Medical Devices

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
                                      

Page Last Updated: 10/09/2018
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