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  1. Device Approvals, Denials and Clearances

April 2019 510(K) Clearances

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