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
