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  1. Device Approvals, Denials and Clearances

May 2018 510(k) Clearances

May 2018 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2018


DEVICE: 3.0 Dynamic TiBase
TALLADIUM ESPANA, SL              510(k) NO: K162021(Traditional)
ATTN: ESTEBAN  XAM-MAR            PHONE NO : 0034 9 73289580 
PLAZA UTXESA 7                    SE DECISION MADE: 04-MAY-18
LLEIDA  ES 25002                  510(k) STATEMENT
                                                    

DEVICE: Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
Foremount Enterprise Co, Ltd.     510(k) NO: K170663(Traditional)
ATTN: John  Yang                  PHONE NO : 886 4 25618788 
No. 17, Alley 15, Lane 5, Shenan SSE DECISION MADE: 11-MAY-18
Taichung City  TW 42944           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GBR system
SURGIDENT                         510(k) NO: K170697(Traditional)
ATTN: Duck-su  Hur                PHONE NO : 82 31 7372875 
#209~210, Woolim Lion’s Valley, 27SE DECISION MADE: 24-MAY-18
Seongnam-si  KR 13219             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Arthroscopic Electrode (with Pencil)
Modern Medical Equipment Manufactu510(k) NO: K170703(Traditional)
ATTN: Jerry  Cheung               PHONE NO : 852 2420 9068 
35-41 Tai Lin Pai Rd, Unit F 5th FSE DECISION MADE: 31-MAY-18
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fluorescence Mode
Carl Zeiss Suzhou Co., Ltd.       510(k) NO: K171007(Traditional)
ATTN: Huang  XiaoDong             PHONE NO : 86 512 8227 1388
Modern Industrial Square 3b No. 33SE DECISION MADE: 03-MAY-18
Suzhou  CN 215126                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ScioCardio ECG Transmitter
Synergen Technology Labs LLC      510(k) NO: K171019(Traditional)
ATTN: Sunil  Konda                PHONE NO : 214 4350633 
3131 McKinney Avenue Suite 602    SE DECISION MADE: 30-MAY-18
Dallas TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Metacem
Meta Biomed Co., Ltd              510(k) NO: K171449(Traditional)
ATTN: Suk Song Oh                 PHONE NO : 82 43 2308959 
270, Osong Saengmyeong 1-ro, OsongSE DECISION MADE: 15-MAY-18
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
Dimesol, Inc.                     510(k) NO: K171505(Traditional)
ATTN: Stephen P. Callaghan        PHONE NO : 717 9388391 
509 Fishing Creek Road            SE DECISION MADE: 17-MAY-18
Lewisberry PA  17339              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smartcord, Smartcord X
EASTDENT Co., Ltd                 510(k) NO: K171577(Traditional)
ATTN: Hyonsu  Kim                 PHONE NO : 82 31 6935767 
601-1 Sogong B/D, 64 Gugal-ro, GihSE DECISION MADE: 03-MAY-18
Yongin-si  KR 16972               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trident Extremity Fixation System
Trident Orthopedics               510(k) NO: K171690(Traditional)
ATTN: Al  Austin                  PHONE NO : 410 9039038 
212 Copperwood Court              SE DECISION MADE: 08-MAY-18
Millersville MD  21108            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETCO2 Sensor
Orantech Inc.                     510(k) NO: K171828(Traditional)
ATTN: Yunxi  Xiong                PHONE NO : 86 755 23699939 
Zone#A,4F,1st Bld, 7th Industrial SE DECISION MADE: 31-MAY-18
Shenzhen  CN 518106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: URIS OMNI System
TruAbutment Inc.                  510(k) NO: K172100(Traditional)
ATTN: Brandon  Kim                PHONE NO : 714 9561488 
300 South Harbor Blvd #520        SE DECISION MADE: 04-MAY-18
Anaheim CA  92805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIEZOTOME CUBE
Satelec - Acteon Group            510(k) NO: K172137(Traditional)
ATTN: Philippe  Girard            PHONE NO : 011 33 556340607 
17 Avenue Gustave Eiffel          SE DECISION MADE: 03-MAY-18
Merignac  FR 33708                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad
Medela AG                         510(k) NO: K172145(Traditional)
ATTN: Georges  Hakim              PHONE NO : 41 041 5621651 
Lattichstrasse 4b                 SE DECISION MADE: 09-MAY-18
Baar  CH 6341                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STAR 65
Skanray Technologies Pvt Ltd      510(k) NO: K172147(Traditional)
ATTN: Mahadevan  J                PHONE NO : 91 821 2407000 
#360, KIADB Industrial Area, HebbaSE DECISION MADE: 25-MAY-18
Mysore  IN 570018                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERIZONE VP4 Sterilizer
TSO3 Inc                          510(k) NO: K172191(Traditional)
ATTN: Alexandre  Jokic            PHONE NO : 418 6510003 287
2505 Avenue Dalton                SE DECISION MADE: 09-MAY-18
Quebec  CA G1P 3S5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AURA ICP MONITORING SYSTEM
Branchpoint Technologies, INC.    510(k) NO: K172209(Traditional)
ATTN: Nicholas  Hu                PHONE NO : 949 8291868 
1 Technology Drive, Suite I-811   SE DECISION MADE: 18-MAY-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DripAssist Plus
Shift Labs, Inc.                  510(k) NO: K172242(Traditional)
ATTN: Beth  Kolko                 PHONE NO : 206 3691216 
1600 Dexter Ave N, Suite A        SE DECISION MADE: 25-MAY-18
Seattle WA  98109                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trackit T4 EEG Amplifier
Lifelines Ltd.                    510(k) NO: K172271(Traditional)
ATTN: Michael  Hulin              PHONE NO : 44 012 64782226 
7 Clarendon Court                 SE DECISION MADE: 04-MAY-18
Over Wallop  GB SO20 8HU          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lite
Tzora Active Systems Ltd.         510(k) NO: K172409(Traditional)
ATTN: Adi  Shemer                 PHONE NO : 972 2 9908207 
                                  SE DECISION MADE: 02-MAY-18
Kibbutz Tzora  IL 9980300         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BacterioScan 216Dx System
BacterioScan, Inc.                510(k) NO: K172412(Traditional)
ATTN: Rhonda  Soest               PHONE NO : 844 2227226 
4041 Forest Park Ave.             SE DECISION MADE: 01-MAY-18
St. Louis MO  63108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArgenIS Titanium Abutments
Argen Corporation                 510(k) NO: K172430(Traditional)
ATTN: Paul  Cascone               PHONE NO : 1 858 4557900 
5855 Oberlin Drive                SE DECISION MADE: 18-MAY-18
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VENTANA CD30 (Ber-H2) RxDx Assay
Ventana Medical Systems, Inc.     510(k) NO: K172471(Traditional)
ATTN: Jeffrey  Catania            PHONE NO : 1 800 2272155 
1910 E Innovation Park Dr         SE DECISION MADE: 08-MAY-18
Tuscon AZ  87555                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: icotec Interbody Cage System
icotec ag                         510(k) NO: K172480(Traditional)
ATTN: Valeria  Consiero           PHONE NO : 41 71 7570055 
Industriestrasse 12               SE DECISION MADE: 17-MAY-18
9450 Altstaetten  CH              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A-CIFT SoloFuse
SpineFrontier, Inc.               510(k) NO: K172484(Traditional)
ATTN: Vito  Lore                  PHONE NO : 978 2323990 275
350 Main Street 3rd Floor         SE DECISION MADE: 08-MAY-18
Malden MA  02148                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: µCor Heart Failure and Arrhythmia Management System
ZOLL Manufacturing Corporation    510(k) NO: K172510(Traditional)
ATTN: Dawn  Chang                 PHONE NO : 412 9683333 31815
121 Gamma Drive                   SE DECISION MADE: 11-MAY-18
Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Navigation System
SeaSpine Orthopedics Corporation  510(k) NO: K172517(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 11-MAY-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Persona Personalized Knee System
Zimmer, Inc.                      510(k) NO: K172524(Traditional)
ATTN: Nicole  Meredith            PHONE NO : 574 3773718 
P.O. Box 708                      SE DECISION MADE: 17-MAY-18
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
Huizhou Foryou Medical Devices Co.510(k) NO: K172554(Traditional)
ATTN: Huida  Huang                PHONE NO : 86 0752 5302185 
North Shangxia Rd., Dongjiang Hi-tSE DECISION MADE: 01-MAY-18
Huizhou  CN 516005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAPPHIRE, ELEVARE SAPPHIRE
Omm Imports, Inc. d/b/a Zero Gravi510(k) NO: K172555(Traditional)
ATTN: Zivan  Habibi               PHONE NO : 305 5275593 
9737 NW 41St Street               SE DECISION MADE: 01-MAY-18
Doral FL  33178                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervage
PRECIFIT MEDICAL LTD              510(k) NO: K172568(Traditional)
ATTN: Zhen Yu (Eric)  Wu          PHONE NO : 
2233 5th Street East              SE DECISION MADE: 04-MAY-18
St. Paul MN  55119                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALGS6 Ag Alginate Wound Dressing
Foshan United Medical Technologies510(k) NO: K172570(Traditional)
ATTN: Una  Chen                   PHONE NO : 0086 0757 89961126 
89 Taoyuan East Road, Shishan, NanSE DECISION MADE: 11-MAY-18
Foshan  CN 528225                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern
Euroimmun US, Inc.                510(k) NO: K172582(Traditional)
ATTN: Michael A. Locke            PHONE NO : 973 6561000 
1 Bloomfield Avenue               SE DECISION MADE: 24-MAY-18
Mountain Lakes NJ  07046          510(k) STATEMENT
                                                    

DEVICE: OrthoPediatrics PediNail Intramedullary Platform
OrthoPediatrics, Inc.             510(k) NO: K172583(Traditional)
ATTN: Adam  Cargill               PHONE NO : 574 2686379 
2850 Frontier Drive               SE DECISION MADE: 10-MAY-18
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CADD Yellow High Volume Administration Set with NRFit connector
Smiths Medical ASD, Inc.          510(k) NO: K172592(Traditional)
ATTN: Michael R. Johnson          PHONE NO : 763 3833341 
6000 Nathan Lane North            SE DECISION MADE: 17-MAY-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator Helical Introducer, Right; Caldera Medical Transobturator Large Helical Introducer, Left; Caldera Medical Transobturator Large Helical Introducer, Right; Caldera Medical Transobturator Inside-Out Introducer, Left
Caldera Medical, Inc.             510(k) NO: K172614(Traditional)
ATTN: Vicki  Gail                 PHONE NO : 818 4837602 
5171 Clareton Drive               SE DECISION MADE: 04-MAY-18
Agoura Hills CA  91301            510(k) STATEMENT
                                                    

DEVICE: Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor
Nonin Medical Inc.                510(k) NO: K172625(Traditional)
ATTN: Kim E. Aves                 PHONE NO : 763 5773196 
13700 1st Avenue North            SE DECISION MADE: 11-MAY-18
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dentium Implantium & SuperLine Prosthetics
Dentium Co., Ltd.                 510(k) NO: K172640(Abbreviated)
ATTN: Sangpil  Yoon               PHONE NO : 82 31 2072200 
150, Eondong-ro, Giheung-gu       SE DECISION MADE: 14-MAY-18
Yongin-si  KR 16985               510(k) STATEMENT
                                                    

DEVICE: BiliLux
Draeger Medical Systems, Inc.     510(k) NO: K172656(Traditional)
ATTN: Gale  Winarsky              PHONE NO : 215 6602239 
3135 Quarry Road                  SE DECISION MADE: 01-MAY-18
Telford PA  18969                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fetzer Medical Gynecological Forceps
Fetzer Medical GmbH & Co. KG      510(k) NO: K172661(Traditional)
ATTN: Harald  Jung                PHONE NO : 49 7462 94799182 
Unter Buchsteig 5                 SE DECISION MADE: 08-MAY-18
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords
Wilson-Cook Medical, Inc. / Cook E510(k) NO: K172665(Traditional)
ATTN: Theresa  de Prat            PHONE NO : 336 7440157 396518
4900 Bethania Station Road        SE DECISION MADE: 24-MAY-18
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Varian Cervical Sleeves
Varian Medical Systems, Inc.      510(k) NO: K172675(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 16-MAY-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ToFscan
Idmed                             510(k) NO: K172690(Traditional)
ATTN: Frédéric  BERNERT           PHONE NO : 0033 49 1118784 
Hotel Technoptic - 2 rue Marc DonaSE DECISION MADE: 31-MAY-18
Marseille  FR 13013               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2Bacteria Panel
T2 Biosystems, Inc.               510(k) NO: K172708(Traditional)
ATTN: Tom  Lowery                 PHONE NO : 781 4571223 
101 Hartwell Avenue               SE DECISION MADE: 24-MAY-18
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Tissue Processing Unit
BSL Co.                           510(k) NO: K172717(Traditional)
ATTN: Jun Suk Lee                 PHONE NO : 82 55 3289235 
6-13, Chilsan-ro 237 beon-gil     SE DECISION MADE: 25-MAY-18
Gimhae-Si  KR 51006               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthBeacon HB2 Sharps Bin
HealthBeacon Ltd                  510(k) NO: K172719(Traditional)
ATTN: Joyce  Power                PHONE NO : 353 1 4508480 
Unit 20, Naas Road Business Park, SE DECISION MADE: 11-MAY-18
Dublin  IE Dublin 12              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polypectomy Snare
Hangzhou AGS MedTech CO., Ltd     510(k) NO: K172729(Traditional)
ATTN: Chunqi  Han                 PHONE NO : 86 571 87671223 
Building 6, Kangxin Road No.597 QiSE DECISION MADE: 21-MAY-18
Hangzhou  CN 311106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7
PAJUNK GmbH Medizintechnologie    510(k) NO: K172777(Traditional)
ATTN: Christian G. H. Quass       PHONE NO : 49 7704 9291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 03-MAY-18
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esophageal Stent System
Micro-Tech (Nanjing) Co.,Ltd.     510(k) NO: K172813(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
No.10 Gaoke Third Road            SE DECISION MADE: 18-MAY-18
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MN-111
W&H Sterilization s.r.l.          510(k) NO: K172825(Traditional)
ATTN: Marco  Parolini             PHONE NO : 39 035 6663000 
Via Bolgara, 2                    SE DECISION MADE: 30-MAY-18
Brusaporto  IT                    510(k) STATEMENT
                                                    

DEVICE: Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Maxter Glove Manufacturing Sdn Bhd510(k) NO: K172864(Traditional)
ATTN: Yap Peak Geeh               PHONE NO : 603 614 52328 
Lot 6070, Jalan Haji Abdul Manah 6SE DECISION MADE: 02-MAY-18
Klang  MY 41050                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange
GMP MEDICARE SDN BHD (F25)        510(k) NO: K172867(Traditional)
ATTN: Noraini  Raus               PHONE NO : 603 33926317 
LOT/PT64593, JLN Dahlia/KU8, KAW PSE DECISION MADE: 10-MAY-18
Klang  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: SpineKure Kyphoplasty System
Hanchang Co., Ltd.                510(k) NO: K172871(Traditional)
ATTN: An Kwon Ho                  PHONE NO : 82 32 2340033 
#301-204 Bucheon Techno-park 345, SE DECISION MADE: 29-MAY-18
Bucheon-si  KR 14501              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UINCARE HOME
UINCARE Corp.                     510(k) NO: K172882(Traditional)
ATTN: Youngbean  You              PHONE NO : 82 2 62650944 
A-603, 131, Gasan digital 1-ro    SE DECISION MADE: 10-MAY-18
Geumcheon-gu  KR 08506            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shenzhen Pacom Medical Instruments510(k) NO: K172889(Traditional)
ATTN: Liangzhou  Zhong            PHONE NO : 86 755 32920339 
8 Floor, B District, B Building, NSE DECISION MADE: 25-MAY-18
Shenzhen  CN 518105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shenzhen Jiacom Technology Co ., L510(k) NO: K172894(Traditional)
ATTN: Luo  Tianfeng               PHONE NO : 86 755 29015600 
No. A6 Building, Silicon Valley PoSE DECISION MADE: 17-MAY-18
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeraServer and PeraTrend
PeraHealth, Inc.                  510(k) NO: K172959(Traditional)
ATTN: Joseph  Beals               PHONE NO : 401 4000401 
6302 Fairview Rd.,Suite 310       SE DECISION MADE: 01-MAY-18
Charlotte NC  28210               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micropuncture Pedal Access Set
Cook Incorporated                 510(k) NO: K172980(Traditional)
ATTN: Daniel J Corbin             PHONE NO : 812 3353575 104018
750 Daniels Way                   SE DECISION MADE: 03-MAY-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SB Soft Hood - Straight type, SB Soft Hood - Undercut type
Sumitomo Bakelite Co.,  Ltd       510(k) NO: K173004(Traditional)
ATTN: Shiro  Agehama              PHONE NO : 81 3 54624811 
5-8, Higashi-Shinagawa 2-chome    SE DECISION MADE: 08-MAY-18
Shinagawa-ku  JP 1400002          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SURECELL Gelling Fiber Wound Dressing
Jiangsu Newvalue Medical Producst 510(k) NO: K173005(Traditional)
ATTN: Julie  Chen                 PHONE NO : 86 21 50211200 201
Building G35.the east of KouTai RoSE DECISION MADE: 25-MAY-18
TaiZhou  CN 225300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANGIO-PRESS LITE DVT Compression Device
Pegasus Medical Supply, Inc.      510(k) NO: K173012(Traditional)
ATTN: Pao-Ming  Shih              PHONE NO : 886 3 2753341 
No. 27-1, Ln. 473, Sec. 2, Hezun NSE DECISION MADE: 10-MAY-18
Taoyuan County  TW 32060          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
Cook Incorporated                 510(k) NO: K173035(Traditional)
ATTN: Erum B. Nasir               PHONE NO : 812 3353575 102607
750 Daniels Way                   SE DECISION MADE: 01-MAY-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectrum IQ Infusion System, Dose IQ Safety Software
Baxter Healthcare Corporation     510(k) NO: K173084(Traditional)
ATTN: Dhiraj  Bizzul              PHONE NO : 224 2702177 
32650 N. Wilson Road              SE DECISION MADE: 11-MAY-18
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smoklean
Sejong Medical Co., Ltd.          510(k) NO: K173108(Traditional)
ATTN: Yoojung  Choi               PHONE NO : 82 31 9458191 
11, Sinchon 2-ro                  SE DECISION MADE: 18-MAY-18
Paju-si  KR 10880                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GRAFTSITE
Summit Medical Ltd.               510(k) NO: K173110(Traditional)
ATTN: Robyn  Cochrane             PHONE NO : 44 0 1451821311 
 Bourton Industrial Park          SE DECISION MADE: 18-MAY-18
Bourton on the Water  GB gl54 2hq 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dr's Light2
Good Doctors Co.,Ltd.             510(k) NO: K173157(Traditional)
ATTN: Sungro  Joo                 PHONE NO : 82 32 4246325 
#208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 29-MAY-18
Incheon  KR 21315                 510(k) STATEMENT
                                                    

DEVICE: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set
Sekisui Medical Co., Ltd.         510(k) NO: K173202(Traditional)
ATTN: Kazunori  Saito             PHONE NO : 81 3 32720674 
1-3 Nihonbashi 2-Chome            SE DECISION MADE: 09-MAY-18
Chuo-Ku  JP 103-00227             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANEROID SPHYGMOMANOMETER
Wenzhou Bokang Instruments Co., Lt510(k) NO: K173246(Abbreviated)
ATTN: Youhua  Xiang               PHONE NO : 86 577 86876969 
No. 1500 Haining Road, Haibin LongSE DECISION MADE: 30-MAY-18
Wenzhou  CN 325024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EmbryoScope+
Vitrolife A/S                     510(k) NO: K173264(Traditional)
ATTN: Belinda  Dueholm            PHONE NO : 45 72 217900 
Jens Juuls Vej 20                 SE DECISION MADE: 11-MAY-18
Viby J  DK 8260                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KATOR Suture Anchor
KATOR LLC                         510(k) NO: K173269(Traditional)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 South 600 West, Suite 100     SE DECISION MADE: 30-MAY-18
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
MYCO Medical Supplies, Inc.       510(k) NO: K173279(Traditional)
ATTN: Sanjiv  Kumar               PHONE NO : 919 4602535 
2015 Production Drive             SE DECISION MADE: 14-MAY-18
Apex NC  27539                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magnesium
Abbott Laboratories               510(k) NO: K173294(Traditional)
ATTN: Kimberly  Senseman          PHONE NO : 972 5186854 
1921 Hurd Drive                   SE DECISION MADE: 18-MAY-18
Irving TX  75038                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViaTherm BOOST
ViaTherm Therapeutics, Llc.       510(k) NO: K173300(Traditional)
ATTN: Michael J. Thomas           PHONE NO : 410 7775251 
201 Defense Highway Suite 260     SE DECISION MADE: 01-MAY-18
Annapolis MD  21401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Faxitron VisionCT
Faxitron Bioptics Llc             510(k) NO: K173309(Traditional)
ATTN: Douglas C. Wiegman          PHONE NO : 520 3998180 
3440 E. Britannia Dr. Suite 150   SE DECISION MADE: 09-MAY-18
Tucson AZ  85706                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTHRO-Pump PA304
W.O.M. World of Medicine GmbH     510(k) NO: K173311(Traditional)
ATTN: Soeren  Markworth           PHONE NO : 0049 30 39981594 
Salzufer 8                        SE DECISION MADE: 09-MAY-18
Berlin  DE 10587                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
TaiDoc Technology Corporation     510(k) NO: K173345(Traditional)
ATTN: Sheena  Song                PHONE NO : 88 626 6258188 1158
B1-7F, No. 127, Wugong 2nd Rd., WuSE DECISION MADE: 04-MAY-18
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX
Centinel Spine, Inc.              510(k) NO: K173347(Traditional)
ATTN: Jessica  Staub              PHONE NO : 484 8878803 
900 Airport Road, Suite 3B        SE DECISION MADE: 08-MAY-18
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Athena 190
Medical Rehab Products, LLC       510(k) NO: K173360(Traditional)
ATTN: Brad  Evans                 PHONE NO : 706 2016186 
PO BOX 1182                       SE DECISION MADE: 17-MAY-18
Montreat NC  28757                510(k) STATEMENT
                                                    

DEVICE: OsteoMed QuickFix Hybrid MMF Sterilization Tray
OsteoMed LLC                      510(k) NO: K173391(Traditional)
ATTN: Jessica M. Ruperto          PHONE NO : 972 6774795 
 3885 Arapaho Rd                  SE DECISION MADE: 10-MAY-18
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MECALL CLISIS SYSTEMS, Discovery RF180
General Medical Merate S.P.A      510(k) NO: K173395(Special)
ATTN: Luca  Bianchessi            PHONE NO : 39 035 4525396 
Via Partigiani, 25                SE DECISION MADE: 21-MAY-18
Seriate  IT 24068                 510(k) STATEMENT
                                                    

DEVICE: DiLumen Endolumenal Interventional Scissors (DiLumen Is)
Lumendi, LLC                      510(k) NO: K173405(Traditional)
ATTN: Dennis  Daniels             PHONE NO : 203 4632669 
253 Post Road West                SE DECISION MADE: 22-MAY-18
Westport CT  06880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoWrist 5mm Thoracic Grasper
Intuitive Surgical, Inc.          510(k) NO: K173415(Traditional)
ATTN: Gayle  Perry                PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 31-MAY-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Towako Transmyometrial Embryo Transfer Set
William A. Cook Australia PTY LTD 510(k) NO: K173431(Special)
ATTN: Gordana  Pozvek             PHONE NO : 61 7 38411188 
95 Brandl Street                  SE DECISION MADE: 18-MAY-18
Eight Mile Plains  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EmboTrap ll Revascularization Device
Neuravi Ltd.                      510(k) NO: K173452(Traditional)
ATTN: Mairsil  Claffey            PHONE NO : 353 91 394121 
Block 3, Ballybrit Business Park  SE DECISION MADE: 09-MAY-18
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pure Flow External Counter-Pulsation Device
Xtreem Pulse, LLC                 510(k) NO: K173483(Traditional)
ATTN: Andrew  Barile              PHONE NO : 212 6439062 
353 W 29 St., Suite 3             SE DECISION MADE: 30-MAY-18
New York NY  10001                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioStamp nPoint
MC10 Inc.                         510(k) NO: K173510(Traditional)
ATTN: Rakesh  Lal                 PHONE NO : 857 2145600 
10 Maguire Road Bldg 3 First FloorSE DECISION MADE: 08-MAY-18
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brainsway Deep (DTMS) System
Brainsway Ltd.                    510(k) NO: K173540(Traditional)
ATTN: Ahava  Stein                PHONE NO : 972 2 5824030 
19 Hartom Str.                    SE DECISION MADE: 03-MAY-18
Jerusalem  IL 9777518             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DSM Biomedical Calcium Phosphate Cement with Microspheres
Kensey Nash Corporation dba DSM Bi510(k) NO: K173572(Traditional)
ATTN: Susan  Pileggi              PHONE NO : 484 7132173 
735 Pennsylvania Drive            SE DECISION MADE: 09-MAY-18
Exton PA  19431                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pristina Serena
GE Healthcare                     510(k) NO: K173576(Traditional)
ATTN: Gregory  Pessato            PHONE NO : 33 1 30709316 
283 rue de la Miniere             SE DECISION MADE: 14-MAY-18
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch
Fresenius Medical Care Renal Thera510(k) NO: K173593(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 21-MAY-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
Alere Scarborough, Inc.           510(k) NO: K173653(Dual Track)
ATTN: Danielle A. Briggeman       PHONE NO : 207 7305750 65925
10 Southgate Road                 SE DECISION MADE: 02-MAY-18
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm  Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm  Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes
Medical Components, Inc. (Dba Medc510(k) NO: K173667(Traditional)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 
1499 Delp Drive                   SE DECISION MADE: 17-MAY-18
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: g.Estim PRO
g.tec medical engineering GmbH    510(k) NO: K173684(Third Party - Traditional)
ATTN: Christoph  Guger            PHONE NO : 43 7251 222400 
Siemingerstrasse 14               SE DECISION MADE: 04-MAY-18
Schiedlberg  AU 4521              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Wallaby Avenir Coil System
Wallaby Medical, Inc.             510(k) NO: K173711(Traditional)
ATTN: Rebecca K. Pine             PHONE NO : 760 8095178 
23181 Verdugo Dr.                 SE DECISION MADE: 04-MAY-18
Laguna Hills CA  92653            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liberty Cycler Set
Fresenius Medical Care Renal Thera510(k) NO: K173718(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 01-MAY-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PATRIOT COLONIAL Spacer, SUSTAIN Spacer
Globus Medical Inc.               510(k) NO: K173722(Traditional)
ATTN: Kelly  Baker                PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 23-MAY-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Biopsy Valve
Zhejiang Chuangxiang Medical Techn510(k) NO: K173758(Traditional)
ATTN: Lucius  Long                PHONE NO : 86 571 89167088 8187
301B, No.22, XinYan Road          SE DECISION MADE: 14-MAY-18
Hanzhou  CN 311100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accu O2 Oxygen Analyzer
Precision Medical Inc.            510(k) NO: K173807(Abbreviated)
ATTN: James  Parker               PHONE NO : 610 2626090 
300 Held Drive                    SE DECISION MADE: 02-MAY-18
Northampton PA  18067             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ventripoint Medical System Plus (VMS+)
Ventripoint Diagnostics, Ltd.     510(k) NO: K173810(Traditional)
ATTN: Desmond  Hirson             PHONE NO : 416 8480709 
2 Sheppard Avenue East, Suite 605 SE DECISION MADE: 14-MAY-18
Toronto  CA M2N 5Y7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MC 300R* Nebulizer
Trudell Medical International     510(k) NO: K173825(Traditional)
ATTN: Marianne  Tanton            PHONE NO : 519 4557060 
725 Third Street                  SE DECISION MADE: 02-MAY-18
London  CA n5V 5G4                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Glidesheath Slender
Terumo Medical Corporation        510(k) NO: K173831(Traditional)
ATTN: Liang  Lu                   PHONE NO : 410 3927321 
950 Elkton Blvd                   SE DECISION MADE: 08-MAY-18
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InTice™-C Porous Ti Cervical Interbody System
X-Spine Systems, Inc.             510(k) NO: K173832(Traditional)
ATTN: Charlene  Brumbaugh         PHONE NO : 937 8478400 2192
452 Alexandersville Rd.           SE DECISION MADE: 17-MAY-18
Miamisburg OH  45342              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Pump Console
Spectrum Medical Ltd              510(k) NO: K173834(Traditional)
ATTN: Mark  Drain                 PHONE NO : 44 0 1242650120 
Harrier 4, Meteor Business Park, CSE DECISION MADE: 25-MAY-18
Gloucester  GB GL2 9QL            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Drug Relief
DyAnsys, Inc.                     510(k) NO: K173861(Traditional)
ATTN: San  Mateo                  PHONE NO : 408 4804700 
300 North Bayshore Boulevard      SE DECISION MADE: 02-MAY-18
San Mateo CA  94401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pantheris System
Avinger, Inc.                     510(k) NO: K173862(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 650 2417004 
400 Chesapeake Drive              SE DECISION MADE: 22-MAY-18
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
Origami Surgical LLC              510(k) NO: K173874(Traditional)
ATTN: John  Gillespie             PHONE NO : 973 7656256 
42 Main St. Suite A               SE DECISION MADE: 04-MAY-18
Madison NJ  07945                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® XLX Interbody System
NuVasive, Incorporated            510(k) NO: K173892(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 858 3204549 
7475 Lusk Blvd.                   SE DECISION MADE: 04-MAY-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MyoSure MANUAL Tissue Removal Device
Hologic, Inc.                     510(k) NO: K173901(Traditional)
ATTN: Anne-Marie  Keefe           PHONE NO : 508 2638851 
250 Campus Drive                  SE DECISION MADE: 08-MAY-18
Marlbrough MA  01752              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories
Intuitive Surgical, Inc.          510(k) NO: K173906(Traditional)
ATTN: Elaine  Lee                 PHONE NO : 408 5238887 
1266 Kifer Road                   SE DECISION MADE: 31-MAY-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube
Smiths Medical ASD, Inc.          510(k) NO: K173912(Traditional)
ATTN: Donna M. Semlak             PHONE NO : 763 3833076 
6000 Nathan Lane North            SE DECISION MADE: 08-MAY-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDRAD® Imaging Bulk Package Transfer Set
Bayer U.S. LLC                    510(k) NO: K173913(Traditional)
ATTN: Leslie S. O'Nan             PHONE NO : 412 4063165 
1 Bayer Drive                     SE DECISION MADE: 04-MAY-18
Indianola PA  15051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VORTRAN Cuff Inflator (VCI)
VORTRAN Medical Technology 1, Inc.510(k) NO: K173914(Traditional)
ATTN: James  Lee                  PHONE NO : 916 6488460 15
21 Goldenland Court #100          SE DECISION MADE: 25-MAY-18
Sacramento CA  95834              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MindMotion(TM) GO
MindMaze SA                       510(k) NO: K173931(Traditional)
ATTN: Sylvian  Bourriquet         PHONE NO : 41 21 5520807 
Chemin de Roseneck 5              SE DECISION MADE: 17-MAY-18
Lausanne  CH CH-1006              510(k) STATEMENT
                                                    

DEVICE: IS-III Bioactive Fixture
Neobiotech Co., Ltd.              510(k) NO: K173938(Traditional)
ATTN: Young-Ko  Heo               PHONE NO : 82 2 5822885 
#312-1, 36, Digital-ro 27-gil, GurSE DECISION MADE: 24-MAY-18
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astroid Planning App
.decimal, LLC.                    510(k) NO: K173940(Traditional)
ATTN: Kevin  Erhart               PHONE NO : 407 3303300 
121 Central Park Place            SE DECISION MADE: 15-MAY-18
Sanford FL  32771                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADAPT for Gamma3
Stryker GmbH                      510(k) NO: K173946(Traditional)
ATTN: Nesli  Karakaya             PHONE NO : 41 32 6416930 
Bohnackerweg 1                    SE DECISION MADE: 02-MAY-18
Selzach  CH 2545                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Legend Acetabular Liners
Ortho Development Corporation     510(k) NO: K173951(Special)
ATTN: Drew  Weaver                PHONE NO : 801 6193419 
12187 South Business Park Drive   SE DECISION MADE: 30-MAY-18
Draper UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biowy PlCC Catheter
Biowy Corporation                 510(k) NO: K173956(Traditional)
ATTN: Andre von Muller            PHONE NO : 1 949 3058211 
27031/27002 Vista Terrace         SE DECISION MADE: 21-MAY-18
Lake Forest CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2008T BlueStar Hemodialysis Machine
Fresenius Medical Care Renal Thera510(k) NO: K173972(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 10-MAY-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORE-SIGHT ELITE Module Tissue Oximeter
CAS Medical Systems, Inc.         510(k) NO: K180003(Traditional)
ATTN: Ron  Jeffrey                PHONE NO : 203 4886056 
44 East Industrial Road           SE DECISION MADE: 10-MAY-18
Branford CT  06405                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAAS Workstation
Pie Medical Imaging BV            510(k) NO: K180019(Traditional)
ATTN: Annemiek  Bouts             PHONE NO : 31 43 3281328 
Philipsweg 1                      SE DECISION MADE: 03-MAY-18
Maastricht  NL 6227 AJ            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook 810 Set, Desilets-Hoffman Introducer Set
Cook Incorporated                 510(k) NO: K180028(Traditional)
ATTN: Carly  Powell               PHONE NO : 812 3392235 104913
750 Daniels Way                   SE DECISION MADE: 02-MAY-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endopath Electrosurgery Probe Plus II
Ethicon Endo-Surgery, LLC         510(k) NO: K180031(Traditional)
ATTN: Carmen  Ortiz               PHONE NO : 787 2726500 
475 Calle C                       SE DECISION MADE: 07-MAY-18
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Weinmann Tracheostomy Exchange Set
Cook Incorporated                 510(k) NO: K180034(Traditional)
ATTN: Paul  Meyer                 PHONE NO : 812 3392235 105299
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 07-MAY-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XSTAT 30, 1-Pack
RevMedx, Inc.                     510(k) NO: K180051(Traditional)
ATTN: Amy K. Pointer              PHONE NO : 503 2182172 
25999 SW Canyon Creek Road, Suite SE DECISION MADE: 18-MAY-18
Wilsonville OR  97070             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STYLO Interbody Fusion Device
Legend Spine Technologies         510(k) NO: K180071(Traditional)
ATTN: Gwendolyn  DeBoer           PHONE NO : 610 3660077 
1803 Apple Tree Lane              SE DECISION MADE: 03-MAY-18
Bethlehem PA  18015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
Hill-Rom Inc.                     510(k) NO: K180079(Traditional)
ATTN: Sarah Marie Fitzgerald      PHONE NO : 812 9312924 
1069 State Route 46 East          SE DECISION MADE: 07-MAY-18
Batesville IN  47006              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A.M. Surgical Intramedullary Fixation Device
A.M. Surgical, Inc                510(k) NO: K180087(Traditional)
ATTN: Gavriel  Feuer              PHONE NO : 631 6566410 
222 Middle Country Road Suite 202 SE DECISION MADE: 18-MAY-18
Smithtown NY  11787               510(k) STATEMENT
                                                    

DEVICE: HEALIX ADVANCE KNOTLESS BR Anchor
Medos International SARL          510(k) NO: K180101(Traditional)
ATTN: Ashley  Goncalo             PHONE NO : 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 10-MAY-18
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearGuard HD Antimicrobial Barrier Cap
Pursuit Vascular, Inc.            510(k) NO: K180111(Traditional)
ATTN: Douglas  Killion            PHONE NO : 612 4249006 
6901 East Fish Lake Road, Suite 16SE DECISION MADE: 25-MAY-18
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QT ECG
QT Medical, Inc.                  510(k) NO: K180157(Traditional)
ATTN: Ruey-Kang  Chang            PHONE NO : 1 424 5583500 
1001 W Carson Street Suite U      SE DECISION MADE: 04-MAY-18
Torrance CA  90502                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VivaScope System
Caliber Imaging & Diagnostics, Inc510(k) NO: K180162(Special)
ATTN: Joel  Radford               PHONE NO : 585 2399800 
50 Methodist Hill Dr. Suite 1000  SE DECISION MADE: 03-MAY-18
Rochester NY  14623               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TransEnterix Senhance Surgical System
TransEnterix, Inc.                510(k) NO: K180163(Traditional)
ATTN: Stephanie  Fitts            PHONE NO : 1 919 7658430 
635 Davis Drive, Suite 300        SE DECISION MADE: 25-MAY-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Playtex Stella Tampons
Playtex Manufacturing, Inc.       510(k) NO: K180167(Traditional)
ATTN: Ludjane  Fiorillo           PHONE NO : 201 7858047 
804 Walker Road                   SE DECISION MADE: 30-MAY-18
Dover DE  19904                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Belun Ring
Belun Technology Company Limited  510(k) NO: K180174(Traditional)
ATTN: Leung Lap Wai Lydia         PHONE NO : 852 3706 5640 
Rm531B, floor 5, Core Building 2, SE DECISION MADE: 29-MAY-18
Sha Tin  HK                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erchonia FX-635
Erchonia Corporation              510(k) NO: K180197(Traditional)
ATTN: Steven  Shanks              PHONE NO : 321 4731251 
650 Atlantis Rd.                  SE DECISION MADE: 21-MAY-18
Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Route 92 Medical Access System
Route 92 Medical, Inc.            510(k) NO: K180201(Traditional)
ATTN: Kirsten  Valley             PHONE NO : 650 2798427 
1700 S EI Camino Real Suite 206   SE DECISION MADE: 23-MAY-18
San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Repris Bladder Injection System
URO-1, Inc.                       510(k) NO: K180214(Traditional)
ATTN: Thomas  Lawson              PHONE NO : 336 9305456 
391 Technology Way Suite 168      SE DECISION MADE: 03-MAY-18
Winston Salem NC  27101           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VESTEX Apparel
Vestagen Protective Technologies, 510(k) NO: K180217(Traditional)
ATTN: Scott  Pease                PHONE NO : 407 7812572 
1301 W. Colonial Dr.              SE DECISION MADE: 18-MAY-18
Orlando FL  32804                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAGICO OSI Spinal System by Osimplant
Spinal Analytics & Geometrical Imp510(k) NO: K180220(Traditional)
ATTN: James J Gibson Jr.          PHONE NO : 813 8303636 
2189 W Busch Blvd                 SE DECISION MADE: 21-MAY-18
Tampa FL  33612                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Additive Orthopaedics Patient Specific 3D Printed Bone Segments
Additive Orthopaedics, LLC        510(k) NO: K180239(Traditional)
ATTN: Gregory  Kowalczyk          PHONE NO : 732 8826633 
83 Amelia Circle                  SE DECISION MADE: 16-MAY-18
Little Silver NJ  07739           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Hypodermic Needle for Single Use
Jiangsu Shenli Medical Production 510(k) NO: K180259(Traditional)
ATTN: Tina  Cai                   PHONE NO : 86 519 88731071 
No 20, Changzheng Road, Zhenglu   SE DECISION MADE: 18-MAY-18
Changzhou City  CN 213111         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
Gold Standard Diagnostics         510(k) NO: K180264(Traditional)
ATTN: Napoleon  Monce             PHONE NO : 530 7598000 
2851 Spafford St.                 SE DECISION MADE: 02-MAY-18
Davis CA  95618                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellvizio 100 Series Systems with Confocal Miniprobes
Mauna Kea Technologies            510(k) NO: K180270(Traditional)
ATTN: Veronique  Dentan           PHONE NO : 33 170 080994 
9 Rue d'Enghien                   SE DECISION MADE: 22-MAY-18
Paris  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silk'n MODEL H5003 device
Home Skinovations Ltd.            510(k) NO: K180279(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 09-MAY-18
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GSI Corti
Grason-Stadler Inc.               510(k) NO: K180287(Traditional)
ATTN: Amy  Yanta                  PHONE NO : 952 9476097 
10395 West 70th Street            SE DECISION MADE: 11-MAY-18
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Retia 2
CenterVue SpA                     510(k) NO: K180293(Traditional)
ATTN: Roberto  Gabriotti          PHONE NO : 39 049 5018399 
Via S. Marco 9H                   SE DECISION MADE: 30-MAY-18
Padova  IT 35129                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Afinion HbA1c Dx
Alere Technologies AS             510(k) NO: K180296(Traditional)
ATTN: Monica  Vallestad           PHONE NO : 47 2405 6000 
Kjelsaasveien 161                 SE DECISION MADE: 07-MAY-18
Oslo  NO NO-0884                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apollo TMS Therapy System
Mag & More GmbH                   510(k) NO: K180313(Abbreviated)
ATTN: Kerstin  Haringer           PHONE NO : 49 89 20185248 
Machtlfinger Strasse l3           SE DECISION MADE: 04-MAY-18
Munich  DE 81379                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
MicroPort Orthopedics, Inc.       510(k) NO: K180317(Traditional)
ATTN: Grace  Johnson-Bann         PHONE NO : 901 2905904 
5677 Airline Road                 SE DECISION MADE: 04-MAY-18
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 7D Surgical System
7D Surgical Inc.                  510(k) NO: K180352(Special)
ATTN: Daniel  Ziskind             PHONE NO : 647 4840079 
60 Scarsdale Road, Unit 118       SE DECISION MADE: 02-MAY-18
Toronto  CA M3B 2R7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: inui In-Home Urine Analysis Test System
Scanadu, Inc.                     510(k) NO: K180356(Traditional)
ATTN: Daya  Ranamukhaarachchi     PHONE NO : 301 5691213 
1196 Borregas Ave., Ste 200       SE DECISION MADE: 25-MAY-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OKTAGON Implant System
Hager & Meisinger GmbH            510(k) NO: K180360(Traditional)
ATTN: Adam  Tomczak               PHONE NO : 0049 2131 20120 
Hansemannstrasse 10               SE DECISION MADE: 10-MAY-18
Neuss  DE 41468                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MICRORAPTOR REGENESORB Suture Anchor
Smith and Nephew, Inc             510(k) NO: K180361(Traditional)
ATTN: Katherine  Marcaccio        PHONE NO : 508 2613602 
7135 Goodlett Farms Parkway       SE DECISION MADE: 30-MAY-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The IQoolTM Warm System
Brain Cool AB                     510(k) NO: K180375(Traditional)
ATTN: Martin  Waleij              PHONE NO : 46 733 937076 
Scheelevägen 2                    SE DECISION MADE: 18-MAY-18
Medicon Village  SE SE-223 81     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Light based hair removal device
Shenzhen GSD Tech Co., Ltd        510(k) NO: K180383(Traditional)
ATTN: Ziyi  Gui                   PHONE NO : 86 755 29169431 8040
Building A Junsd Hi-Tech Park, WesSE DECISION MADE: 11-MAY-18
Shenzhen  CN 518106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Body Thermometer
HeTaiDa Technology Co., Ltd.      510(k) NO: K180385(Traditional)
ATTN: Tom  Chen                   PHONE NO : 86 020 82245821 
4F, BaiShiDa High-Tech Park, XiangSE DECISION MADE: 11-MAY-18
Foshan City  CN 523820            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Meron Plus QM
Voco GmbH                         510(k) NO: K180386(Traditional)
ATTN: M. Th.  Plaumann            PHONE NO : 49 4721 7190 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 08-MAY-18
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
Topcon Medical Laser Systems, Inc.510(k) NO: K180402(Traditional)
ATTN: Sweta  Srivastava           PHONE NO : 925 2457721 
606 Enterprise Ct.                SE DECISION MADE: 25-MAY-18
Livermore CA  94550               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length; ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 45 cm Shaft Length
Ethicon Endo-Surgery, LLC         510(k) NO: K180403(Traditional)
ATTN: Sigfrido  Delgado           PHONE NO : 787 2726500 
475 Calle C                       SE DECISION MADE: 23-MAY-18
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS40 Diagnostic Ultrasound System
Samsung Medison Co, Ltd.          510(k) NO: K180409(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 2 21941594 
3366, Hanseo-ro, Nam-myeon, HongchSE DECISION MADE: 11-MAY-18
Gangwon-do  KR 25108              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump; Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump Canister
Penumbra, Inc.                    510(k) NO: K180412(Traditional)
ATTN: Richard  Kimura             PHONE NO : 510 9952034 
One Penumbra Place                SE DECISION MADE: 15-MAY-18
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPX-4440FN Digital Video Processor with Light Source
FUJIFILM New Development U.S.A., I510(k) NO: K180414(Traditional)
ATTN: Stephen  Mariano            PHONE NO : 781 8602463 
318 Bear Hill Road                SE DECISION MADE: 24-MAY-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hexanium® TLIF
SpineVision, SAS                  510(k) NO: K180437(Traditional)
ATTN: Anaella  Gallego            PHONE NO : 33 1 53332525 
10 Rue de la Renaissance, BatimentSE DECISION MADE: 04-MAY-18
Antony  FR 92160                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: reVive Light Therapy LED Ultrasonic Wrinkle System
LED Technologies, Inc.            510(k) NO: K180445(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 6460543 117
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 15-MAY-18
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuralBot
Neural Analytics, Inc.            510(k) NO: K180455(Traditional)
ATTN: Javad  Seyedzadeh           PHONE NO : 914 4731678 
2440 S Sepulveda Blvd. Suite 115  SE DECISION MADE: 22-MAY-18
Los Angeles CA  90064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Theradome LH40
Theradome, Inc.                   510(k) NO: K180460(Traditional)
ATTN: Tamim  Hamid                PHONE NO : 510 7140525 
4900 Hopyard Road, Suite 100      SE DECISION MADE: 18-MAY-18
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navi e/Navi s/Navi X Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K180461(Traditional)
ATTN: Jiang  Xiaosan              PHONE NO : 86 755860 077888003 
1st and 5th Floor,No. 6 Building PSE DECISION MADE: 09-MAY-18
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEVUMED PHANTOM Suture Anchors
Aevumed, Inc.                     510(k) NO: K180464(Traditional)
ATTN: Saif  Khalil                PHONE NO : 610 7457284 
877 Richards Road                 SE DECISION MADE: 31-MAY-18
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlowTriever Catheter, 6-10 mm; FlowTreiver Catheter, 11-14 mm; FlowTreiver Catheter, 15-18 mm; Aspiration Guide Catheter; Retraction Aspirator
Inari Medical                     510(k) NO: K180466(Traditional)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Road Suite 124      SE DECISION MADE: 17-MAY-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Comfort Rubber Gloves Industries S510(k) NO: K180476(Traditional)
ATTN: Chan Yew Men                PHONE NO : 605 8472777 
Lot 821, Jalan Matang             SE DECISION MADE: 15-MAY-18
Matang  MY 34750                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATEC Universal Spacer System
Alphatec Spine, Inc               510(k) NO: K180480(Traditional)
ATTN: Jeremy  Markovich           PHONE NO : 760 4946893 
5818 El Camino Real               SE DECISION MADE: 31-MAY-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JOULE SYSTEM
Sciton, Inc.                      510(k) NO: K180508(Traditional)
ATTN: Jay M/ Patel                PHONE NO : 650 5438348 
925 Commercial Street             SE DECISION MADE: 18-MAY-18
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CustomizedBone Service
Fin-Ceramica Faenza S.p.A         510(k) NO: K180513(Traditional)
ATTN: Marina  Monticelli          PHONE NO : 0039 0546 607311 
via Ravegnana 186                 SE DECISION MADE: 15-MAY-18
Faenza  IT 48018                  510(k) STATEMENT
                                                    

DEVICE: HARRIER-SA™ Lumbar Interbody System
Choice Spine, LP                  510(k) NO: K180519(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 16-MAY-18
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EEG-Now
EncephaloDynamics, Inc.           510(k) NO: K180524(Traditional)
ATTN: J. Chris Sackellares        PHONE NO : 352 3279127 
4320 NW 23rd Avenue, Suite 1      SE DECISION MADE: 18-MAY-18
Gainesville FL  32606             510(k) STATEMENT
                                                    

DEVICE: IS3
Hiossen, Inc.                     510(k) NO: K180527(Traditional)
ATTN: David  Kim                  PHONE NO : 1 267 7597031 
85 Ben Fairless Dr.               SE DECISION MADE: 16-MAY-18
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
Samsung Electronics Co.,Ltd.      510(k) NO: K180543(Traditional)
ATTN: Jaesang  Noh                PHONE NO : 82 31 2001764 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 24-MAY-18
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VACUETTE SAFELINK Holder with male luer lock
Greiner Bio-One NA Inc.           510(k) NO: K180545(Traditional)
ATTN: Manfred  Abel               PHONE NO : 1 704 2617823 
4238 Capital Drive                SE DECISION MADE: 21-MAY-18
Monroe NC  28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY Spore Test Strip for S40 Sterilant
Steris Corporation                510(k) NO: K180553(Traditional)
ATTN: Marcia L. Benedict          PHONE NO : 440 3927695 
5960 Heisley Road                 SE DECISION MADE: 29-MAY-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10
Supersonic Imagine                510(k) NO: K180572(Traditional)
ATTN: Laurence  Hermitte          PHONE NO : 33 442 992424 
Les Jardins de la Duranne - Bat E&SE DECISION MADE: 29-MAY-18
Aix-en-Provence  FR 13857         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sternal Cable System
A & E Medical Corporation         510(k) NO: K180582(Traditional)
ATTN: Hollie  Johnson             PHONE NO : 732 7387335 
5206 Asbury Road                  SE DECISION MADE: 31-MAY-18
Farmingdale NJ  07727             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Collagentex Rx-6
Tanses Technologies inc.          510(k) NO: K180585(Traditional)
ATTN: Kirk  Kiremitci             PHONE NO : 1 450 6224004 
4450 Highway 13                   SE DECISION MADE: 11-MAY-18
Fabreville  CA H7R 6E9            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venue
GE Medical Systems Ultrasound and 510(k) NO: K180599(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
LLC 9900 W. Innovation Drive      SE DECISION MADE: 02-MAY-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMAVAC Device
SOMAVAC Medical Solutions, Inc.   510(k) NO: K180606(Traditional)
ATTN: Esra  Roan                  PHONE NO : 901 6646370 
20 South Dudley Street, Suite 100 SE DECISION MADE: 31-MAY-18
Memphis TN  38103                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rodo Smilekey
Rodo Medical, Inc.                510(k) NO: K180609(Traditional)
ATTN: Michael  Parsons            PHONE NO : 408 2457636 
6399 San Ignacio Ave., Suite 100  SE DECISION MADE: 23-MAY-18
San Jose CA  95119                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ulthera System
Ulthera, Inc                      510(k) NO: K180623(Traditional)
ATTN: Jessica  Newhard            PHONE NO : 480 6194069 
1840 South Stapley Drive Suite 200SE DECISION MADE: 04-MAY-18
Mesa AZ  85204                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guided Growth Plate System Plus
Orthofix Srl                      510(k) NO: K180624(Special)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via delle Nazioni 9               SE DECISION MADE: 15-MAY-18
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rondek PGA Suture (Beige or Violet)
RK Manufacturing Corporation      510(k) NO: K180625(Traditional)
ATTN: Joshua  Hubbard             PHONE NO : 203 7978700 
34 Executive Drive                SE DECISION MADE: 10-MAY-18
Danbury CT  06810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invenia ABUS Viewer
GE Healthcare                     510(k) NO: K180641(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 04-MAY-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pro-Link® Ti Stand-Alone Cervical Spacer System
Life Spine Inc.                   510(k) NO: K180642(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 10-MAY-18
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex FastThread Interference Screw
Arthrex Inc.                      510(k) NO: K180662(Special)
ATTN: Jessica L. Singelais        PHONE NO : 1 239 5984302 73091
1370 Creekside Boulevard          SE DECISION MADE: 22-MAY-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
LIVERMORETECH Inc.                510(k) NO: K180663(Traditional)
ATTN: Jae Hong Kim                PHONE NO : 1 214 2570113 
801 North Jupiter Rd, Suite 200   SE DECISION MADE: 18-MAY-18
Plano TX  75074                   510(k) STATEMENT
                                                    

DEVICE: SeaSpine Daytona Small Stature Spinal System
SeaSpine Orthopedics Corporation  510(k) NO: K180686(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 14-MAY-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Lumber IBF System
Reliance Medical Systems          510(k) NO: K180687(Special)
ATTN: Bret M Berry                PHONE NO : 801 2953280 
545 West 500 South Suite 100      SE DECISION MADE: 15-MAY-18
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KYPHON HV-R Bone Cement
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K180700(Traditional)
ATTN: Laveeda  Leflore            PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 18-MAY-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Endoscopic CO2 Regulator GW-100
FUJIFILM Corporation              510(k) NO: K180711(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 25-MAY-18
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LineUp
CurveBeam, LLC                    510(k) NO: K180727(Third Party - Traditional)
ATTN: Stuti  Singh                PHONE NO : 267 4838081 
175 Titus Ave Suite 300           SE DECISION MADE: 11-MAY-18
Warrington PA  18976              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VitriGuard
ORIGIO a/s                        510(k) NO: K180740(Special)
ATTN: Roaida  Johnson             PHONE NO : 45 46790200 
Knardrupvej 2                     SE DECISION MADE: 04-MAY-18
Malov  DK 2760                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnsoETM
Advanced Cooling Therapy, Inc. d/b510(k) NO: K180742(Traditional)
ATTN: Erik  Kulstad               PHONE NO : 708 6510736 
3440 S. Dearborn St. #215-South   SE DECISION MADE: 17-MAY-18
Chicago IL  60616                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Wire Guide Introducer
COOK Incorporated                 510(k) NO: K180756(Traditional)
ATTN: Carly  Powell               PHONE NO : 812 3392235 104913
750 Daniels Way P.O. Box 489      SE DECISION MADE: 24-MAY-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acro HCG Pregnancy Rapid Test
ACRO Biotech, Inc.                510(k) NO: K180771(Traditional)
ATTN: Joseph  Fan                 PHONE NO : 1 909 4666892 
9500 Seventh Street, Suite M      SE DECISION MADE: 18-MAY-18
Rancho Cucamonga CA  91730        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable and Self-Adhesive Electrodes
Shaoxing DongZhi Electrical Techno510(k) NO: K180773(Traditional)
ATTN: Haze  XU                    PHONE NO : 0086 0575 82597860 
Xinsha Village, Cao E Street, ShanSE DECISION MADE: 22-MAY-18
Shaoxing  CN 312352               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cytal Wound Particulate
ACell, Inc.                       510(k) NO: K180776(Special)
ATTN: Andrea  Artman              PHONE NO : 410 9538549 
6640 Eli Whitney Drive Suite 200  SE DECISION MADE: 11-MAY-18
Columbia MD  21046                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spineology Navigation Instruments
Spineology Inc.                   510(k) NO: K180796(Special)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 02-MAY-18
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clarius Ultrasound Scanner
Clarius Mobile Health Corp.       510(k) NO: K180799(Third Party - Traditional)
ATTN: Brendan  Seward             PHONE NO : 1 778 8009975 
350 - 3605 Gilmore Way            SE DECISION MADE: 14-MAY-18
Burnaby  CA V5G 4X5               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Celling Aspiration Needle
SpineSmith Holdings, LLC          510(k) NO: K180807(Traditional)
ATTN: Clifton (Chris) Naivar      PHONE NO : 512 6372068 
4719 S Congress Ave               SE DECISION MADE: 24-MAY-18
Austin TX  78745                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omni Foot Plating System
Extremity Medical, LLC            510(k) NO: K180808(Traditional)
ATTN: Brian  Smekal               PHONE NO : 973 5888980 
300 Interpace Parkway, Suite 410  SE DECISION MADE: 22-MAY-18
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Vision
Siemens Medical Solutions USA, Inc510(k) NO: K180811(Traditional)
ATTN: Alaine  Medio               PHONE NO : 865 2182703 
810 Innovation Drive              SE DECISION MADE: 23-MAY-18
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AERIAL™ Interspinous Fixation
Globus Medical Inc.               510(k) NO: K180817(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 21-MAY-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
Menicon Co., Ltd.                 510(k) NO: K180819(Traditional)
ATTN: Kenichi  Tanaka             PHONE NO : 81 52 9351676 
21-19, Aoi 3, Naka-ku             SE DECISION MADE: 16-MAY-18
Nagoya  JP 460-0006               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches
ArthroCare Corporation            510(k) NO: K180848(Special)
ATTN: Shruthi  Bhat               PHONE NO : 512 8951295 
7000 West William Cannon Drive    SE DECISION MADE: 01-MAY-18
Austin TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
Edan Instruments, Inc             510(k) NO: K180862(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 26858736 
#15 Jinhui Road,Jinsha Community KSE DECISION MADE: 24-MAY-18
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DTRAX Spinal System
Providence Medical Technology, Inc510(k) NO: K180876(Traditional)
ATTN: Edward  Liou                PHONE NO : 415 9239376 
3857 Hopyard Rd. Suite 300        SE DECISION MADE: 18-MAY-18
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 5D Viewer
Samsung Medison Co., Ltd.         510(k) NO: K180883(Third Party - Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 2 21941594 
42, Teheran-ro 108-gil Gangnam-gu SE DECISION MADE: 15-MAY-18
Seoul  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL
Liofilchem s. r. l.               510(k) NO: K180886(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 18-MAY-18
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: EVOL Spinal Interbody System, EVOS Lumbar Interbody System
Cutting Edge Spine, LLC           510(k) NO: K180891(Special)
ATTN: Kyle  Kuntz                 PHONE NO : 704 2430892 
101 Waxhaw Professional Park, SuitSE DECISION MADE: 04-MAY-18
Waxhaw NC  28173                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low Dose CT Lung Cancer Screening Option
Hitachi Healthcare Americas       510(k) NO: K180901(Traditional)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 16-MAY-18
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Conformis, Inc.                   510(k) NO: K180906(Special)
ATTN: Emmanuel  Nyakako           PHONE NO : 781 3459001 
600 Technology Park Drive, 4 FloorSE DECISION MADE: 16-MAY-18
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Irrigation Tubing Bipolar Cord Set
New Deantronics Taiwan Ltd        510(k) NO: K180908(Traditional)
ATTN: Jane  Liu                   PHONE NO : 886 2 22681726 
12F., No.51, Sec.4, Chong Yang Rd.SE DECISION MADE: 18-MAY-18
New Taipei City  TW 23675         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VSI Micro-Introducer Kit
Vascular Solutions, Inc.          510(k) NO: K180913(Third Party - Traditional)
ATTN: Jake  Schultz               PHONE NO : 763 6564300 
6464 Sycamore Court North         SE DECISION MADE: 09-MAY-18
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Empower H100, Cyber Ho 100, Litho 100
quanta system spa                 510(k) NO: K180922(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
via Acquedotto 109                SE DECISION MADE: 08-MAY-18
Samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic HD® Hip System
Total Joint Orthopedics, Inc.     510(k) NO: K180929(Special)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 09-MAY-18
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diamond Orthopedic Bone Fixation Screws and Pins
Diamond Orthopedic, LLC           510(k) NO: K180932(Special)
ATTN: Roy  Bivens                 PHONE NO : 704 5858258 
1104 Spruce St                    SE DECISION MADE: 09-MAY-18
Belmont NC  28012                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Graftgun Universal Graft Delivery System
Surgentec, LLC                    510(k) NO: K180937(Special)
ATTN: Boca  Raton                 PHONE NO : 561 9907882 
7601 N Federal Hwy #150A          SE DECISION MADE: 10-MAY-18
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indigo Aspiration System - Modified 110 Aspiration Tubing
Penumbra, Inc.                    510(k) NO: K180939(Special)
ATTN: Richard  Kimura             PHONE NO : 510 9952034 
One Penumbra Place                SE DECISION MADE: 03-MAY-18
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadiForce MX194
EIZO Corporation                  510(k) NO: K180961(Abbreviated)
ATTN: Hiroaki  Hashimoto          PHONE NO : 81 76 2742468 
153 Shimokashiwano                SE DECISION MADE: 10-MAY-18
Hakusan  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
Pixxgen Corporation               510(k) NO: K180976(Traditional)
ATTN: John  Ross                  PHONE NO : 82 70 48468888 
5F SMART BAY, 123, Beolmal-ro, DonSE DECISION MADE: 24-MAY-18
Anyang-si  KR 14056               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XableCath Support Catheter Product Family
XableCath, Inc.                   510(k) NO: K180986(Special)
ATTN: Rick  Gaykowski             PHONE NO : 617 4474000 
417 South Wakara Way, Suite 3510  SE DECISION MADE: 15-MAY-18
Salt Lake City UT  84108-1457     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Confida Brecker Guidewire
Medtronic Core Valve, LLC.        510(k) NO: K181001(Third Party - Traditional)
ATTN: Gerardine  Drummond         PHONE NO : 353 91 708914 
Parkmore West                     SE DECISION MADE: 03-MAY-18
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: VIVIX-S 1717V
Vieworks Co., Ltd.                510(k) NO: K181003(Traditional)
ATTN: Jordin  Kim                 PHONE NO : 82 70 44961859 
(Gwanyang-dong) 41-3, Burim-ro 170SE DECISION MADE: 15-MAY-18
Anyang-si  KR 431-060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter
Meril Life Sciences Private Limite510(k) NO: K181023(Special)
ATTN: Utpal  Thakor               PHONE NO : 91 9601 260306 
Bilakhia House, Survey No. 135/139SE DECISION MADE: 17-MAY-18
Vapi  IN 396191                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
DFI Co., Ltd.                     510(k) NO: K181024(Traditional)
ATTN: Bella  Cho                  PHONE NO : 82 55 3461882 
388-25, Gomo-ro, Jillye-myeon, GimSE DECISION MADE: 23-MAY-18
Gyeongsangnam-do  KR 621-881      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halcyon
Varian Medical Systems Inc.       510(k) NO: K181032(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 09-MAY-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
Boston Scientific Corporation     510(k) NO: K181042(Special)
ATTN: Jennifer L. Foley           PHONE NO : 952 9558049 
3 Scimed Place                    SE DECISION MADE: 17-MAY-18
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: geko T-3 Neuromuscular Stimulator
Firstkind Limited                 510(k) NO: K181059(Special)
ATTN: Neil  Buckley               PHONE NO : 44 0 1494572040 
Hawk House, Peregrine Business ParSE DECISION MADE: 23-MAY-18
High Wycombe  GB HP13 7DL         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlignX Ankle Fusion System
Extremity Medical, LLC            510(k) NO: K181067(Special)
ATTN: Brian  Smekal               PHONE NO : 973 5888980 
300 Interpace Parkway, Suite 410  SE DECISION MADE: 23-MAY-18
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ActiGraph CentrePoint Insight Watch
ActiGraph                         510(k) NO: K181077(Special)
ATTN: Brian  Bell                 PHONE NO : 850 3327900 
49 E Chase St                     SE DECISION MADE: 24-MAY-18
Pensacola FL  32502               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: McKesson Cardiology
Change Healthcare Israel Ltd.     510(k) NO: K181080(Traditional)
ATTN: Nadia  Marchant             PHONE NO : 972 3 7698000 
HaRokmim 26                       SE DECISION MADE: 24-MAY-18
Holon  IL 5885849                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
Siemens Healthcare Diagnostics, In510(k) NO: K181082(Traditional)
ATTN: Kathleen  Dray-Lyons        PHONE NO : 617 6886117 
500 GBC Drive                     SE DECISION MADE: 25-MAY-18
Newark NJ  19714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc510(k) NO: K181098(Third Party - Traditional)
ATTN: Christine  Dunbar           PHONE NO : 925 3742045 
685 East Middlefield Road         SE DECISION MADE: 31-MAY-18
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Fresenius Liberty Select Cycler
Fresenius Medical Care Renal Thera510(k) NO: K181108(Special)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 24-MAY-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated INFINITY Instruments
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K181111(Special)
ATTN: Tejas  Patel                PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 17-MAY-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARDIOSAVE Intra-Aortic Balloon Pump
Datascope Corp.                   510(k) NO: K181122(Special)
ATTN: Hemang  Kotecha             PHONE NO : 973 7097376 
1300 MacArthur Blvd.              SE DECISION MADE: 31-MAY-18
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tri-Ad 2.0 Adams Tricuspid Band
Medtronic                         510(k) NO: K181132(Special)
ATTN: Tracy  Gray                 PHONE NO : 949 3991678 
1851 East Deere Ave               SE DECISION MADE: 29-MAY-18
Santa Ana CA  92705               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CS 9600
Trophy                            510(k) NO: K181136(Traditional)
ATTN: Marie-Pierre  Labat-Camy    PHONE NO : 33 1 64808500 
4 Rue F. Pelloutier               SE DECISION MADE: 24-MAY-18
Croissy Beaubourg  FR 77435       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse Treatment Planning System
Varian Medical Systems, Inc.      510(k) NO: K181145(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hensen Way                    SE DECISION MADE: 18-MAY-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProtekDuo Mini Veno-Venous Cannula Set
CardiacAssist Inc                 510(k) NO: K181150(Special)
ATTN: Greg  Johnson               PHONE NO : 412 9637770 
240 Alpha Drive                   SE DECISION MADE: 25-MAY-18
Pittsburg PA  15238               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICEfx Cryoablation System
Galil Medical Inc.                510(k) NO: K181153(Special)
ATTN: Rachel  Owens               PHONE NO : 651 2875024 
4364 Round Lake Road              SE DECISION MADE: 15-MAY-18
Arden Hills MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interventional Workspot
Philips Medical Systems Nederland 510(k) NO: K181177(Special)
ATTN: Chandrika  Srinivasan       PHONE NO : 91 974 0900311 
Veenpluis 4-6                     SE DECISION MADE: 31-MAY-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrainScope One
BrainScope Company Inc.           510(k) NO: K181179(Special)
ATTN: Michael E Singer            PHONE NO : 240 7527680 
4350 East West Hwy, Ste 1050      SE DECISION MADE: 18-MAY-18
Bethesda MD  20814                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVEREST Spinal System
K2M Inc.                          510(k) NO: K181188(Special)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Pkwy. SE                 SE DECISION MADE: 30-MAY-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    


         TOTAL 510(k)s THIS PERIOD   252                                     
         TOTAL WITH SUMMARIES        236                                     
         TOTAL WITH STATEMENTS        16