FDA 510(k) Applications Received During July, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K151933 07/14/2015 BRX PRO Bruxism Guard 12TH MAN TECHNOLOGIES, INC. ALEX STENZLER
K152060 07/24/2015 3M Attest Rapid Readout Biological Indicator 1295 3M COMPANY MATT MORTENSEN
K152086 07/27/2015 3Shape Ortho System 3Shape A/S Hanne Nielsen
K152078 07/27/2015 Implant Studio 2015 3Shape Medical A/S Hanne Nielsen
K151953 07/15/2015 A&D Medical TM-2657 Family of Digital Blood Pressure Monitors A&D COMPANY, LTD JERRY WANG
K151822 07/06/2015 ab medica irrigation/suction gravity system AB MEDICA S.A.S. ALEXANDRE BLANC
K151783 07/01/2015 COMPACT INTUITIV Multiple-Use Pack Abbott Medical Optics Inc. Priya Viswanathan
K152135 07/31/2015 Quantitative Electrocardiographic Detector (QED 2000) ACME Portable Machines, Inc. James Cheng
K151886 07/09/2015 Acumed Ankle and Small Fragment Base Set Update Acumed, LLC Kara Budor
K152040 07/22/2015 X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) ADVANCED BRAIN MONITORING, INC. DANIEL J. LEVENDOWSKI
K151971 07/16/2015 STERRAD CYCLESURE 24 Biological Indicator ADVANCED STERILIZATION PRODUCTS SUN CHOI
K151938 07/14/2015 S4 Cervical Spinal and Occiput Systems AESCULAP IMPLANT SYSTEMS, LLC LISA BOYLE
K151858 07/08/2015 Caiman Seal and Cut Technology Aesculap, Inc. Denise Adams
K151865 07/08/2015 PremiPatch PTFE Pledget AESCULAP, INC. KATHY A. RACOSKY
K151935 07/14/2015 Alere Signify H. pylori Whole Blood, Serum, Plasma; Alere Signify H. pylori Whole Blood Only;Alere Clearview H. pylori Whole Blood, Serum, Plasma; Alere Clearview H. pylori Whole Blood Only ALERE SAN DIEGO, INCORPORATED JOSEPH DE LA ROSA
K151809 07/02/2015 Alere Afinion HbA1c, Alere Afinion AS100 Analyzer Alere Technologies AS Kari Skinnemoen
K152122 07/30/2015 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) ALFA SCIENTIFIC DESIGNS, INC. MICHAEL CHANG-CHIEN
K151839 07/06/2015 AMC Health VitalCaregiving System AMC Health Jonathan Shankman
K152058 07/24/2015 Tyvek Sterilization Pouches with Chevron Seal Andersen Sterilizers,Inc. William K Andersen
K152003 07/20/2015 iHealth BP3L Wireless Blood Pressure Monitor ANDON HEALTH CO.,LTD Liu Yi
K151877 07/09/2015 MicroTract Access System ARSTASIS, INC. Debra Cogan
K152046 07/23/2015 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) ART OPTICAL CONTACT LENS, INC. MICHAEL JOHNSON
K151897 07/10/2015 MultiFIX« P Knotless Fixation Device ArthroCare Corporation Laura Kasperowicz
K152047 07/23/2015 INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid ASCENSION ORTHOPEDICS WILLIAM GARZON
K152025 07/22/2015 AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) ASSURE TECH. CO., LTD. ERIC LIN
K151998 07/20/2015 TraceIT Tissue Marker - 3mL AUGMENIX, INC. NOEL ROLON
K152032 07/22/2015 ELUMI 810 + 980 Soft Tissue Laser AZENA MEDICAL, LLC ALEX DI SESSA
K152050 07/23/2015 Pencylcap B. BRAUN MELSUNGEN AG HANS-ULRICH GAUDIN
K151918 07/13/2015 Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist BAUSCH & LOMB INCORPORATED Barbara Klube-Falso
K152129 07/31/2015 FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution BAXTER HEALTHCARE CORPORATION TIFFANY LIN
K152057 07/24/2015 OsteoCool V-3 RF Ablation System BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K151866 07/09/2015 BD BACTEC Peds Plus/F Culture Vials (plastic) BECTON DICKINSON AND COMPANY ASHANTI C. BROWN
K151870 07/09/2015 BD U-500 INSULIN SYRINGE BECTON, DICKINSON AND COMPANY LUISA F. METRIO
K151834 07/06/2015 BEMER Classic Set, BEMER Pro-Set BEMER Int. AG Sven Bieler
K151903 07/10/2015 Slendertone connect Abs BIO-MEDICAL RESEARCH LTD. ANNE-MARIE KEENAN
K151876 07/09/2015 Bio2 Fusion Implant System Bio2 Technologies, Inc Janet Krevolin
K151955 07/15/2015 YuGo System BIOGAMING LTD. RONIT HARPAZ
K151817 07/06/2015 VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL BIOMERIEUX INC KAREN RUSSELL
K151873 07/09/2015 Etest Ceftaroline (0.002 - 32ug/ml) BIOMERIEUX SA CLAIRE DUMAS
K152075 07/27/2015 VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) bioMerieux, Inc Cherece L Jones
K151923 07/13/2015 VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) BIOMERIEUX, INC. Cherece L Jones
K151974 07/16/2015 Polaris Spinal System BIOMET SPINE ALEXANDRA BECK
K151910 07/13/2015 Ultrasound Scanner System BK2300 BK MEDICAL APS Randi Hauerberg
K152052 07/23/2015 Ultrasound Scanner System bk2300 BK MEDICAL APS Michael J. Doyle
K151801 07/02/2015 Arc Endocuff Vision BODDINGTONS PLASTICS LTD PAUL BLACKMORE
K151990 07/20/2015 Tissue Removal System BOEHRINGER LABORATORIES LLC CHRIS RADL
K152125 07/31/2015 Oral Surgery System and Accessories BONART CO., LTD. BANKSON TSAI
K152020 07/21/2015 Bindex BI-100 BONE INDEX FINLAND, LTD. JANNE KARJALAINEN
K151895 07/10/2015 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle BOSTON SCIENTIFIC CORPORATION YINGYING GAO
K151840 07/06/2015 Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire Boston Scientific Corporation Nikki M Wahlberg
K151802 07/02/2015 Resolution Clip BOSTON SCIENTIFIC CORPORATION ELENA NIEVES
K151957 07/16/2015 BOX DICOM Viewer BOX INC. CRISPEN MAUNG
K152113 07/29/2015 BioHPP - breCAM.BioHPP Bredent GmbH & Co.KG Stefanie Bochtler
K151985 07/17/2015 PowerPICC« EtOH Catheter and PowerPICC SOLO«2 EtOH Catheter C.R. Bard, Inc Bryan Stone
K152136 07/31/2015 Recovery Cone Removal System C.R. Bard, Inc. Joni Creal
K151778 07/01/2015 Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating CARDINAL HEALTH 200, INC. CAROLINE MICELI
K151788 07/01/2015 Cardinal Health Sterilization Wrap Cardinal Health 200, LLC MEGAN MIDDAUGH
K151959 07/16/2015 AirLife Infant Single Limb Heated Wire Circuit CAREFUSION INC ERIKA FERNANDEZ
K151774 07/01/2015 CARESTREAM Vue Motion CARESTREAM HEALTH, INC. CAROLYN L WAGNER
K151875 07/09/2015 Pavati Zirconia CCRI, INC. ROBIN CARDEN
K151784 07/01/2015 ActTrust CONDOR INSTRUMENTS LTDA. - EPP RODRIGO TREVISAN OKAMOTO
K152033 07/22/2015 Cook ECM Powder Cook Biotech Incorporated Perry W Guinn
K152044 07/23/2015 Flexor Radial Hydrophilic Introducer Access Set COOK INCORPORATED SARAH REEVES
K151845 07/07/2015 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) COOPERSURGICAL, INC. ROAIDA JOHNSON
K152084 07/27/2015 Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug CORENTEC CO., LTD J S Daniel
K152127 07/31/2015 CorMatrix Tyke CORMATRIX CARDIOVASCULAR, INC. ANDREW M. GREEN
K152095 07/28/2015 Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) COSMEDICO LIGHT, INC. STEVEN SCHLITT
K152072 07/27/2015 CrossRoads Screw System CrossRoads Extremity Systems, LLC Vernon Hartgegen
K151896 07/10/2015 Houdini Catheter Cruzar Medsystems, Inc. Tom Kramer
K151854 07/07/2015 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display D-VIEW DISPLAY TECHNOLOGY CO., LTD. JIANFEI SUN
K151795 07/02/2015 ML24000 UVA-1 Phototherapy Cabinet DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K151987 07/17/2015 DCI Edge Dental Chair with Operative Unit DCI ROBERT BELLINGHAM
K151945 07/14/2015 Triumph Resin Dam DENALI CORPORATION JAN G. STANNARD
K151926 07/14/2015 QuickRay HD Intraoral Sensor DENTERPRISE INTERNATIONAL, INC. CLAUDE BERTHOIN
K151885 07/09/2015 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System DEPUY SYNTHES, Inc. Karen K Sylvia
K151867 07/09/2015 STA R MAX DIAGNOSTICA STAGO S.A.S. ARNAUD COLLIN
K151860 07/08/2015 Infinity CentralStation Wide Draeger Medical Systems, Inc. Thomas Ostrowski
K151942 07/14/2015 EVS 3643 DRTECH Corporation Choul-Woo Shin
K152110 07/29/2015 e-1 etchants E DENTAL PRODUCTS JEFF BANYAS
K151912 07/13/2015 AIR-FLOW handy 3.0 PLUS E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Suzanne Fassio-Hardy
K152034 07/22/2015 FS-PACS EC-WEB CO., LTD. KE-MIN JEN
K151978 07/17/2015 EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control EDAN INSTRUMENTS, INC. TRACY YUE
K151787 07/01/2015 Holter System EDAN INSTRUMENTS, INC. QUEENA CHEN
K151878 07/09/2015 Video Colposcope EDAN INSTRUMENTS, INC. Queena Chen
K151883 07/09/2015 5MP Monochrome LCD Monitor, RadiForce GX540 EIZO CORPORATION HIROAKI HASHIMOTO
K152096 07/28/2015 DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive Ethicon, Inc. Donna Marshall
K152070 07/27/2015 BioZorb LP Marker FOCAL THERAPEUTICS George Hermann
K151893 07/10/2015 P.R.O. CG Manual Wheelchair FREEDOM DESIGNS, INC. Nancy F Schmidt
K151944 07/14/2015 Luggie Super Freerider Corporation Arthur Wang
K151888 07/10/2015 Frontier Medical Devices In-line Orthopedic Cable Cerclage System FRONTIER MEDICAL DEVICES, INC. BETHANY BYMAN
K152138 07/31/2015 FDR D-EVO GL Flat Panel Detector System FUJIFILM MEDICAL SYSTEM U.S.A., INC. Katherine Y Choi
K151859 07/08/2015 Synapse Cardiovascular FUJIFILM MEDICAL SYSTEMS U.S.A., INC. JYH-SHYAN LIN
K152133 07/31/2015 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System GALIL MEDICAL LTD LYNNE DAVIES
K152099 07/28/2015 Genesys Spine Apache« Anchored Cervical Interbody Fusion System GENESYS SPINE BEN KELLER
K152039 07/22/2015 Genesys Spine TiLock2 Spinal System Genesys Spine William W Sowers
K151846 07/07/2015 Rainbow LS Pressing GENOSS BYUNGSUN KIM
K151844 07/07/2015 Rainbow Shade GENOSS BYUNGSUN KIM
K151842 07/07/2015 Rainbow Shine GENOSS BYUNGSUN KIM
K151939 07/14/2015 COALITION Spacers GLOBUS MEDICAL INC. KELLY J. BAKER
K152022 07/21/2015 SUSTAIN« R Spacers, PATRIOT« Spacers, CALIBER« Spacers, RISE« Spacers, COALITION« Spacers, COALITION AGXÖ Spacers, INDEPENDENCE« Spacers, FORTIFY«-R Corpectomy Spacers, FORTIFY« I-R Corpectomy Spacers, XPand«-R Corpectomy Spacers, NIKO« Corpectomy Spacers GLOBUS MEDICAL INC. KELLY J. BAKER
K152029 07/22/2015 HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 HAMILTON MEDICAL AG STEFFEN BODEN
K152077 07/27/2015 MaxiGen HANS BIOMED CORP. LUCY CHOI
K151997 07/20/2015 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) HARTALEGA NGC SDN BHD Kuan Mun Leong
K151836 07/06/2015 NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK HARTALEGA NGC SDN BHD KUAN MUN LEONG
K152107 07/29/2015 HealthChek Network Health Station HEALTHCHEK NETWORK, LLC JAMES EVANS
K151968 07/16/2015 Cryocare CS-3 Surgical System version 5 HEALTHTRONICS SCOTT EDEN
K151905 07/13/2015 3400E series; E5400 series; E6400 series; Sundazzler series HEARTLAND TANNING, INC. Jon Marcum
K152126 07/31/2015 UST-5550-R; UST-5536-R; L43K HITACHI ALOKA MEDICAL AMERICA, INC. ANGELA VAN ARSDALE
K152087 07/27/2015 HeatLux Pro II HOME SKINOVATIONS LTD. Ahava Stein
K151969 07/16/2015 Hospira Extension Sets Hospira, Inc. Charles Neitzel
K151977 07/17/2015 icotec Pedicle System ICOTEC AG JORG SCHNEIDER
K152006 07/21/2015 Cogent Hemodynamic Monitoring System ICU MEDICAL INC. Natalie Hepworth
K151941 07/14/2015 DEXIS Webview Imaging Sciences International /Gendex/Dexis Sanjay Ahuja
K152097 07/28/2015 Retraction Aspirator INARI MEDICAL EBEN GORDON
K151793 07/01/2015 InMode RF System INMODE MD LTD. AHAVA STEIN
K151785 07/01/2015 Px HA PEEK IBF System INNOVASIS, INC. MARSHALL MCCARTY
K152013 07/21/2015 QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls INOVA DIAGNOSTICS, INC. Gabriella Lakos
K151819 07/06/2015 Integrity Spine Lumbar Interbody Fusion System INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM LISA PETERSON
K152112 07/29/2015 VisualEyes INTERACOUSTICS A/S ERIK NIELSEN
K151794 07/01/2015 da Vinci Xi Surgical System Intuitive Surgical, Inc. Brandon Hansen
K151894 07/10/2015 IPS Ivocolor IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K152103 07/29/2015 IPS Style Ceram, IPS Style Ceram One, IPS Style Press Ivoclar Vivadent AG Sandra Cakebread
K151781 07/01/2015 Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor IVY BIOMEDICAL SYSTEMS INC. DICK LISTRO
K152091 07/27/2015 Fingertip Pulse Oximeter Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd Li Xu
K152089 07/27/2015 Wrist Pulse Oximeter Jiangsu Konsung Bio-Medical Science & Technology Co. Ltd Li Xu
K151949 07/15/2015 Disposable Insulin Syringe JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K151991 07/20/2015 Safelock Disposable Blood Collection Set, Disposable Blood Collection Set JIANGYIN CAINA TECHNOLOGY CO., LTD. JUN LU
K152015 07/21/2015 Pyrenees Cervical Plate System K2M, INC. NANCY GIEZEN
K152080 07/27/2015 Metacross OTW PTA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K151962 07/16/2015 KBL Sunlamp Products (= Device Bundling name) KBL AG NORBERT BECKER
K152098 07/28/2015 ODALYS Pedicle Screw System Kisco International Hiroko Ito
K151970 07/16/2015 KJ Mini Implant System KJ MEDITECH CO., LTD. GOONG-SAN NAM
K151983 07/17/2015 KLS Martin LSS Plating System KLS MARTIN L.P. JENNIFER DAMATO
K151824 07/06/2015 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested KOSSAN INTERNATIONAL SDN. BHD. CHO SOW FONG
DEN150030 07/02/2015 KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay KRONUS, INC. BRIAN DEIS
K152137 07/31/2015 FacetBRIDGE System LDR SPINE USA James Wilson
K151934 07/14/2015 ROI-C Titanium-Coated Implant System LDR SPINE USA JAMES WILSON
K151835 07/06/2015 Vital Signs Patch System LIFEWATCH TECHNOLOGIES LTD. ASHER KASSEL
K152120 07/30/2015 OPTIS Mobile System LIGHTLAB IMAGING, INC. PADMINI SURAVARAM
K152008 07/21/2015 Physica PS Knee System LIMACORPORATE S.P.A. EMANUELE BUTTAZZONI
K151857 07/08/2015 Love Alchemy's Love Lotion LOVE ALCHEMY LLC Eric Weiss
K151947 07/15/2015 LightSheer Desire Light Laser System LUMENIS LTD ELISSA BURG
K151906 07/13/2015 ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) LUMINEX CORPORATION RONALD DUNN
K151917 07/13/2015 ARIES System LUMINEX CORPORATION RONALD DUNN
K151814 07/06/2015 SERVO-U Ventilator System, SERVO-n Ventilator System MAQUET CRITICAL CARE AB MARIA VON BAHR
K151965 07/16/2015 Dentti System Martz, Inc Andrew Martz
K152028 07/22/2015 Volpara Imaging Software MATAKINA TECHNOLOGIES LIMITED RALPH HIGHNAM
K152041 07/22/2015 Renaissance X System Mazor Robotics Ltd. Ayelet Matia
K151850 07/07/2015 McKesson Cardiology MCKESSON ISRAEL LTD. GILBERT WONG
K152121 07/30/2015 NuVent EM Sinus Dilation System MEDTRONIC XOMED, INC. Gabriela Anchondo
K152054 07/23/2015 Confida Adaptive Sheath Medtronic, Inc. Matthew Lobeck
K152116 07/30/2015 5.5 F Worley Advanced LVI Lateral Vein Introducer MERIT MEDICAL SYSTEMS, INC. ALINA STUBBS
K151967 07/16/2015 Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter Merit Medical Systems, Inc. Susan Christensen
K151925 07/13/2015 Elation Wireguided Balloon Dilation Catheter MERIT MEDICAL SYSTEMS, INC. DAVID THOMAS
K151776 07/01/2015 Central Venous Pressure System Mespere LifeSciences Inc. Helen Tan
K152001 07/20/2015 Sterile Repositionable Hemostasis Clipping Device Micro-Tech (Nanjing) CO.,Ltd. Becky Li
K151869 07/09/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND GERHARD FRICK
K151913 07/13/2015 MIM-Thin Client (mobile) MIM Software Inc. Lynn Hanigan
K151825 07/06/2015 Viradius Neurowire MIVI NEUROSCIENCE, INC. RANDY LABOUNTY
K152059 07/24/2015 Disposable General Electrode MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED THOMAS CHAN TSZ FUNG
K151872 07/09/2015 Avance Y-Connector S MOLNLYCKE HEALTH CARE, US LLC ANGELA BUNN
K152051 07/23/2015 ClearMet Mycone Dental Supply Co., t/a Keystone Industries Tracey Schwear
K151861 07/08/2015 JUSHA-C23C LCD Monitor NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MA JING
K151972 07/16/2015 JUSHA-C43 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Ma Jing
K152004 07/20/2015 Nanova Universal Composite NANOVA BIOMATERIALS INC ANDREW RITTS
K151943 07/14/2015 Vas-Q-Clip NANOVA BIOMATERIALS INC ANDREW RITTS
K152069 07/27/2015 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter NAVILYST MEDICAL, INC. MICHAEL P. HANLEY
K152031 07/22/2015 New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with NEW DEANTRONICS TAIWAN, LTD. JANE LIU
K151995 07/20/2015 Painmaster MCT Patch NEWMARK, INC. Francis Powell
K151797 07/02/2015 Nuocande Plastic Manual Wheelchair Model NKD L07 NINGBO LECOUNT MEDICAL TECHNOLOGY CO., LTD. CHARLES SHEN
K152093 07/28/2015 NobelZygoma 45? NOBEL BIOCARE AB JI EUN HWANG
K151909 07/13/2015 Noris Medical Zygomatic Dental Implant System NORIS MEDICAL LTD. SIMHA SIBONY
K151982 07/17/2015 Stat Profile Prime ABG Analyzer System NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K152071 07/27/2015 NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) NOVABONE PRODUCTS, LLC RICHARD A. DAVIS
K152088 07/27/2015 IV-eye Novarix Limited JOHN SCOTT
K151832 07/06/2015 NOVATECH TALCAIR NOVATECH S.A. JENNIFER NEFF
K152055 07/24/2015 Ceramax Skin Barrier Cream OCULUS INNOVATIVE SCIENCES BRIAN W. MARTIN
K152092 07/28/2015 Resection Electrodes Olympus Winter & Ibe GmbH Katharina Schnackenburg
K151976 07/16/2015 Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode OMNITECH SYSTEMS, INC. JON D. BARRETT
K151946 07/14/2015 Thermofit ORFIT INDUSTRIES EDDY MAROVOET
K152005 07/20/2015 MONTAGE Settable, Resorbable Hemostatic Bone Putty ORTHOCON, INC. HOWARD SCHRAYER
K151979 07/17/2015 STARband, STARlight ORTHOMERICA PRODUCTS, INC. DAVID C. KERR
K151951 07/15/2015 Destino Reach Oscor Inc. Jan Flegeau
K152067 07/24/2015 Ponto bone anchored hearing system OTICON MEDICAL AB Carolina Anker Wessling
K151852 07/07/2015 PacEndo Sodium Hyprochlorite PAC-DENT INTERNATIONAL, INC. WENYING ZHU
K151929 07/14/2015 PERSYST 13 (P13) EEG REVIEW AND ANALYSIS SOFTWARE PERSYST DEVELOPMENT CORPORATION DARI DARABBEIGI
K151799 07/02/2015 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 PHADIA AB CARINA MAGNUSSON
K151812 07/02/2015 PATIENT MONITORS VARIOUS MODELS PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K151780 07/01/2015 CAAS Workstation PIE MEDICAL IMAGING B.V. FLORIE DANIELS
K152014 07/21/2015 MTS300 Multiple Tray Sterilization System PMBS, LLC MICHELE E. MAUZERALL
K151790 07/01/2015 PMT Platinum Depthalon Depth Electrode PMT CORPORATION KIM SCHMELZER
K151940 07/14/2015 Thora-3Di, Model T-01 PneumaCare LIMITED MARK HARWOOD
K151830 07/06/2015 Hummingbird Tympanostomy Tube PRECEPTIS MEDICAL Keith Leland
K151863 07/08/2015 Precision Spine Interspinous Plate System PRECISION SPINE, INC. MICHAEL C. DAWSON
K151798 07/02/2015 Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K152021 07/21/2015 Pure Tilt Proactive Comfort, LLC Tracy Augustine
K151821 07/06/2015 ER-REBOA Catheter Pryor Medical Devices, Inc Christopher Banas
K152030 07/22/2015 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) Qingdao Hisense Medical Equipment Co., Ltd. Liu Zhitang
K151829 07/06/2015 Atlas SPEEDER Header/Neck Quality Electrodynamics, LLC KATHLEEN ARAS
K152012 07/21/2015 EVO platform Quanta System SpA Francesco Dell'Antonio
K152117 07/30/2015 Dropper hsCRP High Sensitivity CRP Control Quantimetrix Corporation Kaylna Snylyk
K151924 07/13/2015 Q-Rad Radiographic System with Auto-Tracker Option QUANTUM MEDICAL IMAGING DIVISON OF CARESTREAM MARK CAMIRAND
K152085 07/27/2015 Liquid CO2-2 (LCO2-2) RANDOX LABORATORIES LTD PAULINE ARMSTRONG
K151884 07/09/2015 K-Y Marilyn Pleasure Gel Reckitt Benckiser LLC ELIZABETH TORRE
K151880 07/09/2015 Wingman Crossing Catheter REFLOW MEDICAL REBECCA K PINE
K152131 07/31/2015 Reliance Spinal Screw System Reliance Medical Systems, LLC BRET M BERRY
K152124 07/31/2015 Tempus IC2 REMOTE DIAGNOSTICS TECHNOLOGIES LTD CHRIS HANNAN
K151901 07/10/2015 AirView RESMED LTD. Jasjit Baveja
K152068 07/24/2015 Astral 100/150 RESMED LTD. Peter Jennings
K151786 07/01/2015 Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet Roche Diagnostics Kelli Turner
K152105 07/29/2015 Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set ROCKET MEDICAL PLC TRACY CHARLTON
K151921 07/13/2015 STERISPINE PS SAFE ORTHOPAEDICS PIERRE DUMOUCHEL
K151874 07/09/2015 BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal Salter Labs Mara Caler
K152094 07/28/2015 GR40CW SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K151808 07/02/2015 3D/5D Viewer SAMSUNG MEDISON CO., LTD KIM JIYOUNG
K152043 07/23/2015 Diagnostic Station DS20 SCHILLER AG ZHENRONG YU
DEN150033 07/31/2015 Sensor Monitored Alimentary Restriction Therapy (SMART) Device SCIENTIFIC INTAKE William Longley
K151856 07/08/2015 ABL80 FLEX CO-OX with AQURE connectivity SENDX MEDICAL INC. Vibeke Agerlin
K151849 07/07/2015 Seneka I Polyscrew Pedicle Fixation System Senecka Spine Khalid Sethi
K151960 07/16/2015 Sterile High-pressure Angiographic Syringes for Single-use SHENZHEN BAOAN MEDICAL SUPPLIES CO., LTD MINGAN MU
K151954 07/15/2015 A7 Anesthesia System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. TANG HAO
K151810 07/02/2015 Bpump Blood Pressure Cuff SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. XIE QIONGYU
K151996 07/20/2015 TAURUS C1 SHINHUNG COMPANY LTD SKY SHIN
K151964 07/16/2015 Xprecia Stride Coagulation System, Xprecia System PT Controls SIEMENS HEALTHCARE DIAGNOSTICS NOOR MALKI
K151986 07/17/2015 ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS INC. MATTHEW GEE
K152061 07/24/2015 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. SUSAN BROCCHI
K151792 07/01/2015 Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System Siemens Healthcare Diagnostics,Inc. Philip Liu
K152036 07/22/2015 SOMATOM Definition Edge, SOMATOM Definition AS/AS+ SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K151887 07/10/2015 syngo VSim SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K151847 07/07/2015 SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens SMART PERFORMER CORP. LTD. JEFFERSION SHEN
K151902 07/10/2015 REDAPT? Revision Femoral System SMITH & NEPHEW, INC. Natalie P. Williams
K152000 07/20/2015 SMV Scientific Bone Plate and Screw System SMV Scientific Nephi Zufelt
K152011 07/21/2015 Lucent Intervertebral Body Fusion Device Spinal Elements Inc. Julie Lamothe
K151813 07/02/2015 Sniper Spine System SPINE WAVE, INC. Ronald K Smith
K151911 07/13/2015 WorkMate Claris System, WorkMate Claris System Display Plus ST. JUDE MEDICAL MELISSA FRANK
K152115 07/29/2015 Renew NCP-5 External Counterpulsation System Stage 2 Innovations Richard Kotz
K152009 07/21/2015 DENSEEMAMMO v1.0 STATLIFE STEPHANE RAGUSA
K152090 07/27/2015 Reprocessed Steerable Introducer STERILMED, INC. Patricia Kaufman
K152134 07/31/2015 Reprocessed Vessel Sealer STERILMED, INC. PATRICIA KAUFMAN
K151928 07/14/2015 PUR Dental Implant System STERNGOLD DENTAL, LLC MARIA RAO
K151922 07/13/2015 StimSox(TM) System StimMed, LLC Robert E Kaplan
K152076 07/27/2015 PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority Stryker Jonathan Schell
K151932 07/14/2015 Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing STRYKER CORPORATION SOMI EKWEALOR
K151879 07/09/2015 VariAx 2 One-Third Tubular Plating System STRYKER GMBH HEIKE GUSTKE
K151855 07/08/2015 SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber SURGICAL LASER INCORPORATED GORDON WILLOX
K152111 07/29/2015 Symmetry Surgical Quad-Lock Container System SYMMETRY SURGICAL INC. LORA TJOMSTOL
K151936 07/14/2015 Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle SYNAPTIC MEDICAL LIMITED Yang Tiecheng
K152100 07/28/2015 Evogue Dental Unit TAKARA BELMONT CORPORATION Toshinori Kiyomatsu
K152066 07/24/2015 Luminesse Anterior Zirconia AT TALLADIUM, INC. Edward Harms
K152023 07/21/2015 Luminesse Shaded Zirconia SZ TALLADIUM, INC. Edward Harms
K152081 07/27/2015 Weck Auto Endo5 Hem-o-lok Ligating Clip Applier Teleflex Medical, Inc. Ashlea Ricci
K151791 07/01/2015 Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir TERUMO CARDIOVASCULAR SYSTEMS CORPORATION JAIME LEE
K151816 07/06/2015 TLC-2000 Therapeutic Medical Laser System Theralase Inc. Roger Dumoulin-White
K151984 07/17/2015 Thommen Milling Abutment for CAD/CAM THOMMEN MEDICAL AG DANIEL SNETIVY
K152128 07/31/2015 2-in-1 Abdominal Muscle Training & Back Pain Relief System Tohkai Precision Electrical Manufactory (Shenzhen) Limited Yuk Wing Li
K151952 07/15/2015 Synergy ODM TOPCON MEDICAL SYSTEMS, INC. Michael Gusel
K151833 07/06/2015 Aquilion Lightning (TSX-035A/2, V7.0) TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K151916 07/13/2015 TRI Dental Implant System TRI DENTAL IMPLANTS INT. AG SANDRO VENANZONI
K151837 07/06/2015 CS 3D Imaging TROPHY MARIE-PIERRE LABAT-CAMY
K152019 07/21/2015 HairMD TROPHY SKIN, INC. IMRAN KARIM
K152064 07/24/2015 Astringedent Clear ULTRADENT PRODUCTS, INC. COREY JASEPH
K152035 07/22/2015 iSnare system-Lariat United States Endoscopy Group, Inc Carroll Martin
K151889 07/10/2015 Infinity ERCP Sampling Device UNITED STATES ENDOSCOPY GROUP, INC. CARROLL MARTIN
K152018 07/21/2015 Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets VARIAN MEDICAL SYSTEMS, INC. Peter J. Coronado
K151882 07/09/2015 Varian Treatment (VTx) VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K151981 07/17/2015 Turnpike catheter VASCULAR SOLUTION, INC. BEKA VITE
K152106 07/29/2015 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart VATECH CO., LTD DANIEL KIM
K152082 07/27/2015 Vesocclude Polymer Ligating Clip Vesocclude Medical, LLC Freddy Cannady
K151881 07/09/2015 X-Fix Line Additions VILEX IN TENNESSEE, INC SYLVIA SOUTHARD
K151988 07/17/2015 Visible Patient Suite VISIBLE PATIENT, SAS AUDE PETITJEAN
K151919 07/13/2015 Vitrea CT Lung Density Analysis Software VITAL IMAGES, INC. KATIE RYAN
K151956 07/15/2015 Admira Fusion x-tra VOCO GMBH M TH PLAUMANN
K151904 07/13/2015 SyncVision System VOLCANO CORPORATION ELAINE ALAN
K151961 07/16/2015 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens Volk Optical Inc. Meghan M Leonard
K152109 07/29/2015 HD-Camera HDC1000 W.O.M. WORLD OF MEDICINE GmbH Soeren Markworth
K151900 07/10/2015 VariLift-L Interbody Fusion Device WENZEL SPINE, INC. BECKINAM NOWATZKE
K151777 07/01/2015 Intradermal Adapter WEST PHARMACEUTICAL SERVICES INC. JEFFREY RAVEL
K152118 07/30/2015 Zenostar MT, Zenostar Color Liquids WIELAND DENTAL + TECHNIK GMBH & CO. KG BETINA KISTNER
K152056 07/24/2015 Winco Model S550 Stretchair WINCO MANUFACTURING LLC JAMES ANKOVIAK
K151841 07/06/2015 Ultraviolet Sunlamps Wolff System Technology Corp. Michael Stepp
K152038 07/22/2015 MammoGRIP Women's Imaging Solutions Enterprises LLC Nancy DeRobertis
K152062 07/24/2015 BIOFOAM Bone Wedge WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K151838 07/06/2015 PRO-TOE Hammertoe Fixation System Wright Medical Technology, Inc. Michael Mullins
K152045 07/23/2015 SALVATION« External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE REDDEN
K151890 07/10/2015 Medical Diode Laser Systems Wuhan Gigaa Optronics Technology Co., Ltd Nie Xinxing
K152132 07/31/2015 X-spine Pedicle Screw System X-spine Systems, Inc. David Kirschman
K151963 07/16/2015 SmartSite Vented Vial Access Device YUKON MEDICAL, LLC CARL DUPPER
K151789 07/01/2015 LOCATOR F-Tx Attachment System ZEST ANCHORS, LLC ANNIE WRIGHT
K151848 07/07/2015 Cable-Ready« Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System ZIMMER, INC. PATRICK MCCULLAGH
K151907 07/13/2015 Cable-Ready« Cable Grip System: Cable-Ready« GTR System, Cable-Ready« 1.8mm Cerclage Cables ZIMMER, INC. PATRICK MCCULLAGH
K151992 07/20/2015 FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control ZIMMER, INC. PATRICK MCCULLAGH
K151818 07/06/2015 SImmetry Sacroiliac Joint Fusion System Zyga Technology, Inc. Diane Brinza


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