)
ATTN: Diane Sung PHONE NO : 513 8942931
300 E-Business Way, Fifth Floor SE DECISION MADE: 14-APR-21
Cincinnati OH 45241 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cannulated Fasteners and Nuts
OsteoCentric Technologies 510(k) NO: K210754(Special)
ATTN: Todd Evans PHONE NO : 1 800 9690639
75 West 300 North, Suite #150 SE DECISION MADE: 14-APR-21
Logan UT 84321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flyte
Pelvital USA, Inc. 510(k) NO: K210764(Special)
ATTN: Dale Wahlstrom PHONE NO : 612 8041319
1000 LaSalle Avenue, SCH 435 SE DECISION MADE: 13-APR-21
Minneapolis MN 55403 510(k) STATEMENT
DEVICE: Extended HA Half Pins
Smith & Nephew, Inc. 510(k) NO: K210784(Special)
ATTN: Thomas Fearnley PHONE NO : 901 3991224
1450 E Brooks Rd SE DECISION MADE: 02-APR-21
Memphis TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Instylla Microcatheter 1.2
Instylla, Inc. 510(k) NO: K210808(Special)
ATTN: Jennifer Greer PHONE NO : 781 6229293
201 Burlington Road, North BuildinSE DECISION MADE: 15-APR-21
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identify
Varian Medical Systems Inc. 510(k) NO: K210835(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 20-APR-21
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SoundBite Crossing System - Peripheral (14P)
Soundbite Medical Solutions, Inc. 510(k) NO: K210839(Special)
ATTN: Dominique Abecassis PHONE NO : 514 9562525 3352__
2300 Boulevard Alfred-Nobel SE DECISION MADE: 20-APR-21
Montreal CA H4S 2A4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAS 3D
Adas3D Medical S.L 510(k) NO: K210850(Special)
ATTN: Antonio Riu PHONE NO : 0034 93 3283964
Paris 179, 2-2 SE DECISION MADE: 05-APR-21
Barcelona ES 08036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DiLumen Endolumenal Interventional Platform ("DiLumen")
Lumendi, LLC 510(k) NO: K210851(Special)
ATTN: Dennis Daniels PHONE NO : 203 4632669
253 Post Road West SE DECISION MADE: 21-APR-21
Westport CT 06880 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuEra Tight RF, NuEra Tight RF Plus
BIOS s.r.l. 510(k) NO: K210867(Special)
ATTN: Eliana Russo PHONE NO : 0039 02 27304252
Via Guido Rossa 10/12 SE DECISION MADE: 21-APR-21
Vimodrone IT 20090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dayspring
Koya Medical, Inc. 510(k) NO: K210885(Special)
ATTN: Andy Doraiswamy PHONE NO : 404 5797682
2461 Peralta St. SE DECISION MADE: 23-APR-21
Oakland CA 94607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GPS Cervical Spacers
G Surgical LLC 510(k) NO: K210890(Special)
ATTN: Donald Grafton PHONE NO : 512 4944749
9433 Bee Cave Road Building 3, SuiSE DECISION MADE: 23-APR-21
Austin TX 78733 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restoration Anatomic Shell
Howmedica Osteonics Corp. a.k.a. S510(k) NO: K210893(Special)
ATTN: Alexandra Kirby PHONE NO :
325 Corporate Drive SE DECISION MADE: 22-APR-21
Mahwah NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2
Canon Medical Systems Corporation 510(k) NO: K210900(Special)
ATTN: Paul Biggins PHONE NO : 714 7305000
1385 Shimoshigami SE DECISION MADE: 12-APR-21
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
Intuitive Surgical, Inc. 510(k) NO: K210918(Special)
ATTN: Connor McCarty PHONE NO : 805 7984205
1266 Kifer Road SE DECISION MADE: 26-APR-21
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuityDRe
Radmedix LLC 510(k) NO: K210919(Traditional)
ATTN: Gabriel Issa PHONE NO : 844 7236334
2510 Lance Dr. SE DECISION MADE: 30-APR-21
Dayton OH 45409 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
Boston Scientific 510(k) NO: K210925(Third Party - Traditional)
ATTN: Rebecca Perrine PHONE NO : 419 4102427
300 Boston Scientific Way SE DECISION MADE: 28-APR-21
Marlborough MA 01564 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue)
Harbour Health LLC 510(k) NO: K210944(Third Party - Traditional)
ATTN: Jared Koenig PHONE NO : 949 6295068
4590 MacArthur Boulevard, Suite 50SE DECISION MADE: 29-APR-21
Newport Beach CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: U2 Total Knee System, XPE Tibial Insert, PS PLUS
United Orthopedic Corporation 510(k) NO: K210961(Special)
ATTN: Lois Ho PHONE NO : 886 3 5773351 2220
No 57, Park Ave 2, Science Park SE DECISION MADE: 21-APR-21
Hsinchu TW 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resonic Rapid Acoustic Pulse Device
Soliton Inc. 510(k) NO: K210964(Special)
ATTN: Leslie Honda PHONE NO : 206 3758586
5304 Ashbrook Drive SE DECISION MADE: 27-APR-21
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pure Vu System
Motus GI Medical Technologies Ltd.510(k) NO: K210981(Special)
ATTN: Mark Pomeranz PHONE NO : 908 7458599
22 Keren Ha'yesod Str. SE DECISION MADE: 29-APR-21
Tirat Carmel IL 3902638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMX Navigate
GE Medical Systems, LLC 510(k) NO: K210982(Special)
ATTN: Martha Kamrow PHONE NO : 262 5482673
3000 N. Grandview Blvd SE DECISION MADE: 28-APR-21
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1717FCC
Rayence Co., Ltd 510(k) NO: K210985(Special)
ATTN: Kevin Kim PHONE NO : 82 31 80156459
14, Samsung 1-ro, 1-gil SE DECISION MADE: 28-APR-21
Hwaseong-si KR 445-170 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yushan X-Ray Flat Panel Detector with DROC
InnoCare Optoelectronics Corp. 510(k) NO: K210988(Traditional)
ATTN: Yumei Cheng PHONE NO : 886 6 7007238 22598
Rm. B, No. 2, Sec. 2, Huanxi Rd., SE DECISION MADE: 21-APR-21
Tainan City TW 744 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CereLink ICP Monitor
Integra LifeSciences Production Co510(k) NO: K210993(Special)
ATTN: MaryBeth Carson PHONE NO : 609 3737461
11 Cabot Boulevard SE DECISION MADE: 30-APR-21
Mansfield MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Imperative Care Inc. 510(k) NO: K210996(Special)
ATTN: Kristin Ellis PHONE NO : 408 8570934
1359 Dell Avenue SE DECISION MADE: 23-APR-21
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Illusion Aligners
Laxmi Dental Exports Pvt Ltd 510(k) NO: K211010(Third Party - Traditional)
ATTN: Sameer Merchant PHONE NO : 0091 982 0268438
Survey No. 201/1, Village Gundale,SE DECISION MADE: 26-APR-21
Boisar IN 401501 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
Inari Medical, Inc. 510(k) NO: K211013(Special)
ATTN: Larry Boucher PHONE NO : 949 6008433
9 Parker, Suite 100 SE DECISION MADE: 30-APR-21
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Safety Trocar Cannula
Boston Scientific Corporation 510(k) NO: K211072(Traditional)
ATTN: Lingling Guo PHONE NO : 508 3820456
100 Boston Scientific Way SE DECISION MADE: 27-APR-21
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
3M Company, Unitek Orthodontic Pro510(k) NO: K211190(Third Party - Traditional)
ATTN: Yanine Garcia-Quezada PHONE NO : 909 5768208
2510 Conway Avenue SE DECISION MADE: 23-APR-21
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 255
TOTAL WITH SUMMARIES 243
TOTAL WITH STATEMENTS 12
