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  1. Device Approvals, Denials and Clearances

July 2019 510(K) Clearances

July 2019 510(K) Clearances

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