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
