510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2019
DEVICE: A&D Medical Blood Pressure Monitors
A&D Company, Ltd 510(k) NO: K173065(Traditional)
ATTN: Jerry Wang PHONE NO : 408 3343326
1756 Automation Parkway SE DECISION MADE: 24-APR-19
San Jose CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ToxCO
Bedfont Scientific Ltd 510(k) NO: K173238(Traditional)
ATTN: Louise Bateman PHONE NO : 44 01622 851122
Station Road, Harrietsham SE DECISION MADE: 04-APR-19
Maidstone GB ME17 1JA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OJR215 Pressure Relief Manifold
Fisher & Paykel Healthcare Limited510(k) NO: K173770(Traditional)
ATTN: Adele Bindon PHONE NO : 64 9 5740100
15 Maurice Paykel Place, East TamaSE DECISION MADE: 05-APR-19
Auckland NZ 2013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUSION Plus Curing Light
DentLight Inc. 510(k) NO: K180065(Traditional)
ATTN: Richard Liu PHONE NO : 972 8898857
1825 Summit Ave. Ste 210 SE DECISION MADE: 19-APR-19
Plano TX 75074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DAEHAN Disposable CUP Electrodes
Daehan Medical Systems Co., Ltd. 510(k) NO: K180232(Traditional)
ATTN: Da Roo Ha PHONE NO : 82 31 4326275
250 Okgucheondong-Ro SE DECISION MADE: 03-APR-19
Siheung-City KR 15084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-Clip; D-Clip Applier
Peter Lazic GmbH 510(k) NO: K180757(Traditional)
ATTN: Sven Lazic PHONE NO : 49 7461 966430
Immelmannweg 2 SE DECISION MADE: 12-APR-19
Tuttlingen DE 78532 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIgH-Flo Super26 Subcutaneous Needle Sets
Repro-Med Systems, Inc. dba RMS Me510(k) NO: K180843(Traditional)
ATTN: Cynthia Lacatena PHONE NO : 845 6105579
24 Carpenter Road SE DECISION MADE: 04-APR-19
Chester NY 10918 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROPHYflex 4
Kaltenbach & Voigt GmbH 510(k) NO: K181110(Traditional)
ATTN: Stefan Trampler PHONE NO : 49 7351 563515
Bismarckring 39 SE DECISION MADE: 10-APR-19
Biberach DE 88400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Biomet Ceramic Heads
Zimmer, Inc 510(k) NO: K181171(Traditional)
ATTN: Carol Vierling PHONE NO : 706 4762938
P.O Box 708 SE DECISION MADE: 02-APR-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Syntec Femoral Nail System
Syntec Scientific Corporation 510(k) NO: K181296(Traditional)
ATTN: Nicole Tseng PHONE NO : 886 4 7987099
No.2, Kung San Road, Chuan Shing ISE DECISION MADE: 11-APR-19
Chang Hua TW 50971 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brux Night Guard
Brux Night Guard 510(k) NO: K181361(Traditional)
ATTN: John Scalco PHONE NO : 747 9982789
8201 Canoga Ave. #9066 SE DECISION MADE: 11-APR-19
Canoga Park CA 91309 510(k) STATEMENT
DEVICE: AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
Advanced Sterilization Products (A510(k) NO: K181472(Traditional)
ATTN: Andrea L. Ruth PHONE NO : 949 7893872
33 Technology Drive SE DECISION MADE: 23-APR-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
Andon health Co., Ltd 510(k) NO: K181541(Traditional)
ATTN: Yi Liu PHONE NO : 86 22 60526161
No.3 Jinping Street,Ya An Road, NaSE DECISION MADE: 16-APR-19
Tianjin CN 300190 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
Mark Abramson, D.D.S., Inc 510(k) NO: K181571(Traditional)
ATTN: Mark Abramson PHONE NO : 650 3699227
35 Renato Court SE DECISION MADE: 19-APR-19
Redwood City CA 94061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Le'Pen
KMIHH Ltd 510(k) NO: K181597(Traditional)
ATTN: Or Ramot PHONE NO : 0097 23 3030163
9 Hamovil Str., SE DECISION MADE: 01-APR-19
Kfar-Saba IL 4442411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rigi10 Malleable Penile Prosthesis
Rigicon Inc. 510(k) NO: K181673(Abbreviated)
ATTN: Ahmet Melih Luleci PHONE NO : 631 6302271
150 Motor Pkwy S401 SE DECISION MADE: 15-APR-19
Hauppauge NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InterSpace Knee Extra-Large Size, InterSpace Knee ATS
Tecres SpA 510(k) NO: K181732(Traditional)
ATTN: Massimo Grazioli PHONE NO : 39 045 9217311
via Andrea Doria 6 SE DECISION MADE: 27-APR-19
Sommacampagna IT 37066 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthodontic Appliance
Shandong Huge Dental Material Corp510(k) NO: K181747(Traditional)
ATTN: Maggie Zheng PHONE NO : 86 633 2277285
No. 68 Shanhai Road, Donggang DistSE DECISION MADE: 18-APR-19
Rizhao City CN 276800 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELRA Electrode
STARmed Co., Ltd. 510(k) NO: K181758(Traditional)
ATTN: Jun-Young Jung PHONE NO : 82 70 46738657
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 11-APR-19
Goyang-si KR 10355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
Cedic S.r.l. 510(k) NO: K181787(Traditional)
ATTN: Tiziana Melis PHONE NO : 3902 5530 0174 110
Via Liberazione, 63/9 SE DECISION MADE: 25-APR-19
Peschiera Borromeo IT 20068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device
Guangdong Transtek Medical Electro510(k) NO: K181832(Traditional)
ATTN: Nicole Hu PHONE NO : 086 760 85166220
Zone A, No 105 Dongli Road, Torch SE DECISION MADE: 09-APR-19
Zhongshan CN 528437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: One Touch
Thai Nippon Rubber Industry Public510(k) NO: K181844(Abbreviated)
ATTN: Pisut Chanwatarungkull PHONE NO : 66 38 317999
1 Charoenrat Road, Thungwatdon, SaSE DECISION MADE: 15-APR-19
Bangkok TH 10120 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ascent Cardiorespiratory Diagnostic Software
Medical Graphics Corporation 510(k) NO: K181912(Third Party - Traditional)
ATTN: Jim McGurran PHONE NO : 651 7663495
350 Oak Grove Parkway SE DECISION MADE: 12-APR-19
Saint Paul MN 55127-8599 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
iXensor Co., LTD. 510(k) NO: K181915(Traditional)
ATTN: Ariel Huang PHONE NO : 886 287511335
6F., No.9 Aly. 2, Ln. 35, Jihu RoaSE DECISION MADE: 12-APR-19
Taipei TW 114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Patient Monitor
Guangdong Biolight Meditech Co., L510(k) NO: K181919(Traditional)
ATTN: Dan Hou PHONE NO : 86 0756 3399971
No.2 Innovation First Road, TechnoSE DECISION MADE: 05-APR-19
Zhuhai CN 519085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GMC Upper Arm Automatic Blood Pressure Monitor
GMC Inc. 510(k) NO: K181931(Traditional)
ATTN: Yolanda Lin PHONE NO : 86 550 2172888
No. 686, Su Chu Rd. SE DECISION MADE: 04-APR-19
Chuzhou CN 239000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
Cook Incorporated 510(k) NO: K181971(Traditional)
ATTN: Paul Meyer PHONE NO : 812 3392235 105299
750 Daniels Way SE DECISION MADE: 23-APR-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: eMurmur ID
CSD Labs GmbH 510(k) NO: K181988(Traditional)
ATTN: Andreas Reinisch PHONE NO : 43 650 5272666
Niklaiplatz 4 SE DECISION MADE: 17-APR-19
Graz AT 8020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Compex HD
AdDent, Inc. 510(k) NO: K182017(Traditional)
ATTN: Joshua Friedman PHONE NO : 203 7780200
43 Miry Brook Road SE DECISION MADE: 29-APR-19
Danbury CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: exCellerator Cervical Collection Device
ExCell Company LLC 510(k) NO: K182049(Traditional)
ATTN: Jim Snyder PHONE NO : 317 3589610
1540 West Main Street SE DECISION MADE: 25-APR-19
Carmel IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Multi-Sideport Catheter Infusion Set
Cook Incorporated 510(k) NO: K182071(Traditional)
ATTN: Reuben Lidster PHONE NO : 812 3353575 104866
P.O. Box 489, 750 Daniels Way SE DECISION MADE: 25-APR-19
Bloomington IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Intelliport System
Becton, Dickinson, and Company 510(k) NO: K182092(Traditional)
ATTN: Rahul Ram PHONE NO : 201 8474712
1 Becton Drive SE DECISION MADE: 30-APR-19
Franklin Lakes NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Smile Makers Personal Lubricant
LFBeauty (Thailand) Limited 510(k) NO: K182100(Traditional)
ATTN: Apasara Kaewlor PHONE NO : 66 2 9876500 315
21/7 Moo 6 Kookot SE DECISION MADE: 25-APR-19
Lamlukka TH 12130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Psychemedics Microplate EIA for Fentanyl in Hair
Psychemedics Corporation 510(k) NO: K182103(Traditional)
ATTN: Virginia Hill PHONE NO : 310 2167776
5832 Uplander Way SE DECISION MADE: 18-APR-19
Culver City CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Portable Electro-Stimulation Therapy Device
Guangzhou Longest Science & Techno510(k) NO: K182108(Traditional)
ATTN: Xiaobing Luo PHONE NO : 86 020 66353999
5&6f, Building B4, No.11, Kaiyuan SE DECISION MADE: 26-APR-19
Guangzhou CN 510530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
Medline Industries, Inc. 510(k) NO: K182172(Traditional)
ATTN: Pauline Maralit PHONE NO : 847 9492283
Three Lakes Drive SE DECISION MADE: 24-APR-19
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TCD-X
Atys 510(k) NO: K182175(Traditional)
ATTN: Christine Turlat PHONE NO : 33 4 78056969
17, Parc D'arbora SE DECISION MADE: 05-APR-19
Soucieu En Jarrest FR 69510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
Ezisurg (Suzhou) Medical Co., Ltd.510(k) NO: K182217(Traditional)
ATTN: Jingtian Ren PHONE NO : 86 21 50456176 8026
Building 16, No.8 Jinfeng Rd. SuzhSE DECISION MADE: 16-APR-19
Suzhou CN 215163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bencox Mirabo Cup Multi Hole
Corentec Co., Ltd 510(k) NO: K182221(Special)
ATTN: J.S. Daniel PHONE NO : 82 41 5857144
12, Yeongsanhong 1-gil, Ipjang-MyeSE DECISION MADE: 01-APR-19
Cheonan-si KR 31056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIST IC
Imagine Milling Technologies, LLC 510(k) NO: K182246(Traditional)
ATTN: Felix Chung PHONE NO : 703 7256015
14225-E Sullyfield Circle SE DECISION MADE: 16-APR-19
Chantilly VA 20151 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Video Bronchoscopes
FUJIFILM Corporation 510(k) NO: K182253(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 04-APR-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
Flat Medical Co., Ltd. 510(k) NO: K182268(Traditional)
ATTN: Shao-Wei Tseng PHONE NO : 88 62 25672959 13
Rm. 1, 9F., No.27, Sec.1, Chang' aSE DECISION MADE: 05-APR-19
Taipei TW 10441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
Sterilmed, Inc. 510(k) NO: K182272(Traditional)
ATTN: Jan Flegeau PHONE NO : 786 5755903
5010 Cheshire Parkway N, Suite 2 SE DECISION MADE: 15-APR-19
Plymouth MN 55446 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDINAUT Plus
Imedicom Co., Ltd. 510(k) NO: K182287(Traditional)
ATTN: Bonggu Ha PHONE NO : 82 31 4791156
#612, 172, LS-ro SE DECISION MADE: 06-APR-19
Gunpo-si KR 435824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vera
Reflexion Health, Inc. 510(k) NO: K182333(Traditional)
ATTN: Walter Cordiglia PHONE NO : 619 6377018
225 Broadway Ste. 300 SE DECISION MADE: 09-APR-19
San Diego CA 92101 510(k) STATEMENT
DEVICE: Pantheris SV
Avinger, Inc. 510(k) NO: K182341(Traditional)
ATTN: Thomas Lawson PHONE NO : 650 2417004
400 Chesapeake Drive SE DECISION MADE: 09-APR-19
Redwood City CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONCORDE LIFT
Medos International, SARL 510(k) NO: K182349(Traditional)
ATTN: Desiree Saracino PHONE NO : 508 9773804
Chemin-Blanc 38 SE DECISION MADE: 03-APR-19
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
Globus Medical Inc. 510(k) NO: K182375(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 08-APR-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Supreme Diagnostic Electrophysiology Catheter
Innovative Health, LLC. 510(k) NO: K182386(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 23-APR-19
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KardiaMobile, KardiaStation
AliveCor, Inc. 510(k) NO: K182396(Traditional)
ATTN: Prabhu Raghavan PHONE NO : 650 3968553
444 Castro Street, Suite 600 SE DECISION MADE: 12-APR-19
Mountain View CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Park Blade Septostomy Catheter
Cook Incorporated 510(k) NO: K182399(Traditional)
ATTN: Rebecca Odulio PHONE NO : 812 3353575 104673
750 Daniels Way SE DECISION MADE: 04-APR-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
Brivant Limited (Lake Region Medic510(k) NO: K182457(Traditional)
ATTN: Tom J. Healy PHONE NO : 35 39 1385037
Parkmore West Business Park SE DECISION MADE: 18-APR-19
Galway IE H91 CK22 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FluChip-8G Influenza A+B Assay
InDevR, Inc. 510(k) NO: K182513(Traditional)
ATTN: Erica Dawson PHONE NO : 303 4029100
2100 Central Avenue, Suite 106 SE DECISION MADE: 22-APR-19
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Comprehensive Nano Stemless Shoulder
Biomet Manufacturing Corp 510(k) NO: K182516(Traditional)
ATTN: Jeff Gensler PHONE NO : 574 3711053
56 East Bell Drive SE DECISION MADE: 22-APR-19
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: InstaRISPACS / InstaZFP / InstaMobi v5.0
Meddiff Technologies Pvt. Ltd. 510(k) NO: K182572(Special)
ATTN: Mr. Sanjeev PHONE NO : 91 80 65350192
Salarpuria Palladium, 3rd flor, #2SE DECISION MADE: 12-APR-19
Bangalore IN 560 008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oryum and Ovem Epidermal Deri Prick Test Applicator
Allergy & Applicator Depot, LLC 510(k) NO: K182582(Traditional)
ATTN: Steve Tramontano PHONE NO : 800 5310237
9 Shore Drive SE DECISION MADE: 10-APR-19
Sound Beach NY 11789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO Actively Trying Personal Lubricant
United Consortium 510(k) NO: K182585(Traditional)
ATTN: Stephanie Morris PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 26-APR-19
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared thermometer
Shenzhen Pango Electronic Co., Ltd510(k) NO: K182597(Traditional)
ATTN: Youjian Xie PHONE NO : 86 755 33825988 301
No. 25, 1st Industry Zone, FenghuaSE DECISION MADE: 03-APR-19
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
GenMark Diagnostics, Incorporated 510(k) NO: K182619(Traditional)
ATTN: Alan Maderazo PHONE NO : 760 4484308
5964 La Place Court SE DECISION MADE: 12-APR-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Philips IntelliVue XDS Software
Philips Medizin Systeme Boeblingen510(k) NO: K182637(Traditional)
ATTN: Michael Asmalsky PHONE NO : 49 7031 4631277
Hewlett-Packard Str. 2 SE DECISION MADE: 26-APR-19
Boeblingen DE 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue)
Shandong Hengya Packaging Printing510(k) NO: K182640(Traditional)
ATTN: Sunny Hu PHONE NO : 86 536 2197068
Hetou village, Yingqiu town, ChangSE DECISION MADE: 12-APR-19
Weifang City CN 262416 510(k) STATEMENT
DEVICE: NAV PAK Needle, NIM NAV PAK Needle
Boston Endo Surgical Tech, 510(k) NO: K182662(Traditional)
ATTN: James Rogers PHONE NO : 203 3367453
Division of Lacey Manufacturing CoSE DECISION MADE: 10-APR-19
Bridgeport CT 06610 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEKURE Creatine Kinase Assay
SEKISUI DIAGNOSTICS P.E.I. INC. 510(k) NO: K182702(Traditional)
ATTN: Jeanna MacLeod PHONE NO : 902 6280207
70 Watts Avenue SE DECISION MADE: 17-APR-19
Charlottetown CA C1E 2B9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexible HD Cysto-Urethroscope System
KARL STORZ Endoscopy-America, Inc.510(k) NO: K182723(Traditional)
ATTN: Nozomi Yagi PHONE NO : 424 2188351
2151 E. Grand Avenue SE DECISION MADE: 23-APR-19
El Segundo CA 90245 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3T 32 Channel Head Coil
Nova Medical, Inc. 510(k) NO: K182737(Traditional)
ATTN: Cheryl Ledden PHONE NO : 978 9885553
150 West Street, Suite 201 SE DECISION MADE: 12-APR-19
Wilmington MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Adult Intraosseous Infusion Device
Einstein Works, L.L.C 510(k) NO: K182770(Traditional)
ATTN: Linda Taylor PHONE NO : 888 7377978
5312 Elm Street SE DECISION MADE: 09-APR-19
Houston TX 77081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC GLOSSFILL XR
S&C Polymer Silicon- und Composite510(k) NO: K182778(Traditional)
ATTN: Christian Boettcher PHONE NO : 0049 4121 4830
Robert-Bosch-Str. 2 SE DECISION MADE: 22-APR-19
Elmshorn DE 25335 510(k) STATEMENT
DEVICE: Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer
Surgical Instrument Service and Sa510(k) NO: K182828(Traditional)
ATTN: Stephanie Boyle Mays PHONE NO : 541 9233375
(dba Medline ReNewal) 1500 NE HemlSE DECISION MADE: 15-APR-19
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cardinal HealthTM Poly-Coated Open-Back Protective Gown
Cardinal Health 200, LLC 510(k) NO: K182830(Traditional)
ATTN: Caroline Miceli PHONE NO : 312 2702013
3651 Birchwood Drive SE DECISION MADE: 26-APR-19
Waukegan IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Endoscope Model EG-740N
FUJIFILM Corporation 510(k) NO: K182836(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 02-APR-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Element Pediatric Wheelchair
Leggero llc 510(k) NO: K182840(Traditional)
ATTN: Gabriela Romero PHONE NO : 406 5519443
P O Box 485 SE DECISION MADE: 29-APR-19
Burnet TX 78611 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LINK GEMINI SL Total Knee System
Waldemar Link GmbH & Co. KG 510(k) NO: K182872(Traditional)
ATTN: Andre von Malotki PHONE NO : 49 40 53995448
Oststrabe 4-10 SE DECISION MADE: 03-APR-19
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRCAT Pelvis
Philips Medical Systems MR Finland510(k) NO: K182888(Traditional)
ATTN: Janne Marvola PHONE NO : 358 9 615800
Ayritie 4 SE DECISION MADE: 30-APR-19
Vantaa FI 01510 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants
CS Medical L.L.C. 510(k) NO: K182891(Traditional)
ATTN: Kendall Ashe PHONE NO : 919 2559472
2179 East Lyon Station Road SE DECISION MADE: 12-APR-19
Creedmoor NC 27522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Treatment System
Weifang KM Electronics Co., LTD 510(k) NO: K182924(Traditional)
ATTN: Andy Pang PHONE NO : 86 136 06464486
No. 7999 Health East Street, High-SE DECISION MADE: 15-APR-19
Weifang CN 261000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX Nitinol Staple System
Nvision Biomedical Technologies, L510(k) NO: K182943(Traditional)
ATTN: Diana Langham PHONE NO : 210 5453713
4754 Shavano Oak, Suite 101 SE DECISION MADE: 04-APR-19
San Antonio TX 78249 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dr. Amplatz Micro Plug
KA Medical, LLC 510(k) NO: K182944(Traditional)
ATTN: John Oslund PHONE NO : 651 2560802
2890 Centre Pointe Drive SE DECISION MADE: 17-APR-19
Roseville MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Andorate Auxiliary Water Connector
Smartdata Suzhou Co., Ltd 510(k) NO: K182998(Third Party - Traditional)
ATTN: Cindy Ye PHONE NO : 86 512 65983722
4f, Block 7, 198#, Jinshan Rd SE DECISION MADE: 17-APR-19
Suzhou CN 215011 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: General Cutting Contra Handpiece
Nakanishi Inc. 510(k) NO: K182999(Traditional)
ATTN: Kimihiko Satoh PHONE NO : 81 289 643380
700 Shimonhinata SE DECISION MADE: 16-APR-19
Kanuma-shi JP 322-8666 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PuraSinus
3-D Matrix, Inc. 510(k) NO: K183015(Traditional)
ATTN: Lisa Spirio PHONE NO : 617 8756204
250 First Ave., Suite 205 SE DECISION MADE: 12-APR-19
Needham MA 02494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter
Imperative Care Inc. 510(k) NO: K183043(Traditional)
ATTN: Jake Wolenberg PHONE NO : 248 4960198
1359 Dell Avenue SE DECISION MADE: 17-APR-19
Campbell CA 95008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eclipse 2L
Balt USA, LLC 510(k) NO: K183045(Traditional)
ATTN: Nancy Xu PHONE NO : 949 7881443
29 Parker SE DECISION MADE: 30-APR-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSURE® Anterior Cervical Plate System
Globus Medical, Inc. 510(k) NO: K183056(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
Valley Forge Business Center 2560 SE DECISION MADE: 19-APR-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PUMA-G System
CoapTech LLC 510(k) NO: K183057(Traditional)
ATTN: Jack Kent PHONE NO : 443 5746981
8 Market Pl., Suite 804 SE DECISION MADE: 10-APR-19
Baltimore MD 21202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Relieva Tract Balloon Dilation System
Acclarent, Inc. 510(k) NO: K183090(Traditional)
ATTN: Leena Sorathia PHONE NO : 1 949 9234118
33 Technology Drive SE DECISION MADE: 19-APR-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CyclaPlex Correction System
Cycla Orthopedics Ltd 510(k) NO: K183094(Traditional)
ATTN: Rafi Herzog PHONE NO : 972 4 6443544
14 Hame Yasdim st. SE DECISION MADE: 26-APR-19
Bat shlomo IL 30992 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ranfac Cartilage Biopsy Needle
Ranfac Corporation 510(k) NO: K183146(Traditional)
ATTN: Eric Kreuz PHONE NO : 508 5884400 137
30 Doherty Ave SE DECISION MADE: 25-APR-19
Avon MA 02322 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Phoenix
US Bionics, Inc. (DBA suitX) 510(k) NO: K183152(Traditional)
ATTN: Kelly Mettler PHONE NO : 1 510 6102188
4512 Hollis Street SE DECISION MADE: 17-APR-19
Emeryville CA 94608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-Laser
WONTECH Co., Ltd. 510(k) NO: K183156(Traditional)
ATTN: Erin Park PHONE NO : 82 70 87308833
64 Techno 8-Ro, Yuseong-Gu SE DECISION MADE: 24-APR-19
Daejeon KR 305-500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FlareHawk Interbody Fusion System
Integrity Implants Inc 510(k) NO: K183184(Traditional)
ATTN: Lauren Kamer PHONE NO : 561 5293861
850 Parkway Street SE DECISION MADE: 03-APR-19
Jupiter FL 33477 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ultra OTC Facial Toning System
Micro Current Technology, Inc. 510(k) NO: K183189(Traditional)
ATTN: David Suzuki PHONE NO : 206 7741133
2244 1st Ave. South SE DECISION MADE: 17-APR-19
Seattle WA 98134 510(k) STATEMENT
DEVICE: CapsoCam Plus (SV-3)
CapsoVision, Inc. 510(k) NO: K183192(Special)
ATTN: Azimun Jamal PHONE NO : 408 6241488
18805 Cox Avenue, Suite 250 SE DECISION MADE: 19-APR-19
Saratoga CA 95070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYRAMESH™ Implant System
Medtronic Sofamor Danek USA, INC. 510(k) NO: K183197(Traditional)
ATTN: ANkit K. Shah PHONE NO : 901 3963133
1800 Pyramid Pl. SE DECISION MADE: 04-APR-19
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Deep Learning Image Reconstruction
GE Medical Systems, LLC. 510(k) NO: K183202(Traditional)
ATTN: Lee Bush PHONE NO : 262 5482848
3000 N. Grandview Blvd. SE DECISION MADE: 12-APR-19
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bone VCAR (BVCAR)
GE Medical Systems SCS 510(k) NO: K183204(Traditional)
ATTN: Elizabeth Matthew PHONE NO : 262 4247774
283 rue de la Miniere SE DECISION MADE: 08-APR-19
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Synapse Enterprise Viewer Version 1.0
FUJIFILM Corporation 510(k) NO: K183248(Traditional)
ATTN: Randy Vader PHONE NO :
26-30 Nishiazabu, 2-Chome SE DECISION MADE: 25-APR-19
Minato-Ku Tokyo JP 106-8620 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Kossan International Sdn. Bhd. 510(k) NO: K183287(Traditional)
ATTN: Cho Sow Fong PHONE NO : 603 32910516
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 05-APR-19
Klang MY 42100 510(k) STATEMENT
DEVICE: KY Banksy Aloe
RB Health (US) LLC 510(k) NO: K183302(Traditional)
ATTN: Elizabeth Viguerie PHONE NO : 1 973 4042600
399 Interpace Parkway SE DECISION MADE: 16-APR-19
Parsippany NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Prettau, ICE, Z-White zirconia blanks
Zirkonzahn srl 510(k) NO: K183304(Traditional)
ATTN: Julian Steger PHONE NO : 39 0474 066660
Via An der Ahr 7 SE DECISION MADE: 04-APR-19
Gais IT 39030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOCARD® W onyx Blood Glucose Monitoring System
ARKRAY Factory, Inc. 510(k) NO: K183306(Special)
ATTN: Yoshiharu Uehata PHONE NO : 81 50 58300922
Yousuien-Nai, 59 Gansuin-Cho SE DECISION MADE: 10-APR-19
Kamigyo-Ku JP 602-0008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ilumien Optis, Optis Integrated, Optis Mobile
St. Jude Medical (now Abbott Medic510(k) NO: K183320(Traditional)
ATTN: Steve Vitale PHONE NO : 651 7562000
One St. Jude Medical Drive SE DECISION MADE: 02-APR-19
St. Paul MN 55117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: “BRAXX” Esophageal Brachytherapy Applicator
BRAXX Biotech Co. Ltd 510(k) NO: K183332(Traditional)
ATTN: Judy Kao PHONE NO : 886 92 1988206
6F., No.10, Songde Rd., Xinyi DistSE DECISION MADE: 16-APR-19
Taipei City TW 11076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SambaScrew 3D SI Fusion System
Orthofix Inc. 510(k) NO: K183342(Traditional)
ATTN: Jacki Koch PHONE NO : 214 9372100
3451 Plano Parkway SE DECISION MADE: 30-APR-19
Lewisville TX 75056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Total Ankle Flat Cut Talar Components
Exactech Inc 510(k) NO: K183343(Traditional)
ATTN: Shing Jen Tai PHONE NO : 352 3771140
2320 NW 66th Court SE DECISION MADE: 01-APR-19
Gainesville FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EkoSonic Endovascular Device with Control Unit 4.0
BTG International, Inc. 510(k) NO: K183361(Traditional)
ATTN: Benjamin Hornsey PHONE NO : 425 4153143
11911 N Creek Pkwy S SE DECISION MADE: 05-APR-19
Bothell WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HORIZON TMS Therapy System with Navigation
Magstim Company Ltd. 510(k) NO: K183376(Traditional)
ATTN: Tom Campbell PHONE NO : 44 01994 240798
Spring Gardens SE DECISION MADE: 03-APR-19
Whitland GB SA34 0HR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K183377(Traditional)
ATTN: Shi Jufang PHONE NO : 86 755 81886293
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 04-APR-19
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex 2.5 mm Tenodesis Screw
Arthrex Inc. 510(k) NO: K183395(Traditional)
ATTN: Rebecca R. Homan PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard SE DECISION MADE: 17-APR-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endoform Restella
Aroa Biosurgery Ltd. 510(k) NO: K183398(Traditional)
ATTN: Tina O’Brien PHONE NO : 64 09 8693035
2 Kingsford Smith Place SE DECISION MADE: 11-APR-19
Airport Oaks NZ 2022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETi 88 Peripheral Thrombectomy System
Walk Vascular, LLC 510(k) NO: K183403(Traditional)
ATTN: David Look PHONE NO : 949 7529642
17171 Daimler Street SE DECISION MADE: 17-APR-19
Irvine CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Avulsion Forceps
STERIS Corporation 510(k) NO: K183428(Traditional)
ATTN: Eileen McCafferty PHONE NO : 440 3927189
5976 Heisley Rd SE DECISION MADE: 16-APR-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Erbe APCapplicators
Erbe Elektromedizin GmbH 510(k) NO: K183445(Traditional)
ATTN: Julia Weller PHONE NO : 0049 7071 7550
Waldhoernlestrasse 17 SE DECISION MADE: 04-APR-19
Tuebingen DE 72072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface
Medtronic Inc 510(k) NO: K183490(Traditional)
ATTN: Wendy Pinor PHONE NO : 763 5263309
7611 Northland Dr SE DECISION MADE: 12-APR-19
Minneapolis MN 55428 510(k) STATEMENT
DEVICE: R190/R191 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K183494(Traditional)
ATTN: Zilong Liang PHONE NO : 0086 25 83305050
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 05-APR-19
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K183496(Traditional)
ATTN: Zilong Liang PHONE NO : 0086 25 83305050
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 08-APR-19
Nanjing CN 210036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Codman Electrosurgical Generator, Foot Pedal
KLS Martin GmbH + Co. KG 510(k) NO: K183526(Traditional)
ATTN: Hanna Huttmeyer PHONE NO : 49 761 557997175
Am Flughafen 18 SE DECISION MADE: 11-APR-19
Freiburg im Breisgau DE 79108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PANAVIA SA Cement Universal
Kuraray Noritake Dental Inc. 510(k) NO: K183537(Traditional)
ATTN: Yasujiro Ohara PHONE NO : 81 3 67011736
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 25-APR-19
Chiyoda-ku JP 100-0004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ergoline Sunrise 7200 Hybrid Technology
JK-Holding GmbH 510(k) NO: K183539(Traditional)
ATTN: Juergen Gerstenmeier PHONE NO : 49 2224 818330
Koehlershohner Strabe 60 SE DECISION MADE: 08-APR-19
Windhagen DE 53578 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL)
NeoMed, Inc. 510(k) NO: K183540(Traditional)
ATTN: Tony Lair PHONE NO : 888 8762225
100 Londonderry Ct, Suite 112 SE DECISION MADE: 30-APR-19
Woodstock GA 30188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16
Siemens Medical Solutions USA, Inc510(k) NO: K183548(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Blvd. SE DECISION MADE: 15-APR-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vitality® Spinal Fixation System
Zimmer Biomet Spine, Inc. 510(k) NO: K183550(Traditional)
ATTN: Brendon Gareth Heyerdahl PHONE NO : 303 5130911
10225 Westmoor Drive SE DECISION MADE: 08-APR-19
Westminster CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JO H2O Jelly Original Personal Lubricant
United Consortium 510(k) NO: K183584(Traditional)
ATTN: Stephanie Morris PHONE NO : 661 2951700
29000 N. Hancock Pkwy. SE DECISION MADE: 17-APR-19
Valencia CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lung Vision System
Body Vision Medical Ltd. 510(k) NO: K183593(Traditional)
ATTN: Dorian Averbuch PHONE NO : 646 8637848
34 Sokolov St. SE DECISION MADE: 18-APR-19
Ramat Hasharon IL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
Infraredx, Inc. 510(k) NO: K183599(Traditional)
ATTN: Stephen Sum PHONE NO : 781 3459651
34 Third Avenue SE DECISION MADE: 12-APR-19
Burlington MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoTouch
CryoConcepts LP 510(k) NO: K183601(Traditional)
ATTN: Sam Niedbala PHONE NO : 855 3552796
205 Webster Street SE DECISION MADE: 18-APR-19
Bethlehem PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
ScandiDos AB 510(k) NO: K183606(Traditional)
ATTN: Thomas Matzen PHONE NO : 46 18 4723030
Dag Hammarskjölds väg 52A SE DECISION MADE: 08-APR-19
Uppsala SE 752 37 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: exGraft, exGraft Carbon
PECA Labs 510(k) NO: K183613(Traditional)
ATTN: Doug Bernstein PHONE NO : 877 8422873
4424 Penn Ave, Suite 201 SE DECISION MADE: 22-APR-19
Pittsburgh PA 15224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device
Boston Scientific Corporation 510(k) NO: K183619(Traditional)
ATTN: Laura Kelly PHONE NO : 952 9306252
10700 Bren Road West SE DECISION MADE: 16-APR-19
Minnetonka MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stasis Monitoring System
Stasis Labs, Inc. 510(k) NO: K183634(Traditional)
ATTN: Derek Nielsen PHONE NO : 518 5989399
9121 Airdrome St. SE DECISION MADE: 17-APR-19
Los Angeles CA 90035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SmartLinx Vitals Plus Patient Monitoring System
Capsule Technologie 510(k) NO: K183638(Special)
ATTN: Maylin Truesdell PHONE NO : 978 4822365
300 Brickstone Square, Suite 203 SE DECISION MADE: 17-APR-19
Andover MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K183660(Traditional)
ATTN: Jiang Haosen PHONE NO : 86 755 81886183
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 09-APR-19
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Occlusion Balloon Catheter
QXMedical, LLC 510(k) NO: K183679(Traditional)
ATTN: Fernando Di Caprio PHONE NO : 651 8422053
2820 Patton Road SE DECISION MADE: 24-APR-19
Roseville MN 55113 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OIC External Fixation System
Orthopaedic Implant Company 510(k) NO: K183682(Traditional)
ATTN: Douglas Fulton PHONE NO : 774 6368281
770 Smithridge Dr. #400 SE DECISION MADE: 08-APR-19
Reno NV 89502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Magnetic Surgical System
Levita Magnetics International Cor510(k) NO: K190006(Traditional)
ATTN: Alberto Rodrigues-Navarro PHONE NO : 650 2410320
1730 S. Amphlett Blvd, Suite 240 SE DECISION MADE: 29-APR-19
San Mateo CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xbody Newave USA
XBody Hungary Kft. 510(k) NO: K190038(Traditional)
ATTN: Peter Tar PHONE NO :
Gyorgy Aladar u. 35-39 SE DECISION MADE: 05-APR-19
Budapest HU 1125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann BLX Line Extension - New Abutments
Institut Straumann AG 510(k) NO: K190040(Traditional)
ATTN: Ana C.M. Vianna PHONE NO : 41 61 9651512
Peter Merian Weg 12 SE DECISION MADE: 08-APR-19
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Brainlab Elements Image Fusion Angio
Brainlab AG 510(k) NO: K190042(Traditional)
ATTN: Rainer Birkenbach PHONE NO : 004 9899 915680
Olof-Palme-Str. 9 SE DECISION MADE: 25-APR-19
Munchen DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Halley resin
Dentsply Sirona 510(k) NO: K190043(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 24-APR-19
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PureSleep (OTC use)
Sleep Science Partners, Inc. 510(k) NO: K190058(Traditional)
ATTN: Noel P. Lindsay PHONE NO : 415 4841451
900 Larkspur Landing Circle Suite SE DECISION MADE: 11-APR-19
Larkspur CA 94939 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sonopet iQ Ultrasonic Aspirator System
Stryker Corporation 510(k) NO: K190070(Traditional)
ATTN: Julia Helgeson PHONE NO : 269 3894789
4100 E. Milham Ave. SE DECISION MADE: 11-APR-19
Kalamazoo MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BriefCase
Aidoc Medical, Ltd. 510(k) NO: K190072(Traditional)
ATTN: Nimrod Epstein PHONE NO : 972 73 7946870
92 Yigal Alon St. SE DECISION MADE: 15-APR-19
Tel Aviv IL 67891 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ArgenZ HT+
The Argen Corporation 510(k) NO: K190079(Traditional)
ATTN: Craig Jolicoeur PHONE NO : 858 4557900 471
5855 Oberlin Drive SE DECISION MADE: 12-APR-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Straumann BLX Variobase Abutment
Institut Straumann AG 510(k) NO: K190082(Traditional)
ATTN: Viviana Horhoiu PHONE NO : 41 61 9651512
Peter Merian Weg-12 SE DECISION MADE: 17-APR-19
Basel CH CH-4002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
Inova Diagnostics, Inc. 510(k) NO: K190088(Traditional)
ATTN: Roger Albesa PHONE NO : 858 5869900 1391
9900 Old Grove Rd. SE DECISION MADE: 17-APR-19
San Diego CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
STERIS Corporation 510(k) NO: K190103(Special)
ATTN: Anthony Piotrkowski PHONE NO : 440 3927437
5960 Heisley Rd SE DECISION MADE: 05-APR-19
Mentor OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
Beckman Coulter, Inc. 510(k) NO: K190109(Traditional)
ATTN: Elaine Duncan PHONE NO : 916 3743279
1584 Enterprise Blvd. SE DECISION MADE: 18-APR-19
West Sacramento CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NanoBone SBX PUTTY, NanoBone QD
Artoss Gmbh 510(k) NO: K190110(Traditional)
ATTN: Walter Gerike PHONE NO : 49 0381 54345701
Friedrich-Barnewitz Strasse 3 SE DECISION MADE: 23-APR-19
Rostock DE 18119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags
Corinth MedTech, Inc. 510(k) NO: K190113(Traditional)
ATTN: Sandeep Saboo PHONE NO : 408 9962517
1601 S. De Anza Blvd, Suite 200 SE DECISION MADE: 24-APR-19
Cupertino CA 95014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
ConvaTec Limited 510(k) NO: K190114(Traditional)
ATTN: Karen Howes PHONE NO : 44 0 1244832195
GDC, First Avenue, Deeside IndustrSE DECISION MADE: 30-APR-19
Deeside GB CH5 2NU 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc. 510(k) NO: K190131(Traditional)
ATTN: Serena Sanginthirath PHONE NO : 442 2326178
2210 Faraday Ave., Suite 100 SE DECISION MADE: 02-APR-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CleverLock Guidewire Locking Device and Biopsy Cap
Olympus Surgical Technologies Amer510(k) NO: K190164(Traditional)
ATTN: Mary Anne Patella PHONE NO : 508 8042600
136 Turnpike Road SE DECISION MADE: 04-APR-19
Southborough MA 01772-2104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S-MAK XL
Merit Medical Systems Inc. 510(k) NO: K190175(Traditional)
ATTN: David Thomas PHONE NO : 801 3164956
1600 West Merit Parkway SE DECISION MADE: 10-APR-19
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation 510(k) NO: K190180(Traditional)
ATTN: Alexandra Wells PHONE NO : 609 7507872
311 Enterprise Drive SE DECISION MADE: 01-APR-19
Plainsboro NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microperimeter MP-3, Microperimeter MP-3 Type S
Nidek Co., Ltd 510(k) NO: K190198(Traditional)
ATTN: Mizuno Yoneji PHONE NO : 011 815 33678901
34-14 Maehama, Hiroishi-cho SE DECISION MADE: 01-APR-19
Gamagori JP 443-0038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXS Vecta Aspiration System
Stryker Neurovascular 510(k) NO: K190212(Special)
ATTN: Shazia Hakim PHONE NO : 510 4132636
47900 Bayside Parkway SE DECISION MADE: 24-APR-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iFuse Implant System®
SI-BONE, Inc. 510(k) NO: K190230(Traditional)
ATTN: Meirav Harsat PHONE NO : 650 8624942
471 El Camino Real, Suite 101 SE DECISION MADE: 03-APR-19
Santa Clara CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARIETTA 50
Hitachi Healthcare Americas 510(k) NO: K190248(Traditional)
ATTN: Aaron Pierce PHONE NO : 330 4251313
1959 Summit Commerce Park SE DECISION MADE: 02-APR-19
Twinsburg OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Karma® Fixation System
Spinal Elements Inc 510(k) NO: K190289(Traditional)
ATTN: Julie Lamothe PHONE NO : 760 6071816
3115 Melrose Dr., Suite 200 SE DECISION MADE: 03-APR-19
Carlsbad CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AltiVate Reverse Humeral Stem, 48mm
Encore Medical, L.P. 510(k) NO: K190290(Special)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd. SE DECISION MADE: 26-APR-19
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Confirm Rx Insertable Cardiac Monitor
Abbott (St. Jude Medical) 510(k) NO: K190295(Traditional)
ATTN: Laura Sparks PHONE NO : 818 4932734
15900 Valley View Ct. SE DECISION MADE: 10-APR-19
Sylmar CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Additive Cap
International Medical Industries, 510(k) NO: K190305(Traditional)
ATTN: Peter Lehel PHONE NO : 954 9179570 227
2981 Gateway Drive SE DECISION MADE: 30-APR-19
Pompano Beach FL 33069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zavation Spinal System
Zavation Medical Products, LLC 510(k) NO: K190317(Traditional)
ATTN: Frankie Cummins PHONE NO : 601 9191119
220 Lakeland Parkway SE DECISION MADE: 11-APR-19
Flowood MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PreXion3D Explorer
PreXion Corporation 510(k) NO: K190320(Traditional)
ATTN: Hiroaki Takahashi PHONE NO : 81 3 52977551
1-14-1, Kanda Suda-cho SE DECISION MADE: 15-APR-19
Chiyoda-ku JP 101-0041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENConnect 40 mm Screw Cap to ENPlus Adapter
Cedic S.r.l. 510(k) NO: K190327(Traditional)
ATTN: Tiziana Melis PHONE NO : 3902 5530 0174 110
Via Liberazione, 63/9 SE DECISION MADE: 09-APR-19
Peschiera Borromeo IT 20068 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CancelleX Porous Titanium Lumbar Interbody Device
Xenco Medical, LLC 510(k) NO: K190364(Traditional)
ATTN: Jason Haider PHONE NO : 858 2021505
9930 Mesa Rim Road SE DECISION MADE: 18-APR-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Baby Gorilla/Gorilla Plating System
Paragon 28, Inc. 510(k) NO: K190365(Special)
ATTN: Eric Lintula PHONE NO : 888 7281888
4B Inverness Ct. E, STE 280 SE DECISION MADE: 12-APR-19
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M-Y Sheath
RAM Medical Innovations, Inc. 510(k) NO: K190369(Traditional)
ATTN: Mubin Syed PHONE NO : 937 2150878
326 Braytonburne Drive SE DECISION MADE: 17-APR-19
Springfield OH 45503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Parcus ATLAS
Parcus Medical, LLC 510(k) NO: K190375(Special)
ATTN: Paul Vagts PHONE NO : 941 7557965
6423 Parkland Dr SE DECISION MADE: 24-APR-19
Sarasota FL 34243 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CryoLab
CryoConcepts LP 510(k) NO: K190407(Traditional)
ATTN: Sam Niedbala PHONE NO : 610 5975501
205 Webster St SE DECISION MADE: 22-APR-19
Bethlehem PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS Plating System
MiRus, LLC 510(k) NO: K190415(Traditional)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway, Suite 108 SE DECISION MADE: 19-APR-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Dome Electrode
Coapt, LLC 510(k) NO: K190416(Abbreviated)
ATTN: Blair Lock PHONE NO : 844 2627800 700
222 W. Ontario Street, Unit #300 SE DECISION MADE: 04-APR-19
Chicago IL 60654 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NDOHD High Definition Imaging System (NDOHD)
Altaravision Inc. 510(k) NO: K190420(Special)
ATTN: Stuart Bradley PHONE NO : 919 3425778
130 Salem Town Court SE DECISION MADE: 15-APR-19
Apex NC 27502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7400 Ultrasound Systems
Navigant Consulting - on behalf of510(k) NO: K190447(Special)
ATTN: Allison Scott PHONE NO : 317 2725419
9100 Keystone Crossing Suite 500 SE DECISION MADE: 01-APR-19
Indianapolis IN 46240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VisCalor bulk
VOCO GmbH 510(k) NO: K190453(Special)
ATTN: Th. Plaumann PHONE NO : 49 4 7217190
Anton-Flettner-Str. 1-3 SE DECISION MADE: 11-APR-19
Cuxhaven DE 27472 510(k) STATEMENT
DEVICE: Cepheid Xpert C. difficile/Epi Control Panel
Microbiologics, Inc. 510(k) NO: K190463(Traditional)
ATTN: Tina Sobania PHONE NO : 320 2297050
200 Cooper Avenue North SE DECISION MADE: 19-APR-19
St. Cloud MN 56303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Penumbra System 3D Revascularization Device
Penumbra, Inc. 510(k) NO: K190464(Traditional)
ATTN: Denise Aycox PHONE NO : 510 9952075
One Penumbra Place SE DECISION MADE: 26-APR-19
Alameda CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elcam Stopcocks and Manifolds
Elcam Medical ACAL 510(k) NO: K190489(Special)
ATTN: Avital Levertov PHONE NO : 972 52 8313380
Kibbutz Baram SE DECISION MADE: 23-APR-19
Kibbutz Baram IL 1386000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
CEFLA S.C. 510(k) NO: K190496(Traditional)
ATTN: Elena Arcangeli PHONE NO : 39 0542 653441
Via Selice Provinciale 23/A SE DECISION MADE: 24-APR-19
Imola IT 40026 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NeoForm Annuloplasty Ring
Genesee BioMedical, Inc 510(k) NO: K190506(Traditional)
ATTN: Woodrow Mathison PHONE NO : 303 7773000
700 W Mississippi Ave, Unit D5 SE DECISION MADE: 18-APR-19
Denver CO 80223-4509 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS XT Chemistry Products GLU-Ca Slides
Ortho-Clinical Diagnostics, Inc. 510(k) NO: K190520(Traditional)
ATTN: Darlene Phillips PHONE NO : 585 4534253
100 Indigo Creek Drive SE DECISION MADE: 03-APR-19
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyCHROM CRE
Hardy Diagnostics 510(k) NO: K190553(Traditional)
ATTN: Rianna Malherbe PHONE NO : 805 3462766 5714
1430 West McCoy Lane SE DECISION MADE: 29-APR-19
Santa Maria CA 93455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bio-Medicus Insertion Kit
Medtronic, Inc. 510(k) NO: K190557(Special)
ATTN: Huda Yusuf PHONE NO : 763 5149805
8200 Coral Street NE SE DECISION MADE: 03-APR-19
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Amplatzer Treviso Intravascular Delivery System
Abbott Medical 510(k) NO: K190581(Special)
ATTN: Mary Johnson PHONE NO : 651 7562213
5050 Nathan Lane SE DECISION MADE: 05-APR-19
Plymouth MN 55442 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Monster® Screw System
Paragon 28, Inc. 510(k) NO: K190586(Special)
ATTN: Eric Lintula PHONE NO : 888 7281888
4B Inverness Ct. E, STE 280 SE DECISION MADE: 03-APR-19
Englewood CO 80112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: YelloPort Elite Port Access System
Surgical Innovations Limited 510(k) NO: K190592(Traditional)
ATTN: Shazia Chaudhry PHONE NO : 004 411 3230759730 312
Clayton Wood House 6 Clayton Wood SE DECISION MADE: 29-APR-19
Leeds GB LS16 6QZ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSWAY Spinal Access System
Globus Medical Inc. 510(k) NO: K190598(Special)
ATTN: Kelly J. Baker PHONE NO : 610 9301800 1670
2560 General Armistead Ave. SE DECISION MADE: 05-APR-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MasteRad MX30
MedicaTech USA 510(k) NO: K190601(Traditional)
ATTN: George Makar PHONE NO : 949 6792881
50 Maxwell SE DECISION MADE: 25-APR-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIVIX-S 1751S
Vieworks Co., Ltd. 510(k) NO: K190611(Traditional)
ATTN: Jordin Kim PHONE NO : 82 70 44961859
(Gwanyang-dong) 41-3, Burim-ro 170SE DECISION MADE: 08-APR-19
Anyang-si KR 431-060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aspiron(TM) Aspiration Catheter
Meril Life Sciences Private Limite510(k) NO: K190619(Traditional)
ATTN: Utpal Thakor PHONE NO : 91 9601 260306
Bilakhia House, Survey No. 135/139SE DECISION MADE: 29-APR-19
Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
Sumitomo Bakelite Co., Ltd 510(k) NO: K190621(Traditional)
ATTN: Shiro Agehama PHONE NO : 81 3 54624811
5-8, Higashi-Shinagawa 2-chome SE DECISION MADE: 23-APR-19
Shinagawa-ku JP 1400002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SyncVision System
Volcano Corporation 510(k) NO: K190626(Traditional)
ATTN: Rand Daoud PHONE NO : 858 7204049
3721 Valley Centre Dr., Suite 500 SE DECISION MADE: 12-APR-19
San Diego CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VALO Grand Corded
Ultradent Products, Inc. 510(k) NO: K190627(Special)
ATTN: Karen Kakunes PHONE NO : 801 5534366
505 West Ultradent Drive (10200 SoSE DECISION MADE: 29-APR-19
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBSWIN and VISTAEASY Imaging Software
Durr Dental SE 510(k) NO: K190629(Traditional)
ATTN: Oliver Lange PHONE NO : 49 0 7142705190
Hopfigheimer Strasse 17 SE DECISION MADE: 01-APR-19
Bietigheim-Bissingen DE D-74321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: M.U.S.T. MINI Posterior Cervical Screws System
Medacta International SA 510(k) NO: K190631(Special)
ATTN: Stefano Baj PHONE NO : 41 91 6966060
Strada Regina SE DECISION MADE: 10-APR-19
Castel San Pietro CH CH-6874 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Guide Sheath
Surmodics, Inc. 510(k) NO: K190644(Traditional)
ATTN: Peggy Ju PHONE NO : 651 3193602
9924 West 74th Street SE DECISION MADE: 18-APR-19
Eden Prairie MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExcelsiusGPS
Globus Medical Inc. 510(k) NO: K190653(Special)
ATTN: Kelly J. Baker PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 09-APR-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
SeaSpine Orthopedics Corporation 510(k) NO: K190655(Traditional)
ATTN: Alicia McArthur PHONE NO : 760 2165117
5770 Armada Drive SE DECISION MADE: 29-APR-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS Bunion Plating System
CrossRoads Extremity Systems, LLC 510(k) NO: K190658(Special)
ATTN: Chad Hollis PHONE NO : 901 2218406
6055 Primacy Pkwy, Suite 140 SE DECISION MADE: 12-APR-19
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Brainlab AG 510(k) NO: K190664(Special)
ATTN: Rainer Birkenbach PHONE NO : 0049 89 9915680
Olof-Palme-Str. 9 SE DECISION MADE: 12-APR-19
München DE 81829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VersaCross Steerable Sheath, VersaCross Transseptal Dilator
Baylis Medical Company Inc. 510(k) NO: K190688(Special)
ATTN: May Tsai PHONE NO : 1 905 6024875
2580 Matheson Blvd. E SE DECISION MADE: 17-APR-19
Mississauga CA L4W 4J1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
SORIN GROUP ITALIA S.R.L. 510(k) NO: K190690(Special)
ATTN: Luigi Vecchi PHONE NO : 39 346 3910707
Via Statale 12 Nord, 86 SE DECISION MADE: 13-APR-19
Mirandola IT 41037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pixx2430 Digital Diagnostic X-Ray Receptor Panel
Pixxgen Corporation 510(k) NO: K190691(Traditional)
ATTN: John Ross PHONE NO : 82 70 48468888
5F, Smart Bay, 123, Beolmal-ro, DoSE DECISION MADE: 04-APR-19
Anyang-si KR 14056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEM-6410T-ZL Wrist Blood Pressure Monitor
Omron Healthcare, Inc. 510(k) NO: K190693(Special)
ATTN: Renee Thornborough PHONE NO : 847 247 5626
1925 West Field Court, Suite 100 SE DECISION MADE: 17-APR-19
Lake Forest IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream
Wholepower Biotech Co., Ltd. 510(k) NO: K190705(Traditional)
ATTN: William Gao PHONE NO : 86 20 87004606
Unit 4, Dongjun Palza, DongfengdonSE DECISION MADE: 15-APR-19
Guangzhou CN 510008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex SwiveLock Anchors
Arthrex Inc. 510(k) NO: K190728(Special)
ATTN: Jessica L. Singelais PHONE NO : 239 5984302 73091
1370 Creekside Boulevard SE DECISION MADE: 17-APR-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY Portable Handheld Imaging (SPY-PHI) System
Novadaq Technologies ULC. (now a p510(k) NO: K190729(Special)
ATTN: Agatha Szeliga PHONE NO : 604 4227516
8329 Eastlake Drive, Unit 101 SE DECISION MADE: 19-APR-19
Burnaby CA V5A 4W2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EverCrossTM 0.035" OTW PTA Dilatation Catheter
Medtronic, Inc. (formerly d.b.a. e510(k) NO: K190753(Special)
ATTN: Breanna Fautsch PHONE NO : 763 5913530
3033 Campus Drive, Suite N550 SE DECISION MADE: 23-APR-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
Cepheid 510(k) NO: K190771(Special)
ATTN: Yi-Ping Lin PHONE NO : 408 4006838
904 Caribbean Drive SE DECISION MADE: 25-APR-19
Sunnyvale CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Elecsys TSH
Roche Diagnostics 510(k) NO: K190773(Traditional)
ATTN: Edie Eads PHONE NO : 317 5214668
9115 Hague Road SE DECISION MADE: 16-APR-19
Indianapolis IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Eye Prime
Ellex Medical Pty Ltd. 510(k) NO: K190786(Third Party - Traditional)
ATTN: Andrew Pfeiffer PHONE NO : 61 8 70748104
3-4 Second Avenue Mawson Lakes SE DECISION MADE: 11-APR-19
Mawson Lakes AU 5095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: Disposable Standard Clamp
Standard Bariatrics 510(k) NO: K190788(Special)
ATTN: Alison Sathe PHONE NO : 513 3047971
4362 Glendale Milford Rd. SE DECISION MADE: 18-APR-19
Cincinnati OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IntelliCartTM System
Dornoch Medical Systems 510(k) NO: K190789(Special)
ATTN: Larry Smith PHONE NO : 816 5954419
200 North West Parkway SE DECISION MADE: 24-APR-19
Riverside MO 64150 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ez3D-i/E3
EwooSoft Co., Ltd. 510(k) NO: K190791(Special)
ATTN: Young Seok Kim PHONE NO : 82 31 80156172
801-ho, Vatechnetworks Bldg. 13, SSE DECISION MADE: 19-APR-19
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS XT Chemistry Products TBIL-ALKP Slides
Ortho-Clinical Diagnostics, Inc. 510(k) NO: K190807(Traditional)
ATTN: Darlene Phillips PHONE NO : 585 4534253
100 Indigo Creek Drive SE DECISION MADE: 26-APR-19
Rochester NY 14626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAYSCAN a-Expert3D
RAY Co., Ltd 510(k) NO: K190812(Special)
ATTN: Changhwan Lee PHONE NO : 82 35 6051000
332-7, Samsung 1-ro SE DECISION MADE: 24-APR-19
Hwaseong-si KR 18380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Model 5392 External Pulse Generator (EPG)
Medtronic, Inc. 510(k) NO: K190825(Special)
ATTN: Alexandra Theisen PHONE NO : 763 5266758
8200 Coral Sea Street NE SE DECISION MADE: 30-APR-19
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XmaruView V1 (Xmaru Chiroview, Xmaru Podview)
Rayence Co., Ltd 510(k) NO: K190866(Special)
ATTN: Kevin Kim PHONE NO : 82 31 80156459
14, Samsung 1-ro, 1-gil SE DECISION MADE: 30-APR-19
Hwaseong-si KR 18449 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTIM Patient Cushion Immobilization System
Essebi Medical SRL 510(k) NO: K190894(Third Party - Traditional)
ATTN: Pietro Sordina PHONE NO : 00378 0549 963858
Strada Campo del Fiume 84 SE DECISION MADE: 30-APR-19
Faetano SM 47896 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MyDay
CooperVision, Inc. 510(k) NO: K190965(Special)
ATTN: Marie Dutton PHONE NO : 925 2516645
5870 Stoneridge Drive, Suite 1 SE DECISION MADE: 29-APR-19
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 219
TOTAL WITH SUMMARIES 211
TOTAL WITH STATEMENTS 8
