U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. September 2018 510(k) Clearances
  1. Device Approvals, Denials and Clearances

September 2018 510(k) Clearances

September 2018 510(k) Clearances

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


DEVICE: mediCAD 4.0
mediCAD Hectec Gmbh               510(k) NO: K170702(Traditional)
ATTN: Claas-Fabian  Luers         PHONE NO : 49 871 33020315 
Opalstrasse 54                    SE DECISION MADE: 07-SEP-18
Altdorf  DE 84032                 510(k) STATEMENT
                                                    

DEVICE: TruBase S
TruAbutment Inc.                  510(k) NO: K171532(Traditional)
ATTN: Brandon  Kim                PHONE NO : 714 9561488 
300 South Harbor Blvd #520        SE DECISION MADE: 11-SEP-18
Anaheim CA  92805                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tandry Locking Plate System
Microware Precision Co., Ltd.     510(k) NO: K171904(Traditional)
ATTN: Harrison  Du                PHONE NO : 886 4 24636275 100
No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 18-SEP-18
Taichung  TW 407630               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOLOASSIST II
AKTORmed GmbH                     510(k) NO: K171947(Traditional)
ATTN: Andreas  Mohr               PHONE NO : 49 9401 9320150 
Borsigstrabe 13                   SE DECISION MADE: 21-SEP-18
Barbing  DE 93092                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OpenSight
Novarad Corporation               510(k) NO: K172418(Traditional)
ATTN: Doug  Merrill               PHONE NO : 801 6421001 
752 East 1180 South #200          SE DECISION MADE: 21-SEP-18
American Fork UT  84003           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS device-HeadaTerm, eEspress
WAT Medical Technology (Ningbo) Co510(k) NO: K172450(Traditional)
ATTN: Rodney  Zhang               PHONE NO : 86 574 65060811 
Room703-711, No.2 North Taoyuan RoSE DECISION MADE: 13-SEP-18
Ningbo  CN 315600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dual output digital therapy massager
Shenzhen OSTO Technology Co., Ltd.510(k) NO: K172834(Traditional)
ATTN: Li  Yang                    PHONE NO : 86 755 29769546 
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 06-SEP-18
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kawasumi Laboratories Blood Drawing Kit (BDK) System
Kawasumi Laboratories, Inc.       510(k) NO: K172957(Traditional)
ATTN: Takayuki  Nakajima          PHONE NO : 81 3 57692663 
Shinagawa Intercity Tower B, 9th FSE DECISION MADE: 28-SEP-18
Tokyo  JP 108-6109                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
Skyla Corporation H.S.P.B.        510(k) NO: K173127(Traditional)
ATTN: Cindy  Lu                   PHONE NO : 886 3 5787722 5829
1f. No. 8, Dusing Rd., Hsinchu SciSE DECISION MADE: 25-SEP-18
Hsinchu  TW 30078                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CSM Submerged3-L Implant System
CSM Implant                       510(k) NO: K173141(Traditional)
ATTN: Sung Am Cho                 PHONE NO : 82 53 9528261 
B205 Techno B/D, 47 Gyeongdae-ro, SE DECISION MADE: 19-SEP-18
Daegu  KR 41566                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioSphere Flex
Synergy Biomedical                510(k) NO: K173424(Traditional)
ATTN: Mark  Borden                PHONE NO : 484 9028141 
100 Springhouse Dr. Suite 108     SE DECISION MADE: 12-SEP-18
Collegeville PA  19426            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoBase 2 Non-derivatized MSMS Kit
Wallac Oy, Subsidiary of PerkinElm510(k) NO: K173568(Traditional)
ATTN: Brian  Carney               PHONE NO : 781 6635651 
940 Winter Street                 SE DECISION MADE: 04-SEP-18
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSafe Sure-Lok Needle-Free Connector
Amsino International, Inc.        510(k) NO: K173665(Traditional)
ATTN: Cathy  Hong                 PHONE NO : 909 6265888 
708 Corporate Center Drive        SE DECISION MADE: 05-SEP-18
Pomona CA  91768                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A-FIT
HIRONIC Co., Ltd.                 510(k) NO: K173676(Traditional)
ATTN: Sangwon  Hwang              PHONE NO : 82 31 5257400 
19F, 767, Sinsu-ro, Suji-gu       SE DECISION MADE: 14-SEP-18
Gyeonggi-do  KR 16827             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surveyor Patient Monitor
Mortara Instrument, Inc.          510(k) NO: K173765(Traditional)
ATTN: Manisha  Gokuli             PHONE NO : 414 3541600 
7865 North 86th Street            SE DECISION MADE: 04-SEP-18
Milwaukee WI  53224               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Hair Removal Device Joy Version
Shen Zhen CosBeauty Co., Ltd      510(k) NO: K173813(Traditional)
ATTN: Nicole  Hu                  PHONE NO : 86 1831 6858036 
UnitA-3F, Qiao De Industrial Park,SE DECISION MADE: 07-SEP-18
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anchor Tissue Retrieval System by CONMED
Conmed Corporation                510(k) NO: K173822(Traditional)
ATTN: Rachelle D Fitzgerald       PHONE NO : 516 2364060 
525 French Road                   SE DECISION MADE: 11-SEP-18
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightScalpel
LightScalpel LLC                  510(k) NO: K173827(Traditional)
ATTN: David  Walters              PHONE NO : 425 3681588 
11818 North Creek Parkway N Suite SE DECISION MADE: 14-SEP-18
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAC VU360 Resting ECG Analysis System
GE Medical Systems Information Tec510(k) NO: K173830(Traditional)
ATTN: Marcella  Entwisle          PHONE NO : 414 7213809 
9900 West Innovation Drive        SE DECISION MADE: 18-SEP-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CRP Vario
SENTINEL CH. SpA                  510(k) NO: K173833(Traditional)
ATTN: Patricia  Dupe              PHONE NO : 39 02 34551496 
Via Robert Koch 2                 SE DECISION MADE: 27-SEP-18
Milano  IT 20152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
Suzhou Hengrui Callisyn Biomedical510(k) NO: K173871(Traditional)
ATTN: Xiao  Chen                  PHONE NO : 86 512 68050607 
Buliding 9, No. 8 Jinfeng Road, NeSE DECISION MADE: 17-SEP-18
Suzhou  CN 215163                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FibriCheck
Qompium nv                        510(k) NO: K173872(Traditional)
ATTN: Jo Van der Auwera           PHONE NO : 32 479 393153 
Kempische Steenweg 311/27         SE DECISION MADE: 28-SEP-18
Hasselt  BE 3500                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: External Fixation System
Life Spine Inc.                   510(k) NO: K173883(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 07-SEP-18
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trabis
coLigne, AG                       510(k) NO: K173893(Traditional)
ATTN: Robert  Lange               PHONE NO : 41 43 3438000 
Utoquai 43                        SE DECISION MADE: 06-SEP-18
Zurich  CH CH 8008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroPort Orthopedics Total Hip Systems MR Labeling
MicroPort Orthopedics Inc. (MPO)  510(k) NO: K173898(Traditional)
ATTN: Usman  Rashid               PHONE NO : 901 2905274 
5677 Airline Road                 SE DECISION MADE: 20-SEP-18
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Impress SFS System
Cable Fix Medical LLC             510(k) NO: K173910(Traditional)
ATTN: Carey  Bryant               PHONE NO : 901 5528088 
1050 Getwell Road S               SE DECISION MADE: 14-SEP-18
Hernando MS  38632                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HD-500 Video Endoscope System
Sonoscape Medical Corp.           510(k) NO: K173921(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f Yizhe buSE DECISION MADE: 05-SEP-18
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DORADOnova MR3T
LAP GmbH Laser Applikationen      510(k) NO: K173926(Traditional)
ATTN: Martin  Pfabel              PHONE NO : 49 4131 9511267 
Zeppelinstrasse 23                SE DECISION MADE: 14-SEP-18
Lueneburg  DE 21337               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sorrento Bioglass Bone Graft Substitute
Xenco Medical, LLC                510(k) NO: K173933(Traditional)
ATTN: Michelle  Willis            PHONE NO : 858 2021505 
9930 Mesa Rim Road                SE DECISION MADE: 13-SEP-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliSpace Perinatal Rev.K.00
Philips Medizin Systeme Boeblingen510(k) NO: K173941(Traditional)
ATTN: Christoph  Krause           PHONE NO : 49 7031 4631734 
Hewlett-Packard-Str.-2            SE DECISION MADE: 10-SEP-18
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Corail AMT Hip Prosthesis
DePuy France S.A.S.               510(k) NO: K173960(Traditional)
ATTN: David  Holzwarth            PHONE NO : 
7 Allee Irene Joliot Curie Bp256  SE DECISION MADE: 21-SEP-18
Saint Priest Cedex Rhone-Alpes  FR510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Acoustic Respiration Sensors, infant and neonate
Masimo Corporation                510(k) NO: K173976(Abbreviated)
ATTN: Karina  Simpson             PHONE NO : 949 2977387 
52 Discovery                      SE DECISION MADE: 05-SEP-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTIFY Corpectomy Spacers
Globus Medical Inc.               510(k) NO: K173982(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 2950
2560 General Armistead Ave.       SE DECISION MADE: 19-SEP-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Malecot Nephrostomy Catheter/Stent Set
Cook Incorporated                 510(k) NO: K180029(Traditional)
ATTN: Minjin  Choi                PHONE NO : 812 3392235 104901
750 Daniels Way                   SE DECISION MADE: 21-SEP-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioCode Gastrointestinal Pathogen Panel (GPP)
Applied Biocode, Inc.             510(k) NO: K180041(Traditional)
ATTN: Robert Di Tullio            PHONE NO : 562 8010050 
10020 Pioneer Blvd. Suite 102     SE DECISION MADE: 28-SEP-18
Santa Fe Springs CA  90670        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sof-Flex Ureteral Stent Set
Cook Incorporated                 510(k) NO: K180053(Traditional)
ATTN: Minjin  Choi                PHONE NO : 812 3392235 104901
750 Daniels Way                   SE DECISION MADE: 13-SEP-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORISE Gel
Boston Scientific                 510(k) NO: K180068(Traditional)
ATTN: Thomas  Hirte               PHONE NO : 508 6834454 
100 Boston Scientific Way         SE DECISION MADE: 28-SEP-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Agile Esophageal Stent System
Boston Scientific Corporation     510(k) NO: K180144(Traditional)
ATTN: Kayla  Mackey               PHONE NO : 508 6834534 
100 Boston Scientific Way         SE DECISION MADE: 21-SEP-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guidewire
Shanghai Kindly Medical Instrument510(k) NO: K180177(Traditional)
ATTN: Xu  Jianhai                 PHONE NO : 086 021 59140056 8870
No. 925, Jinyuan yi Road          SE DECISION MADE: 13-SEP-18
Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Introducer Set
Shanghai Kindly Medical Instrument510(k) NO: K180178(Traditional)
ATTN: Xu  Jianhai                 PHONE NO : 086 021591 400568870 
No. 925, Jinyuan yi Road          SE DECISION MADE: 10-SEP-18
Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter
Cook Incorporated                 510(k) NO: K180182(Traditional)
ATTN: Samuel  Engelman            PHONE NO : 812 3392235 104340
750 Daniels Way                   SE DECISION MADE: 14-SEP-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
Life Spine Inc.                   510(k) NO: K180215(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 13-SEP-18
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Seidmon Antegrade AQ Stent Set
Cook Incorporated                 510(k) NO: K180216(Traditional)
ATTN: Rebecca  Odulio (Li-Chun-LiuPHONE NO : 812 3353575 104673
750 Daniels Way P.O. Box 489      SE DECISION MADE: 28-SEP-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orthocaps Twinaligner
Ortho Caps GmbH                   510(k) NO: K180241(Traditional)
ATTN: Wajeeh  Khan                PHONE NO : 49 0 23859219 0
An der Bewer 8                    SE DECISION MADE: 28-SEP-18
Hamm 59069  DE                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellulize
Ward Photonics LLC                510(k) NO: K180338(Traditional)
ATTN: Terry  Ward                 PHONE NO : 800 3925950 
1980 N Atlantic Avenue            SE DECISION MADE: 21-SEP-18
Cocoa Beach FL  32931             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation       510(k) NO: K180340(Traditional)
ATTN: Adam  Heroux                PHONE NO : 781 8940800 
200 Prospect St.                  SE DECISION MADE: 26-SEP-18
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoTool SubQ
Monarch Medical Technologies, Inc.510(k) NO: K180366(Traditional)
ATTN: Linda  Beneze               PHONE NO : 704 3231300 
2137 South Blvd Suite 300         SE DECISION MADE: 20-SEP-18
Charlotte NC  28203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
Relievant Medsystems              510(k) NO: K180369(Traditional)
ATTN: Alex  DiNello               PHONE NO : 650 3681000 
385 Moffett Park Drive, Suite 105 SE DECISION MADE: 14-SEP-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Provata Implant System
Southern Implants (Pty) Ltd       510(k) NO: K180465(Traditional)
ATTN: Lauranda G. Breytenbach     PHONE NO : 27 12 6671046 
1 Albert Road                     SE DECISION MADE: 06-SEP-18
Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEVADAPTOR Closed Drug Reconstitution and Transfer System
Teva Medical Ltd., Migada Plant   510(k) NO: K180489(Traditional)
ATTN: Nadav  Reuben               PHONE NO : 972 4 6908826 
North Industrial Zone             SE DECISION MADE: 21-SEP-18
Kiryat Shmona  IL 10258           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Probe Covers for Thermometers
K-jump Health Co., Ltd.           510(k) NO: K180714(Abbreviated)
ATTN: JM  Lin                     PHONE NO : 886 2 22991378 
No. 56, Wu Kung 5th Rd. New TaipeiSE DECISION MADE: 24-SEP-18
New Taipei City  TW 24890         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spinal Elements Cerclage System
Spinal Elements Inc               510(k) NO: K180728(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071816 
3115 Melrose Dr., Suite 200       SE DECISION MADE: 06-SEP-18
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exceed Microneedling Device
MT.DERM GmbH                      510(k) NO: K180778(Traditional)
ATTN: Anderas  Pachten            PHONE NO : 49 30 8458854 
Gustav-Krone-Str.3                SE DECISION MADE: 07-SEP-18
Berlin  DE 14167                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bard Vertus Foley Catheter
C. R. Bard, Inc.                  510(k) NO: K180781(Traditional)
ATTN: Sharon  Lambert             PHONE NO : 770 7846208 
8195 Industrial Blvd.             SE DECISION MADE: 19-SEP-18
Covington GA  30014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BeautiBond Universal
Shofu Dental Corporation          510(k) NO: K180803(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 Stone Drive                  SE DECISION MADE: 26-SEP-18
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: Portable Nebulizer
MicroBase Technology Corporation  510(k) NO: K180871(Traditional)
ATTN: Molly  Hsieh                PHONE NO : 011 886 33767555 
No. 756, Jiadong Road             SE DECISION MADE: 14-SEP-18
Bade District, Taoyuan City  TW 33510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POLY REJUV
Medtek Skincare, LLC              510(k) NO: K180875(Traditional)
ATTN: Gary  Richardson            PHONE NO : 518 7473310 
3 Depot Street                    SE DECISION MADE: 14-SEP-18
Hudson Falls NY  12839            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IHM Technology Bandage
Protege Biomedical                510(k) NO: K180893(Traditional)
ATTN: Mike  Corcoran              PHONE NO : 612 2262915 
10909 Valley View Rd.             SE DECISION MADE: 19-SEP-18
Eden Prairie MN  55344            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magnetic Surgical System
Levita Magnetics International Cor510(k) NO: K180894(Traditional)
ATTN: Alberto  Rodrigues-Navarro  PHONE NO : 650 2410320 
1730 S. Amphlett Blvd, Suite 240  SE DECISION MADE: 19-SEP-18
San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iNtuition-T1 Mapping and T2/T2* Mapping
TeraRecon Inc.,                   510(k) NO: K180916(Traditional)
ATTN: Megha  Jain                 PHONE NO : 650 3721100 
4000 East 3rd Avenue, Suite 200   SE DECISION MADE: 24-SEP-18
Foster City CA  94404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DenTek Ultimate Dental Guard
Medtech Products Inc.             510(k) NO: K180933(Traditional)
ATTN: Mary Beth Fritz             PHONE NO : 914 5246842 
660 White Plains Rd Suite 250     SE DECISION MADE: 17-SEP-18
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscope Sterilization Tray
Intuitive Surgical, Inc.          510(k) NO: K180964(Traditional)
ATTN: Kunal  Gunjal               PHONE NO : 408 5238017 
1266 Kifer Road, Building 101     SE DECISION MADE: 28-SEP-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Libertas Hip Replacement System
Maxx Orthopedics, Inc             510(k) NO: K180973(Traditional)
ATTN: Corey  Perine               PHONE NO : 484 3420092 
531 Plymouth Road, Suite 526      SE DECISION MADE: 28-SEP-18
Plymouth Meeting PA  19462        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
Stimwave Technologies Incorporated510(k) NO: K180981(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 1 800 9655134 
1310 Park Central Boulevard South SE DECISION MADE: 19-SEP-18
Pompano Beach FL  33064           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioHorizons CAD/CAM Bars
BioHorizons Implant Systems, Inc. 510(k) NO: K180998(Traditional)
ATTN: Michael  Davis              PHONE NO : 205 9677880 
2300 Riverchase Center            SE DECISION MADE: 28-SEP-18
Birmingham AL  35244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SelectFlex 072 Neurovascular Access System
Q'Apel                            510(k) NO: K181000(Traditional)
ATTN: Ken  Peartree               PHONE NO : 310 3953950 
330 Wilshire Boulevard            SE DECISION MADE: 13-SEP-18
Santa Monica CA  90401            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BB-613 Watch Oximeter
Bio-Beat Technologies Ltd.        510(k) NO: K181006(Traditional)
ATTN: Johanan  May                PHONE NO : 972 3 9333022 
26 Magshimim Street               SE DECISION MADE: 21-SEP-18
Petach Tikvah  IL 4934835         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EmboCube Embolization Gelatin
Biosphere Medical, S.A.           510(k) NO: K181021(Traditional)
ATTN: Alix  Fonlladosa            PHONE NO : 33 1 48172529 
Parc des Nations – Paris Nord 2, 3SE DECISION MADE: 27-SEP-18
Roissy en France  FR 95700        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pocket Colposcope System
Hadleigh Health Technologies, LLC 510(k) NO: K181034(Traditional)
ATTN: Robert  Miros               PHONE NO : 415 4543005 1003
30 Castro Ave.                    SE DECISION MADE: 21-SEP-18
San Rafael CA  94901              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin Optimized Positioning System (OPS) Femoral
Corin USA                         510(k) NO: K181061(Traditional)
ATTN: Lucinda  Gerber             PHONE NO : 1 813 9774469 
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 07-SEP-18
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
ECO Medi Glove Sdn Bhd            510(k) NO: K181066(Traditional)
ATTN: Suresh  Kumar               PHONE NO : 605 8912777 
Lot 23826, Jalan Tembaga Kuning KaSE DECISION MADE: 26-SEP-18
Perak  MY 34600                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PureSet Tray
Nobel Biocare AB                  510(k) NO: K181075(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 27-SEP-18
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Sex Gel
Necessaire, Inc.                  510(k) NO: K181078(Traditional)
ATTN: Randi Christiansen Stanley  PHONE NO : 512 5605750 
10 Arbolo Court                   SE DECISION MADE: 10-SEP-18
Manhattan Beach CA  90266         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSP Crosser Transseptal Access System
Transseptal Solutions Ltd.        510(k) NO: K181088(Traditional)
ATTN: Mary P. LeGraw              PHONE NO : 508 6917038 
10 HaGavish St., P.O. Box 4060    SE DECISION MADE: 28-SEP-18
Natanya  IL 4250708               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThermaCare Quick Therapy TENS
Pfizer Inc.                       510(k) NO: K181102(Traditional)
ATTN: Nicola  Romano              PHONE NO : 973 6605858 
235 East 42nd Street              SE DECISION MADE: 15-SEP-18
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acessa ProVu System
Acessa Health, Inc.               510(k) NO: K181124(Traditional)
ATTN: Brian J. Bergeron           PHONE NO : 508 7351590 
7004 Bee Cave Road, Bldg 3, Suite SE DECISION MADE: 28-SEP-18
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)
Contego Medical, LLC              510(k) NO: K181128(Traditional)
ATTN: Elizabeth  Saylors          PHONE NO : 
3921 Sunset Ridge Rd, Suite 102   SE DECISION MADE: 06-SEP-18
Raliegh NC  27607                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
Liaoning Upcera Co., Ltd          510(k) NO: K181167(Traditional)
ATTN: Charles  Shen               PHONE NO : 086 24 45565006 
No.122 Xianghuai Road, Economic DeSE DECISION MADE: 02-SEP-18
Benxi  CN 117004                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Katalyst Mark 1 Muscle Stimulation System Model 2
Katalyst Inc.                     510(k) NO: K181199(Traditional)
ATTN: Bjoern  Woltermann          PHONE NO : 206 4883939 
316 Occidental Ave. South Suite B3SE DECISION MADE: 20-SEP-18
Seattle WA  98104                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEROmini Tracheobronchial Stent System
Merit Medical Systems, Inc        510(k) NO: K181200(Traditional)
ATTN: David  Thomas               PHONE NO : 801 3164956 
1600 West Merit Parkway           SE DECISION MADE: 21-SEP-18
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Centers for Disease Control and Pr510(k) NO: K181205(Traditional)
ATTN: Yon  Yu                     PHONE NO : 404 6393046 
1600 Clifton Road NE, MS-C18      SE DECISION MADE: 20-SEP-18
Atlanta GA  30329                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Human Tecar HCR 1002
UNIBELL S.r.l                     510(k) NO: K181211(Traditional)
ATTN: Mario  Scerri               PHONE NO : 39 039991131 
Via Indipendenza, 27              SE DECISION MADE: 10-SEP-18
Calco  IT 23885                   510(k) STATEMENT
                                                    

DEVICE: TirboLOX-C Cervical IBFD
Captiva Spine, Inc.               510(k) NO: K181229(Traditional)
ATTN: Jackie  Ferro               PHONE NO : 877 7725571 719
967 N. Alternate A1A, Ste. 1      SE DECISION MADE: 19-SEP-18
Jupiter FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys FT4 III
Roche Diagnostics                 510(k) NO: K181233(Traditional)
ATTN: Reanna  Toney               PHONE NO : 317 5214516 
9115 Hague Road                   SE DECISION MADE: 18-SEP-18
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HySil Impression Materials
OSSTEM IMPLANT CO LTD             510(k) NO: K181236(Traditional)
ATTN: Jungmin  Yoo                PHONE NO : 82 51 8502575 
203, GEOJE-DAERO YEONJE-GU        SE DECISION MADE: 13-SEP-18
BUSAN  KR 611-804                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P.                   510(k) NO: K181241(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial Pkwy SE DECISION MADE: 13-SEP-18
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EUSRA RF Electrode
STARmed Co., Ltd.                 510(k) NO: K181249(Traditional)
ATTN: Jun-Young  Jung             PHONE NO : 82 70 46738657 
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 04-SEP-18
Goyang-si  KR 10355               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRODENSE Bone Graft Substitute
Wright Medical Technology, Inc.   510(k) NO: K181255(Traditional)
ATTN: Rachel  Roberts             PHONE NO : 901 8679708 
1023 Cherry Road                  SE DECISION MADE: 12-SEP-18
Memphis TN  37117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable SpO2 Sensors, Reusable SpO2 Sensors
Orantech Inc.                     510(k) NO: K181270(Traditional)
ATTN: Yunxi  Xiong                PHONE NO : 86 075 523699939 
Zone#A, 4F, 1st Bld, 7th IndustriaSE DECISION MADE: 07-SEP-18
Shenzhen  CN 518132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-CUBE 12
Alpinion Medical Systems Co., Ltd.510(k) NO: K181277(Traditional)
ATTN: Boyeon  Cho                 PHONE NO : 82 707 4652104 
1FL and 6FL, Verdi Tower, 72, DigiSE DECISION MADE: 28-SEP-18
Seoul  KR 08393                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OralTox Oral fluid Drug Test
Premier Biotech, Inc.             510(k) NO: K181305(Traditional)
ATTN: Jacqueline  Gale            PHONE NO : 612 8395563 
723 Kasota Avenue SE              SE DECISION MADE: 20-SEP-18
Minneapolis MN  55414             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips Hemodynamic Application R1.0
Philips Medical Systems Nederlands510(k) NO: K181311(Abbreviated)
ATTN: Owen  Callaghan             PHONE NO : 31 621 394159 
Veenpluis 4-6                     SE DECISION MADE: 07-SEP-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension
Philips Medizin Systeme Boeblingen510(k) NO: K181314(Traditional)
ATTN: Stefan  Breuer              PHONE NO : 49 7031 4632321 
Hewlett-Packard-Str. 2            SE DECISION MADE: 04-SEP-18
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caprolon
Resorba Medical GmbH              510(k) NO: K181320(Traditional)
ATTN: Helen  Topping              PHONE NO : 49 9128 91150 
Am Flachmoor 16                   SE DECISION MADE: 18-SEP-18
Nuremberg  DE 90475               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 STRATOSPHERE™ Expandable Corpectomy System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K181328(Traditional)
ATTN: Kanesha  Hines              PHONE NO : 901 3992670 
1800 Pyramid Place                SE DECISION MADE: 19-SEP-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sypher Spacer System
Biogennix, LLC                    510(k) NO: K181337(Traditional)
ATTN: Tim  Bumbalough             PHONE NO : 949 2530994 
18007 Sky Park Circle, Suite f    SE DECISION MADE: 18-SEP-18
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens
Visco Vision Inc                  510(k) NO: K181349(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 19-SEP-18
Taoyuan City  TW 33341            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REDAPT Porous Acetabular Shell
Smith & Nephew, Inc.              510(k) NO: K181366(Traditional)
ATTN: Bryan  Cowell               PHONE NO : 978 7491093 
7135 Goodlett Farms Parkway       SE DECISION MADE: 24-SEP-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LnK Lumbar Interbody Fusion Cage System
L&K BIOMED Co., Ltd.              510(k) NO: K181380(Traditional)
ATTN: Jihyeon  Seo                PHONE NO : 82 2 67171983 
#201, 202, 16-25, Dongbaekjungang-SE DECISION MADE: 11-SEP-18
Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System
OrthoPediatrics, Corp             510(k) NO: K181390(Traditional)
ATTN: Mark  Fox                   PHONE NO : 574 2686379 
2850 Frontier Drive               SE DECISION MADE: 18-SEP-18
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DualX
Innovasive, Inc.                  510(k) NO: K181397(Traditional)
ATTN: Andy  Choi                  PHONE NO : 949 6984854 
26020 Acero, Ste 200              SE DECISION MADE: 27-SEP-18
Mission Viejo CA  92691           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
Canon Medical Systems Corporation 510(k) NO: K181415(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 10-SEP-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aequalis Flex Revive Shoulder System
Tornier, Inc.                     510(k) NO: K181420(Traditional)
ATTN: Laurie  Lewandowski         PHONE NO : 612 7704038 
10801 Nesbitt Ave South           SE DECISION MADE: 20-SEP-18
Bloomington MN  55437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
Amsino International Inc.         510(k) NO: K181423(Traditional)
ATTN: Jane  Gao                   PHONE NO : 909 6265888 
708 Corporate Center Drive        SE DECISION MADE: 07-SEP-18
Pomona CA  91768                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeDIA
PeDIA, LLC                        510(k) NO: K181424(Traditional)
ATTN: Diane  Miller               PHONE NO : 703 9669578 
2804 Albany Court                 SE DECISION MADE: 25-SEP-18
Fairfax VA  22031                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortoma Treatment Solution - OTS
Ortoma AB                         510(k) NO: K181449(Traditional)
ATTN: Linus  Bystrom              PHONE NO : 46 73 8103660 
Vadursgatan 5                     SE DECISION MADE: 19-SEP-18
Goteborg  SE S-41250              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProSun sunlamp products, Luxura sunlamp products
ProSun International LLC          510(k) NO: K181455(Traditional)
ATTN: Tom  Henkemans              PHONE NO : 727 8250400 
2442 23rd Street North            SE DECISION MADE: 10-SEP-18
Saint Petersburg FL  33713        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cadwell Zenith System
Cadwell Industries, Inc.          510(k) NO: K181466(Traditional)
ATTN: Alison  Hull                PHONE NO : 800 2453001 210
909 North Kellogg Street          SE DECISION MADE: 01-SEP-18
Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prime&Bond active Universal Adhesive
Dentsply Sirona                   510(k) NO: K181476(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street, SuitSE DECISION MADE: 28-SEP-18
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Pediatric Mandibular Distractor 2
Stryker                           510(k) NO: K181504(Traditional)
ATTN: Gregory  Gohl               PHONE NO : 269 3894319 
750 Trade Centre Way - Suite 200  SE DECISION MADE: 11-SEP-18
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECHOLASER X4
El.En Electronic Engineering Spa  510(k) NO: K181510(Traditional)
ATTN: Paolo  Peruzzi              PHONE NO : 39 0558826807 
Via Baldanzese 17                 SE DECISION MADE: 04-SEP-18
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sebacia Microparticles
Sebacia, Inc.                     510(k) NO: K181518(Traditional)
ATTN: Todd J. Meyer               PHONE NO : 678 8121150 
2905 Premiere Parkway, Suite 150  SE DECISION MADE: 06-SEP-18
Duluth GA  30097                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INNOVANCE Free PS Ag
Siemens Healthcare Diagnostics Pro510(k) NO: K181525(Traditional)
ATTN: Petra  Dissmann             PHONE NO : 49 172 3692459 
Emil-von-Behring Strasse 76       SE DECISION MADE: 07-SEP-18
Marburg  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Alteon Monobloc Revision Stem
Exactech, Inc.                    510(k) NO: K181532(Special)
ATTN: Zach  Sharrah               PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 04-SEP-18
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLOW800
Leica Microsystems (Schweiz) AG   510(k) NO: K181537(Traditional)
ATTN: Georges  Hakim              PHONE NO : 41 71 7263245 
Max Schmidheiny-Strasse 201       SE DECISION MADE: 07-SEP-18
Heerbrugg  CH 9435                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
Gelflex Laboratories              510(k) NO: K181558(Traditional)
ATTN: David  Masel                PHONE NO : 61 8 94434944 
52 Mulgul Road                    SE DECISION MADE: 06-SEP-18
Malaga  AU 6090                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology
Access Scientific, LLC            510(k) NO: K181563(Traditional)
ATTN: Martina  Nguyen             PHONE NO : 858 2598333 
3910 Sorrento Valley Boulevard, SuSE DECISION MADE: 26-SEP-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IPL Salon Hair Reduction System
Medical Device Branch of Zhangzhou510(k) NO: K181568(Traditional)
ATTN: Bruce  Wu                   PHONE NO : 86 1366 6097743 
4th Floor of Building #1, No.228, SE DECISION MADE: 11-SEP-18
Zhangzhou  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Planmeca Viso
Planmeca Oy                       510(k) NO: K181576(Traditional)
ATTN: Lars  Moring                PHONE NO : 358 20 7795500 
Asentajankatu 6                   SE DECISION MADE: 13-SEP-18
Helsinki  FI 00880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fixated Asfora BULLET CAGE® (FABC)
Medical Designs, LLC              510(k) NO: K181591(Traditional)
ATTN: Kristi  Vondra              PHONE NO : 605 2751032 
6709 S. Minnesota Ave, Suite 204  SE DECISION MADE: 26-SEP-18
Sioux Falls SD  57108             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectralis HRA+OCT and variants with OCT Angiography Module
Heidelberg Engineering GmbH       510(k) NO: K181594(Traditional)
ATTN: Christoph  Schoess          PHONE NO : 49 6221 64630 
Max-Jarecki-Strasse 8             SE DECISION MADE: 13-SEP-18
Heidelberg  DE 69115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prime E-CLASS XLPE Liner
MicroPort Orthopedics Inc.        510(k) NO: K181598(Traditional)
ATTN: Sarah Evonne Stroupe        PHONE NO : 901 2905165 
5677 Airline Road                 SE DECISION MADE: 14-SEP-18
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Standard Clamp
Standard Bariatrics               510(k) NO: K181608(Traditional)
ATTN: Alison  Sathe               PHONE NO : 513 3047971 
4362 Glendale Milford Rd.         SE DECISION MADE: 27-SEP-18
Cincinnati OH  45242              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comprehensive Reverse Shoulder System
Biomet Manufacturing Corp         510(k) NO: K181611(Traditional)
ATTN: Dalene  Binkley             PHONE NO : 574 3726789 
56 East Bell Drive                SE DECISION MADE: 24-SEP-18
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PSM 3-Way Silicone Foley Catheter
Pathway, LLC                      510(k) NO: K181616(Traditional)
ATTN: David  Stroup               PHONE NO : 619 4150103 701
8779 Cottonwood Avenue, Suite 105 SE DECISION MADE: 21-SEP-18
Santee CA  92071                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscopic Linear Cutting Staplers and Loading Units for Single Use
Ezisurg (Suzhou) Medical Co., Ltd.510(k) NO: K181620(Traditional)
ATTN: Renjing  Tian               PHONE NO : 86 21 50456176 8026
Building 16, No. 8 Jinfeng Rd., SuSE DECISION MADE: 18-SEP-18
Suzhou  CN 215163                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venacure 1470 Pro
Quanta System Spa                 510(k) NO: K181632(Traditional)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
Via Acquedotto 109                SE DECISION MADE: 17-SEP-18
Samarate (Va)  IT 21017           510(k) STATEMENT
                                                    

DEVICE: Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
Ethicon, Inc.                     510(k) NO: K181652(Traditional)
ATTN: Donna  Marshall             PHONE NO : 908 5413990 
Route 22 West, P.O. Box 151       SE DECISION MADE: 28-SEP-18
Somerville NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed
Ethicon Endo-Surgery, LLC         510(k) NO: K181653(Traditional)
ATTN: Sigfrido  Delgado           PHONE NO : 787 2726144 
475 Calle C                       SE DECISION MADE: 18-SEP-18
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovis S180 Lateral Lumbar Interbody Fusion System
Renovis Surgical Technologies     510(k) NO: K181655(Traditional)
ATTN: Anthony  Debenedictis       PHONE NO : 909 5572360 
1901 W. Lugonia                   SE DECISION MADE: 11-SEP-18
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Iridex TruFocus LIO Premiere
Iridex Corporation                510(k) NO: K181662(Special)
ATTN: Edward J. Sinclair          PHONE NO : 650 2189149 
1212 Terra Bella Avenue           SE DECISION MADE: 05-SEP-18
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN
Becton,Dickinson and Company      510(k) NO: K181665(Traditional)
ATTN: Monica E. Giguere           PHONE NO : 410 3164287 
7 Loveton Circle MC 694           SE DECISION MADE: 21-SEP-18
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R-C1 TENS and EMS Stimulator; R-E1- EMS Stimulator; R-T1 TENS Stimulator
Shenzhen Roundwhale Technology Co.510(k) NO: K181688(Traditional)
ATTN: Kevin  Zhang                PHONE NO : 86 755 23212776 
No. 615, Building C of Sanlian IndSE DECISION MADE: 07-SEP-18
Shenzhen  CN 518108               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 5cm Tag Applicator, 7cm Tag Applicator, 10 cm  Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack)
Health Beacons, Inc.              510(k) NO: K181692(Traditional)
ATTN: Nancy  Confrey              PHONE NO : 978 2874635 
34 Walden St., #753               SE DECISION MADE: 25-SEP-18
Concord MA  01742                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tranquil-L Interbody System
Nexus Spine, LLC                  510(k) NO: K181702(Traditional)
ATTN: Jared  Crocker              PHONE NO : 801 7028342 
2825 E Cottonwood Parkway, Suite 3SE DECISION MADE: 21-SEP-18
Salt Lake City UT  84121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Everyway Wireless TENS & EMS Unit
Everyway Medical Instruments Co., 510(k) NO: K181707(Traditional)
ATTN: Paul  Hung                  PHONE NO : 886 2 26620038 
3Fl., No. 5, Lane 155, Section 3, SE DECISION MADE: 26-SEP-18
Shenkeng District, New Taipei City510(k) STATEMENT
                                                    

DEVICE: Ceracell Ortho Foam
curasan AG                        510(k) NO: K181721(Traditional)
ATTN: Gregor  Thomas              PHONE NO : 49 6027 409000 
Lindigstrasse 4                   SE DECISION MADE: 17-SEP-18
Kleinostheim  DE 63801            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Patient Cables and Lead Wires
Medline Industries, Inc.          510(k) NO: K181726(Traditional)
ATTN: Dinah  Rincones             PHONE NO : 847 9792687 
Three Lakes Drive                 SE DECISION MADE: 20-SEP-18
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beurer IPL 8500 device/ IPL VelvetSkin Pro
Home Well Trading LTD             510(k) NO: K181734(Traditional)
ATTN: Martin  Gurovich            PHONE NO : 213 3353521 
Omar Hodge Building, Road Town    SE DECISION MADE: 19-SEP-18
Tortola  VG                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
Stryker GmbH                      510(k) NO: K181742(Traditional)
ATTN: Tina  Mornak                PHONE NO : 201 8316365 
325 Corporate Drive               SE DECISION MADE: 27-SEP-18
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MICRORAPTOR Knotless Suture Anchor
Smith and Nephew, Inc.            510(k) NO: K181746(Traditional)
ATTN: Katherine  Marcaccio        PHONE NO : 508 2613602 
7135 Goodlett Farms Parkway       SE DECISION MADE: 28-SEP-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magnesium
Abbott Laboratories               510(k) NO: K181748(Traditional)
ATTN: Mark  Littlefield           PHONE NO : 972 5186062 
1921 Hurd Drive                   SE DECISION MADE: 12-SEP-18
Irving TX  75038                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex FiberTak Suture Anchor
Arthrex, Inc.                     510(k) NO: K181769(Traditional)
ATTN: David L. Rogers             PHONE NO : 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 21-SEP-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RightEye Vision System
RightEye, LLC                     510(k) NO: K181771(Traditional)
ATTN: Adam  Gross                 PHONE NO : 301 9797970 
7979 Old Georgetown Rd., Suite 801SE DECISION MADE: 28-SEP-18
Bethesda MD  20814                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synapse 3D Optional Tools
FUJIFILM Corporation              510(k) NO: K181773(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 25-SEP-18
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ P9; LOGIQ P7
GE Healthcare                     510(k) NO: K181783(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 20-SEP-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VeriSuite
MedCom GmbH                       510(k) NO: K181789(Abbreviated)
ATTN: Johannes  Messow            PHONE NO : 49 6151 9514720 
Dolivostrasse 11                  SE DECISION MADE: 21-SEP-18
Darmstadt  DE 64293               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Truliant Porous Femoral Components
Exactech, Inc.                    510(k) NO: K181794(Special)
ATTN: Patrick  Hughes             PHONE NO : 352 3274762 
2320 NW 66th CT                   SE DECISION MADE: 28-SEP-18
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AST Model MA012 and MS019 Rehab Wheelchair
Sichuan AST Medical Equipment Co.,510(k) NO: K181795(Traditional)
ATTN: Johnson  Van                PHONE NO : 86 830 8130286 
No.58, Jin-Peng Road, C Area, LuxiSE DECISION MADE: 25-SEP-18
Luzhou City  CN 646100            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReTrace Ureteral Access Sheath
Coloplast A/S                     510(k) NO: K181811(Special)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 07-SEP-18
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
Amsino International, Inc.        510(k) NO: K181814(Traditional)
ATTN: Cathy  Hong                 PHONE NO : 909 6265888 
708 Corporate Center Drive        SE DECISION MADE: 04-SEP-18
Pomona CA  91768                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOSS VRS Spinal System
Biedermann Motech GmbH & Co. KG   510(k) NO: K181821(Traditional)
ATTN: Gerd  Federle               PHONE NO : 49 7720 8510545 
Bertha-von-Suttner-Strasse 23     SE DECISION MADE: 13-SEP-18
Villingen-Schwenningen  DE 78054  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MX40 Mobile Digital X-ray System
Huestis Machine Corporation       510(k) NO: K181874(Traditional)
ATTN: Frederick M. Correira       PHONE NO : 401 2535500 144
68 Buttonwood Street              SE DECISION MADE: 14-SEP-18
Bristol RI  02809                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kiierr 272 Laser, Kiierr 148 Laser
Kiierr International, LLC         510(k) NO: K181878(Traditional)
ATTN: Michael  Anderson           PHONE NO : 435 8408199 
863 East Downington Avenue        SE DECISION MADE: 05-SEP-18
Salt Lake City UT  84105-3211     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Penicillin 0.002- 32 µg/mL
Liofilchem s. r. l.               510(k) NO: K181889(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 13-SEP-18
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: 5 FR Dual Lumen Piper PICC
Piper Access LLC                  510(k) NO: K181904(Traditional)
ATTN: Jay  Muse                   PHONE NO : 801 2102886 
3981 South 700 East Suite 15      SE DECISION MADE: 25-SEP-18
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InVivo Web Viewer
Anatomage Inc.                    510(k) NO: K181926(Traditional)
ATTN: Changxin  Xu                PHONE NO : 408 8851474 
303 N. Almaden Blvd. Suite 700    SE DECISION MADE: 21-SEP-18
San Jose CA  95110                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30
Oxoid Limited (Part of Thermo Fish510(k) NO: K181975(Traditional)
ATTN: Philip  Brame               PHONE NO : 440 1256 694279 
Wade Road                         SE DECISION MADE: 27-SEP-18
Basingstoke  GB RG24 8PW          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsseoScrew System
Alphatec Spine, Inc.              510(k) NO: K181980(Traditional)
ATTN: Jeremy  Markovich           PHONE NO : 760 4946893 
5818 El Camino Real               SE DECISION MADE: 25-SEP-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NxStage Connected Health System
NxStage Medical, Inc              510(k) NO: K181991(Traditional)
ATTN: Christina  Marabella        PHONE NO : 978 4505275 
350 Merrimack Street              SE DECISION MADE: 26-SEP-18
Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Chiral Surgical Pedicle Screw System
Chiral Surgical                   510(k) NO: K181995(Traditional)
ATTN: Andy  Choi                  PHONE NO : 973 2240437 
17310 Red Hill Ave, STE 335       SE DECISION MADE: 20-SEP-18
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
Arthrex Inc.                      510(k) NO: K182039(Traditional)
ATTN: Courtney  Smith             PHONE NO : 1 239 6435553 71720
1370 Creekside Boulevard          SE DECISION MADE: 28-SEP-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored)
Hebei Titans Hongsen Medical Techn510(k) NO: K182043(Traditional)
ATTN: ShaoZhang  Nan              PHONE NO : 86 319 7295820 
Eastern Industrial Zone           SE DECISION MADE: 21-SEP-18
Nangong  CN 051800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultravision™ Visual Field Clearing System
Alesi Surgical Ltd.               510(k) NO: K182053(Special)
ATTN: David  Broderick            PHONE NO : 44 02920 291022 
Cardiff MediCentre, HeathPark     SE DECISION MADE: 07-SEP-18
Cardiff  GB CF14 4UJ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SECULOK™ ACP System
U&i Corporation                   510(k) NO: K182055(Traditional)
ATTN: Kwang-Eun  Song             PHONE NO : 82 31 8606837 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 10-SEP-18
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
MEDTEC Inc. dba CIVCO Medical Solu510(k) NO: K182079(Third Party - Traditional)
ATTN: Alena  Newgren              PHONE NO : 319 2486650 
1401 8th Street SE                SE DECISION MADE: 07-SEP-18
Orange City IA  51041-3020        510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Scope Antifogging System
Xodus Medical, Inc.               510(k) NO: K182080(Traditional)
ATTN: Paul  Lloyd                 PHONE NO : 724 3375500 
702 Prominence Drive              SE DECISION MADE: 19-SEP-18
New Kensington PA  15068          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
Eleckta Limited                   510(k) NO: K182138(Traditional)
ATTN: Andrew  Hedges              PHONE NO : 44 1293 654201 
Linac House, Fleming Way          SE DECISION MADE: 05-SEP-18
Crawley  GB rh10 9rr              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bi-Flex Evo
Promepla Sam                      510(k) NO: K182144(Special)
ATTN: Alexandre  Bareille         PHONE NO : 377 97 984244 
9 Avenue Albert II                SE DECISION MADE: 07-SEP-18
Monaco  MC 98000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CTXX85
Analogic Corporation              510(k) NO: K182147(Traditional)
ATTN: Karen  Provencher           PHONE NO : 978 3264668 
8 Centennial Drive                SE DECISION MADE: 07-SEP-18
Peabody MA  01960                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SILVERBACK Gorilla Plating System
Paragon 28, Inc.                  510(k) NO: K182148(Special)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E, STE 280       SE DECISION MADE: 07-SEP-18
Engelwood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasound System SONIMAGE HS1
KONICA MINOLTA, INC.              510(k) NO: K182153(Special)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 06-SEP-18
Hino-shi  JP 191-8511             510(k) STATEMENT
                                                    

DEVICE: BioSign Flu A+B
Princeton BioMeditech Corp.       510(k) NO: K182157(Special)
ATTN: Kyung-ah  Kim               PHONE NO : 732 2741000 
4242 US Highway 1                 SE DECISION MADE: 18-SEP-18
Monmouth Junction NJ  08852       510(k) STATEMENT
                                                    

DEVICE: Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth
Imediplus, Inc.                   510(k) NO: K182196(Third Party - Traditional)
ATTN: Moriah  Hsieh               PHONE NO : 886 3 6587700 325
2F, 12, ShengYi Rd. Sec.2         SE DECISION MADE: 11-SEP-18
Chupei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: RiX70 DC
Trident s.r.l                     510(k) NO: K182206(Traditional)
ATTN: Giorgio  Rizzo              PHONE NO : 39 03 02732485 
Via Artigiani 4                   SE DECISION MADE: 13-SEP-18
Castenedolo  IT 25014             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.via View&GO (Version VA10A)
Siemens Healthcare GmbH           510(k) NO: K182208(Third Party - Abbreviated)
ATTN: Elango Alampalayam RangappanPHONE NO : 49 9191 184429 
Siemensstr. 1                     SE DECISION MADE: 07-SEP-18
Forchheim  DE 91301               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: QT Ultrasound Breast Scanner - 1
QT Ultrasound LLC                 510(k) NO: K182213(Special)
ATTN: Mark W. Lenox               PHONE NO : 865 3822649 
3 Hamilton Landing, Suite 160     SE DECISION MADE: 14-SEP-18
Novato CA  94949                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DizzyDoctor System 1.0.0
DizzyDoctor Systems, LLC          510(k) NO: K182214(Third Party - Traditional)
ATTN: Ian  Purcell                PHONE NO : 619 7645751 
7625 Mesa College Drive, Suite 200SE DECISION MADE: 14-SEP-18
San Diego CA  92111               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
Canon Medical Systems USA         510(k) NO: K182223(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 14-SEP-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirStrip RPM InvisionHeart Adapter
AirStrip Technologies, Inc.       510(k) NO: K182226(Third Party - Traditional)
ATTN: Kirk  Johnson               PHONE NO : 210 8050444 
335 E. Sonterra Blvd., Suite #200 SE DECISION MADE: 11-SEP-18
San Antonio TX  78258             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Multi Modality Viewer
Vital Images, Inc.                510(k) NO: K182230(Traditional)
ATTN: Fei  Li                     PHONE NO : 952 4879539 
5850 Opus Parkway, Suite 300      SE DECISION MADE: 07-SEP-18
Minnetonka MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Octane Mechanical Thrombectomy System
Vascular Solutions, Inc.          510(k) NO: K182232(Special)
ATTN: Iroquois  Ledbeter          PHONE NO : 763 6564300 
6401 Sycamore Ct N                SE DECISION MADE: 11-SEP-18
Maple Grove MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optima XR240amx
GE Medical Systems, LLC           510(k) NO: K182234(Special)
ATTN: Chris  Paulik               PHONE NO : 262 5482010 
3000 N. Grandview Blvd.           SE DECISION MADE: 06-SEP-18
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The CVC WAND Safety Introducer with Valved Peelable Sheath
Access Scientific, LLC            510(k) NO: K182243(Special)
ATTN: Martina  Nguyen             PHONE NO : 858 2598333 
3910 Sorrento Valley Boulevard, SuSE DECISION MADE: 18-SEP-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
United States Endoscopy Group, Inc510(k) NO: K182258(Special)
ATTN: Carroll L. Martin           PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 21-SEP-18
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: PALACOS MV
Heraeus Medical GmbH              510(k) NO: K182260(Special)
ATTN: Ute  Greiner                PHONE NO : 49 61 81352808 
Philipp-Reis-Str. 8-13            SE DECISION MADE: 17-SEP-18
Wehrheim  DE 61273                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RetCam 3 ; RetCam Shuttle ; RetCam Portable
Natus Medical Incorporated        510(k) NO: K182263(Special)
ATTN: Brian R. Ackley             PHONE NO : 925 2011600 
1183 Quarry Lane, Suite A         SE DECISION MADE: 07-SEP-18
Pleasanton CA  94566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Seal Single Use Biopsy Valve
Boston Scientific Corporation     510(k) NO: K182275(Special)
ATTN: Andrew  Akers               PHONE NO : 508 6834612 
100 Boston Scientific Way         SE DECISION MADE: 13-SEP-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oh'Care Lite Smart Blood Glucose Monitoring System
OSANG Healthcare Co., Ltd.        510(k) NO: K182286(Special)
ATTN: Jin Ho An                   PHONE NO : 82 31 4600415 
132, Anyangcheondong-Ro, Dongan-GuSE DECISION MADE: 19-SEP-18
Anyang  KR 14040                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IBM iConnect Access
Merge Healthcare Incorporated     510(k) NO: K182290(Traditional)
ATTN: Tracey  Fox                 PHONE NO : 262 3670700 
900 Walnut Ridge Drive            SE DECISION MADE: 25-SEP-18
Hartland WI  53209                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Volpara Imaging Software
Volpara Health Technologies Limite510(k) NO: K182310(Special)
ATTN: Ralph  Highnam              PHONE NO : 64 4 4996029 
Level 7, 44 Victoria Street, WelliSE DECISION MADE: 21-SEP-18
Wellington  NZ 6011               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magic Torque DLVR Guidewire
Boston Scientific Corporation     510(k) NO: K182315(Special)
ATTN: Andrea  Dance               PHONE NO : 763 4941743 
3 Scimed Place                    SE DECISION MADE: 26-SEP-18
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMADEO M-DR mini, AMADEO M-AX mini
OEHM UND REHBEIN GMBH             510(k) NO: K182317(Traditional)
ATTN: Markus  Brueggmann          PHONE NO : 49 381 36600730 
Neptunallee 7 C                   SE DECISION MADE: 24-SEP-18
Rostock  DE 18057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode RF System
Inmode MD Ltd.                    510(k) NO: K182325(Special)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 26-SEP-18
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CPX 4 Breast Tissue Expander with Smooth Surface
Mentor Worldwide LLC              510(k) NO: K182335(Special)
ATTN: Martin  Sprunck             PHONE NO : 949 7898589 
33 Technology Drive               SE DECISION MADE: 25-SEP-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NICO Myriad
NICO Corporation                  510(k) NO: K182340(Special)
ATTN: Sean  Spence                PHONE NO : 317 6607118 
250 East 96th Street, Suite 125   SE DECISION MADE: 20-SEP-18
Indianapolis IN  46240            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spineology Navigation Instruments
Spineology Inc                    510(k) NO: K182345(Special)
ATTN: Karen  Roche                PHONE NO : 651 2568500 
7800 Third Street N., Suite 600   SE DECISION MADE: 21-SEP-18
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk AST Eravacycline 20µg (ERV20)
Hardy Diagnostics                 510(k) NO: K182357(Traditional)
ATTN: Anna  Klavins               PHONE NO : 800 2662222 5752
1430 West McCoy Lane              SE DECISION MADE: 26-SEP-18
Santa Maria CA  93455             510(k) STATEMENT
                                                    

DEVICE: Acculoc Total Knee System
RootLoc Co., Ltd.                 510(k) NO: K182370(Special)
ATTN: Jungsun  Ha                 PHONE NO : 82 2 69414300 
#1206, 1210, 68, Digital-ro 9-gil,SE DECISION MADE: 27-SEP-18
Seoul  KR 08512                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Harmony
Topcon Medical Systems, Inc.      510(k) NO: K182376(Special)
ATTN: James  Lorkowski            PHONE NO : 201 5995553 
111 Bauer Drive                   SE DECISION MADE: 28-SEP-18
Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CarboClear® Pedicle Screw System
CarboFix Orthopedics Ltd.         510(k) NO: K182377(Special)
ATTN: Hila  Wachsler-Avrahami     PHONE NO : 972 99511511 
11 Ha'hoshlim St.                 SE DECISION MADE: 27-SEP-18
Herzeliya  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoLink View Plating System
In2Bones USA, LLC                 510(k) NO: K182402(Special)
ATTN: Christine  Scifert          PHONE NO : 901 8318053 
6060 Poplar Ave, Suite 380        SE DECISION MADE: 27-SEP-18
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alphenix, INFX-8000F/B, V8.0
Canon Medical Systems Corporation 510(k) NO: K182415(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 28-SEP-18
Otawara  JP 324-8550              510(k) SUMMARY AVAILABLE FROM FDA
                                                    


               TOTAL 510(k)s THIS PERIOD   203                                     
               TOTAL WITH SUMMARIES        193                                     
               TOTAL WITH STATEMENTS        10