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 (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
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