510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2019
DEVICE: DROWZLE
Resonea, Inc. 510(k) NO: K173974(Traditional)
ATTN: Ruchir Sehra PHONE NO :
11445 E Via Linda Suite 24 SE DECISION MADE: 14-JUL-19
Scottsdale AZ 85259 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hamilton-G5
Hamiton Medical AG 510(k) NO: K180295(Traditional)
ATTN: Frederick Bruhschwein-MandiPHONE NO : 41 58 6101568
Via Crusch 8 SE DECISION MADE: 30-JUL-19
Bonaduz CH 7402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRAMA White Implant Systems
Sweden & Martina S.p.A. 510(k) NO: K180365(Traditional)
ATTN: Alessia Pezzato PHONE NO : 39 049 9124300
via Veneto 10 SE DECISION MADE: 08-JUL-19
Due Carrare IT 35020 510(k) STATEMENT
DEVICE: Maxima Electric System
Handpiece Headquarters - HPR Inc. 510(k) NO: K180845(Traditional)
ATTN: Timothy Ropchan PHONE NO : 714 5790175
620 S. Placentia Avenue SE DECISION MADE: 25-JUL-19
Placentia CA 92870 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AlphaDent Implants Dental Implants System
AlphaDent Implants Ltd 510(k) NO: K180968(Traditional)
ATTN: Natalia Kenig PHONE NO : 49 715 23834221
Carl-Zeiss-Str 4 SE DECISION MADE: 03-JUL-19
Leonberg-Gebershein DE 71229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biotex
Purgo Biologics Inc. 510(k) NO: K180992(Abbreviated)
ATTN: Seonghwan Song PHONE NO : 82 31 6984969
E-607, 700, Pangyo-ro Bundang-gu SE DECISION MADE: 16-JUL-19
Seongnam-si KR 13516 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F
Interrad Medical Inc 510(k) NO: K180994(Traditional)
ATTN: Denise Lenz PHONE NO : 763 2256699
181 Cheshire Lane, Suite 100 SE DECISION MADE: 09-JUL-19
Plymouth MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trilogy Evo
Respironics Inc. 510(k) NO: K181166(Traditional)
ATTN: Colleen Witt PHONE NO : 412 6131670
1001 Murry Ridge Lane SE DECISION MADE: 18-JUL-19
Murrysville PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Trilogy Evo Universal
Respironics Inc. 510(k) NO: K181170(Traditional)
ATTN: Colleen Witt PHONE NO : 412 6131670
1001 Murry Ridge Lane SE DECISION MADE: 18-JUL-19
Murrysville PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScopeFlow Pure(TM)
Partnership Medical Limited 510(k) NO: K181418(Traditional)
ATTN: Rob Hartley PHONE NO :
Hartley House, Galveston Grove SE DECISION MADE: 11-JUL-19
Fenton GB ST43PE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bard Power-Injectable Implantable Ports (PowerPorts®)
C.R. Bard, Inc. 510(k) NO: K181446(Traditional)
ATTN: Jeff Peterson PHONE NO : 480 3032738
605 North 5600 West SE DECISION MADE: 08-JUL-19
Salt Lake City UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
Tuttnauer Ltd. 510(k) NO: K181456(Traditional)
ATTN: Aline Peled PHONE NO : 972 2 1111111
Har Tuv B Industrial Park SE DECISION MADE: 08-JUL-19
Beit Shemesh IL 510(k) STATEMENT
DEVICE: EndoStream(TM)
Partnership Medical Limited 510(k) NO: K181457(Traditional)
ATTN: Rob Hartley PHONE NO :
Hartley House, Galveston Grove SE DECISION MADE: 11-JUL-19
Fenton GB ST43PE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Transfer Accessory (BTA)
NSP Tech Pte Ltd 510(k) NO: K181743(Traditional)
ATTN: HC Tan PHONE NO : 65 6747 8817
45A Macpherson Road SE DECISION MADE: 30-JUL-19
Singapore SG 348470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blood Collection Accessory (BUCA)
NSP Tech Pte Ltd 510(k) NO: K181754(Traditional)
ATTN: HC Tan PHONE NO : 65 6747 8817
45A Macpherson Road SE DECISION MADE: 30-JUL-19
Singapore SG 348470 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
Tianchang Jiarui Packaging Materia510(k) NO: K181957(Traditional)
ATTN: Zhang Ruiqing PHONE NO : 86 550 7981778
Yeshan Industria Zone SE DECISION MADE: 09-JUL-19
TianChang CN 239300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
Platinum Glove Industries Sdn Bhd 510(k) NO: K182089(Traditional)
ATTN: Foo Khon Pu PHONE NO : 03 3291 8261
Lot 6491-A, Batu 5 3/4, Sementa, JSE DECISION MADE: 30-JUL-19
Selangor Darul Ehsan MY 42100 510(k) STATEMENT
DEVICE: Osstem Abutment System
Osstem Implant Co., Ltd. 510(k) NO: K182091(Traditional)
ATTN: Jungmin Yoo PHONE NO : 82 51 8502500
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 12-JUL-19
Busan KR 612-070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNiD Patient-matched PLIF cage
MEDICREA INTERNATIONAL S.A. 510(k) NO: K182158(Traditional)
ATTN: David RYAN PHONE NO : 33 04 72018787
5389 route de Strasbourg-Vancia SE DECISION MADE: 15-JUL-19
Rillieux-la-Pape FR 69140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shear Stress Therapeutics SST 3000
Shear Stress Therapeutics, LLC 510(k) NO: K182163(Traditional)
ATTN: John Owen PHONE NO : 918 5249483
6207 East 78th Place SE DECISION MADE: 09-JUL-19
Tulsa OK 74136 510(k) STATEMENT
DEVICE: ACR | LAB Urine Analysis Test System
Healthy.io Ltd 510(k) NO: K182384(Traditional)
ATTN: Ron Zohar PHONE NO : 972 54 4454514
2 Ibn Gabirol SE DECISION MADE: 26-JUL-19
Tel Aviv IL 6407702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Exceed Microneedling device
Mt. Derm GmbH 510(k) NO: K182407(Traditional)
ATTN: Andreas Pachten PHONE NO : 49 308 458854
Gustav-Krone-Str.3 SE DECISION MADE: 19-JUL-19
Berlin DE 14167 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aesculap® SterilContainer(TM) S2 System
Aesculap, Inc. 510(k) NO: K182414(Traditional)
ATTN: Sierra Mertz PHONE NO : 610 9849076
3773 Corporate Parkway SE DECISION MADE: 05-JUL-19
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A.B. DENTAL DEVICES Dental Implants System
A.B. Dental Device Ltd. 510(k) NO: K182455(Traditional)
ATTN: Gabi Krauss PHONE NO : 972 8 8531388
19 Hayalomim Street SE DECISION MADE: 15-JUL-19
Ashdod IL 7761117 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scooter
Tianjin Kepler Vehicle Industry Co510(k) NO: K182471(Traditional)
ATTN: ChunXi Zhang PHONE NO : 86 22 61027905
Xinmin Road, West Area of EconomicSE DECISION MADE: 10-JUL-19
Tian Jin CN 300462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CerusEndo Microcatheter
Cerus Endovascular, Inc. 510(k) NO: K182487(Traditional)
ATTN: Theresa Brandner PHONE NO : 650 8687268
47757 Fremont Boulevard SE DECISION MADE: 20-JUL-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novidia Flowable Composite
Nobio Ltd. 510(k) NO: K182580(Traditional)
ATTN: Inbal Beinglass Peled PHONE NO : 972 3 9059966
20 Hamagshimim St. SE DECISION MADE: 03-JUL-19
Petach Tikva IL 4934829 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surgikor Dental Implant System
Surgikor LLC 510(k) NO: K182615(Traditional)
ATTN: Jeremy Barbanell PHONE NO : 855 3731614
1299 W Jefferson Blvd SE DECISION MADE: 08-JUL-19
Los Angeles CA 90007 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Galilei G6 Lens Professional
SIS AG, Surgical Instrument System510(k) NO: K182659(Traditional)
ATTN: Frank Ziemer PHONE NO : 41 32 3327070
Allmendstrasse 11 SE DECISION MADE: 25-JUL-19
Port CH CH-2502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Novidia Bulk Fill Flow Composite
Nobio Ltd. 510(k) NO: K182714(Traditional)
ATTN: Inbal Beinglass Peled PHONE NO : 972 3 9059966
8 Hamatechet St. SE DECISION MADE: 12-JUL-19
Kadima IL 6092000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XP Composite
S&C Polymer Silicon- und Composite510(k) NO: K182780(Traditional)
ATTN: Christian Boettcher PHONE NO : 0049 4121 4830
Robert-Bosch-Str. 2 SE DECISION MADE: 03-JUL-19
Elmshorn DE 25335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BionicGym Powered Muscle Stimulator
Medical Currents Ltd 510(k) NO: K182794(Traditional)
ATTN: Louis Crowe PHONE NO : 353 87 2393473
8 Cuffe Lane SE DECISION MADE: 18-JUL-19
Dublin 2 IE D02W840 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIDScore D3
Vitrolife A/S 510(k) NO: K182798(Traditional)
ATTN: Belinda Dueholm PHONE NO : 45 72 217900
Jens Juuls Vej 20 SE DECISION MADE: 19-JUL-19
Viby J DK 8260 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Rael Tampon
Rael, Inc. 510(k) NO: K182814(Traditional)
ATTN: Binna Won PHONE NO : 800 5731516
6940 Beach Blvd D-608 & 609 SE DECISION MADE: 15-JUL-19
Buena Park CA 90621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CottonDay Tampon
Taebong Co., Ltd 510(k) NO: K182817(Traditional)
ATTN: Ha Neul Jeong PHONE NO : 82 70 42624781
684-2 Illgok-Dong, Buk-Gu SE DECISION MADE: 22-JUL-19
Gwangju Gwangyeogsi KR 61039 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The POD
Advanced Facialdontics LLC 510(k) NO: K182820(Traditional)
ATTN: Scott Simonetti PHONE NO : 631 3793902
325 Lake Ave. Unit 759 SE DECISION MADE: 17-JUL-19
St. James NY 11780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Scepter Mini Occlusion Balloon Catheter
MicroVention Inc. 510(k) NO: K182829(Traditional)
ATTN: Marina Emond PHONE NO : 714 2478000
35 Enterprise SE DECISION MADE: 10-JUL-19
Aliso Viejo CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hudson RCI Voldyne Volumetric Exerciser
Teleflex Medical, Inc 510(k) NO: K182847(Traditional)
ATTN: Sirisha Kommana PHONE NO : 919 4334831
3015 Carrington Mill Blvd , Suite SE DECISION MADE: 01-JUL-19
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC FujiCEM 2 (Improved)
GC America Inc. 510(k) NO: K182854(Traditional)
ATTN: Mark Heiss PHONE NO : 708 9263090
3737 W. 127th Street SE DECISION MADE: 11-JUL-19
Alsip IL 60803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DeepCT
Deep01 Limited 510(k) NO: K182875(Traditional)
ATTN: William Lai PHONE NO : 886 2 23659959
Rm. 5, 11F., No.162, Sec. 4, RooseSE DECISION MADE: 10-JUL-19
Taipei City TW 10091 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Uro-N Cystoscope
UroViu Corporation 510(k) NO: K182876(Traditional)
ATTN: Thomas Lawson PHONE NO : 650 3975174
5337 - 14th Place SE SE DECISION MADE: 02-JUL-19
Bellevue WA 98006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KLS Martin Individual Patient Solutions (IPS) Planning System
KLS-Martin L.P. 510(k) NO: K182889(Traditional)
ATTN: Jennifer Damato PHONE NO : 800 6251557
11201 Saint Johns Industrial ParkwSE DECISION MADE: 26-JUL-19
Jacksonville FL 32246 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
Canon Medical Systems Corporation 510(k) NO: K182901(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 05-JUL-19
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.MR Applications
Siemens Medical Solutions USA, Inc510(k) NO: K182904(Traditional)
ATTN: Cordell L. Fields PHONE NO : 610 4486469
40 Liberty Blvd Mailcode 65-1A SE DECISION MADE: 05-JUL-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ziacom Dental Implant Systems
Ziacom Medical SL 510(k) NO: K182908(Traditional)
ATTN: Olegario Cuevas PHONE NO : 34 91723 3306
Calle Buhos, 2 SE DECISION MADE: 18-JUL-19
Pinto ES 28320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PerioLase Nd:YAG Pulsed Dental Laser System
Millennium Dental Technologies, In510(k) NO: K182930(Traditional)
ATTN: Robert H. Gregg PHONE NO : 562 8602908
10945 South Street, Suite 104-A SE DECISION MADE: 12-JUL-19
Cerritos CA 90703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Surdial DX Hemodialysis System
Nipro Medical Corporation 510(k) NO: K182940(Traditional)
ATTN: Jessica Oswald-McLeod PHONE NO : 305 5997174
3150 NW 107th Ave. SE DECISION MADE: 19-JUL-19
Doral FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Canon OCT-A1
Canon Inc. 510(k) NO: K182942(Traditional)
ATTN: Tatsuya Yamazaki PHONE NO : 011 81 337582111
9-1, Imaikami-cho SE DECISION MADE: 24-JUL-19
Nakahara-ku, Kawasaki JP 211-0850510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SpaceOAR Vue Hydrogel
Augmenix, Inc 510(k) NO: K182971(Traditional)
ATTN: Marcus Garcia PHONE NO : 781 5411360
21 Burlington Road SE DECISION MADE: 19-JUL-19
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MaxiTears Contacts PF
Omnivision AG 510(k) NO: K182984(Traditional)
ATTN: Joachim Kolter PHONE NO : 41 52 6750015
Zentralstr. 100 SE DECISION MADE: 24-JUL-19
Neuhausen am Rheinfall CH CH-8212510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Roadrunner PC Wire Guide, Olcott Torque Device
Cook Incorporated 510(k) NO: K182985(Traditional)
ATTN: Daniel J. Corbin PHONE NO : 812 3353575 104018
750 Daniels Way SE DECISION MADE: 22-JUL-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
Osteoremedies LLC 510(k) NO: K183017(Traditional)
ATTN: Chris Hughes PHONE NO : 901 4533141
6800 Poplar Avenue Suite 120 SE DECISION MADE: 25-JUL-19
Memphis TN 38138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Full Digital Colour Doppler Ultrasonic Diagnostic System
Wuhan Zoncare Bio-medical Electron510(k) NO: K183041(Traditional)
ATTN: Chenglin Tian PHONE NO : 0086 027 86637765
Zoncare Building, #380, High-tech SE DECISION MADE: 10-JUL-19
Wuhan CN 430206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Quantisal II Oral Fluid Collection Device
Immunalysis Corporation 510(k) NO: K183048(Traditional)
ATTN: Wenying (Jessica) Zhu PHONE NO : 909 4820480
829 Towne Center Drive SE DECISION MADE: 29-JUL-19
Pomona CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLISSANT Intimate Lubricant
Vjuvenate, LLC 510(k) NO: K183050(Traditional)
ATTN: Karyn Eilber PHONE NO : 424 8354372
3435 Ocean Park Blvd, Suite 107 SE DECISION MADE: 08-JUL-19
Santa Monica CA 90405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
Cook Incorporated 510(k) NO: K183051(Traditional)
ATTN: Yan Li PHONE NO : 812 3352235 104987
750 Daniels Way SE DECISION MADE: 16-JUL-19
Bloomington IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arm-type Electronic Blood Pressure Monitor
Shenzhen BSX Technology Electronic510(k) NO: K183058(Traditional)
ATTN: Zhijian Zhao PHONE NO : 86 755 28702440
Rm301.3F&4F, 8th Building, LiHao ISE DECISION MADE: 03-JUL-19
Shenzhen CN 518116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI Silverway
Asahi Intecc Co., LTD. 510(k) NO: K183062(Traditional)
ATTN: Yasuyuki Kawahara PHONE NO : 81 52 7681211
1703 Wakita-cho, Moriyama-ku SE DECISION MADE: 01-JUL-19
Nagoya JP 463-0024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model
Access Scientific, LLC 510(k) NO: K183066(Traditional)
ATTN: Martina Nguyen PHONE NO : 858 2598333
3910 Sorrento Valley Boulevard, SuSE DECISION MADE: 25-JUL-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Conometric Abutments
Dentsply Sirona Inc. 510(k) NO: K183079(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 10-JUL-19
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Qraypen
AIOBIO Co., Ltd. 510(k) NO: K183121(Traditional)
ATTN: Jongcheol Yoon PHONE NO : 82 31 6984991
#306. Sunil Technopia 555, DunchonSE DECISION MADE: 18-JUL-19
Seongnam-si KR 13215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medtronic Total Hip Arthroplasty System
Medtronic Advanced Energy 510(k) NO: K183129(Traditional)
ATTN: Gina Cunsolo PHONE NO : 603 8426210
180 International Drive SE DECISION MADE: 26-JUL-19
Portsmouth NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Certain BellaTek Express and BellaTek Flex Abutments
Biomet 3i 510(k) NO: K183138(Traditional)
ATTN: Krupal Patel PHONE NO : 561 7766923
4555 Riverside Drive, SE DECISION MADE: 02-JUL-19
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
Central Medicare Sdn. Bhd. 510(k) NO: K183149(Traditional)
ATTN: Muhammad Abdul Rahman PHONE NO : 60 562 90000
PT 2609-2620, BT 8, Jalan ChangkatSE DECISION MADE: 04-JUL-19
Teluk Intan MY 36000 510(k) STATEMENT
DEVICE: Microwave Ablation System
Surgnova Healthcare Technologies (510(k) NO: K183153(Traditional)
ATTN: Guofang Ma PHONE NO : 86 10 64116115
No.1 XinXing Yilu Road, Emerging ISE DECISION MADE: 08-JUL-19
Cixi CN 315300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTMED Ultrasound System
Lightmed USA, Inc 510(k) NO: K183173(Traditional)
ATTN: Hedy Chiang PHONE NO : 949 2189555
1130 Calle Cordillera SE DECISION MADE: 01-JUL-19
San Clemente CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex Eclipse Shoulder Prosthesis System
Arthrex Inc. 510(k) NO: K183194(Traditional)
ATTN: David L Rogers PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard SE DECISION MADE: 26-JUL-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Velofix TLIF Cage
U&i Corporation 510(k) NO: K183243(Special)
ATTN: Jee Ae Bang PHONE NO : 82 31 8606846
20, Sandan-ro 76beon-gil(Rd) SE DECISION MADE: 10-JUL-19
Uijeongbu-si KR 11781 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage
STRYKER SPINE 510(k) NO: K183249(Traditional)
ATTN: Deirdre Jayko PHONE NO : 201 7498339
2 Pearl Court SE DECISION MADE: 25-JUL-19
Allendale NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silent Nite sl
Prismatik Dentalcraft, Inc. 510(k) NO: K183270(Traditional)
ATTN: Mythili Reguraman PHONE NO : 949 4402739
2181 Dupont Dr. SE DECISION MADE: 17-JUL-19
Irvine CA 92612 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AI-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc510(k) NO: K183271(Traditional)
ATTN: Kimberly Mangum PHONE NO : 610 4486477
40 Liberty Blvd. SE DECISION MADE: 26-JUL-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs
Smart Glove Corporation Sdn. Bhd. 510(k) NO: K183280(Traditional)
ATTN: Khon Pu Foo PHONE NO : 60 03 329116100
Lot 6487, Batu 5 3/4, Sementa, JalSE DECISION MADE: 26-JUL-19
Klang MY 42100 510(k) STATEMENT
DEVICE: Transcutaneous Electrical Nerve Stimulator
Shenzhen Kentro Medical Electronic510(k) NO: K183288(Traditional)
ATTN: Zewu Zhang PHONE NO : 86 755338 25998
No.3, Xihu Industry Zone, Xikeng VSE DECISION MADE: 30-JUL-19
Shenzhen CN 518115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: physIQ Heart Rhythm and Respiratory Module
physIQ, Inc 510(k) NO: K183322(Traditional)
ATTN: George Allen Hides PHONE NO : 312 6541010
300 E. 5th Avenue, Suite 105 SE DECISION MADE: 10-JUL-19
Naperville IL 60563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Modus Nav
Synaptive Medical Inc. 510(k) NO: K183325(Traditional)
ATTN: Maham Ansari PHONE NO : 647 2433122
555 Richmond Street West, Suite 80SE DECISION MADE: 14-JUL-19
Toronto CA M5V 3B1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AeroDVx System
Sun Scientific Inc 510(k) NO: K183349(Traditional)
ATTN: Allan Alward PHONE NO : 914 4795108
145 Palisade Street SE DECISION MADE: 19-JUL-19
Dobbs Ferry NY 10522 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSafe(R) Pre-Filled Normal Saline Flush Syringe
Amsino International, Inc. 510(k) NO: K183473(Traditional)
ATTN: Jim Barley PHONE NO : 909 6265888
708 Corporate Center Drive SE DECISION MADE: 12-JUL-19
Pomona CA 91768 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RapidVit™ Oocyte, RapidWarm™ Oocyte
Vitrolife Sweden AB 510(k) NO: K183486(Traditional)
ATTN: Nina Arvidsson PHONE NO : 46 31 7218000
Gustaf Werners gata 2 SE DECISION MADE: 26-JUL-19
Vastra Frolunda SE 421 32 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Latitud Hip Replacement System
Meril Healthcare Pvt. Ltd. 510(k) NO: K183532(Traditional)
ATTN: Gayathri Nair PHONE NO : 91 260 3052178
Survey No. 135/2/B & 174/2, H1-H3,SE DECISION MADE: 18-JUL-19
Vapi IN 396191 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Anspach Helix Dissection Tools
The Anspach Effort, Inc. 510(k) NO: K183545(Traditional)
ATTN: Tamara J. West PHONE NO : 561 4943712
4500 Riverside Drive SE DECISION MADE: 19-JUL-19
Palm Beach Gardens FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
Medtronic 510(k) NO: K183547(Traditional)
ATTN: Matthew Lobeck PHONE NO : 763 5149515
8200 Coral Sea St NE SE DECISION MADE: 30-JUL-19
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L
FUJIFILM Corporation 510(k) NO: K183572(Traditional)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 16-JUL-19
Ashigarakami-Gun JP 258-8538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LifeSPARC Pump, LifeSPARC Controller
CardiacAssist Inc 510(k) NO: K183623(Traditional)
ATTN: Greg Johnson PHONE NO : 412 9637770 266
620 Alpha Drive SE DECISION MADE: 09-JUL-19
Pittsburgh PA 15238 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Digital Infrared Ear Thermometer
Microlife Intellectual Property Gm510(k) NO: K183663(Special)
ATTN: Gerhard Frick PHONE NO : 41 717 277059
Espenstrasse 139 SE DECISION MADE: 16-JUL-19
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
Shenzhen Mindray Bio-medical Elect510(k) NO: K190011(Traditional)
ATTN: Yanhong Bai PHONE NO : 86 755 81888998
Mindray Building, Keji 12th Road SSE DECISION MADE: 10-JUL-19
Shenzhen CN 518057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Tech Dots - Adhesive and conductive gel
Spes Medica S.r.l. 510(k) NO: K190050(Traditional)
ATTN: Giorgio Facco PHONE NO : 39 0828 614191
Via Europa - zona industriale SE DECISION MADE: 19-JUL-19
Battipaglia (SA) IT 84091 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATCLAVE G4 Chamber Autoclave
SciCan Ltd. 510(k) NO: K190062(Abbreviated)
ATTN: Teresa Boyce PHONE NO : 416 4451600
1440 Don Mills Road SE DECISION MADE: 26-JUL-19
Toronto CA M3B 3P9 510(k) STATEMENT
DEVICE: nView system 1
nView medical, Inc. 510(k) NO: K190064(Traditional)
ATTN: Lisa Last PHONE NO : 617 2837053
2681 E. Parleys Way Suite 107 SE DECISION MADE: 08-JUL-19
Salt Lake City UT 84109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VeriSplint
Whip Mix Corporation 510(k) NO: K190107(Traditional)
ATTN: John Waters PHONE NO : 502 6345357
361 Farmington Avenue SE DECISION MADE: 10-JUL-19
Louisville KY 40217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MicroPort CoCr Femoral Heads
MicroPort Orthopedics Inc. 510(k) NO: K190123(Traditional)
ATTN: Tejas Patel PHONE NO : 901 2905175
5677 Airline Road SE DECISION MADE: 15-JUL-19
Arlington TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
Medtronic 510(k) NO: K190132(Traditional)
ATTN: Matthew Lobeck PHONE NO : 763 5149515
8200 Coral Sea St NE SE DECISION MADE: 30-JUL-19
Mounds View MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Identify
Varian Medical Systems Inc. 510(k) NO: K190137(Traditional)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
911 Hansen Way SE DECISION MADE: 10-JUL-19
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sage 2-in-1 Personal Lubricant and Moisturizer
Fairhaven Health, LLC 510(k) NO: K190150(Traditional)
ATTN: Suzanne Munson PHONE NO : 360 5437888 207
1410 11th St SE DECISION MADE: 16-JUL-19
Bellingham WA 98225 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALARA Neuro Access Kit
SurGenTec, LLC 510(k) NO: K190163(Traditional)
ATTN: Travis Greenhalgh PHONE NO : 561 9907882
7601 N Federal Highway #150A SE DECISION MADE: 16-JUL-19
Boca Raton FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TriMed Nitinol Staple System
TriMed, Inc. 510(k) NO: K190166(Traditional)
ATTN: David Medoff PHONE NO : 661 2557406
27533 Avenue Hopkins SE DECISION MADE: 01-JUL-19
Santa Clarita CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Miethke Shunt System GAV 2.0 and SA 2.0 Valves
Aesculap, Inc. 510(k) NO: K190174(Traditional)
ATTN: Kathy A. Racosky PHONE NO : 610 9849291
3773 Corporate Parkway SE DECISION MADE: 05-JUL-19
Center Valley PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker PEEK Customized Cranial Implant Kit
Stryker 510(k) NO: K190229(Traditional)
ATTN: Zainab Amini PHONE NO : 269 3898349
750 Trade Centre Way - Suite 200 SE DECISION MADE: 11-JUL-19
Portage MI 49002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask
Sleepnet Corporation 510(k) NO: K190254(Traditional)
ATTN: Jennifer Kennedy PHONE NO : 603 7586625
5 Merrill Industrial Drive SE DECISION MADE: 05-JUL-19
Hampton NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERIZONE(R) VP4 Sterilizer
TSO3 Inc 510(k) NO: K190260(Traditional)
ATTN: Sandy Cliche PHONE NO : 418 6510003 252
2505 Avenue Dalton SE DECISION MADE: 19-JUL-19
Quebec CA G1P 3S5 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bluephase PowerCure
Ivoclar Vivadent, AG 510(k) NO: K190272(Traditional)
ATTN: Sandra Cakebread PHONE NO : 423 2353535
Bendererstrasse 2 SE DECISION MADE: 03-JUL-19
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Endotracheal Tube
Tianjin Medis Medical Device Co., 510(k) NO: K190274(Traditional)
ATTN: Yongzhi Wu PHONE NO : 86 13 920213115
No. 15-A, Saida One Avenue, XiqingSE DECISION MADE: 30-JUL-19
Tainjin CN 300385 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProVate Vaginal Support
ConTIPI Medical Ltd. 510(k) NO: K190277(Traditional)
ATTN: Tsvia Erlich PHONE NO : 972 4 6276066
2 Alon Ha'Tavor st. Caesarea IndusSE DECISION MADE: 08-JUL-19
Caesarea IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Materialise Glenoid Positioning System
Materialise NV 510(k) NO: K190286(Traditional)
ATTN: Mieke Janssen PHONE NO : 32 16 744571
Technologielaan 15 SE DECISION MADE: 08-JUL-19
Leuven BE 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Addivation Medical Cervical Interbody System
Addivation Medical, LLC 510(k) NO: K190291(Traditional)
ATTN: Gregory Stebbins PHONE NO : 908 9101256
44 Riverdale Avenue SE DECISION MADE: 30-JUL-19
Monmouth Beach NJ 07750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Passio Pump Drainage System
Bearpac Medical 510(k) NO: K190292(Traditional)
ATTN: Jay Zimmerman PHONE NO : 603 6825710
124 West Point Road SE DECISION MADE: 25-JUL-19
Moultonborough NH 03254 510(k) STATEMENT
DEVICE: OrthoPediatrics Cannulated Screw System
Orthopediatrics, Corp 510(k) NO: K190324(Traditional)
ATTN: Jen Gregory PHONE NO : 574 2670880
2850 Frontier Drive SE DECISION MADE: 05-JUL-19
Warsaw IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Helioseal F Plus
Ivoclar Vivadent, AG 510(k) NO: K190339(Abbreviated)
ATTN: Sandra Cakebread PHONE NO : 423 235 3535
Bendererstrasse 2 SE DECISION MADE: 29-JUL-19
Schaan LI FL-9494 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silverlon Wound Contact, Burn Contact Dressings
Argentum Medical, LLC 510(k) NO: K190343(Traditional)
ATTN: Aftab Ahmad PHONE NO : 630 2322507 141
2571 Kaneville CT SE DECISION MADE: 18-JUL-19
Geneva IL 60134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Site Seal SV
Ensite Vascular 510(k) NO: K190351(Traditional)
ATTN: Thomas Reidy PHONE NO : 913 7775277
10900 S. Clay Blair Blvd. Ste 800 SE DECISION MADE: 02-JUL-19
Olathe KS 66061 510(k) STATEMENT
DEVICE: Immucise
Terumo Corporation 510(k) NO: K190427(Traditional)
ATTN: Rudima L Jackson PHONE NO : 732 3024900 4990
44-1, 2-Chome, Hatagaya SE DECISION MADE: 18-JUL-19
Shibuya-Ku JP 151-0072 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Koios DS for Breast
Koios Medical, Inc. 510(k) NO: K190442(Traditional)
ATTN: Lev Barinov PHONE NO : 732 5295755
500 7th Avenue, 8th Floor SE DECISION MADE: 03-JUL-19
New York NY 10018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BTL 799-2L
BTL Industries, Inc. 510(k) NO: K190456(Traditional)
ATTN: David Chmel PHONE NO : 866 2851656
362 Elm Street SE DECISION MADE: 05-JUL-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERITON CT whole body SPECT/CT system
Spectrum Dynamics Medical Ltd 510(k) NO: K190457(Traditional)
ATTN: Igor Naroditsky PHONE NO : 972 73 7374548
22 Bareket St. SE DECISION MADE: 12-JUL-19
North Industrial Park. Caesarea I510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4CIS® Chiron Spinal Fixation System
Solco Biomedical Co., Ltd. 510(k) NO: K190471(Traditional)
ATTN: Kim Il PHONE NO : 82 31 6644101
154 Seotan-Ro, Seotan-Myeon SE DECISION MADE: 24-JUL-19
Pyeongtaek KR 17704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
Kawasumi Laboratories, Inc. 510(k) NO: K190485(Traditional)
ATTN: Katsu Furuya PHONE NO : 81 3 57692663
Shinagawa Intercity Tower B, 9th FSE DECISION MADE: 08-JUL-19
Tokyo JP 108-6109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ProLift Expandable System
Life Spine Inc. 510(k) NO: K190488(Traditional)
ATTN: Angela Batker PHONE NO : 847 8846117
13951 S Quality Drive SE DECISION MADE: 23-JUL-19
Huntley IL 60142 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Peralta Stone Removal Catheter
Calcula Technologies, Inc 510(k) NO: K190492(Traditional)
ATTN: Raymond Buzz Bonneau PHONE NO : 650 2690048
959 Peralta Ave SE DECISION MADE: 18-JUL-19
San Francisco CA 94110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
Pioneer Surgical Technology, Inc. 510(k) NO: K190498(Traditional)
ATTN: Kristina Hall PHONE NO : 386 4188888 4511
11621 Research Circle SE DECISION MADE: 05-JUL-19
Alachua FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRopen 0.5 T
ASG Superconductors S.p.A. 510(k) NO: K190524(Traditional)
ATTN: Luisella De Benedetti PHONE NO : 39 010 6489358
Corso Ferdinando Maria Perrone 73/SE DECISION MADE: 01-JUL-19
Genova IT 16152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MariGen Wound Extra
Kerecis Limited 510(k) NO: K190528(Traditional)
ATTN: Gudmundur Fertram SigurjonssPHONE NO : 3 54 5622601
Eyrargata 2 SE DECISION MADE: 10-JUL-19
Isafjordur IS 400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented
Sleepnet Corporation 510(k) NO: K190533(Traditional)
ATTN: Jennifer Kennedy PHONE NO : 603 7586625
5 Merrill Industrial Drive SE DECISION MADE: 26-JUL-19
Hampton NH 03842 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMONITOR III, Remote Assistant III
Biotronik, Inc. 510(k) NO: K190548(Traditional)
ATTN: Jon Brumbaugh PHONE NO : 888 3450374
6024 Jean Road SE DECISION MADE: 05-JUL-19
Lake Oswego OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IKON 40 Manual Wheelchair
Broda Seating (Broda LP) 510(k) NO: K190550(Traditional)
ATTN: Jeremy Ballard PHONE NO : 844 5527632
560 Bingemans Centre Drive SE DECISION MADE: 01-JUL-19
Kitchener CA N2B3X9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Shaders ZR
Digital Age Dental Lab 510(k) NO: K190569(Traditional)
ATTN: Tim McKimson PHONE NO : 877 5303235
2110 Artesia Blvd, Ste. B-132 SE DECISION MADE: 29-JUL-19
Redondo Beach CA 90278 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iBreastExam
UE LifeSciences Inc. 510(k) NO: K190575(Abbreviated)
ATTN: Mihir Shah PHONE NO : 631 9808340
3401 Market St, Suite 200 SE DECISION MADE: 16-JUL-19
Philadelphia PA 19104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Coolrail Linear Pen
AtriCure, Inc 510(k) NO: K190587(Special)
ATTN: Jake Lawson PHONE NO : 513 7554100
7555 Innovation Way SE DECISION MADE: 24-JUL-19
Mason OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments
Cochlear Americas 510(k) NO: K190589(Traditional)
ATTN: Laura Blair PHONE NO : 303 2642752
13059 E. Peakview Avenue SE DECISION MADE: 03-JUL-19
Centennial CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AngioVac C20, AngioVac C180
AngioDynamics, Inc. 510(k) NO: K190594(Traditional)
ATTN: Kasey Newcomb PHONE NO : 508 6587813
26 Forest St. SE DECISION MADE: 05-JUL-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wrap accessory electrodes
Hi-Dow International Inc. 510(k) NO: K190617(Traditional)
ATTN: Eric Chen PHONE NO : 314 5692888
2555 Metro Blvd SE DECISION MADE: 02-JUL-19
Maryland Heights MO 63043 510(k) STATEMENT
DEVICE: SpeediCath Flex Coude Pro
Coloplast 510(k) NO: K190620(Traditional)
ATTN: Delaney McDougal PHONE NO : 612 3808030
1601 West River Road North SE DECISION MADE: 10-JUL-19
Minneapolis MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
Cardiovascular Systems Inc. 510(k) NO: K190634(Traditional)
ATTN: Kris Miller PHONE NO : 651 2591656
1225 Old Highway 8 NW SE DECISION MADE: 02-JUL-19
St. Paul MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Arthrex NanoScope System
Arthrex Inc. 510(k) NO: K190645(Traditional)
ATTN: Heli F. Chambi Infantas PHONE NO : 1 239 5984302 73187
1370 Creekside Boulevard SE DECISION MADE: 05-JUL-19
Naples FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1
Medtronic Navigation Inc 510(k) NO: K190672(Traditional)
ATTN: Elizabeth Waite PHONE NO : 720 8903300
826 Coal Creek Circle SE DECISION MADE: 31-JUL-19
Louisville CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TempSure
Cynosure, Inc 510(k) NO: K190678(Traditional)
ATTN: Michael King PHONE NO : 781 9932454
5 Carlisle Road SE DECISION MADE: 24-JUL-19
Westford MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAVO S-TLIF
Silony Medical GmbH 510(k) NO: K190680(Traditional)
ATTN: Melanie Lubjuhn PHONE NO : 49 7117 825250
Leinfelder StraBe 60 SE DECISION MADE: 18-JUL-19
Leinfelden-Echterdingen DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Growth System
Xuzhou Kernel Medical Equipment Co510(k) NO: K190685(Traditional)
ATTN: Wang Jing PHONE NO : 86 0516 87732208
Kernel Mansion, Economic DevelopmeSE DECISION MADE: 26-JUL-19
Xuzhou CN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Twilite Appliance
Stephen J Harkins, DDS, PC 510(k) NO: K190687(Traditional)
ATTN: Stephen Harkins PHONE NO : 520 4657203
4781 E. Camp Lowell Dr., #101 SE DECISION MADE: 02-JUL-19
Tucson AZ 85712 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Unifi Workspace v1.0.0
Hologic, Inc. 510(k) NO: K190694(Traditional)
ATTN: Meghan Wakeford PHONE NO : 203 7027819
36 Apple Ridge Road SE DECISION MADE: 11-JUL-19
Danbury CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zygomatic Implants
JJGC Industria e Comercio de Mater510(k) NO: K190718(Traditional)
ATTN: Mariana Soares Hartmann PHONE NO : 55 41 21694058
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 11-JUL-19
Curitiba BR 81270-200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MD-Temp Plus
Meta Biomed Co., Ltd 510(k) NO: K190724(Traditional)
ATTN: Suk Song Oh PHONE NO : 82 43 2308959
270, Osong Saengmyeong 1-ro, OsongSE DECISION MADE: 03-JUL-19
Cheongju-si KR 28161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P200TxE
Optos Plc 510(k) NO: K190732(Traditional)
ATTN: Rachel Reay PHONE NO : 0044 1383 843300
Queensferry House, Carnegie CampusSE DECISION MADE: 31-JUL-19
Dunfermline GB ky11 8gr 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 087 Balloon Guide Catheter System
Q'Apel 510(k) NO: K190749(Traditional)
ATTN: Ken Peartree PHONE NO : 310 3953950
330 Wilshire Boulevard SE DECISION MADE: 15-JUL-19
Santa Monica CA 90401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
Medos International SARL 510(k) NO: K190774(Traditional)
ATTN: LeeAnn Walosin PHONE NO : 612 2309909
Chemin-Blanc 38 SE DECISION MADE: 25-JUL-19
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DemeTECH DemeFORCE Nonabsorbable Surgical Suture
DemeTECH Corporation 510(k) NO: K190777(Traditional)
ATTN: Tracy Chadwrick PHONE NO : 305 8241048
14175 NW 60th Ave SE DECISION MADE: 31-JUL-19
Miami Lakes FL 33014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PressOn Electrode Headset
Rhythmlink International, LLC 510(k) NO: K190801(Traditional)
ATTN: Gabriel Orsinger PHONE NO : 803 3659664
1140 First Street South SE DECISION MADE: 10-JUL-19
Columbia SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Sample Imaging for Senographe Pristina
GE Healthcare 510(k) NO: K190809(Traditional)
ATTN: Nicole Landreville PHONE NO : 289 2082365
283 rue de la Miniere SE DECISION MADE: 29-JUL-19
Buc FR 78530 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K190818(Special)
ATTN: Gerhard Frick PHONE NO : 41 71 7277000
Espenstrasse 139 SE DECISION MADE: 10-JUL-19
Widnau CH 9443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Silicone PHMB Foam Wound Dressing
Advanced Medical Solutions Ltd. 510(k) NO: K190819(Traditional)
ATTN: Adam Gregory PHONE NO : 44 1606 863500
Premier Park, 33 Road One, WinsforSE DECISION MADE: 25-JUL-19
Winsford GB CW7 3RT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Corin Optimized Position System Functional Hip Analysis (OPS FHA)
Corin USA 510(k) NO: K190834(Traditional)
ATTN: Lucinda Gerber PHONE NO : 1 813 9774469
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 22-JUL-19
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infrared Ear/Forehead Thermometer
Joytech Healthcare Co., Ltd. 510(k) NO: K190873(Traditional)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 26-JUL-19
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Non-invasive blood pressure measurement systems
Joytech Healthcare Co., Ltd 510(k) NO: K190886(Special)
ATTN: Ren Yunhua PHONE NO : 86 571 81957767
No. 365, Wuzhou Road, Yuhang EconoSE DECISION MADE: 29-JUL-19
Hangzhou CN 311100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fluobeam LX
Fluoptics 510(k) NO: K190891(Traditional)
ATTN: Odile Allard PHONE NO :
7 Parvis Louis Neel, CS 20050 SE DECISION MADE: 31-JUL-19
Grenoble Cedex 9 FR 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
Medos International Sarl 510(k) NO: K190895(Traditional)
ATTN: Sheree Geller PHONE NO : 508 8283291
Chemin-Blanc 38 SE DECISION MADE: 18-JUL-19
Le Locle CH 2400 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
Becton, Dickinson and Company 510(k) NO: K190905(Traditional)
ATTN: Laura Stewart PHONE NO : 410 3164435
7 Loveton Circle, MC 694 SE DECISION MADE: 01-JUL-19
Sparks MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System
ZEUS Scientific, Inc. 510(k) NO: K190907(Traditional)
ATTN: Mark J. Kopnitsky PHONE NO : 908 2434904
P.O. Box 38 SE DECISION MADE: 29-JUL-19
Raritan NJ 08869 510(k) STATEMENT
DEVICE: PrisMax System Version 2
Baxter Healthcare Corp 510(k) NO: K190910(Traditional)
ATTN: Chris Scavotto PHONE NO : 763 4634621
7601 Northland Drive Suite 170 SE DECISION MADE: 25-JUL-19
Brooklyn Park MN 55428 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OsteoFab Suture Anchors
Oxford Performance Materials, Inc.510(k) NO: K190915(Traditional)
ATTN: Andrus Maandi PHONE NO : 860 6989300
30 South Satellite Road SE DECISION MADE: 03-JUL-19
South Windsor CT 06074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revitive Medic Plus, Revitive Advanced 2
Actegy, Ltd. 510(k) NO: K190924(Traditional)
ATTN: Lawrence Brookfield PHONE NO : 44 0 1344236037
Reflex, Cain Road SE DECISION MADE: 05-JUL-19
Bracknell GB RG12 1HL 510(k) STATEMENT
DEVICE: Hammertoe Truss System (HTS)
4Web, Inc. 510(k) NO: K190926(Traditional)
ATTN: Jessee Hunt PHONE NO : 800 2857090
2801 Network Blvd., Suite 620 SE DECISION MADE: 23-JUL-19
Frisco TX 75034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ScanX Barrier Envelopes
Air Techniques Inc. 510(k) NO: K190949(Traditional)
ATTN: Samir Ghevariya PHONE NO : 1 516 2145514
1295 Walt Whitman Road SE DECISION MADE: 26-JUL-19
Melville NY 11747 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced)
Medline Industries, Inc. 510(k) NO: K190950(Traditional)
ATTN: Pauline Maralit PHONE NO : 847 9492283
Three Lakes Drive SE DECISION MADE: 04-JUL-19
Northfield IL 60093 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology
Medtronic Sofamor Danek USA, Inc 510(k) NO: K190959(Traditional)
ATTN: Emmarie Halteman PHONE NO : 901 3963133
1800 Pyramid Place SE DECISION MADE: 03-JUL-19
Memphis TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nalu Lead Blank (50cm)
Nalu Medical, Inc. 510(k) NO: K190960(Traditional)
ATTN: Sunny Gill PHONE NO : 760 8276466
2320 Faraday Avenue, Suite 100 SE DECISION MADE: 11-JUL-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
Synthes (USA) Products LLC 510(k) NO: K190963(Traditional)
ATTN: Jeffrey Krawiec PHONE NO : 610 7195356
1301 Goshen Parkway SE DECISION MADE: 23-JUL-19
West Chester PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPE REPROCESSOR OER-Elite
Olympus Medical Systems Corp. 510(k) NO: K190969(Traditional)
ATTN: Toshiyuki Nakajima PHONE NO : 81 42 6422694
2951 Ishikawa-cho SE DECISION MADE: 09-JUL-19
Hachioji-Shi JP 192-8507 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Ambu aScope 4 RhinoLaryngo Intervention
Ambu A/S 510(k) NO: K190972(Traditional)
ATTN: Gurpreet Kaur Rehal PHONE NO : 45 7225 2116
Baltorpbakken 13 SE DECISION MADE: 12-JUL-19
Ballerup DK 2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Plexus SCD110 Sequential Compression Device Sleeve
Midway Medical, LLC. 510(k) NO: K190975(Traditional)
ATTN: Jim Tobin PHONE NO : 484 6956209
3004 Gill Street SE DECISION MADE: 22-JUL-19
Bloomington IL 61704 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Radial Medical Compression System
Radial Medical, Inc. 510(k) NO: K190976(Special)
ATTN: Eric Johnson PHONE NO : 707 8430871
2500 Grant Road SE DECISION MADE: 12-JUL-19
Mountain View CA 94040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
Innovative Health, LLC. 510(k) NO: K190980(Traditional)
ATTN: Amanda Babcock PHONE NO : 480 5255911
1435 North Hayden Road, Suite 100 SE DECISION MADE: 01-JUL-19
Scottsdale AZ 85257 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bonus Therapeutics Mixing and Delivery System
Bonus Therapeutics Ltd. 510(k) NO: K190996(Traditional)
ATTN: Nir Shtayer PHONE NO : 972 73 2067100
Matam Advanced Technology Park, BuSE DECISION MADE: 28-JUL-19
Haifa IL 3190501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SureForm 45 Curved Tip, SureForm 45 Gray Reload
Intuitive Surgical, Inc. 510(k) NO: K190999(Traditional)
ATTN: Nadine Nasr PHONE NO : 408 5237093
1266 Kifer Road SE DECISION MADE: 12-JUL-19
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iLab Polaris Multi-Modality Guidance System
Boston Scientific Corporation 510(k) NO: K191008(Traditional)
ATTN: Mugdha Dongre PHONE NO : 408 6357239
150 Baytech Drive SE DECISION MADE: 02-JUL-19
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors
Surgical Instrument Service and Sa510(k) NO: K191018(Traditional)
ATTN: Stephanie Boyle Mays PHONE NO : 541 9233375
(dba Medline ReNewal) 1500 NE HemlSE DECISION MADE: 03-JUL-19
Redmond OR 97756 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Salvo™ Spine System
Spine Wave, Inc. 510(k) NO: K191045(Traditional)
ATTN: Amy Noccioli PHONE NO : 203 9449494
3 Enterprise Drive, Suite 210 SE DECISION MADE: 10-JUL-19
Shelton CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AcuSnare Polypectomy Snare - Duckbill
Wilson-Cook Medical, Inc. 510(k) NO: K191048(Special)
ATTN: Doris A. Hawks PHONE NO : 336 7440157 396293
4900 Bethania Station Road SE DECISION MADE: 18-JUL-19
Winston-Salem NC 27105 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow
Siemens Medical Solutions, USA Inc510(k) NO: K191050(Traditional)
ATTN: Milind Dhamankar PHONE NO : 610 4486467
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 12-JUL-19
Malvern PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Xtreme-Loop
Xiros Ltd 510(k) NO: K191053(Traditional)
ATTN: Stephen Seed PHONE NO : 44 113 2387200
Springfield House Lane, WhitehouseSE DECISION MADE: 17-JUL-19
Leeds GB LS17 7UE 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit
ACIST Medical Systems, Inc. 510(k) NO: K191060(Traditional)
ATTN: Matthew D. Stepanek PHONE NO : 952 9939300
7905 Fuller Road SE DECISION MADE: 18-JUL-19
Eden Prairie MN 35344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powersculp laser lipolysis system
Wuhan Lotuxs Technology Co., Ltd. 510(k) NO: K191068(Traditional)
ATTN: Na Wu PHONE NO : 86 27 87619668
5 F, E2 Building, NO 999 Gaoxin AvSE DECISION MADE: 17-JUL-19
East lake High-Tech development Zo510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAROnova Access Sheath Kit
BAROnova, Inc. 510(k) NO: K191078(Traditional)
ATTN: Lian Cunningham PHONE NO : 650 6389796
1551 Industrial Road SE DECISION MADE: 22-JUL-19
San Carlos CA 94070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Powder-Free Vinyl Patient Examination Gloves, Yellow Color
Anhui Intco Medical Products Co. L510(k) NO: K191092(Traditional)
ATTN: Jacken Cai PHONE NO : 86 13 853653818
No. 1 Haitang Road, Suixi DistrictSE DECISION MADE: 22-JUL-19
Huaibei CN 235100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ExcelsiusGPS Spine 1.1 Interbody Module
Globus Medical Inc. 510(k) NO: K191100(Traditional)
ATTN: Kelly J. Baker PHONE NO : 610 9301800
2560 General Armistead Ave. SE DECISION MADE: 24-JUL-19
Audubon PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NvisionVLE Low-profile Optical Probe
NinePoint Medical, Inc 510(k) NO: K191117(Traditional)
ATTN: Eman Namati PHONE NO : 617 2507147
12 Oak Park Drive SE DECISION MADE: 19-JUL-19
Bedford MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Access CT
Philips Healthcare (Suzhou) Co., L510(k) NO: K191136(Traditional)
ATTN: Ray Sun PHONE NO : 86 1310 9886838
No.258, ZhongYuan Road, Suzhou IndSE DECISION MADE: 29-JUL-19
Suzhou CN 215024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
JVC Kenwood Corporation 510(k) NO: K191137(Traditional)
ATTN: Hideki Tengeiji PHONE NO : 81 45 4502715
3-12, Moriya-cho, Kanagawa-ku SE DECISION MADE: 02-JUL-19
Yokohama JP 221-0022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AeroForm Tissue Expander, Smooth
AirXpanders, Inc. 510(k) NO: K191138(Special)
ATTN: Belinda Pinedo PHONE NO : 650 2828131
3047 Orchard Parkway SE DECISION MADE: 11-JUL-19
San Jose CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONTAGE-QS Settable, Resorbable Hemostatic Bone
Orthocon, Inc. 510(k) NO: K191140(Traditional)
ATTN: Howard L. Schrayer PHONE NO : 609 9249510
1 Bridge Street, Suite 121 SE DECISION MADE: 18-JUL-19
Irvington NY 10533 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Hair Boom 69
Wontech 510(k) NO: K191154(Traditional)
ATTN: Gyuri (Erin) Park PHONE NO : 82 70 78051237
64 Techno 8-ro, Yuseong-gu SE DECISION MADE: 29-JUL-19
Daejeon KR 305-500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EpiLaze Multi-wavelength Laser
Rohrer Aesthetics, LLC 510(k) NO: K191162(Traditional)
ATTN: Mark Rohrer PHONE NO : 205 3561172
105 Citation Court SE DECISION MADE: 09-JUL-19
Homewood AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Fungitell STAT
Associates of Cape Cod, Inc 510(k) NO: K191167(Traditional)
ATTN: Alison Skinner PHONE NO : 508 5403444
124 Bernard East Saint Jean Drive SE DECISION MADE: 17-JUL-19
East Falmouth MA 02536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NuVasive® Camber Laminoplasty System
NuVasive, Incorporated 510(k) NO: K191169(Traditional)
ATTN: Thao Huynh PHONE NO : 858 3205256
7475 Lusk Blvd. SE DECISION MADE: 03-JUL-19
San Diego CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires
Abbott Vascular 510(k) NO: K191173(Traditional)
ATTN: Namratha Manthani PHONE NO : 408 8450734
3200 Lakeside Drive SE DECISION MADE: 25-JUL-19
Santa Clara CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EyeBOX
Oculogica, Inc. 510(k) NO: K191183(Traditional)
ATTN: Rosina Samadani PHONE NO : 484 3932694
33 Irving Place SE DECISION MADE: 31-JUL-19
New York NY 10003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infinity Fixation System
ConMed Corporation 510(k) NO: K191204(Special)
ATTN: Orjada Dervishleri PHONE NO : 727 3995491
525 French Road SE DECISION MADE: 03-JUL-19
Utica NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JOURNEY II Unicompartmental Knee System
Smith & Nephew, Inc. 510(k) NO: K191211(Traditional)
ATTN: Meenakshi Gupta PHONE NO : 901 3996139
7135 Goodlett Farms Parkway SE DECISION MADE: 25-JUL-19
Cordova TN 38016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Zimmer Guide Wire Devices
Zimmer, Inc 510(k) NO: K191238(Traditional)
ATTN: Annette Minthorn PHONE NO : 574 3724294
PO Box 708 SE DECISION MADE: 05-JUL-19
Warsaw IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test System
ZEUS Scientific Inc. 510(k) NO: K191240(Traditional)
ATTN: Mark J. Kopnitsky PHONE NO : 908 2434904
P.O. BOX 38 SE DECISION MADE: 29-JUL-19
Raritan NJ 08869 510(k) STATEMENT
DEVICE: Gem FlowCoupler System
Baxter/ Synovis Micro Companies Al510(k) NO: K191252(Traditional)
ATTN: Julie Carlston PHONE NO : 651 7967511
2875 University Ave. West SE DECISION MADE: 09-JUL-19
St. Paul MN 55114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stryker CrossFlow Integrated Arthroscopy Pump
Stryker Corp. 510(k) NO: K191259(Traditional)
ATTN: Justin Florence PHONE NO : 408 6208312
5900 Optical Ct SE DECISION MADE: 12-JUL-19
San Jose CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Wearable Device, Wearable Package
Current Health Ltd. 510(k) NO: K191272(Traditional)
ATTN: Edwin Lindsay PHONE NO : 44 131 5503723
Playfair House, 12A Broughton StreSE DECISION MADE: 12-JUL-19
Edinburgh GB EH1 3LY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
Davol Inc., Subsidiary of C.R. Bar510(k) NO: K191287(Special)
ATTN: Angelica Hutchison PHONE NO : 401 8258537
100 Crossings Blvd SE DECISION MADE: 16-JUL-19
Warwick RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Bone Screw Line Addition
Vilex in Tennessee, Inc 510(k) NO: K191289(Traditional)
ATTN: Victor Lavi PHONE NO : 931 4747550
111 Moffitt Street SE DECISION MADE: 29-JUL-19
McMinnville TN 37110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.via MI Workflows VB40A, Scenium
Siemens Medical Soultions USA, Inc510(k) NO: K191309(Special)
ATTN: Veronica Padharia PHONE NO : 630 8775761
2501 N. Barrington Road SE DECISION MADE: 19-JUL-19
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Remington Medical, Inc. Automatic Cutting Needle (NAC)
Remington Medical, Inc. 510(k) NO: K191315(Traditional)
ATTN: Caitlin Senter PHONE NO : 770 8888520
6830 Meadowridge Court SE DECISION MADE: 12-JUL-19
Alpharetta GA 30005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: StitchKit
Origami Surgical 510(k) NO: K191317(Traditional)
ATTN: John Gillespie PHONE NO : 973 7656256
42 Main St. Suite A SE DECISION MADE: 12-JUL-19
Madison NJ 07940 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMPOWR Partial Knee
Encore Medical, L.P. 510(k) NO: K191325(Traditional)
ATTN: Teffany Hutto PHONE NO : 512 8346255
9800 Metric Blvd. SE DECISION MADE: 16-JUL-19
Austin TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Megadyne Foot Switch
Megadyne Medical Products, Inc. 510(k) NO: K191328(Traditional)
ATTN: Sharon Sussex PHONE NO :
1506 S State St SE DECISION MADE: 26-JUL-19
Draper UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Pegasus System
A.M. Surgical, Inc. 510(k) NO: K191345(Traditional)
ATTN: Vincent Pascale PHONE NO : 1 631 9799777
285 Middle Country Road, Suite 206SE DECISION MADE: 17-JUL-19
Smithtown NY 11787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stat Profile Prime ES Comp Plus Analyzer System
Nova Biomedical Corporation 510(k) NO: K191365(Traditional)
ATTN: Cesidio Tempesta PHONE NO : 781 8940800
200 Prospect St. SE DECISION MADE: 19-JUL-19
Waltham MA 02454 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Harrier-SA Lumbar Interbody System
ChoiceSpine LLC 510(k) NO: K191367(Special)
ATTN: Kim Finch PHONE NO : 865 2433969
400 Erin Drive SE DECISION MADE: 05-JUL-19
Knoxville TN 37922 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DreaMed Advisor Pro
DreaMed Diabetes Ltd 510(k) NO: K191370(Traditional)
ATTN: Eran Atlas PHONE NO : 972 52 3166684
5 Mota Gur Street SE DECISION MADE: 18-JUL-19
Petah Tikva IL 4952701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Lyra
Interacoustics A/S 510(k) NO: K191372(Traditional)
ATTN: Erik Nielsen PHONE NO : 45 63 713555
Audiometer Alle 1 SE DECISION MADE: 15-JUL-19
Middelfart DK DK-5500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revival Modular Hip Stem
Corin USA Limited 510(k) NO: K191374(Traditional)
ATTN: Rachel King PHONE NO : 813 9774469
12750 Citrus Park Lane SE DECISION MADE: 22-JUL-19
Tampa FL 33625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RayCare 2.3
RaySearch Laboratories AB (publ) 510(k) NO: K191384(Traditional)
ATTN: David Hedfors PHONE NO : 46 8 51053000
Sveavagen 44 SE DECISION MADE: 08-JUL-19
Stockholm SE 11134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
Horiba ABX SAS 510(k) NO: K191396(Traditional)
ATTN: Caroline Ferrer PHONE NO : 0033 4670 141516
Parc Euromedecine, Rue du Caducee SE DECISION MADE: 26-JUL-19
Montpellier Cedex 4 FR 341184 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test System
ZEUS Scientific Inc. 510(k) NO: K191398(Traditional)
ATTN: Mark J. Kopnitsky PHONE NO : 908 2434904
P.O. BOX 38 SE DECISION MADE: 29-JUL-19
Raritan NJ 08869 510(k) STATEMENT
DEVICE: Nexxt Matrixx System
Nexxt Spine LLC 510(k) NO: K191408(Special)
ATTN: Andy Elsbury PHONE NO : 317 4367801
14425 Bergen Blvd, Suite B SE DECISION MADE: 10-JUL-19
Noblesville IN 46060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CMDR 2CW (Multiple models)
MinXray, Inc 510(k) NO: K191451(Special)
ATTN: Keith Kretchmer PHONE NO : 847 5640323
3611 Commercial Ave SE DECISION MADE: 03-JUL-19
Northbrook IL 60062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Atellica CH Amylase_2 (AMY_2)
Siemens Healthcare Diagnostics Inc510(k) NO: K191454(Traditional)
ATTN: Catherine Daigle PHONE NO : 302 6317310
500 GBC Drive P.O. Box 6101, M/S 5SE DECISION MADE: 30-JUL-19
Newark DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PWD Platform Wound Dressing 3” x 5” Oblong
Applied Tissue Technologies LLC 510(k) NO: K191460(Special)
ATTN: Michael Broomhead PHONE NO : 781 3663848
99 Derby St., Suite 700 SE DECISION MADE: 02-JUL-19
Hingham MA 02043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
Canon Medical Systems Corporation 510(k) NO: K191467(Traditional)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 19-JUL-19
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: syngo.CT Dual Energy
Siemens Medical Solutions, USA, In510(k) NO: K191468(Special)
ATTN: Cynthia Busch PHONE NO : 847 6436818
2501 N. Barrington Road SE DECISION MADE: 03-JUL-19
Hoffman Estates IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Senhance Surgical System
TransEnterix Inc. 510(k) NO: K191482(Special)
ATTN: Kaitlyn Alexander PHONE NO : 919 7658400 8505
635 Davis Drive, Suite 300 SE DECISION MADE: 11-JUL-19
Morrisville NC 27560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Renuvion/J-Plasma Precise Handpiece
Apyx Medical Corporation(formerly 510(k) NO: K191484(Traditional)
ATTN: Topaz Kirlew PHONE NO : 727 8038617
5115 Ulmerton Road SE DECISION MADE: 30-JUL-19
Clearwater FL 33760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Biopsy Positioner
FUJIFILM Corporation 510(k) NO: K191495(Special)
ATTN: Randy Vader PHONE NO : 360 3566821
798 Miyanodai Kaisei-Machi SE DECISION MADE: 03-JUL-19
Ashigarakami-Gun JP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
Hycor Biomedical 510(k) NO: K191510(Traditional)
ATTN: Kaitlyn Weinkauf PHONE NO : 714 9333020
7272 Chapman Avenue SE DECISION MADE: 31-JUL-19
Garden Grove CA 92841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ID NOW Influenza A & B 2
Abbott Diagnostics Scarborough, In510(k) NO: K191534(Special)
ATTN: Angela Drysdale PHONE NO : 207 4151393
10 Southgate Road SE DECISION MADE: 11-JUL-19
Scarborough ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CoLink® Mini Plating System
In2Bones USA, LLC 510(k) NO: K191535(Traditional)
ATTN: Christine Scifert PHONE NO :
6000 Poplar Ave, Suite 115 SE DECISION MADE: 29-JUL-19
Memphis TN 38119 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vave Personal Ultrasound System
Vave Health, Inc. 510(k) NO: K191541(Third Party - Traditional)
ATTN: Joseph Ko PHONE NO : 415 2645284
2955 Campus Drive, Suite 110 SE DECISION MADE: 10-JUL-19
San Mateo CA 94403 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CentriMag Acute Circulatory Support System
Thoratec Corporation (now part of 510(k) NO: K191557(Special)
ATTN: Lori Dondiego PHONE NO : 925 2275834
6035 Stoneridge Drive SE DECISION MADE: 10-JUL-19
Pleasanton CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control
Siemens Healthcare Diagnostics Inc510(k) NO: K191578(Traditional)
ATTN: Matthew Gee PHONE NO : 914 3729169
511 Benedict Avenue SE DECISION MADE: 17-JUL-19
Tarrytown NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Voyant System
Viseon, Inc. 510(k) NO: K191579(Special)
ATTN: Cora Sim PHONE NO : 949 6623959 106
13900 Alton Parkway, Suite 125 SE DECISION MADE: 11-JUL-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
Varian Medical Systems, Inc. 510(k) NO: K191580(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 08-JUL-19
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: iNtuition-Structural Heart Module
TeraRecon Inc. 510(k) NO: K191585(Traditional)
ATTN: Megha Jain PHONE NO : 650 3721100
4000 East, 3rd Ave, Suite 200 SE DECISION MADE: 12-JUL-19
Foster City CA 94402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Calprest, EasyCal
Eurospital S.p.A. 510(k) NO: K191589(Special)
ATTN: Chiara Pelillo PHONE NO : 39 040 8997266
Via Flavia 122 SE DECISION MADE: 10-JUL-19
Trieste IT 34147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CalprestNG, EasyCal
Eurospital S.p.A. 510(k) NO: K191592(Special)
ATTN: Chiara Pelillo PHONE NO : 39 040 8997266
Via Flavia 122 SE DECISION MADE: 10-JUL-19
Trieste IT 34147 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Digital Automatic Blood Pressure Monitor MD36 Series
Grandway Technology (Shenzhen) Lim510(k) NO: K191593(Special)
ATTN: Patrick Chow PHONE NO : 852 28516789
no. 5, 2nd Industrial Zone, ZhukenSE DECISION MADE: 22-JUL-19
Shenzhen CN 518118 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Nuvis Battery Arthroscope
Integrated Endoscopy, Inc. 510(k) NO: K191594(Special)
ATTN: Albert Rego PHONE NO : 949 6328126
16 Technology Drive, Suite 165 SE DECISION MADE: 11-JUL-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOS ES Retrograde Femoral Nail
Advanced Orthopaedic Solutions, In510(k) NO: K191598(Special)
ATTN: Elaine Nguyen PHONE NO : 310 5339966
3203 Kashiwa Street SE DECISION MADE: 18-JUL-19
Torrance CA 90505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Valleylab FT10 Electrosurgical Platform
Covidien 510(k) NO: K191601(Special)
ATTN: Jennie van Diemen PHONE NO : 303 5817037
5920 Longbow Drive SE DECISION MADE: 12-JUL-19
Boulder CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Impress Angiographic Catheter
Merit Medical Systems, Inc. 510(k) NO: K191608(Special)
ATTN: Luke Meidell PHONE NO : 801 2084623
1600 West Merit Parkway SE DECISION MADE: 16-JUL-19
South Jordan UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Diode Laser Therapy Systems
Wingderm Electro-Optics Ltd. 510(k) NO: K191611(Traditional)
ATTN: Juan Zhou PHONE NO : 086 010 57734966
Room 312, Building D-3, Dongsheng SE DECISION MADE: 31-JUL-19
Beijing CN 100192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Huvitz Imaging System
Huvitz Co., Ltd. 510(k) NO: K191615(Special)
ATTN: Hyung Min Heo PHONE NO : 82 31 4289059
38, Burim-ro, 170beon-gil, Dongan-SE DECISION MADE: 18-JUL-19
Anyang-si, Dongan-gu KR 14055 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Orthophos S
Dentsply Sirona 510(k) NO: K191616(Traditional)
ATTN: Karl Nittinger PHONE NO : 717 8494424
221 West Philadelphia Street, SuitSE DECISION MADE: 16-JUL-19
York PA 17401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Infyna Chic
Hollister Incorporated 510(k) NO: K191633(Special)
ATTN: Michelle Schiltz-Taing PHONE NO : 847 6802122
2000 Hollister Drive SE DECISION MADE: 19-JUL-19
Libertyville IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Optilite IgM Kit
The Binding Site Group Ltd. 510(k) NO: K191635(Special)
ATTN: Natasha Verhaak PHONE NO : 44 0121 4569500
8 Calthorpe Road SE DECISION MADE: 15-JUL-19
Edgbaston GB B15 1QT 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mariner MIS Pedicle Screw System; SeaSpine Navigation System
SeaSpine Orthopedics Corporation 510(k) NO: K191648(Special)
ATTN: Alicia McArthur PHONE NO : 760 2165117
5770 Armada Drive SE DECISION MADE: 19-JUL-19
Carlsbad CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARTO 3 EP Navigation System, Version 7.1 and Accessories
Biosense Webster, Inc. 510(k) NO: K191660(Special)
ATTN: Phuong Chau PHONE NO : 949 9234238
33 Technology Drive SE DECISION MADE: 20-JUL-19
Irvine CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Vantage Orian 1.5T, MRT-1550, V4.5
Canon Medical Systems Corporation 510(k) NO: K191662(Special)
ATTN: Paul Biggins PHONE NO : 714 6697808
1385 Shimoishigami SE DECISION MADE: 23-JUL-19
Otawara-shi JP 324-8550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Discovery XR656 HD with VolumeRad
GE Hualun Medical Systems Co., Ltd510(k) NO: K191699(Traditional)
ATTN: Chris Paulik PHONE NO : 0086 10 57388715
No. 1 Yong Chang North Road, EconoSE DECISION MADE: 24-JUL-19
Beijing CN 100176 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOLOC™ SPS Shoulder Plating System
Tornier Inc. 510(k) NO: K191711(Special)
ATTN: Renee Stoffel PHONE NO : 952 6837471
10801 Nesbitt Ave South SE DECISION MADE: 17-JUL-19
Bloomington MN 55437 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
Asahi Intecc Co., Ltd. 510(k) NO: K191714(Special)
ATTN: Yasuyuki Kawahara PHONE NO : 81 561 561859
3-100 Akatsuki-cho SE DECISION MADE: 26-JUL-19
Seto JP 489-0071 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
Roche Molecular Systems, Inc. 510(k) NO: K191729(Special)
ATTN: Kaitlyn Hameister PHONE NO : 925 7308813
4300 Hacienda Drive SE DECISION MADE: 24-JUL-19
Pleasanton CA 94588-2722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: The ZIP Accessory Shuttle for PleuraFlow System
ClearFlow, Inc. 510(k) NO: K191733(Special)
ATTN: Dov Gal PHONE NO : 714 9165014
1630 S. Sunkist St. Suite E SE DECISION MADE: 26-JUL-19
Anaheim CA 92806 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30
Intuitive Surgical 510(k) NO: K191736(Special)
ATTN: Vishal Kanani PHONE NO : 408 5232035
1266 Kifer Road SE DECISION MADE: 26-JUL-19
Sunnyvale CA 94086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPAR-K Instruments (for use with Gemini SL Total Knee System)
Waldemar Link GmbH & Co. KG 510(k) NO: K191755(Special)
ATTN: Stefanie Fuchs PHONE NO : 49 40 53995517
Oststraße 4-10 SE DECISION MADE: 18-JUL-19
Norderstedt DE 22844 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUROPA Pedicle Screw System
MiRus, LLC 510(k) NO: K191757(Special)
ATTN: Jordan Bauman PHONE NO : 678 3246272
2150 Newmarket Parkway SE DECISION MADE: 19-JUL-19
Marietta GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Mobius3D
Varian Medical Systems, Inc 510(k) NO: K191761(Special)
ATTN: Peter J. Coronado PHONE NO : 650 4246320
3100 Hansen Way SE DECISION MADE: 31-JUL-19
Palo Alto CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Inion BioRestore
Inion Oy 510(k) NO: K191764(Special)
ATTN: Tiina Tyni PHONE NO : 358 10 8306600
Lääkärinkatu 2 SE DECISION MADE: 31-JUL-19
Tampere FI 33520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXS Vecta Aspiration System
Stryker Neurovascular 510(k) NO: K191768(Special)
ATTN: Shazia Hakim PHONE NO : 510 4132636
47900 Bayside Parkway SE DECISION MADE: 30-JUL-19
Fremont CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE BIO-A Tissue Reinforcement
W.L. Gore & Associates, Inc. 510(k) NO: K191773(Special)
ATTN: Barbara L. Smith PHONE NO : 410 5068189
301 Airport Road SE DECISION MADE: 31-JUL-19
Elkton MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
GE Medical Systems, LLC 510(k) NO: K191777(Special)
ATTN: Laura Turner PHONE NO : 262 5484588
3000 N. Grandview Blvd SE DECISION MADE: 26-JUL-19
Waukesha WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Stonetome Stone Removal Device
Boston Scientific Corporation 510(k) NO: K191789(Special)
ATTN: Laura Kuroski PHONE NO : 508 6834406
100 Boston Scientific Way SE DECISION MADE: 25-JUL-19
Marlborough MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOCup Lens Case with AODisc
Alcon Laboratories, Inc. 510(k) NO: K191795(Special)
ATTN: Katryna Warren PHONE NO : 817 6155076
6201 South Freeway SE DECISION MADE: 31-JUL-19
Fort Worth TX 76134-2099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BiomarC Fiducial Marker
Carbon Medical Technologies 510(k) NO: K191797(Special)
ATTN: Eric Furlich PHONE NO : 651 6538512
1290 Hammond Rd. SE DECISION MADE: 29-JUL-19
St. Paul MN 55110-5876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ActivOrtho Continuous Compression Screw System
ActivOrtho, Inc. 510(k) NO: K191817(Traditional)
ATTN: Paul Hindrichs PHONE NO : 651 3413805
14405 21st Avenue N SE DECISION MADE: 26-JUL-19
Plymouth MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
Hardy Diagnostics 510(k) NO: K191931(Traditional)
ATTN: Anna Klavins PHONE NO : 800 2662222 5752
1430 West McCoy Lane SE DECISION MADE: 31-JUL-19
Santa Maria CA 93455 510(k) STATEMENT
TOTAL 510(k)s THIS PERIOD 267
TOTAL WITH SUMMARIES 252
TOTAL WITH STATEMENTS 15
