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  1. 510(k) Clearances

June 2018 510(k) Clearances

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


DEVICE: FIJI SUN FLUORESCENT TANNING UNIT
KDB INC. (DBA) SPERTI SUNLAMP     510(k) NO: K151721(Abbreviated)
ATTN: JAMES  SHEPERD              PHONE NO : 1 800 5443757 
2550 AMERICAN COURT               SE DECISION MADE: 22-JUN-18
CRESCENT SPRINGS KY  41017        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perfadex Plus
XVIVO Perfusion AB                510(k) NO: K170826(Traditional)
ATTN: Kathleen  Johnson           PHONE NO : 
                                  SE DECISION MADE: 22-JUN-18
Goteborg  SE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
Hightech Development              510(k) NO: K170835(Traditional)
ATTN: Martin  Boros               PHONE NO : 420 608 465625 
Janovskeho 979/11                 SE DECISION MADE: 15-JUN-18
Prague  CZ 170 00                 510(k) STATEMENT
                                                    

DEVICE: HOMED Mesh Nebulizer
Shenzhen Homed Medical Device Co,.510(k) NO: K170886(Traditional)
ATTN: Shengming  Shi              PHONE NO : 86 755 29821675 8011
3rd Floor, Block 2, Longgu IndustrSE DECISION MADE: 21-JUN-18
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zuga Dental Implant System
Zuga Medical, Inc.                510(k) NO: K171197(Traditional)
ATTN: Chan  Wang                  PHONE NO : 216 2925910 
24400 Chagrin Blvd, Suite 250     SE DECISION MADE: 30-JUN-18
Beachwood OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
Ever Global (Vietnam) Enterprise C510(k) NO: K171422(Abbreviated)
ATTN: Jerry  Lin                  PHONE NO : 84 613 514022 
Long Thanh Industrial Zone Taman VSE DECISION MADE: 11-JUN-18
Dong Nai Province  VN 810000      510(k) STATEMENT
                                                    

DEVICE: Check-Flo Performer Introducer Micropuncture Radial Artery Access Set
Cook Incorporated                 510(k) NO: K171609(Traditional)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 04-JUN-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silverwear Silver Pro Garment Device
Media Plus, LLC                   510(k) NO: K171798(Traditional)
ATTN: Rita  Vacco                 PHONE NO : 201 5411222 
560 Sylvan Aveue, 3rd Floor       SE DECISION MADE: 01-JUN-18
Englewood Cliffs NJ  07632        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System)
HMicro, Inc.                      510(k) NO: K172011(Traditional)
ATTN: Kim  Tompkins               PHONE NO : 408 9814889 
39355 California Street, #303     SE DECISION MADE: 14-JUN-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kenz Cardico1211
Suzuken Co.,Ltd.                  510(k) NO: K172068(Traditional)
ATTN: Eiji  Yamaguchi             PHONE NO : 81 52 9506327 
8 Higashikataha-machi, Higashi-ku SE DECISION MADE: 01-JUN-18
Nagoya  JP 461-0015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Thermometer
Fudakang Industrial Co., Ltd      510(k) NO: K172121(Traditional)
ATTN: Bob  Yu                     PHONE NO : 86 769 81098181 
No. 8 Yinghe Road, Yuanjiangyuan MSE DECISION MADE: 07-JUN-18
Dongguan  CN 523560               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100
TaiDoc Technology Corporation     510(k) NO: K172221(Traditional)
ATTN: Anne  Kuo                   PHONE NO : 886 2 66258188 1195
6F, No.127, Wugong 2nd Rd., Wugu DSE DECISION MADE: 06-JUN-18
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oxygen Concentrator
SysMed (China) Co., Ltd           510(k) NO: K172234(Traditional)
ATTN: Jian  Yue                   PHONE NO : 86 24 24696136 
11-2-3 No. 17 Wensu Str., Hunnan NSE DECISION MADE: 01-JUN-18
Shenyang  CN 110171               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IU Implant System
Warantec Co.,Ltd.                 510(k) NO: K172345(Traditional)
ATTN: Dong-Hwa  Jang              PHONE NO : 82 31 7786328 
#411, #412, 474, Dunchon-daero, JuSE DECISION MADE: 18-JUN-18
Seongnam-si  KR 13229             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: sterEOS Workstation
EOS imaging                       510(k) NO: K172346(Traditional)
ATTN: Mathias  Breuil             PHONE NO : 33 155 256060 
10 rue Mercoeur                   SE DECISION MADE: 19-JUN-18
Paris  FR 75011                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters
Smiths Medical ASD, Inc.          510(k) NO: K172410(Traditional)
ATTN: Michael R. Johnson          PHONE NO : 763 3833341 
6000 Nathan Lane North            SE DECISION MADE: 01-JUN-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
Deltex Medical Limited            510(k) NO: K172457(Traditional)
ATTN: Mark  Baylis                PHONE NO : 44 1243 523174 
Terminus Road                     SE DECISION MADE: 28-JUN-18
Chichester  GB PO19 8TX           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kopac Sterile Needle
Poonglim Pharmatech Inc.          510(k) NO: K172483(Traditional)
ATTN: Cho Hee Min                 PHONE NO : 82 63 4518141 
21, Jayumuyeok 1-gil              SE DECISION MADE: 21-JUN-18
Gunsan-si  KR 54001               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEOSHIELD
JMS North America Corporation     510(k) NO: K172499(Traditional)
ATTN: Sho  Hosoki                 PHONE NO : 510 8889090 
22320 Foothill Blvd. Suite 350    SE DECISION MADE: 01-JUN-18
Hayward CA  94541                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atlas Percussion Adjusting Instrument
Spinalight, Inc                   510(k) NO: K172536(Traditional)
ATTN: Stanford  Pierce            PHONE NO : 727 5424591 
6721 23rd Street North            SE DECISION MADE: 20-JUN-18
St. Petersburg FL  33702          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trinity PLUS Acetabular Shell
Corin USA Limited                 510(k) NO: K172551(Traditional)
ATTN: Rachel  King                PHONE NO : 813 9774469 
12750 Citrus Park Lane            SE DECISION MADE: 15-JUN-18
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TubeClear System
Actuated Medical, Inc.            510(k) NO: K172556(Traditional)
ATTN: Michael T. Britton          PHONE NO : 814 3550003 
310 Rolling Ridge Dr.             SE DECISION MADE: 29-JUN-18
Bellefonte PA  16823              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vios Monitoring System™ Model 2050
Vios Medical, Inc.                510(k) NO: K172586(Traditional)
ATTN: Amit  Patel                 PHONE NO : 651 7648467 
7300 Hudson Blvd N                SE DECISION MADE: 22-JUN-18
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FOCAL ONE
EDAP Technomed, Inc.              510(k) NO: K172721(Traditional)
ATTN: Hugo  Embert                PHONE NO : 512 8327956 
5321 Industrial Oaks Blvd, Suite 1SE DECISION MADE: 07-JUN-18
AUSTIN TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VT Dressing Kits
Carilex Medical, Inc.             510(k) NO: K172725(Traditional)
ATTN: Henry  Kao                  PHONE NO : 886 3 3287882 
No. 77 Keji 1st Rd., Guishan Dist.SE DECISION MADE: 08-JUN-18
Taoyuan City  TW 333              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmuGlo HEp-2 Elite IFA
IMMCO Diagnostics, Inc.           510(k) NO: K172745(Traditional)
ATTN: Kevin  Lawson               PHONE NO : 716 4915245 
60 Pineview Dr.                   SE DECISION MADE: 05-JUN-18
Buffalo NY  14228                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder
Zhejiang Kindley medical devices C510(k) NO: K172763(Traditional)
ATTN: Yong  Zhang                 PHONE NO : 86 577 86960616 
No.758, 5th Binhai Road, Binhai InSE DECISION MADE: 04-JUN-18
Wenzhou  CN 325025                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart Moves Complete
Great Lakes Orthodontics Ltd      510(k) NO: K172765(Traditional)
ATTN: David  Graver               PHONE NO : 716 8711161 
200 Cooper Ave                    SE DECISION MADE: 01-JUN-18
Tonawanda NY  14150               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIROS 6 Sequential Compression Device
AIROS Medical, Inc.               510(k) NO: K172770(Traditional)
ATTN: Darren  Behuniak            PHONE NO : 866 9916956 
2501 Monroe Blvd, Suite 1200      SE DECISION MADE: 22-JUN-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIROS 8 Sequential Compression Device
AIROS Medical, Inc.               510(k) NO: K172779(Traditional)
ATTN: Darren  Behuniak            PHONE NO : 866 9916956 
2501 Monroe Blvd., Suite 1200     SE DECISION MADE: 22-JUN-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SD1 Ultrasonic Pocket Doppler
Edan Instruments Inc              510(k) NO: K172780(Traditional)
ATTN: Alice  Yang                 PHONE NO : 86 755 26858736 
#15 Jinhui Road,Jinsha Community, SE DECISION MADE: 06-JUN-18
Shenzhen  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Access hs Tnl
Beckman Coulter, Inc.             510(k) NO: K172783(Traditional)
ATTN: Kerrie Sue Oetter           PHONE NO : 952 3687858 
1000 Lake Hazeltine Drive MS R-540SE DECISION MADE: 12-JUN-18
Chaska MN  55318-1084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Access hsTnl
Beckman Coulter, Inc.             510(k) NO: K172787(Traditional)
ATTN: Jennifer Lee Bennett        PHONE NO : 952 3682040 
Immunodiagnostic Development CenteSE DECISION MADE: 14-JUN-18
Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MONET™ Anterior Cervical Interbody Fusion Cage System
CTL Medical Corporation           510(k) NO: K172788(Traditional)
ATTN: Tosan  Onosode              PHONE NO : 214 5455820 
4550 Excel Parkway, Suite 300     SE DECISION MADE: 25-JUN-18
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors
Smiths Medical ASD, Inc.          510(k) NO: K172800(Traditional)
ATTN: Michael R. Johnson          PHONE NO : 763 3833341 
6000 Nathan Lane North            SE DECISION MADE: 14-JUN-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silicone Foley Catheter for single use
Changzhou Rongxin Medicine Minimal510(k) NO: K172807(Traditional)
ATTN: Ping  Liu                   PHONE NO : 86 0519 82446628 
No. 8, Jianerkang Road, IndustrialSE DECISION MADE: 04-JUN-18
Jintan City  CN 213251            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ti-one 101 TS Dental Implant System
Hung Chun Bio-S Co.,Ltd.          510(k) NO: K172821(Traditional)
ATTN: Jethro  Liou                PHONE NO : 886 7 6955369 
No.12, Luke 1st Rd., Luzhu Dist., SE DECISION MADE: 11-JUN-18
Kaohsiung City  TW 821            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portex NRFit Epidural Needles
Smiths Medical ASD, Inc.          510(k) NO: K172823(Traditional)
ATTN: Sunita  Teekasingh          PHONE NO : 763 3833336 
6000 Nathan Lane North            SE DECISION MADE: 12-JUN-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Perfusor® Space Syringe Infusion Pump System
B.Braun Medical Inc               510(k) NO: K172831(Traditional)
ATTN: Tracy  Maddock              PHONE NO : 610 5962545 
901 Marcon Blvd                   SE DECISION MADE: 12-JUN-18
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-XPE Acetabular Components and U-Motion II Acetabular Cup
United Orthopedic Corporation     510(k) NO: K172833(Traditional)
ATTN: Gimpel  Chien               PHONE NO : 886 3 5773351 2217
No 57, Park Ave 2, Science Park   SE DECISION MADE: 12-JUN-18
Hsinchu  TW 300                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GRI-Alleset Veress Needle
GRI Medical and Electronic Technol510(k) NO: K172835(Traditional)
ATTN: Martin  Paugh               PHONE NO : 86 135 11359722 
105 Honggao Road, Xiuzhou IndustrySE DECISION MADE: 11-JUN-18
Jiaxing  CN 314031                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GCE704 Breast Pump
Globalcare                        510(k) NO: K172842(Traditional)
ATTN: Chiara  Cavagnolo           PHONE NO : 86 760 22589901 
No7 factory European Ind. Park No.SE DECISION MADE: 18-JUN-18
Xiaolan Town, Zhongshan City  CN 5510(k) STATEMENT
                                                    

DEVICE: Uterine Manipulator
Beijing HangTian KaDi Technology R510(k) NO: K172846(Traditional)
ATTN: Liying  Zhang               PHONE NO : 86 10 56407751 
Room301-11, Third floor, Building SE DECISION MADE: 26-JUN-18
Beijing  CN 101102                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819
Ageless Health Industrial Co., Ltd510(k) NO: K172895(Traditional)
ATTN: Victor  Wan                 PHONE NO : 86 769 81158038 
3/F, A1 Bldg, Dongshen Sima IndustSE DECISION MADE: 18-JUN-18
Dongguan  CN 523000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEVARE, PERFECTIO 4
Omm Imports d/b/a Zero Gravity    510(k) NO: K172909(Traditional)
ATTN: Zivan  Habibi               PHONE NO : 305 5275593 
9737 NW 41St Street               SE DECISION MADE: 07-JUN-18
Doral FL  33178                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Sterile Needle
Jiangsu Caina Medical Co., Ltd.   510(k) NO: K172938(Traditional)
ATTN: Jun  Lu                     PHONE NO : 86 510 86205183 
No.23, Huanxi Road, Zhutang Town  SE DECISION MADE: 14-JUN-18
Jiangyin  CN 214425               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Prevention CoolZone Gown
Medline Industries, Inc.          510(k) NO: K172954(Traditional)
ATTN: Pauline  Maralit            PHONE NO : 847 9492283 
3 Lakes Drive                     SE DECISION MADE: 15-JUN-18
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAC HWL
Sit Sordina Iort Technologies Spa 510(k) NO: K172961(Traditional)
ATTN: Alessia  Giaffreda          PHONE NO : 39 0444 233711 
Galleria del Rosso Posso 13       SE DECISION MADE: 11-JUN-18
Vicenza  IT 36100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
Synthes (USA) Products LLC/DePuy O510(k) NO: K172975(Traditional)
ATTN: Suchitra  Basu              PHONE NO : 610 7195448 
1301 Goshen Parkway               SE DECISION MADE: 21-JUN-18
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable SpO2 Sensors, Disposable SpO2 Sensors
APK Technology Co., Ltd.          510(k) NO: K172981(Traditional)
ATTN: Caifang  Wang               PHONE NO : 86 755 27325581 
6Floor, B2 Building, Industry of HSE DECISION MADE: 08-JUN-18
Shenzhen  CN 518126               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthCCS
Zebra Medical Vision Ltd.         510(k) NO: K172983(Traditional)
ATTN: Matan  Neeman               PHONE NO : 972 9 8827795 
Shefayim Commercial Center PO Box SE DECISION MADE: 13-JUN-18
Shefayim  IL 6099000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ligation Device
Leo Medical Co., Ltd.             510(k) NO: K172985(Traditional)
ATTN: Yunpeng  Ma                 PHONE NO : 86 519 85150750 620
2 Floor, 10 Building 18 Huashan RoSE DECISION MADE: 14-JUN-18
Changzhou  CN 213022              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
HealthSTATS International Pte Ltd 510(k) NO: K173028(Special)
ATTN: Ngak Hwee Chua              PHONE NO : 65 68 583248 
3 Ang Mo Kio Street 62 #08-25/26, SE DECISION MADE: 21-JUN-18
Singapore  SG 536199              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paxman Scalp Cooler
Paxman Coolers Limited            510(k) NO: K173032(Traditional)
ATTN: Richard  Paxman             PHONE NO : 44 0 1484349444 
International House, Penistone RoaSE DECISION MADE: 07-JUN-18
Huddersfield  GB HD8 0LE          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oximeter
Shenzhen Greatmade Tech limited   510(k) NO: K173045(Traditional)
ATTN: Mei  Mei                    PHONE NO : 0086 755 23463462 
3th floor, B building, BaiFuli IndSE DECISION MADE: 05-JUN-18
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POWDER FREE LATEX EXAMINATION GLOVE
Professional Latex Sdn Bhd        510(k) NO: K173053(Traditional)
ATTN: Yoon Lim Kok                PHONE NO : 605 89 11637 
Lot 52, Jalan Logam 2, Kamunting RSE DECISION MADE: 06-JUN-18
Kamunting  MY 34600               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSEODUO Shaver and Drill System
Bien-Air Surgery SA               510(k) NO: K173066(Traditional)
ATTN: Adil  Slimani               PHONE NO : 41 032 9533535 
Rue de I'Ouest 2b                 SE DECISION MADE: 22-JUN-18
Le Noirmont  CH 2340              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HSW Resection Instruments
Henke-Sass, Wolf GmbH             510(k) NO: K173070(Traditional)
ATTN: Anna  Reifschneider         PHONE NO : 49 7462 9466147 
Keltenstrasse 1                   SE DECISION MADE: 08-JUN-18
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TAMA BEMS device
TAMA Research Corporation         510(k) NO: K173093(Traditional)
ATTN: Ali  Shambayati             PHONE NO : 602 3548185 
7600 North 16th Street, Suite 205 SE DECISION MADE: 05-JUN-18
Phoenix AZ  85020                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KJ ZIRCONIA Implant System
KJ Meditech Co., Ltd              510(k) NO: K173116(Traditional)
ATTN: Hyukki  Moon                PHONE NO : 82 2 85682822 
21, Cheomdan Venture-ro, 40 Beon-gSE DECISION MADE: 28-JUN-18
Gwangju  KR 500-470               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus
Bionime Corporation               510(k) NO: K173139(Traditional)
ATTN: Kay  Wu                     PHONE NO : 886 4 23692388 
No. 100, Sec. 2, Daqing St., SouthSE DECISION MADE: 19-JUN-18
Taichung  TW 40242                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperNO2VA Et Device
Revolutionary Medical Devices, Inc510(k) NO: K173147(Traditional)
ATTN: David M. Kane               PHONE NO : 520 8443729 
4090 E. Bujia Primera             SE DECISION MADE: 20-JUN-18
Tucson AZ  85718                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pakter Curved Needle Set
Cook Incorporated                 510(k) NO: K173155(Traditional)
ATTN: Johnathan  Liu              PHONE NO : 812 3353575 104509
750 Daniels Way                   SE DECISION MADE: 07-JUN-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integrated CardioRespiratory System
Sensydia, Inc.                    510(k) NO: K173156(Traditional)
ATTN: Thomas  Bruggere            PHONE NO : 310 5393019 
907 Westwood Boulevard, Suite 358 SE DECISION MADE: 08-JUN-18
Los Angeles CA  90024             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide
Ethicon, Inc                      510(k) NO: K173162(Traditional)
ATTN: Julie Tom Wing              PHONE NO : 908 2182595 
P.O. Box 151, Route 22 West       SE DECISION MADE: 28-JUN-18
Somerville NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ecolab POU Water Filter
Ecolab Inc.                       510(k) NO: K173164(Traditional)
ATTN: Jennifer  Willner           PHONE NO : 651 2504348 
One Ecolab Place                  SE DECISION MADE: 29-JUN-18
St. Paul MN  55102                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumfuse TP
Precifit Medical Ltd              510(k) NO: K173189(Traditional)
ATTN: Zhen Yu (Eric) Wu           PHONE NO : 
2233 5th Street East              SE DECISION MADE: 08-JUN-18
St Paul MN  55119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOFIA Plus Aspiration Catheter
MicroVention, Inc.                510(k) NO: K173200(Traditional)
ATTN: Naomi  Gong                 PHONE NO : 714 2478055 
1311 Valencia Avenue              SE DECISION MADE: 11-JUN-18
Tustin CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interlude and private label Unscented 3-piece compact applicator tampon
ALBAAD fem                        510(k) NO: K173225(Traditional)
ATTN: Shlomo  Helvits             PHONE NO : 972 4 6223860 
1, Alon Hatavor St.               SE DECISION MADE: 15-JUN-18
Caesarea Ind. Park  IL 3800900    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
Case Medical, Inc                 510(k) NO: K173259(Traditional)
ATTN: Tania  Lupu                 PHONE NO : 201 3131999 
19 Empire Blvd                    SE DECISION MADE: 13-JUN-18
South Hackensack NJ  07606        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy Device; SpeedBird Model SBU99 Soft Tissue Biopsy Device
TransMed7, LLC                    510(k) NO: K173316(Traditional)
ATTN: James  Vetter               PHONE NO : 650 4000101 
117 Solana Road                   SE DECISION MADE: 19-JUN-18
Portola Valley CA  94028          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PanNAT STEC Test
Micronics, Inc                    510(k) NO: K173330(Traditional)
ATTN: Karen  Hedine               PHONE NO : 425 8959197 
8464 154th Ave NE                 SE DECISION MADE: 01-JUN-18
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 0.9% Sodium Chloride Injection, USP
Medline Industries, Inc.          510(k) NO: K173348(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 21-JUN-18
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: IV Administration Set
B.Braun Medical Inc.              510(k) NO: K173361(Traditional)
ATTN: Nancy  Skocypec             PHONE NO : 610 5960500 
901 Marcon Blvd                   SE DECISION MADE: 26-JUN-18
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASI Evolution
Arlington Scientific, Inc. (ASI)  510(k) NO: K173376(Traditional)
ATTN: David  Binks                PHONE NO : 801 4898911 
1840 North Technology Dr.         SE DECISION MADE: 14-JUN-18
Springville UT  84663             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advance Biliary Balloon Catheter
Cook Incorporated                 510(k) NO: K173414(Traditional)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
750 Daniels Way P.O. Box 489      SE DECISION MADE: 22-JUN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgTech Bipolar Head System
SurgTech, Inc.,                   510(k) NO: K173455(Traditional)
ATTN: Xuegong  Yu                 PHONE NO : 
24600 Center Ridge Road, Suite 195SE DECISION MADE: 14-JUN-18
Westlake OH  44145                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pollogen Legend System
Pollogen Ltd.                     510(k) NO: K173503(Traditional)
ATTN: Einat  Shammai              PHONE NO : 972 3 5104110 
6 Kaufman St.                     SE DECISION MADE: 11-JUN-18
Tel Aviv  IL 6801298              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
Philips Healthcare (Suzhou) Co., L510(k) NO: K173507(Abbreviated)
ATTN: Gordon  Shu                 PHONE NO : 86 512 67336804 
No. 258, Zhongyuan Road Suzhou IndSE DECISION MADE: 15-JUN-18
Suzhou  CN 215024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tetric CAD
Ivoclar Vivadent AG               510(k) NO: K173573(Abbreviated)
ATTN: Sandra  Cakebread           PHONE NO : 423 2353535 
Bendererstrasse 2                 SE DECISION MADE: 07-JUN-18
Schaan  LI 9494                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DenSeeMammo
Statlife                          510(k) NO: K173574(Traditional)
ATTN: Stephane  Ragusa            PHONE NO : 33 660 848385 
39 rue Camille Desmoulins         SE DECISION MADE: 26-JUN-18
Villejuif  FR 94800               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guarded Luer Connector
International Medical Industries I510(k) NO: K173577(Traditional)
ATTN: Brandon  Hunt               PHONE NO : 954 9179570 
2981 Gateway Drive                SE DECISION MADE: 07-JUN-18
Pompano Beach FL  33069           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shear Wave Quantificational Ultrasound Diagnostic System
Wuxi Hisky Medical Technologies Co510(k) NO: K173595(Traditional)
ATTN: Jinhua  Shao                PHONE NO : 86 10 82151572 
Room B401, 530 Plaza, University SSE DECISION MADE: 22-JUN-18
Wuxi  CN 214135                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICOPLUS Laser System
Lutronic Corporation              510(k) NO: K173700(Traditional)
ATTN: Jhung Won  Vojir            PHONE NO : 
Lutronic Center, 219, Sowon-ro    SE DECISION MADE: 19-JUN-18
Deogyang-gu, Goyang-si  KR 410220 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piccolo Implants and Accessories
Southern Implants (Pty) Ltd.      510(k) NO: K173706(Traditional)
ATTN: Lauranda  Breytenbach       PHONE NO : 27 12 6671046 
1 Albert Road                     SE DECISION MADE: 08-JUN-18
Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integra TITAN Reverse Shoulder System
Integra LifeSciences Corporation  510(k) NO: K173717(Special)
ATTN: Kathleen  McGuire           PHONE NO : 609 9367916 
8700 Cameron Road Suite 100       SE DECISION MADE: 21-JUN-18
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuMoDx GBS Assay
NeuMoDx Molecular, Inc.           510(k) NO: K173725(Traditional)
ATTN: Kay  Fuller                 PHONE NO : 734 8467852 
1250 Eisenhower Place             SE DECISION MADE: 26-JUN-18
Ann Arbor MI  48108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoMD Automated Ejection Fraction Software
Bay Labs, Inc.                    510(k) NO: K173780(Traditional)
ATTN: Charles  Cadieu             PHONE NO : 516 2200119 
290 King Street                   SE DECISION MADE: 14-JUN-18
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System
Medos International SARL          510(k) NO: K173787(Traditional)
ATTN: Sheree  Geller              PHONE NO : 508 8283291 
Chemin-Blanc 38                   SE DECISION MADE: 11-JUN-18
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnican fine
B. Braun Medical Inc.             510(k) NO: K173803(Traditional)
ATTN: Kimberly  Smith             PHONE NO : 610 5962326 
901 Marcon Blvd.                  SE DECISION MADE: 11-JUN-18
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allergan Botox Needle Electrode
Natus Manufacturing Limited       510(k) NO: K173815(Traditional)
ATTN: Maria  Connolly             PHONE NO : 353 091 647473 
IDA Business Park                 SE DECISION MADE: 29-JUN-18
Gort  IE H91 PD92                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LungQ Software
Thirona Corporation               510(k) NO: K173821(Traditional)
ATTN: Eva van Rikxoort            PHONE NO : 31 0 647142838 
Toernooiveld 300                  SE DECISION MADE: 05-JUN-18
Nijmegen  NL 6525 EC              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Express 4 Sleep appliance/CPAP Sidekick appliance
Moses Appliances LLC              510(k) NO: K173856(Traditional)
ATTN: Allen J. Moses              PHONE NO : 760 3400601 
75-768 Valle Vista Drive          SE DECISION MADE: 26-JUN-18
Indian Wells CA  92210            510(k) STATEMENT
                                                    

DEVICE: Surgic Pro, Surgic Pro+
Nakanishi Inc.                    510(k) NO: K173905(Traditional)
ATTN: Kimihiko  Satoh             PHONE NO : 81 289 643380 
700 Shimonhinata                  SE DECISION MADE: 19-JUN-18
Kanuma-shi  JP 322-8666           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DESS Dental Smart Solutions
Terrats Medical SL                510(k) NO: K173908(Traditional)
ATTN: Roger  Terrats              PHONE NO : 34 935 646006 
Carrer Mogoda 75-99               SE DECISION MADE: 15-JUN-18
Barbera del Valles  ES 08210      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Natus Photic Stimulator
Natus Medical Incorporated DBA Exc510(k) NO: K173936(Traditional)
ATTN: Sanjay  Mehta               PHONE NO : 905 2875055 
2568 Bristol Circle               SE DECISION MADE: 15-JUN-18
Oakville  CA l6h 5s1              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann BLX Implant System
Institut Straumann AG             510(k) NO: K173961(Traditional)
ATTN: Viviana  Horhoiu            PHONE NO : 41 61 9651512 
Peter Merian Weg 12               SE DECISION MADE: 05-JUN-18
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UF(II) Wide Fixture
DIO Corporation                   510(k) NO: K173975(Traditional)
ATTN: Jiae  Park                  PHONE NO : 82 51 7457836 
66, Centum seo-ro Haeundae-gu     SE DECISION MADE: 01-JUN-18
Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module
Biosense Webster, Inc.            510(k) NO: K173977(Traditional)
ATTN: Phuong  Chau                PHONE NO : 949 9234238 
33 Technology Drive               SE DECISION MADE: 14-JUN-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System
Penumbra, Inc.                    510(k) NO: K180008(Traditional)
ATTN: Richard  Kimura             PHONE NO : 510 9952034 
One Penumbra Place                SE DECISION MADE: 20-JUN-18
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Proton Positioing and Immobilization Devices
MEDTEC, Inc. d/b/a "CIVCO Medical 510(k) NO: K180021(Traditional)
ATTN: Alena  Newgren              PHONE NO : 712 7378688 
140 l 8th Street SE               SE DECISION MADE: 29-JUN-18
Orange City IA  51041             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bowel Management Device, Bowel Management Irrigation Set
Applied Medical Technology, Inc.  510(k) NO: K180026(Traditional)
ATTN: Michelle  Scott             PHONE NO : 440 7174000 
8006 Katherine Boulevard          SE DECISION MADE: 01-JUN-18
Brecksville OH  44141             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Pulse System
NuVasive, Incorporated            510(k) NO: K180038(Traditional)
ATTN: Olga  Lewis                 PHONE NO : 858 3204588 
7475 Lusk Blvd.                   SE DECISION MADE: 29-JUN-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnipod DASH Insulin Management System
Insulet Corporation               510(k) NO: K180045(Traditional)
ATTN: Matthew  King               PHONE NO : 978 6007427 
600 Technology Park Drive Suite 20SE DECISION MADE: 01-JUN-18
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRIaudio PREM System
MRIaudio                          510(k) NO: K180100(Traditional)
ATTN: Joe  Caruso                 PHONE NO : 858 9144217 
2720 Loker Ave., Suite N          SE DECISION MADE: 14-JUN-18
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
Medtronic, Inc.                   510(k) NO: K180122(Traditional)
ATTN: Nancy  Cameron              PHONE NO : 763 5262355 
8200 Coral Sea St. NE             SE DECISION MADE: 07-JUN-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZQuiet
Sleeping Well,LLC                 510(k) NO: K180124(Abbreviated)
ATTN: Daniel  Webster             PHONE NO : 802 9853013 
5247 Shelburne Rd, Ste 204        SE DECISION MADE: 12-JUN-18
Shelburne VT  05482               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ensizor Monopolar Endoscopic Scissors
Slater Endoscopy, LLC             510(k) NO: K180134(Traditional)
ATTN: John  Starkey               PHONE NO : 305 8893350 
14000 NW 58 Court                 SE DECISION MADE: 29-JUN-18
Miami Lakes FL  33014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioNude Lubricant
Good Clean Love, Inc.             510(k) NO: K180136(Traditional)
ATTN: Wendy  Strgar               PHONE NO : 541 3444483 
207 West 5th Avenue               SE DECISION MADE: 01-JUN-18
Eugene OR  97401                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gel-e Flex
gel-e, Inc.                       510(k) NO: K180152(Traditional)
ATTN: Elsa  Abruzzo               PHONE NO : 301 4053585 
387 Technology Dr., Suite 3110B   SE DECISION MADE: 22-JUN-18
College Park MD  20742            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Spine Lumbar Fixation System (SENTRY)
Life Spine, Inc.                  510(k) NO: K180166(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 22-JUN-18
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish
Genea Biomedx Pty Ltd             510(k) NO: K180188(Traditional)
ATTN: Kea  Dent                   PHONE NO : 61 2 84847677 
Level 2, 321 Kent Street          SE DECISION MADE: 07-JUN-18
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode System with Fractora3D/3D-90 Applicators
Inmode MD Ltd.                    510(k) NO: K180189(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building Shaar Yokneam      SE DECISION MADE: 01-JUN-18
Yoqneam Illt  IL 2069200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperBall Meniscal Repair System
Arcuro Medical Ltd.               510(k) NO: K180191(Traditional)
ATTN: Lee  Ranon                  PHONE NO : 972 72 2607000 
17 Tchelet St.                    SE DECISION MADE: 05-JUN-18
Misgav  IL 2017400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT
Biosense Webster, Inc.            510(k) NO: K180238(Traditional)
ATTN: Phuong  Chau                PHONE NO : 949 9234238 
33 Technology Drive               SE DECISION MADE: 01-JUN-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Vinyl Patient Examination Gloves (Yellow, White)
Shanxi Hongjin Plastic Technology 510(k) NO: K180260(Traditional)
ATTN: Wu  Zhigang                 PHONE NO : 86 311 66179653 
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 12-JUN-18
Linfen City  CN 042399            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS Internal Hex Dental Implant System
MIS Implants Technologies Ltd.    510(k) NO: K180282(Traditional)
ATTN: Arbel  Shezaf               PHONE NO : 972 4 9016800 
P.O. Box 7, Bar Lev Industrial ParSE DECISION MADE: 22-JUN-18
Bar Lev Industrial Park  IL 201560510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Natus Brain Monitor Amplifier
Natus Medical Incorporated DBA Exc510(k) NO: K180290(Traditional)
ATTN: Sanjay  Mehta               PHONE NO : 905 2875055 
2568 Bristol Circle               SE DECISION MADE: 14-JUN-18
Oakville  CA L6H 5S1              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexy
Next Sight srl                    510(k) NO: K180306(Traditional)
ATTN: Arianna Dalla Ba            PHONE NO : 39 04 9769933 
Via IV Novembre 6/E               SE DECISION MADE: 08-JUN-18
Limena  IT 35010                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use MultiClip Device
Micro-Tech (Nanjing) CO., Ltd     510(k) NO: K180325(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 Gaoke Third Road           SE DECISION MADE: 01-JUN-18
Nanjing  CN                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Pain Relieve Device
Shenzhen Dongdixin Technology Co.,510(k) NO: K180331(Traditional)
ATTN: Siping  Yuan                PHONE NO : 0086 755 27652471 
No. 3 Building Xilibaimang XushengSE DECISION MADE: 22-JUN-18
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 17HK700G-W
LG Electronics                    510(k) NO: K180332(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
222, Lg-ro, Cheongho-ri           SE DECISION MADE: 08-JUN-18
Jinwi-myeon Pyeongtaek-si  KR 1770510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HD LifeSciences Cervical IBFD System
HD LifeSciences LLC               510(k) NO: K180364(Traditional)
ATTN: John  Sullivan              PHONE NO : 603 2344321 
38 Montvale Ave Ste 380           SE DECISION MADE: 27-JUN-18
Stoneham MA  02180                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fracture and Correction System
In2Bones USA, LLC                 510(k) NO: K180377(Traditional)
ATTN: Rebecca  Wahl               PHONE NO : 
6060 Poplar Ave, Suite 380        SE DECISION MADE: 20-JUN-18
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venera 508 Deep Vein Thrombosis (DVT) Prevention System
Suzhou Minhua Medical Apparatus Su510(k) NO: K180389(Traditional)
ATTN: Michael  Ying               PHONE NO : 86 0512 63091066 
No.789, Wu Fang Road, Friendship ISE DECISION MADE: 29-JUN-18
Suzhou  CN 215222                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TiWAVE-C™ Porous Titanium Cervical Cage
Kalitec Direct, LLC               510(k) NO: K180401(Traditional)
ATTN: Scott  Winn                 PHONE NO : 407 5452063 
618 E. South Street Suite 500     SE DECISION MADE: 14-JUN-18
Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARK Fentanyl Assay
ARK Diagnostics, Inc.             510(k) NO: K180427(Traditional)
ATTN: Cherry  Mun                 PHONE NO : 510 2706288 
48089 Fremont Boulevard           SE DECISION MADE: 06-JUN-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
Stryker Trauma GmbH               510(k) NO: K180436(Traditional)
ATTN: Heike  Gustke               PHONE NO : 49 4348 702637 
Prof-Kuentscher-Str. 1-5          SE DECISION MADE: 06-JUN-18
Schoenkirchen  DE 24232           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: reVive Light Therapy LED Cleansing System
LED Technologies, Inc.            510(k) NO: K180447(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 6460543 117
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 04-JUN-18
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Aspiration Needle NA-U200H
Olympus Medical Systems Corp.     510(k) NO: K180449(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 08-JUN-18
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
Riverstone Resources SDN BHD      510(k) NO: K180452(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 603 602 83033 
Lot 56, No 15, Jalan Jasmin 2     SE DECISION MADE: 12-JUN-18
Bukit Beruntung  MY 48300         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Shockwave Medical Intravascular Lithotripsy (IVL) System
Shockwave Medical, Inc.           510(k) NO: K180454(Traditional)
ATTN: Plessy  Paul                PHONE NO : 510 6249266 
48501 Warm Springs Blvd Suite 108 SE DECISION MADE: 27-JUN-18
Fremont CA  94539                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERASENSE for Zimmer Biomet Persona
OrthoSensor, Inc.                 510(k) NO: K180459(Traditional)
ATTN: Deborah  Johnson            PHONE NO : 954 5777770 
1855 Griffin Road, Suite A-310    SE DECISION MADE: 07-JUN-18
Dania Beach FL  33004             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViSi Mobile Monitoring System
Sotera Wireless, Inc.             510(k) NO: K180472(Traditional)
ATTN: Lan  Herrington             PHONE NO : 858 3734823 
10020 Huenneckens Street          SE DECISION MADE: 19-JUN-18
Lan Herrington CA  92121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Servator B SALF Solution
S.A.L.F. spa                      510(k) NO: K180481(Traditional)
ATTN: Carmelo  Gagliano           PHONE NO : 39 035 940097 
Via Marconi 2                     SE DECISION MADE: 29-JUN-18
Cenate Sotto  IT 24069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A3 Total Knee System
Beijing AK Medical Co., Ltd.      510(k) NO: K180493(Traditional)
ATTN: Aiguo  Liu                  PHONE NO : 86 10 80109581 
No. 10 Baifuquan Road             SE DECISION MADE: 22-JUN-18
Beijing  CN 102200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scone Mask
ResMed Ltd                        510(k) NO: K180497(Traditional)
ATTN: Kim  Kuan LEE               PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 15-JUN-18
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx 2 System
Stryker GmbH                      510(k) NO: K180500(Traditional)
ATTN: Paul  Nelson                PHONE NO : 201 8315691 
325 Corporate Drive               SE DECISION MADE: 04-JUN-18
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S128 Anterior Lumbar Interbody Fusion (ALIF) System
Renovis Surgical Technologies Inc.510(k) NO: K180502(Traditional)
ATTN: Anthony  DeBenedictis       PHONE NO : 909 5572360 
1901 W. Lugonia Ave., Ste 340     SE DECISION MADE: 14-JUN-18
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
Hartalega Sdn. Bhd.               510(k) NO: K180505(Traditional)
ATTN: Kuan Kam Hon                PHONE NO : 603 6277 1733 
Dataran SD PJU9                   SE DECISION MADE: 14-JUN-18
Bandar Sri Damansara  MY 52200    510(k) STATEMENT
                                                    

DEVICE: Sherlock 3CG+ T ip Confirmation System
C.R. Bard, Inc.                   510(k) NO: K180560(Traditional)
ATTN: Christopher M. Phillips     PHONE NO : 801 5225965 
605 North 5600 West               SE DECISION MADE: 18-JUN-18
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
Zirkonzahn Gmbh                   510(k) NO: K180562(Traditional)
ATTN: Julian  Steger              PHONE NO : 39 0474 066660 
Gewerbegebiet - Zona Industriale ASE DECISION MADE: 28-JUN-18
Gais  IT 39030                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PEAK NS033CF, PEAK NS017CF
Neosil Co., Ltd                   510(k) NO: K180565(Traditional)
ATTN: Woo-ryong  Ryou             PHONE NO : 82 51 2655144 
63, Gongdanseo-ro 18beon-gil, GeumSE DECISION MADE: 13-JUN-18
Gyeongsangnam-do  KR 46332        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioPlex 2200 25-OH Vitamin D Kit
Bio-Rad Laboratories              510(k) NO: K180577(Traditional)
ATTN: Arlene  Carillo             PHONE NO : 510 7414613 
5500 East Second Street           SE DECISION MADE: 22-JUN-18
Benicia CA  94510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UV Lamps for Sunlamp Products
Feilo Sylvania Germany GmbH       510(k) NO: K180581(Traditional)
ATTN: Achim  Tonat                PHONE NO : 49 9131 793242 
Graf-Zepplin-Str.9                SE DECISION MADE: 22-JUN-18
Erlangen  DE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD
Richard Wolf Medical Instruments C510(k) NO: K180583(Traditional)
ATTN: Michael  Loiterman          PHONE NO : 847 9131113 
353 Corporate Woods Parkway       SE DECISION MADE: 28-JUN-18
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vbeam Prima Laser System
Syneron-Candela                   510(k) NO: K180593(Traditional)
ATTN: Sharon  Timberlake          PHONE NO : 508 3580304 
530 Boston Post Road              SE DECISION MADE: 05-JUN-18
Wayland MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Knotless SutureTak Anchors
Arthrex, Inc.                     510(k) NO: K180594(Traditional)
ATTN: Ivette  Galmez              PHONE NO : 239 6435553 71263
1370 Creekside Boulevard          SE DECISION MADE: 22-JUN-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lunoa System
NightBalance BV                   510(k) NO: K180608(Traditional)
ATTN: Sophia  Lam                 PHONE NO : 31 15 7009700 
Benoordenhoustseweg 46-13         SE DECISION MADE: 05-JUN-18
Den Haag  NL                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
Howmedica Osteonics Corp aka Stryk510(k) NO: K180612(Traditional)
ATTN: Emily  DiMambro             PHONE NO : 201 8315140 
325 Corporate Dr.                 SE DECISION MADE: 07-JUN-18
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Up
Y&J BIO Co, Ltd.,                 510(k) NO: K180617(Traditional)
ATTN: Kwang Sic Kim               PHONE NO : 82  34000325 
No. C-413, Munjeong Hyundai KnowleSE DECISION MADE: 01-JUN-18
Seoul  KR 05836                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoMark, EchoMark LP
Sonavex, Inc.                     510(k) NO: K180621(Traditional)
ATTN: David  Narrow               PHONE NO : 443 8622024 
2835 O'Donnell Street, Suite 200  SE DECISION MADE: 06-JUN-18
Baltimore MD  21224               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartClip Soft Tissue Marker
Elucent Medical, Inc.             510(k) NO: K180640(Traditional)
ATTN: Debra  Kridner              PHONE NO : 763 4434476 
7480 Flying Cloud Drive, Suite 101SE DECISION MADE: 04-JUN-18
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
Halyard Health                    510(k) NO: K180646(Abbreviated)
ATTN: Christine L. Macauley       PHONE NO : 470 4485158 
5405 Windward Parkway             SE DECISION MADE: 27-JUN-18
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeautiCem Veneer Kit
Shofu Dental Corporation          510(k) NO: K180649(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 736 3277202 
1225 Stone Drive                  SE DECISION MADE: 11-JUN-18
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: Avanti
Optovue, Inc.                     510(k) NO: K180660(Traditional)
ATTN: Indu  Lakshman              PHONE NO : 510 8971575 
2800 Bayview Drive                SE DECISION MADE: 08-JUN-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGMA Sterilization Pouch and Roll
Sigma Medical Supplies Corp.      510(k) NO: K180661(Abbreviated)
ATTN: Mason  Huang                PHONE NO : 886 4 24366111 127
NO.34, Ding-Ping Road, Rui Fang InSE DECISION MADE: 05-JUN-18
New Taipei City  TW 224           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterilization Pouch/Roll Made with Tyvek
Sigma Medical Supplies Corporation510(k) NO: K180672(Abbreviated)
ATTN: Mason  Huang                PHONE NO : 886 4 24366111 127
NO.34, Ding-Ping Road, Rui Fang InSE DECISION MADE: 06-JUN-18
New Taipei City  TW 224           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOL® ha-C Cervical Interbody Fusion System
Cutting Edge Spine, LLC           510(k) NO: K180674(Traditional)
ATTN: Kyle  Kuntz                 PHONE NO : 704 2430892 
101 Waxhaw Professional Park, SuitSE DECISION MADE: 25-JUN-18
Waxhaw NC  28173                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atlas Spine Expandable Cervical Interbody System
Atlas Spine, Inc.                 510(k) NO: K180675(Traditional)
ATTN: Thomas  Smith               PHONE NO : 561 7411108 
1555 Jupiter Park Drive, Suite 1  SE DECISION MADE: 13-JUN-18
Jupiter FL  33458                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aptima Combo 2 Assay (Panther System)
Hologic, Inc.                     510(k) NO: K180681(Traditional)
ATTN: Jeffrey  Hergesheimer       PHONE NO : 858 4108536 
10210 Genetic Center Drive        SE DECISION MADE: 13-JUN-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigation Instruments
Globus Medical Inc.               510(k) NO: K180690(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 25-JUN-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafePath Suturing System
SafePath Medical, Inc.            510(k) NO: K180701(Traditional)
ATTN: Howard L. Schrayer          PHONE NO : 609 9249510 
21 Water Street - 5th Floor       SE DECISION MADE: 25-JUN-18
Amesbury MA  01913                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truSculpt RF Device; truSculpt; truSculpt 3D
Cutera, Inc.                      510(k) NO: K180709(Traditional)
ATTN: Brad  Renton                PHONE NO : 415 6575704 
3240 Bayshore Blvd.               SE DECISION MADE: 06-JUN-18
Brisbane CA  94005                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed DecaNav Diagnostic Electrophysiology Catheter
Innovative Health, LLC.           510(k) NO: K180710(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road Suite 100  SE DECISION MADE: 19-JUN-18
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coconut Infused Hybrid Personal Lubricant
United Consortium                 510(k) NO: K180712(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 06-JUN-18
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode Diolaze System
InMode MD Ltd.                    510(k) NO: K180719(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 49097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 14-JUN-18
Yokneam  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel
Medibio Usa LLC.                  510(k) NO: K180720(Traditional)
ATTN: Jatin  Rajani               PHONE NO : 
4846 Citrus Way                   SE DECISION MADE: 27-JUN-18
Cooper City FL  33330             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAPERE Thrombectomy System
KP Medcure, Inc.                  510(k) NO: K180722(Traditional)
ATTN: Samuel  Shaolian            PHONE NO : 949 3784742 
1500 S. Sunkist Street, Suite H   SE DECISION MADE: 11-JUN-18
Anaheim CA  92806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPIRA Open Matrix LLIF
Camber Spine Technologies LLC     510(k) NO: K180724(Traditional)
ATTN: Sean S. Bishop              PHONE NO : 484 4204286 
418 E. Lancaster Ave.             SE DECISION MADE: 25-JUN-18
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Savion DLVR Guidewire, Savion FLX Guidewire
Boston Scientific Inc.            510(k) NO: K180726(Traditional)
ATTN: Jake  Baldauf               PHONE NO : 763 4942591 
Three Scimed Place                SE DECISION MADE: 18-JUN-18
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FaSet Fixation System
Huvexel Co., Ltd                  510(k) NO: K180729(Traditional)
ATTN: Sung  Hee-Lee               PHONE NO : 82 31 7763690 
101-105 Megacenter, SKn TechnoparkSE DECISION MADE: 28-JUN-18
Seongnam-si  KR 13207             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter
Compactcath, Inc.                 510(k) NO: K180738(Special)
ATTN: Naama S. Breckler           PHONE NO : 408 8939776 
887 Federation Way                SE DECISION MADE: 14-JUN-18
Palo Alto CA  94303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Balanced Knee Revision System - Offset Junction Box
Ortho Development Corporation     510(k) NO: K180743(Traditional)
ATTN: Dan  Petersen               PHONE NO : 801 5539991 
12187 So. Business Park Drive     SE DECISION MADE: 20-JUN-18
Draper UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Spine SIMPACT Sacroiliac Joint Fixation System
Life Spine Inc.                   510(k) NO: K180749(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 15-JUN-18
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SD LTM STIM Cortical Stimulator
micromed S.p.A.                   510(k) NO: K180761(Traditional)
ATTN: Monica  Camillo             PHONE NO : 39 041 5937000 
Via Giotto 2                      SE DECISION MADE: 18-JUN-18
Mogliano Veneto  IT 31021         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endiscope, Endiscope Cervical
Elliquence, LLC                   510(k) NO: K180766(Traditional)
ATTN: Paul D. Buhrke              PHONE NO : 516 2779010 
2455 Grand Avenue                 SE DECISION MADE: 11-JUN-18
Baldwin NY  11510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SecurAcath
Interrad Medical Inc              510(k) NO: K180769(Special)
ATTN: Denise  Lenz                PHONE NO : 
181 Cheshire Lane, Suite 100      SE DECISION MADE: 26-JUN-18
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSLEEVE Introducer Set
Boston Scientific Corporation     510(k) NO: K180785(Traditional)
ATTN: Toni  Guidarelli            PHONE NO : 763 4942870 
Three Scimed Place                SE DECISION MADE: 22-JUN-18
Maple Grove MN  55446             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann BLX Surgical Cassette
Institut Straumann AG             510(k) NO: K180791(Traditional)
ATTN: Anna  Vianna                PHONE NO : 41 61 9651512 
Peter Merian Weg 12               SE DECISION MADE: 21-JUN-18
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Colonic Plus Regular, Small, and Straight Shape Hydrokit
Colonic Plus                      510(k) NO: K180800(Traditional)
ATTN: Rosa  Alvarez               PHONE NO : 760 3400720 
73-925 Hwy 111, Ste. L            SE DECISION MADE: 01-JUN-18
Palm Desert CA  92260             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eclipse II
Carestream Health, Inc            510(k) NO: K180809(Traditional)
ATTN: Diane  Koetter              PHONE NO : 585 6276505 
150 Verona Street                 SE DECISION MADE: 21-JUN-18
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTL 799-2
BTL Industries, Inc.              510(k) NO: K180813(Traditional)
ATTN: David  Chmel                PHONE NO : 866 2851656 
362 Elm Street                    SE DECISION MADE: 14-JUN-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIM - SPECTRA Quant
MIM Software Inc.                 510(k) NO: K180815(Traditional)
ATTN: Lynn  Hanigan               PHONE NO : 216 4550600 
25800 Science Park Drive - Suite 1SE DECISION MADE: 22-JUN-18
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Tenon Medical, Inc.               510(k) NO: K180818(Traditional)
ATTN: Kal  Mentak                 PHONE NO : 925 3629492 
2100 Omega Road Suite F           SE DECISION MADE: 13-JUN-18
San Ramon CA  94583               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VaPro 2 Intermittent Catheter
Hollister Incorporated            510(k) NO: K180824(Special)
ATTN: Michelle  Schiltz-Taing     PHONE NO : 847 6802122 
2000 Hollister Drive              SE DECISION MADE: 22-JUN-18
Libertyville IL  60048            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
Ethicon, Inc                      510(k) NO: K180829(Traditional)
ATTN: Stephanie  Saati            PHONE NO : 908 2183318 
Route 22 West, P.O. Box 151       SE DECISION MADE: 28-JUN-18
Somerville NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SALVATION External Fixation System
Wright Medical Technology, Inc.   510(k) NO: K180832(Special)
ATTN: Rachel  Roberts             PHONE NO : 901 8679708 
1023 Cherry Road                  SE DECISION MADE: 06-JUN-18
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AT 030
Carl Zeiss Meditec AG             510(k) NO: K180839(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 7364 206985 
Goeschwitzer Strasse 51-52        SE DECISION MADE: 07-JUN-18
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neutrogena Light Therapy Acne Mask+
Johnson & Johnson Consumer Inc.   510(k) NO: K180847(Traditional)
ATTN: Timothy  Kline              PHONE NO : 312 2737241 
7050 Camp Hill Rd                 SE DECISION MADE: 19-JUN-18
Fort Washington PA  19034         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Examination Glove (Clear, Non-Colored)
Huifu Trading Co., Ltd            510(k) NO: K180849(Traditional)
ATTN: Kangkang  Wang              PHONE NO : 86 533 3819144 
North Shanghai Road Zhangdian DistSE DECISION MADE: 11-JUN-18
ZiBo  CN 255000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
KCI USA, Inc.                     510(k) NO: K180855(Traditional)
ATTN: Kimberly  McCoy             PHONE NO : 210 2556481 
6203 Farinon Drive                SE DECISION MADE: 01-JUN-18
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neutrogena Light Therapy Aging Mask+
Johnson & Johnson Consumer, Inc.  510(k) NO: K180856(Traditional)
ATTN: Cindy R. Abraham            PHONE NO : 215 2737602 
7050 Camp Hill Road               SE DECISION MADE: 19-JUN-18
Fort Washington PA  19034         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CALLISTO eye
Carl Zeiss Meditec AG             510(k) NO: K180858(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 7364 206985 
Goeschwitzer Str. 51-52           SE DECISION MADE: 27-JUN-18
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Examination Glove (Clear, Non-Colored)
Zhicheng Trading Co., Ltd.        510(k) NO: K180861(Traditional)
ATTN: Chong  Zhao                 PHONE NO : 86 533 3819144 
North Beijing Road, Zhangdian DistSE DECISION MADE: 13-JUN-18
ZiBo  CN 255000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZMI Self-Adhesive Electrodes
ZMI Electronics, Ltd.             510(k) NO: K180865(Traditional)
ATTN: Wayne  Chen                 PHONE NO : 886 78150053 379
6F-1, 286-4, Shin Ya Road         SE DECISION MADE: 28-JUN-18
Kaohsiung  TW 806                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HairMax Laser
Lexington International, LLC      510(k) NO: K180885(Traditional)
ATTN: David  Michaels             PHONE NO : 561 4170200 
1040 Holland Drive                SE DECISION MADE: 20-JUN-18
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alleye
Oculocare Medical AG              510(k) NO: K180895(Traditional)
ATTN: Lucas  Bachmann             PHONE NO : 41 447004228 
Verena Conzett Strasse 9          SE DECISION MADE: 27-JUN-18
Zurich  CH ZH 8004                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sniper Infusion Catheter with Balloon Occlusion
Embolx, Inc                       510(k) NO: K180904(Third Party - Traditional)
ATTN: Greg  Haistead              PHONE NO : 408 9902949 
530 Lakeside, Suite 200           SE DECISION MADE: 08-JUN-18
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Visura Technologies TEECAD System
Visura Technologies, LLC          510(k) NO: K180911(Traditional)
ATTN: Eric  Sandberg              PHONE NO : 630 4870140 
9337 Harding Avenue               SE DECISION MADE: 20-JUN-18
Evanston IL  60203                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire II PRO Balloon Dilatation Catheter
OrbusNeich Medical Trading Inc.   510(k) NO: K180921(Traditional)
ATTN: John  Pazienza              PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 28-JUN-18
Fort Lauderdale FL  33060         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMR 570
Shanghai United Imaging Healthcare510(k) NO: K180925(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 21 67076888 6776
No.2258 Chengbei Road., Jiading InSE DECISION MADE: 06-JUN-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMR 560
Shanghai United Imaging Healthcare510(k) NO: K180926(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 21 67076888 6776
No.2258 Chengbei Road., Jiading InSE DECISION MADE: 06-JUN-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orthopantomograph OP 3D
PaloDEx Group Oy                  510(k) NO: K180947(Traditional)
ATTN: Terho  Turkumaki            PHONE NO : 358 10 2702000 
Nahkelantie 160                   SE DECISION MADE: 07-JUN-18
Tuusula  FI 04300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
Terumo Cardiovascular Systems Corp510(k) NO: K180950(Traditional)
ATTN: Adam  Pickholtz             PHONE NO : 800 2623304 7237
125 Blue Ball Road                SE DECISION MADE: 22-JUN-18
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator
Shenzhen Roundwhale Technology Co.510(k) NO: K180956(Traditional)
ATTN: Kevin  Zhang                PHONE NO : 86 755 23212776 
No. 615, Building C of Sanlian IndSE DECISION MADE: 07-JUN-18
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phenom 27 Catheter
Cathera, Inc.                     510(k) NO: K180959(Special)
ATTN: Victor  Ham                 PHONE NO : 650 3885088 
627 National Ave.                 SE DECISION MADE: 11-JUN-18
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTA Flash HMGCR Reagents
Inova Diagnostics, Inc.           510(k) NO: K180975(Traditional)
ATTN: Roger  Albesa               PHONE NO : 858 5869900 
9900 Old Grove Rd.                SE DECISION MADE: 25-JUN-18
San Diego CA  92131-1638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
Supervision Optimax SDN BHD       510(k) NO: K180985(Traditional)
ATTN: Yap Peak Geeh               PHONE NO : 603 61452328 
Lot 38, Putra Industrial Park, BukSE DECISION MADE: 08-JUN-18
Sungai Buloh  MY 40160            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc.             510(k) NO: K180988(Abbreviated)
ATTN: James A. Bonafini           PHONE NO : 585 4588409 
1667 Lake Avenue, Suite 354       SE DECISION MADE: 08-JUN-18
Rochester NY  14615               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PEDRA-17F Digital Flat Panel X-ray Detector
Radisen Inc.                      510(k) NO: K180989(Traditional)
ATTN: John  Lim                   PHONE NO : 82 70 75252147 
14F, Gongduk B/D, 11, Saechang-ro,SE DECISION MADE: 13-JUN-18
Seoul  KR 04168                   510(k) STATEMENT
                                                    

DEVICE: Beacon Advanced CO2 Laser System
OmniGuide, Inc                    510(k) NO: K180993(Traditional)
ATTN: Sam  Wade                   PHONE NO : 617 5518410 
4 Maguire Road                    SE DECISION MADE: 28-JUN-18
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vscan Extend
GE Medical Systems Ultrasound and 510(k) NO: K180995(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W. Innovation Drive          SE DECISION MADE: 25-JUN-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BUHLMANN fCAL ELISA
BUHLMANN Laboratories AG          510(k) NO: K181012(Traditional)
ATTN: Alicja  Ritz                PHONE NO : 
Baselstrasse 55                   SE DECISION MADE: 04-JUN-18
Schonenbuch  CH CH-4124           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
Qualimed SRL                      510(k) NO: K181050(Traditional)
ATTN: Tereza  Uhrova              PHONE NO : 39 0331 1629910 
Corso Sempione 176                SE DECISION MADE: 13-JUN-18
Busto Arsizio  IT 21052           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm
Shape Memory Medical              510(k) NO: K181051(Traditional)
ATTN: Meghan  Reu                 PHONE NO : 408 6495175 711
807 Aldo Avenue, Suite 109        SE DECISION MADE: 22-JUN-18
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CREO® Stabilization System, REVERE® Stabilization System
Globus Medical Inc.               510(k) NO: K181068(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 29-JUN-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated
Covidien                          510(k) NO: K181085(Traditional)
ATTN: James R. Davis              PHONE NO : 303 5816964 
5920 Longbow Drive                SE DECISION MADE: 21-JUN-18
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyMRI
SyntheticMR AB                    510(k) NO: K181093(Traditional)
ATTN: Maria  Almesaker            PHONE NO : 46 070 4151007 
Storgatan 11                      SE DECISION MADE: 12-JUN-18
Linkoping  SE 582 23              510(k) STATEMENT
                                                    

DEVICE: CoLink™ Afx Plating System
In2Bones USA, LLC                 510(k) NO: K181113(Traditional)
ATTN: Rebecca  Wahl               PHONE NO : 
6060 Poplar Ave, Suite 380        SE DECISION MADE: 15-JUN-18
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Range (Denali and Mesa) Spinal Systems
K2M, Inc.                         510(k) NO: K181119(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 26-JUN-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro
Home Well Trading LTD             510(k) NO: K181121(Traditional)
ATTN: Martin  Gurovich            PHONE NO : 213 3353521 
Omar Hodge Building, Road Town    SE DECISION MADE: 28-JUN-18
Tortola  VG 1110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OverStitch Endoscopic Suturing System and Accessories
Apollo Endosurgery                510(k) NO: K181141(Special)
ATTN: Maritza  Ward               PHONE NO : 512 2795114 
1120 S. Capital of Texas Hwy Ste. SE DECISION MADE: 27-JUN-18
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Angled Tip Ureteral Catheter
Cook Incorporated                 510(k) NO: K181144(Traditional)
ATTN: Chelsea  Woods              PHONE NO : 812 3353575 104707
750 Daniels Way                   SE DECISION MADE: 28-JUN-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sentry IVC Filter
Novate Medical Ltd.               510(k) NO: K181202(Special)
ATTN: Gordon  Crowley             PHONE NO : 353 91750030 
Block 11, Galway Technology Park, SE DECISION MADE: 06-JUN-18
Galway  IE H91 VE0H               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Juliet Ti
Spineart                          510(k) NO: K181203(Special)
ATTN: Frank  Pennesi              PHONE NO : 41 22 5701200 
3 Chemin du Pré Fleuri            SE DECISION MADE: 28-JUN-18
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
Everyway Medical Instruments CO., 510(k) NO: K181207(Special)
ATTN: Paul  Hung                  PHONE NO : 886 2 26620038 
3 Fl., No. 5, Lane 155, Sec.3 BeisSE DECISION MADE: 06-JUN-18
New Taipei City  TW 22203         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA
Largan Medical Co. Ltd.           510(k) NO: K181230(Traditional)
ATTN: Amy  Tien                   PHONE NO : 886 4 36000203 
2F., No. 14, 23rd Rd., Taichung InSE DECISION MADE: 25-JUN-18
Taichung  TW 40850                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
Largan Medical Co. Ltd.           510(k) NO: K181232(Traditional)
ATTN: Amy  Tien                   PHONE NO : 886 4 36000203 
2F, No 14, 23rd RD. Taichung IndusSE DECISION MADE: 29-JUN-18
Taichung  TW 40850                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QLAB Advanced Quantification Software
Philips Ultrasound Inc.           510(k) NO: K181264(Third Party - Traditional)
ATTN: Penny  Greco                PHONE NO : 508 8430282 
3000 Minuteman Road               SE DECISION MADE: 07-JUN-18
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Signature Orthodontic System
Signature Orthodontics            510(k) NO: K181271(Third Party - Traditional)
ATTN: Alfred Charles Griffin      PHONE NO : 540 2991236 
16 Miner Street Suite 406         SE DECISION MADE: 13-JUN-18
Boston MA  02215                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Ysio Max
Siemens Medical Solutions, Inc.   510(k) NO: K181279(Special)
ATTN: Denise  Adams               PHONE NO : 610 4486139 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 13-JUN-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patello-Femoral Wave (Kahuna) Arthroplasty System
Arthrosurface, Inc.               510(k) NO: K181280(Special)
ATTN: Dawn J. Wilson              PHONE NO : 508 5203003 
28 Forge Parkway                  SE DECISION MADE: 14-JUN-18
Franklin MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine Pedicle Screw System
Altus Partners, LLC               510(k) NO: K181281(Special)
ATTN: Mark  Melton                PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 11-JUN-18
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Bx 2.0
Focal Healthcare Inc.             510(k) NO: K181290(Special)
ATTN: Karen  Zhou                 PHONE NO : 1 647 4799603 
10 Morrow Ave., Unit 101          SE DECISION MADE: 15-JUN-18
Toronto  CA M6R 2J1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Harmony XL Multi-Application Platform
Alma Lasers Inc.                  510(k) NO: K181298(Special)
ATTN: Rekha  Anand                PHONE NO : 224 3772000 2019
485 Half Day Rd, Suite #100       SE DECISION MADE: 13-JUN-18
Buffalo Grove IL  60089           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart External Drain (SED) System
Aqueduct Critical Care, Inc.      510(k) NO: K181301(Special)
ATTN: Thomas  Clement             PHONE NO : 425 9851571 
11822 North Creek Parkway North SuSE DECISION MADE: 14-JUN-18
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POGO Automatic Blood Glucose Monitoring System
Intuity Medical, Inc.             510(k) NO: K181316(Special)
ATTN: Robb  Hesley                PHONE NO : 510 9468861 
3500 West Warren Avenue           SE DECISION MADE: 14-JUN-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aspiration Guide Catheter; Retraction Aspirator
Inari Medical                     510(k) NO: K181325(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 114
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 17-JUN-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
Phadia AB                         510(k) NO: K181329(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18165000 
Rapsgatan 7P                      SE DECISION MADE: 25-JUN-18
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeartSee Cardiac P.E.T. Processing Software
Bracco Diagnostics Inc.           510(k) NO: K181343(Traditional)
ATTN: Patrice  Marchildon         PHONE NO : 1 609 5142200 
259 Prospect Plains Road, BuildingSE DECISION MADE: 12-JUN-18
Monroe Township NE  08831         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cartiva SCI Disposable Instrumentation Set
Cartiva, Inc.                     510(k) NO: K181348(Special)
ATTN: Tanya  Eberle               PHONE NO : 770 7543800 
6120 Windward Parkway Suite 220   SE DECISION MADE: 20-JUN-18
Alpharetta GA  30005              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Double Flexible Tipped Wire Guides
Cook Incorporated                 510(k) NO: K181351(Special)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 14-JUN-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Televere Digital Dental Imaging System
Televere Systems, Inc.            510(k) NO: K181358(Traditional)
ATTN: Randell  Quaal              PHONE NO : 800 3859593 
1160 Cavalier Road                SE DECISION MADE: 20-JUN-18
Arnold MD  21012                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EcoVue Sterile and Non-Sterile Ultrasound Gels
HR Pharmaceuticals, Inc.          510(k) NO: K181363(Third Party - Traditional)
ATTN: Colby  Wiesman              PHONE NO : 717 2521110 104
2600 Eastern Boulevard Suite 201  SE DECISION MADE: 13-JUN-18
York PA  17402                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Swiss LithoClast Trilogy
EMS Electro Medical Systems SA    510(k) NO: K181364(Special)
ATTN: Sonia  Callegaro            PHONE NO : 41 229944700 
Ch dela Vuarpilliere              SE DECISION MADE: 20-JUN-18
Nyon  CH 1260                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-YS Micafungin (<=0.06 -="">8 µg/mL)
bioMerieux, Inc.                  510(k) NO: K181368(Special)
ATTN: Jolyn  Tenllado             PHONE NO : 314 7318386 
595 Anglum Rd.                    SE DECISION MADE: 20-JUN-18
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
Covidien                          510(k) NO: K181389(Special)
ATTN: Celso  Duran                PHONE NO : 303 5306445 
5920 Longbow Drive                SE DECISION MADE: 19-JUN-18
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator
Varian Medical Systems, Inc.      510(k) NO: K181404(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 28-JUN-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MotoCLIP/HiMAX Implant System
CrossRoads Extremity Systems, LLC 510(k) NO: K181410(Special)
ATTN: Chad  Hollis                PHONE NO : 901 2218406 
6055 Primacy Parkway, Suite 140   SE DECISION MADE: 29-JUN-18
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uDR 592h, uDR 596i
Shanghai United Imaging Healthcare510(k) NO: K181413(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 2167 0768886776 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 27-JUN-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CELERITY 20 HP Biological Indicator
STERIS Corporation                510(k) NO: K181429(Special)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Road                 SE DECISION MADE: 13-JUN-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test
Sekisui Diagnostics, LLC          510(k) NO: K181436(Special)
ATTN: Shelly  Harris              PHONE NO : 858 7772672 
6659 Top Gun Street               SE DECISION MADE: 22-JUN-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pure Vu System
Motus GI Medical Technologies Ltd.510(k) NO: K181437(Special)
ATTN: Hagit  Ephrath              PHONE NO : 972 4 6214447 
22 Keren Ha'yesod St.             SE DECISION MADE: 21-JUN-18
Tirat Carmel  IL 3902638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
Diazyme Laboratories Inc.         510(k) NO: K181438(Special)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 26-JUN-18
Poway CA  92130                   510(k) STATEMENT
                                                    

DEVICE: VERIFY Assert Self-Contained Biological Indicator
STERIS Corporation                510(k) NO: K181442(Special)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Road                 SE DECISION MADE: 13-JUN-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpaceOAR System
Augmenix, Inc.                    510(k) NO: K181465(Special)
ATTN: Marcus  Garcia              PHONE NO : 781 5414360 
201 Burlington Road               SE DECISION MADE: 25-JUN-18
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArtiClip LAA Exclusion System
AtriCure, Inc.                    510(k) NO: K181474(Special)
ATTN: Jonathan  McElwee           PHONE NO : 513 6444249 
7555 Innovation Way               SE DECISION MADE: 28-JUN-18
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue
Zirkonzahn Srl                    510(k) NO: K181484(Third Party - Traditional)
ATTN: Sandra  Leitner             PHONE NO : 39 0474 066784 
Gewerbegebiet - Zona Industriale aSE DECISION MADE: 18-JUN-18
Gais  IT 39030                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Elecsys CA 15-3 II
Roche Diagnostics                 510(k) NO: K181492(Traditional)
ATTN: Adennis  Cora               PHONE NO : 317 5213915 
9115 Hague Road, P.O. Box 50416   SE DECISION MADE: 22-JUN-18
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    


            TOTAL 510(k)s THIS PERIOD   260                                     
            TOTAL WITH SUMMARIES        250                                     
            TOTAL WITH STATEMENTS        10