FDA 510(k) Decisions During January, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K142034 01/08/2015 3M STERI-VAC STERILIZER/AERATOR 3M COMPANY MATT MORTENSEN
K143573 01/16/2015 Audit MicroControls Linearity FD Tumor Markers II AALTO SCIENTIFIC LTD. Robert Burda
K143571 01/23/2015 Audit MicroControls Linearity LQ Cystatin-C AALTO SCIENTIFIC, LTD. ROBERT BURDA
K153086 11/20/2015 RX ACCUNET Embolic Protection System ABBOTT VASCULAR Aruna Akkapeddi
K142816 01/14/2015 AbbVie J ABBVIE INC. Katherine Wortley
K142792 01/14/2015 AbbVie NJ ABBVIE INC. Katherine Wortley
K142793 01/14/2015 AbbVie PEG AbbVie Inc. Katherine Wortley
K152573 11/25/2015 4Sight ACCUTOME, INC. ADAM PICKHOLTZ
K143394 01/23/2015 Acumed Small Fragment Base Set ACUMED LLC Nathan Wolf
K141622 01/09/2015 ILLUMINATED MEDIASTINOSCOPE AEGIS SURGICAL LTD TAMMY CARREA
K150637 11/19/2015 Aerin Medical Wand Model FG011 Aerin Medical, Inc. Scott Wolf
K141142 01/23/2015 MAMMAPRINT FFPE AGENDIA Guido Brink
K142316 01/06/2015 IMPAX Agility AGFA HEALTHCARE N.V. Jodi Coleman
K142284 01/26/2015 CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE ALCON LABORATORIES, INC. ALICIA PLESNARSKI
DEN150001 11/20/2015 RELIZORB ALCRESTA, INC. ROBERT GALLOTTO
K143630 11/18/2015 Invisalign System ALIGN TECHNOLOGY, INC. Margaret Anderson
K142743 01/27/2015 AliveCor Heart Monitor AliveCor, Inc. Albert Boniske
K143149 01/05/2015 Arsenal Spinal Fixation System ALPHATEC SPINE, INC. RENEE MURPHY
K152939 11/25/2015 Picasso Plus, Picasso Lite Plus AMD GROUP LLC SCOTT A. EDWARDS
K141852 01/06/2015 IFS ADVANCED FEMTOSECOND LASER SYSTEM AMO MANUFACTURING USA, LLC RODNEY HUANG
K140932 01/23/2015 AMSEL OCCLUDER DEVICE AMSEL MEDICAL CORPORATION LEO BASTA
K150645 11/19/2015 AN1087 Dosimeter ANDERSEN STERILIZERS, INC. William K. Andersen
K150644 11/18/2015 AN85/AN86 EO Indicators ANDERSEN STERILIZERS, INC. William K. Andersen
K151585 11/18/2015 Andersen EOGas 4 SteriTest Andersen Sterilizers, Inc. William K Andersen
K150646 11/18/2015 EOGas 4 Ethylene Oxide Gas Sterilizer ANDERSEN STERILIZERS, INC. WILLIAM K. ANDERSEN
K152058 11/18/2015 Tyvek Sterilization Pouches with Chevron Seal Andersen Sterilizers,Inc. William K Andersen
K142889 01/27/2015 Celerity PICC Tip Confirmation System ANGIODYNAMICS, INC. Michael Hanley
K150612 11/16/2015 Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy Nitrile Patient Examination Glove (powdered and powder-free) ANHUI ANYU LATEX PRODUCTS CO., LTD NONE PROVIDED
K150609 11/16/2015 Annuy Latex Surgeon's Gloves (Powdered and Powder Free) ANHUI ANYU LATEX PRODUCTS CO., LTD NONE PROVIDED
K143757 01/08/2015 ANUTRA Feedback Aspiration Syringe ANUTRA MEDICAL, INC. CAMERON PERKINS
K150102 11/05/2015 SnoreSounds APPIAN MEDICAL, INC. MICHAEL J THOMAS
K142256 01/07/2015 Applied BioPhotonics Phototherapy System ABPT1003 APPLIED BIOPHOTONICS LTD. ERIC HSIEH
K142989 01/29/2015 Mini ONE Enteral Extension Set APPLIED MEDICAL TECHNOLOGY, INC. Joshua Meinke
K140957 01/15/2015 GENASIS HIPATH IHC FAMILY APPLIED SPECTRAL IMAGING LTD. ILAN SHARON
K142914 01/12/2015 DacryoCATH ARMADILLO BIOMEDICAL, LLC Bruce Becker, M.D.
K152272 11/23/2015 Arrow Endurance Extended Dwell Peripheral Catheter System ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) TRACY LARISH
K142641 01/12/2015 Intelliwave4 ART OPTICAL CONTACT LENS, INC. MICHAEL JOHNSON
K152046 11/24/2015 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) ART OPTICAL CONTACT LENS, INC. MICHAEL JOHNSON
K143139 01/16/2015 Arthrex Fracture System ARTHREX, INC. David Rogers
K152252 11/16/2015 Arthrex iBalance TKA System ARTHREX, INC. LEON BROWN
K152382 11/12/2015 Arthrex iBalance TKA System ARTHREX, INC. LEON BROWN
K143614 01/16/2015 Arthrex Low Profile Screws ARTHREX, INC. David L Rogers
K153115 11/23/2015 Arthrex Univers Apex, Size 5 Stem ARTHREX, INC. COURTNEY SMITH
K141189 01/30/2015 NANOBONE / GRANULATE ARTOSS GMBH WALTER GERIKE
K141751 01/30/2015 ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR ASAHI INTECC CO., LTD. SEMIH OKTAY
K133891 01/30/2015 MULTIPULSE TM+1470 ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K152740 11/16/2015 Radifocus Glidewire ASHITAKA FACTORY OF TERUMO CORP. PHEBE VARGHESE
K152151 11/10/2015 ATAL 9 ATLAIM CORPORATION JOHN ROSS
K152923 11/05/2015 BD ChloraShield IV Dressing with CHG Antimicrobial AVERY DENNISON BELGIE BVBA LISA BARTAKOVICS
K150800 11/12/2015 Valved Safety Centesis Catheter B. Braun Medical Inc Nancy Skocypec
K152618 11/12/2015 PANTHER Cutter Stapler B. J. ZH. F. PANTHER MEDICAL EQUIPMENT CO.,LTD LINA YUN
K150942 11/25/2015 Contour Next USB Blood Glucose Monitoring System BAYER HEALTHCARE JENNIFER L. GREGORY
K152057 11/24/2015 OsteoCool V-3 RF Ablation System BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K142363 01/09/2015 NUSTAT, NUSTAT XR Beeken Biomedical Richard Kendall
K141024 01/13/2015 EXTERNAL PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Diana Hong
K150963 11/05/2015 AnsCare ChitoClot Pad BENQ MATERIALS CORPORATION Kenix Chang
K151469 11/25/2015 CORVUS Radiation Therapy Planning System BEST NOMOS VINEET GUPTA
K150388 11/12/2015 Dental Implant System BIO CONCEPT CO., LTD HUA CAO
K151903 11/06/2015 Slendertone connect Abs BIO-MEDICAL RESEARCH LTD. ANNE-MARIE KEENAN
K141114 01/09/2015 BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D Bio-Rad Laboratories Juang Wang
K151692 11/20/2015 BioArchitects Patient Specific Cranial/Craniofacial Plate BioArchitects USA, LLC Mark E. Ulrich
K141830 01/23/2015 STIMULAN KIT, STIMULAN RAPID CURE BIOCOMPOSITES LTD. MARIE WHALLEY
K141132 01/09/2015 ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT BIOFILM, INC. Sherry Castello
K143178 01/30/2015 FilmArray 2.0 System BioFire Diagnostics, LLC Kristen Kanack, PhD
K143171 01/30/2015 FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 Biofire Diagnostics, LLC. Kristen Kanack, PhD
K142828 01/15/2015 osteoSPAN Morpheus BIOGENNIX Edwin Clayton Shors
K143022 01/08/2015 BioHorizons Tapered Internal Implants BIOHORIZONS IMPLANT SYSTEMS, INC. Michael Davis
K143023 01/16/2015 Nitinol Compression Plating System BioMedical Enterprises, Inc. Joe Soward
K143543 01/30/2015 Prelude PF Patellae BIOMET INC. JARED COOPER
K143037 01/20/2015 SnapShot Fixation System BIOMET MANUFACTURING CORP. Adam Cargill
K151019 11/03/2015 SternaLock« 360 Sternal Closure System BIOMET MICROFIXATION LAUREN JASPER
K151974 11/13/2015 Polaris Spinal System BIOMET SPINE ALEXANDRA BECK
K150571 11/20/2015 3i T3 Short Implants BIOMET3I CHRIS MCKEE
K151296 11/19/2015 Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) BIOS S.R.L. RICCARDO PISATI
K133733 01/28/2015 WINSIX Implant System BIOSAF IN S.R.L. MAURIZIO PANTALEONI
K153102 11/23/2015 QuadraSphere Microspheres BIOSPHERE MEDICAL, S.A. Alix Fonlladosa
K142276 01/16/2015 MCS Bone Graft BIOSTRUCTURES, LLC John Brunelle, Ph.D.
K143298 01/16/2015 Ultrasound Scanner System bk2300 BK MEDICAL APS RANDI HAUERBERG
K143006 01/16/2015 GUARDIAN-SG Inflatable Bone Expander System BM KOREA CO., LTD. June Han
K152853 11/20/2015 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary BOSTON SCIENTIFIC CORP. CARAH KUCHARSKI
K143587 01/15/2015 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire BOSTON SCIENTIFIC CORPORATION NIKKI M WAHLBERG
K151315 11/10/2015 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle BOSTON SCIENTIFIC CORPORATION YINGYING GAO
K153049 11/13/2015 LithoVue System BOSTON SCIENTIFIC CORPORATION JEANNE O'TOOLE
K142922 01/16/2015 SpyGlass DS Direct Visualization System BOSTON SCIENTIFIC CORPORATION CARTER NAVARRO
K152570 11/02/2015 Bovie J-Plasma Precise 360 Handpiece BOVIE MEDICAL CORPORATION BRIAN KUNST
K143151 01/26/2015 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) BSN MEDICAL GMBH MARTIN SPENGLER
K143040 01/15/2015 Exilis XP BTL INDUSTRIES INC Jan Zarsky
K150353 11/13/2015 BTL-4000 BTL INDUSTRIES, INC Jan Zarsky
K150514 11/20/2015 Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters C.R. Bard, Inc. James R. Davis
K143522 01/12/2015 Presto Inflation Device C.R. BARD, INC. TIMOTHY WADE
K143490 01/26/2015 VERTA Corpectomy Cage CAMBER SPINE Daniel A. Pontecorvo
K143718 01/22/2015 Mammography Color Display DP-M3010 CANON INC. MASAKI TAMURA
K143199 01/29/2015 Capillus 272 Pro Capillus, LLC Frances Pina Brea
K142030 01/23/2015 STGC-LORDOTIC CARDINAL SPINE, LLC KEVIN A. THOMAS
K141465 01/09/2015 CARDIOGARD EMBOLI PROTECTION CANNULA CARDIOGARD MEDICAL LTD SHEILA H HEYER
K151125 11/24/2015 AVAflex Vertebral Balloon System CAREFUSION Joy Greidanus
K141722 01/23/2015 CAREFUSION GOLD TISSUE MARKER CAREFUSION JOY GREIDANUS
K142529 01/08/2015 Genesis Reusable Rigid Container System CareFusion 2200 Inc Jane Weber
K142862 01/16/2015 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). Careplus (M) SDN BHD Lim Kwee Shyan
K153058 11/10/2015 CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. LEILEI LI
K153142 11/25/2015 Carestream DRX-1 System with DRX Plus 4343 Detectors CARESTREAM HEALTH, INC. VICTORIA WHEELER
K150397 11/09/2015 Divine 9 CarraShield Labs, Inc. Dean Fresonke
K151638 11/13/2015 Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter Cathera, Inc. Victor Ham
K143392 01/23/2015 Quattro Bolt Tenodesis Screw CAYENNE MEDICAL, INC Shima Hashemian
K133412 01/08/2015 S200, S300 CEFLA S.C. BERTHOIN CLAUDE
K143247 01/22/2015 Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) CENTRAL MEDICARE SDN BHD TH Chong
K141400 01/28/2015 DCCERAM SYSTEM CERAMAY GMBH & CO.KG PAMELA PAPINEAU, RAC
K150684 11/18/2015 WASTON General Spinal System CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD Jack Lu
K142655 01/26/2015 CB PROT II Posterior Spinal System CHIN BONE TECHNIQUE CORP CHENG-KUNG CHENG
K143396 01/23/2015 omni TRAX Active Patient Tracker CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions Amanda Stahle
K141608 01/16/2015 COLLAGEN DURA MEMBRANE COLLAGEN MATRIX, INC. PEGGY HANSEN
K150825 11/20/2015 Collagen Dural Regeneration Matrix COLLAGEN MATRIX, INC. GLORIA ZUCLICH
K143182 01/20/2015 Speedicath Compact Male COLOPLAST A/S Brian Schmidt
K141685 01/26/2015 CROC COMBAT MEDICAL SYSTEMS, LLC Calley Herzog
K142825 01/20/2015 Zmachine CONSOLIDATED RESEARCH OF RICHMOND, INC Richard Kaplan
K133130 01/09/2015 BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER COOK, INC. DAVID E CHADWICK, PHD., RAC
K140893 01/03/2015 CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY CORAMED TECHNOLOGIES, LLC NORMAN E BRUNNER
K143412 01/14/2015 ADROIT Guiding Catheter CORDIS CORPORATION BABU PERIASAMY
K150550 11/24/2015 SilverCoat Silicone Foley Catheter COVALON TECHNOLOGIES, INC. Kim Crooks
K142929 01/27/2015 Ligasure Blunt Tip Sealer/Divider COVIDIEN CELSO DURAN
K142335 01/14/2015 RapidVac Smoke Evacuator System COVIDIEN JOSE MARQUEZ
K142656 01/29/2015 Surgical Gut Suture COVIDIEN Mary Mellows
K151376 11/05/2015 superDimension Navigation System Covidien LLC Jenny Jiang
K143625 01/15/2015 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K141354 01/30/2015 NAVAJO PTA BALLOON DILATATION CATHETER CURATIVE MEDICAL INC. BILL JACQMEIN
K143317 01/20/2015 Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) Currie Medical Specialties, Inc. Owen J. Bry
K141511 01/23/2015 SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS CYNOSURE, INC. HUDA YUSUF
K152349 11/23/2015 Star+ VPS Scannable Impression Material DANVILLE MATERIALS LLC DONG HUA
K151682 11/17/2015 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Daxwell, LLC Frank Zhang
K142106 01/18/2015 DECISIO HEALTH PATIENT DASHBOARD DECISIO HEALTH, INC. RONALD S WARREN
K143310 11/19/2015 MoisturemeterD DELFIN TECHNOLOGIES LTD. Theodore Sullivan
K142932 01/22/2015 Deltex Medical KDP72 Doppler Probe DELTEX MEDICAL LIMITED Paul Dwane
K150985 11/19/2015 Medihoney Wound Gel DERMA SCIENCES, INC. SHARMINI ATHERAY
DEN140038 01/23/2015 Dexcom Share Direct Secondary Displays DEXCOM, INC. Andrew K Balo
K133178 11/24/2015 LUXATOR LX HANDPIECE DIRECTA AB HENRIC KARSK
K142229 01/02/2015 Laparoscopic FMsealer DOMAIN SURGICAL, INC. CURTIS JENSEN
K142475 01/15/2015 EVS 4343 DRTECH Corporation Choul-Woo Shin
K152110 11/20/2015 e-1 etchants E DENTAL PRODUCTS JEFF BANYAS
K142107 01/21/2015 ECHO TRUE 3D VIEWER ECHO PIXEL INC. SERGIO AGUIRRE
K153023 11/06/2015 Ablatherm Integrated Imaging EDAP TECHNOMED, INC. MARC OCZACHOWSKI
K151414 11/20/2015 IQQA Guide EDDA TECHNOLOGY XIAOLAN ZENG
K152225 11/24/2015 Edwards eSheath Introducer Set EDWARDS LIFESCIENCES KAREN REYNOLDS
K141206 01/16/2015 EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM EDWARDS LIFESCIENCES LLC. Nina Brooke
K152762 11/23/2015 Fogarty Occlusion Catheter EDWARDS LIFESCIENCES, LLC. Naren Murugan
K142749 01/18/2015 TruWave Disposable Pressure Transducer EDWARDS LIFESCIENCES, LLC. ANDREW S. MAZURKIEWICZ
K152713 11/20/2015 8MP Color LCD Monitor, RadiForce RX850, RX850-AR EIZO CORPORATION HIROAKI HASHIMOTO
K142599 01/16/2015 PRECISE Trauma Nail System Ellipse Technologies, Incorporated Rebecca Shelburne
K142155 01/20/2015 ENDOCHOICE WATER BOTTLE CAP SYSTEM ENDOCHOICE, INC. DANIEL HOEFER
K152580 11/03/2015 rescuenet ENDOCHOICE, INC. DANIEL HOEFER
K141615 01/07/2015 ENDOPHYS BLOOD PRESSURE MONITOR ENDOPHYS, INC. RONALD S WARREN
K141275 01/07/2015 ENDOPHYS PRESSURE SENSING SHEATH KIT ENDOPHYS, INC. RONALD S WARREN
K152435 11/20/2015 PassAssist LED Light Fiber ENTELLUS MEDICAL, INC. KAREN E. PETERSON
K152434 11/20/2015 XprESS Multi-Sinus Dilation System ENTELLUS MEDICAL, INC. KAREN E. PETERSON
K142773 01/22/2015 EOS System EOS IMAGING Karine Chevrie
K142207 01/23/2015 TransferMan 4m Micromanipulator EPPENDORF AG CORNELIA HILDEBRANDT
K150219 11/05/2015 Equashield Closed System drug Transfer Device (CSTD) EQUASHIELD MEDICAL LTD Raymond J Kelly
K141986 01/30/2015 ELUX 810 LASER EQUIPMED NORTH AMERICA, INC. JIM BARLEY
K143007 01/15/2015 Erchonia Zerona Z6 OTC ERCHONIA CORPORATION Steve Shanks
K152490 11/25/2015 DERMABOND PRINEO Skin Closure System ETHICON, INC. DONNA MARSHALL
K140547 01/22/2015 EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM EXCERA ORTHOPEDICS, INC. TIM M LOHNES
K152183 11/02/2015 EXELINT SecureTouch Safety Hypodermic Needle EXELINT INTERNATIONAL CO. Navid Hamid
K143129 01/29/2015 easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler;Loading Unit) EziSurg Medical Co.,Ltd. Johnny Yan
K151470 11/02/2015 Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus FIRST QUALITY HYGIENIC, INC. Melanie Leibowitz
K143124 01/26/2015 KA01 Chitosan Wound Dressing FOSHAN UNITED MEDICAL TECHNOLOGIES LTD. JOHN CEN
K133187 01/08/2015 FREERIDER FR1, models FR1-13, FR1-15, FR1-17 FREERIDER CORP AARON CHANG
K152953 11/05/2015 CRIT-LINE CLIP (CLIC) BLOOD CHAMBER FRESENIUS MEDICAL CARE NORTH AMERICA Denise Oppermann
K152138 11/05/2015 FDR D-EVO GL Flat Panel Detector System FUJIFILM MEDICAL SYSTEM U.S.A., INC. Katherine Y Choi
K152983 11/12/2015 FUJIFILM SonoSite iViz Ultrasound System FUJIFILM SONOSITE,INC. PATRICIA LIAU
K151378 11/24/2015 Lumipulse G HE4 Immunoreaction Cartridges, Lumipulse G HE4 Calibrators Fujirebio Diagnostics, Inc. Diana Dickson
K150488 11/13/2015 Humelock II Reversible Shoulder System FX SOLUTIONS Jean-Jacques Martin
K143452 01/29/2015 LOGIQ P9, LOGIQ P7 GE HEALTHCARE BRYAN BEHN
K142840 01/07/2015 Unity Network ID GE HEALTHCARE Robert Casarsa
K152567 11/06/2015 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System GE Healthcare Ayesha Pergadia
K150298 11/12/2015 Entropy Module, E-ENTROPY-01 GE HEALTHCARE FILAND OY JOEL KENT
K152758 11/18/2015 Venue 50 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS TRACEY ORTIZ
K152242 11/24/2015 G3? Active Plate« Large Fragment System GENESIS FRACTURE CARE, INC. MICHAEL BOTTLANG
K143633 01/30/2015 CREO Stabilization System GLOBUS MEDICAL INC. Kelly J. Baker
K151504 11/16/2015 ICS Impulse GN OTOMETRICS ANDERS RASMUSSEN
K150358 11/12/2015 Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K150094 11/19/2015 Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon Vanilla Good Clean Love, Inc. Wendy Strgar
K143497 11/04/2015 Safety Auto-Disable Syrine with Needle (Auto-Lock) GUANGDONG INTMED MEDICAL APPLIANCE CO., LTD HU YIHAN
K140265 01/23/2015 ELECTRODE FOR URINARY INCONTINENCE GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD FIELD FU
K150923 11/06/2015 Breast Pump Guangzhou Jinxinbao Electronic Co.,Ltd Jiacheng Guo
K143535 01/13/2015 CR3 Keyless Split Sample Cup Secobarbital- Methadone GUANGZHOU WONDFO BIOTECH CO., LTD. Ben Chen
K152495 11/23/2015 Wondfo Propoxyphene Urine Test Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K142350 01/08/2015 PK J-HOOK GYRUS ACMI INC. NEIL KELLY
K142759 01/13/2015 PK Cutting Forceps for ESG-400 Workstation GYRUS ACMI, INC. DOLAN MILLS
K141892 01/28/2015 QK-SYSTEMIC THERAPEUTIC APPARATUS HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. WANG XIANGLIN
K152838 11/24/2015 HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 HARDY DIAGNOSTICS WENDY HADLEY
K152846 11/24/2015 HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 HARDY DIAGNOSTICS WENDY HADLEY
K143187 01/27/2015 Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) Healgen Scientific LLC Jianqiu Fang
K151656 11/25/2015 HEARTWAY Power Mobility Scooter HEARTWAY MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K142703 01/15/2015 Powder-free PVC Vinyl Exam Gloves Hebei Grandeast Plastic Products Co., Ltd. Wei Liu
K142837 01/29/2015 HEINE SIGMA 250 & HEINE SIGMA 250 M2 HEINE Optotechnik GmbH & Co. KG Bettina Seim
K150916 11/10/2015 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO HemCon Medical Technologies, Inc. Jody Oyama
K142348 01/23/2015 OsteoSeal Bone Hemostat HEMOSTASIS, LLC Bernard Horwath
K151679 11/27/2015 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) HEZE YUZE GLOVE CO., LTD LILY ZHU
K152661 11/16/2015 HICAT Air HICAT GmbH Frederik Kunze
K142368 01/14/2015 NOBLUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI ALOKA MEDICAL, LTD. ANGELA VAN ARSDALE
K152592 11/02/2015 PROBEAT-V Hitachi, Ltd.,Health Care Company NAOYA NISHIMURA
K141921 01/16/2015 HIVOX SPOPAD EMS HIVOX BIOTEK, INC. Ke-Min Jen
K143594 01/09/2015 VaPro Pocket Hollister Incorporated Jeanne Lee
K152723 11/13/2015 Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices HOLOGIC, INC CATHERINE EATON
K153219 11/20/2015 ProFlu+ Assay HOLOGIC, INC. RON DOMINGO
K142974 01/09/2015 Extension Sets Hospira, Inc David Blonski
K142622 01/15/2015 IV Administration HOSPIRA, INC. DAVID BLONSKI
K141789 01/16/2015 PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE HOSPIRA, INC. Yuliya Matlin
K150528 11/25/2015 Cortisol Saliva Luminescence Immunoassay IBL INTERNATIONAL GMBH NICOLA KAISER
K142057 01/13/2015 INFIX CANNULATED SCREW SYSTEM INFIX MEDICAL LLC JAMES C HOLLEY
K142952 01/13/2015 InMode Diolaze Device INMODE MD LTD. Ahava Stein
K150799 11/19/2015 Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula INNOVACYN, INC. Victor Torcat Mallen
K153150 11/24/2015 AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 Inova Diagnostics, Inc. Gabriella Lakos
K141210 01/29/2015 QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K140722 01/06/2015 INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS INTEGRA LIFESCIENCES CORPORATION JANET KAY
K151819 11/10/2015 Integrity Spine Lumbar Interbody Fusion System INTEGRITY SPINE LUMBAR INTERBODY FUSION SYSTEM LISA PETERSON
K142939 01/13/2015 Revolution Spinal Fixation System INTELLIGENT IMPLANT SYSTEMS, LLC Michael Nutt
K141783 01/09/2015 TDX SP2 POWER WHEECHAIR INVACARE CORPORATION DOUG UELMEN
K153073 11/16/2015 UroNav (Version 2.0) INVIVO CORPORATION Kenneth Revennaugh
DEN150008 11/02/2015 INVOcell INVO BIOSCIENCE Kathleen Karloff
K143154 01/02/2015 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) IRIDEX CORPORATION PAUL H HARDIMAN
K143142 11/06/2015 JDENTALCARE Implant System J DENTAL CARE S.r.l Giacomo Grandi
K141861 01/07/2015 HILTHERA 4.0 JEISYS MEDICAL, INC. Priscilla Chung
K142957 01/30/2015 Ideal pedicle screw spinal system JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. Wei Li
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K142838 01/20/2015 Synapse Occipital-Cervical-Thoracic (OCT) System SYNTHES USA PRODUCTS, LLC KATE LAROSE
K150259 11/06/2015 CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L TAIWAN SURGICAL CORPORATION Hsiu-Ping Huang
K143189 01/09/2015 t:flex Insulin Delivery System Tandem Diabetes Care, Inc. John Sheridan
K140984 01/12/2015 TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM TANGO3, LLC LORI HOLDER
K141379 01/16/2015 VICTUS FEMTOSECOND LASER PLATFORM TECHNOLAS PERFECT VISION GMBH KEN NEHMER
K143299 01/21/2015 Percuvance(R) Percutaneous Surgical System Teleflex Medical, Inc. Holly Hallock
K150603 11/27/2015 Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Teleflex Medical, Inc. Lori Pfohl
K142500 01/29/2015 One Way Soft Valve Terumo Cardiovascular Systems Corporation Suzanne Grenier
K151791 11/19/2015 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
K152525 11/10/2015 TR BAND Radial Compression Device TERUMO MEDICAL CORPORATION LIANG LU
K141448 01/23/2015 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM TEVA MEDICAL LTD., MIGADA PLANT ROGER L GRAY
K151759 11/06/2015 Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS THE BINDING SITE GROUP LTD. STEPHANIE THOULESS
K151816 11/19/2015 TLC-2000 Therapeutic Medical Laser System Theralase Inc. Roger Dumoulin-White
K140264 01/05/2015 MADM THORNHILL RESEARCH INC. CLIFF ANSEL
K142940 01/28/2015 Endoskeleton TCS System TITAN SPINE, LLC Jane Rodd
K141070 01/15/2015 SUPER SHEATH TOGO MEDIKIT CO., LTD. IZUMI MARUO
K143059 01/26/2015 TAMTEC-HANA TENS / EMS (Sport Muscle Stimulator) TONE-A-MATIC INTERNATIONAL INC. MANUEL CHUCK
K151673 11/27/2015 Aquilion ONE Vision with FIRST 1.0 (CCRS-001A) TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K143223 01/12/2015 CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K143225 01/09/2015 INFX-8000V with Wireless Footswitch TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K143281 01/29/2015 Ultimax-i TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K152785 11/25/2015 XIDF-AWS801, Angio Workstation, V6.20 TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K143113 01/28/2015 Klassic BiPolar System Total Joint Orthopedics Chris Weaber
K153075 11/13/2015 Klassic Knee System TOTAL JOINT ORTHOPEDICS, INC. Chris Weaber
K134051 01/29/2015 TRANSONIC ELSA SYSTEM TRANSONIC SYSTEMS, INC. NAVEEN THURAMALLA
K151034 11/21/2015 PainKARE TrioWave Technologies Huiyou Zhu
K152019 11/16/2015 HairMD TROPHY SKIN, INC. IMRAN KARIM
K143311 01/15/2015 Pre-vacuum Tabletop Autoclave TUTTNAUER USA CO. LTD. Robert Basile
K153180 11/25/2015 Tyber Medical MST Trauma Screw TYBER MEDICAL LLC Mark F. Schenk
K150386 11/05/2015 Tyece OTC TENS Device TYECE LTD Parshid Falahati
K152678 11/17/2015 TYRX Neuro Antibacterial Envelope TYRX, INC. REGINA NOVAK
K151344 11/19/2015 Cytoflex Tefguard Ti-Enforced Membrane Unicare Biomedical, Inc. Stan Yang
K142553 01/14/2015 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle UNISIS CORP. Tadashi Yasuda
K152255 11/16/2015 BoneCam Suture Anchors VALERIS MEDICAL DANIEL LANOIS
K140359 01/07/2015 MAXIMIS SPINAL FIXATION SYSTEM VALOREM SURGICAL PATRICK MOORE
K152761 11/25/2015 Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) VARIAN MEDICAL SYSTEMS, INC. MARCIA PAGE
K142136 01/08/2015 ACCUCATH MIDLINE CATHETER SYSTEM VASCULAR PATHWAYS, INC. SCOTT PEASE
K151234 11/18/2015 R350 guidewire VASCULAR SOLUTIONS, INC. BEKA VITE
K140852 01/30/2015 VECTRAPLEX CMS VECTRACOR, INC BRAD S SCHRECK
K142059 01/09/2015 FOX MOBILE VECTURA GMBH PAUL DRYDEN
K142946 01/08/2015 TIVA Velano Vascular, Inc. Tiffini Diage
K153101 11/19/2015 BladderScan Prime System VERATHON INCORPORATED Rhonda M Kops
K152518 11/30/2015 Vonflex S Putty VERICOM CO., LTD MYUNG-HWAN OH
K152822 11/25/2015 VidiStar HeartView VIDISTAR, LLC CRAIG WALKER
K150211 11/10/2015 EzFuze Implant System VILEX IN TENNESSEE, INC. SYLVIA SOUTHARD
K141561 01/16/2015 VM PACS WITH VM MEDICAL WORKSTATION VISUAL MEDICA MELISSA LLABRES GRAU
K143549 01/14/2015 Vivorte Trabexus VIVORTE, INC ROBERT BURDEN
K143547 01/14/2015 Vivorte Trabexus EB VIVORTE, INC Robert Burden
K143486 01/07/2015 Ufi Gel hard C VOCO GMBH M.Th. Plaumann
K152829 11/19/2015 Visions PV.014P RX Digital IVUS Catheter Volcano Corporation Mary Stanners
K143704 11/23/2015 Advanced Air System W & H Dentalwerk Buermoos GmbH Anja Lindner
K152551 11/09/2015 First Sign« Drug of Abuse Buprenorphine Cup Test, First Sign« Drug of Abuse Buprenorphine Dip Card Test, First Sign« Drug of Abuse Butalbital Cup Test, First Sign« Drug of Abuse Butalbital Dip Card Test, First Sign« Drug of Abuse Morphine Cup Test, First W.H.P.M., INC. JOHN WAN
K143179 01/30/2015 The LINK« Endo-Model« Knee System Waldemar Link GmbH & Co. KG Helmut D. Link
K142233 01/05/2015 zenostar MO, Zenostar T, Zenostar VisualiZr WIELAND DENTAL + TECHNIK GMBH & CO. KG Betina Kistner
K142144 01/15/2015 DISPOSABLE INJECTION NEEDLE WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED LIJUAN ZHANG
K143460 01/23/2015 Cannulated Screw System WRIGHT MEDICAL TECHNOLOGY, INC. Tara Conrad
K143220 01/08/2015 SIDEKICK EZ FRAME External Fixation System WRIGHT MEDICAL TECHNOLOGY, INC. Leslie Fitch
K142075 01/08/2015 BI-FUNNEL GASTROSTOMY FEEDING TUBE, TRI-FUNNEL GASTROSTOMY FEEDING TUBE XERIDIEM (FORMERLY MRI) JESUS VALENCIA
K142297 01/08/2015 Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set XERIDIEM (FORMERLY MRI) Jesus Valencia
K151764 11/23/2015 YAMAHACHI PMMA DISKS YAMAHACHI DENTAL PRODUCTS USA, INC. LAWRENCE G. GREENWALD
K152514 11/18/2015 Clickfine AutoProtect Pen Needle YPSOMED AG STEPHAN AFFOLTER
K142283 01/16/2015 Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color) YTY INDUSTRY (MANJUNG) SDN. BHD. Arivalagan Subramaniam
K143190 01/16/2015 Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
K142491 01/26/2015 ZEL TIQ CoolSculpting System ZELTIQ AESTHETICS, INC. SHRUTI JAYAKUMAR
K142539 01/08/2015 EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set ZEVEX, INC. Dianne Batch
K142572 01/21/2015 Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System Zimmer Dental, Inc. Christina Boydston
K151992 11/02/2015 FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control ZIMMER, INC. PATRICK MCCULLAGH
K152494 11/25/2015 Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments ZIMMER, INC. MARK D WARNER
K152841 11/24/2015 Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws ZIMMER, INC. DOROTHY SNYDER
K133239 01/16/2015 ZOLL E SERIES ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS TANMAY B SHUKLA
K141549 01/15/2015 SImmetry Sacroiliac Joint Fusion System Zyga Technology, Inc. Diane Brinza


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