510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD September 2020
DEVICE: Portable Electro-Stimulation Therapy Device
Guangzhou Longest Science & Techno510(k) NO: K182020(Traditional)
ATTN: Xiaobing Luo PHONE NO : 86 020 66353999
5&6f, Building B4, No.11, Kaiyuan SE DECISION MADE: 17-SEP-20
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable Mesh Nebulizer
FeelLife Health Inc. 510(k) NO: K182906(Traditional)
ATTN: Owen Zhang PHONE NO : 86 755 66867080
Room 1903, Building A, No.9 FurongSE DECISION MADE: 27-SEP-20
Shenzhen CN 518104 510(k) STATEMENT
DEVICE: NICU V'02
COSMED Nordic ApS 510(k) NO: K190561(Traditional)
ATTN: Peter Clemensen PHONE NO : 45 65959100
Lucernemarken 23 SE DECISION MADE: 04-SEP-20
Odense DK DK-5260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LaborView™ LV1000 Wireless Electrode System
OBMedical Company 510(k) NO: K190798(Traditional)
ATTN: Mark A. Samuels PHONE NO : 352 2253682
3630 SW 47th Ave, Suite 201 SE DECISION MADE: 18-SEP-20
Gainesville FL 32608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TK Insulin Syringe with/without Saftey Retractable Device
Anhui Tiankang Medical Technology 510(k) NO: K191639(Traditional)
ATTN: Bai Baodong PHONE NO : 86 550 7309187
No.228 Weiyi Road, Economic DeveloSE DECISION MADE: 11-SEP-20
Tianchang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
Philips Medical Systems 510(k) NO: K191738(Traditional)
ATTN: Hong Zhu PHONE NO : 86 185 01616553
Building A2, #718 Lingshi Road, JiSE DECISION MADE: 29-SEP-20
Shanghai CN 200072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
Shenzhen Kentro Medical Electronic510(k) NO: K191982(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 755 33825998
No.3, Xihu Industry Zone, Xikeng VSE DECISION MADE: 25-SEP-20
Shenzhen City CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THINQ
CorticoMetrics LLC 510(k) NO: K192051(Traditional)
ATTN: Nick Schmansky PHONE NO : 1 617 3295042
128 Granite St. SE DECISION MADE: 30-SEP-20
Rockport MA 01966 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tua Face Fitness / Tua Trend Face
Vupiesse S.R.L 510(k) NO: K192077(Traditional)
ATTN: Marco Paolizzi PHONE NO : 39 0541 753020
Via della Lontra, 49 SE DECISION MADE: 30-SEP-20
Rimini RN IT 47923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biodegradable Nitrile Examination Powder Free Glove, Green
Top Glove SDN BHD 510(k) NO: K192111(Traditional)
ATTN: Noor Akilah Saidin PHONE NO : 603 339 21992
Lot 4969, Jalan Teratai, Batu 6, OSE DECISION MADE: 03-SEP-20
Klang MY 41050 510(k) STATEMENT
DEVICE: IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
Philips Medizin Systeme Boeblingen510(k) NO: K192137(Abbreviated)
ATTN: Stefan Breuer PHONE NO : 49 151 19615514
Hewlett-Packard-Str. 2 SE DECISION MADE: 11-SEP-20
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Intellifuse Administration and Intellifuse Blood Administration Sets
Smiths Medical ASD, Inc. 510(k) NO: K192375(Traditional)
ATTN: Wendy Hills PHONE NO :
6000 Nathan Lane North SE DECISION MADE: 18-SEP-20
Minneapolis MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MINT Product Family
Hans Biomed Corporation 510(k) NO: K192423(Traditional)
ATTN: Lucy Choi PHONE NO : 82 02466 2266
7, Jeongui-ro 8-gil, Songpa-gu SE DECISION MADE: 09-SEP-20
Seoul KR 05836 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lyograft
B. Bruan Surgical, SA 510(k) NO: K192452(Traditional)
ATTN: Pau Turon Dols PHONE NO : 34 935 866551
Carretera Terrassa 121 SE DECISION MADE: 03-SEP-20
Rubi ES 08191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lumipulse G CA15-3
Fujirebio Diagnostics, Inc. 510(k) NO: K192524(Traditional)
ATTN: Kristin Maddaloni PHONE NO : 484 3952126
201 Great Valley Parkway SE DECISION MADE: 04-SEP-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Syringe NRFit Lok and BD Syringe NRFit Slip
Becton, Dickinson and Company 510(k) NO: K192538(Traditional)
ATTN: Murtaza Rana PHONE NO : 201 8476980
1 Becton Drive SE DECISION MADE: 04-SEP-20
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Perseus
Orthokey Italia S.r.l. 510(k) NO: K192653(Traditional)
ATTN: Cristiano Paggetti PHONE NO : 39 055324 6012
Piazza Nazioni Unite, 15 SE DECISION MADE: 09-SEP-20
Carrara IT 54033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc. 510(k) NO: K192665(Traditional)
ATTN: Carrene Plummer PHONE NO : 520 4051462
3950 S. Country Club Road #470 SE DECISION MADE: 15-SEP-20
Tucson AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
Synthes (USA) Products LLC 510(k) NO: K192702(Traditional)
ATTN: Jeffrey Krawiec PHONE NO : 610 7195356
1301 Goshen Parkway SE DECISION MADE: 18-SEP-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endofresh Digestive Endoscopy System
HuiZhou Xzing Technology Co., Ltd.510(k) NO: K192704(Traditional)
ATTN: Yonglin Ni PHONE NO : 86 752 5754700
4th Floor, Building D, S-16-2 SoutSE DECISION MADE: 02-SEP-20
Huizhou CN 516000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optiflux F180NR Dialyzer
Fresenius Medical Care Renal Thera510(k) NO: K192707(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 21-SEP-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci SP Surgical System
Intuitive Surgical Inc. 510(k) NO: K192717(Traditional)
ATTN: Brandon Hansen PHONE NO : 408 5237485
1266 Kifer Road SE DECISION MADE: 28-SEP-20
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
BioSystems S.A. 510(k) NO: K192730(Traditional)
ATTN: Noelia Gil PHONE NO : 34 933 110000 4108
Costa Brava, 30 SE DECISION MADE: 09-SEP-20
Barcelona ES 510(k) STATEMENT
DEVICE: Pounce Thrombus Retrieval System
Surmodics, Inc. 510(k) NO: K192814(Traditional)
ATTN: Amy Yanta PHONE NO : 952 5007001
9924 West 74th Street SE DECISION MADE: 21-SEP-20
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Benesta Hysteroscope
Caldera Medical, Inc. 510(k) NO: K192822(Traditional)
ATTN: Vicki Gail PHONE NO : 818 8796555
5171 Clareton Drive SE DECISION MADE: 09-SEP-20
Agoura Hills CA 91301 510(k) STATEMENT
DEVICE: Bright Temporary C&B
DMP Dental Industry S.A. 510(k) NO: K192830(Traditional)
ATTN: Dimitris Prantsidis PHONE NO : 0030 22990 23041
Kalyvion Avenue SE DECISION MADE: 02-SEP-20
Markopoulo GR 19003 510(k) STATEMENT
DEVICE: SentEP
SentiAR, Inc 510(k) NO: K192890(Traditional)
ATTN: Berk Tas PHONE NO : 503 7301901
212 Kingshighway Blvd., Suite 115 SE DECISION MADE: 18-SEP-20
St. Louis MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROIMMUN Anti-BP230-CF ELISA (IgG)
Euroimmun US, Inc. 510(k) NO: K193115(Traditional)
ATTN: Kruti Shah PHONE NO : 800 9132022
1 Bloomfield Ave. SE DECISION MADE: 17-SEP-20
Mountain Lakes NJ 07046 510(k) STATEMENT
DEVICE: BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle
Becton, Dickinson and Company 510(k) NO: K193131(Traditional)
ATTN: Murtaza Rana PHONE NO : 201 8476980
1 Becton Drive SE DECISION MADE: 29-SEP-20
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DSM Biomedical Dental Bone Graft Plus
DSM Biomedical 510(k) NO: K193212(Traditional)
ATTN: Susan Pileggi PHONE NO : 478 7132173
735 Pennsylvania Drive SE DECISION MADE: 10-SEP-20
Exton PA 19431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nerve and Muscle Stimulator
Shenzhen XFT Medical Limited 510(k) NO: K193276(Traditional)
ATTN: Julia Ye PHONE NO : 86 755988 8818
Room 203, Building 1, Biomedicine SE DECISION MADE: 23-SEP-20
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
BioMerieux, Inc. 510(k) NO: K193299(Traditional)
ATTN: Cherece L. Jones PHONE NO : 314 7318684
595 Anglum Rd. SE DECISION MADE: 28-SEP-20
Hazelwood MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
MicroTech Medical, Inc. 510(k) NO: K193340(Traditional)
ATTN: Dore Mark PHONE NO : 408 5440744
3350 Scott Blvd, Bldg.64 SE DECISION MADE: 11-SEP-20
Santa Clara CA 95045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iCTmotor (WL-1)
Dentium Co., Ltd 510(k) NO: K193341(Traditional)
ATTN: Sangwoo Lee PHONE NO : 82 70 70984027
76, Changnyong-daero 256beon-gil, SE DECISION MADE: 04-SEP-20
Suwon-Si KR 16229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smart Correction System
WishBone Medical, Inc. 510(k) NO: K193368(Traditional)
ATTN: Mary Wentorf PHONE NO : 574 3064006 405
2150 North Pointe Drive SE DECISION MADE: 18-SEP-20
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
Altatec GmbH 510(k) NO: K193401(Traditional)
ATTN: Reto Pusterla PHONE NO : 49 7044 94450
Maybachstrasse 5 SE DECISION MADE: 29-SEP-20
Wimsheim DE D-71299 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Simplant Digital Guide
Dentsply Sirona 510(k) NO: K193405(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 02-SEP-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vista Rinse, Vista Rinse Plus
Inter-Med/Vista Dental Products 510(k) NO: K193409(Traditional)
ATTN: Alex Johnson PHONE NO : 262 6315306
2200 South St. Ste. A SE DECISION MADE: 09-SEP-20
Racine WI 53404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Resolution 360™ ULTRA Clip
Boston Scientific Corporation 510(k) NO: K193424(Traditional)
ATTN: Elena Hennessey PHONE NO : 508 6834347
100 Boston Scientific Way SE DECISION MADE: 01-SEP-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEBO Wound Dressing
MEBO Life Science Inc. 510(k) NO: K193439(Traditional)
ATTN: Sidney Hong PHONE NO : 626 3487978
325 North Puente Street # A SE DECISION MADE: 04-SEP-20
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)
Guangdong Horigen Mother & Baby Pr510(k) NO: K193449(Traditional)
ATTN: Jun Deng PHONE NO : 86 754 83613668
No. 18, Pingnan Industrial Zone, MSE DECISION MADE: 11-SEP-20
Shantou CN 515100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ClotTriever Thrombectomy System
Inari Medical 510(k) NO: K193462(Traditional)
ATTN: Eben Gordon PHONE NO : 949 6008433
9 Parker, Suite 100 SE DECISION MADE: 09-SEP-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Distal Centralizers
Biomet Inc. 510(k) NO: K193546(Traditional)
ATTN: Jessica Andreshak PHONE NO : 262 7163028
56 East Bell Drive, PO Box 587 SE DECISION MADE: 25-SEP-20
Warsaw IN 46581 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Restrata®
Acera Surgical, Inc. 510(k) NO: K193583(Special)
ATTN: Lily Jeng PHONE NO : 844 8792237
10880 Baur Blvd. SE DECISION MADE: 25-SEP-20
St. Louis MO 63132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
21st Century Scientific, Inc. 510(k) NO: K193599(Traditional)
ATTN: RD Davidson PHONE NO : 208 6678800
4931 N Manufacturing Way SE DECISION MADE: 03-SEP-20
Coeur d'Alene ID 83815 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExactechGPS System
Blue Ortho 510(k) NO: K193618(Traditional)
ATTN: Matthieu Coic PHONE NO : 0033 4 58003525
6 Allee de Bethleem SE DECISION MADE: 02-SEP-20
Gieres FR 38610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSLS6QF TENS/PMS Device
Self Doctor Care, LLC 510(k) NO: K193655(Traditional)
ATTN: Wei Wei PHONE NO : 516 2898425
8811 Teel Pkwy Ste 100, Unit 6141 SE DECISION MADE: 04-SEP-20
Frisco TX 75036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Enteral Feeding Syringe with Enfit Connector
Shinva Ande Healthcare Apparatus C510(k) NO: K193657(Traditional)
ATTN: Xiaolei Tian PHONE NO : 86 533 3917821
No.77 Development Zone North Road SE DECISION MADE: 12-SEP-20
Zibo CN 255086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SubQKath Catheter and Needle Set
HK Surgical 510(k) NO: K193664(Traditional)
ATTN: Gary Mocnik PHONE NO : 949 4330413
1271 Puerto del Sol SE DECISION MADE: 09-SEP-20
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
Jiangsu Caina Medical Co., Ltd. 510(k) NO: K200027(Traditional)
ATTN: Jianwei Pan PHONE NO : 86 18 273696900
No.23, Huanxi Road, Zhutang Town SE DECISION MADE: 09-SEP-20
Jiangyin CN 214415 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUGGLE Enteral Feeding Pump and Feeding Set
Amsino International Inc. 510(k) NO: K200051(Traditional)
ATTN: Jane Gao PHONE NO : 909 6265888
708 Corporate Center Drive SE DECISION MADE: 25-SEP-20
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Breezing Med
TF Health Co. 510(k) NO: K200076(Traditional)
ATTN: Erik Herrmann PHONE NO : 480 6295360
1761 W. University Dr., Suite 140 SE DECISION MADE: 25-SEP-20
Tempe AZ 85281 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS Dental Implant System
Dentsply Sirona 510(k) NO: K200102(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 W Philadelphia Street, Suite 6SE DECISION MADE: 03-SEP-20
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cavetto-SA Cervical Cage System
NeuroStructures, Inc. 510(k) NO: K200115(Special)
ATTN: Moti Altarac PHONE NO : 800 3526103
199 Technology Drive, Suite 110 SE DECISION MADE: 24-SEP-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Accessories for the SixFix® Hexapod Fixator
Arrowhead DE, LLC 510(k) NO: K200123(Traditional)
ATTN: Thomas J. Twardzik PHONE NO : 901 8534366
328 Poplar View Lane East, Suite 2SE DECISION MADE: 22-SEP-20
Collierville TN 38017 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RGK Daily Range Wheelchairs
RGK Wheelchairs, Ltd. 510(k) NO: K200135(Traditional)
ATTN: Devin McElroy PHONE NO : 44 1543 670077
Units 8 B/C Ring RD 2 Burntwood BuSE DECISION MADE: 10-SEP-20
Burntwood GB WS7 3JQ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIA-ROOT BIO MTA
Diadent Group International 510(k) NO: K200174(Traditional)
ATTN: Kab Sun Lee PHONE NO : 82 43 2662315
16, Osongsaengmyeong 4-ro, Osong-eSE DECISION MADE: 18-SEP-20
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
Innovative Health, LLC. 510(k) NO: K200212(Traditional)
ATTN: Rick Ferreira PHONE NO : 877 4003740
1435 North Hayden Road, Suite 100 SE DECISION MADE: 03-SEP-20
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVO
Catheter Precision, Inc. 510(k) NO: K200313(Traditional)
ATTN: Steve Adler PHONE NO : 973 6912000
500 International Drive, Suite 255SE DECISION MADE: 14-SEP-20
Mt. Olive NJ 07828 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FusionFrame Ring Lock System
GLW Medical Innovation 510(k) NO: K200343(Traditional)
ATTN: Elijah Wreh PHONE NO : 917 4562939
300 Sylvan Ave SE DECISION MADE: 14-SEP-20
Englewood Cliffs NJ 07632 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pulse Oximeter
Shenzhen Aeon Technology Co., Ltd.510(k) NO: K200414(Traditional)
ATTN: Xie Hua PHONE NO : 86 755 86182140
RM6H02, Block 27-29, Tianxia IC InSE DECISION MADE: 23-SEP-20
Shenzhen CN 518000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Boston One Step Liquid Enzymatic Cleaner
Bausch & Lomb Incorporated 510(k) NO: K200416(Traditional)
ATTN: Pinal Shah PHONE NO : 908 9270535
400 Somerset Corporate Boulevard SE DECISION MADE: 23-SEP-20
Bridgewater NJ 08807 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Precice® Ankle Salvage System
NuVasive Specialized Orthopedics, 510(k) NO: K200430(Traditional)
ATTN: Ivanna Lopez PHONE NO : 858 9091878
101 Enterprise, Suite 100 SE DECISION MADE: 16-SEP-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EtchPro Etching Gel
Belport Company, Inc., Gingi-Pak 510(k) NO: K200462(Traditional)
ATTN: Daniel Wang PHONE NO : 805 4841051
4825 Calle Alto, SE DECISION MADE: 02-SEP-20
Camarillo CA 93012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAPAYA 3D Premium & PAPAYA 3D Premium Plus
Genoray Co.,Ltd 510(k) NO: K200469(Traditional)
ATTN: Hyunju Hwang PHONE NO : 82 31 7404198
# 512, 560, Dunchon-daero, JungwonSE DECISION MADE: 16-SEP-20
Seongnam-si KR 13230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IDS-iSYS Ostase BAP
Immunodiagnostic Systems Ltd. 510(k) NO: K200475(Traditional)
ATTN: Mick Henderson PHONE NO : 44 191 5190660
10 Didcot Way, Boldon Business ParSE DECISION MADE: 30-SEP-20
Boldon GB NE35 9PD 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATL Anchors
International Life Sciences 510(k) NO: K200503(Traditional)
ATTN: Tiffini Wittwer PHONE NO : 707 7996732
2252 Northwest Parkway SE Suite G SE DECISION MADE: 02-SEP-20
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCT-Camera ID 21101A3
OptoMedical Technologies GmbH 510(k) NO: K200516(Traditional)
ATTN: Julia Behrens PHONE NO : 49 451 16086520
Maria-Goeppert-Strasse 9 SE DECISION MADE: 02-SEP-20
Luebeck DE 23562 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMICUS Separator System
Fresenius Kabi AG 510(k) NO: K200530(Traditional)
ATTN: Kim Forch PHONE NO : 847 5507962
3 Corporate Drive SE DECISION MADE: 11-SEP-20
Lake Zurich IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring)
Jiangsu Shenli Medical Production 510(k) NO: K200557(Traditional)
ATTN: Tina Cai PHONE NO : 86 519 88731071
No. 20, Changzheng Road, Zhenglu SE DECISION MADE: 28-SEP-20
Changzhou City CN 213111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayStation
RaySearch Laboratories AB (publ) 510(k) NO: K200569(Traditional)
ATTN: Viktoria Hammarstedt PHONE NO : 46 85 1053000
Sveavägen 44 SE DECISION MADE: 24-SEP-20
Stockholm SE 11134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AAA Model
Philips Ultrasound, Inc 510(k) NO: K200603(Traditional)
ATTN: Hebe Sun PHONE NO : 425 2191223
22100 Bothell Everett Highway SE DECISION MADE: 20-SEP-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HaloGUARD Protective Disc with CHG
ATTWILL Medical Solutions 510(k) NO: K200641(Traditional)
ATTN: Attilio Di Fiore PHONE NO : 608 5926925
925 Development Drive SE DECISION MADE: 03-SEP-20
Lodi WI 53555 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid iq
GE Medical Systems Ultrasound and 510(k) NO: K200708(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
Primary Care Diagnostics, LLC 9900SE DECISION MADE: 09-SEP-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICTUS Femtosecond Laser Platform
Technolas Perfect Vision GmbH 510(k) NO: K200724(Traditional)
ATTN: Friedrich Moritz PHONE NO : 49 174 3494062
Messerschmittstr. 1 + 3 SE DECISION MADE: 01-SEP-20
Munich DE 80992 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
Philips Image Guided Therapy Corpo510(k) NO: K200812(Traditional)
ATTN: Rand Daoud PHONE NO : 858 7204049
3721 Valley Centre Drive., Suite 5SE DECISION MADE: 02-SEP-20
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCATOR R-Tx
Ivory Super Holdco, Incp. 510(k) NO: K200827(Special)
ATTN: Marysa Loustalot PHONE NO : 760 7437744
2875 Locker Ave East SE DECISION MADE: 02-SEP-20
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX-1 Rhythm Express Remote Cardiac Monitoring System
VivaQuant Inc. 510(k) NO: K200833(Traditional)
ATTN: Brian Brockway PHONE NO : 651 2172176
4339 Nancy Place, Suite 100 SE DECISION MADE: 02-SEP-20
St. Paul MN 55126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad
3M Company 510(k) NO: K200835(Traditional)
ATTN: Hilary B. Hovde PHONE NO : 651 7360364
Bldg. 275-5W-06 SE DECISION MADE: 04-SEP-20
St. Paul MN 55144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs
O&M Halyard, Inc. 510(k) NO: K200843(Abbreviated)
ATTN: Steven Dowdley PHONE NO : 678 4518062
9120 Lockwood Blvd SE DECISION MADE: 22-SEP-20
Mechanicsville VA 23116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Navigation Module of the Momentum System
ulrich medical USA 510(k) NO: K200845(Traditional)
ATTN: Hans Stover PHONE NO : 636 5190268
18221 Edison Avenue SE DECISION MADE: 10-SEP-20
Chesterfield MO 63005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vivid T8, Vivid T9
GE Medical Systems Ultrasound and 510(k) NO: K200851(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 W. Innovation Drive SE DECISION MADE: 09-SEP-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EchoPAC Software Only, EchoPAC Plug-In
GE Medical Systems Ultrasound and 510(k) NO: K200852(Traditional)
ATTN: Tracey Ortiz PHONE NO : 262 4701003
9900 Innovation Drive SE DECISION MADE: 18-SEP-20
Wauwatosa WI 53226 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy PINNACLE Dual Mobility Liner
DePuy Ireland UC 510(k) NO: K200854(Traditional)
ATTN: Erin Combs PHONE NO : 574 3727211
Loughbeg Ringaskiddy SE DECISION MADE: 11-SEP-20
Co. Cork IE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Feelix Stethoscope
Sonavi Labs, Inc. 510(k) NO: K200862(Traditional)
ATTN: Ian McLane PHONE NO : 410 4178167
1100 Wicomico St., Suite 600 SE DECISION MADE: 14-SEP-20
Baltimore MD 21230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Administration Set
Cyclomedica Australia Pty Ltd 510(k) NO: K200916(Traditional)
ATTN: Niamh Mc Aree PHONE NO : 61 2 95410411
Unit 4, 1 The Crescent SE DECISION MADE: 01-SEP-20
Kingsgrove AU NSW 2208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fitbit ECG App
Fitbit, Inc. 510(k) NO: K200948(Traditional)
ATTN: Shruti Rajagopalan PHONE NO : 415 5131000
199 Fremont Street SE DECISION MADE: 11-SEP-20
San Francisco CA 94105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LTJ Screws and Washer
AzurMeds inc. 510(k) NO: K200987(Traditional)
ATTN: Jean-Marie Berger PHONE NO : 612 8107221
4809 N Ravenswood Avenue Suite 119SE DECISION MADE: 22-SEP-20
Chicago IL 60604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optixon 1-Day
Optixon Inc. 510(k) NO: K201013(Traditional)
ATTN: Oh Jeong Ju PHONE NO : 82 53354 9700
105/106 ho, 164, Obong-ro, Buk-Gu SE DECISION MADE: 18-SEP-20
Daegu KR 41500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann BoneCeramic
Institut Straumann AG 510(k) NO: K201051(Traditional)
ATTN: Christelle Gerspach-Gasser PHONE NO : 4 61 9651666
Peter Merian-Weg 12 SE DECISION MADE: 24-SEP-20
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Seaspine WaveForm C Interbody System
SeaSpine Orthopedics Corporation 510(k) NO: K201073(Traditional)
ATTN: Aly Alvarez PHONE NO : 760 2165622
5770 Armada Drive SE DECISION MADE: 18-SEP-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta III Lithotripter
Dornier MedTech America, Inc. 510(k) NO: K201074(Traditional)
ATTN: John Hoffer PHONE NO : 770 5146163
1155 Roberts Blvd, Suite 100 SE DECISION MADE: 03-SEP-20
Kennesaw GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Structur CAD
VOCO GmbH 510(k) NO: K201090(Traditional)
ATTN: M. TH. Plaumann PHONE NO : 49 47217190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 09-SEP-20
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: Xeleris V Processing and Review Systems
GE Healthcare 510(k) NO: K201103(Traditional)
ATTN: Alexandra Lifshits PHONE NO : 972 4 8563666
4 Hayozma Street SE DECISION MADE: 25-SEP-20
Tirat Hacarmel IL 30200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex NanoScope System
Arthrex, Inc. 510(k) NO: K201134(Traditional)
ATTN: Heli F Chambi Infantas PHONE NO : 239 6435553 71263
1370 Creekside Boulevard SE DECISION MADE: 04-SEP-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Image1 S CCU, Image1 S 4U Camera Head
Karl Storz Endoscopy-America, Inc.510(k) NO: K201135(Traditional)
ATTN: Alita McElroy PHONE NO : 424 2188376
2151 E. Grand Avenue SE DECISION MADE: 01-SEP-20
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-Pac Expandable Lumbar Cage System
Expanding Innovations, Inc. 510(k) NO: K201145(Traditional)
ATTN: Mbithi Muthini PHONE NO : 650 8613129
110 Pioneer Way, Suite I SE DECISION MADE: 10-SEP-20
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Athletis PTA Balloon Dilatation Catheter
Boston Scientific Corporation 510(k) NO: K201170(Traditional)
ATTN: Jennifer Mrkvicka PHONE NO : 763 2550917
3 Scimed Place SE DECISION MADE: 15-SEP-20
Maple Grove MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Clear Guide SCENERGY
Clear Guide Medical 510(k) NO: K201188(Traditional)
ATTN: Jack Kent PHONE NO : 410 2151638
3600 Clipper Mill Road, Suite 400 SE DECISION MADE: 30-SEP-20
Baltimore MD 21211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc. 510(k) NO: K201194(Traditional)
ATTN: James A. Bonafini PHONE NO : 585 4588409
1667 Lake Avenue, Suite 354 SE DECISION MADE: 08-SEP-20
Rochester NY 14615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cliq Aspirator
Anest Iwata Sparmax Co., Ltd. 510(k) NO: K201203(Traditional)
ATTN: Lika Lo PHONE NO : 886 2 23451868
4B-03 Taipei World Trade Center, 4SE DECISION MADE: 03-SEP-20
Taipei TW 11011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
Fresenius Medical Care Renal Thera510(k) NO: K201207(Traditional)
ATTN: Denise Oppermann PHONE NO : 781 9969103
920 Winter Street SE DECISION MADE: 18-SEP-20
Waltham MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halo AF Detection System
LIVMOR 510(k) NO: K201208(Traditional)
ATTN: Ken Persen PHONE NO : 612 7479595
16470 Bake Pkwy., Ste. 200 SE DECISION MADE: 23-SEP-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
Shenzhen Beacon Display Technology510(k) NO: K201211(Traditional)
ATTN: Fu Ailing PHONE NO : 86 075536 8683635150
12F, Block B1, Nanshan Zhiyuan, NoSE DECISION MADE: 03-SEP-20
Shenzhen CN 518055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical Generator
New Deantronics Taiwan Ltd 510(k) NO: K201221(Traditional)
ATTN: Jane Liu PHONE NO : 886 2226 81726
12F., No.51, Sec.4, Zhongyang Rd.,SE DECISION MADE: 28-SEP-20
New Taipei City TW 23675 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Electrosurgical Generator and Accessories
Medrange 510(k) NO: K201224(Traditional)
ATTN: Helen Xie PHONE NO : 1 909 8599055
480 Apollo Street, Suite D. SE DECISION MADE: 18-SEP-20
Brea CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Neodent Implant System - GM Helix Implants 7.0
JJGC Industria e Comercio de Mater510(k) NO: K201225(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41____ 21694000
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 04-SEP-20
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Spectralis HRA+OCT and variants
Heidelberg Engineering GmbH 510(k) NO: K201252(Traditional)
ATTN: Christoph Schoess PHONE NO : 49 622164630
Max-Jarecki-Strasse 8 SE DECISION MADE: 09-SEP-20
Heidelberg DE 69115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dermal Cooling System
R2 Technologies, Inc. 510(k) NO: K201260(Traditional)
ATTN: Ragan Reppond PHONE NO : 925 3784400
2603 Camino Ramon, Suite 200 SE DECISION MADE: 24-SEP-20
San Ramon CA 94583 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ImageSPECTRUM
Canon Inc. 510(k) NO: K201273(Traditional)
ATTN: Akira Hirai PHONE NO : 011 81 337582111
9-1, Imaikami-cho SE DECISION MADE: 25-SEP-20
Nakahara-ku, Kawasaki JP 211-8501510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral-B Dry Mouth Oral Rinse
The Proctor & Gamble Company 510(k) NO: K201277(Traditional)
ATTN: Michael A Kaminski PHONE NO : 513 6222879
1 Proctor & Gamble Plaza SE DECISION MADE: 02-SEP-20
Cincinnati OH 45202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: World Hip Stem, World Cup, World Liner
Signature Orthopaedics Pty Ltd. 510(k) NO: K201278(Traditional)
ATTN: Declan Brazil PHONE NO : 61 29428 5181
7 Sirius Road SE DECISION MADE: 21-SEP-20
Lane Cove AU 2066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline DeNovo 4Pro Electrical Stimulation Device
Medline Industries Inc 510(k) NO: K201290(Traditional)
ATTN: Leontyne Banks PHONE NO : 224 9311484
Three Lakes Drive SE DECISION MADE: 21-SEP-20
Northfield IL 60090 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VX1
Volta Medical 510(k) NO: K201298(Traditional)
ATTN: Théophile Mohr Durdez PHONE NO : 33 6 52579694
29 Boulevard de Louvain SE DECISION MADE: 16-SEP-20
Marseille FR 13008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFORM Humeral System – Stem
Tornier, Inc. 510(k) NO: K201315(Traditional)
ATTN: Renee Stoffel PHONE NO : 952 6837471
10801 Nesbitt Avenue South SE DECISION MADE: 11-SEP-20
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tigereye CTO-Crossing Catheter
Avinger, Inc. 510(k) NO: K201330(Traditional)
ATTN: Thomas Lawson PHONE NO : 650 2417004
400 Chesapeake Drive SE DECISION MADE: 10-SEP-20
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SABER .035 PTA Dilatation Catheter
Cordis Corporation 510(k) NO: K201333(Traditional)
ATTN: Kyungyoon Kang PHONE NO : 408 2733121
14201 N.W. 60TH AVE. SE DECISION MADE: 11-SEP-20
MIAMI LAKES FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
Synthes (USA) Products, LLC 510(k) NO: K201336(Traditional)
ATTN: Pol Fort Grebol PHONE NO : 41 76371 5269
1301 Goshen Parkway SE DECISION MADE: 03-SEP-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap 3D Imaging and Mapping Catheter
Acutus Medical, Inc. 510(k) NO: K201341(Traditional)
ATTN: Karla Schaffner PHONE NO : 442 2326161
2210 Faraday Ave., Suite 100 SE DECISION MADE: 15-SEP-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm
Synthes (USA) Products, LLC 510(k) NO: K201346(Traditional)
ATTN: Keith Knapp PHONE NO : 610 7195942
1301 Goshen Parkway SE DECISION MADE: 23-SEP-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORVUS
Best Nomos 510(k) NO: K201350(Traditional)
ATTN: Vineet Gupta PHONE NO : 412 3126700
One Best Drive SE DECISION MADE: 20-SEP-20
Pittsburgh PA 15202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlareHawk TiHawk9 Interbody Fusion System
Integrity Implants Inc. 510(k) NO: K201367(Traditional)
ATTN: Lauren Kamer PHONE NO : 561 5293869
354 Hiatt Drive SE DECISION MADE: 23-SEP-20
Palm Beach Gardens FL 33418 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVA (Augmented Vascular Analysis)
See-Mode Technologies Pte. Ltd. 510(k) NO: K201369(Traditional)
ATTN: Sadaf Monajemi PHONE NO : 61 415 952782
32 Carpenter Street, #03-01 SE DECISION MADE: 16-SEP-20
Singapore SG 059911 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
Medline Industires, Inc. 510(k) NO: K201390(Traditional)
ATTN: Adam Ostrower PHONE NO : 224 9311153
Three Lakes Drive SE DECISION MADE: 18-SEP-20
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon™ Spinal System
Medtronic Sofamor Danek USA, INC. 510(k) NO: K201407(Traditional)
ATTN: Usman Rashid PHONE NO : 901 3993559
1800 Pyramid Place SE DECISION MADE: 10-SEP-20
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ventilator, Non-continuous (Respirator)
Respironics, Inc. 510(k) NO: K201439(Traditional)
ATTN: Jennifer Richardson PHONE NO : 812 3221116
1001 Murry Ridge Lane SE DECISION MADE: 25-SEP-20
Murrysville PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straight T Clear Dental Aligner
Straight T, Inc. 510(k) NO: K201450(Traditional)
ATTN: Minh Trinh PHONE NO : 623 4743841
16952 W. Bell Rd #301 SE DECISION MADE: 10-SEP-20
Surprise AZ 85374 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
Bioland Technology Ltd. 510(k) NO: K201467(Traditional)
ATTN: Yiqing Feng PHONE NO : 86 755 36900999
No. A6B7 (Block G), ShangRong InduSE DECISION MADE: 21-SEP-20
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Medical Face Mask
JKH USA, LLC 510(k) NO: K201470(Traditional)
ATTN: Bill Quanqin Dai PHONE NO : 909 9299896
20505 Valley Blvd. Suite 108 SE DECISION MADE: 08-SEP-20
Walnut CA 91789 510(k) STATEMENT
DEVICE: ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Advin Biotech, Inc. 510(k) NO: K201494(Traditional)
ATTN: Daniel Hsu PHONE NO : 858 8668382
10237 Flanders Ct SE DECISION MADE: 17-SEP-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
Meditech Spine, LLC 510(k) NO: K201506(Special)
ATTN: Bruce Dunaway PHONE NO : 678 9745287
1447 Peachtree St NE Suite 440 SE DECISION MADE: 11-SEP-20
Atlanta GA 30309 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plain Surgical Mask
AOK Tooling Limited 510(k) NO: K201517(Traditional)
ATTN: Francis Nithyananthan PHONE NO : 852 0 23101703
#8, Longtian 3Rd, Longtian Street,SE DECISION MADE: 04-SEP-20
Shenzhen CN 518122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
Arthrex Inc. 510(k) NO: K201522(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 03-SEP-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B&J DVT Calf/Thigh Garments, Models 801/830 Series
B & J Manufacturing Ltd. 510(k) NO: K201532(Traditional)
ATTN: Billy Yu PHONE NO : 86 0755 88210239
Room 701 & 101, Building 24, BlockSE DECISION MADE: 19-SEP-20
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Protective Face Mask for Medical Use
Shandong Shengquan New Material Co510(k) NO: K201537(Traditional)
ATTN: Xiumei Zhang PHONE NO : 86 138 64136816
Diaozhen Industrial Development ZoSE DECISION MADE: 04-SEP-20
Jinan CN 250204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Life Spine SIMPACT Sacroiliac Joint Fixation System
Life Spine Inc. 510(k) NO: K201538(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 18-SEP-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Keeogo Dermoskeleton System
B-Temia Inc. 510(k) NO: K201539(Traditional)
ATTN: Alexandre Jokic PHONE NO : 1 418 6531010 248
4780, rue St-Felix-unite 105 SE DECISION MADE: 09-SEP-20
St Augustin de Desmaure CA G3A 2J510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B&J DVT Foot Garments, Models 820 Series
B&J Manufacturing Ltd. 510(k) NO: K201547(Traditional)
ATTN: Billy Yu PHONE NO : 86 0755 88210239
Room 701&101, Building 24, Block BSE DECISION MADE: 18-SEP-20
Shenzhen CN 518106 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KetoSens BT Blood B-Ketone Monitoring System
i-SENS, Inc. 510(k) NO: K201551(Special)
ATTN: Joon Ho Jung PHONE NO : 82 2 9166191
43, Banpo-daero 28-gil, Seocho-gu SE DECISION MADE: 09-SEP-20
Seoul KR 06646 510(k) STATEMENT
DEVICE: ApolloVue S100 Image System
Apollo Medical Optics, Ltd. 510(k) NO: K201552(Traditional)
ATTN: Chi-Hua Wu PHONE NO : 886 2 87523198
2F., No.43, Ln. 188, Ruiguang Rd.,SE DECISION MADE: 02-SEP-20
Taipei City TW 114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PF4 Enhanced assay
Immucor GTI Diagnostics, Inc. 510(k) NO: K201570(Special)
ATTN: Allison Stray PHONE NO : 262 7541089
20925 Crossroads Circle SE DECISION MADE: 11-SEP-20
Waukesha WI 53186 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Variable Angle Locking Patella Plating System
Synthes (USA) Products, LLC 510(k) NO: K201578(Traditional)
ATTN: Enrico Gindro PHONE NO : 41 799 127359
1301 Goshen Parkway SE DECISION MADE: 09-SEP-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flat Panel Detector
KA Imaging Inc. 510(k) NO: K201591(Traditional)
ATTN: Samuel To PHONE NO : 1 226 2159897
560 Parkside Dr #3 SE DECISION MADE: 03-SEP-20
Waterloo CA N2L 5Z4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaWrap Nerve Protector
Alafair Biosciences Inc 510(k) NO: K201631(Traditional)
ATTN: Angela Mallery PHONE NO : 800 2055586
6101 W Courtyard Drive ste 2-225 SE DECISION MADE: 14-SEP-20
Austin TX 78730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Chalice Medical Ltd 510(k) NO: K201642(Traditional)
ATTN: Stephen Horan PHONE NO : 44 0909 470777
Manton Wood Enterprise Park SE DECISION MADE: 18-SEP-20
Worksop GB S80 2RS 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Massage Compression Boots
JKH USA, LLC 510(k) NO: K201645(Traditional)
ATTN: Bill Quanqin Dai PHONE NO : 909 9299896
20505 Valley Blvd. Suite 108 SE DECISION MADE: 15-SEP-20
Walnut CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shoreline ACS (Anterior Cervical System)
SeaSpine Orthopedics Corporation 510(k) NO: K201646(Traditional)
ATTN: Alicia McArthur PHONE NO : 760 2165622
5770 Armada Drive SE DECISION MADE: 14-SEP-20
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIX Elbow System
Jeil Medical Corporation 510(k) NO: K201656(Traditional)
ATTN: Sejin Ryu PHONE NO : 82 2 8503583
702,703,704,705,706,804,805,807,81SE DECISION MADE: 15-SEP-20
Seoul KR 08378 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set
Medos International, SARL 510(k) NO: K201661(Traditional)
ATTN: Nicole Aeschbacher PHONE NO : 41 61965 6118
Chemin-Blanc 38 SE DECISION MADE: 16-SEP-20
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIREBIRD SI Fusion System
Orthofix Inc. 510(k) NO: K201664(Traditional)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 15-SEP-20
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Collaboration Live
Philips Ultrasound, Inc. 510(k) NO: K201665(Traditional)
ATTN: Colin S. Jacob PHONE NO : 425 9081209
22100 Bothell Everett Highway SE DECISION MADE: 15-SEP-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMS Cementless Stem
Medacta International SA 510(k) NO: K201673(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 18-SEP-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Mesh Plates
Arthrex Inc. 510(k) NO: K201677(Traditional)
ATTN: Rebecca R Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 02-SEP-20
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIST Radial Access Catheter
RIST Neurovascular, Inc. 510(k) NO: K201682(Traditional)
ATTN: Marianne Grumwaldt PHONE NO : 305 4953883
11611 Interchange Circle South SE DECISION MADE: 28-SEP-20
Miramar FL 33025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-Silicone for Bite Registration
Shandong Huge Dental Material Corp510(k) NO: K201684(Traditional)
ATTN: Maggie Zheng PHONE NO : 086 633 2277285
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 24-SEP-20
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide
Ethicon Inc. 510(k) NO: K201686(Traditional)
ATTN: Ariell Joiner PHONE NO : 908 2182348
Route 22 West SE DECISION MADE: 17-SEP-20
Somerville NJ 08876-0151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Single-Use Surgical Mask With Ear Loop
Qiqihar Hengxin Medical Supplies, 510(k) NO: K201691(Traditional)
ATTN: Sihui Xiong PHONE NO : 86 452 5656959
10th Beijiang Road in Tiefeng InduSE DECISION MADE: 17-SEP-20
Qiqihar CN 161000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Cathena Safety IV Catheter
Becton Dickinson Infusion Therapy 510(k) NO: K201717(Special)
ATTN: Paul Holman PHONE NO : 801 8343607
9450 South State Street SE DECISION MADE: 22-SEP-20
Sandy UT 84070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TruLift Expandable Spacer System
Life Spine Inc. 510(k) NO: K201721(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 04-SEP-20
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Body Sculpture System
Shanghai Apolo Medical Technology 510(k) NO: K201731(Traditional)
ATTN: Felix Li PHONE NO : 86 138 49190618
Room 301-310, Building 11, No.388,SE DECISION MADE: 10-SEP-20
Shanghai CN 200231 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SubNovii Advanced Plasma Technology
Cartessa Aesthetics 510(k) NO: K201738(Traditional)
ATTN: Gabe Lubin PHONE NO : 877 6622783
175 Broadhollow Rd SE DECISION MADE: 10-SEP-20
Melville NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tempus Pro Patient Monitor
Remote Diagnostic Technologies Lim510(k) NO: K201746(Special)
ATTN: Timothy Bubb PHONE NO : 44 0 1256362400
Pavilion C2, Ashwood Park, AshwoodSE DECISION MADE: 18-SEP-20
Basingstoke GB RG23 8BG 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent
Stryker Sustainability Solutions 510(k) NO: K201756(Traditional)
ATTN: Scott English PHONE NO : 480 7635333
1810 W Drake Drive SE DECISION MADE: 25-SEP-20
Tempe AZ 85283 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartHDM-510 System
Mesa Laboratories, Inc. 510(k) NO: K201765(Special)
ATTN: Jamie Louie PHONE NO : 303 9878000
12100 West 6th Ave. SE DECISION MADE: 02-SEP-20
Lakewood CO 80228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cavetto [MAX] Cervical Cage System
NeuroStructures, Inc. 510(k) NO: K201769(Traditional)
ATTN: Moti Altarac PHONE NO : 945 2954115
199 Technology Drive, Suite 110 SE DECISION MADE: 03-SEP-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
Masimo Corporation 510(k) NO: K201770(Special)
ATTN: Katelynn Kirby PHONE NO : 949 2977000
52 Discovery SE DECISION MADE: 24-SEP-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
PT. Medisafe Technologies 510(k) NO: K201774(Traditional)
ATTN: Sajeev Joseph PHONE NO : 62 61 30007134
J1 Batang Kuis, Gg Tambak Rejo PasSE DECISION MADE: 16-SEP-20
Tanjung Morawa, Medan ID 20362 510(k) STATEMENT
DEVICE: HotDog Temperature Management Controller
Augustine Temperature Management 510(k) NO: K201779(Special)
ATTN: Temi Ogunse PHONE NO : 952 4653539
7656 West 78th Street SE DECISION MADE: 11-SEP-20
Minneapolis MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Light Cure Dental Adhesive
Rizhao HuGe Biomaterials Company, 510(k) NO: K201787(Traditional)
ATTN: Maggie Zheng PHONE NO : 86 633 2277268
No.2 North Zhaoyang Road, DistrictSE DECISION MADE: 25-SEP-20
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dual Cure Resin Cement
Rizhao HuGe Biomaterials Company, 510(k) NO: K201790(Traditional)
ATTN: Maggie Zheng PHONE NO : 86 633 2277268
No.2 North Zhaoyang Road, DistrictSE DECISION MADE: 29-SEP-20
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transcend
Ultradent Product, Inc. 510(k) NO: K201795(Abbreviated)
ATTN: Karen Kakunes PHONE NO : 801 5534366
505 West Ultradent Drive (10200 SoSE DECISION MADE: 28-SEP-20
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit
Becton, Dickinson and Company 510(k) NO: K201814(Traditional)
ATTN: Niya Su PHONE NO : 206 7797758
2350 Qume Dr. SE DECISION MADE: 28-SEP-20
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cadwell Apollo System
Cadwell Industries, Inc. 510(k) NO: K201819(Traditional)
ATTN: Brad Weeks PHONE NO : 800 2453001 232
909 North Kellogg Street SE DECISION MADE: 29-SEP-20
Kennewick WA 99336 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System
NuVasive, Incorporated 510(k) NO: K201820(Traditional)
ATTN: Daniela Mahan PHONE NO : 858 4582285
7475 Lusk Blvd SE DECISION MADE: 25-SEP-20
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
Medline Industries, Inc. 510(k) NO: K201829(Traditional)
ATTN: Jennifer Mason PHONE NO : 847 6433652
Three Lakes Drive SE DECISION MADE: 09-SEP-20
Northfield IL 60030 510(k) STATEMENT
DEVICE: EyeBOX
Oculogica, Inc. 510(k) NO: K201841(Traditional)
ATTN: Rosina Samadani PHONE NO : 484 3932694
33 Irving Place SE DECISION MADE: 06-SEP-20
New York NY 10003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eNAT molecular collection and preservation medium
Copan Italia S.p.A. 510(k) NO: K201849(Traditional)
ATTN: Elena Simeonato PHONE NO : 39 030 2687290
Via F. Perotti 10 SE DECISION MADE: 17-SEP-20
Brescia IT 25125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPOGEN Laser Cap
Nature Incredible Inc 510(k) NO: K201854(Traditional)
ATTN: John Lee PHONE NO : 508 8694606
3422 Old Capitol Trail #569 SE DECISION MADE: 01-SEP-20
Wilmington DE 19808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Porcine Mineral Collagen Composite Moldable
Collagen Matrix, Inc. 510(k) NO: K201859(Traditional)
ATTN: Gloria Zuclich PHONE NO : 201 4051477
15 Thornton Road SE DECISION MADE: 11-SEP-20
Oakland NJ 07436 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cefaly Dual
CEFALY Technology 510(k) NO: K201895(Traditional)
ATTN: Rufus Kay Moberly PHONE NO : 32 4 3676722
Rue Louis Plescia 34 SE DECISION MADE: 29-SEP-20
Seraing BE 4102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3D GraftRasp System
SurGenTec 510(k) NO: K201900(Traditional)
ATTN: Andrew Shoup PHONE NO : 561 9907882
911 Clint Moore Rd SE DECISION MADE: 03-SEP-20
Boca Raton FL 33847 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RxSight Contact Lens
RxSight, Inc. 510(k) NO: K201909(Traditional)
ATTN: Maureen O'Connell PHONE NO : 978 2071245
100 Colombia SE DECISION MADE: 10-SEP-20
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoscope Reprocessor OER-Elite
Olympus Medical Systems Corp. 510(k) NO: K201920(Special)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 01-SEP-20
Hachioji-shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: e-Ortho Shoulder Software
FH Industrie 510(k) NO: K201928(Traditional)
ATTN: Oscar Ramirez PHONE NO : 33 2 98556895
ZI de Kernevez - 6 rue Nobel SE DECISION MADE: 30-SEP-20
Quimper FR 29000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
Synthes (USA) Products, LLC 510(k) NO: K201944(Special)
ATTN: Prem Pisupati PHONE NO : 610 7191019
1301 Goshen Parkway SE DECISION MADE: 10-SEP-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcroDTI Visualizer
AcroViz Inc. 510(k) NO: K201948(Traditional)
ATTN: Yung-Chin Hsu PHONE NO : 886 982 963908
Rm. 6. HF, No. 152, Sec. 1. ZhongxSE DECISION MADE: 09-SEP-20
Taipei TW 10050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System
DePuy Synthes 510(k) NO: K201959(Traditional)
ATTN: Stacey Bonnell PHONE NO : 484 2387519
1301 Goshen Parkway SE DECISION MADE: 11-SEP-20
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array
7D Surgical Inc. 510(k) NO: K201966(Special)
ATTN: Daniel Zisind PHONE NO : 647 4840079
60 Scarsdale Road, Unit 118 SE DECISION MADE: 03-SEP-20
Toronto CA M3B 2R7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Caption Guidance
Caption Health 510(k) NO: K201992(Traditional)
ATTN: Sam Surette PHONE NO : 571 3356532
2000 Sierra Point Pkwy SE DECISION MADE: 18-SEP-20
Brisbane CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LZI Oxycodone III Enzyme Immunoassay
Lin-Zhi International, Inc. 510(k) NO: K202007(Traditional)
ATTN: Bernice Lin PHONE NO : 408 9708811
2945 Oakmead Village Court SE DECISION MADE: 17-SEP-20
Santa Clara CA 95051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Vinyl Glove
Best Care Trading Co., LTD 510(k) NO: K202008(Traditional)
ATTN: Chongfeng Zhao PHONE NO : 86 1350 8943885
Yuying Village, Fangzhen, ZhangdiaSE DECISION MADE: 10-SEP-20
Zibo CN 255000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
Siemens Medical Solutions USA, Inc510(k) NO: K202014(Traditional)
ATTN: Andrew Turner PHONE NO : 610 8505627
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 08-SEP-20
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE)
Medacta International SA 510(k) NO: K202022(Traditional)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 18-SEP-20
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Honorst Implant System
Medimecca Co., Ltd. 510(k) NO: K202039(Special)
ATTN: Seung Yoon Lee PHONE NO : 82 2 8568282
Daeryung Techno Town 3-Cha 104,105SE DECISION MADE: 25-SEP-20
Seoul KR 08505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap PAS-Port Proximal Anastomosis System
Aesculap Inc. 510(k) NO: K202124(Special)
ATTN: Sierra Mertz PHONE NO : 610 9849076
3773 Corporate Parkway SE DECISION MADE: 02-SEP-20
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dynex Micro
Vilex, LLC 510(k) NO: K202143(Traditional)
ATTN: Joyce Thacker PHONE NO : 931 4747550
111 Moffitt Street SE DECISION MADE: 11-SEP-20
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Responsive Arthroscopy Suture Anchor System
Responsive Arthroscopy LLC 510(k) NO: K202153(Special)
ATTN: Douglas Korhs PHONE NO : 952 2509505
701 N. 3rd Street, Suite 208 SE DECISION MADE: 09-SEP-20
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMOND-5A/6A/8A
DRGEM Corporation 510(k) NO: K202156(Special)
ATTN: Ki-Nam Yang PHONE NO : 82 2 8698566
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 10-SEP-20
Gwangmyeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System
FUJIFILM SonoSite Inc. 510(k) NO: K202160(Special)
ATTN: Anoush Frankian PHONE NO : 425 9516824
21919 30th Dr SE SE DECISION MADE: 01-SEP-20
Bothell WA 98021-3904 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
Qura S.r.l 510(k) NO: K202169(Special)
ATTN: Raffaella Tommasini PHONE NO : 39 0535 1803050
Via di Mezzo, 23 SE DECISION MADE: 02-SEP-20
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
Medical Components Inc. (Dba Medco510(k) NO: K202176(Special)
ATTN: Courtney Nix PHONE NO : 215 2564201
1499 Delp Drive SE DECISION MADE: 03-SEP-20
Harleysville PA 19438 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
Imperative Care Inc. 510(k) NO: K202182(Special)
ATTN: Jake Wolenberg PHONE NO : 248 4960198
1359 Dell Avenue SE DECISION MADE: 02-SEP-20
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEX Vessel Prep System
VentureMed Group, Inc. 510(k) NO: K202187(Traditional)
ATTN: Jill Schweiger PHONE NO : 763 9510280
2800 Camput Drive, Suite 50 SE DECISION MADE: 11-SEP-20
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRUXXURE®-L and STRUXXURE®-A Plate System
Nexxt Spine LLC 510(k) NO: K202192(Traditional)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 17-SEP-20
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Astopad Patient Warming System
Stihler Electronic GmbH 510(k) NO: K202197(Third Party - Traditional)
ATTN: Jens- Peter Weege PHONE NO : 49 711 720670
Julius-Hoelder-Strasse 36 SE DECISION MADE: 04-SEP-20
Stuttgart DE 70597 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Vantage Orian 1.5T, MRT-1550, V6.0
Canon Medical Systems Corporation 510(k) NO: K202210(Special)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 22-SEP-20
Otawara-Shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
Roche Molecular Systems, Inc. 510(k) NO: K202215(Traditional)
ATTN: Rita Hoady PHONE NO : 925 4871055
4300 Hacienda Drive SE DECISION MADE: 02-SEP-20
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EPIQ Series Diagnostic Ultrasound Systems
Philips Ultrasound, Inc. 510(k) NO: K202216(Third Party - Traditional)
ATTN: Colin S. Jacob PHONE NO : 425 9081209
22100 Bothell Everett Highway SE DECISION MADE: 02-SEP-20
Bothell WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Artus™ cervical plate system
Ulrich GmbH & Co. KG 510(k) NO: K202227(Traditional)
ATTN: Christoph Ulrich PHONE NO : 49 0731 96541304
Buchbrunnenweg 12 SE DECISION MADE: 14-SEP-20
Ulm DE 89081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArtPIX DRF
CMT Medical Technologies Ltd 510(k) NO: K202235(Special)
ATTN: Dror Wertman PHONE NO : 972 4 8566220
7/2 Hacarmel St., POB 111, IndustrSE DECISION MADE: 03-SEP-20
Yokneam Ilit IL 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNA Artist
GE Healthcare (Tianjin) Company Li510(k) NO: K202238(Special)
ATTN: Qiang Ding PHONE NO : 86 133 11385163
No. 266 Jingsan Road,Tianjin AirpoSE DECISION MADE: 04-SEP-20
Tianjin CN 300308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HS Fiber
Riverpoint Medical, LLC 510(k) NO: K202242(Special)
ATTN: Edwin Anderson PHONE NO : 503 5178001
825 NE 25th Ave SE DECISION MADE: 10-SEP-20
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N),
Asahi Intecc Co., Ltd. 510(k) NO: K202252(Special)
ATTN: Yasuyuki Kawahara PHONE NO : 81 561 561859
3-100 Akatsuki-Cho SE DECISION MADE: 08-SEP-20
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3Shape Implant Studio
3Shape Medical A/S 510(k) NO: K202256(Third Party - Traditional)
ATTN: Jenny Axel PHONE NO : 45 7027 2620
Holmens Kanal 7 SE DECISION MADE: 09-SEP-20
Copenhagen DK DK-1060 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Surgical Face Mask
Jiangxi 3L Medical Products Group 510(k) NO: K202277(Traditional)
ATTN: Ge Zhang PHONE NO : 86 791 88112546
No.599, Huoju Street, High-tech DeSE DECISION MADE: 25-SEP-20
Nanchang City CN 330029 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tulsa-Pro System
Profound Medical Inc 510(k) NO: K202286(Special)
ATTN: Goldy Singh PHONE NO : 1 647 4761350 403
2400 Skymark Avenue, Unit 6 SE DECISION MADE: 16-SEP-20
Mississauga CA L4W 5K5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ran-Flex-B Bone Marrow Aspiration Needle
Ranfac Corporation 510(k) NO: K202287(Traditional)
ATTN: Eric Kreuz PHONE NO : 508 5884400 137
30 Doherty Street SE DECISION MADE: 18-SEP-20
Avon MA 02322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aline Ablation Intelligence
Mirada Medical Ltd 510(k) NO: K202297(Third Party - Traditional)
ATTN: David Clafton PHONE NO : 44 1865 817600
New Barclay House, 234 Botley RoadSE DECISION MADE: 11-SEP-20
Oxford GB OX2 0HP 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Marathon Flow Directed Micro Catheter
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K202318(Special)
ATTN: Elizabeth Campion PHONE NO : 949 2975804
9775 Toledo Way SE DECISION MADE: 14-SEP-20
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CD Horizon Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K202328(Special)
ATTN: Venkata Sandeep Manne PHONE NO : 901 3463133
1800 Pyramid Place SE DECISION MADE: 08-SEP-20
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambra ProViewer
Dicom Grid, Inc, dba Ambra Health 510(k) NO: K202335(Third Party - Traditional)
ATTN: Patrice Nedelec PHONE NO : 888 5872280
199 Water St., 34th Floor SE DECISION MADE: 04-SEP-20
New York NY 10038 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNIFUSE Infusion System with Cooper Wire
AngioDynamics, Inc. 510(k) NO: K202347(Special)
ATTN: Brandon M. Brackett PHONE NO : 1 508 6587984
26 Forest Street, Suite 200 SE DECISION MADE: 15-SEP-20
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgical Mask-Model Number CW01
Hunan Heng Chang Pharmaceutical Co510(k) NO: K202354(Traditional)
ATTN: Tao Jingfeng PHONE NO : 86 18 774961605
Floor 2,3, 102 of Building 16, StaSE DECISION MADE: 08-SEP-20
Changsha CN 410000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ziehm Vision RFD 3D
Ziehm Imaging GmbH 510(k) NO: K202360(Special)
ATTN: Stefan Fidler PHONE NO : 49 0911 2172219
Lina-Ammon-Strasse 10 SE DECISION MADE: 16-SEP-20
Nuremberg DE 90471 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EverLift Submucosal Lifting Agent
Gi Supply, Inc. 510(k) NO: K202376(Special)
ATTN: Erika Parry PHONE NO : 717 5627580
5069 Ritter Road Suite 104 SE DECISION MADE: 30-SEP-20
Mechanicsburg PA 17055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOSedge
EOS imaging 510(k) NO: K202394(Special)
ATTN: Bernard Ismael PHONE NO : 33 155 256060
10 rue Mercoeur SE DECISION MADE: 16-SEP-20
Paris FR F-75011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OrthoButton FL
Riverpoint Medical 510(k) NO: K202399(Special)
ATTN: Amanda Cole PHONE NO : 503 5178001
825 NE 25th Ave. SE DECISION MADE: 18-SEP-20
Portland OR 97232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Butterfly iQ Ultrasound System
Butterfly Network, Inc. 510(k) NO: K202406(Third Party - Traditional)
ATTN: Brian Sawin PHONE NO : 855 2966188
530 Old Whitfield Street SE DECISION MADE: 16-SEP-20
Guilford CT 06437 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BD Preset Syringe & BD A-Line Syringe
Becton, Dickinson, and Company 510(k) NO: K202446(Special)
ATTN: Avital Merl PHONE NO : 201 8474739
1 Becton Drive SE DECISION MADE: 25-SEP-20
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
Alcon Laboratories, Inc. 510(k) NO: K202448(Special)
ATTN: Sherri Lakota PHONE NO : 1 817 6155472
6201 South Freeway SE DECISION MADE: 22-SEP-20
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Disposable Surgical Mask
Unisources Group LLC 510(k) NO: K202463(Third Party - Traditional)
ATTN: Henry Shen PHONE NO : 267 7369484
7460 NW 52nd Street SE DECISION MADE: 18-SEP-20
Miami FL 33166 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EndoGI S-Path Biliary Stent System
Endo GI Medical 510(k) NO: K202477(Special)
ATTN: Omri Naveh PHONE NO : 972 52 4625474
13 Wadi El Hadj SE DECISION MADE: 24-SEP-20
Nazareth IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBS Implant System
InnoBioSurg Co., Ltd. 510(k) NO: K202479(Special)
ATTN: Bo-Yeon Lim PHONE NO : 82 42 9332879
44-19, Techno 10-ro, Yuseong-gu SE DECISION MADE: 23-SEP-20
Daejeon KR 34027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cordera Hip System
Conformis, Inc. 510(k) NO: K202484(Special)
ATTN: Nancy Giezen PHONE NO : 781 3459058
600 Technology Park Drive SE DECISION MADE: 24-SEP-20
Billerica MA 01821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diamond Digital Sleep Orthotic (DDSO)
Diamond Orthotic Laboratory 510(k) NO: K202499(Third Party - Traditional)
ATTN: Matt Rago PHONE NO : 619 7246400
7859 el Cajon Blvd. SE DECISION MADE: 03-SEP-20
La Mesa CA 91942 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Synchro SELECT Guidewire
STRYKER NEUROVASCULAR 510(k) NO: K202522(Special)
ATTN: Hailey Hinkle PHONE NO : 510 4132500
47900 Bayside Parkway SE DECISION MADE: 25-SEP-20
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Allura Vaginal Stent
PMT Corporation 510(k) NO: K202542(Third Party - Traditional)
ATTN: Matt Cree PHONE NO : 952 4700865
1500 Park Road SE DECISION MADE: 30-SEP-20
Chanhassen MN 55317 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
Volcano Corporation 510(k) NO: K202543(Special)
ATTN: Patrick Juarez PHONE NO : 858 6923412
3721 Valley Centre Drive, Ste 500 SE DECISION MADE: 28-SEP-20
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LVivo Seamless
DiA Imaging Analysis Ltd 510(k) NO: K202546(Special)
ATTN: Michal Yaacobi PHONE NO : 972 77 7648318
77 Haenergia Street SE DECISION MADE: 29-SEP-20
Beer-Sheva IL 8470912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DigitalDiagnost C90
Philips Medical Systems DMC GmbH 510(k) NO: K202564(Third Party - Special)
ATTN: Ming Xiao PHONE NO : 49 40 349712306
Röntgenstraße 24 SE DECISION MADE: 30-SEP-20
Hamburg DE 22335 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Wiygul Catheter
Big Blue Biotech, Inc. 510(k) NO: K202566(Third Party - Traditional)
ATTN: Russ Olsen PHONE NO : 781 3292993
690 Canton Street, Suite 302 SE DECISION MADE: 30-SEP-20
Westwood MA 02090 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
Guangzhou Wondfo Biotech Co., Ltd.510(k) NO: K202567(Traditional)
ATTN: Yi Mei PHONE NO : 86 20 32296069
No. 8 Lizhishan Road, Science CitySE DECISION MADE: 25-SEP-20
Guangzhou CN 510641 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Responsive Arthroscopy Interference Screw System
Responsive Arthroscopy LLC 510(k) NO: K202569(Special)
ATTN: Douglas Kohrs PHONE NO : 952 2509505
701 N. 3rd Street, Suite 208 SE DECISION MADE: 23-SEP-20
Minneapolis MN 55401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GXR-Series Diagnostic X-Ray System
DRGEM Corporation 510(k) NO: K202572(Special)
ATTN: Ki-Nam Yang PHONE NO :
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 24-SEP-20
Gwangmyeong-si KR 14322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eon Aligner
Eon Dental Jordan LLC 510(k) NO: K202685(Third Party - Traditional)
ATTN: Fadi Samawi PHONE NO : 962 780 606066
385 King Abdullah II Street SE DECISION MADE: 28-SEP-20
Amman JO 11810 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 245
TOTAL WITH SUMMARIES 233
TOTAL WITH STATEMENTS 12
