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  1. 510(k) Clearances

October 2018 510(k) Clearances

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


DEVICE: Swaive Thermometer SWT1A
E-Care Technology Co., Ltd.       510(k) NO: K170723(Traditional)
ATTN: K.Y.  Ko                    PHONE NO : 886 3 5534996 
8F-11, No. 35, Hsintai Road       SE DECISION MADE: 25-OCT-18
Chubei  TW 302                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biomate Dental Implant System
Biomate Medical Devices Technology510(k) NO: K170732(Traditional)
ATTN: Leslie  Su                  PHONE NO : 886 795 25999 
1F., No.59, Luke 2nd Rd Luzhu DistSE DECISION MADE: 26-OCT-18
Kaohsiung City  TW 820            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AVIEW
Coreline Soft Co., Ltd.           510(k) NO: K171199(Traditional)
ATTN: Hye Yi Park                 PHONE NO : 
4,5F (Yeonnam-dong), 49, World CupSE DECISION MADE: 31-OCT-18
Seoul  KR 03991                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUXEN Zr, LUXEN Smile
Dentalmax Co., Ltd                510(k) NO: K171585(Traditional)
ATTN: Jindong  Kim                PHONE NO : 82 415 233580 
50-7, Pungsesandan 2-ro Pungse-myeSE DECISION MADE: 31-OCT-18
Cheonan-si  KR 31217              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NOxBOXi Nitric Oxide Delivery System
Praxair Distribution, Inc         510(k) NO: K171696(Traditional)
ATTN: Michael E. Skrjanc          PHONE NO : 330 9493324 
10 Riverview Drive                SE DECISION MADE: 02-OCT-18
Danbury CT  06810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GM Implant Tubes, Length Cutting Gauge
Varian Medical Systems, Inc.      510(k) NO: K172533(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246230 
3100 Hansen Way                   SE DECISION MADE: 22-OCT-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Single Use, Hypodermic Syringe
Becton, Dickinson and Company     510(k) NO: K172670(Traditional)
ATTN: Victoria  Morrow            PHONE NO : 201 8476626 
1 Becton Drive                    SE DECISION MADE: 23-OCT-18
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELAN 4 Electro Motor System Tools
Aesculap, Inc.                    510(k) NO: K172709(Traditional)
ATTN: Kathy A. Racosky            PHONE NO : 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 17-OCT-18
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TD-1035 Thermometer
TaiDoc Technology Corporation     510(k) NO: K172733(Traditional)
ATTN: Sheena  Song                PHONE NO : 886 2 66258188 1158
B1-7F, No.127, Wugong 2nd Rd., WugSE DECISION MADE: 22-OCT-18
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellent Spinal Systems
Jiangsu Trauhui Medical Instrument510(k) NO: K172826(Traditional)
ATTN: Zhou  Yu                    PHONE NO : 86 519 88769966 
No.2 Longqing Road, Wujin Hi-Tech SE DECISION MADE: 10-OCT-18
Changzhou  CN 213118              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CURA 16; ScintCare CT16
FMI Medical Systems Inc.          510(k) NO: K173076(Traditional)
ATTN: Scott  LeMaster             PHONE NO : 440 6005952 
29001 Solon Road, UnitA           SE DECISION MADE: 04-OCT-18
Solon OH  44139                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Temperature Probe
Orantech Inc.                     510(k) NO: K173194(Traditional)
ATTN: Hsin  Xiong                 PHONE NO : 86 755 33941160 
Zone#A,4F,1st Bld,7th Industrial ZSE DECISION MADE: 10-OCT-18
Guangming New District, Shenzhen  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panpac Flexi Shelf Pessary
Panpac Medical Corporation        510(k) NO: K173351(Abbreviated)
ATTN: Yen-Ming  Pan               PHONE NO : 886 2 86472242 
6F-1,-2, No. 202, Sec. 3, Ta-Tong SE DECISION MADE: 31-OCT-18
Shi-Chih Dist.  TW 22103          510(k) STATEMENT
                                                    

DEVICE: Straumann cerabone
Institut Straumann AG             510(k) NO: K173594(Traditional)
ATTN: Christelle  Gerspach-Gasser PHONE NO : 41 61 9651666 
Peter Merian Weg 12               SE DECISION MADE: 19-OCT-18
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monarch Airway Clearance System
Hill-Rom Holdings, Inc.           510(k) NO: K173603(Traditional)
ATTN: Joseph  Braido              PHONE NO : 312 8199324 
1 Yishun Ave 7                    SE DECISION MADE: 24-OCT-18
Singapore  SG                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLOCKNER SURGICAL BOX
Soadco, S.L.                      510(k) NO: K173642(Abbreviated)
ATTN: Maria  Mitjaneta            PHONE NO : 376 800590 
Avgda. Fiter I Rossell, 4 Bis- LocSE DECISION MADE: 02-OCT-18
Escaldes-Engordany  AD AD700      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MPS2 Myocardial Protection System Console
Quest Medical, Inc.               510(k) NO: K173716(Traditional)
ATTN: Jan  Hodges                 PHONE NO : 972 3326352 
One Allentown Parkway             SE DECISION MADE: 01-OCT-18
Allen TX  75002-4211              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Certus 140 2.45GHz Ablation System
NeuWave Medical, Inc.             510(k) NO: K173756(Traditional)
ATTN: Dan  Kosednar               PHONE NO : 608 5121592 
3529 Anderson Street              SE DECISION MADE: 24-OCT-18
Madison WI  53704                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Humeral Short Stem System
Shoulder Innovations Inc          510(k) NO: K173824(Traditional)
ATTN: Don  Running                PHONE NO : 616 2941026 
13827 Port Sheldon Street         SE DECISION MADE: 23-OCT-18
Holland MI  49424                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LS OIL
J. Mortia USA, Inc.               510(k) NO: K173920(Traditional)
ATTN: Keith A. Barritt            PHONE NO : 202 7835070 
9 Mason                           SE DECISION MADE: 11-OCT-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endocular Viewing Lenses and Silicone Ring
Phakos                            510(k) NO: K173944(Traditional)
ATTN: J. D. Webb                  PHONE NO : 512 3880199 
62 Rue Kleber                     SE DECISION MADE: 25-OCT-18
Montreuil  FR 93100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann SC Variobase Abutments
Institut Straumann AG             510(k) NO: K173945(Traditional)
ATTN: Christopher  Klaczyk        PHONE NO : 41 61 9651260 
Peter Merian Weg 12               SE DECISION MADE: 05-OCT-18
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Implant Planning Software
Inteware Co. Ltd.                 510(k) NO: K173965(Traditional)
ATTN: Wayne  Tsai                 PHONE NO : 886 965111210 
4F., No.93, Xinzheng 5th St.      SE DECISION MADE: 26-OCT-18
Minxiong Township, Chiayi Country 510(k) STATEMENT
                                                    

DEVICE: HemoScreen Hematology Analyzer
PixCell Medical Technologies, Ltd.510(k) NO: K180020(Traditional)
ATTN: Yaaya  Ben-Yosef            PHONE NO : 972 4 9593516 
6 Hayezira St.                    SE DECISION MADE: 29-OCT-18
Yoknaem Ilit  IL 2069202          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Rad-97 and Accessories
Masimo Corporation                510(k) NO: K180046(Traditional)
ATTN: Sindura  Penubarthi         PHONE NO : 949 2977541 
52 Discovery                      SE DECISION MADE: 23-OCT-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Royal Flush Plus High-Flow Catheter
Cook Incorporated                 510(k) NO: K180054(Traditional)
ATTN: Jessica  Swafford           PHONE NO : 812 3353575 104260
750 Daniels Way                   SE DECISION MADE: 05-OCT-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optilite High Sensitivity C-Reactive Protein Kit
The Binding Site Group Ltd        510(k) NO: K180099(Traditional)
ATTN: Kirsty  Samuels             PHONE NO : 44 0121 4569500 
8 Calthorpe Road, Edgbaston West MSE DECISION MADE: 12-OCT-18
Birmingham  GB B15 1QT            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts
Immuno Concepts, NA, Ltd.         510(k) NO: K180202(Traditional)
ATTN: Eric S Hoy                  PHONE NO : 916 3632649 
9825 Goethe Rd., Suite 350        SE DECISION MADE: 19-OCT-18
Sacramento CA  95827              510(k) STATEMENT
                                                    

DEVICE: AVELLE Negative Pressure Wound Therapy System
ConvaTec Limited                  510(k) NO: K180205(Traditional)
ATTN: Justin  Lovelace            PHONE NO : 1 336 5424745 
First Avenue                      SE DECISION MADE: 19-OCT-18
Deeside  GB CH5 2NU               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme 1,5-AG Assay
Diazyme Laboratories Inc.         510(k) NO: K180209(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 04-OCT-18
Poway CA  92130                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Titanium TomoFix Medial High Tibia Plate Anatomical
Synthes (USA) Products, LLC       510(k) NO: K180213(Traditional)
ATTN: Stephan  Jepards            PHONE NO : 41 32 7204159 
1301 Goshen Parkway               SE DECISION MADE: 19-OCT-18
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic(NIBP) Blood Pressure Monitor
Health & Life Co. Ltd.            510(k) NO: K180240(Traditional)
ATTN: J. S. Hsu                   PHONE NO : 886 2 82271300 1201
9F, No. 186 Jian Yi Road          SE DECISION MADE: 17-OCT-18
Zhonghe District, New Taipei City 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OmniPore DUROMAX Surgical Implants
Matrix Surgical Holdings, LLC/Matr510(k) NO: K180249(Traditional)
ATTN: John  O'Shaughnessy         PHONE NO : 404 8554592 
4025 Welcome All Road Suite 120   SE DECISION MADE: 11-OCT-18
Atlanta GA  30349                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpeediCath Standard
Coloplast                         510(k) NO: K180258(Traditional)
ATTN: Ngoc Linh Pham Latchman     PHONE NO : 612 3578262 
1601 West River Road North        SE DECISION MADE: 25-OCT-18
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VAMP Optima closed blood sampling system
Edwards Lifesciences LLC          510(k) NO: K180275(Traditional)
ATTN: Jennifer  Wilbur            PHONE NO : 949 7564436 
One Edwards Way                   SE DECISION MADE: 24-OCT-18
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical Video Colonoscope EC34-i10T Series
PENTAX Medical of America, Inc    510(k) NO: K180285(Traditional)
ATTN: James W. Monroe             PHONE NO : 201 5712300 2129
3 Paragon Drive                   SE DECISION MADE: 26-OCT-18
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyethylene Catheter
Cook Incorporated                 510(k) NO: K180286(Traditional)
ATTN: Jessica  Swafford           PHONE NO : 812 3353575 104260
750 Daniels Way                   SE DECISION MADE: 26-OCT-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook Silicone Balloon HSG Catheter
Cook Incorporated                 510(k) NO: K180291(Traditional)
ATTN: Yan  Li                     PHONE NO : 812 3353575 104987
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 26-OCT-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Video Upper G.I. Scope EG34-i10
PENTAX Medical of America, Inc    510(k) NO: K180292(Traditional)
ATTN: James W. Monroe             PHONE NO : 201 5712300 2129
3 Paragon Drive                   SE DECISION MADE: 12-OCT-18
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Margolin HSG Cannula, Goldstein Sonohysterography Catheter
Cook Incorporated                 510(k) NO: K180300(Traditional)
ATTN: Naomi  Funkhouser           PHONE NO : 812 3353575 104371
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 26-OCT-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
Cook Incorporated                 510(k) NO: K180302(Traditional)
ATTN: Naomi  Funkhouser           PHONE NO : 812 3353575 104371
750 Daniels Way P.O. Box 489      SE DECISION MADE: 24-OCT-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uroject12 Syringe Lever
UroGen Pharma Ltd.                510(k) NO: K180345(Traditional)
ATTN: Liz  Schindel               PHONE NO : 972 9 7707600 
9 Ha`Ta`asiya Street              SE DECISION MADE: 17-OCT-18
Ra’anana  IL 4365007              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UroGen Ureteral Catheter
UroGen Pharma Ltd.                510(k) NO: K180354(Traditional)
ATTN: James G. Ottinger           PHONE NO : 972 9 7707600 
9 Ha`Ta`asiya Street              SE DECISION MADE: 30-OCT-18
Ra’anana  IL 4365007              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliant(TM) Multistage Dilatation Balloon Catheter
Micro-Tech (Nanjing) CO., Ltd.    510(k) NO: K180418(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 Gaoke Third Road           SE DECISION MADE: 15-OCT-18
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: b-ONE Total Knee System
b-One Ortho Corp.                 510(k) NO: K180446(Traditional)
ATTN: Allison  Gecik              PHONE NO : 973 8793694 
3 Wing Drive Suite #259           SE DECISION MADE: 12-OCT-18
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SBG Blue Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc             510(k) NO: K180467(Traditional)
ATTN: Jeffrey  Richardson         PHONE NO : 706 8626740 
579 Edison Street                 SE DECISION MADE: 10-OCT-18
Menlo CA  30731-6335              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SBG Black Nitrile Powder Free Medical Examination Glove
Showa Best Glove, Inc.            510(k) NO: K180468(Traditional)
ATTN: Jeffrey  Richardson         PHONE NO : 706 8626740 
579 Edison Street                 SE DECISION MADE: 10-OCT-18
Menlo CA  30731-6335              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TNI softFlow 50
TNI Medical AG                    510(k) NO: K180474(Third Party - Traditional)
ATTN: Joseph P. McMenamin         PHONE NO : 804 9214856 
Hofmannstr. 8                     SE DECISION MADE: 18-OCT-18
Wuerzburg  DE 97084               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Peak.me
Breathe me LTD                    510(k) NO: K180487(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 972 76 8899800 
13 Zarchin street                 SE DECISION MADE: 26-OCT-18
Ra'anana  IL 4366241              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EchoS
Echolight Spa                     510(k) NO: K180516(Traditional)
ATTN: Sergio  Casciaro            PHONE NO : 39 0832 1592607 
Via Raffaello Sanzio 18           SE DECISION MADE: 19-OCT-18
Lecce  IT 73100                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANTHEM Fracture System
Globus Medical Inc.               510(k) NO: K180554(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Avenue VallSE DECISION MADE: 22-OCT-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ergoline Prestige 1600 Hybrid Performance
JK Holding GmbH                   510(k) NO: K180555(Traditional)
ATTN: Juergen  Gerstenmeier       PHONE NO : 49 0 2224818330 
Koehlershohner Strasse 60         SE DECISION MADE: 11-OCT-18
Windhagen  DE 53578               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
ELITechGroup                      510(k) NO: K180559(Traditional)
ATTN: Terry  Trimingham           PHONE NO : 425 4825190 
21720 23rd Drive SE Suite 150     SE DECISION MADE: 29-OCT-18
Bothell WA  98021                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KidCap
Eastern Cranial Affiliates, LLC   510(k) NO: K180568(Traditional)
ATTN: Joseph  Terpenning          PHONE NO : 703 8075899 
10523 Main Street                 SE DECISION MADE: 16-OCT-18
Fairfax VA  22030                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GastroFlush
Bionix Development Corporation    510(k) NO: K180605(Traditional)
ATTN: James  Huttner              PHONE NO : 419 7278421 
5154 Enterprise Blvd.             SE DECISION MADE: 24-OCT-18
Toledo OH  43612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endophys Pressure Sensing Sheath Kit
Endophys Holdings, LLC            510(k) NO: K180620(Special)
ATTN: Phillip  Purdy              PHONE NO : 214 8010578 
1601 Elm Street, Suite 3500       SE DECISION MADE: 12-OCT-18
Dallas TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port
Covidien                          510(k) NO: K180622(Traditional)
ATTN: Alexis  Erazo               PHONE NO : 508 4524673 
15 Hampshire Street               SE DECISION MADE: 23-OCT-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
Laclede, Inc.                     510(k) NO: K180680(Traditional)
ATTN: Michael  Pellico            PHONE NO : 310 6054280 
2103 E. University Dr.            SE DECISION MADE: 11-OCT-18
Rancho Dominguez CA  90220        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLENDERTONE CoreFit Abs 8, Type 734
Bio-Medical Research Ltd          510(k) NO: K180688(Traditional)
ATTN: Eoin  Keating               PHONE NO : 353 91 774300 
Parkmore Business Park West       SE DECISION MADE: 25-OCT-18
Galway  IE H91 NHT7               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX  Low Profile Gastrostomy Feeding Tube, PromaX  LP Patient Care Kit with ENFit
Xeridiem Medical Devices, A Spectr510(k) NO: K180708(Traditional)
ATTN: Steve  Murray               PHONE NO : 520 8826849 
4700 S. Overland Dr.              SE DECISION MADE: 18-OCT-18
Tucson AZ  85714                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
TOMY, Inc.                        510(k) NO: K180718(Traditional)
ATTN: Jinichi  Watanabe           PHONE NO : 81 42 3631151 
Tenko Bldg. 3-16-7                SE DECISION MADE: 30-OCT-18
Midori-cho, Fuchu City  JP 183-000510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endomat Select
Karl Storz SE & Co. KG            510(k) NO: K180735(Traditional)
ATTN: Serkan  Sezer               PHONE NO : 49 0 74617080 
Dr.-Karl-Storz-StraBe 34          SE DECISION MADE: 31-OCT-18
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WishBone Medical Plate and Screw System
WishBone Medical, Inc.            510(k) NO: K180736(Traditional)
ATTN: Gary  Barnett               PHONE NO : 1 574 3064006 
1250 North Pointe Drive           SE DECISION MADE: 04-OCT-18
Warsaw IN  46992                  510(k) STATEMENT
                                                    

DEVICE: Osteocera Resorbable Bone Substitute
Wiltrom Corporation Limited       510(k) NO: K180758(Traditional)
ATTN: Yi-Chun  Su                 PHONE NO : 886 3 6107168 
1F., No. 26, Sec. 2, Shengyi Rd.  SE DECISION MADE: 24-OCT-18
Zhubei City  TW 30261             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gas Module 3
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K180788(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81885635 
Mindray Building, Keji 12th Road SSE DECISION MADE: 24-OCT-18
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCARLET SRF
Viol Co., Ltd.                    510(k) NO: K180872(Traditional)
ATTN: Chai Kyoung Woo             PHONE NO : 82 31 80177893 
C-808, 809 Bundang Technopark C, 7SE DECISION MADE: 11-OCT-18
Seongnam-si  KR 13510             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Universal Base Abutment
Nobel Biocare AB                  510(k) NO: K180899(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 31-OCT-18
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE Tri-Lumen Catheter
W.L. Gore and Associates Inc.     510(k) NO: K180919(Traditional)
ATTN: Michael  Ivey               PHONE NO : 928 8643790 
1505 N. Fourth St.                SE DECISION MADE: 05-OCT-18
Flagstaff AZ  86005               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KODEX EPD System
Philips Medical Systems Nederland 510(k) NO: K180940(Traditional)
ATTN: Gina  Crossetta             PHONE NO : 41 22 8401440 
Veenpluis 4, -6                   SE DECISION MADE: 24-OCT-18
PC Best  NL 5684                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ortho System
3Shape A/S                        510(k) NO: K180941(Traditional)
ATTN: Kristian Worziger Nielsen   PHONE NO : 45 702 72620 
Holmens Kanal 7                   SE DECISION MADE: 17-OCT-18
Copenhagen  DK 1060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTA Flash Calprotectin and Fecal Extraction Device
Inova Diagnostics, Inc.           510(k) NO: K180971(Traditional)
ATTN: Roger  Albesa               PHONE NO : 858 5869900 1391
9900 Old Grove Road               SE DECISION MADE: 16-OCT-18
San Diego CA  92131-1638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Clavicle System
Jeil Medical Corporation          510(k) NO: K180972(Traditional)
ATTN: Seungyong  Lee              PHONE NO : 82 2 3503533 
702,703,704,705,706,804,805,807,81SE DECISION MADE: 03-OCT-18
Seoul  KR 08378                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System
Camber Spine Technologies LLC     510(k) NO: K180980(Traditional)
ATTN: Tom  Zamorski               PHONE NO : 484 4204286 
418 E. Lancaster Ave.             SE DECISION MADE: 27-OCT-18
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AG 100s
Hospitech Respiration Ltd.        510(k) NO: K180991(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 972 3 9191648 
20 Hamagshimim St. Kiryat Matalon SE DECISION MADE: 12-OCT-18
Petach Tikva  IL 49348            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuFACE Trinity
Carol Cole Company dba NuFACE     510(k) NO: K181008(Traditional)
ATTN: Donald  Ellis               PHONE NO : 760 5091264 
1325 Sycamore Ave. Suite A        SE DECISION MADE: 11-OCT-18
Vista CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoBridge™ IDSF System
Merete GmbH                       510(k) NO: K181026(Special)
ATTN: Paul  Munch                 PHONE NO : 49 30 7799800 
Alt-Lankwitz 102                  SE DECISION MADE: 17-OCT-18
Berlin  DE 12247                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSI Transseptal Introducer
Pressure Products Medical Device M510(k) NO: K181031(Traditional)
ATTN: Andrew  Armour              PHONE NO : 610 2859858 
1 School Street                   SE DECISION MADE: 26-OCT-18
Morton PA  19070                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)
CorMatrix Cardiovascular, Inc.    510(k) NO: K181038(Traditional)
ATTN: Wendy  Perreault            PHONE NO : 678 5662628 
1100 Old Ellis Rd.                SE DECISION MADE: 10-OCT-18
Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Ear Thermometer
Joytech Healthcare Co., Ltd.      510(k) NO: K181081(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 02-OCT-18
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AxSOS 3 Ti
Stryker GmbH                      510(k) NO: K181091(Traditional)
ATTN: Saad  Attiyah               PHONE NO : 201 8315655 
Bohnackerweg 1                    SE DECISION MADE: 11-OCT-18
Selzach  CH 2545                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONVIVO
Carl Zeiss Meditec AG             510(k) NO: K181116(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 736 4206985 
Goeschwitzer Str. 51-52           SE DECISION MADE: 25-OCT-18
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IS-III active System
Neobiotech Co., Ltd.              510(k) NO: K181138(Traditional)
ATTN: Young-Ku  Heo               PHONE NO : 82 2 5822885 
#312-1, 36, Digital-ro 27-Gil, GurSE DECISION MADE: 03-OCT-18
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitare Platinum Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K181186(Traditional)
ATTN: Ryan  Kenney                PHONE NO : 949 2975489 
9775 Toledo Way                   SE DECISION MADE: 25-OCT-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIP Fix
Hand Biomechanics Lab, Inc.       510(k) NO: K181192(Traditional)
ATTN: Dustin  Dequine             PHONE NO : 916 9235073 
77 Scripps Drive, Suite 104       SE DECISION MADE: 22-OCT-18
Sacramento CA  95825              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Caretaker Remote Display App and Caretaker Software Library
Caretaker Medical, LLC            510(k) NO: K181196(Traditional)
ATTN: Jeff  Pompeo                PHONE NO : 434 4091945 
941 Glenwood Station Ln, Suite 301SE DECISION MADE: 03-OCT-18
Charlottesville VA  22901         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Juell 3D Volo Base
Park Dental Research Corporation  510(k) NO: K181220(Traditional)
ATTN: Ronald A Bulard             PHONE NO : 800 2437372 
2401 N. Commerce Street Suite E   SE DECISION MADE: 12-OCT-18
Ardmore OK  73401                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImPACT
ImPACT Applications, Inc.         510(k) NO: K181223(Traditional)
ATTN: Michael  Zagorski           PHONE NO : 412 5678400 
9665 Granite Ridge Drive, Suite 55SE DECISION MADE: 20-OCT-18
San Diego CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
Joytech Healthcare Co.,Ltd        510(k) NO: K181239(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No. 365 Wuzhou Road, Yuhang EconomSE DECISION MADE: 29-OCT-18
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rhino-Laryngo Fiberscope Olympus ENF-GP2
Olympus Medical Systems Corp.     510(k) NO: K181240(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 04-OCT-18
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comarch e-Care Platform
Comarch Healthcare SA             510(k) NO: K181248(Traditional)
ATTN: Irmina  Serafin             PHONE NO : 48 126461000 
al. Jana Pawla II 39a,            SE DECISION MADE: 22-OCT-18
Krakow  PL 31-864                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quadra P
Medacta International SA          510(k) NO: K181254(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 22-OCT-18
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Sola
Siemens Medical Solutions USA, Inc510(k) NO: K181322(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
65 Valley Stream Parkway 65-1A    SE DECISION MADE: 05-OCT-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeoMatriX Wound Matrix
NeXtGen Biologics, Inc.           510(k) NO: K181330(Traditional)
ATTN: Jonelle L. Toothman         PHONE NO : 904 5993264 
747 SW 2nd Ave - IMB 5            SE DECISION MADE: 11-OCT-18
Gainesville FL  32601             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 074 Zenith Flex System
InNeuroCo Inc.                    510(k) NO: K181354(Traditional)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 25-OCT-18
Sunrise FL  33315                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMR 780
Shanghai United Imaging Healthcare510(k) NO: K181370(Traditional)
ATTN: Xin  GAO                    PHONE NO : 86 2167 0768885386 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 03-OCT-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMR 790
Shanghai United Imaging Healthcare510(k) NO: K181371(Traditional)
ATTN: Xin  GAO                    PHONE NO : 86 216707 68885386 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 03-OCT-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Extended Lipid Panel Assay
Laboratory Corporation of America 510(k) NO: K181373(Traditional)
ATTN: Suzette  Warner             PHONE NO : 919 3885539 
500 Perimeter Park Drive          SE DECISION MADE: 18-OCT-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
Jiangsu Micsafe Medical Technology510(k) NO: K181426(Traditional)
ATTN: Tony  Yang                  PHONE NO : 086 1 365192966 
Xituan Industrial Park, Dafeng DisSE DECISION MADE: 11-OCT-18
Yancheng  CN 224125               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Vida
Siemens Medical Solutions USA, Inc510(k) NO: K181433(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 610 4486545 
40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 19-OCT-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSure Hydrophilic Intermittent Catheter
Amsino International Inc.         510(k) NO: K181445(Traditional)
ATTN: Zoe  Wu                     PHONE NO : 909 6265888 
708 Corporate Center Drive        SE DECISION MADE: 01-OCT-18
Pomona CA  91768                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter
Innovative Health, LLC.           510(k) NO: K181458(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 27-OCT-18
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OnePacs System
OnePacs, LLC                      510(k) NO: K181460(Traditional)
ATTN: Justin  Falk                PHONE NO : 877 8817227 117
530 Lytton Ave                    SE DECISION MADE: 11-OCT-18
Palo Alto CA  94301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hybrid3D
Hermes Medical Solutions AB       510(k) NO: K181468(Traditional)
ATTN: Joakim  Arwidson            PHONE NO : 46 8 190325 
Strandbergsgatan 16               SE DECISION MADE: 25-OCT-18
Stockholm  SE 11251               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
Ethicon Endo-Surgery, LLC         510(k) NO: K181488(Traditional)
ATTN: Sigfrido  Delgado           PHONE NO : 787 2726500 
475 Calle C Suite 202             SE DECISION MADE: 30-OCT-18
Guynabo PR  00969                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K181503(Traditional)
ATTN: Haiying  Zhao               PHONE NO : 86 108 8798300 6020
No.9 Shuangyuan Road, Badachu Hi-tSE DECISION MADE: 11-OCT-18
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senhance Surgical System
TransEnterix, Inc.                510(k) NO: K181517(Traditional)
ATTN: Kaitlyn  Alexander          PHONE NO : 1 919 7658400 8505
635 Davis Drive, Suite 300        SE DECISION MADE: 09-OCT-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sirona Dental CAD/CAM System
Dentsply Sirona                   510(k) NO: K181520(Traditional)
ATTN: Karl J. Nittinger           PHONE NO : 717 8494424 
221 West Philadelphia St., Suite 6SE DECISION MADE: 11-OCT-18
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System
ACON Laboratories, Inc.           510(k) NO: K181527(Traditional)
ATTN: Qiyi  Xie                   PHONE NO : 858 8758011 
10125 Mesa Rim Road               SE DECISION MADE: 03-OCT-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: World Total Knee System
Signature Orthopaedics Pty Ltd.   510(k) NO: K181530(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 24-OCT-18
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
SpineEX Inc.                      510(k) NO: K181531(Traditional)
ATTN: Andrew  Rogers              PHONE NO : 510 5736165 
4046 Clipper Court                SE DECISION MADE: 05-OCT-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSDSIGN Cranioplug
OssDsign AB                       510(k) NO: K181539(Traditional)
ATTN: Ulrik  Birgersson           PHONE NO : 46 018 553993 
Virdings Alle 2                   SE DECISION MADE: 12-OCT-18
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Spin
Siemens Medical Solutions USA, Inc510(k) NO: K181550(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 30-OCT-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Immunalysis Ethyl Alcohol Enzyme Assay
Immunalysis Corporation           510(k) NO: K181553(Traditional)
ATTN: Weying (Jessica)  Zhu       PHONE NO : 909 4516697 
829 Towne Center Drive            SE DECISION MADE: 31-OCT-18
Pomona CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cios Alpha
Siemens Medical Systems USA, Inc. 510(k) NO: K181560(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard, 65-1A       SE DECISION MADE: 24-OCT-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nutrifill
Contamac Ltd.                     510(k) NO: K181566(Traditional)
ATTN: Rob  McGregor               PHONE NO : 44 1799 542000 
Carlton House Shire Hill          SE DECISION MADE: 22-OCT-18
Saffron Walden  GB CB11 3AU       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BKS Revision Sleeves System
Ortho Development Corporation     510(k) NO: K181569(Traditional)
ATTN: Dan  Petersen               PHONE NO : 801 5539991 
12187 So. Business Park Drive     SE DECISION MADE: 12-OCT-18
Draper UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DemeTECH PTFE Nonabsorbable Surgical Suture
Demetech Corporation              510(k) NO: K181578(Traditional)
ATTN: Linda  Hernandez            PHONE NO : 305 8241048 
14175 NW 60th Ave.                SE DECISION MADE: 11-OCT-18
Miami Lakes FL  33104             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOLOC SPS Shoulder Plating System
Tornier Inc.                      510(k) NO: K181587(Traditional)
ATTN: Renee  Stoffel              PHONE NO : 952 6837471 
10801 Nesbitt Ave South           SE DECISION MADE: 05-OCT-18
Bloomington MN  55437             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spine Wave Navigated Instruments
Spine Wave, Inc.                  510(k) NO: K181596(Traditional)
ATTN: Amy  Noccioli               PHONE NO : 203 9449494 
3 Enterprise Drive, Suite 210     SE DECISION MADE: 24-OCT-18
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
K2M Inc.                          510(k) NO: K181603(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Pkwy. SE                 SE DECISION MADE: 05-OCT-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Thorecon Rigid Fixation System
A&E Medical Corporation           510(k) NO: K181607(Traditional)
ATTN: Dana  Rodriguez             PHONE NO : 732 9382266 
5206 Asbury Road, PO Box 758      SE DECISION MADE: 12-OCT-18
Farmingdale NJ  07727             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-CUBE 8
Alpinion Medical Systems Co., Ltd.510(k) NO: K181617(Traditional)
ATTN: Boyeon  CHO                 PHONE NO : 82 70 74652104 
1FL and 6FL, Verdi Tower, 72, DigiSE DECISION MADE: 11-OCT-18
Seoul  KR 08393                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Torqr Diagnostic EP Catheter
Innovative Health, LLC.           510(k) NO: K181618(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 18-OCT-18
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stable-C Interbody System
Nexus Spine, LLC                  510(k) NO: K181621(Traditional)
ATTN: Jared  Crocker              PHONE NO : 801 7028342 
2825 E Cottonwood Parkway, Suite 3SE DECISION MADE: 19-OCT-18
Salt Lake City UT  84121          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StrataMR guider tool
Medtronic Neurosurgery            510(k) NO: K181622(Traditional)
ATTN: Xiaojian  Sun               PHONE NO : 805 5718758 
125 Cremona Dr                    SE DECISION MADE: 01-OCT-18
Goleta CA  93117                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-BOLT Hip Fracture Fixation System
X-Bolt Orthopaedics               510(k) NO: K181640(Traditional)
ATTN: Brian  Thornes              PHONE NO : 01 425 2961705 
Unit 5 Northwood Court Santry, DubSE DECISION MADE: 12-OCT-18
Dublin  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B-Laser Atherectomy System
Eximo Medical Ltd.                510(k) NO: K181642(Traditional)
ATTN: Yossi  Muncher              PHONE NO : 972 508 580308
3 Pekeris St.                     SE DECISION MADE: 05-OCT-18
Rehovot  IL 7670203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EIT Cellular Titanium® Lumbar Cage LLIF
EIT Emerging Implant Technologies 510(k) NO: K181644(Traditional)
ATTN: Barbara  Wirth              PHONE NO : 49 746 11716904 
Eisenbahnstrasse 83               SE DECISION MADE: 12-OCT-18
Wurmlingen  DE 78573              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radial Medical Compression System
Radial Medical, Inc.              510(k) NO: K181651(Traditional)
ATTN: Eric  Johnson               PHONE NO : 707 8430871 
2500 Grant Road                   SE DECISION MADE: 12-OCT-18
Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and 510(k) NO: K181685(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
LLC 9900 W. Innovation Drive      SE DECISION MADE: 25-OCT-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Spine Laminoplasty System
Life Spine Inc.                   510(k) NO: K181717(Traditional)
ATTN: Angela  Batker              PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 12-OCT-18
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD FlowSmart Set/MiniMed Pro-Set
Becton, Dickinson and Company     510(k) NO: K181718(Traditional)
ATTN: Meriam  Youssef             PHONE NO : 201 8476557 
1 Becton Drive                    SE DECISION MADE: 18-OCT-18
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005)
Avenu Medical, Inc.               510(k) NO: K181725(Traditional)
ATTN: Rebecca K. Pine             PHONE NO : 760 8095178 
27123 Calle Arroyo, Suite 2101    SE DECISION MADE: 05-OCT-18
San Juan Capistrano CA  92675     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Muscle Trainer
Shenzhen Kentro Medical Electronic510(k) NO: K181728(Traditional)
ATTN: Zewu  Zhang                 PHONE NO : 86 755 33825998 
No.3, Xihu Industry Zone, Xikeng VSE DECISION MADE: 17-OCT-18
Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Invisalign System with Mandibular Advancement Feature
Align Technology, Inc.            510(k) NO: K181739(Traditional)
ATTN: Somi  Ekwealor              PHONE NO : 408 4701432 
2820 Orchard Pkwy                 SE DECISION MADE: 26-OCT-18
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
Teleflex Medical Incorporated     510(k) NO: K181774(Traditional)
ATTN: Andrea  Curria              PHONE NO : 508 9646030 
375 Forbes Boulevard              SE DECISION MADE: 10-OCT-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medax Biopsy Systems III
Medax Srl Unipersonale            510(k) NO: K181803(Traditional)
ATTN: Stefano  Cavalieri          PHONE NO : 053 51812757 
Via R.Piva, 1/A                   SE DECISION MADE: 18-OCT-18
Poggio Rusco  IT 46025            510(k) STATEMENT
                                                    

DEVICE: DynaBridge
Fusion Orthopedics, LLC           510(k) NO: K181815(Traditional)
ATTN: Adam  Cundiff               PHONE NO : 800 4036876 
4135 S. Power Rd., Suite 110      SE DECISION MADE: 15-OCT-18
Mesa AZ  85212                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scarlet AL-T
Spineart                          510(k) NO: K181818(Traditional)
ATTN: Franck  Pennesi             PHONE NO : 41 22 5701200 
3 Chemin du Pré Fleuri            SE DECISION MADE: 09-OCT-18
Plan Les Ouates  CH 1228          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADAPT for Gamma3, Gamma3
Stryker GMBH                      510(k) NO: K181848(Traditional)
ATTN: Tina  Mornak                PHONE NO : 201 8316365 
325 Corporate Drive               SE DECISION MADE: 12-OCT-18
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Percuvance Percutaneous Surgical System
Teleflex Medical, Inc.            510(k) NO: K181852(Traditional)
ATTN: Kim  Campbell               PHONE NO : 919 3614021 
3015 Carrington Mill Blvd         SE DECISION MADE: 12-OCT-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Cohere Thoracolumbar Interbody System
NuVasive, Incorporated            510(k) NO: K181860(Traditional)
ATTN: Olga  Lewis                 PHONE NO : 858 9093360 
7475 Lusk Blvd.                   SE DECISION MADE: 05-OCT-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elvie Pump
Chiaro Technology Limited         510(k) NO: K181863(Traditional)
ATTN: Jonathan  O'Toole           PHONE NO : 044 203 7455201 
2nd Floor 63-66 Hatton Garden     SE DECISION MADE: 10-OCT-18
London  GB EC1N 8LE               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deka Smartxide2 Trio
El.En Electronic Engineering Spa  510(k) NO: K181867(Special)
ATTN: Paolo  Peruzzi              PHONE NO : 39 055 8826807 
Via Baldanzese 17                 SE DECISION MADE: 02-OCT-18
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SHINY RPL System
IDS, Ltd.                         510(k) NO: K181868(Traditional)
ATTN: C.J.  Park                  PHONE NO : 82 2 20251153 
#105, Byoksan Digital Valley 3 chaSE DECISION MADE: 05-OCT-18
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Outlet Sacroiliac Joint Fusion System
SIJ Surgical                      510(k) NO: K181881(Traditional)
ATTN: Daniel  Hoehn               PHONE NO : 314 4940313 
6829 Falls of Neuse Rd., Ste 103  SE DECISION MADE: 03-OCT-18
Raleigh NC  27615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIREFLY® Midline Navigation Guide
Mighty Oak Medical Inc.           510(k) NO: K181883(Traditional)
ATTN: Mark A. Wylie               PHONE NO : 720 3989703 
750 W. Hampden Avenue, Suite 120  SE DECISION MADE: 03-OCT-18
Englewood CO  80110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voyant System
Viseon, Inc.                      510(k) NO: K181885(Traditional)
ATTN: Cora  Sim                   PHONE NO : 949 6623959 106
13900 Alton Parkway, Suite 125    SE DECISION MADE: 02-OCT-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ziostation2
Ziosoft, Inc.                     510(k) NO: K181892(Traditional)
ATTN: Tsuyoshi  Nagata            PHONE NO : 81 3 54271903 
MitaKokusai Bldg., 1-4-28 Mita    SE DECISION MADE: 09-OCT-18
Minato-ku  JP 108-0073            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Two-Step Implant System
Trilliant Surgical                510(k) NO: K181898(Traditional)
ATTN: Jon  Olson                  PHONE NO : 800 4952919 
727 N Shepherd Dr. STE 100        SE DECISION MADE: 26-OCT-18
Houston TX  77007                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Codman Certas Plus Electronic Tool Kit
Integra LifeSciences Corp.        510(k) NO: K181902(Traditional)
ATTN: Nancy  MacDonald            PHONE NO : 781 9715664 
11 Cabot Blvd                     SE DECISION MADE: 25-OCT-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
Varian Medical Systems, Inc.      510(k) NO: K181903(Traditional)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 03-OCT-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BracePaste MTP Light Cure Primer
American Orthodontics             510(k) NO: K181910(Traditional)
ATTN: Trang  Adams                PHONE NO : 920 4575051 
3524 Washington Avenue            SE DECISION MADE: 15-OCT-18
Sheboygan WI  53081               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonendo Material A
Sonendo, Inc.                     510(k) NO: K181922(Traditional)
ATTN: Eric  Simon                 PHONE NO : 949 7663636 
26061 Merit Circle, Suite 102     SE DECISION MADE: 22-OCT-18
Laguna Hills CA  92653            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DyeVert PLUS EZ Contrast Reduction System
Osprey Medical, Inc.              510(k) NO: K181936(Special)
ATTN: Vic  Fabano                 PHONE NO : 952 9558247 
5600 Rowland Rd, Suite 250        SE DECISION MADE: 25-OCT-18
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pump In Style Advanced, Advanced Personal Double Breastpump
Medela LLC                        510(k) NO: K181937(Traditional)
ATTN: PJ  Pasia                   PHONE NO : 815 5782455 
1101 Corporate Drive              SE DECISION MADE: 16-OCT-18
McHenry IL  60050                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swift System
Emblation Ltd                     510(k) NO: K181941(Traditional)
ATTN: Mairi  MacFadyen            PHONE NO : 44 1259 236132 
Forrester Lodge                   SE DECISION MADE: 18-OCT-18
Alloa  GB FK10 2HU                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Ventilation Module
Spectrum Medical Ltd              510(k) NO: K181942(Traditional)
ATTN: Mark  Drain                 PHONE NO : 44 0 1242650120 
Harrier 4, Meteor Business Park, CSE DECISION MADE: 18-OCT-18
Gloucester  GB GL2 9QL            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QuickScreen Pro Multi Drug Screening Test, Model 9395Z
Phamatech Inc.                    510(k) NO: K181945(Traditional)
ATTN: Robert  Merlock             PHONE NO : 858 6435555 
15175 Innovation Drive            SE DECISION MADE: 18-OCT-18
San Diego CA  92128               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Persona Revision Knee System
Zimmer Inc.                       510(k) NO: K181947(Traditional)
ATTN: Nicole  Meredith            PHONE NO : 574 3773718 
P.O. Box 708                      SE DECISION MADE: 25-OCT-18
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYMPHONY™ OCT System
Medos International SARL          510(k) NO: K181949(Traditional)
ATTN: Sheree  Geller              PHONE NO : 508 8283291 
Chemin-Blanc 38                   SE DECISION MADE: 04-OCT-18
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JiveX
Visus Health IT GmbH              510(k) NO: K181964(Traditional)
ATTN: Axel  Schreiber             PHONE NO : 49 234 93693337 
Gesundheitscampus-Sued 15-17      SE DECISION MADE: 23-OCT-18
Bochum  DE 44801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Aspiration Needle NA-U201H
Olympus Medical Systems Corp.     510(k) NO: K181994(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 31-OCT-18
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integra TITAN Reverse Shoulder System
Integra Lifesciences Corporation  510(k) NO: K181999(Traditional)
ATTN: Blesson  Abraham            PHONE NO : 512 8523942 
11101 Metric Blvd.                SE DECISION MADE: 12-OCT-18
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cumulus Remover
Kitazato Corporation              510(k) NO: K182002(Traditional)
ATTN: Futoshi  Inoue              PHONE NO : 81 545 662202 
81 Fuji                           SE DECISION MADE: 23-OCT-18
Shizuoka  JP 416-0907             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piccolo Composite® Plate System
CarboFix Orthopedics Ltd.         510(k) NO: K182015(Traditional)
ATTN: Yael  Rubin                 PHONE NO : 972 9 9511511 
11 Ha'hoshlim St.                 SE DECISION MADE: 11-OCT-18
Herzeliya  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bluetooth blood pressure monitor
Shenzhen Kingyield Technology Co.,510(k) NO: K182018(Special)
ATTN: Dacheng  Gong               PHONE NO : 86 755 27371997 
Section C2, Fuhai Industrial Zone,SE DECISION MADE: 06-OCT-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arterys MICA
Arterys Inc.                      510(k) NO: K182034(Traditional)
ATTN: Sharon  Cholowsky           PHONE NO : 403 9239688 
51 Federal Street, Suite 305      SE DECISION MADE: 17-OCT-18
San Francisco CA  94107           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroBlate System
Monteris Medical                  510(k) NO: K182036(Traditional)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North Suite C   SE DECISION MADE: 15-OCT-18
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dexcom G6 Glucose Program Continuous Glucose Monitoring System
Dexcom, Inc.                      510(k) NO: K182041(Traditional)
ATTN: Luke  Olson                 PHONE NO : 858 8755307 
6340 Sequence Dr.                 SE DECISION MADE: 26-OCT-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Randox Calcium (Ca)
Randox Laboratories Ltd.          510(k) NO: K182042(Traditional)
ATTN: Pauline  Armstrong          PHONE NO : 44 28 94422413 
55 Diamond Road                   SE DECISION MADE: 23-OCT-18
Crumlin  GB BT29 4QY              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch
Siemens Medical Solutions USA, Inc510(k) NO: K182050(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 610 4486545 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 03-OCT-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Duodenoscope Model
FUJIFILM Corporation              510(k) NO: K182051(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 02-OCT-18
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prase MIS Spinal System
GBS Commonwealth Co., Ltd.        510(k) NO: K182059(Traditional)
ATTN: Jimmy  Kim                  PHONE NO : 82 2 69254469 
B-1007-1, Woolim Lion's Valley, 16SE DECISION MADE: 04-OCT-18
Geumcheon-gu  KR 08507            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
Sysmex America, Inc.              510(k) NO: K182062(Traditional)
ATTN: Jessica  Rivera-Montejo     PHONE NO : 224 5439650 
577 Aptakisic Road                SE DECISION MADE: 30-OCT-18
Lincolnshire IL  60069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System
Ortho-Clinical Diagnostics, Inc.  510(k) NO: K182063(Traditional)
ATTN: Marlene  Hanna              PHONE NO : 585 4534041 
100 Indigo Creek Drive            SE DECISION MADE: 30-OCT-18
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
Cook Incorporated                 510(k) NO: K182066(Traditional)
ATTN: Carly  Powell               PHONE NO : 812 3392235 104913
750 Daniels Way                   SE DECISION MADE: 30-OCT-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioHorizons Tapered IM Implants
BioHorizons Implant Systems, Inc. 510(k) NO: K182070(Special)
ATTN: Michael  Davis              PHONE NO : 205 9677880 
2300 Riverchase Center            SE DECISION MADE: 10-OCT-18
Birmingham AL  35244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides
Ortho-Clinical Diagnostics, Inc.  510(k) NO: K182072(Traditional)
ATTN: Marlene  Hanna              PHONE NO : 585 4534041 
100 Indigo Creek Drive            SE DECISION MADE: 30-OCT-18
Rochester NY  14626               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tumark for Eviva, Tumark for Brevera
Somatex Medical Technologies GmbH 510(k) NO: K182082(Traditional)
ATTN: Burkhard  Jakob             PHONE NO : 49 30 319822500 
Rheinstrasse 7d                   SE DECISION MADE: 31-OCT-18
Teltow  DE 14513                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Balanced Knee Revision System Trabecular Tibial Cone Augments
Ortho Development Corporation     510(k) NO: K182085(Traditional)
ATTN: Adrienne  von Foller        PHONE NO : 801 5539991 
12187 So. Business Park Drive     SE DECISION MADE: 31-OCT-18
Draper UT  84020                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynaMesh-POSTERIOR
FEG Textiltechnik Forschungs- und 510(k) NO: K182087(Traditional)
ATTN: Stefan  Schneemelcher       PHONE NO : 011 49 2411892374 0
mbH Prager Ring 70                SE DECISION MADE: 31-OCT-18
Aachen  DE D-52070                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
Fotona d.o.o.                     510(k) NO: K182088(Traditional)
ATTN: Marko  Berdajs              PHONE NO : 386 1 5009100 
Stegne 7                          SE DECISION MADE: 31-OCT-18
Ljubljana  SI 1000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTL 799-2T
BTL Industries, Inc.              510(k) NO: K182106(Traditional)
ATTN: David  Chmel                PHONE NO : 1 866 2851656 
362 Elm Street                    SE DECISION MADE: 23-OCT-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sense System with IBT Electrodes
Infinite Biomedical Technologies, 510(k) NO: K182112(Traditional)
ATTN: Rahul  Kaliki               PHONE NO : 443 4517175 
8 Market Place, Suite 500         SE DECISION MADE: 05-OCT-18
Baltimore MD  21202               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Patient Examination Gloves
Ping An Medical Products Co., Ltd.510(k) NO: K182115(Traditional)
ATTN: Fu Dong  Zhang              PHONE NO : 86 315 4167652 
Zhe Ji road, High-tech Industrial SE DECISION MADE: 03-OCT-18
Jiu Jiang  CN 332000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vinyl Patient Examination Gloves
Jiangxi Zhonghong Pulin Medical Pr510(k) NO: K182117(Traditional)
ATTN: Joe  Zhang                  PHONE NO : 86 315 4168700 
Yinsha Wan Industrial Park, High-tSE DECISION MADE: 06-OCT-18
Jiu Jiang  CN 332000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ureteric Catheters
Coloplast Corp                    510(k) NO: K182122(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 04-OCT-18
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Sola
Siemens Medical Solutions USA, Inc510(k) NO: K182129(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
65 Valley Stream Parkway 65-1A    SE DECISION MADE: 12-OCT-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical, Inc           510(k) NO: K182140(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 24-OCT-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate
CTL Medical Corporation           510(k) NO: K182151(Traditional)
ATTN: Andrea  Wilcox              PHONE NO : 214 5455820 
4550 Excel Parkway, Suite 300     SE DECISION MADE: 11-OCT-18
Addison TX  75001                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Depuy Synthes Femoral Neck System
Synthes (USA) Products, LLC       510(k) NO: K182154(Traditional)
ATTN: Stephan  Jepards            PHONE NO : 41 32 7204159 
1301 Goshen Parkway               SE DECISION MADE: 16-OCT-18
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SMV Scientific K-Wire and Pins
Summit MedVentures                510(k) NO: K182171(Traditional)
ATTN: Nephi  Zufelt               PHONE NO : 719 3377579 
7500 Rialto Blvd, Bldg 1, Ste 225 SE DECISION MADE: 25-OCT-18
Austin TX  78738                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accipiolx
MaxQ-Al Ltd.                      510(k) NO: K182177(Traditional)
ATTN: Joshua  Schulman            PHONE NO : 617 7650333 103
76 Yigal Alon Street, 5th Floor   SE DECISION MADE: 26-OCT-18
Tel Aviv  IL 6706701              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Encompass SRS Headframe ; Encompass MR SRS Headframe
Qfix                              510(k) NO: K182189(Special)
ATTN: Alexandra Low Smythe        PHONE NO : 610 2680585 
440 Church Road                   SE DECISION MADE: 04-OCT-18
Avondale PA  19311                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearLink Controlled Phototherapy Equipment
Daavlin Distributing Company      510(k) NO: K182215(Traditional)
ATTN: Michele  Thiel              PHONE NO : 419 6366304 
205 W. Bement Street              SE DECISION MADE: 29-OCT-18
Bryan OH  43506                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apiration Guide Catheter ; FlowTriever Catheter
Inari Medical                     510(k) NO: K182233(Traditional)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 15-OCT-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMI 550 PET/CT System
Shanghai United Imaging Healthcare510(k) NO: K182237(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 2167 0768886776 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 12-OCT-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OLYMPIC Posterior Spinal Fixation System
Astura Medical, LLC               510(k) NO: K182239(Traditional)
ATTN: Parker  Kelch               PHONE NO : 760 8148047 
3186 Lionshead Ave, Suite 100     SE DECISION MADE: 18-OCT-18
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASS LP Spinal System
Medicrea International S.A.       510(k) NO: K182240(Traditional)
ATTN: David  Ryan                 PHONE NO : 0033 4 72018787 
5389 route de Strasbourg          SE DECISION MADE: 17-OCT-18
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voyant Electrosurgical Generator
Applied Medical Resources Corp.   510(k) NO: K182244(Special)
ATTN: Andrew  Nguyen              PHONE NO : 949 7135458 
22872 Avenida Empresa             SE DECISION MADE: 11-OCT-18
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
VizionFocus, Inc.                 510(k) NO: K182247(Traditional)
ATTN: Angus  Shih                 PHONE NO : 037 5 82900 
No.66, Youyi Rd.                  SE DECISION MADE: 12-OCT-18
Zhunan Township  TW 350           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NvisionVLE Imaging System, NvisionVLE Optical Probe
NinePoint Medical, Inc.           510(k) NO: K182261(Special)
ATTN: Eman  Namati                PHONE NO : 617 2507147 
12 Oak Park Drive                 SE DECISION MADE: 16-OCT-18
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICONN Revolution Knotless Suture Anchor
ICONN Orthopedics, LLC            510(k) NO: K182264(Traditional)
ATTN: Whitt  Israel               PHONE NO : 205 9132068 
400 Union Hill Drive, Suite 150   SE DECISION MADE: 19-OCT-18
Birmingham AL  35209              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech
C.R. Bard                         510(k) NO: K182281(Traditional)
ATTN: Sari  Stevens               PHONE NO : 801 5225756 
605 N 5600 West                   SE DECISION MADE: 24-OCT-18
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Orian 1.5T, MRT-1550, V4.5
Canon Medical Systems Corporation 510(k) NO: K182282(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 19-OCT-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUSE Pedicle Screw System
Black Box Medical                 510(k) NO: K182283(Special)
ATTN: Todd  Stanaford             PHONE NO : 432 3129977 
4516 East County Road 45          SE DECISION MADE: 23-OCT-18
Midland TX  79705                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile High-pressure Angiographic Syringes for Single-use
Shenzhen Baoan Medical Supplies Co510(k) NO: K182289(Special)
ATTN: Mingan  Mu                  PHONE NO : 86 755 28638515 
No.6, Shenkeng Road, Shenkeng InduSE DECISION MADE: 10-OCT-18
Shenzhen  CN 518173               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Aera
Siemens Medical Solutions USA Inc.510(k) NO: K182299(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 610 4486545 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 26-OCT-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Retina Workplace
Carl Zeiss Meditec, Inc           510(k) NO: K182318(Traditional)
ATTN: Maria  Golovina             PHONE NO : 925 2161078 
5160 Hacienda Drive               SE DECISION MADE: 24-OCT-18
Dublin CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Duo Lumbar Interbody Fusion Device
Spineology Inc                    510(k) NO: K182322(Traditional)
ATTN: Karen  Roche                PHONE NO : 651 2568500 
7800 Third Street N., Suite 600   SE DECISION MADE: 24-OCT-18
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYBRID Guidewire
Balt USA, LLC                     510(k) NO: K182337(Third Party - Traditional)
ATTN: Nancy  Xu                   PHONE NO : 949 7881443 
29 Parker                         SE DECISION MADE: 04-OCT-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 14HK701G-W
LG Electronics Inc.               510(k) NO: K182348(Traditional)
ATTN: Jinhwan  Jun                PHONE NO : 82 31 80665641 
222, LG-Ro                        SE DECISION MADE: 18-OCT-18
Jinwi-Myeon Pyeongtaek-Si  KR 1770510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TempSure System
Cynosure, Inc                     510(k) NO: K182365(Traditional)
ATTN: Amy  Tannenbaum             PHONE NO : 781 9932454 
5 Carlisle Road                   SE DECISION MADE: 24-OCT-18
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wilson-Cook Mini Basket
Wilson-Cook Medical, Inc          510(k) NO: K182381(Traditional)
ATTN: Tiffanny A. Thomas          PHONE NO : 336 7440157 396680
4900 Bethania Station Road        SE DECISION MADE: 30-OCT-18
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Frozen C
B.M. Tech. Worldwide Co., Ltd.    510(k) NO: K182392(Traditional)
ATTN: Jenny  Cho                  PHONE NO : 82 31 7395544 
#609, 808, 1001~1007, Jungang lnduSE DECISION MADE: 30-OCT-18
Seongnam-si  KR 13202             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGLUMI 2000 FT4
Shenzhen New Industries Biomedical510(k) NO: K182423(Traditional)
ATTN: Jie  Rao                    PHONE NO : 86 755 21536601 
No.16, Jinhui Road, Pingshan New DSE DECISION MADE: 04-OCT-18
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POWEREASE System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K182436(Special)
ATTN: Ankit K. Shah               PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 04-OCT-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid S60N, Vivid S70N
GE Medical Systems Ultrasound and 510(k) NO: K182450(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
9900 W. Innovation Drive          SE DECISION MADE: 19-OCT-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeekMed
Peek Health, S.A.                 510(k) NO: K182464(Traditional)
ATTN: Sara  Silva                 PHONE NO : 351 935 147151 
Praca Conde de Agrolongo, n 123   SE DECISION MADE: 25-OCT-18
Braga  PT 4700-312                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AOS Calcaneal Plating System
Advanced Orthopaedic Solutions    510(k) NO: K182466(Traditional)
ATTN: Elaine  Nguyen              PHONE NO : 310 5339966 
3203 Kashiwa Street               SE DECISION MADE: 30-OCT-18
Torrance CA  90505                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Swiss LithoClast Trilogy
EMS Electro Medical Systems SA    510(k) NO: K182490(Special)
ATTN: Sonia  Callegaro            PHONE NO : 41 22 9944700 
Ch de la Vuarpilliere             SE DECISION MADE: 09-OCT-18
Nyon  CH 1260                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geminus Volar Distal Radius Plate System
Skeletal Dynamics, LLC            510(k) NO: K182492(Special)
ATTN: Ana M. Escagedo             PHONE NO : 305 5967585 
7300 North Kendall Drive, Suite 40SE DECISION MADE: 10-OCT-18
Miami FL  33156                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hair Laser Headband
Pulsaderm LLC                     510(k) NO: K182501(Special)
ATTN: Gloria  Avendano            PHONE NO : 239 2250635 
12801 Commonwealth Dr. Units 2-6  SE DECISION MADE: 26-OCT-18
Fort Myers FL  33913              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3.0T Air MP M, 3.0T Air MP L
GE Healthcare Coils (USA Instrumen510(k) NO: K182504(Traditional)
ATTN: Veronica A. Meridith        PHONE NO : 262 9555427 
1515 Danner Drive                 SE DECISION MADE: 12-OCT-18
Aurora OH  44202                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System (Modified 110 Aspiration Tubing)
Penumbra, Inc.                    510(k) NO: K182522(Special)
ATTN: Micaela  Victoria           PHONE NO : 510 9952083 
One Penumbra Place                SE DECISION MADE: 12-OCT-18
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xperius Ultrasound System
Philips Ultrasound, Inc.          510(k) NO: K182529(Third Party - Traditional)
ATTN: Deep  Pal                   PHONE NO : 425 4877000 
22100 Bothell Everett Highway     SE DECISION MADE: 23-OCT-18
Bothell WA  98021-8431            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ClotTriever Thrombectomy System
Inari Medical                     510(k) NO: K182531(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Road Suite 124      SE DECISION MADE: 10-OCT-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels
Pixxgen Corporation               510(k) NO: K182533(Traditional)
ATTN: John  Ross                  PHONE NO : 82 70 48468888 
5F, Smart Bay, 123, Beolmal-ro, DoSE DECISION MADE: 04-OCT-18
Anyang-si  KR 14056               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap
Exactech, Inc.                    510(k) NO: K182536(Special)
ATTN: Zach  Sharrah               PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 12-OCT-18
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2MP Color LCD Monitor CL-R211
JVC Kenwood Corporation           510(k) NO: K182539(Traditional)
ATTN: Masafumi  Yugami            PHONE NO : 81 258 246611 
3-12, Moriya-cho, Kanagawa-ku     SE DECISION MADE: 03-OCT-18
Yokohama  JP 221-0022             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiLumen Endolumenal Interventional Platform
Lumendi, LLC                      510(k) NO: K182540(Traditional)
ATTN: Dennis  Daniels             PHONE NO : 203 4632669 
253 Post Road West                SE DECISION MADE: 30-OCT-18
Westport CT  06880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alphenix, INFX-8000H/B, V8.0
Canon Medical Systems Corporation 510(k) NO: K182546(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 17-OCT-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K182550(Traditional)
ATTN: Meng  Li                    PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 17-OCT-18
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K182551(Traditional)
ATTN: Meng  Li                    PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 17-OCT-18
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UroNav (Version 3.0)
Invivo Corporation                510(k) NO: K182561(Third Party - Traditional)
ATTN: Kenneth M. Revennaugh       PHONE NO : 352 3848590 
3545 SW 47th Ave.                 SE DECISION MADE: 19-OCT-18
Gainesville FL  32608             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Spectralis HRA+OCT and variants with High Magnification Module
Heidelberg Engineering GmbH       510(k) NO: K182569(Special)
ATTN: Arianna  Schoess            PHONE NO : 49 6221 64630 
Max-Jarecki-Strasse 8             SE DECISION MADE: 18-OCT-18
Heidelberg  DE 69115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port
Medtronic, Inc.                   510(k) NO: K182586(Special)
ATTN: Linda L. Julia Davila       PHONE NO : 763 5149521 
8200 Coral Street NE              SE DECISION MADE: 19-OCT-18
Mounds View MN  55125             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider
Surgical Instrument Service and Sa510(k) NO: K182588(Traditional)
ATTN: Stephanie  Boyle Mays       PHONE NO : 541 9233375 
1500 NE Hemlock Ave.              SE DECISION MADE: 31-OCT-18
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA
GE Healthcare                     510(k) NO: K182590(Traditional)
ATTN: Veronica  Meridith          PHONE NO : 262 9555427 
3200 N. Grandview Blvd            SE DECISION MADE: 19-OCT-18
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadiForce RX360, RX360-AR
EIZO Corporation                  510(k) NO: K182591(Abbreviated)
ATTN: Hiroaki  Hashimoto          PHONE NO : 81 76 2742468 
153 Shimokashiwano                SE DECISION MADE: 18-OCT-18
Hakusan  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RCT700
RAY Co.,Ltd                       510(k) NO: K182614(Special)
ATTN: Changhwan  Lee              PHONE NO : 82 35 6051000 
332-7, Samsung 1-ro               SE DECISION MADE: 16-OCT-18
Hwaseong-si  KR 18380             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GU60A, GU60A-65
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K182622(Special)
ATTN: Jaesang  NOH                PHONE NO : 82 2 21932444 
129, SAMSUNG-RO, YEONGTONG-GU     SE DECISION MADE: 23-OCT-18
SUWON-SI  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Abbott                            510(k) NO: K182644(Special)
ATTN: Cody  Johnson               PHONE NO : 651 7564217 
One St. Jude Medical Drive        SE DECISION MADE: 19-OCT-18
St. Paul MN  55177                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GC70
Samsung Electronics Co., Ltd.     510(k) NO: K182647(Special)
ATTN: Jaesang  Noh                PHONE NO : 82 2 21932444 
129, Samsung-Ro, Yeongtong-Gu,    SE DECISION MADE: 24-OCT-18
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Youlaser CO2
Quanta System SpA                 510(k) NO: K182669(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 0039 0331 376797 
Via Acquedotto 109                SE DECISION MADE: 17-OCT-18
Samarate  IT 21017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
Canon Medical Systems Corporation 510(k) NO: K182679(Third Party - Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 31-OCT-18
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: External upper limb tremor stimulator
Cala Health, Inc.                 510(k) NO: K182706(Special)
ATTN: Scott A. Wilson             PHONE NO : 925 8765480 
875 Mahler Road, Suite 168        SE DECISION MADE: 25-OCT-18
Burlingame CA  94010              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paragonix SherpaPak Cardiac Transport System
Paragonix Technologies            510(k) NO: K182735(Special)
ATTN: Lisa M. Anderson            PHONE NO : 617 8177790 
639 Granite Street #408           SE DECISION MADE: 19-OCT-18
Braintree MA  02184               510(k) STATEMENT
                                                    

DEVICE: A6 OTC Pain Relief TENS
Everyway Medical Instruments Co., 510(k) NO: K182753(Special)
ATTN: Paul  Hung                  PHONE NO : 886 2 26620038 
3Fl., No. 5, Lane 155, Sec. 3, BeiSE DECISION MADE: 26-OCT-18
New Taipei City  TW 22203         510(k) STATEMENT
                                                    

DEVICE: V2 OTC Pain Relief TENS
Everyway Medical Instruments Co., 510(k) NO: K182767(Special)
ATTN: Paul  Hung                  PHONE NO : 886 2 26620038 
3Fl., No. 5, Lane 155, Sec. 3 BeisSE DECISION MADE: 26-OCT-18
New Taipei City  TW 22203         510(k) STATEMENT
                                                    

DEVICE: Ormco Spark Aligner System
Sybron Dental Specialties         510(k) NO: K182826(Third Party - Traditional)
ATTN: Mey  Saied                  PHONE NO : 909 9625675 
1717 W. Collins Ave.              SE DECISION MADE: 11-OCT-18
Orange CA  92687                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Halifax Imaging Kit
Halifax Biomedical, Inc.          510(k) NO: K182880(Special)
ATTN: Crystal  Jones              PHONE NO : 1 902 9452762 
11493 Route 19                    SE DECISION MADE: 31-OCT-18
Mabou  CA B0E1X0                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MC3 Vascular Access Kit 21030
MC3 Incorporated                  510(k) NO: K182914(Third Party - Traditional)
ATTN: Adam  Viitala               PHONE NO : 1 734 9959089 324
2555 Bishop Circle West           SE DECISION MADE: 29-OCT-18
Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW


      TOTAL 510(k)s THIS PERIOD   254                                     
      TOTAL WITH SUMMARIES        246                                     
      TOTAL WITH STATEMENTS         8