U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. May 2019 510(K) Clearances
  1. 510(k) Clearances

May 2019 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD May 2019


DEVICE: Air Relax
Maxstar Industrial Co., Ltd       510(k) NO: K173158(Special)
ATTN: Lee  BungHyun               PHONE NO : 82 31 9893543 
152 - 12 Hwanggeum-ro 23beon-gil, SE DECISION MADE: 30-MAY-19
Gimpo  KR 415843                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SD Abutment
Surgident Co., Ltd.               510(k) NO: K173570(Traditional)
ATTN: Ju Youn  Choi               PHONE NO : 82 31 7372875 
#209-210, Woolim Lion's Valley, 27SE DECISION MADE: 17-MAY-19
Seongnam-si  KR 13229             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tel-O-Graph
I.E.M. Industrielle Entwicklung an510(k) NO: K173895(Traditional)
ATTN: Hella  Witt                 PHONE NO : 49 2402 95000 
Vertriebsgesellschaft mbH CockerilSE DECISION MADE: 16-MAY-19
Stolberg  DE 52222                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Manual Wheelchair W54
Jiangsu Jumao Medical Equipment Co510(k) NO: K180309(Traditional)
ATTN: Qian  Gao                   PHONE NO : 86 511 86197066 
No.36 Danyan road                 SE DECISION MADE: 03-MAY-19
Danyang City  CN 212300           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NS 120P-TRS Airway Pressure Gauge
Instrumentation Industries, Inc.  510(k) NO: K180510(Traditional)
ATTN: Doris  Walter               PHONE NO : 412 8541133 
2990 Industrial Blvd.             SE DECISION MADE: 01-MAY-19
Bethel Park PA  15102             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clearlink System Solution Set
Baxter Healthcare Corporation     510(k) NO: K180739(Third Party - Traditional)
ATTN: Jeanette  Licata            PHONE NO : 224 9483996 
32650 N. Wilson Road              SE DECISION MADE: 28-MAY-19
Round Lake IL  60073              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Conical Plus Implant System
OsseoFuse International, Inc.     510(k) NO: K181157(Traditional)
ATTN: Jennifer  Cha               PHONE NO : 888 4469995 
5023 North Parkway Calabasas      SE DECISION MADE: 24-MAY-19
Calabasas CA  91302               510(k) STATEMENT
                                                    

DEVICE: FLIX-EMS
Casgarum Investment, S.L.         510(k) NO: K181419(Traditional)
ATTN: Rafael  Castillo            PHONE NO : 34 92 5512667 
Calle Real, 17 Bº E               SE DECISION MADE: 14-MAY-19
Illescas  ES 45200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delta Dual Mobility System
Limacorporate S.p.A.              510(k) NO: K181491(Traditional)
ATTN: Roberto  Gabetta            PHONE NO : 39 04 32945511 
Via Nazionale 52                  SE DECISION MADE: 09-MAY-19
Villanova di San Daniele  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hysteroscope System
Shanghai AnQing Medical Instrument510(k) NO: K181545(Traditional)
ATTN: Lina  FEI                   PHONE NO : 86 137 74253128 
150 Cailun Road, Zhangjiang High-TSE DECISION MADE: 10-MAY-19
Shanghai  CN 201210               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution External Plating System
New Standard Device DBA Metalogix 510(k) NO: K181630(Traditional)
ATTN: Bryant  Phamvu              PHONE NO : 210 4921511 
4766 Research Drive               SE DECISION MADE: 29-MAY-19
San Antonio TX  78240             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cocoon Convective Warming System
Care Essentials Pty Ltd           510(k) NO: K181671(Special)
ATTN: Abhay  Sinha                PHONE NO : 613 52771455 
25 Slevin St                      SE DECISION MADE: 02-MAY-19
North Geelong  AU 3215            510(k) STATEMENT
                                                    

DEVICE: OssBuilder System
Osstem Implant Co., Ltd..         510(k) NO: K181854(Traditional)
ATTN: Jungmin  Yoo                PHONE NO : 82 51 8502500 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 07-MAY-19
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOF-Cuff monitor
RGB Medical Devices SA            510(k) NO: K181894(Abbreviated)
ATTN: Ricardo  Ruiz               PHONE NO : 34 91 3042011 
Calle de Alfonso Gomez 42         SE DECISION MADE: 09-MAY-19
Madrid  ES 28037                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Sterilization Container System
Synthes (USA) Products LLC / DePuy510(k) NO: K181933(Traditional)
ATTN: Thomas  Shea                PHONE NO : 610 7195679 
1301 Goshen Parkway               SE DECISION MADE: 09-MAY-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter
Teleflex Medical, Inc.            510(k) NO: K181979(Traditional)
ATTN: Sirisha  Kommana            PHONE NO : 919 4334831 
3015 Carrington Mill Blvd, Suite 6SE DECISION MADE: 24-MAY-19
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: armor LC
Mavrik Dental Systems Ltd         510(k) NO: K182118(Traditional)
ATTN: Sherwyn  Davidson           PHONE NO : 972 9 9740100 
25 Ha Haroshet Street, 6th floor  SE DECISION MADE: 03-MAY-19
Raanana  IL                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPEAC System
Brain Sentinel, Inc.              510(k) NO: K182180(Traditional)
ATTN: Richard  Waite              PHONE NO : 214 6629277 
8023 Vantage Dr., Suite 216       SE DECISION MADE: 11-MAY-19
San Antonio TX  78230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brush Biopsy Set ; Deflectable Brush Biopsy Set
Cook Incorporated                 510(k) NO: K182231(Traditional)
ATTN: Thomas  Palmer              PHONE NO : 812 3392235 104964
750 Daniels Way                   SE DECISION MADE: 01-MAY-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OnSite Waste Sharps Container
Bluestone Medical, Inc.           510(k) NO: K182235(Traditional)
ATTN: Jon  Bricken                PHONE NO : 914 8863958 
(DBA OnSite Waste Technologies, InSE DECISION MADE: 20-MAY-19
East Hampton NY  11937            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed ViewFlex Xtra ICE Catheter
Stryker Sustainability Solutions  510(k) NO: K182238(Traditional)
ATTN: Ramona  Kulik               PHONE NO : 480 7632952 
1810 West Drake Drive             SE DECISION MADE: 08-MAY-19
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOLUTION NitrX Medial-Pivot Knee
MircoPort Orthopedics, Inc.       510(k) NO: K182251(Traditional)
ATTN: Byron  Ledbetter            PHONE NO : 901 2905943 
5677 Airline Road                 SE DECISION MADE: 16-MAY-19
Arlington TN  38002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook Unimpregnated Central Venous Catheter
Cook Incorporated                 510(k) NO: K182252(Traditional)
ATTN: Johnathan  Liu              PHONE NO : 812 3353575 104509
750 Daniels Way                   SE DECISION MADE: 17-MAY-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CardioGard Emboli Protection Cannula
CardioGard Medical Ltd            510(k) NO: K182302(Traditional)
ATTN: Orit  Ronan                 PHONE NO : 972 3 5467163 
6 Yoni Netanyahu Street           SE DECISION MADE: 17-MAY-19
Or-Yehuda  IL 6037604             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs
Sri Trang Gloves (Thailand) Co., L510(k) NO: K182308(Abbreviated)
ATTN: Anan  Pruksanusak           PHONE NO : 66 74 344663 
10 Soi 10 Phetkasem Road          SE DECISION MADE: 30-MAY-19
Hatyai  TH 90110                  510(k) STATEMENT
                                                    

DEVICE: MobileLink Acetabular Cup System
Waldemar Link GmbH & Co. KG       510(k) NO: K182321(Traditional)
ATTN: Karen  Sonnenberger         PHONE NO : 49 40 53995517 
Oststrabe 4-10                    SE DECISION MADE: 24-MAY-19
Norderstedt  DE 22844             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VeriClear Digital Early Result Pregnancy Test
True Diagnostics, Inc.            510(k) NO: K182328(Traditional)
ATTN: Jerry  Lee                  PHONE NO : 888 5718597 700
2782 Loker Ave West               SE DECISION MADE: 15-MAY-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntraLock Lapidus System
Fusion Orthopedics, LLC           510(k) NO: K182342(Traditional)
ATTN: Eli  Jacobson               PHONE NO : 800 4036876 
4135 S. Power Rd., Suite 110      SE DECISION MADE: 21-MAY-19
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Ceramic
Baot Biological Technology Co., LT510(k) NO: K182350(Traditional)
ATTN: Liqun  Zhu                  PHONE NO : 86 760 87893826 
Unit 1, Second Floor, No 12 BuildiSE DECISION MADE: 22-MAY-19
Zhongshan  CN 528437              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MaxCap Ped and MaxCap Neo
Maxtec, LLC                       510(k) NO: K182362(Traditional)
ATTN: Tammy  Lavery               PHONE NO : 385 5498049 
2305 S 1070 W                     SE DECISION MADE: 23-MAY-19
Salt Lake City UT  84119          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAC S
Sit Sordina Iort Technologies Spa 510(k) NO: K182374(Traditional)
ATTN: Alessia  Giaffreda          PHONE NO : 39 0444 233711 
Galleria Del Rosso Pozzo 13       SE DECISION MADE: 22-MAY-19
Vicenza  IT 36100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMPEDE-FX Embolization Plug
Shape Memory Medical              510(k) NO: K182390(Traditional)
ATTN: Meghan  Reu                 PHONE NO : 408 6495175 711
807 Aldo Avenue, Suite 109        SE DECISION MADE: 23-MAY-19
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WiZARD 310/320 Series CPAP Mask
Apex Medical Corp.                510(k) NO: K182394(Traditional)
ATTN: Frank  Lin                  PHONE NO : 886 2 22685568 
No. 9 Min Sheng St. Tu-Cheng      SE DECISION MADE: 17-MAY-19
New Taipei City  TW 23679         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peel-Away Introducer
Cook Incorporated                 510(k) NO: K182403(Traditional)
ATTN: Johnathan  Liu              PHONE NO : 812 3352235 104509
750 Daniels Way                   SE DECISION MADE: 29-MAY-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Olympus Medical Systems Corp.     510(k) NO: K182408(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 15-MAY-19
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlucoLeader Enhance Blood Glucose Monitoring System
HMD BioMedical Inc.               510(k) NO: K182428(Traditional)
ATTN: Jen  Ke-Min                 PHONE NO : 88 63 5895000 
No. 181 Minsheng St., Xinpu TownshSE DECISION MADE: 08-MAY-19
Hsin Chu County  TW 30542         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLEARFIL MAJESTY IC
Kuraray Noritake Dental Inc.      510(k) NO: K182430(Traditional)
ATTN: Yasujiro  Ohara             PHONE NO : 81 3 67011706 
Ote Center Bldg. 7F, 1-1-3, OtemacSE DECISION MADE: 03-MAY-19
Chiyoda-ku  JP 100-0004           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Intelligent Thermometer
Shenzhen Jumper Medical Equipment 510(k) NO: K182437(Traditional)
ATTN: Tom  Tom                    PHONE NO : 86 755 26696279 
D Building, No. 71, Xintian Road, SE DECISION MADE: 05-MAY-19
Shenzhen  CN 518100               510(k) STATEMENT
                                                    

DEVICE: Pristine Hemodialysis Catheter
Pristine Access Technologies Ltd. 510(k) NO: K182443(Traditional)
ATTN: Ron  Livne                  PHONE NO : 972 775055645 
21 (B) Habarzel Street            SE DECISION MADE: 31-MAY-19
Tel Aviv  IL 6971029              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Longterm NPWT Foam Dressing Kit
Zhejiang Longterm Medical Technolo510(k) NO: K182458(Traditional)
ATTN: Claudia  Zsang              PHONE NO : 1 416 2769555 
No. 493 North Huancheng Road MoganSE DECISION MADE: 23-MAY-19
Deqing  CN 313200                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MD-6000P Bladder Scanner
Meda Co., LTD                     510(k) NO: K182460(Traditional)
ATTN: Linda  Zhang                PHONE NO : 86 22 83713808 
F2C,F3D,F4C,F5, F6C, Bldg C2, XinmSE DECISION MADE: 06-MAY-19
Tianjin  CN 300384                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
BioSystems S.A.                   510(k) NO: K182474(Traditional)
ATTN: Noelia  Gil                 PHONE NO : 34 933 110000 4108
Costa Brava, 30                   SE DECISION MADE: 02-MAY-19
Barcelona  ES 08030               510(k) STATEMENT
                                                    

DEVICE: Surgical Face Mask
Wuhan Dymex Healthcare Co., Ltd   510(k) NO: K182515(Traditional)
ATTN: Ada  Liu                    PHONE NO : 86 278462 18988003 
Room 1701, Unit 2, Building 5, JinSE DECISION MADE: 27-MAY-19
Wuhan  CN 430000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible Overtube
Sumitomo Bakelite Co., Ltd        510(k) NO: K182520(Traditional)
ATTN: Shiro  Agehama              PHONE NO : 81 354 624811 
5-8, Higashi-Shinagawa 2-chome    SE DECISION MADE: 15-MAY-19
Shinagawa-ku  JP 1400002          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)
Vcomin Technology Limited         510(k) NO: K182526(Traditional)
ATTN: Han  JieLin                 PHONE NO : 86 755 33826016 
2&3 FI., No. 1, Kangzheng Rd., BujSE DECISION MADE: 29-MAY-19
Shenzhen  CN 518110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liba3 System
National Cardiac, Inc.            510(k) NO: K182532(Traditional)
ATTN: Scott  Mallett              PHONE NO : 800 5514354 
221 W. Crest Street Suite 205     SE DECISION MADE: 15-MAY-19
Escondido CA  92025               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccelFix Spinal Fixation System
L&K BioMed Co., Ltd.              510(k) NO: K182544(Traditional)
ATTN: Jihyeon  Seo                PHONE NO : 82 2 67171983 
#201, 202 16-25, Dongbaekjungang-rSE DECISION MADE: 28-MAY-19
Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Jiangxi Jaysun Medicare Co., Ltd. 510(k) NO: K182575(Traditional)
ATTN: Zong  Run                   PHONE NO : 
No.1 Jaysun Road, Penghuwan IndustSE DECISION MADE: 24-MAY-19
Jiujiang  CN 332708               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solax Powered Wheelchair
Dongguan Prestige Sporting Goods C510(k) NO: K182576(Traditional)
ATTN: Zhang  Zhao                 PHONE NO : 86 137 63128800 
3rd Ind. District, Qiaotou Area, HSE DECISION MADE: 21-MAY-19
Dongguan  CN 523950               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOFIA EX Intracranial Support Catheter
Micro Vention Inc.                510(k) NO: K182602(Traditional)
ATTN: Tina  Ariaee                PHONE NO : 714 2478000 8366
35 Enterprise                     SE DECISION MADE: 15-MAY-19
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Qangio XA 3D
Medis Medical Imaging Systems bv  510(k) NO: K182611(Traditional)
ATTN: B.  Goedhart                PHONE NO : 31 71 5241700 
Schuttersveld 9                   SE DECISION MADE: 30-MAY-19
Leiden  NL 2316 xG                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue)
Zibo Yahao Supplies Co., LTD      510(k) NO: K182612(Traditional)
ATTN: Fiona  Xin                  PHONE NO : 86 533 7871082 
The 6th floor, NO.8, Niushan Road,SE DECISION MADE: 10-MAY-19
Zibo  CN 255414                   510(k) STATEMENT
                                                    

DEVICE: ATEC IOM Accessory Instruments
Alphatec Spine, Inc               510(k) NO: K182617(Traditional)
ATTN: Jeremy  Markovich           PHONE NO : 760 4946893 
5818 El Camino Real               SE DECISION MADE: 09-MAY-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitreq disposable laser probes, light fibers and Chandelier
Vitreq B.V.                       510(k) NO: K182646(Traditional)
ATTN: JanKees  Wouts              PHONE NO : 31 181 745090 
Segglant-Noord 2                  SE DECISION MADE: 01-MAY-19
Vierpolders  NL 3237MG            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GaltTWS
Galt Medical Corp.                510(k) NO: K182660(Traditional)
ATTN: David  Derrick              PHONE NO : 972 2715177 
2220 Merritt Drive                SE DECISION MADE: 30-MAY-19
Garland TX  75087                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling
Zimmer, Inc                       510(k) NO: K182678(Traditional)
ATTN: Caleb  Barylski             PHONE NO : 574 3710250 
PO Box 708                        SE DECISION MADE: 31-MAY-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)
Kelyniam Global Inc.              510(k) NO: K182711(Traditional)
ATTN: Eric  Boyea                 PHONE NO : 800 2808192 
97 River Road, Suite A            SE DECISION MADE: 21-MAY-19
Canton CT  06019                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brain Perfusion (BP) application
Philips Medical Systems Nederland 510(k) NO: K182716(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 1 800 7229377 
Veenpluis 4-6                     SE DECISION MADE: 29-MAY-19
Best Noord-Brabant  NL 5684 PC    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apis
SweetBio, Inc                     510(k) NO: K182725(Traditional)
ATTN: Kayla  Graff                PHONE NO : 415 3611649 
20 Dudley Street, Suite 900       SE DECISION MADE: 31-MAY-19
Memphis TN  38103-4904            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
UNICON Optical CO., LTD           510(k) NO: K182734(Traditional)
ATTN: HSIAO-WEI  SHEN             PHONE NO : 886 3 5775586 
No 16, Gongye E. 9th Rd. Hsinchu SSE DECISION MADE: 16-MAY-19
Hsinchu County  TW 30075          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Instruments Kits
JJGC Industria e Comercio de Mater510(k) NO: K182865(Traditional)
ATTN: Julianne de Oliveira CapuchoPHONE NO : 55 41 21694058 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 07-MAY-19
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HALF DOME Posterior Lumbar Interbody System
Astura Medical, LLC               510(k) NO: K182877(Traditional)
ATTN: Parker  Kelch               PHONE NO : 760 8148047 
3186 Lionshead Ave, Suite 100     SE DECISION MADE: 03-MAY-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Segmented Esophageal Stent System
Micro-Tech (Nanjing) Co., Ltd.    510(k) NO: K182910(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
No. 10 Gaoke Third Road           SE DECISION MADE: 29-MAY-19
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upstream GoBack Crossing Catheter
Upstream Peripheral Technologies, 510(k) NO: K182937(Traditional)
ATTN: Dan  Rottenberg             PHONE NO : 972 4 6239014 
ARAN Building, P.O. Box 3067; 43 HSE DECISION MADE: 23-MAY-19
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wallace Dual Lumen Oocyte Recovery System
CooperSurgical Inc.               510(k) NO: K182959(Traditional)
ATTN: Roaida  Johnson             PHONE NO : 203 6015200 3325
95 Corporate Drive                SE DECISION MADE: 10-MAY-19
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAKO 7
Boston Scientific Corporation     510(k) NO: K182975(Traditional)
ATTN: Ibhina  Sherchan            PHONE NO : 508 6834215 
100 Boston Scientific Way         SE DECISION MADE: 21-MAY-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SteriCap Mini Needle
OcuJet, LLC                       510(k) NO: K183016(Special)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
1441 Avocado Ave, Suite 204       SE DECISION MADE: 07-MAY-19
Newport Beach CA  92660           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
Cook Incorporated                 510(k) NO: K183035(Traditional)
ATTN: Yan  Li                     PHONE NO : 812 3352235 104987
750 Daniels Way                   SE DECISION MADE: 17-MAY-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYNMESH System
DePuy Synthes Spine               510(k) NO: K183054(Traditional)
ATTN: Michelle  Hughes            PHONE NO : 904 6081262 
325 Paramount Drive               SE DECISION MADE: 23-MAY-19
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Delta Xtend Reverse Shoulder System
DePuy (Ireland)                   510(k) NO: K183077(Traditional)
ATTN: Yayoi  Fujimaki             PHONE NO : 508 8283541 
Loughbeg Ringaskiddy              SE DECISION MADE: 17-MAY-19
Co. Cork Munster  IE              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fuji Cervical Plate System
Altus Partners, LLC               510(k) NO: K183084(Special)
ATTN: Mark  Melton                PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 29-MAY-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ControlRad Trace Model 8
ControlRad, Inc.                  510(k) NO: K183109(Traditional)
ATTN: Guillaume  Bailliard        PHONE NO : 1 610 9772422 
150 N. Radnor Chester Road, Suite SE DECISION MADE: 13-MAY-19
Radnor PA  19087                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electrosurgical accessory
New Deantronics Taiwan Ltd        510(k) NO: K183126(Traditional)
ATTN: Jane  Liu                   PHONE NO : 886 2 22681726 
                                  SE DECISION MADE: 08-MAY-19
New Taipei City  TW 23675         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
Haemonetics Corporation           510(k) NO: K183160(Traditional)
ATTN: Nancy  Bengtson             PHONE NO : 847 6531407 
400 Wood Road                     SE DECISION MADE: 09-MAY-19
Braintree MA  02184               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF
Richard Wolf Medical Instruments C510(k) NO: K183188(Traditional)
ATTN: Mike  Loiterman             PHONE NO : 847 9131113 
353 Corporate Woods Parkway       SE DECISION MADE: 03-MAY-19
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRIO Handpiece
OmniGuide, Inc.                   510(k) NO: K183199(Traditional)
ATTN: Samuel  Wade                PHONE NO : 617 5518410 
4 Maguire Road                    SE DECISION MADE: 02-MAY-19
Lexington MA  02412               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
EmCyte Corporation                510(k) NO: K183205(Special)
ATTN: Patrick  Pennie             PHONE NO : 239 4817725 
4331 Veronica S. Shoemaker Blvd, SSE DECISION MADE: 30-MAY-19
Fort Myers FL  33916              510(k) STATEMENT
                                                    

DEVICE: ET IV SA Dental Implants
Hiossen, Inc.                     510(k) NO: K183242(Special)
ATTN: Peter  Lee                  PHONE NO : 888 6780001 
85 Ben Fairless Drive             SE DECISION MADE: 21-MAY-19
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpO2 Sensor
Shenzhen Upnmed Equipment Co., Ltd510(k) NO: K183277(Traditional)
ATTN: Fu  Jian                    PHONE NO : 86 755 29728789 
4th Floor, Building #1 East, HuijuSE DECISION MADE: 15-MAY-19
Shenzhen  CN 518107               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Topaz Mobile DR System
DRGEM Corporation                 510(k) NO: K183292(Traditional)
ATTN: Ki-Nam  Yang                PHONE NO : 82 2 8698566 
7F E-B/D Gwangmyeong Techno-Park 6SE DECISION MADE: 15-MAY-19
Gwangmyeong-si  KR 14322          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Encore System
Siesta Medical, Inc               510(k) NO: K183310(Traditional)
ATTN: Michael  Kolber             PHONE NO : 408 5056626 
101 Church Street, Suite 3        SE DECISION MADE: 09-MAY-19
Los Gatos CA  95030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triangle System
AliveCor, Inc.                    510(k) NO: K183319(Traditional)
ATTN: Prabhu  Raghavan            PHONE NO : 650 3968553 
444 Castro Street, Suite 600      SE DECISION MADE: 10-MAY-19
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Entuit PEG, Entuit PEGJ
Wilson-Cook Medical, Inc          510(k) NO: K183336(Traditional)
ATTN: Tiffany A. Thomas           PHONE NO : 336 7440157 396680
4900 Bethania Station Road        SE DECISION MADE: 29-MAY-19
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2
DMG Chemisch-Pharmazeutische Fabri510(k) NO: K183337(Traditional)
ATTN: Sonja  Toeppen              PHONE NO : 49 040 840060 
Elbgaustrasse 248                 SE DECISION MADE: 29-MAY-19
Hamburg  DE 22547                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigation Enabled Instruments
STRYKER                           510(k) NO: K183381(Traditional)
ATTN: Megan  Callanan             PHONE NO : 201 7498000 
2 Pearl Court                     SE DECISION MADE: 17-MAY-19
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
GE Healthcare Finland Oy          510(k) NO: K183394(Special)
ATTN: Joel  Kent                  PHONE NO : 358 10 39411 
Kuortaneenkatu 2                  SE DECISION MADE: 01-MAY-19
Helsinki  FI FI-00510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruWave Disposable Pressure Transducer
Edwards Lifeciences, LLC          510(k) NO: K183413(Traditional)
ATTN: Ye Seul  Kim                PHONE NO : 949 2502445 
One Edwards Way                   SE DECISION MADE: 01-MAY-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iRestore Professional 282
Freedom Laser Therapy, Inc.       510(k) NO: K183417(Traditional)
ATTN: Craig  Nabat                PHONE NO : 714 6699888 
16782 Von Karman Avenue, Unit #15 SE DECISION MADE: 17-MAY-19
Irvine CA  92606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas u 601 urinalysis test system
Roche Diagnostics                 510(k) NO: K183432(Traditional)
ATTN: Angela  Clements            PHONE NO : 317 5217338 
9115 Hague Road                   SE DECISION MADE: 07-MAY-19
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SomnoDent Avant
SomnoMed Inc.                     510(k) NO: K183443(Abbreviated)
ATTN: Dorene  Markwiese           PHONE NO : 1 888 4476673 
6513 Windcrest Drive              SE DECISION MADE: 08-MAY-19
Plano TX  75024                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter
Teleflex Medical, Inc             510(k) NO: K183461(Traditional)
ATTN: Lori  Pfohl                 PHONE NO : 919 4918960 
3015 Carrington Mill Blvd , Suite SE DECISION MADE: 08-MAY-19
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KY Banksy Moisture
RB Health (US) LLC                510(k) NO: K183505(Traditional)
ATTN: Elizabeth  Viguerie         PHONE NO : 973 4042600 
399 Interpace Parkway             SE DECISION MADE: 17-MAY-19
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Moore Park Mask
ResMed Ltd                        510(k) NO: K183512(Traditional)
ATTN: Nerida  Hunt                PHONE NO : 612 8884 1000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 07-MAY-19
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR8 Drill System, Midas Rex MR8 ClearView Tools
Medtronic Powered Surgical Solutio510(k) NO: K183515(Traditional)
ATTN: Jenna  Groves               PHONE NO : 817 7886686___ 
4620 North Beach Street           SE DECISION MADE: 12-MAY-19
Fort Worth TX  76137              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruDiagnosis System
Akonni Biosystems Inc.            510(k) NO: K183530(Traditional)
ATTN: Charles  Daitch             PHONE NO : 301 6980101 
400 Sagner Ave, Suite 300         SE DECISION MADE: 24-MAY-19
Frederick MD  21701               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fully Automatic Electronic Blood Pressure Monitor
Andon Health Co., Ltd.            510(k) NO: K183534(Abbreviated)
ATTN: Liu  Yi                     PHONE NO : 86 22 87611660 9060
No. 3 Jin Ping Street, Ya An Road,SE DECISION MADE: 16-MAY-19
Tianjin  CN 300190                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luna 3D GEN2 Interbody Fusion System
Benvenue Medical, Inc.            510(k) NO: K183560(Traditional)
ATTN: Laurent  Schaller           PHONE NO : 408 4549300 
4590 Patrick Henry Dr.            SE DECISION MADE: 23-MAY-19
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Quick-Clear Wand
Medline Industries, Inc.          510(k) NO: K183577(Traditional)
ATTN: Dinah  Rincones             PHONE NO : 847 9792687 
Three Lakes Drive                 SE DECISION MADE: 04-MAY-19
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vanguard Complete Knee System
Zimmer Inc.                       510(k) NO: K183583(Traditional)
ATTN: Charles  Neitzel            PHONE NO : 262 7163243 
P.O. Box 708                      SE DECISION MADE: 10-MAY-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QIAstat-Dx Respiratory Panel
QIAGEN GmbH                       510(k) NO: K183597(Traditional)
ATTN: Lindsey  Howard             PHONE NO : 1 240 6867826 
Qiagen Strasse 1                  SE DECISION MADE: 18-MAY-19
Hilden  DE 40724                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soniquence RF Generator and Soniquence Electrodes
Soniquence, LLC                   510(k) NO: K183611(Traditional)
ATTN: Suzanne  Lucas              PHONE NO : 516 6548017 
2473 Grand Avenue                 SE DECISION MADE: 22-MAY-19
Baldwin NY  11510                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revolution Radial Head
Ignite Orthopedics, Inc.          510(k) NO: K183618(Traditional)
ATTN: Russ  Parrott               PHONE NO : 574 5272864 
210 North Buffalo Street          SE DECISION MADE: 17-MAY-19
Warsaw, IN  46580                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mariner Outrigger Revision System
SeaSpine Orthopedics Corporation  510(k) NO: K183639(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 23-MAY-19
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stealth-Midas MR8 System
Medtronic Powered Surgical Solutio510(k) NO: K183644(Traditional)
ATTN: Jenna  Groves               PHONE NO : 817 7886686 
4620 North Beach Street           SE DECISION MADE: 22-MAY-19
Fox Worth TX  76137               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silver High Performance Dressing
Advanced Medical Solutions Ltd.   510(k) NO: K183645(Traditional)
ATTN: Amy  Turner                 PHONE NO : 44 1606 863500 
Premier Park, 33 , Winsford IndustSE DECISION MADE: 29-MAY-19
Winsford  GB CW7 3RT              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure
Edwards Lifeciences, LLC          510(k) NO: K183646(Traditional)
ATTN: Lisa  Gilman                PHONE NO : 949 2501478 
One Edwards Way                   SE DECISION MADE: 21-MAY-19
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: APAS Independence with Urine Analysis Module
Clever Culture Systems AG         510(k) NO: K183648(Traditional)
ATTN: Julie  Winson               PHONE NO : 61 2 99062984 
Seestrasse 204a                   SE DECISION MADE: 15-MAY-19
Bach  CH CH-8806                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus
PENTAX of America, Inc.           510(k) NO: K183654(Special)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 23-MAY-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VersaCross Transseptal Sheath
Baylis Medical Company Inc.       510(k) NO: K183655(Traditional)
ATTN: Meghal  Khakhar             PHONE NO : 1 905 6024875 252
2645 Matheson Blvd. East          SE DECISION MADE: 20-MAY-19
Mississauga  CA L4W 4J1           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Rad-97 and Accessories
Masimo Corporation                510(k) NO: K183697(Traditional)
ATTN: Sindura  Penubarthi         PHONE NO : 949 2977592 
52 Discovery                      SE DECISION MADE: 15-MAY-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker ChestShield Sterilization Tray System
Paragon Medical                   510(k) NO: K183701(Traditional)
ATTN: Rebecca  Walker             PHONE NO : 574 5942140 
8 Matchett Dr.                    SE DECISION MADE: 07-MAY-19
Pierceton IN  46562               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Ansell Healthcare Products, LLC.  510(k) NO: K190018(Traditional)
ATTN: Don  Cronk                  PHONE NO : 775 4707106 
2301 Robb Drive                   SE DECISION MADE: 23-MAY-19
Reno NV  89523                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SteriStay
Toul Meditech AB                  510(k) NO: K190027(Traditional)
ATTN: Tomas  Hansson              PHONE NO : 46 21 135000 
Tunbytorpsgatan 31                SE DECISION MADE: 10-MAY-19
Vasteras  SE 72137                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REMY Medical Therapy Laser System
Footdocprenur, LLC                510(k) NO: K190034(Traditional)
ATTN: David  Zuckerman            PHONE NO : 1 856 2292939 
1803 Country Club Drive           SE DECISION MADE: 15-MAY-19
Cherry Hill NJ  08003             510(k) STATEMENT
                                                    

DEVICE: Arrowhead Hexapod Fixator
Arrowhead DE, LLC                 510(k) NO: K190069(Traditional)
ATTN: Thomas J. Twardzik          PHONE NO : 901 8534366 
328 Poplar View Lane East, Suite 2SE DECISION MADE: 14-MAY-19
Collierville TN  38017            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove
Molnlycke Health Care, US LLC     510(k) NO: K190077(Traditional)
ATTN: Leonard  Stewart            PHONE NO : 470 3750178 
5550 Peachtree Parkway, Suite 500 SE DECISION MADE: 24-MAY-19
Norcross GA  30092                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leaf Photocoagulator
Norlase ApS                       510(k) NO: K190083(Traditional)
ATTN: Jan  Forstberg              PHONE NO : 011 4540 109302 
Brydehusvej 302750                SE DECISION MADE: 03-MAY-19
Ballerup  DK                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNiD Patient specific 3D printed TLIF cage
Medicrea International S.A.       510(k) NO: K190092(Traditional)
ATTN: David  Ryan                 PHONE NO : 0033 4 72018787 
5389 route de Strasbourg          SE DECISION MADE: 08-MAY-19
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire
T.A.G. Medical Products Corporatio510(k) NO: K190125(Traditional)
ATTN: Shlomi  Dines               PHONE NO : 972 4 9858400 
Gaaton                            SE DECISION MADE: 19-MAY-19
Gaaton  IL 2513000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor-HL158TB
Health & Life Co., Ltd.           510(k) NO: K190134(Special)
ATTN: JS  Hsu                     PHONE NO : 886 2 82271300 1201
9F, No. 186, Jian Yi Road         SE DECISION MADE: 20-MAY-19
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COLOSSEUM Mesh
Globus Medical Inc.               510(k) NO: K190147(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 08-MAY-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
bioMerieux SA                     510(k) NO: K190154(Traditional)
ATTN: Marine  Taravant            PHONE NO : 33 04 78872126 
376, chemin de l'Orme             SE DECISION MADE: 01-MAY-19
Marcy-l'Etoile  FR 69280          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
Showa Best Glove, Inc.            510(k) NO: K190159(Traditional)
ATTN: Jefferey  Richardson        PHONE NO : 706 8626000 
579 Edison Street                 SE DECISION MADE: 06-MAY-19
Menlo GA  30731-6355              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: neXus Ultrasonic Surgical Aspirator System
Misonix, Inc.                     510(k) NO: K190160(Traditional)
ATTN: John  Salerno               PHONE NO : 631 9279123 
1938 New Highway                  SE DECISION MADE: 30-MAY-19
Farmingdale NY  11735             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
Gebauer Company                   510(k) NO: K190161(Traditional)
ATTN: Brittney  Cooper            PHONE NO : 216 5813030 
4444 East 153rd Street            SE DECISION MADE: 07-MAY-19
Cleveland OH  44128               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capstone Control™ Spinal System
Medtronic Sofamor Danek USA, INC. 510(k) NO: K190165(Traditional)
ATTN: Justin  O'Connor            PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 06-MAY-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MitraClip G4 Steerable Guide Catheter
Abbott                            510(k) NO: K190167(Special)
ATTN: Ekta  Lad                   PHONE NO : 408 8450937 
3200 Lakeside Drive               SE DECISION MADE: 29-MAY-19
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MVP Cervical Plate System
GS Medical Co., Ltd.              510(k) NO: K190170(Traditional)
ATTN: Barry  Sands                PHONE NO : 352 3274641 
90, Osongsaengmyeong 4-Ro         SE DECISION MADE: 13-MAY-19
Osong-Eup  KR 363-951             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
JK-Holding GmbH                   510(k) NO: K190173(Traditional)
ATTN: Juergen  Gerstenmeier       PHONE NO : 49 2224 818330 
Koehlershohner Strabe 60          SE DECISION MADE: 10-MAY-19
Windhagen  DE 53578               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unity Subcutaneous Delivery System for Remodulin
DEKA Research & Development       510(k) NO: K190182(Traditional)
ATTN: Brian  Carney               PHONE NO : 603 6695139 
340 Commercial Street             SE DECISION MADE: 06-MAY-19
Manchester NH  03101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gynescope System
Illumigyn Ltd.                    510(k) NO: K190187(Traditional)
ATTN: Lior  Greenstein            PHONE NO : 972 2 5476319 
Communication Center              SE DECISION MADE: 08-MAY-19
Neve Ilan  IL 9085000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
PENTAX Medical, A Division of PENT510(k) NO: K190194(Traditional)
ATTN: Gurvinder Singh Nanda       PHONE NO : 650 3168601 
303 Convention Way, Suite 1       SE DECISION MADE: 31-MAY-19
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unscented Menstrual Tampon
Qingdao Youjia Hygiene Technology 510(k) NO: K190218(Traditional)
ATTN: Huiying  Zhao               PHONE NO : 86 532 86613616 
No. 778 Mingyue Road, Huangdao ZonSE DECISION MADE: 09-MAY-19
Qingdao  CN 266400                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simplexa VZV Direct, Simplexa VZV Positive Control Pack
DiaSorin Molecular LLC            510(k) NO: K190219(Traditional)
ATTN: Sharon  Young               PHONE NO : 562 2406500 
11331 Valley View Street          SE DECISION MADE: 13-MAY-19
Cypress CA  90630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FilmArray Pneumonia/Pneumoniaplus Control
Maine Molecular Quality Controls, 510(k) NO: K190222(Traditional)
ATTN: Joan  Gordon                PHONE NO : 207 8851072 
23 Mill Brook Road                SE DECISION MADE: 03-MAY-19
Saco ME  04072                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cepheid Xpert CT/NG Control Panel
Microbiologics, Inc.              510(k) NO: K190223(Traditional)
ATTN: Tina  Sobania               PHONE NO : 320 2297050 
200 Cooper Avenue North           SE DECISION MADE: 08-MAY-19
St. Cloud MN  56303               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Boomerang™ Anterior Cervical Plate System
ChoiceSpine, LP                   510(k) NO: K190227(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433375 
400 Erin Drive                    SE DECISION MADE: 01-MAY-19
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InCore® Lapidus Sterile Kits
Nextremity Solutions, Inc.        510(k) NO: K190231(Traditional)
ATTN: Greg  Denham                PHONE NO : 732 3837901 
210 North Buffalo Street          SE DECISION MADE: 24-MAY-19
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K-Shield Advantage Port Access Infusion Set (PAIS)
Kawasumi Laboratories, Inc.       510(k) NO: K190233(Special)
ATTN: Katsu  Furuya               PHONE NO : 81 3 57692664 
Shinagawa Intercity Tower B, 9th FSE DECISION MADE: 02-MAY-19
Tokyo  JP 108-6109                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tiger Sharps Containers
International Marketing Specialist510(k) NO: K190240(Traditional)
ATTN: Rod  Calderon               PHONE NO : 606 6772616 
1278 HWY 461                      SE DECISION MADE: 31-MAY-19
Somerset KY  42503                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroShield
Monarch Bioimplants GmbH          510(k) NO: K190246(Traditional)
ATTN: Rivelino  Montenegro        PHONE NO : 41 41 4552261 
Platz 4                           SE DECISION MADE: 31-MAY-19
Root  CH 6039                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoLSD MSMS Kit
PerkinElmer Inc.                  510(k) NO: K190266(Traditional)
ATTN: Brian  Ciccariello          PHONE NO : 781 6635651 
940 Winter Street                 SE DECISION MADE: 03-MAY-19
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenePOC Carba
GenePOC Inc.                      510(k) NO: K190275(Traditional)
ATTN: Dany  Leblanc               PHONE NO : 1 418 6503535 
360 rue Franquet                  SE DECISION MADE: 10-MAY-19
Quebec  CA G1P 4N3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AuraGen 123 Suction Lipoplasty System (A123)
AuraGen Aesthetics LLC            510(k) NO: K190278(Traditional)
ATTN: Yiannis  Monovoukas         PHONE NO : 617 8184008 
11 Dellbrook Road                 SE DECISION MADE: 03-MAY-19
Weston MA  02493                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)
Spectrum Medical Ltd              510(k) NO: K190282(Traditional)
ATTN: Colleen  Powell             PHONE NO : 440 1242 387082 
Harrier 4, Meteor Business Park, CSE DECISION MADE: 24-MAY-19
Gloucester  GB GL2 9QL            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex DynaNite® PIP (Hammertoe) Implant
Arthrex Inc.                      510(k) NO: K190287(Traditional)
ATTN: Rebecca R. Homan            PHONE NO : 1 239 6435553 73429
1370 Creekside Boulevard          SE DECISION MADE: 03-MAY-19
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity HP Incubator
Steris Corporation                510(k) NO: K190297(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd                   SE DECISION MADE: 14-MAY-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U Deliver Bolink ENFit Enteral Feeding Sets
U Deliver Medical, LLC            510(k) NO: K190310(Traditional)
ATTN: Brian  Johnson              PHONE NO : 952 2000720 
7900 Excelsior Blvd Suite 108     SE DECISION MADE: 31-MAY-19
Hopkins MN  55343                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
Phadia AB                         510(k) NO: K190315(Traditional)
ATTN: Ulf  Karlberg               PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 14-MAY-19
Uppsala  SE 75137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aperio AT2 DX System
Leica Biosystems Imaging, Inc.    510(k) NO: K190332(Traditional)
ATTN: Christine  Kishi            PHONE NO : 760 5391194 
1360 Park Center Dr.              SE DECISION MADE: 20-MAY-19
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VPC
Pajunk GmbH Medizintechnologie    510(k) NO: K190345(Traditional)
ATTN: Christian G.H Quass         PHONE NO : 49 770 49219586 
Karl-Hall-Str. 1                  SE DECISION MADE: 16-MAY-19
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Casting Solutions Total Knee System
Precision Casting Solutions, Inc. 510(k) NO: K190355(Traditional)
ATTN: Jim  Moore                  PHONE NO : 503 4211251 
20031 Henrici Road                SE DECISION MADE: 16-MAY-19
Oregon City OR  97045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HealthPNX
Zebra Medical Vision  Ltd.        510(k) NO: K190362(Traditional)
ATTN: Flair  Bar                  PHONE NO : 972 9 8827795 
Shefayim Commercial Center, PO BoxSE DECISION MADE: 06-MAY-19
Shefayim  IL 6099000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew Tablet Application
Smith & Nephew                    510(k) NO: K190367(Traditional)
ATTN: Janice  Haselton            PHONE NO : 978 7491494 
150 Minuteman Road                SE DECISION MADE: 21-MAY-19
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aveta System
Meditrina, Inc.                   510(k) NO: K190372(Traditional)
ATTN: Csaba  Truckai              PHONE NO : 408 4714877 
1601 S. De Anza Blvd, Suite 165   SE DECISION MADE: 16-MAY-19
Cupertino CA  95014               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASS LP Spinal System
Medicrea International S.A.       510(k) NO: K190376(Traditional)
ATTN: David  Ryan                 PHONE NO : 0033 4 72018788 
5389 Route De Strasbourg - Vancia SE DECISION MADE: 02-MAY-19
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix
Bioncise NV                       510(k) NO: K190378(Traditional)
ATTN: Jaak  Janssens              PHONE NO : 32 11 271557 
Bodemstraat 16                    SE DECISION MADE: 24-MAY-19
Wellen  BE 3500                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wingman 14C Crossing Catheter
ReFlow Medical, Inc.              510(k) NO: K190393(Special)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
208 Avenida Fabricante #100       SE DECISION MADE: 09-MAY-19
San Clemente CA  92672            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BACT/ALERT MP Reagent System
bioMerieux, Inc.                  510(k) NO: K190405(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 15-MAY-19
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MatrixRIB Fixation System
DePuy Synthes                     510(k) NO: K190409(Traditional)
ATTN: Francoise  Cettour-Delbart  PHONE NO : 41 61 9656765 
1301 Goshen Parkway               SE DECISION MADE: 03-MAY-19
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
Roche Molecular Systems, Inc.     510(k) NO: K190433(Traditional)
ATTN: Nobuko  Nakajima            PHONE NO : 925 7308215 
4300 Hacienda Drive               SE DECISION MADE: 22-MAY-19
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KATANA Zirconia Block
Kuraray Noritake Dental Inc.      510(k) NO: K190436(Traditional)
ATTN: Yasujiro  Ohara             PHONE NO : 81 3 67011736 
Ote Center Bldg. 7F               SE DECISION MADE: 23-MAY-19
Chiyoda-ku  JP 100-0004           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
Cepheid                           510(k) NO: K190441(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 23-MAY-19
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HERA I10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K190444(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 2 21941594 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 22-MAY-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightLas Pattern Scanning System - TruScan Pro
Light-Med(USA), INC.              510(k) NO: K190448(Traditional)
ATTN: Hedy  Chiang                PHONE NO : 949 2189555 
1130 Calle Cordillera             SE DECISION MADE: 24-MAY-19
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aptima BV Assay
Hologic, Inc.                     510(k) NO: K190452(Traditional)
ATTN: Jeffrey  Hergesheimer       PHONE NO : 858 4108536 
10210 Genetic Center Drive        SE DECISION MADE: 23-MAY-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nihon Kohden SVM-7200 Series Vital Signs Monitor
Nihon Kohden Corporation          510(k) NO: K190468(Third Party - Traditional)
ATTN: Thomas  Bento               PHONE NO : 949 6809048 
1-31-4 Nishiochiai, Shinjuku-Ku   SE DECISION MADE: 28-MAY-19
Tokyo  JP 161-8560                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ERBEFLO 2 Disposable Tubing System
Erbe USA, Inc.                    510(k) NO: K190469(Traditional)
ATTN: John  Tartal                PHONE NO : 770 9554400 
2225 Northwest Parkway            SE DECISION MADE: 23-MAY-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aptima CV/TV Assay
Hologic, Inc.                     510(k) NO: K190472(Traditional)
ATTN: Jeffrey  Hergesheimer       PHONE NO : 858 4108536 
10210 Genetic Center Drive        SE DECISION MADE: 16-MAY-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLock PEEK Suture Anchor
Medacta International SA          510(k) NO: K190474(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 28-MAY-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IGNITE Bone Void Filler
Wright Medical Technology, Inc.   510(k) NO: K190482(Traditional)
ATTN: Alayne  Melancon            PHONE NO : 901 2905986 
1023 Cherry Road                  SE DECISION MADE: 28-MAY-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Recovery Pump, 737R (RPX)
Mego Afek AC Ltd.                 510(k) NO: K190493(Traditional)
ATTN: Reuven  Yunger              PHONE NO : 972 77 984276 
Kibbutz Afek                      SE DECISION MADE: 15-MAY-19
Kibbutz Afek  IL 3004200          510(k) STATEMENT
                                                    

DEVICE: Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
Relievant Medsystems              510(k) NO: K190504(Traditional)
ATTN: Alex  DiNello               PHONE NO : 650 3681000 
358 Moffett Park Drive, Suite 105 SE DECISION MADE: 03-MAY-19
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GuttaSil
Meta Biomed Co., Ltd.             510(k) NO: K190510(Traditional)
ATTN: Suk Song Oh                 PHONE NO : 82 43 2308959 
270, Osong Saengmyeong 1-ro. OsongSE DECISION MADE: 29-MAY-19
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aptima Combo 2 Assay (Panther System)
Hologic, Inc.                     510(k) NO: K190515(Traditional)
ATTN: Jeffrey  Hergesheimer       PHONE NO : 858 4108536 
10210 Genetic Center Drive        SE DECISION MADE: 23-MAY-19
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RELIEVA ULTIRRA Sinus Balloon Catheter
Acclarent, Inc.                   510(k) NO: K190525(Traditional)
ATTN: Leena  Sorathia             PHONE NO : 1 949 9234118 
33 Technology Drive               SE DECISION MADE: 03-MAY-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruDi NAV Wire
Acclarent, Inc.                   510(k) NO: K190532(Traditional)
ATTN: Leena  Sorathia             PHONE NO : 1 949 9234118 
33 Technology Drive               SE DECISION MADE: 03-MAY-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Manual Wheelchair SIVFH2A102
Jiangsu Horizon Medical Science & 510(k) NO: K190534(Traditional)
ATTN: Cheng  Gong                 PHONE NO : 86 0511 86808686 
No.1 Guanhe Road                  SE DECISION MADE: 29-MAY-19
Situ Town, DAnyang City  CN 212331510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ponto 4
Oticon Medical AB                 510(k) NO: K190540(Traditional)
ATTN: Lise  Terkelsen             PHONE NO : 45 24 225146 
Datavagen 37 B                    SE DECISION MADE: 02-MAY-19
Askim  SE SE-436 32               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soliton Acoustic Wave Device
Soliton Inc.                      510(k) NO: K190542(Traditional)
ATTN: Leslie  Honda               PHONE NO : 206 3758586 
5304 Ashbrook Drive               SE DECISION MADE: 24-MAY-19
Houston TX  77081                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cannulated Hemi Implant
Vilex in Tennessee, Inc.          510(k) NO: K190543(Traditional)
ATTN: Sylvia  Southard            PHONE NO : 931 4747550 
111 Moffitt Street                SE DECISION MADE: 31-MAY-19
McMinnville TN  37110             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEXXT MATRIXX Stand Alone Cervical System
Nexxt Spine LLC                   510(k) NO: K190546(Traditional)
ATTN: Andy  Elsbury               PHONE NO : 317 4367801 
14425 Bergen Blvd, Suite B        SE DECISION MADE: 31-MAY-19
Noblesville IN  46060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VASERlipo System
Solta Medical                     510(k) NO: K190551(Special)
ATTN: Manal  Morcos               PHONE NO : 510 2595299 
11720 North Creek Pkwy N., Suite 1SE DECISION MADE: 01-MAY-19
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerX Lipo System
Solta Medical                     510(k) NO: K190555(Special)
ATTN: Manal  Morcos               PHONE NO : 510 2595299 
11720 North Creek Pkway N. Suite 1SE DECISION MADE: 01-MAY-19
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface
Nonin Medical, Inc.               510(k) NO: K190560(Traditional)
ATTN: Nancy  DeAngelo             PHONE NO : 763 5339968 2674
13700 1st Avenue North            SE DECISION MADE: 02-MAY-19
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Plate
EiserTech, LLC                    510(k) NO: K190565(Traditional)
ATTN: Lukas  Eisermann            PHONE NO : 888 2622817 
9988 Hibert Street Suite 302      SE DECISION MADE: 31-MAY-19
San Diego CA  92131               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KeYi Spinal Fixation System
Beijing KeYi Medical Device Techno510(k) NO: K190567(Traditional)
ATTN: Jenny  Jiang                PHONE NO : 86 10 67853877 
Building 1, 30 Yongchang South RoaSE DECISION MADE: 08-MAY-19
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAYMAN LP Plate System
K2m, Inc.                         510(k) NO: K190584(Traditional)
ATTN: Casey  Hinckley             PHONE NO : 1 571 9192318 
600 Hope Parkway, SE              SE DECISION MADE: 15-MAY-19
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aptis Medical Distal Radio Ulnar Joint Implant
Aptis Medical, LLC                510(k) NO: K190599(Traditional)
ATTN: Bryan  Babb                 PHONE NO : 502 4258584___ 
3602 Glenview Ave.                SE DECISION MADE: 03-MAY-19
Glenview KY  40025                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tria Firm Ureteral Stent
Boston Scientific Corporation     510(k) NO: K190603(Special)
ATTN: Justin  Kapitan             PHONE NO : 508 6834518 
100 Boston Scientific Way         SE DECISION MADE: 24-MAY-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIVO
Velano Vascular                   510(k) NO: K190604(Special)
ATTN: Tiffini  Wittwer            PHONE NO : 844 8352668 
221 Pine St #200                  SE DECISION MADE: 13-MAY-19
San Francisco CA  94104           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile
Kossan International Sdn. Bhd.    510(k) NO: K190606(Traditional)
ATTN: Cho Sow Fong                PHONE NO : 603 3291 0516 
Wisma Kossan, Lot 782, Jalan SungaSE DECISION MADE: 28-MAY-19
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
Medtronic                         510(k) NO: K190623(Traditional)
ATTN: Rahul  Shah                 PHONE NO : 763 5149846 
7611 Northland Drive              SE DECISION MADE: 30-MAY-19
Minneapolis MN  55428             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexSeal Introducer Sheath with Hydrophilic Coating
Freudenberg Medical MIS, Inc      510(k) NO: K190628(Third Party - Traditional)
ATTN: Larry  Bender               PHONE NO : 812 2802354 
2301 Centennial Boulevard         SE DECISION MADE: 30-MAY-19
Jeffersonville IN  47130          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Endosee System
CooperSurgical, Inc.              510(k) NO: K190639(Special)
ATTN: Christine  Kupchick         PHONE NO : 203 6015200 
95 Corporate Drive                SE DECISION MADE: 15-MAY-19
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Electrocautery Pencil
Medline Industries, Inc.          510(k) NO: K190643(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 06-MAY-19
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: FUJIFILM Endoscope Model EC-760S-V/L
FUJIFILM Corporation              510(k) NO: K190649(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 07-MAY-19
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CYGNUS™ Anterior Cervical Plate System
MiRus, LLC                        510(k) NO: K190666(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 678 3246272 
2150 Newmarket Parkway            SE DECISION MADE: 09-MAY-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOLOC™ 2 Lapidus with Rotation System
Wright Medical Technology, Inc.   510(k) NO: K190670(Traditional)
ATTN: Alayne  Melancon            PHONE NO : 901 2905986 
1023 Cherry Road                  SE DECISION MADE: 14-MAY-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
Siemens Healthcare Diagnostics, In510(k) NO: K190675(Traditional)
ATTN: Laura J. Duggan             PHONE NO : 302 6317654 
500 GBC Drive                     SE DECISION MADE: 17-MAY-19
Newark DE  19714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optilite IgM CSF Kit
The Binding Site Group Ltd.       510(k) NO: K190686(Traditional)
ATTN: Kanika  Darbar              PHONE NO : 440 121 4569500 
8 Calthorpe Road                  SE DECISION MADE: 28-MAY-19
Edgbaston  GB B15 1qt             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rowheels Revolution 1.0
Rowheels Inc.                     510(k) NO: K190699(Traditional)
ATTN: Matthew  Doeppers           PHONE NO : 608 2689670 
8001 Terrace Ave, Ste 204         SE DECISION MADE: 09-MAY-19
Middleton WI  53562               510(k) STATEMENT
                                                    

DEVICE: Connector System
Orthofix Inc.                     510(k) NO: K190751(Traditional)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 22-MAY-19
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Avanto Fit
Siemens Medical Solution USA, Inc.510(k) NO: K190757(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 31-MAY-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgicalAR
MEDIVIS, Inc.                     510(k) NO: K190764(Traditional)
ATTN: Amy  Lynn                   PHONE NO : 954 6008299 
20 Jay Street Suite 312           SE DECISION MADE: 13-MAY-19
Brooklyn NY  11201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PALACOS fast R+G
Heraeus Medical GmbH              510(k) NO: K190766(Traditional)
ATTN: Ute  Greiner                PHONE NO : 0049 6181 352808 
Philipp-Reis-Strasse 8/13         SE DECISION MADE: 31-MAY-19
Wehrheim  DE 61273                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bladder Scanner (Models: M2, M2-W, M1, M1-W)
Suzhou Lischka Medtech Co., Ltd.  510(k) NO: K190769(Traditional)
ATTN: Shi  Jing                   PHONE NO : 86 512 36692288 831
NO.999 Qujia Road, Qiandeng Town  SE DECISION MADE: 22-MAY-19
Kunshan  CN 215341                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Envision ultrasound pad and cover
CIVCO Medical Solutions           510(k) NO: K190802(Third Party - Traditional)
ATTN: Jim  Leong                  PHONE NO : 319 6564447 
102 First St. South               SE DECISION MADE: 24-MAY-19
Kalona IA  52247                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: HS Fiber
Riverpoint Medical                510(k) NO: K190817(Special)
ATTN: Edwin  Anderson             PHONE NO : 503 5178001 
825 NE 25th Ave.                  SE DECISION MADE: 01-MAY-19
Portland OR  97232                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Erbe ESU Model VIO 3 with Accessories
Erbe Elektromedizin GmbH          510(k) NO: K190823(Third Party - Traditional)
ATTN: Julia  Weller               PHONE NO : 49____ 7071 755172 
Waldhoernlestrasse 17             SE DECISION MADE: 22-MAY-19
Tuebingen  DE 72072               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K190831(Traditional)
ATTN: Zilong  Liang               PHONE NO : 0086 25 83305050 
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 31-MAY-19
Nanjing  CN 210036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synchro2 Support Guidewire
Stryker                           510(k) NO: K190843(Special)
ATTN: Lorraine  Mazzeo            PHONE NO : 510 4132676 
47900 Bayside Parkway             SE DECISION MADE: 01-MAY-19
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K190848(Traditional)
ATTN: Zilong  Liang               PHONE NO : 0086 25 83305050 
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 14-MAY-19
Nanjing  CN 210036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYDRASHIFT 2/4 daratumumab
Sebia                             510(k) NO: K190851(Special)
ATTN: Karen  Anderson             PHONE NO : 1 770 4463707 3704
1705 Corporate Drive, Suite 400   SE DECISION MADE: 02-MAY-19
Norcross GA  30093                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Therm-X
Zenith Technical Innovations      510(k) NO: K190854(Abbreviated)
ATTN: Greg  Binversie             PHONE NO : 1 847 6727481 
1396 St. Paul Ave.                SE DECISION MADE: 10-MAY-19
Gurnee IL  60031                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Juliet® Ti LL Lumbar Interbody Device
SPINEART                          510(k) NO: K190877(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 chemin du pre Fleuri            SE DECISION MADE: 29-MAY-19
Plan Ouates  CH 1228              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: N Latex FLC kappa, N Latex FLC lambda
Siemens Healthcare Diagnostics Pro510(k) NO: K190879(Special)
ATTN: Christine  Perkins          PHONE NO : 302 6318811 
Emil-von-Behring Str-76           SE DECISION MADE: 03-MAY-19
Marburg  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BriefCase
Aidoc Medical, Ltd.               510(k) NO: K190896(Traditional)
ATTN: Nimrod  Epstein             PHONE NO : 972 73 7946870 
92 Yigal Alon St.                 SE DECISION MADE: 31-MAY-19
Tel-Aviv  IL 6789134              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph Vision
Siemens Medical Solutions USA, Inc510(k) NO: K190900(Special)
ATTN: Alaine  Medio               PHONE NO : 865 8060337 
810 Innovation Drive              SE DECISION MADE: 06-MAY-19
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
Wenzhou Renhua Instruments Co., Lt510(k) NO: K190902(Traditional)
ATTN: Wang  Saijie                PHONE NO : 86 577 86893308 
#.1-1704 Wanda Business Building YSE DECISION MADE: 22-MAY-19
Wenzhou  CN 325024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Doxycycline 0.016 - 256 µg/mL
Liofilchem s. r. l.               510(k) NO: K190914(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 29-MAY-19
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems
STERIS Corporation                510(k) NO: K190917(Special)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Road                 SE DECISION MADE: 09-MAY-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioCardia 8.5 F Avance Steerable lntroducer
BioCardia, Inc.                   510(k) NO: K190941(Third Party - Traditional)
ATTN: Kevin  DeMartini            PHONE NO : 650 2260134 
125 Shoreway Road, Suite B        SE DECISION MADE: 06-MAY-19
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Magic Clear Aligners
Voodoo Manufacturing, Inc.        510(k) NO: K190948(Third Party - Traditional)
ATTN: Max  Friefeld               PHONE NO : 1 646 8544173 
361 Stagg Street #408             SE DECISION MADE: 09-MAY-19
Brooklyn NY  112062               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: D'Vill Introducer
NuMED, Inc.                       510(k) NO: K190974(Special)
ATTN: Nichelle  LaFlesh           PHONE NO : 315 3284491 
2880 Main Street                  SE DECISION MADE: 14-MAY-19
Hopkinton NY  12965               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BAROnova Insufflation System, BAROnova Accessory Kit
BAROnova, Inc.                    510(k) NO: K190985(Traditional)
ATTN: Lian  Cunningham            PHONE NO : 650 6389796 
1551 Industrial Road              SE DECISION MADE: 14-MAY-19
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6400 Ultrasound System (MyLabX6, MyLabX7)
Esaote, S.p.A.                    510(k) NO: K190989(Special)
ATTN: Piet de Jong                PHONE NO : 39 055 4229319 
Via Enrico Melen 77               SE DECISION MADE: 10-MAY-19
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExactVu High Resolution Micro-Ultrasound System
Exact Imaging, Inc.               510(k) NO: K190995(Third Party - Special)
ATTN: Randy  AuCoin               PHONE NO : 905 4150030 
7676 Woodbine Ave., Unit 15       SE DECISION MADE: 10-MAY-19
Markham  CA l3r 2n2               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Carnation Ambulatory Monitor
Bardy Diagnostics, Inc            510(k) NO: K191000(Special)
ATTN: Brit  Baird                 PHONE NO : 206 3996938 
316 Occidental Avenue South, SuiteSE DECISION MADE: 16-MAY-19
Seattle WA  98104                 510(k) STATEMENT
                                                    

DEVICE: Scope ProTech
Meditech Endoscopy Ltd            510(k) NO: K191011(Third Party - Traditional)
ATTN: Peter  Ramsey               PHONE NO : 44 1268 534035 
Bowden House, Luckyn Lane         SE DECISION MADE: 07-MAY-19
Basildon  GB ss14 3ax             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
Cook Incorporated                 510(k) NO: K191015(Special)
ATTN: Ian  Herrman                PHONE NO : 812 3353575 104034
750 Daniels Way P.O. Box 489      SE DECISION MADE: 17-MAY-19
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dolphin/IQ, Dolphin/4D and Dolphin/MAX
Viasonix Ltd.                     510(k) NO: K191023(Special)
ATTN: Shlomi  Deler               PHONE NO : 972 5 44301056 
10 Hamelacha Street               SE DECISION MADE: 16-MAY-19
Raanana  IL 4366105               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DRX-Revolution Mobile X-ray System
Carestream Health Inc.            510(k) NO: K191025(Special)
ATTN: Gina  Maiolo                PHONE NO : 585 6276543 
150 Verona Street                 SE DECISION MADE: 17-MAY-19
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T-R), Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT), Affinity® NT Integrated Trillium™ CVR/Membrane Oxygenator (Model 541TT-R), Affinity NT™ Oxygenator with Cortiva™ BioActive Surface (Model CB511), Affinity NT™ Integrated Uncoated CVR/Oxygenator with Cortiva™ BioActive Surface (Model CB541)
Medtronic, Inc.                   510(k) NO: K191029(Special)
ATTN: Sammie C Joseph-Fredericks  PHONE NO : 763 5262337 
7611 Northland Drive              SE DECISION MADE: 17-MAY-19
Minneapolis MN  55428             510(k) STATEMENT
                                                    

DEVICE: syngo.via (Version VB40A)
Siemens Healthcare GmbH           510(k) NO: K191040(Third Party - Abbreviated)
ATTN: Elango Alampalayam RangappanPHONE NO : 49 9191 184429 
Siemensstr. 1                     SE DECISION MADE: 16-MAY-19
Forchheim  DE 91301               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: L10 LED Light Source with AIM, L11 LED Light Source with AIM
Stryker                           510(k) NO: K191046(Special)
ATTN: Agatha  Szeliga             PHONE NO : 604 4227516 
5900 Optical Court                SE DECISION MADE: 10-MAY-19
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARGOS
SANTEC CORPORATION                510(k) NO: K191051(Third Party - Traditional)
ATTN: Changho  Chong              PHONE NO : 568 793535 
5823 Ohkusa-Nenjozaka             SE DECISION MADE: 16-MAY-19
Komaki  JP 485-0802               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Arc Endocuff Glide AEG110 & AEG120
Boddingtons Plastics Ltd          510(k) NO: K191067(Special)
ATTN: Shimaa  Elsawy              PHONE NO : 0044 7801 572833 
Wheelbarrow Park Estate, PattendenSE DECISION MADE: 30-MAY-19
Tonbridge  GB Tn12 9QJ            510(k) STATEMENT
                                                    

DEVICE: Ambu aScope 4 RhinoLaryngo Slim
Ambu A/S                          510(k) NO: K191080(Special)
ATTN: Gurpreet Kaur Rehal         PHONE NO : 45 72 252000 
Baltorpbakken 13                  SE DECISION MADE: 22-MAY-19
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COMPLETE CONTROL System Gen2
Coapt, LLC                        510(k) NO: K191083(Special)
ATTN: Blair A Lock                PHONE NO : 844 2627800 
222 W. Ontario Street, Suite #300 SE DECISION MADE: 24-MAY-19
Chicago IL  60654                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart One Lumbar Interbody Fusion System
Spineology, Inc.                  510(k) NO: K191091(Special)
ATTN: Andrew  Adams               PHONE NO : 651 2568500 
7800 3rd Street North, Suite 600  SE DECISION MADE: 23-MAY-19
Saint Paul MN  55128              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M RelyX Pediatric Resin Modified Glass Ionomer Cement
3M ESPE Dental Products           510(k) NO: K191122(Third Party - Traditional)
ATTN: Lin  Ma                     PHONE NO : 651 7334734 
2510 Conway Ave.                  SE DECISION MADE: 29-MAY-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Swiss LithoClast Trilogy
EMS Electro Medical Systems SA    510(k) NO: K191124(Special)
ATTN: Timothee  Deblock           PHONE NO : 41 22 9944700 
Ch. De la Vuarpilliere 31         SE DECISION MADE: 29-MAY-19
Nyon  CH 1260                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MasterLock Extension
Medacta International SA          510(k) NO: K191145(Special)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 30-MAY-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMR 780, uMR 790
Shanghai United Imaging Healthcare510(k) NO: K191157(Special)
ATTN: Xin  Gao                    PHONE NO : 86 021 67076888 5386
No. 2258 Chengbei Road            SE DECISION MADE: 29-MAY-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASHK100G
LG Electronics                    510(k) NO: K191188(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
222, Lg-ro, Cheongho-ri           SE DECISION MADE: 30-MAY-19
Jinwi-myeon Pyeongtaek-si  KR 1770510(k) SUMMARY AVAILABLE FROM FDA
                                                    


        TOTAL 510(k)s THIS PERIOD   246                                     
        TOTAL WITH SUMMARIES        230                                     
        TOTAL WITH STATEMENTS        16