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  1. Device Approvals, Denials and Clearances

February 2019 510(K) Clearances

February 2019 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD February 2019


DEVICE: NobelParallel Conical Connection
Nobel Biocare AB                  510(k) NO: K173418(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
Vastra Hamngatan 1                SE DECISION MADE: 21-FEB-19
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpiroSphere
eReserchTechnology GmbH           510(k) NO: K173937(Third Party - Traditional)
ATTN: Johannes  Thalhammer        PHONE NO : 0049 930572060 
Sieboldstrasse 3                  SE DECISION MADE: 15-FEB-19
Estenfeld  DE 97230               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Byte Aligner System
Straight Smile, LLC               510(k) NO: K180346(Traditional)
ATTN: Sepi  Abbasi                PHONE NO : 281 8134631 
528 Palisades Drive, #553         SE DECISION MADE: 19-FEB-19
Pacific Palisades CA  90272       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReDS System
Sensible Medical Innovations Ltd. 510(k) NO: K180479(Traditional)
ATTN: Inbal  Ben-Tzvi             PHONE NO : 972 54 2445822 
6 Meir Areil St.                  SE DECISION MADE: 28-FEB-19
Netanya, POB 8702  IL 4059300     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quo-Test A1c System
EKF-diagnostic GmbH               510(k) NO: K180509(Dual Track)
ATTN: Mick  Fenton                PHONE NO : 49 3 92035110 
Ebendorfer Chaussee 3             SE DECISION MADE: 16-FEB-19
Barleben  DE 30179                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pedimax II - Pedicular Screw Spinal System
Gm Dos Reis Industria E Comerico L510(k) NO: K180626(Traditional)
ATTN: Paula  Oliveira             PHONE NO : 55 193 7659900 
Avenida Pierre Simon De LaPlace, 6SE DECISION MADE: 01-FEB-19
Campinas  BR 13069320             510(k) STATEMENT
                                                    

DEVICE: AeroPro Cordless Prophy System
Premier Dental Company Products   510(k) NO: K180682(Traditional)
ATTN: Noel  Hetrick               PHONE NO : 610 2396000 
1710 Romano Drive                 SE DECISION MADE: 27-FEB-19
Plymouth Meeting PA  19462        510(k) STATEMENT
                                                    

DEVICE: TrueDorsal Devices
True Function Laboratory, Inc.    510(k) NO: K180691(Traditional)
ATTN: Frank  Madrigal             PHONE NO : 619 4661872 
7851 University Ave., #102        SE DECISION MADE: 11-FEB-19
La Mesa CA  91942                 510(k) STATEMENT
                                                    

DEVICE: SEKURE Acetaminophen L3K Assay
Sekisui Diagnostics PEI Inc.      510(k) NO: K180835(Traditional)
ATTN: Penny  White                PHONE NO : 902 6280934 
70 Watts Avenue                   SE DECISION MADE: 08-FEB-19
Charlottetown  CA C1E 2B9         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AnyCheck IMT-100
DMS Co., Ltd.                     510(k) NO: K180953(Traditional)
ATTN: Guntae  Kim                 PHONE NO : 82 33 7423210 
#201 #202 & #204, Oriental MedicalSE DECISION MADE: 20-FEB-19
Wonju-si  KR 26339                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
Andon health Co., Ltd             510(k) NO: K181070(Traditional)
ATTN: Yi  Liu                     PHONE NO : 86 22 60526161 
No.3 Jinping Street, Ya An Road, NSE DECISION MADE: 01-FEB-19
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Absoanchor Microimplant
Dentos Inc                        510(k) NO: K181142(Traditional)
ATTN: Kim  Jin-Hyun               PHONE NO : 82 53 5925908 
41, Seongseo-ro 68-gil, Dalseo-gu SE DECISION MADE: 05-FEB-19
Daegu  KR 42697                   510(k) STATEMENT
                                                    

DEVICE: Keeler TonoCare Tonometer
Keeler Instruments Inc.           510(k) NO: K181143(Traditional)
ATTN: Eugene  VanArsdale          PHONE NO : 610 8890200 
3222 Phoenixville Pike            SE DECISION MADE: 08-FEB-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wu's Powered Wheelchair
Wu's Tech Co., Ltd.               510(k) NO: K181163(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 886 3 5382105 
No. 225, Yuan Peir St.            SE DECISION MADE: 16-FEB-19
Hsin-Chu City  CN 30093           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartMouth DryMouth Oral Rinse
Triumph Pharmaceuticals, Inc.     510(k) NO: K181194(Traditional)
ATTN: Andrew  Burch               PHONE NO : 314 9953090 
12312 Olive Blvd., Ste. 250       SE DECISION MADE: 15-FEB-19
St. Louis MO  63141               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeartCheck  Cardi Beat ECG Monitor with GEMS Mobile
CardioComm Solutions, Inc.        510(k) NO: K181310(Traditional)
ATTN: Jill  Turcotte              PHONE NO : 416 9779425 252
259 Yorkland Road, Suite 200      SE DECISION MADE: 22-FEB-19
North York  CA L0A 1J0            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing
Winner Medical Co., Ltd           510(k) NO: K181315(Traditional)
ATTN: Dan  Wang                   PHONE NO : 86 755 28138888 
Winner Industrial Park, No. 660 BuSE DECISION MADE: 14-FEB-19
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
Wilson-Cook Medical, Inc.         510(k) NO: K181317(Traditional)
ATTN: Sierra  Lowe                PHONE NO : 336 7440157 396506
4900 Bethania Station Road        SE DECISION MADE: 08-FEB-19
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cemented TSI Hip Stem
Signature Orthopaedics Pty Ltd.   510(k) NO: K181340(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 11-FEB-19
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lunderquist® Fixed Core Wire Guide
Cook  Incorporated                510(k) NO: K181353(Traditional)
ATTN: Jennifer L. Allman          PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 15-FEB-19
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEMA Elbow System
Limacorporate S.p.A.              510(k) NO: K181362(Traditional)
ATTN: Roberto  Gabetta            PHONE NO : 39 0 432945511 
via Nazionale 52                  SE DECISION MADE: 16-FEB-19
Villanova di San Daniele  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP
VALMED SRL                        510(k) NO: K181393(Traditional)
ATTN: Parravicini  Christian      PHONE NO : 39 0342 771049 
Via dell'Industria 3              SE DECISION MADE: 15-FEB-19
Tovo di Sant'Agata  IT 23030      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pressure Therapy System PT1003
Xiamen Senyang Co., Ltd.          510(k) NO: K181409(Traditional)
ATTN: Nina  Cai                   PHONE NO : 086 592 5997502 
4-5 Floor, Xingbei Industry, No 95SE DECISION MADE: 19-FEB-19
Xinglin Xiamen  CN 361000         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line
Oridion Medical 1987 Ltd.         510(k) NO: K181467(Traditional)
ATTN: Dalia  Givony               PHONE NO : 972 2 5899235 
7 Hamarpe Street P.O. Box 45025   SE DECISION MADE: 08-FEB-19
Jerusalem  IL 9777407             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREVENA RESTOR(TM) Incision Management System
KCI USA, Inc.                     510(k) NO: K181507(Traditional)
ATTN: Kimberly  McCoy             PHONE NO : 210 2556171 
6203 Farinon Drive                SE DECISION MADE: 15-FEB-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U&U Blood Collection Sets
U&U Medical Technology Co.,Ltd    510(k) NO: K181508(Traditional)
ATTN: Nick  Wang                  PHONE NO : 0086 139 02471751 
Dongzhou Village, Hengshanqiao    SE DECISION MADE: 13-FEB-19
Changzhou  CN 213119              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Austin Miller Large External Fixation System
Austin Miller Trauma LLC          510(k) NO: K181528(Traditional)
ATTN: Steve  Miller               PHONE NO : 901 7482581 
3011 Centre Oak Way Suite 102     SE DECISION MADE: 28-FEB-19
Germantown TN  38138              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CIRRUS HD-OCT
Carl Zeiss Meditec, Inc.          510(k) NO: K181534(Traditional)
ATTN: Mandy  Ambrecht             PHONE NO : 925 5574561 
5160 Hacienda Drive               SE DECISION MADE: 15-FEB-19
Dublin CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
Runbio BioTech Co.,Ltd            510(k) NO: K181551(Traditional)
ATTN: Lyn  Chen                   PHONE NO : 86 754 82758965 
Rongsheng Technological Zone, UnivSE DECISION MADE: 22-FEB-19
Shantou  CN 515063                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.              510(k) NO: K181577(Traditional)
ATTN: Greg  Geissinger            PHONE NO : 1 442 2326128 
2210 Faraday Ave., Suite 100      SE DECISION MADE: 07-FEB-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular Stapler for Single Use
Ezisurg Medical Co., Ltd.         510(k) NO: K181657(Traditional)
ATTN: Liang  Xia                  PHONE NO : 86 21 50456176 
Rm. 103, Bldg.2, No.1690 Cailun RoSE DECISION MADE: 01-FEB-19
Shanghai  CN 201203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System
Bio-Rad Laboratories, Inc.        510(k) NO: K181661(Traditional)
ATTN: Steve  Lin                  PHONE NO : 925 4749018 
5731 W. Las Positas Blvd          SE DECISION MADE: 13-FEB-19
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoCue Hb 801 System
HemoCue AB                        510(k) NO: K181751(Traditional)
ATTN: Maria  Fagerberg            PHONE NO : 46 431 481346 
Kuvettgatan 1                     SE DECISION MADE: 01-FEB-19
Angelholm  SE 26271               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use
Wuhan W.E.O Science & Technology D510(k) NO: K181870(Traditional)
ATTN: Chengling  Fu               PHONE NO : 86 27 83389239 
No.18, Huanhu Mid. Rd., Jinyin LakSE DECISION MADE: 26-FEB-19
Wuhun  CN 430040                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS Bunion System
CrossRoads Extremity Systems, LLC 510(k) NO: K181872(Traditional)
ATTN: Chad  Hollis                PHONE NO : 901 2218406 
6055 Primacy Parkway, Suite 140   SE DECISION MADE: 19-FEB-19
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: d-Nav System
Hygieia, Inc                      510(k) NO: K181916(Traditional)
ATTN: Kimberly  Chaperon          PHONE NO : 734 3699980 986
28803 8 Mile Rd, Suite 101        SE DECISION MADE: 04-FEB-19
Livonia MI  48152                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMC Wrist Automatic Blood Pressure Monitor
GMC Inc.                          510(k) NO: K181930(Abbreviated)
ATTN: Yolanda  Li                 PHONE NO : 86 550 2172888 
No. 686, Su Chu Rd.               SE DECISION MADE: 14-FEB-19
Chuzhou  CN 239000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WiEMSpro
Medical Cables, S.L.              510(k) NO: K181955(Traditional)
ATTN: Jose  Fuertes Pena          PHONE NO : 34 95 2218991 
Duque de la Victoria 6, 1         SE DECISION MADE: 12-FEB-19
Malaga  ES 29015                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO2 Sampling Line
Tylenol Medical Instruments Co., L510(k) NO: K181981(Traditional)
ATTN: Kavin  Huang                PHONE NO : 86 760 22819569 
3rd Floor, No. 10, Xinhua Road, SaSE DECISION MADE: 06-FEB-19
Zhong Shan  CN 528445             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRIdian Linac System
ViewRay, Incorporated             510(k) NO: K181989(Traditional)
ATTN: Sean  Delaney               PHONE NO : 650 2520920 
815 E. Middlefield Road           SE DECISION MADE: 20-FEB-19
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lympha Press Optimal Plus
Mego Afek AC Ltd.                 510(k) NO: K182003(Traditional)
ATTN: Reuven  Yunger              PHONE NO : 972 77 9084276 
Kibbutz Afek                      SE DECISION MADE: 27-FEB-19
Kibbutz Afek  IL 3004200          510(k) STATEMENT
                                                    

DEVICE: Coala Heart Monitor
Coala Life AB                     510(k) NO: K182040(Traditional)
ATTN: Philip  Siberg              PHONE NO : 46 70 7906734 
Riddargatan 18                    SE DECISION MADE: 08-FEB-19
Stockholm  SE 114 51              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omni Instrument Tray
Hologic, Inc                      510(k) NO: K182052(Traditional)
ATTN: Rachelle D. Fitzgerald      PHONE NO : 508 2638631 
250 Campus Drive                  SE DECISION MADE: 26-FEB-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Family of Venus RF Systems - Heal
Venus Concept USA Inc.            510(k) NO: K182094(Special)
ATTN: Yoni  Iger                  PHONE NO : 888 9070115 
1880 N Commerce Pkwy, Suite 2     SE DECISION MADE: 01-FEB-19
Weston FL  33326                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
Olympus Medical Systems Corp.     510(k) NO: K182102(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 06-FEB-19
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE® BONE TRANSPORT™ System
NuVasive Specialized Orthopedics, 510(k) NO: K182170(Traditional)
ATTN: Vidhi  Bhatt                PHONE NO : 949 5630655 
101 Enterprise, Suite 100         SE DECISION MADE: 05-FEB-19
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ion Endoluminal System ; Flexision Biopsy Needle
Intuitive Surgical                510(k) NO: K182188(Traditional)
ATTN: Sarah  Rizk                 PHONE NO : 408 5236906 
1266 Kifer Road                   SE DECISION MADE: 14-FEB-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invia Abdominal Dressing Kit
Medela AG                         510(k) NO: K182191(Traditional)
ATTN: Judith  Bernardo            PHONE NO : 41 41 5621656 
Laettichstrasse 4b                SE DECISION MADE: 01-FEB-19
Baar Zug  CH CH-6341              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeAir Smoke Evacuator compact
LiNA Medical APS                  510(k) NO: K182224(Traditional)
ATTN: Natalia  Szychulska         PHONE NO : 48 61 2222143 
ul. Rolna 8A, Sady                SE DECISION MADE: 07-FEB-19
Tarnowo Podgorne  PL 62-080       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm)
AngioDynamics, Inc.               510(k) NO: K182250(Traditional)
ATTN: Kasey  Newcomb              PHONE NO : 508 6587813 
26 Forest St.                     SE DECISION MADE: 28-FEB-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
ACell, Inc.                       510(k) NO: K182259(Traditional)
ATTN: Andrea  Artman              PHONE NO : 410 9538549 
6640 Eli Whitney Drive Suite 200  SE DECISION MADE: 07-FEB-19
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PAT (Pain Alleviation Technologies)
Marchan Medical, LLC              510(k) NO: K182267(Traditional)
ATTN: Mark  Chandler              PHONE NO : 910 7835285 
165 S Ashe St.                    SE DECISION MADE: 27-FEB-19
Southern Pines NC  28387          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsseOne Dental Implant System
Synoross DBA OsseOne              510(k) NO: K182293(Traditional)
ATTN: Gennady  Shapiro            PHONE NO : 310 9803632 
330 N Central Avenue              SE DECISION MADE: 15-FEB-19
Glendale CA  91203                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glo-Tip Spray Catheter
Wilson-Cook Medical, Inc.         510(k) NO: K182319(Traditional)
ATTN: Paula  Joyce                PHONE NO : 336 7440157 396245
4900 Bethania Station Road        SE DECISION MADE: 01-FEB-19
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PhantomMSK
OrthoGrid Systems Inc.            510(k) NO: K182332(Traditional)
ATTN: Sebastian  Edin             PHONE NO : 801 7035866 
3216 South Highland, Suite 202    SE DECISION MADE: 15-FEB-19
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine Interbody Fusion System
Altus Partners, LLC               510(k) NO: K182406(Traditional)
ATTN: Mark  Melton                PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 22-FEB-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA ONE Brain Application
MEDTECH S.A.                      510(k) NO: K182417(Traditional)
ATTN: Serge  Tabet                PHONE NO : 33 46 7107740 
ZAC Eureka - 900 Rue du Mas de VerSE DECISION MADE: 07-FEB-19
Montpellier  FR 34000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Body System
A-1 Engineering                   510(k) NO: K182440(Traditional)
ATTN: Tony  Picciano              PHONE NO : 949 7487488 
30 Mauchly Suite A                SE DECISION MADE: 26-FEB-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Response Diagnostic Electrophysiology Catheter
Innovative Health, LLC.           510(k) NO: K182488(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 22-FEB-19
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowMet-R
Laser Associated Sciences, Inc.   510(k) NO: K182494(Traditional)
ATTN: Sean  White                 PHONE NO : 610 7337519 
16 Foxglove Way                   SE DECISION MADE: 27-FEB-19
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The EPAD 2 System
SafeOp Surgical, Inc.             510(k) NO: K182542(Traditional)
ATTN: Richard  O'Brien            PHONE NO : 410 7739601 
11350 McCormick Rd, Suite 1003    SE DECISION MADE: 22-FEB-19
Hunt Valley MD  21031             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device
Devon Medical Products (Jiangsu) L510(k) NO: K182578(Traditional)
ATTN: Neil  Cheng                 PHONE NO : 86 513 51080988 
East Half of 1-2F, Appt D2, QingfeSE DECISION MADE: 21-FEB-19
Nantong  CN 226017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer
Joytech Healthcare Co., Ltd.      510(k) NO: K182629(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 28-FEB-19
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensus IORT System
Sensus Healthcare, Inc.           510(k) NO: K182641(Traditional)
ATTN: Nicolas  Soro               PHONE NO : 561 9225808 
851 Broken Sound Parkway NW Suite SE DECISION MADE: 21-FEB-19
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRIS 1.0 System
Intuitive Surgical                510(k) NO: K182643(Traditional)
ATTN: Crystal  Ong                PHONE NO : 408 5238636 
1266 Kifer Road                   SE DECISION MADE: 22-FEB-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kava and Kava with Herbst
Sketchpad Innovations LLC         510(k) NO: K182661(Traditional)
ATTN: Phillip "Sonnie" Bocala     PHONE NO : 619 7246040 
10767 Glendover Ln.               SE DECISION MADE: 13-FEB-19
San Diego CA  92126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensus TPS Workstation
Sensus Healthcare, Inc.           510(k) NO: K182665(Traditional)
ATTN: Nicolas  Soro               PHONE NO : 561 9225808 
851 Broken Sound Parkway NW Suite SE DECISION MADE: 21-FEB-19
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynaNail Mini
Medshape, Inc.                    510(k) NO: K182677(Traditional)
ATTN: Akhilesh  Gokhale           PHONE NO : 678 2353311 
1575 Northside Drive, Suite 440   SE DECISION MADE: 14-FEB-19
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
b-ONE Ortho Corp.                 510(k) NO: K182705(Traditional)
ATTN: Allison  Gecik              PHONE NO : 973 5878431 
3 Wing Drive Suite #259           SE DECISION MADE: 14-FEB-19
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
EUROTROL B.V.                     510(k) NO: K182744(Traditional)
ATTN: Mylene  de Boer             PHONE NO : 031 318 695777 
Keplerlaan 20                     SE DECISION MADE: 01-FEB-19
Ede  NL 6716BS                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyoStrain 5.1
Myocardial Solutions              510(k) NO: K182756(Traditional)
ATTN: Linda  Horne                PHONE NO : 919 4599102 
3000 RDU Center Drive, Suite 117  SE DECISION MADE: 14-FEB-19
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TMS-Cobot TS MV
Axilum Robotics                   510(k) NO: K182768(Traditional)
ATTN: Romuald  Ginhoux            PHONE NO : 33 388 556207 
8 rue Schertz                     SE DECISION MADE: 17-FEB-19
Strasbourg  FR 67100              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WavelinQ 4F EndoAVF System
C. R. Bard, Inc.                  510(k) NO: K182796(Traditional)
ATTN: Kulveen  Dhatt              PHONE NO : 480 3792875 
1625 West 3rd Street              SE DECISION MADE: 06-FEB-19
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Ultrasonic Endoscope
FUJIFILM Corporation              510(k) NO: K182825(Special)
ATTN: Randy  Vader                PHONE NO : 350 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 22-FEB-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
The Argen Corporation             510(k) NO: K182833(Traditional)
ATTN: Craig  Jolicoeur            PHONE NO : 858 4557900 471
5855 Oberlin Drive                SE DECISION MADE: 08-FEB-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lifetech Cardio Model 8301 Temporary Pacemaker
Shenzhen Lifetech Cardio Medical E510(k) NO: K182839(Traditional)
ATTN: Stephy  Pan                 PHONE NO : 86 755 86026250 
Rm 201, Bldg No.2, Huahan Sci-techSE DECISION MADE: 28-FEB-19
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Babyleo TN500
Dragerwerk AG & Co. KGaA          510(k) NO: K182859(Special)
ATTN: Dr. Bettina  Mobius         PHONE NO : 49 451 8824100 
Moislinger Allee 53-55            SE DECISION MADE: 22-FEB-19
Lubeck  DE 23542                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fenom Pro Nitric Oxide Test
Spirosure, Inc.                   510(k) NO: K182874(Traditional)
ATTN: Ryan  Leard                 PHONE NO : 925 2647720 
7020 Koll Center Parkway, Suite 11SE DECISION MADE: 13-FEB-19
Pleasanton CA  94566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K182885(Traditional)
ATTN: Kanesha  Hines              PHONE NO : 901 3992670 
1800 Pyramid Place                SE DECISION MADE: 06-FEB-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube
ENvizion Medical Ltd.             510(k) NO: K182915(Traditional)
ATTN: Doron  Besser               PHONE NO : 972 72 2288240 
7 Haarad St                       SE DECISION MADE: 13-FEB-19
Tel Aviv  IL 6971060              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RS85 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K182932(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 2 21941594 
3366, Hanseo-ro, Nam-myeon,       SE DECISION MADE: 15-FEB-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORA P100 Blood Pressure Monitoring System
TaiDoc Technology Corporation     510(k) NO: K182934(Traditional)
ATTN: Diana  Sung                 PHONE NO : 886 2 66258188 
6F, No. 127, Wugong 2nd Rd., Wugu SE DECISION MADE: 12-FEB-19
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX ADVANCE SP PEEK Anchor
Medos International SARL          510(k) NO: K182941(Traditional)
ATTN: Elizabeth  Messana          PHONE NO : 508 8283150 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 26-FEB-19
Le Locle  CH ch 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Reline System
NuVasive, Incorporated            510(k) NO: K182974(Traditional)
ATTN: Joseph  De La Rosa          PHONE NO : 858 3093744 
7475 Lusk Boulevard               SE DECISION MADE: 13-FEB-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpringTMS
eNeura® Inc.                      510(k) NO: K182976(Traditional)
ATTN: David  Rosen                PHONE NO : 408 2456400 
715 North Pastoria Avenue         SE DECISION MADE: 25-FEB-19
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIC Extremity Fusion Plate System
EPIC Extremity, LLC               510(k) NO: K182991(Traditional)
ATTN: Dan  Schwartzbauer          PHONE NO : 724 7794747 
120 Marguerite Drive, Suite 301   SE DECISION MADE: 13-FEB-19
Cranberry Twp PA  16066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uPMR 790
Shanghai United Imaging Healthcare510(k) NO: K183014(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 21 67076888 6776
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 27-FEB-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Stryker GmbH                      510(k) NO: K183039(Traditional)
ATTN: Tina  Mornak                PHONE NO : 201 8316461 
325 Corporate Drive               SE DECISION MADE: 15-FEB-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Lumbar IBF System
Reliance Medical Systems LLC      510(k) NO: K183049(Special)
ATTN: Bret  Berry                 PHONE NO : 801 2953280 
545 West 500 South Suite 100      SE DECISION MADE: 15-FEB-19
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vector Hammertoe Correction System
Nvision Biomedical Technologies, L510(k) NO: K183055(Traditional)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
4754 Shavano Oak, Suite 101       SE DECISION MADE: 19-FEB-19
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems
Philips Medical Systems Nederland 510(k) NO: K183063(Abbreviated)
ATTN: Jan  van de Kerkhof         PHONE NO : 31 61 3300542 
Veenpluis 4-6                     SE DECISION MADE: 14-FEB-19
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoFLIP System
Crospon Ltd                       510(k) NO: K183072(Traditional)
ATTN: John  O'Dea                 PHONE NO : 011 353 91519882 
Galway Business Park, Dangan      SE DECISION MADE: 15-FEB-19
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMG Anterior Cervical Plate System
Sapphire Medical Group            510(k) NO: K183073(Traditional)
ATTN: Anthony  Ruggiero           PHONE NO : 1 949 9398502 
32565 B Golden Lantern Street, SuiSE DECISION MADE: 11-FEB-19
Dana Point CA  92629              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra Optia Apheresis System
Terumo BCT, Inc.                  510(k) NO: K183081(Traditional)
ATTN: Nicholas  Wong              PHONE NO : 303 2392384 
10811 W. Collins Avenue           SE DECISION MADE: 05-FEB-19
Lakewood CO  80215                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shoreline Cervical Interbody RT System
SeaSpine Orthopedics Corporation  510(k) NO: K183083(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 14-FEB-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTIEN Measurement System
St. Jude Medical (now Abbott Medic510(k) NO: K183099(Traditional)
ATTN: Ka Zoua  Xiong              PHONE NO : 651 7562000 
One St. Jude Medical Drive        SE DECISION MADE: 28-FEB-19
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dpl SpotLite
LED Technologies, Inc.            510(k) NO: K183118(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 6460543 117
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 07-FEB-19
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments
Globus Medical Inc.               510(k) NO: K183119(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 2950
Valley Forge Business Center 2560 SE DECISION MADE: 06-FEB-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
Beckman Coulter, Inc.             510(k) NO: K183127(Traditional)
ATTN: Elaine Marie Duncan         PHONE NO : 916 3743279 
1584 Enterprise Blvd.             SE DECISION MADE: 12-FEB-19
West Sacramento CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O & M Halyard, Inc.               510(k) NO: K183132(Abbreviated)
ATTN: Angela L. Bunn              PHONE NO : 470 4485158 
5405 Windward Parkway             SE DECISION MADE: 05-FEB-19
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArcTV Transvaginal Sling System
UroCure LLC                       510(k) NO: K183134(Traditional)
ATTN: John  Nealon                PHONE NO : 612 8506814 
4701 North 3rd Street, Suite 110  SE DECISION MADE: 07-FEB-19
Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscope Sterilization Tray
Intuitive Surgical, Inc.          510(k) NO: K183139(Abbreviated)
ATTN: Brandon  Hansen             PHONE NO : 408 5237485 
1266 Kifer Road                   SE DECISION MADE: 01-FEB-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LINK MP Monoblock Hip Prosthesis
Waldemar Link GmbH & Co. KG       510(k) NO: K183141(Traditional)
ATTN: Andre von Malotki           PHONE NO : 49 40 53995448 
Oststraße 4-10                    SE DECISION MADE: 08-FEB-19
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SnapShot Freeze 2
GE Medical Systems, LLC.          510(k) NO: K183161(Traditional)
ATTN: Laura  Turner               PHONE NO : 262 5484588 
3000 N. Grandview Blvd            SE DECISION MADE: 13-FEB-19
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
Motiva USA, LLC                   510(k) NO: K183163(Traditional)
ATTN: ALberto  Quesada Rivera     PHONE NO : 888 8462915 
712 Fifth Avenue 14th Floor       SE DECISION MADE: 05-FEB-19
New York NY  10019-4108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BacT/ALERT FA Plus; BacT/ALERT PF Plus
bioMerieux, Inc.                  510(k) NO: K183166(Traditional)
ATTN: Mary Beth  Anheuser         PHONE NO : 314 7318516 
595 Anglum Road                   SE DECISION MADE: 11-FEB-19
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens
Bausch & Lomb, Incorporated       510(k) NO: K183167(Traditional)
ATTN: Glenn A. Davies             PHONE NO : 585 3388215 
1400 North Goodman Street         SE DECISION MADE: 12-FEB-19
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPERE Thrombectomy System
Vascular Medcure, Inc.            510(k) NO: K183179(Traditional)
ATTN: Jeffrey P. DuMontelle       PHONE NO : 949 3784742 
1500 S. Sunkist St. - Suite H     SE DECISION MADE: 25-FEB-19
Anaheim CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24
Shanghai United Imaging Healthcare510(k) NO: K183186(Traditional)
ATTN: Xin  Gao                    PHONE NO : 86 216707 68885386 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 08-FEB-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker
Stryker Corporation               510(k) NO: K183196(Traditional)
ATTN: Andrea  Wallen-Gerding      PHONE NO : 1 269 4919234 
Boetzinger Strasse 41             SE DECISION MADE: 14-FEB-19
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dexcom G6 Continuous Glucose Monitoring System
Dexcom, Inc.                      510(k) NO: K183206(Traditional)
ATTN: Bryan  Osborne              PHONE NO : 858 8759896 
6310 Sequence Dr.                 SE DECISION MADE: 14-FEB-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Comply Hydrogen Peroxide Indicator Tape
3M Company                        510(k) NO: K183209(Traditional)
ATTN: Nadia  Battah               PHONE NO : 651 7330929 
3M Center, Building 275-5W-06     SE DECISION MADE: 15-FEB-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Comply Hydrogen Peroxide Chemical Indicator
3M Company                        510(k) NO: K183211(Traditional)
ATTN: Nadia  Battah               PHONE NO : 651 7330929 
3M Center, Building 275-5W-06     SE DECISION MADE: 26-FEB-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device
Touchbeauty Beauty & Health (Shenz510(k) NO: K183217(Traditional)
ATTN: Aaron  Zhai                 PHONE NO : 86 755 33662222 
7/F, Marina Bay Centre A, South ofSE DECISION MADE: 15-FEB-19
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Amira, MAGNETOM Sempra
Siemens Medical Solutions USA, Inc510(k) NO: K183221(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 610 4486545 
40 Liberty Blvd, Mail Code 65-1A  SE DECISION MADE: 14-FEB-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Terra
Siemens Medical Solutions USA Inc.510(k) NO: K183222(Traditional)
ATTN: Milind  Dhamankar           PHONE NO : 610 4486467 
40 Liberty Boulevard              SE DECISION MADE: 15-FEB-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stabil Orthopaedic Solutions Total Knee System
Stabil Orthopaedic Solutions, LLC 510(k) NO: K183225(Traditional)
ATTN: Jim  Moore                  PHONE NO : 503 4211251 
20031 Henrici Road                SE DECISION MADE: 15-FEB-19
Oregon City OR  97045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoSite SII Ultrasound System
FUJIFILM SonoSite, Inc.           510(k) NO: K183235(Third Party - Abbreviated)
ATTN: Aditi  Chaubal              PHONE NO : 425 9511432 
21919 30th Drive SE               SE DECISION MADE: 07-FEB-19
Bothell WA  98021-3904            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Empower RF Catheter
Broncus Medical, Inc              510(k) NO: K183240(Traditional)
ATTN: Aradhana  Dhanabalan        PHONE NO : 650 4281600 
125 Nicholson Lane                SE DECISION MADE: 22-FEB-19
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrainScope TBI (Model: Ahead 400)
BrainScope Company Inc.           510(k) NO: K183241(Traditional)
ATTN: Michael E Singer            PHONE NO : 240 7527680 
4350 East West Hwy, Ste 1050      SE DECISION MADE: 19-FEB-19
Bethesda MD  20814                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carestream DRX-1 System with DRX Plus 2530 Detectors
Carestream Health, Inc.           510(k) NO: K183245(Traditional)
ATTN: Gina L Maiolo               PHONE NO : 585 6276543 
150 Verona Street                 SE DECISION MADE: 08-FEB-19
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
CoaguSense, Inc.                  510(k) NO: K183255(Traditional)
ATTN: Robin  Bush                 PHONE NO : 510 2705442 
48377 Fremont Blvd. Suite #113    SE DECISION MADE: 21-FEB-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI Rad Companion (Engine)
Siemens Medical Solutions USA, Inc510(k) NO: K183272(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 01-FEB-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DR 800 with Tomosynthesis
Agfa N.V.                         510(k) NO: K183275(Traditional)
ATTN: Wim  Govaerts               PHONE NO : 32 3444 6246 
Septestraat 27                    SE DECISION MADE: 01-FEB-19
Mortsel  BE B-2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX Ti ANCHOR with DYNACORD
Medos International SARL          510(k) NO: K183279(Traditional)
ATTN: N/A  N/A                    PHONE NO : 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 21-FEB-19
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200
Thrombolex, Inc.                  510(k) NO: K183290(Traditional)
ATTN: Amy  Katsikis               PHONE NO : 267 8845723 
51 Britain Dr.                    SE DECISION MADE: 25-FEB-19
New Britain PA  18901             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Supria True64 Whole-Body X-Ray CT System
Hitachi Healthcare Americas       510(k) NO: K183291(Traditional)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 01-FEB-19
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)
Euroimmun US, Inc.                510(k) NO: K183313(Traditional)
ATTN: Daniel  Castellanos         PHONE NO : 800 9132022 104
1 Bloomfield Avenue               SE DECISION MADE: 28-FEB-19
Mountain Lakes NJ  07046          510(k) STATEMENT
                                                    

DEVICE: AdvantageRib System
SIG Medical Corporation           510(k) NO: K183317(Special)
ATTN: Andrew  Davison             PHONE NO : 717 5532021 
238 East Chocolate Avenue, Suite 2SE DECISION MADE: 14-FEB-19
Hershey PA  17033                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
Thermo Fisher Scientific          510(k) NO: K183324(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909 322411
1 Thermo Fisher Way               SE DECISION MADE: 15-FEB-19
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: Parcus GFS BTB
Parcus Medical, LLC               510(k) NO: K183331(Special)
ATTN: Paul  Vagts                 PHONE NO : 941 7557965 
6423 Parkland Dr                  SE DECISION MADE: 07-FEB-19
Sarasota FL  34243                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
bioMerieux, Inc                   510(k) NO: K183360(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 26-FEB-19
Hazlewood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Libertas Acetabular Hooded Liner
Maxx Orthopedics, Inc.            510(k) NO: K183365(Special)
ATTN: Priscilla  Herpai           PHONE NO : 484 3420092 
2460 General Armistead Avenue, SuiSE DECISION MADE: 22-FEB-19
Norristown PA  19403              510(k) STATEMENT
                                                    

DEVICE: GrayDuck Stent
POLL Medical LLC                  510(k) NO: K183374(Traditional)
ATTN: Adrian  Polliack            PHONE NO : 503 3193096 
8630 SW Scholls Ferry Rd, Suite 22SE DECISION MADE: 26-FEB-19
Beaverton OR  97008               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
Horiba, Ltd                       510(k) NO: K183375(Traditional)
ATTN: Naoyuki  Nomura             PHONE NO : 81 80 43580440 
2 Miyanohigashi, Kisshoin, Minami-SE DECISION MADE: 12-FEB-19
Kyoto  JP 601-8510                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JADE Mobile X-Ray
DRGEM Corporation                 510(k) NO: K183388(Traditional)
ATTN: Ki-Nam  Yang                PHONE NO : 82 2 8698566 
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 05-FEB-19
Gwangmyeong-si  KR 14322          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HANAROSTENT FASTTM Biliary (NNN)
M.I.Tech Co., Ltd.                510(k) NO: K183396(Traditional)
ATTN: Inae  Kim                   PHONE NO : 82 70 43047450 
174, Habuk 2-gil, Jinwi-myeon     SE DECISION MADE: 11-FEB-19
Pyeongtaek-si  KR 17706           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Athena II Cervical Plate System
Medyssey USA, Inc.                510(k) NO: K183409(Traditional)
ATTN: Shawn  Kim                  PHONE NO : 847 4270200 
1550 E. Higgins Road, Suite 123   SE DECISION MADE: 11-FEB-19
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
bioMerieux, Inc.                  510(k) NO: K183415(Traditional)
ATTN: Craig  Buehler              PHONE NO : 314 7318358 
595 Anglum Road                   SE DECISION MADE: 20-FEB-19
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
Ethicon Endo-Surgery, LLC         510(k) NO: K183435(Traditional)
ATTN: Sigfrido  Delgado           PHONE NO : 787 2726500 
475 Calle C Suite 202             SE DECISION MADE: 06-FEB-19
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EIT Cellular Titanium Lumbar Cage - T/PLIF
EIT Emerging Implant Technologies 510(k) NO: K183447(Traditional)
ATTN: Barbara  Wirth              PHONE NO : 49 7461 1716904 
Eisenbahnstrasse 84               SE DECISION MADE: 04-FEB-19
Wurmlingen  DE 78573              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vbeam Prima Laser System
Candela Corp.                     510(k) NO: K183452(Special)
ATTN: Sharon  Timberlake          PHONE NO : 508 3580304 
530 Boston Post Road              SE DECISION MADE: 01-FEB-19
Wayland MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyece OTC EMS System
Tyece Ltd.                        510(k) NO: K183454(Traditional)
ATTN: Parshid  Falahati           PHONE NO : 852 2 3497456 
Unit 801, Block A, Po Lung Centre,SE DECISION MADE: 26-FEB-19
Kowloon, Hong Kong  HK            510(k) STATEMENT
                                                    

DEVICE: easyPPHTM Hemorrhoidal Stapler for Single Use
Ezisurg Medical Co., Ltd.         510(k) NO: K183477(Traditional)
ATTN: Liang  Xia                  PHONE NO : 86 21 50456176 
Rm.103, Bldg.2, No.1690 Cailun Rd.SE DECISION MADE: 11-FEB-19
Shanghai  CN 201203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K183498(Traditional)
ATTN: Zilong  Liang               PHONE NO : 86 25 83305050 
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 05-FEB-19
Nanjing  CN 210036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K183499(Traditional)
ATTN: Zilong  Liang               PHONE NO : 0086 25 83305050 
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 04-FEB-19
Nanjing  CN 210036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX ADVANCE Anchor with DYNACORD Suture
Medos International SARL          510(k) NO: K183506(Traditional)
ATTN: Tatyana  Korsunsky          PHONE NO : 508 8283122 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 14-FEB-19
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ammonia II
Roche Diagnostics Operations (RDO)510(k) NO: K183517(Traditional)
ATTN: Noel B. Mencias             PHONE NO : 317 5213172 
9115 Hague Road                   SE DECISION MADE: 08-FEB-19
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEM Premier ChemSTAT
Instrumentation Laboratory Co.    510(k) NO: K183546(Traditional)
ATTN: Gabriella  Erdosy           PHONE NO : 781 8614571 
180 Hartwell Road                 SE DECISION MADE: 16-FEB-19
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEM Premier ChemSTAT
Instrumentation Laboratory Co.    510(k) NO: K183549(Traditional)
ATTN: Gabriella  Erdosy           PHONE NO : 781 8614571 
180 Hartwell Road                 SE DECISION MADE: 16-FEB-19
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEM Premier ChemSTAT
Instrumentation Laboratory Co.    510(k) NO: K183555(Traditional)
ATTN: Gabriella  Erdosy           PHONE NO : 781 8614571 
180 Hartwell Road                 SE DECISION MADE: 16-FEB-19
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: oCare Wrist Pulse Oximeter
Taiwan Biophotonic Corporation    510(k) NO: K183556(Traditional)
ATTN: JC  Chen                    PHONE NO : 886 3 6670888 201
4F-1, No. 6-1, Sec.2, Shengyi Rd. SE DECISION MADE: 15-FEB-19
Zhubei  TW 30261                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device
Titan Spine, Inc                  510(k) NO: K183557(Special)
ATTN: Jane  Rodd                  PHONE NO : 262 2427801 
6140 W. Executive Dr., Suite A    SE DECISION MADE: 11-FEB-19
Mequon WI  53092                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DD cube ONE ML
Dental Direkt GmbH                510(k) NO: K183569(Special)
ATTN: Uwe  Greitens               PHONE NO : 0049 05225 869190 
Industriezentrum 106-108          SE DECISION MADE: 14-FEB-19
Spenge  DE 32139                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capture-CMV
Immucor, Inc.                     510(k) NO: K183571(Traditional)
ATTN: Howard  Yorek               PHONE NO : 770 4412051 
3130 Gateway Drive                SE DECISION MADE: 04-FEB-19
Norcross GA  30071                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elitone Device
Elidah, Inc.                      510(k) NO: K183585(Traditional)
ATTN: Gloria  Kolb                PHONE NO : 978 4354324 
810 Main St., Ste C               SE DECISION MADE: 11-FEB-19
Monroe CT  06468                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Hawkeye Vertebral Body Replacement (VBR) System
Choice Spine                      510(k) NO: K183588(Special)
ATTN: Kim  Finch                  PHONE NO : 865 2463333 
400 Erin Drive                    SE DECISION MADE: 22-FEB-19
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration Hole, 28cm; Laparoscopic Wire L-Hook Electrode, Retractable, Aspiration, 36cm ; Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Hole, 28cm ; Laparoscopic Straight Spatula Electrode, Hollow, 28cm ; Laparoscopic Curved Spatula Electrode, Hollow, 28cm; Laparoscopic Wire J-Hook Electrode, Hollow, 28cm ; Laparoscopic Wire L-Hook Electrode, Hollow, 28cm ; Laparoscopic Cylindrical Tip Electrode, Hollow, 28cm
New Deantronics Taiwan Ltd        510(k) NO: K183594(Traditional)
ATTN: Jane  Liu                   PHONE NO : 886 2 22681726 
12F., No.51, Sec.4, Chong Yang Rd.SE DECISION MADE: 19-FEB-19
New Taipei City  TW 23675         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMMA 1.5T MRI System
Time Medical Limited              510(k) NO: K183621(Abbreviated)
ATTN: Nick  Tse                   PHONE NO : 852 21561711 
G/F, Bio-Informatics Center No., 2SE DECISION MADE: 22-FEB-19
Shatin, nT, Hong Kong  CN         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PhotoFix Decellularized Bovine Pericardium
CryoLife, Inc.                    510(k) NO: K183635(Special)
ATTN: Heather  Emerick            PHONE NO : 770 4193355 4502
1655 Roberts Blvd. NW             SE DECISION MADE: 14-FEB-19
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cruxcan (CRX-1000)
Cruxell Corp.                     510(k) NO: K183637(Traditional)
ATTN: Daeseok  Hwang              PHONE NO : 82 42 9352554 
A-405, Migun Techno World II 187 tSE DECISION MADE: 12-FEB-19
Daejeon  KR 34025                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
Mauna Kea Technologies            510(k) NO: K183640(Special)
ATTN: Veronique  Dentan           PHONE NO : 33 170 080994 
9 Rue d'Enghien                   SE DECISION MADE: 22-FEB-19
Paris  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnia Medical Rotary PLIF System
Omnia Medical, LLC                510(k) NO: K183659(Traditional)
ATTN: Troy  Schifano              PHONE NO : 304 4134851 
6 Canyon Rd Suite 300             SE DECISION MADE: 06-FEB-19
Morgantown WV  26508              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5
FUJIFILM Corporation              510(k) NO: K183683(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 27-FEB-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Endoscope Model EG-530N
Fujifilm Corporation              510(k) NO: K183686(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 28-FEB-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Doctor Tecar
Mectronic Medicale S.r.l.         510(k) NO: K183693(Traditional)
ATTN: Gloria  Aloisini            PHONE NO : 39 035 656080 
Via Orio al Serio, 15             SE DECISION MADE: 22-FEB-19
Grassobbio  IT 24050              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zap-X Radiosurgery System
Zap Surgical Systems              510(k) NO: K183698(Traditional)
ATTN: Jim  Talbot                 PHONE NO : 650 7938250 
590 Taylor Way                    SE DECISION MADE: 25-FEB-19
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RX-1 Rhythm Express Remote Cardiac Monitoring System
VivaQuant Inc.                    510(k) NO: K183704(Third Party - Traditional)
ATTN: Brian  Brockway             PHONE NO : 651 2172176 
4339 Nancy Place, Suite 100       SE DECISION MADE: 16-FEB-19
St. Paul MN  55126                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Biomet Headless Compression and Twist-Off Screws
Biomet Inc                        510(k) NO: K190035(Special)
ATTN: Andrew  Steward             PHONE NO : 574 3733314 
56 East Bell Drive                SE DECISION MADE: 07-FEB-19
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
Alcon Laboratories, Inc.          510(k) NO: K190045(Special)
ATTN: Heather  Smith              PHONE NO : 678 4156884 
6201 South Freeway                SE DECISION MADE: 06-FEB-19
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SECULOK™ ACP System
U&i Corporation                   510(k) NO: K190053(Special)
ATTN: Kwang-Eun  Song             PHONE NO : 82 31 8606837 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 01-FEB-19
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KOWA VK-2s
KOWA Co. Ltd. CHOFU               510(k) NO: K190056(Traditional)
ATTN: Rinji  Kondo                PHONE NO : 81 42 4407612 
3-1, Chofugaoka 3-chome           SE DECISION MADE: 12-FEB-19
Chofu  JP 182-0021                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velofix Interbody Fusion System
U&i Corporation                   510(k) NO: K190067(Special)
ATTN: Jee-Ae  Bang                PHONE NO : 82 31 8606846 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 04-FEB-19
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perla® Posterior Cervico-Thoracic Fixation System
SPINEART                          510(k) NO: K190071(Special)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 Chemin du pre Fleuri            SE DECISION MADE: 25-FEB-19
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Presero 3D Scanning System
Certis Health                     510(k) NO: K190074(Third Party - Traditional)
ATTN: Richard Vogel  Vogel        PHONE NO : 954 6285908 
3630 Park Central Boulevard North SE DECISION MADE: 14-FEB-19
Pompano Beach FL  33064           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Aurora Evacuator
Rebound Therapeutics              510(k) NO: K190075(Special)
ATTN: Donald  Atienza             PHONE NO : 949 3058111 
13900 Alton Parkway, Suite 120    SE DECISION MADE: 12-FEB-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntraSight
Volcano Corporation               510(k) NO: K190078(Special)
ATTN: Kimberly  Simon             PHONE NO : 858 7204113 
3721 Valley Ctrre Dr Ste 500      SE DECISION MADE: 11-FEB-19
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Journey II Unicompartmental Knee System
Smith & Nephew Inc                510(k) NO: K190085(Special)
ATTN: Amy  Winegarden             PHONE NO : 412 6833844 4138
7135 Goodlett Farms Parkway       SE DECISION MADE: 11-FEB-19
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EzDent-i / E2 / Prora View
EWOO SOFT Co., Ltd.               510(k) NO: K190087(Traditional)
ATTN: Young Seok Kim              PHONE NO : 82 31 80153172 
801-ho, Vatechnetworks Bldg., 13 SSE DECISION MADE: 27-FEB-19
Hwaseong-si  KR 18449             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZOOM Aspiration Pump
Taiwan Biomaterial Co., Ltd.      510(k) NO: K190105(Special)
ATTN: Monoj Mon Kalita            PHONE NO : 886 3 6683088 309
6F, No. 26-1, Sec.2, Shengyi Rd.  SE DECISION MADE: 21-FEB-19
Zhubei  TW 30261                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Aera
Siemens Medical Solutions USA, Inc510(k) NO: K190138(Special)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
40 Liberty Boulevard, Mailcode 65-SE DECISION MADE: 15-FEB-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COBRA Fusion Ablation System
AtriCure, Inc.                    510(k) NO: K190151(Special)
ATTN: Melissa  Smallwood          PHONE NO : 513 7554100 
7555 Innovation Way               SE DECISION MADE: 25-FEB-19
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FibermarX Radiopaque Tissue Marker
Viscus Biologics, LLC             510(k) NO: K190155(Third Party - Traditional)
ATTN: Justin  Baker               PHONE NO : 216 7442744 
10000 Cedar Avenue                SE DECISION MADE: 27-FEB-19
Cleveland OH  44106               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Sensus Healthcare TVM Balloon Applicator
Sensus Healthcare, Inc            510(k) NO: K190255(Traditional)
ATTN: Nicolas  Soro               PHONE NO : 561 9225808 
851 Broken Sound Parkway NW, SuiteSE DECISION MADE: 21-FEB-19
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClariFix
Arrinex, Inc                      510(k) NO: K190356(Special)
ATTN: Tracey  Henry               PHONE NO : 650 4686176 
127 Independence drive            SE DECISION MADE: 26-FEB-19
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

                TOTAL 510(k)s THIS PERIOD   185                                     
                TOTAL WITH SUMMARIES        176                                     
                TOTAL WITH STATEMENTS        9