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. November 2018 510(k) Clearances
  1. 510(k) Clearances

November 2018 510(k) Clearances

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


DEVICE: Miracu
Feeltech Co., Ltd.                510(k) NO: K172602(Traditional)
ATTN: Keun-Sik  Kim               PHONE NO : 82 63 4686626 
3,4 Floor Standard Factory 2-dong,SE DECISION MADE: 14-NOV-18
Gunsan-si  KR 573-540             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: W Zirconia Implants
TAV Medical Ltd.                  510(k) NO: K172668(Traditional)
ATTN: Revital  Shabtai            PHONE NO : 972 4 9808615 
Dora Industrial Park, P.O. Box 88 SE DECISION MADE: 06-NOV-18
Shlomi  IL 2283202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Handheld Pulse Oximeter, Model SP-20
Shenzhen Creative Industry Co., Lt510(k) NO: K172792(Traditional)
ATTN: Jia  Wang                   PHONE NO : 86 755 26431671 
2/F, Block 3, Nanyou Tian'an IndusSE DECISION MADE: 13-NOV-18
Shenzhen  CN 518054               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Low-frequency Multi-function physiotherapy instrument
Shenzhen OSTO Technology Co., Ltd.510(k) NO: K172837(Traditional)
ATTN: Li  Yang                    PHONE NO : 86 755 29769546 
No.43 Longfeng Road, Xinsheng CommSE DECISION MADE: 26-NOV-18
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELAN 4 Air Motor System
Aesculap, Inc.                    510(k) NO: K172907(Traditional)
ATTN: Jessica  Stigliano          PHONE NO : 610 9849063 
3773 Corporate Parkway            SE DECISION MADE: 09-NOV-18
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uWS-MR
Shanghai United Imaging Healthcare510(k) NO: K172999(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 021 67076888 6776
No.2258 Chengbei Road             SE DECISION MADE: 07-NOV-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uWS-CT
Shanghai United Imaging Healthcare510(k) NO: K173001(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 021670 768886776 
No.2258 Chengbei Road             SE DECISION MADE: 07-NOV-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeT T-Piece Resuscitator
Ventlab, LLC                      510(k) NO: K173373(Traditional)
ATTN: Rob  Yamashita              PHONE NO : 616 2598373 
2710 Northridge Drive NW - Suite ASE DECISION MADE: 16-NOV-18
Grand Rapids MI  49544            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Hot Biopsy Forceps FD-231
Olympus Medical Systems Corp.     510(k) NO: K173495(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 30-NOV-18
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prizma
G-Medical Innovations Ltd.        510(k) NO: K173589(Traditional)
ATTN: N.  Epstein                 PHONE NO : 972 8 9584777 
5 Openheimer St, Park Rabin       SE DECISION MADE: 30-NOV-18
Rehovot  IL 7670105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Implant-One System
Implant Logistics, Inc.           510(k) NO: K173701(Traditional)
ATTN: Thomas  Arendt              PHONE NO : 608 4984855 
3rd Street South                  SE DECISION MADE: 29-NOV-18
La Crosse WI  54601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProFuse CAD
Eigen                             510(k) NO: K173744(Traditional)
ATTN: William  Mandel             PHONE NO : 530 2741240 
16633 Grass Valley Ave.           SE DECISION MADE: 21-NOV-18
Grass Valley CA  95945            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Tacrolimus
Roche Diagnostics                 510(k) NO: K173857(Traditional)
ATTN: Khoa  Tran                  PHONE NO : 317 5213409 
9115 Hague Road                   SE DECISION MADE: 06-NOV-18
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finapres Nova Noninvasive Hemodynamic Monitor
Finapres Medical Systems B.V.     510(k) NO: K173916(Traditional)
ATTN: Iris van Uitert             PHONE NO : 31 88 1152700 
Institutenweg 25                  SE DECISION MADE: 06-NOV-18
Enschede  NL 7521 PH              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: neoClose PDS
neoSurgical Ltd                   510(k) NO: K173917(Traditional)
ATTN: Orla  Brennan               PHONE NO : 353 91 421000 
Block 12, Galway Technology Park  SE DECISION MADE: 08-NOV-18
Galway  IE H91 E4YD               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent
Yeti Dentalprodukte Gmbh          510(k) NO: K173971(Traditional)
ATTN: Thomas  Biskupski           PHONE NO : 49 77 3394100 
Industriestrasse 3a               SE DECISION MADE: 15-NOV-18
Engen  DE 78234                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
Fiab SpA                          510(k) NO: K180047(Traditional)
ATTN: Alberto  Calabro            PHONE NO : 39 055 8497914 
Via Costoli, 4                    SE DECISION MADE: 08-NOV-18
Vicchio  IT 50039                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN)
M.I. Tech Co., Ltd.               510(k) NO: K180180(Traditional)
ATTN: Inae  Kim                   PHONE NO : 82 70 43047450 
174, Habuk 2-gil, Jinwi-myeon     SE DECISION MADE: 02-NOV-18
Pyeongtaek-si  KR 17706           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
Dentalpoint AG                    510(k) NO: K180184(Traditional)
ATTN: Anja  Lieberherr            PHONE NO : 41 44 5424171 
Bodenackerstrasse 5               SE DECISION MADE: 16-NOV-18
Spreitenbach  CH 8957             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-contact Infrared Thermometer
Alicn Medical (Shenzhen), Inc     510(k) NO: K180207(Traditional)
ATTN: Meisong  Fang               PHONE NO : 86 755 26501548 
4/F, B Building, Shenfubao Modern SE DECISION MADE: 28-NOV-18
Shezhen  CN 518122                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAEHAN Adhesive Surface Electrodes
Daehan Medical Systems Co., Ltd.  510(k) NO: K180247(Traditional)
ATTN: Da Pin  Jeong               PHONE NO : 82 31 4326275 
250 Okgucheondong-Ro              SE DECISION MADE: 01-NOV-18
Siheung City  KR 15084            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sheridan Endobronchial Tubes
Teleflex Medical                  510(k) NO: K180253(Traditional)
ATTN: Lori  Pfohl                 PHONE NO : 919 4918960 
3015 Carrington Mills Blvd        SE DECISION MADE: 02-NOV-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: welloStationX
Wello, Inc                        510(k) NO: K180298(Traditional)
ATTN: Alan Camerik(Rik) Heller    PHONE NO : 469 5181228 
3939 Belt Line Road, Suite 400    SE DECISION MADE: 30-NOV-18
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Trauma Orthopedic Plates and Screws
Synthes (USA) Products LLC/DePuy O510(k) NO: K180310(Traditional)
ATTN: Jeffrey  Krawiec            PHONE NO : 610 7195434 
1301 Goshen Parkway               SE DECISION MADE: 01-NOV-18
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer
Bonraybio Co., Ltd.               510(k) NO: K180343(Traditional)
ATTN: Clare  Huang                PHONE NO : 886 4 24912385 
4F., No.118, Gongye 9th Rd. Dali DSE DECISION MADE: 16-NOV-18
Taichung  TW 41280                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear-Tip EUS-FNA
Finemedix Co. Ltd.                510(k) NO: K180363(Traditional)
ATTN: Heon Sik Lee                PHONE NO : 82 53 7418388 
60, Maeyeo-ro, Dong-gu            SE DECISION MADE: 01-NOV-18
Daegu  KR 41065                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Vinyl Patient Examination Gloves
Shanxi Hongjin Plastic Technology 510(k) NO: K180381(Traditional)
ATTN: Wu  Zhigang                 PHONE NO : 86 311 66179653 
Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 07-NOV-18
Linfen City  CN 042399            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transcend 365 miniCPAP System
Somnetics International, Inc.     510(k) NO: K180388(Traditional)
ATTN: Eric  Becker                PHONE NO : 651 6211804 
33 5th Ave NW, Suite 500          SE DECISION MADE: 30-NOV-18
New Brighton MN  55112            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZ-IO Intraosseous Vascular Access System
Arrow International, Inc.  (Subsid510(k) NO: K180395(Traditional)
ATTN: Frank  Pelc                 PHONE NO : 610 3780131 
2400 Bernville Road               SE DECISION MADE: 09-NOV-18
Reading PA  19605                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invia White Foam NPWT
Medela AG                         510(k) NO: K180415(Traditional)
ATTN: Georges  Hakim              PHONE NO : 41 41 7695151 651
Laettichstrasse 4b                SE DECISION MADE: 02-NOV-18
Baar Zug  CH CH-6341              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digistat Smart Central
ASCOM UMS srl unipersonale        510(k) NO: K180430(Traditional)
ATTN: Paolo  Burchietti           PHONE NO : 011 39 0550512161 
Via Amilcare Ponchielli 29        SE DECISION MADE: 23-NOV-18
Scandicci (FI)  IT 50018          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AI-ECG Platform
Shenzhen Carewell Electronics., Lt510(k) NO: K180432(Traditional)
ATTN: Chang  Liu                  PHONE NO : 86 755 86170389 
2/F, Building 1, Glory Medical IndSE DECISION MADE: 19-NOV-18
Shenzhen  CN 518116               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apoller Flow Light Cure Flowable Composite
Greenway YW LLC                   510(k) NO: K180463(Abbreviated)
ATTN: Scott  Yin                  PHONE NO : 847 5255258 
21 N. Skokie Hwy., Suite 204      SE DECISION MADE: 14-NOV-18
Lake Bluff IL  60044              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
Coloplast Corp                    510(k) NO: K180469(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 06-NOV-18
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RectalPro 75 Endorectal Balloon
QLRAD International Ltd.          510(k) NO: K180478(Traditional)
ATTN: Arjen  Winkel               PHONE NO : 31 85 0490888 
Wormerweg 6                       SE DECISION MADE: 13-NOV-18
Almere  NL 1311 XB                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZOLL Propaq M
ZOLL Medical Corporation          510(k) NO: K180482(Traditional)
ATTN: Pooja  Dalvi                PHONE NO : 978 8056293 
269 & 271 Mill Road               SE DECISION MADE: 30-NOV-18
Chelmsford MA  01824-4105         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tinnitus Sound Generator Module
GN Hearing A/S                    510(k) NO: K180495(Traditional)
ATTN: Lars  Hagander              PHONE NO : 45 4575 1111 
Lautrupbjerg 7                    SE DECISION MADE: 30-NOV-18
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Reline Fenestrated Screws, High V+ Bone Cement
NuVasive, Incorporated            510(k) NO: K180498(Traditional)
ATTN: Martin  Yahiro              PHONE NO : 858 6385589 
7475 Lusk Blvd.                   SE DECISION MADE: 28-NOV-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InstruSafe(R) Sterilization Container
Summit Medical Inc.               510(k) NO: K180528(Traditional)
ATTN: Nicole  Dove                PHONE NO : 651 7893939 
815 Northwest Parkway, Suite 100  SE DECISION MADE: 16-NOV-18
St. Paul MN  55121                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes 2.0 mm Quick Insertion Screws
Synthes USA Products, LLC         510(k) NO: K180541(Traditional)
ATTN: Nicholas  Fountoulakis      PHONE NO : 610 7196553 
1301 Goshen Parkway               SE DECISION MADE: 21-NOV-18
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jet Power Injectable PICC
Jet Medical, Inc.                 510(k) NO: K180546(Traditional)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 
97 Main Street                    SE DECISION MADE: 21-NOV-18
Schwenksville PA  19473           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Monolith Cervical Corpectomy System
NuVasive, Incorporated            510(k) NO: K180550(Traditional)
ATTN: Martin  Yahiro              PHONE NO : 858 6385589 
7475 Lusk Boulevard               SE DECISION MADE: 20-NOV-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Greene Renal Transplant Stent Set
Cook Incorporated                 510(k) NO: K180557(Traditional)
ATTN: Yuan  Zhou                  PHONE NO : 812 3392235 102529
750 Daniels Way                   SE DECISION MADE: 23-NOV-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Responsive Arthroscopy Interference Screw System
Responsive Arthroscopy LLC        510(k) NO: K180573(Traditional)
ATTN: Doug  Kohrs                 PHONE NO : 858 7201847 
701 N. 3rd Street, Suite 202      SE DECISION MADE: 23-NOV-18
Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
Villa Sistemi Medicali S.p.A.     510(k) NO: K180601(Abbreviated)
ATTN: Paolo Casagrande Santin     PHONE NO : 39 02 48859239 
via delle Azalee 3                SE DECISION MADE: 02-NOV-18
Buccinasco  IT I-20090            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
KRONUS, Inc.                      510(k) NO: K180607(Traditional)
ATTN: Brian  Deis                 PHONE NO : 208 3774800 
170 S. Seneca Springs Way Suite 10SE DECISION MADE: 23-NOV-18
Star ID  83669                    510(k) STATEMENT
                                                    

DEVICE: Silk Voice
Sofregen Medical, Inc.            510(k) NO: K180631(Traditional)
ATTN: Anh  Hoang                  PHONE NO : 781 8742356 
200 Boston Avenue, Suite 1100     SE DECISION MADE: 08-NOV-18
Medford MA  02155                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)
MedCu Technologies, Ltd.          510(k) NO: K180643(Traditional)
ATTN: Gadi  Borkow                PHONE NO : 972 544 563666 
23 David Elazar St.               SE DECISION MADE: 23-NOV-18
Herzlia  IL 4627703               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green)
Hartalega Sdn Bhd                 510(k) NO: K180645(Traditional)
ATTN: Mr. Kuan Kam Hon            PHONE NO : 603 627 71733 
C-G-9, Jalan Dataran Sd 1 Dataran SE DECISION MADE: 16-NOV-18
Bandar Sri Damansara  MY 52200    510(k) STATEMENT
                                                    

DEVICE: Amsel Endo Occluder
Amsel Medical Corporation         510(k) NO: K180650(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 617 3958825 
171 Hamilton Street               SE DECISION MADE: 15-NOV-18
Cambridge MA  02139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System
K2M, LLC.                         510(k) NO: K180665(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 28-NOV-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
Olympus Medical Systems Corp.     510(k) NO: K180668(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 15-NOV-18
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Certa Dose Pediatric Midazolam 5mg/mL IM Syringe
Certa Dose, Inc.                  510(k) NO: K180683(Traditional)
ATTN: Caleb  Hernandez            PHONE NO : 
7351 E Lowry Blvd. #400           SE DECISION MADE: 07-NOV-18
Denver CO  80230                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AS-3XX Series Fingertip Pulse Oximeter
Xiamen Acurio Instruments Co., Ltd510(k) NO: K180685(Traditional)
ATTN: Angel  Liu                  PHONE NO : 86 592 6312776 
3rd-4th Floors, BI Park, No.2028 WSE DECISION MADE: 29-NOV-18
Xiamen  CN 361026                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiroCam Capsule Endoscope System
IntroMedic Co., Ltd.              510(k) NO: K180732(Traditional)
ATTN: Jinyoung  Lee               PHONE NO : 82 2 8019300 
Suite 1105, 1106 E&C Venture DreamSE DECISION MADE: 08-NOV-18
Seoul  KR 08375                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff
HARTALEGA SDN. BHD.               510(k) NO: K180786(Traditional)
ATTN: Kuan Kam Hon                PHONE NO : 603 62771773 
Dataran Sd Pju 9                  SE DECISION MADE: 02-NOV-18
Bandar Sri Damansara  MY 52200    510(k) STATEMENT
                                                    

DEVICE: Arterial Pressure Monitoring Set/Tray
Cook Incorporated                 510(k) NO: K180792(Traditional)
ATTN: Johnathan  Liu              PHONE NO : 812 3353575 104509
750 Daniels Way                   SE DECISION MADE: 30-NOV-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Actreen Hi-Lite Cath, Actreen Hi-Lite Set
B. Braun Medical Inc.             510(k) NO: K180801(Traditional)
ATTN: Anita J. Nemeth             PHONE NO : 610 2660500 
901 Marcon Boulevard              SE DECISION MADE: 05-NOV-18
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SaliPen
Saliwell Ltd.                     510(k) NO: K180838(Traditional)
ATTN: Ben Z. Beiski               PHONE NO : 972 3 5347592 
65 Hatamar St.                    SE DECISION MADE: 06-NOV-18
Harutzim  IL 6091700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNO Negative Pressure Wound Therapy System
Genadyne Biotechnologies, Inc.    510(k) NO: K180840(Traditional)
ATTN: Andrew  Goh                 PHONE NO : 516 4878787 
16 Midland Ave                    SE DECISION MADE: 30-NOV-18
Hicksville NY  11801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoSphere Advanced Monitor, HemoSphere Pressure Cable
Edwards Lifesciences, LLC         510(k) NO: K180881(Traditional)
ATTN: Chirag  Shah                PHONE NO : 949 2501580 
One Edwards Way                   SE DECISION MADE: 16-NOV-18
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GC Acrylic Primer
GC America Inc.                   510(k) NO: K180917(Traditional)
ATTN: Mark  Heiss                 PHONE NO : 708 5970900 
3737 W. 127th Street              SE DECISION MADE: 20-NOV-18
Alsip IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Planmed Verity
Planmed Oy                        510(k) NO: K180918(Traditional)
ATTN: Lars  Moring                PHONE NO : 358 20 7795300 
Sorvaajankatu 7                   SE DECISION MADE: 30-NOV-18
Helsinki  FI 00880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steribite
RJR Surgical, Inc.                510(k) NO: K180949(Traditional)
ATTN: John  Redmond               PHONE NO : 216 2412804 
2530 Superior Avenue              SE DECISION MADE: 08-NOV-18
Cleveland OH  44114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Pneumonia Panel
BioFire Diagnostics, LLC          510(k) NO: K180966(Traditional)
ATTN: Kristen J. Kanack           PHONE NO : 801 7366354 1330
515 Colorow Drive                 SE DECISION MADE: 09-NOV-18
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PureFlex Arterial Cannulae
Sorin Group Italia S.r.l          510(k) NO: K180979(Traditional)
ATTN: Luigi  Vecchi               PHONE NO : 011 39 053529811 
86, Via Statale 12 Nord           SE DECISION MADE: 16-NOV-18
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra Optia Apheresis System
Terumo BCT, Inc.                  510(k) NO: K181049(Special)
ATTN: Nicholas  Wong              PHONE NO : 303 2392384 
10811 W. Collins Avenue           SE DECISION MADE: 01-NOV-18
Lakewood CO  80215                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
Invacare Corporation              510(k) NO: K181090(Traditional)
ATTN: Elijah N. Wreh              PHONE NO : 440 3296840 
One Invacare Way                  SE DECISION MADE: 14-NOV-18
Elyria OH  44035                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orchestrate 3D
Orchestrate 3D                    510(k) NO: K181112(Traditional)
ATTN: Todd  Ehrler                PHONE NO : 888 7558320 
1747 North Riverside Ave          SE DECISION MADE: 26-NOV-18
Rialto CA  92376                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ApnoDent Appliance
ApnoMed, Inc.                     510(k) NO: K181123(Traditional)
ATTN: Joseph  Yousefian           PHONE NO : 425 4434020 
1515 116th Ave NE, Suite 105C     SE DECISION MADE: 21-NOV-18
Bellevue WA  98004                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IT-III active System
Neobiotech Co., Ltd.              510(k) NO: K181137(Traditional)
ATTN: Young-Ku  Heo               PHONE NO : 82 2 5822885 
#312-1, 36, Digital-ro 27-Gil, GurSE DECISION MADE: 16-NOV-18
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axis Chena Cervical PEEK Spacer System
Axis Orthopaedics                 510(k) NO: K181140(Traditional)
ATTN: Craig  Wilcox               PHONE NO : 907 2023111 
34355 Poppy Wood St.              SE DECISION MADE: 16-NOV-18
Soldotna AK  99669                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearPoint System
MRI Interventions, Inc.           510(k) NO: K181195(Traditional)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 02-NOV-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
Vygon USA                         510(k) NO: K181208(Traditional)
ATTN: Jillian  Mikovich           PHONE NO : 800 4735414 
2750 Morris Rd Suite A200         SE DECISION MADE: 02-NOV-18
Lansdale PA  19460                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD PhaSeal Optima Closed System Transfer Device
Becton, Dickinson and Company     510(k) NO: K181221(Traditional)
ATTN: Amy  Honey                  PHONE NO : 801 3043908 
1 Becton Drive                    SE DECISION MADE: 30-NOV-18
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea CT Brain Perfusion
Vital Images, Inc.                510(k) NO: K181247(Traditional)
ATTN: Susan  Atwood               PHONE NO : 952 4879759 
5850 Opus Parkway, Suite 300      SE DECISION MADE: 20-NOV-18
Minnetonka MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ConnectedOR Hub with Device and Voice Control
Stryker                           510(k) NO: K181258(Traditional)
ATTN: April  Malmborg             PHONE NO : 408 7542473 
5900 Optical Court                SE DECISION MADE: 05-NOV-18
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Implantswiss Dental Implant System, Implantswiss Dental Abutment System
Novodent SA                       510(k) NO: K181266(Traditional)
ATTN: Cem  Kocer                  PHONE NO : 41 024 5242828 
Y-PARC Technopole Avenue des ScienSE DECISION MADE: 01-NOV-18
Yverdons-les-Bains  CH CH1400     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K181273(Special)
ATTN: Joon Ho Jung                PHONE NO : 82 2 9100453 
43, Banpo-daero 82-gil, Seocho-gu SE DECISION MADE: 01-NOV-18
Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambu aScope RLS Slim
Ambu A/S                          510(k) NO: K181286(Traditional)
ATTN: Camilla  Wismar             PHONE NO : 45 7225 2000 
Baltorpbakken 13                  SE DECISION MADE: 30-NOV-18
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Athelas One
Athelas Inc.                      510(k) NO: K181288(Traditional)
ATTN: Tanay  Tandon               PHONE NO : 408 6031954 
10209 Danube Dr.                  SE DECISION MADE: 05-NOV-18
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
Cogentix Medical, Inc.            510(k) NO: K181292(Traditional)
ATTN: Christa  Blaisdell          PHONE NO : 952 4266161 
40 Ramland Road South             SE DECISION MADE: 15-NOV-18
Orangeburg NY  10962              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DENTIOIII series (DENTIOIII, DENTIOIII-S)
HDX WILL CORP.                    510(k) NO: K181297(Traditional)
ATTN: Lee  Myoung-Joon            PHONE NO : 82 43 7107318 
#105, 106, 201, 202, 203, 204, 38,SE DECISION MADE: 21-NOV-18
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Pneumonia Panel plus
BioFire Diagnostics, LLC          510(k) NO: K181324(Traditional)
ATTN: Kristen J. Kanack           PHONE NO : 801 7366354 1330
515 Colorow Drive                 SE DECISION MADE: 15-NOV-18
Salt Lake City UT  84108          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immucise Intradermal Injection System
Terumo Corporation                510(k) NO: K181369(Traditional)
ATTN: Yuko  Watanabe              PHONE NO : 732 3024900 4120
44-1, 2-Chome, Hatagaya           SE DECISION MADE: 13-NOV-18
Shibuya-Ku,  JP 151-0072          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A.B. Dental Devices Dental Implants System
A.B Dental Device Ltd.            510(k) NO: K181381(Traditional)
ATTN: Gabi  Krauss                PHONE NO : 972 88531388 
19 Hayalomim St.                  SE DECISION MADE: 23-NOV-18
Ashdod  IL 7761117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oral Device OA, Oral Device S
Passion for Life Healthcare (UK) L510(k) NO: K181396(Traditional)
ATTN: Paul  Earps                 PHONE NO : 44 151 5504708 
Pioneer House, Pioneer Business PaSE DECISION MADE: 16-NOV-18
Ellesmere Port  GB CH65 1AD       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
GE Healthcare                     510(k) NO: K181403(Traditional)
ATTN: Michel  Genuer              PHONE NO : 33 01 30704741 
283  Rue de la Miniere            SE DECISION MADE: 02-NOV-18
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX Enteric Viral Panel, BD MAX Instrument
Becton, Dickinson and Company     510(k) NO: K181427(Traditional)
ATTN: Laura  Stewart              PHONE NO : 410 3164435 
7 Loveton Circle                  SE DECISION MADE: 29-NOV-18
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SporView Rapid Read Biological Indicator SteamPlus Test Pack
Crosstex/SPSmedical, A Division of510(k) NO: K181434(Traditional)
ATTN: Megan  Skaar                PHONE NO : 800 7221529 
6789 West Henrietta Road          SE DECISION MADE: 14-NOV-18
Rush NY  14543                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accula RSV Test
Mesa Biotech, Inc.                510(k) NO: K181443(Dual Track)
ATTN: Barbara  Stevens            PHONE NO : 858 7355043 
6190 Cornerstone Court, Suite 220 SE DECISION MADE: 23-NOV-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
Alcon Laboratories, Inc.          510(k) NO: K181454(Traditional)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 21-NOV-18
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cryotop®US-flash and Cryotop®US-scoop
Kitazato Corporation              510(k) NO: K181469(Traditional)
ATTN: Futoshi  Inoue              PHONE NO : 81 545 662202 
81 Nakajima                       SE DECISION MADE: 09-NOV-18
Fuji  JP 416-0907                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HPM-6000UF
BTL Industries, Inc.              510(k) NO: K181497(Traditional)
ATTN: David  Chmel                PHONE NO : 1 866 2851656 
362 Elm Street                    SE DECISION MADE: 14-NOV-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Afina
NeuroVision Imaging, LLC          510(k) NO: K181501(Traditional)
ATTN: Pepe  Davis                 PHONE NO : 925 2867432 
1395 Garden Highway, Suite 250    SE DECISION MADE: 02-NOV-18
Sacramento CA  95833              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
Vyaire Medical, Inc.              510(k) NO: K181524(Traditional)
ATTN: Elmar  Niedermeyer          PHONE NO : 49 931 4972361 
Leibnizstrasse 7                  SE DECISION MADE: 30-NOV-18
Hoechber  DE 97204                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neurosign V4 Intraoperative Nerve Monitor
Magstim Company Ltd.              510(k) NO: K181559(Traditional)
ATTN: Tom  Campbell               PHONE NO : 44 0 1994240798 
Spring Gardens                    SE DECISION MADE: 09-NOV-18
Whitland  GB SA34 0HR             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POPS! one Blood Glucose Monitoring System
TaiDoc Technology Corporation     510(k) NO: K181588(Traditional)
ATTN: Anne  Kuo                   PHONE NO : 886 2 66258188 
6F, No.127, Wugong 2nd Rd., Wugu DSE DECISION MADE: 30-NOV-18
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neurostructures Cavetto® [MAX] Cervical Cage System
NeuroStructures, Inc.             510(k) NO: K181590(Special)
ATTN: Kathleen  Wong              PHONE NO : 949 3704497 
199 Technology Drive, Suite 110   SE DECISION MADE: 08-NOV-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
HRS Co., Ltd.                     510(k) NO: K181604(Traditional)
ATTN: Seunghwan  Go               PHONE NO : 82 31 6558822 
7, Chupalsandan 2-gil, Paengseong-SE DECISION MADE: 28-NOV-18
Gyeonggi-do  KR 17998             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
Siemens Medical Solutions USA, Inc510(k) NO: K181613(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
40 Liberty Blvd Mailcode 65-1A    SE DECISION MADE: 06-NOV-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panta 2 Arthrodesis Nail System
Integra Lifesciences Corporation  510(k) NO: K181639(Special)
ATTN: Blesson  Abraham            PHONE NO : 512 8365001 
11101 Metric Blvd.                SE DECISION MADE: 02-NOV-18
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartBag (SmartPouch)
11 Health Technologies Limited    510(k) NO: K181643(Traditional)
ATTN: Michael  Seres              PHONE NO : 44 0 2083871308 
The Kinetic Business Centre, TheobSE DECISION MADE: 16-NOV-18
Borehamwood  GB WD6 4PJ           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celesteion, PCA-9000A/3, V6.5
Canon Medical Systems Corporation 510(k) NO: K181646(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 16-NOV-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thoraguard System
Centese, Inc.                     510(k) NO: K181667(Traditional)
ATTN: Evan  Luxon                 PHONE NO : 402 4170740 
3929 Harney St Suite 3008         SE DECISION MADE: 29-NOV-18
Omaha NE  68131                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VAMP Plus Venous/Arterial Blood Management Protection System
Edwards Lifesciences, LLC         510(k) NO: K181684(Traditional)
ATTN: Ye Seul Kim                 PHONE NO : 949 2502445 
One Edwards Way                   SE DECISION MADE: 08-NOV-18
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexcomp
Meta Biomed Co., Ltd.             510(k) NO: K181689(Traditional)
ATTN: Suk  Song Oh                PHONE NO : 82 43 2308841 
270, Osong Saengmyeong 1-ro, OsongSE DECISION MADE: 15-NOV-18
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMS Femoral Stem
Medacta International SA          510(k) NO: K181693(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 28-NOV-18
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ChitoZolve
Gyrus ACMI, Inc                   510(k) NO: K181696(Traditional)
ATTN: Dolan  Mills                PHONE NO : 901 3730236 
136 Turnpike Road                 SE DECISION MADE: 30-NOV-18
Southborough MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transpara
ScreenPoint Medical BV            510(k) NO: K181704(Traditional)
ATTN: Nico  Karssemeijer          PHONE NO : 31 024 2020020 
Stationsplein 26                  SE DECISION MADE: 21-NOV-18
Nijmegen  NL 6512AB               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Serenity Piezo Sensor, Serenity Thermocouple Sensor
Neurotronics, Inc.                510(k) NO: K181709(Traditional)
ATTN: David  Pezet                PHONE NO : 352 3729955 
4500 NW 27th Ave Ste C2           SE DECISION MADE: 16-NOV-18
Gainesville FL  32606             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Compatible Aspiration Kit
MRI Interventions, Inc.           510(k) NO: K181731(Traditional)
ATTN: Pete  Piferi                PHONE NO : 949 9006833 
5 Musick                          SE DECISION MADE: 20-NOV-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SITZMARKS
Konsyl Pharmaceuticals            510(k) NO: K181750(Traditional)
ATTN: Frank  Gunsallus III        PHONE NO : 410 822 5192
050 Industrial Park Road          SE DECISION MADE: 15-NOV-18
Easton MD  21601                  510(k) STATEMENT
                                                    

DEVICE: Günther Tulip® Vena Cava Filter Retrieval Set
Cook Incorporated                 510(k) NO: K181757(Traditional)
ATTN: Steven  Lawrie              PHONE NO : 812 3553575 104518
750 Daniels Way; P.O. Box 489     SE DECISION MADE: 06-NOV-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerDot PD-01MT
Smartmissimo Technologies Pte Ltd 510(k) NO: K181759(Abbreviated)
ATTN: Alexey  Pisarev             PHONE NO : 65 83216256 
#28-01, SGX Centre II, 4 Shenton WSE DECISION MADE: 09-NOV-18
Singapore  SG 068807              510(k) STATEMENT
                                                    

DEVICE: DynaClipTM Bone Staple
MedShape, Inc.                    510(k) NO: K181781(Traditional)
ATTN: Jack  Griffis               PHONE NO : 678 2353311 
1575 Northside Drive, Suite 440   SE DECISION MADE: 05-NOV-18
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra S3 Plus
Uzinmedicare Co.                  510(k) NO: K181784(Traditional)
ATTN: Nathan  Ahn                 PHONE NO : 82 31 3751076 
56, Dongtansandan 5-Gil, Dongtan-MSE DECISION MADE: 30-NOV-18
Hwaseong-Si  KR 18487             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Sternal System
Jeil Medical Corporation          510(k) NO: K181806(Traditional)
ATTN: Ahhyeon  Woo                PHONE NO : 82 2 3503533 
702,703,704,705,706,804,805,807,81SE DECISION MADE: 20-NOV-18
Seoul  KR 08378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ceramic Denture Zirconia Ceramics Block
Qinhuangdao Silide Ceramic Technol510(k) NO: K181816(Traditional)
ATTN: Lou  ChunHua                PHONE NO : 86 335 7675829 
No. 1 Yanghe Rd., Quinhuangdao EcoSE DECISION MADE: 29-NOV-18
Qinhuangdao  CN 066000            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMARTRELEASE Endoscopic Soft Tissue Release System
MicroAire Surgical Instruments LLC510(k) NO: K181819(Traditional)
ATTN: Glenn  Gerstenfeld          PHONE NO : 434 9758344 
3590 Grand Forks Blvd             SE DECISION MADE: 06-NOV-18
Charlottesville VA  22911         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Unite Mini Plates and Screws
Medline Industries, Inc.          510(k) NO: K181820(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
Three Lakes Drive                 SE DECISION MADE: 01-NOV-18
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velofix TLIF Cage
U&I Corporation                   510(k) NO: K181829(Special)
ATTN: Jee-Ae  Bang                PHONE NO : 82 31 8606846 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 14-NOV-18
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliVue Multi-Measurement Module MMX
Philips Medizin Systeme Boeblingen510(k) NO: K181831(Abbreviated)
ATTN: Stefan  Breuer              PHONE NO : 49 7031 4632321 
Hewlett-Packard-Str. 2            SE DECISION MADE: 15-NOV-18
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spinal Elements Ti-Bond coated devices
Spinal Elements Inc.              510(k) NO: K181837(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071816 
3115 Melrose Dr., Suite 200       SE DECISION MADE: 02-NOV-18
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System
Globus Medical Inc.               510(k) NO: K181846(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 2950
2560 General Armistead Ave.       SE DECISION MADE: 06-NOV-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inversa Implants
Southern Implants (Pty) Ltd       510(k) NO: K181850(Traditional)
ATTN: Lauranda  Breytenbach       PHONE NO : 27 12 6671046 
1 Albert Road                     SE DECISION MADE: 14-NOV-18
Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Kossan International Sdn. Bhd.    510(k) NO: K181857(Traditional)
ATTN: Cho Sow  Fong               PHONE NO : 603 3291 0516 
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 20-NOV-18
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: VivaSight-SL (TVT) system
ETView Ltd.                       510(k) NO: K181880(Special)
ATTN: Yoram  Levy                 PHONE NO : 972 72 2607063 
M.P Misgav                        SE DECISION MADE: 29-NOV-18
Misgav Business Park  IL 2017900  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VivaSight-DL System
ETView Ltd.                       510(k) NO: K181886(Special)
ATTN: Yoram  Levy                 PHONE NO : 972 72 2607063 
M.P Misgav                        SE DECISION MADE: 14-NOV-18
Misgav Business Park  IL 2017900  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brainlab Compatible K2M Navigation Instruments
K2M                               510(k) NO: K181890(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 09-NOV-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Marinr Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K181897(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 15-NOV-18
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Interlude 100% Cotton Tampon
ALBAAD fem                        510(k) NO: K181911(Traditional)
ATTN: Shlomo  Helvits             PHONE NO : 972 4 6223860 
1, Alon Hatavor St.               SE DECISION MADE: 02-NOV-18
Caesarea Ind. Park  IL 3088900    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioInsight Cardiac Mapping System
Medtronic, Inc.                   510(k) NO: K181918(Traditional)
ATTN: Janell  Colley              PHONE NO : 612 9797529 
8200 Coral Sea Street NE          SE DECISION MADE: 08-NOV-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solidity Vertebral Body Replacement
ulrich medical USA                510(k) NO: K181921(Traditional)
ATTN: Hans  Stover                PHONE NO : 636 5190268 
18221 Edison Avenue               SE DECISION MADE: 16-NOV-18
Chesterfield MO  63005            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid T8, Vivid T9
GE Medical Systems Ultrasound & Pr510(k) NO: K181934(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
9900 W. Innovation Drive          SE DECISION MADE: 06-NOV-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: icobrain
icometrix NV                      510(k) NO: K181939(Traditional)
ATTN: Jan  Verheyden              PHONE NO : 32 16 369000 
Kolonel Begaultlaan 1b/12         SE DECISION MADE: 06-NOV-18
Leuven  BE 3012                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil
RAPID Biomedical GmbH             510(k) NO: K181948(Traditional)
ATTN: Christian  Zimmermann       PHONE NO : 49 9365 88260 
Kettelerstr. 3-11                 SE DECISION MADE: 16-NOV-18
Rimpar  DE 97222                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ostaPek Interbody Fusion Cages
coLigne, AG                       510(k) NO: K181963(Traditional)
ATTN: Robert  Lange               PHONE NO : 41 43 3438000 
Utoquai 43                        SE DECISION MADE: 14-NOV-18
Zurich  CH CH 8008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson E6, Voluson E8, Voluson E10
GE Healthcare                     510(k) NO: K181985(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 15-NOV-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heat Pain Pro
Omron Healthcare, Inc.            510(k) NO: K181992(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court             SE DECISION MADE: 09-NOV-18
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MATRx Plus
Zephyr Sleep Technologies         510(k) NO: K181996(Traditional)
ATTN: Sabina  Bruehlmann          PHONE NO : 587 3320285 
102, 701 64 Ave SE                SE DECISION MADE: 21-NOV-18
Calgary  CA t2h-2c3               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioBand ECG Event Recorder
Samsung Semiconductor Inc.        510(k) NO: K181998(Traditional)
ATTN: Bhupinder  Singh            PHONE NO : 408 8327124 
3655 North First Street           SE DECISION MADE: 15-NOV-18
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wet Organics Personal Lubricant
Trigg Laboratories DBA Wet Interna510(k) NO: K182027(Traditional)
ATTN: Simone  Buntin              PHONE NO : 702 9574400 
4220 W Windmill Lane, Suite 140   SE DECISION MADE: 21-NOV-18
Las Vegas NV  89139               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Faros Mobile
Bittium Biosignals Ltd.           510(k) NO: K182030(Abbreviated)
ATTN: Taneli  Vaaraniemi          PHONE NO : 358 17 5817700 
Pioneerinkatu 6                   SE DECISION MADE: 08-NOV-18
Kuopio  FI FI-70800               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System
Tyson Bioresearch, Inc.           510(k) NO: K182046(Special)
ATTN: Vance  Chang                PHONE NO : 886 37 585988 
5F., No. 16, 18, 20, 22, Kedong 3rSE DECISION MADE: 30-NOV-18
Zhunan Township  TW 35053         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
Tyson Bioresearch, Inc.           510(k) NO: K182047(Special)
ATTN: Vance  Chang                PHONE NO : 886 37 585988 
5F., No. 16, 18, 20, 22, Kedong 3rSE DECISION MADE: 29-NOV-18
Zhunan Township  TW 35053         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mazor X System (Mazor X Stealth Edition)
Mazor Robotics Ltd.               510(k) NO: K182077(Traditional)
ATTN: Marina  Hefetz              PHONE NO : 972 4 6187100 
5 Shacham St. North Industrial ParSE DECISION MADE: 02-NOV-18
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalys Precision Laser System
AMO Manufacturing USA, LLC        510(k) NO: K182083(Traditional)
ATTN: James Patrick Garvey II     PHONE NO : 650 4500577 
510 Cottonwood Drive              SE DECISION MADE: 09-NOV-18
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AposTherapy System
APOS Medical Assets Ltd.          510(k) NO: K182090(Traditional)
ATTN: Cliff  Bleustein            PHONE NO : 917 9932911 
7 Hapelech Street                 SE DECISION MADE: 16-NOV-18
Tel Aviv  IL 6816727              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tina-quant Transferrin ver.2 (urine application)
Roche Diagnostics Operations (RDO)510(k) NO: K182095(Traditional)
ATTN: Lindsay  Jones              PHONE NO : 317 5213544 
9115 Hague Road                   SE DECISION MADE: 05-NOV-18
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs
Owens & Minor Halyard, Inc.       510(k) NO: K182096(Abbreviated)
ATTN: Angela L. Bunn              PHONE NO : 470 4485856 
5405 Windward Parkway             SE DECISION MADE: 02-NOV-18
Alpharetta GA  30004              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: React 71 Catheter
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K182097(Traditional)
ATTN: Ryan  Kenney                PHONE NO : 949 2975489 
9775 Toledo Way                   SE DECISION MADE: 14-NOV-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: N Latex FLC kappa assay, N Latex FLC lambda assay
Siemens Healthcare Diagnostics Pro510(k) NO: K182098(Traditional)
ATTN: Christine  Perkins          PHONE NO : 302 6318811 
Emil-von-Behring-Str. 76          SE DECISION MADE: 01-NOV-18
Marburg  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Riptide Aspiration System (React 71 Catheter)
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K182101(Traditional)
ATTN: Ryan  Kenney                PHONE NO : 949 2975489 
9775 Toledo Way                   SE DECISION MADE: 14-NOV-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NavLock Trackers, Robotic Reference Frame
Medtronic Navigation              510(k) NO: K182104(Traditional)
ATTN: Jainam  Shah                PHONE NO : 720 8902595 
826 Coal Creek Circle             SE DECISION MADE: 02-NOV-18
Louisville CO  80027              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant
United Consortium                 510(k) NO: K182105(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 14-NOV-18
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REDAPT Modular Acetabular Shell
Smith & Nephew, Inc.              510(k) NO: K182109(Traditional)
ATTN: Meenakshi  Gupta            PHONE NO : 901 3996139 
7135 Goodlett Farms Parkway       SE DECISION MADE: 16-NOV-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CDI Blood Parameter Monitoring System 550
Terumo Cardiovascular Systems Corp510(k) NO: K182110(Traditional)
ATTN: Bryan K. Hann               PHONE NO : 734 7415816 
6200 Jackson Road                 SE DECISION MADE: 02-NOV-18
Ann Arbor MI  48103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K182121(Traditional)
ATTN: Erikka  Edwardsen           PHONE NO : 800 8763133 
1800 Pyramid Place                SE DECISION MADE: 02-NOV-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Blood Pressure Monitor Model BP6100
Omron Healthcare, Inc.            510(k) NO: K182127(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court             SE DECISION MADE: 02-NOV-18
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shenzhen AOJ Medical Technology Co510(k) NO: K182133(Traditional)
ATTN: Qihuan  Zhao                PHONE NO : 86 1860 3031299 
Room 202, HaoGu Industry Park, 203SE DECISION MADE: 20-NOV-18
Shenzhen  CN 518103               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARiX RAD Radiographic System
Compania Mexicana De Radiologia CG510(k) NO: K182134(Traditional)
ATTN: Tonatiuh Monroy Soberon     PHONE NO : 55 54 821300 
Fraccionamiento Industrial la NoriSE DECISION MADE: 26-NOV-18
El Marques, Queretaro  MX 76240   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM
Stryker                           510(k) NO: K182160(Traditional)
ATTN: April  Malmborg             PHONE NO : 408 754 2473
5900 Optical Court                SE DECISION MADE: 05-NOV-18
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiBond eXTRa Universal
Kerr Corporation                  510(k) NO: K182162(Traditional)
ATTN: Mohammad Saad Ansari        PHONE NO : 714 5167334 
1717 W. Collins Ave               SE DECISION MADE: 07-NOV-18
Orange CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Blood Pressure Monitor Model BP4350
Omron Healthcare, Inc.            510(k) NO: K182166(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court, Suite 100  SE DECISION MADE: 08-NOV-18
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AdVance XP Male Sling
Boston Scientific Corporation     510(k) NO: K182169(Traditional)
ATTN: Kaitlyn  Rainbow            PHONE NO : 952 6306627 
10700 Bren Road West              SE DECISION MADE: 27-NOV-18
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AdvantageRib Anterior System
SIG Medical Corp.                 510(k) NO: K182179(Traditional)
ATTN: Andrew  Davison             PHONE NO : 717 5532021 
238 E. Chocolate Avenue Suite 2   SE DECISION MADE: 16-NOV-18
Hershey PA  17033                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Persyst 14 EEG Review and Analysis Software
Persyst Development Corporation   510(k) NO: K182181(Traditional)
ATTN: Dari  Darabbeigi            PHONE NO : 858 4614542 109
420 Stevens Avenue, Suite 210     SE DECISION MADE: 29-NOV-18
Solana Beach CA  92075            510(k) STATEMENT
                                                    

DEVICE: YUKON OCT Spinal System
K2M                               510(k) NO: K182182(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 15-NOV-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arco™-SA Lumbar Cage System
NeuroStructures, Inc.             510(k) NO: K182195(Special)
ATTN: Kathleen  Wong              PHONE NO : 949 3704497 
16 Technology Drive, Suite 165    SE DECISION MADE: 09-NOV-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stratum™ Foot Plating System
Nextremity Solutions, Inc.        510(k) NO: K182201(Traditional)
ATTN: Adam  Finley                PHONE NO : 574 8076150 
210 North Buffalo Street          SE DECISION MADE: 16-NOV-18
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit Syringe
Merit Medical Systems, Inc        510(k) NO: K182216(Abbreviated)
ATTN: John  Skousen               PHONE NO : 801 3163724 
1600 W Merit Parkway              SE DECISION MADE: 06-NOV-18
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FerriSmart Analysis System
Resonance Health Analysis Services510(k) NO: K182218(Traditional)
ATTN: Celine  Royet               PHONE NO : 61 8 92865300 
141 Burswood Road                 SE DECISION MADE: 30-NOV-18
Burswood  AU 6100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Curbell branded Patient Monitoring Cables
Curbell Medical Products, Inc.    510(k) NO: K182220(Special)
ATTN: Michael  Winter             PHONE NO : 716 6673377 7419
20 Centre Drive                   SE DECISION MADE: 07-NOV-18
Orchard Park NY  14127            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
Edwards Lifesciences, LLC         510(k) NO: K182245(Traditional)
ATTN: Christine  Chun             PHONE NO : 949 2502773 
One Edwards Way                   SE DECISION MADE: 30-NOV-18
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aspire Venting Tube
Aspire Bariatrics, Inc            510(k) NO: K182248(Traditional)
ATTN: Monica  Ferrante            PHONE NO : 484 2001031 
3200 Horizon Dirve Suite 100      SE DECISION MADE: 13-NOV-18
King of Prussia PA  19406         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
Bausch & Lomb Incorporated        510(k) NO: K182249(Traditional)
ATTN: Barbara  Klube-Falso        PHONE NO : 585 3388503 
1400 North Goodman Street         SE DECISION MADE: 30-NOV-18
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
Aziyo Biologics, Inc.             510(k) NO: K182255(Traditional)
ATTN: Wendy  Perreault            PHONE NO : 
1100 Old Ellis Road, Suite 1200   SE DECISION MADE: 15-NOV-18
Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CodMan Certas Plus Programmable Valve
Integra LifeSciences Corp.        510(k) NO: K182265(Traditional)
ATTN: Nancy  MacDonald            PHONE NO : 781 9715664 
11 Cabot Blvd                     SE DECISION MADE: 20-NOV-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellene CO2 Laser System
Bio-Med USA Inc.                  510(k) NO: K182270(Traditional)
ATTN: Young  Chi                  PHONE NO : 973 2785222 
27 New England Drive              SE DECISION MADE: 02-NOV-18
Ramsey NJ  07446                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT
Bayer Medical Care Inc.           510(k) NO: K182273(Special)
ATTN: Lisa A. Ewing               PHONE NO : 724 8167297 
1 Bayer Drive                     SE DECISION MADE: 01-NOV-18
Indianola PA  15051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orbit Subretinal Delivery System
Orbit Biomedical, Inc.            510(k) NO: K182274(Traditional)
ATTN: Michael  Keane              PHONE NO : 484 8854744 
300 Brookside Ave.                SE DECISION MADE: 20-NOV-18
Ambler PA  19002                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
Bayer Medical Care Inc.           510(k) NO: K182276(Special)
ATTN: Katie  Dillon               PHONE NO : 412 6524408 
1 Bayer Drive                     SE DECISION MADE: 01-NOV-18
Indianola PA  15051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Versana Premier
GE Medical Systems Ultrasound and 510(k) NO: K182277(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W. Innovation Drive          SE DECISION MADE: 21-NOV-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit Syringe
Merit Medical Systems, Inc.       510(k) NO: K182279(Abbreviated)
ATTN: John  Skousen               PHONE NO : 801 3163724 
1600W Merit Parkway               SE DECISION MADE: 06-NOV-18
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TPH Spectra ST Flowable Composite Restorative
Dentsply Sirona                   510(k) NO: K182288(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 20-NOV-18
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6MP Color LCD Monitor
Shenzhen Beacon Display Technology510(k) NO: K182291(Traditional)
ATTN: Fu  Ailing                  PHONE NO : 86 075533 9851185150 
12F, Block B1, Nanshan Zhiyuan, NoSE DECISION MADE: 20-NOV-18
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: hemochroma PLUS System
Immunostics, Inc.                 510(k) NO: K182298(Traditional)
ATTN: Junghee  Kim                PHONE NO : 732 9180770 
38 Industrial Way East, Suite1    SE DECISION MADE: 16-NOV-18
Eatontown NJ  07724               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hyper GP (tisilfocon A) Daily Wear Contact Lens
CONTAMAC LTD.                     510(k) NO: K182304(Traditional)
ATTN: Rob  McGregor               PHONE NO : 44 17 99542000 
Carlton House Shire Hill          SE DECISION MADE: 23-NOV-18
Saffron Walden  GB CB11 3AU       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sunkingdom Slit Lamp
Chongqing Sunkingdom Medical Instr510(k) NO: K182306(Traditional)
ATTN: Joy  Tse                    PHONE NO : 863 6 8643390 
1012, Block A of China Resource CeSE DECISION MADE: 22-NOV-18
Chongqing  CN 400050              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EkoSonic MACH 4 Endovascular Device with EkoSonic Control Unit
BTG International, Inc.           510(k) NO: K182324(Special)
ATTN: Benjamin  Hornsey           PHONE NO : 425 4153413 
11911 N Creek Pkwy S              SE DECISION MADE: 26-NOV-18
Bothell WA  98011                 510(k) STATEMENT
                                                    

DEVICE: SureCure Orthodontic Aligner System
Digital Orthodontic Care          510(k) NO: K182329(Traditional)
ATTN: Jeff  Sheppard              PHONE NO : 647 9777253 
348 Bronte Street, Unit 16        SE DECISION MADE: 08-NOV-18
Milton  CA L925B6                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SubtlePET
Subtle Medical, Inc.              510(k) NO: K182336(Traditional)
ATTN: Enhao  Gong                 PHONE NO : 650 3978709 
880 Santa Cruz Ave, Suite 200     SE DECISION MADE: 30-NOV-18
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Sky Bio Computerized Orthodontic Bracket System
Blue Sky Bio                      510(k) NO: K182338(Third Party - Traditional)
ATTN: Albert  Zickmann            PHONE NO : 718 3760422 
888 E Belvedere Rd Suite 212      SE DECISION MADE: 09-NOV-18
Grayslake IL  60030               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
Exactech, Inc.                    510(k) NO: K182346(Traditional)
ATTN: Meredith  May               PHONE NO : 
2320 N.W. 66th Court              SE DECISION MADE: 26-NOV-18
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SP-LINK™ System
Medical Designs LLC               510(k) NO: K182352(Traditional)
ATTN: Kristi  Vondra              PHONE NO : 605 2751032 
6709 S. Minnesota Ave, Suite 204  SE DECISION MADE: 21-NOV-18
Sioux Falls SD  57108             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
Phadia AB                         510(k) NO: K182353(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18165000 
Rapsgatan 7P                      SE DECISION MADE: 27-NOV-18
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Teleport Microcatheter
OrbusNeich Medical Trading Inc.   510(k) NO: K182360(Traditional)
ATTN: John  Pazienza              PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 09-NOV-18
Fort Lauderdale FL  33060         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore Sapphire
Electrocore, Inc.                 510(k) NO: K182369(Traditional)
ATTN: Mike  Romaniw               PHONE NO : 973 2900097 
150 Allen Road, Suite 201         SE DECISION MADE: 27-NOV-18
Basking Ridge NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEON Endoscopic Stapler
Lexington Medical, Inc.           510(k) NO: K182380(Traditional)
ATTN: Douglas  MacBride           PHONE NO : 617 2573668 
11 Executive Park Drive           SE DECISION MADE: 28-NOV-18
Billerica MA  01862               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASI Automated ASI RPR Test for Syphilis on the ASI Evolution
Arlington Scientific, Inc. (ASI)  510(k) NO: K182391(Traditional)
ATTN: David  Binks                PHONE NO : 801 4898911 
1840 North Technology Dr.         SE DECISION MADE: 30-NOV-18
Springville UT  84663             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dexcom Pro Q Continuous Glucose Monitoring System
Dexcom, Inc                       510(k) NO: K182405(Traditional)
ATTN: Luke  Olson                 PHONE NO : 858 8755307 
6310 Sequence Dr.                 SE DECISION MADE: 02-NOV-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V3 Segmental Plating System
Atlas Spine, Inc.                 510(k) NO: K182418(Traditional)
ATTN: Thomas  Smith               PHONE NO : 561 7411108 
1555 Jupiter Park Drive, Suite 1  SE DECISION MADE: 29-NOV-18
Jupiter FL  33458                 510(k) STATEMENT
                                                    

DEVICE: Universal Mesh - Sterile
Stryker Leibinger GmbH & Co. KG   510(k) NO: K182425(Special)
ATTN: Gregory  Gohl               PHONE NO : 269 3894319 
Boetzinger Strasse 41             SE DECISION MADE: 06-NOV-18
Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
Canon Medical Systems Corporation 510(k) NO: K182427(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 02-NOV-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Konicaminolta DI-X1
Konica Minolta, Inc.              510(k) NO: K182431(Traditional)
ATTN: Tsutomu  Fukui              PHONE NO : 81 42 5898429 
1 Sakura-machi                    SE DECISION MADE: 26-NOV-18
Hino-shi  JP 191-8511             510(k) STATEMENT
                                                    

DEVICE: MiniGuard Arterial Safety Valve
Quest Medical, Inc.               510(k) NO: K182442(Traditional)
ATTN: Tosan  Onosode              PHONE NO : 972 3326338 
One Allentown Parkway             SE DECISION MADE: 06-NOV-18
Allen TX  75002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ERBEFLO Olympus Scope Port Connector
Erbe USA, Inc.                    510(k) NO: K182444(Traditional)
ATTN: John  Tartal                PHONE NO : 770 9554400 
2225 Northwest Parkway            SE DECISION MADE: 06-NOV-18
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
Covidien, LLC                     510(k) NO: K182451(Traditional)
ATTN: Rebecca  Clark              PHONE NO : 303 5306427 
5920 Longbow Drive                SE DECISION MADE: 06-NOV-18
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Alteon Highly Polished Femoral Stem
Exactech, Inc.                    510(k) NO: K182462(Traditional)
ATTN: Zach  Sharrah               PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 08-NOV-18
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simplexa GBS Direct, Simplexa GBS Positive Control Pack
DiaSorin Molecular LLC            510(k) NO: K182467(Traditional)
ATTN: Sharon  Young               PHONE NO : 562 2406680 
11331 Valley View Street          SE DECISION MADE: 07-NOV-18
Cypress CA  90630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Plateau Spacer System
Life Spine                        510(k) NO: K182470(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 26-NOV-18
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cepheid Xpert GBS LB Control Panel
Microbiologics, Inc.              510(k) NO: K182472(Traditional)
ATTN: Tina  Sobania               PHONE NO : 320 2297050 
200 Cooper Avenue North           SE DECISION MADE: 08-NOV-18
St. Cloud MN  56303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEM-6410T-ZM Wrist Blood Pressure Monitor
Omron Healthcare, Inc.            510(k) NO: K182481(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court, Suite 100  SE DECISION MADE: 09-NOV-18
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERITON CT whole body SPECT/CT system
Spectrum Dynamics Medical Ltd     510(k) NO: K182484(Abbreviated)
ATTN: Igor  Naroditsky            PHONE NO : 972 737374548 
22 Bareket St. North Industrial PaSE DECISION MADE: 09-NOV-18
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Skin Renewing Device
Jiangsu Unimed Laser Technology Co510(k) NO: K182498(Traditional)
ATTN: Simon  Wang                 PHONE NO : 86 510 85629369 
2F, Building D4, No.6, West DongshSE DECISION MADE: 30-NOV-18
Jiangyin  CN 214000               510(k) STATEMENT
                                                    

DEVICE: Saxxony™ Posterior Cervical Thoracic System
Nexxt Spine LLC                   510(k) NO: K182508(Traditional)
ATTN: Andy  Elsbury               PHONE NO : 317 4367801 
14425 Bergen Blvd, Suite B        SE DECISION MADE: 13-NOV-18
Noblesville IN  46060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
Largan Medical Co., Ltd.          510(k) NO: K182523(Traditional)
ATTN: Amy  Tien                   PHONE NO : 886 4 36000203 
2F., No. 14, 23rd Rd., Taichung InSE DECISION MADE: 01-NOV-18
Taichung  TW 40850                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Glove Powder Free Black
Haining Medical Products Co., Ltd.510(k) NO: K182528(Traditional)
ATTN: Zhiming  Yao                PHONE NO : 86 315 4167693 
West of Dianchang Road, Luannan CoSE DECISION MADE: 15-NOV-18
Tangshan  CN 063500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOEASY Multi-Drug Test Cup
Shenzhen Bioeasy Biotechnology Co.510(k) NO: K182530(Traditional)
ATTN: Wenhau  Yan                 PHONE NO : 86 755 27948546 
No.2-1, Liuxian 1st Road, Xin'an SSE DECISION MADE: 09-NOV-18
Shenzhen  CN 518101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: R3 Anteverted Liners
Smith & Nephew, Inc.              510(k) NO: K182535(Special)
ATTN: Meenakshi  Gupta            PHONE NO : 901 3996139 
7135 Goodlett Farms Parkway       SE DECISION MADE: 19-NOV-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
snap40 Ltd                        510(k) NO: K182543(Traditional)
ATTN: Edwin  Lindsay              PHONE NO : 44 131 5503723 
24 Forth Street                   SE DECISION MADE: 14-NOV-18
Edinburgh  GB EH1 3LH             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Eravacycline 0.002 - 32 µg/mL
Liofilchem s. r. l.               510(k) NO: K182557(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 02-NOV-18
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: PREMIER Platinum HpSA PLUS
Meridian Bioscience, Inc.         510(k) NO: K182559(Traditional)
ATTN: Jack  Rogers                PHONE NO : 513 2713700 
3471 River Hills Drive            SE DECISION MADE: 05-NOV-18
Cincinnati OH  45244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Boom 69
WonTech                           510(k) NO: K182562(Traditional)
ATTN: Gyuri (Erin)  Park          PHONE NO : 82 70 78051237 
64 Techno 8-ro, Yuseong-gu        SE DECISION MADE: 16-NOV-18
Daejeon  KR 305-500               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AtriCure cryoICE cryoSPHERE cryoablation probe
AtriCure, Inc.                    510(k) NO: K182565(Special)
ATTN: Jonathan  McElwee           PHONE NO : 513 7554100 
7555 Innovation Way               SE DECISION MADE: 09-NOV-18
Mason OH  45040                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PlayMakar Sport Muscle Stimulator, Model PRO-500
PlayMakar Inc.                    510(k) NO: K182581(Traditional)
ATTN: Mike  Williams              PHONE NO : 833 7529625 
1603 Hart Street                  SE DECISION MADE: 21-NOV-18
Southlake TX  76092               510(k) STATEMENT
                                                    

DEVICE: Device Electrosurgical Generator ESG-150
Olympus Winter & Ibe GmbH         510(k) NO: K182587(Traditional)
ATTN: Jan-Oliver  Upmeier         PHONE NO : 49 40 669662098 
Kuehnstrasse 61                   SE DECISION MADE: 29-NOV-18
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
Canon Medical Systems Corporation 510(k) NO: K182596(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 02-NOV-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaLink™ Fixation System
Premia Spine Ltd.                 510(k) NO: K182598(Traditional)
ATTN: Ron  Sacher                 PHONE NO : 972 72 2281200 
8 Hampton Ct                      SE DECISION MADE: 13-NOV-18
Westfield NJ  07090               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
Better Care Plastic Technology Co.510(k) NO: K182600(Traditional)
ATTN: Zhu  Chuyan                 PHONE NO : 86 311 66179653 
Fuqian Xi Road, West district of SSE DECISION MADE: 30-NOV-18
Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Z6 Diagnostic Ultrasound System
Shenzhen Mindray Bio-medical Elect510(k) NO: K182603(Traditional)
ATTN: Jiang  Xiaoyong             PHONE NO : 86 755 81886238 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 14-NOV-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: New Era
Step Up Skin Laser, LLC           510(k) NO: K182604(Traditional)
ATTN: Michelle  Hokama            PHONE NO : 347 6422982 
433 Fifth Avenue 6th Floor        SE DECISION MADE: 14-NOV-18
New York NY  10016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PINPOINT Endoscopic Fluorescence Imaging System
Novadaq Technologies ULC (now a pa510(k) NO: K182606(Traditional)
ATTN: Agatha  Szeliga             PHONE NO : 604 4227516 
8329 Eastlake Drive, Unit 101     SE DECISION MADE: 21-NOV-18
Burnaby  CA V5A 4W2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
NinePoint Medical, Inc.           510(k) NO: K182616(Traditional)
ATTN: Eman  Namati                PHONE NO : 617 2507147 
12 Oak Park Drive                 SE DECISION MADE: 02-NOV-18
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC One
GE Hualun Medical Systems Co., Ltd510(k) NO: K182626(Traditional)
ATTN: Lifeng  Wang                PHONE NO : 86 10 57083145 
No.1 YongChang North Road, BeijingSE DECISION MADE: 16-NOV-18
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Enteral Feeding Syringes with Enfit Connectors
Jiangsu Kangbao Medical Experiment510(k) NO: K182649(Traditional)
ATTN: Qian  Li                    PHONE NO : 86 571 87987813 
78#, North Suzhong Road, Baoying  SE DECISION MADE: 09-NOV-18
Yangzhou  CN 225800               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
Kangfu Medical Equipment Factory  510(k) NO: K182652(Traditional)
ATTN: Zelong  Cao                 PHONE NO : 0086 577 55775583 
No. 380 Ningkang East Road        SE DECISION MADE: 20-NOV-18
Yueqing City  CN 325600           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voyant Maryland Fusion Device
Applied Medical Resources Corp.   510(k) NO: K182653(Special)
ATTN: Andrew  Nguyen              PHONE NO : 949 7135458 
22872 Avenida Empresa             SE DECISION MADE: 14-NOV-18
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
Safecare Biotech (Hangzhou) Co., L510(k) NO: K182654(Traditional)
ATTN: Alex  Qiu                   PHONE NO : 86 571 89712897 
Building 2/203 No.18 Haishu Rd., CSE DECISION MADE: 19-NOV-18
Hangzhou  CN 311121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
FineMEC Co., Ltd.                 510(k) NO: K182663(Traditional)
ATTN: William H. McGrail          PHONE NO : 82 2 3091882 
#604-1, 217, Heojun-ro, Gangseo-guSE DECISION MADE: 30-NOV-18
Seoul  KR 07531                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
Largan Medical Co., Ltd           510(k) NO: K182674(Traditional)
ATTN: Amy  Tien                   PHONE NO : 886 4 36000203 
2F., No. 14, 23rd Rd., Taichung InSE DECISION MADE: 13-NOV-18
Taichung  TW 40850                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HammerTechTM Fixation System
Fusion Orthopedics, LLC           510(k) NO: K182684(Traditional)
ATTN: Eli  Jacobson               PHONE NO : 800 4036876 
4135 S. Power Rd., Suite 110      SE DECISION MADE: 23-NOV-18
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
Accuracy Incorporated             510(k) NO: K182687(Traditional)
ATTN: Keith  Picker               PHONE NO : 608 8243069 
1240 Deming Way                   SE DECISION MADE: 23-NOV-18
Madison WI  53717                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Telepack X LED
KARL STORZ Endoscopy-America, Inc 510(k) NO: K182696(Traditional)
ATTN: Winkie  Wong                PHONE NO : 424 2188379 
2151 E. Grand Ave                 SE DECISION MADE: 20-NOV-18
EI Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Selethru PTCA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd. 510(k) NO: K182699(Traditional)
ATTN: Zane  Wang                  PHONE NO : 86 512 87174080 
F3, BLDG 6, No. 8, Jinfeng Road   SE DECISION MADE: 26-NOV-18
Suzhou  CN 215163                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System
Shenzhen Wisonic Medical Technolog510(k) NO: K182715(Traditional)
ATTN: Jiang  Xiaosan              PHONE NO : 86 755 86007788 8087
1st and 5th Floor, No. 6 Building,SE DECISION MADE: 20-NOV-18
Shenzhen  CN 518055               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATEC ALIF and LLIF Spacer System
Alphatec Spine, Inc.              510(k) NO: K182746(Traditional)
ATTN: Cynthia  Adams              PHONE NO : 760 4946740 
5818 El Camino Real               SE DECISION MADE: 27-NOV-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Espire Elbow Pro, Espire Elbow Hybrid
College Park Industries, Inc.     510(k) NO: K182757(Traditional)
ATTN: Deborah  Mackmin            PHONE NO : 586 2186483 
27955 College Park Drive          SE DECISION MADE: 29-NOV-18
Warren MI  48088                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biop Digital Colposcope
Biop Medical Ltd.                 510(k) NO: K182764(Traditional)
ATTN: Ilan  Landesman             PHONE NO : 972 3 9444670 
10 O'haliav Street                SE DECISION MADE: 27-NOV-18
Ramat-Gan  IL 5252263             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil
Covidien                          510(k) NO: K182772(Traditional)
ATTN: Jennie  van Diemen          PHONE NO : 303 5817037 
5920 Longbow Drive                SE DECISION MADE: 19-NOV-18
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARK EDDP Assay
ARK Diagnostics, Inc.             510(k) NO: K182779(Traditional)
ATTN: Cherry  Mun                 PHONE NO : 510 2706288 
48089 Fremont Boulevard           SE DECISION MADE: 21-NOV-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL
Thermo Fisher Scientific          510(k) NO: K182797(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909 322411
1 Thermo Fisher Way               SE DECISION MADE: 30-NOV-18
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable
Integra LifeSciences Corporation  510(k) NO: K182801(Traditional)
ATTN: Jennifer  Siu               PHONE NO : 781 9715692 
11 Cabot Boulevard                SE DECISION MADE: 27-NOV-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aspida® Anterior Lumbar Plating System
Alphatec Spine, Inc.              510(k) NO: K182808(Traditional)
ATTN: Ruby  Zheng                 PHONE NO : 760 4946884 
5818 El Camino Real               SE DECISION MADE: 09-NOV-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XVWeb 3D
Apteryx, Inc.                     510(k) NO: K182815(Special)
ATTN: Mark  Gniewek               PHONE NO : 330 3760889 
313 S. High St., Suite 200        SE DECISION MADE: 30-NOV-18
Akron OH  44308                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRODENSE Bone Graft Substitute
Wright Medical Technology, Inc.   510(k) NO: K182823(Special)
ATTN: Alayne  Melancon            PHONE NO : 901 2905986 
1023 Cherry Road                  SE DECISION MADE: 02-NOV-18
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Derma-Gide
Geistlich Pharma AG               510(k) NO: K182838(Special)
ATTN: Marco  Steiner              PHONE NO : 41 41 4926764 
Bahnhofstrasse 40                 SE DECISION MADE: 08-NOV-18
Wolhusen  CH CH-6110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System
Philips Ultrasound, Inc.          510(k) NO: K182857(Third Party - Traditional)
ATTN: Kym  Rupp                   PHONE NO : 425 4877127 
22100 Bothell Everett Highway     SE DECISION MADE: 09-NOV-18
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
Conmed Corporation                510(k) NO: K182882(Special)
ATTN: Orjada  Dervishleri         PHONE NO : 727 3995491 
525 French Road                   SE DECISION MADE: 14-NOV-18
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Roth Net Retriever Product Line
United States Endoscopy Group, Inc510(k) NO: K182909(Special)
ATTN: Carroll  Martin             PHONE NO : 440 3586259 
5976 Heisley Road                 SE DECISION MADE: 21-NOV-18
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
LeMaitre Vascular                 510(k) NO: K182916(Special)
ATTN: John N. Bradsher            PHONE NO : 781 4251685 
63 Second Avenue                  SE DECISION MADE: 16-NOV-18
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag
Steris Corporations               510(k) NO: K182931(Special)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 20-NOV-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Heli-FX EndoAnchor System
Medtronic Vascular, Inc.          510(k) NO: K182957(Special)
ATTN: Janelle  Wong Keller        PHONE NO : 707 5432247 
3850 Brickway Blvd                SE DECISION MADE: 21-NOV-18
Santa Rosa CA  95403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1.5T 16ch Breast Coil
NeoCoil, LLC                      510(k) NO: K182958(Traditional)
ATTN: Katie  Gonzalez             PHONE NO : 262 5226124 
N27 W23910 A Paul Rd.             SE DECISION MADE: 16-NOV-18
Pewaukee WI  53072                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visor System
Cerebrotech Medical Systems, Inc. 510(k) NO: K182967(Special)
ATTN: Dawnel  Scott               PHONE NO : 510 5016571 
1048 Serpentine Lane Suite 301    SE DECISION MADE: 23-NOV-18
Pleasanton CA  94566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Isolette 8000 Plus
Draeger Medical Systems, Inc.     510(k) NO: K182977(Special)
ATTN: Karen  Otrupchak            PHONE NO : 215 6602292 
3135 Quarry Road                  SE DECISION MADE: 21-NOV-18
Telford PA  18969                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
Cook Ireland Ltd                  510(k) NO: K182980(Special)
ATTN: Cathrina  McHale            PHONE NO : 011 353 61334440 2905
O' Halloran Rd, National TechnologSE DECISION MADE: 16-NOV-18
Limerick  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iFuse Implant System®
SI-BONE, Inc.                     510(k) NO: K182983(Special)
ATTN: Roxanne  Dubois             PHONE NO : 669 2062482 
471 El Camino Real, Suite 101     SE DECISION MADE: 27-NOV-18
Santa Clara CA  95050             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Afinion HbA1c Dx on Afinion 2
Alere Technologies AS             510(k) NO: K182988(Special)
ATTN: Monica  Vallestad           PHONE NO : 47 240 56000 
Kjelsaasveien 161                 SE DECISION MADE: 29-NOV-18
Oslo  NO NO-0884                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BGM014 Blood Glucose Monitoring System
Apex Biotechnology Corp.          510(k) NO: K182992(Special)
ATTN: Lisa  Liu                   PHONE NO : 886 3 5641952 
No.7, Li-Hsin Rd. V., Hsinchu ScieSE DECISION MADE: 28-NOV-18
Hsinchu  TW 30078                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES
Hemostatix Medical Technologies, L510(k) NO: K183009(Special)
ATTN: Jeff  Cobb                  PHONE NO : 901 2160012 
8400 Wolf Lake Drive, STE 109     SE DECISION MADE: 26-NOV-18
Bartlett TN  38133                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks
Smith & Nephew, Inc.              510(k) NO: K183010(Special)
ATTN: Brad  Sheals                PHONE NO : 901 3996897 
7135 Goodlett Farms Parkway       SE DECISION MADE: 28-NOV-18
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Software Package, VSTP-001A
Canon Medical Systems Corporation 510(k) NO: K183013(Special)
ATTN: Paul  Biggins               PHONE NO : 81 287 266478 
1385 Shimoishigami                SE DECISION MADE: 26-NOV-18
Otawara  JP 324-8550              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Luminex Molecular Diagnostics, Inc510(k) NO: K183023(Special)
ATTN: Tina  Ip                    PHONE NO : 437 3715631 
439 University Avenue             SE DECISION MADE: 30-NOV-18
Toronto  CA M5g 1y8               510(k) STATEMENT
                                                    

DEVICE: xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)
Luminex Molecular Diagnostics, Inc510(k) NO: K183030(Special)
ATTN: Tina  Ip                    PHONE NO : 1 437 3715631 
439 University Avenue             SE DECISION MADE: 30-NOV-18
Toronto  CA M5G 1Y8               510(k) STATEMENT
                                                    

DEVICE: Corin Optimized Positioning System (OPS) Plan
Corin USA                         510(k) NO: K183038(Traditional)
ATTN: Lucinda  Gerber             PHONE NO : 813 9774469 
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 26-NOV-18
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PathLoc-L MIS Spinal System
L&K Biomed Co., Ltd.              510(k) NO: K183117(Special)
ATTN: Jihyeon  Seo                PHONE NO : 82 2 67171983 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 15-NOV-18
Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Clarity Aligners
3M Company                        510(k) NO: K183159(Third Party - Traditional)
ATTN: Yanine  Garcia-Quezada      PHONE NO : 651 7368238 
2510 Conway Avenue                SE DECISION MADE: 26-NOV-18
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FlexCath Advance Steerable Sheath and Dilator
Medtronic CryoCath LP             510(k) NO: K183174(Traditional)
ATTN: Natalie  Sadeghi            PHONE NO : 763 5261035 
8200 Coral Sea Street NE MVS 46   SE DECISION MADE: 26-NOV-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    


         TOTAL 510(k)s THIS PERIOD   280                                     
         TOTAL WITH SUMMARIES        263                                     
         TOTAL WITH STATEMENTS        17