FDA 510(k) Applications Received During December, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K143573 12/17/2014 Audit MicroControls Linearity FD Tumor Markers II AALTO SCIENTIFIC LTD. Robert Burda
K143571 12/17/2014 Audit MicroControls Linearity LQ Cystatin-C AALTO SCIENTIFIC, LTD. ROBERT BURDA
K143434 12/01/2014 One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series ABBOTT MEDICAL OPTICS INC Nooshin Azizi
K143613 12/19/2014 PaxWire Occlusion Balloon System ACCESSCLOSURE, INC. Kelly Jabbal
K143541 12/15/2014 Relieva SpinPlus Balloon Sinuplasty System ACCLARENT, INC. Pavan Sethi
K143450 12/02/2014 Ackermann Intervertebral Body Fusion Device ACKERMANN INSTRUMENTE GMBH Rolf Ackermann
K143449 12/02/2014 ADH 200 Analyzer Software ADAMS MEDITECH LLC CECILIA L. YU
K143719 12/29/2014 Aeroneb USB Contoller System Aerogen Limited Martin Crehan
K143443 12/02/2014 VEGA Knee System, Columbus Total Knee System Aesculap Implants Systems, LLC Julie Tom Wing
K143729 12/29/2014 SterilContainer S AESCULAP, INC. Denise R Adams
K143740 12/30/2014 Battalion Universal Spacer System ALPHATEC SPINE, INC. Nadine Smith
K143604 12/18/2014 Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S BASAK DEMIRCI
K143518 12/12/2014 Valeo Spacer System and Valeo II Interbody Fusion Device System Amedica Corp. William D. Jordan
K143580 12/18/2014 PeriCoach ANALYTICA LTD GEOFF DALY
K143757 12/31/2014 ANUTRA Feedback Aspiration Syringe ANUTRA MEDICAL, INC. CAMERON PERKINS
K143750 12/31/2014 MEG-2B Blood Glucose Monitoring System, MEG-2B Pro Blood Glucose Monitoring System APEX BIO TECHNOLOGY CORP Hsue-Mei Lee
K143536 12/15/2014 Voyant Fine Fusion Device APPLIED MEDICAL RESOURCES JESSICA CHO
K143517 12/12/2014 Voyant Open Sealer-Divider Device APPLIED MEDICAL RESOURCES Jessica Cho
K143702 12/24/2014 Arthrex Blunt Tip Screws with Fiber Tape Arthrex, Inc. David L Roger
K143745 12/31/2014 Arthrex Corkscrew and SwiveLock Suture Anchors Arthrex, Inc. David L Rogers
K143749 12/31/2014 Arthrex Distal Radius System Arthrex, Inc. Laura Medlin
K143614 12/19/2014 Arthrex Low Profile Screws ARTHREX, INC. David L Rogers
K143519 12/12/2014 The MeDioStar NeXT Family ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K143632 12/22/2014 Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens Bausch & Lomb Incorporated Jessica Burger
K143538 12/15/2014 MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit BAYER MEDICAL CARE INC. LISA A. EWING
K143610 12/19/2014 BD INTIMA II CLOSED IV CATHETER Becton Dickinson Infusion Therapy Systems Inc. John Roberts
K143648 12/22/2014 BD MAX Enteric Parasite Panel, BD MAX Instrument BECTON, DICKINSON AND COMPANY PAUL SWIFT
K143462 12/04/2014 AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use) BENQ MATERIALS CORPORATION Kenix Chang
K143715 12/29/2014 Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Better Plastic Co., Ltd. Du Wei
K143524 12/12/2014 Fiber Disks and Blocks (TRINIA) Bicon, LLC Richard Wu
K143492 12/08/2014 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA Judith Clerc
K143543 12/15/2014 Prelude PF Patellae BIOMET INC. JARED COOPER
K143697 12/24/2014 Biomet Proximal Humerus Plating System Biomet Manufacturing Julie Largent
K143503 12/10/2014 BioMonitor BIOTRONIK, INC. JON BRUMBAUGH
K143705 12/29/2014 NeedleCam HD Visualization System BIOVISION TECHNOLOGIES, LLC DAVID SANSO
K143668 12/24/2014 Navio BLUE BELT TECHNOLOGIES, INC. RICHARD G CONFER
K143587 12/18/2014 ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire BOSTON SCIENTIFIC CORPORATION NIKKI M WAHLBERG
K143643 12/22/2014 Brainscope Ahead 200 BRAINSCOPE COMPANY, INC. Michael E Singer
K143559 12/16/2014 XP1000 RF BTL INDUSTRIES, INC Jan Zarsky
K143743 12/31/2014 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH C.R. Bard Inc. FELICIA RULEY
K143522 12/12/2014 Presto Inflation Device C.R. BARD, INC. TIMOTHY WADE
K143490 12/08/2014 VERTA Corpectomy Cage CAMBER SPINE Daniel A. Pontecorvo
K143718 12/29/2014 Mammography Color Display DP-M3010 CANON INC. MASAKI TAMURA
K143496 12/09/2014 Piccolo Composite Plate System CarboFix Orthopedics Ltd. Yael Rubin
K143714 12/29/2014 Powerheart G5 AED CARDIAC SCIENCE CORPORATION Kathleen Roberts
K143432 12/01/2014 Cardio-TriTest CARDIO-PHOENIX INC. MARC BISNAIRE
K143675 12/24/2014 FORE-SIGHT Elite Absolute Tissue Oximeter CAS MEDICAL SYSTEMS, INC. Ron Jeffrey
K143473 12/05/2014 Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles CAYENNE MEDICAL, INC Shima Hashemian
K143599 12/18/2014 Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000 Chemtron Biotech, Inc. Jane Zhang
K143758 12/31/2014 PerioType Rapid CLINICAL HOUSE EUROPE GMBH Judi Weissinger
K143725 12/29/2014 Consensus Knee System Modular Tibial Baseplate Consensus Orthopedics, Inc Matthew M Hills
K143650 12/23/2014 CooperSurgical Advincula Delineator Uterine Manipulator Cooper Surgical Inc. James Keller
K143506 12/10/2014 BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL COVIDIEN TIMOTHY HOLWICK
K143644 12/22/2014 Premium Surgiclip?; Endo Clip?; AcuClip? COVIDIEN Michael Koczocik
K143598 12/18/2014 Lapro-Clip Auto Suture Reusable Long Clip Applier Covidien LLC Rebecca Magnanimo
K143654 12/23/2014 Valleylab LS10 Generator COVIDIEN LLC DONALD HENTON
K143520 12/12/2014 SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) CROSSTEX Michael G Nolan
K143625 12/22/2014 truFreeze System CSA MEDICAL, INC. SHERRIE COVAL-GOLDSMITH
K143530 12/12/2014 Aespire View Datex-Ohmeda, Inc. Michelle Huettner
K143679 12/24/2014 Nuance FLOW Den-Mat Holdings, LLC Helen Ragus
K143475 12/05/2014 VAPR Tripolar Suction Electrode Depuy Mitek Susan Kagan
K143660 12/23/2014 Milagro / Milagro Advance Interference Screw DEPUY MITEK, A JOHNSON & JOHNSON COMPANY Yayoi Fujimaki
K143677 12/24/2014 DeVilbiss Intellipap2/DeVilbiss BLUE DeVilbiss Healthcare, LLC Betty Miller
DEN140038 12/15/2014 Dexcom Share Direct Secondary Displays DEXCOM, INC. Andrew K Balo
K143586 12/18/2014 FACT Medical Imaging Sysytem Dexin Medical Imaging Technology Co., Ltd. Wang Yu
K143551 12/15/2014 Compex Wireless USA DJO, LLC GINA FLORES
K143430 12/01/2014 SmartTENS EASYMED INSTRUMENT CO., LTD. Jeffery Wu(Tingjie Wu)
K143695 12/24/2014 CENTRAL MONITORING SYSTEM EDAN INSTRUMENTS INC QUEENA CHEN
K143645 12/22/2014 EsophyX« Z Fastener Delivery Device ENDOGASTRIC SOLUTIONS, INC. DARREN CROW
K143557 12/15/2014 SupaScoota Motorized vehicle EUROGREEN INTERNATIONAL INC DAVID HSIEH
K143659 12/23/2014 Equinoxe Mega Prosthesis EXACTECH, INC. Thomas McNamara
K143576 12/17/2014 Exactech Ambassador EXACTECH, INC. DAWN DAVISSON
K143666 12/23/2014 Noblex Long Pulse Alexandrite Laser FINEMEC CO.,LTD. GHUN HEE LEE
K143646 12/22/2014 MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit Fisher & Paykel Healthcare Ltd Elizabeth Goldstein
K143484 12/08/2014 BioZorb Marker FOCAL THERAPEUTICS George Hermann
K143651 12/23/2014 Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack FOCUS DIAGNOSTICS, INC. Sharon Young
K143723 12/29/2014 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro FOTONA D.D. STOJAN TROST
K143556 12/15/2014 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T FUJIFILM MEDICAL SYSTEMS U.S.A., INC. MARY MOORE
K143732 12/29/2014 FUJIFILM Endoscope Models EC-600HL and EC-600LS FUJIFILM Medical Systems U.S.A., Inc. Mary Moore
K143721 12/29/2014 PRCT2 FX SOLUTIONS JEAN JACQUES MARTIN
K143564 12/16/2014 Visual-ICE Cryoablation System, Software Revision 1.3.1 GALIL MEDICAL INC. AMY MCKINNEY
K143570 12/17/2014 WIRION GARDIA MEDICAL OHAD HAAS
K143667 12/23/2014 GC KommonBase GC Orthodontics America Inc. Tom Macari
K143452 12/02/2014 LOGIQ P9, LOGIQ P7 GE HEALTHCARE BRYAN BEHN
K143676 12/24/2014 B40i Patient Monitor GE HEALTHCARE FINLAND OY JOEL KENT
K143574 12/17/2014 Melodi Prime Breast Pump Genadyne Biotechnologies, Inc. Chien Ming GOH
K143726 12/29/2014 XLR8 PLUS (XLR8+) GENADYNE BIOTECHNOLOGIES, INC. CHIEN MING GOH
K143591 12/18/2014 Dorsal Appliance GERGENS ORTHODONTIC LAB Chris Morrison
K143438 12/02/2014 Flowtron ACS900 Getinge (Suzhou) Co., Ltd Lenda Hou
K143633 12/22/2014 CREO Stabilization System GLOBUS MEDICAL INC. Kelly J. Baker
K143527 12/12/2014 IPM Wound Gel Bio, IPM Derm Gel Bio GLYCOBIOSCIENCES, INC Kevin Drizen
K143734 12/30/2014 Digital Automatic Blood Pressure Monitor BPM28 Series - MD2800, MD2810 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED Patrick Chow
K143735 12/30/2014 Digital Automatic Blood Pressure Monitor MD2300 Grandway Technology (Shenzhen) Limited Patrick Chow
K143733 12/30/2014 Digital Automatic Wrist Blood Pressure Monitor MD2400 Grandway Technology (Shenzhen) Limited Patrick Chow
K143535 12/15/2014 CR3 Keyless Split Sample Cup Secobarbital- Methadone GUANGZHOU WONDFO BIOTECH CO., LTD. Ben Chen
K143656 12/23/2014 StarCeram« Z-Nature, StarCeram« Z-Smile H.C. Starck Ceramics GmbH Alexandra Krausch
K143539 12/15/2014 Dental Implant OKTAGON Bone Level Hager & Meisinger GmbH Wiebke Stolten
K143537 12/15/2014 Sirius Starmobile tiara HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLEWAITE
K143737 12/30/2014 EM25 - glute toning device HIVOX BIOTEK, INC. CLYTIE CHIOU
K143594 12/18/2014 VaPro Pocket Hollister Incorporated Jeanne Lee
K143437 12/01/2014 Droplet Pen Needles HTL-STREFA S.A. Aleksandra Prazmowska-Wilanowska
K143431 12/01/2014 Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) i-codi Co., Ltd Yoo Hwan Park
K143736 12/30/2014 ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA IMMCO DIAGNOSTICS, INC. Kevin Lawson
K143500 12/10/2014 Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set Immunalysis Corporation Joseph Ginete
K143502 12/10/2014 Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls IMMUNALYSIS CORPORATION JOSEPH GINETE
K143731 12/29/2014 IMPLANET Spine System (ISS) IMPLANET S.A. Regis Le Couedic
K143759 12/31/2014 JAZZ System IMPLANET S.A. REGIS LE COUEDIC
K143563 12/16/2014 Infusion Aspiration Catheter System Inari Medical, Inc. Eben Gordon
DEN140039 12/15/2014 NOVA View Automated Fluorescense Microscope INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K143754 12/31/2014 QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 INOVA DIAGNOSTICS, INC. Gabriella Lakos
K143663 12/23/2014 MiroCam Capsule Endoscope System INTROMEDIC CO., LTD Jinyoung Lee
K143738 12/30/2014 DSS Sinusplasty Balloon Catheter Intuit Medical Products, LLC Jack Griffis
K143436 12/01/2014 InvisionECG System InvisionHeart Inc. Michael Wurst
K143513 12/11/2014 ZIO SR ECG Monitoring Service iRhythm Technologies, Inc. Rich Laguna
K143575 12/17/2014 Accu-Dent XD Tray, Accu-Dent XD Syringe IVOCLAR VIVADENT, INC. Donna Marie Hartnett
K143730 12/29/2014 GBR System JEIL MEDICAL CORPORATION HYEROUNG LEE
K143465 12/04/2014 MASTERmatic LUX Kaltenbach & Voigt Gmbh Stefan Trampler
K143640 12/22/2014 KSEA CMOS Camera System (C-cam) KARL STORZ ENDOSCOPY-AMERICA, INC. Susie S Chen
K143439 12/02/2014 KATANA Zirconia KURARAY NORITAKE DENTAL, INC. Michio Takigawa
K143487 12/08/2014 Lifelines iEEG KVIKNA EHF Gardar Thorvardsson
K143454 12/03/2014 Pruitt F3-S Carotid Shunt LeMaitre Vascular, Inc Xiang Zhang
K143498 12/10/2014 LifeGlobal Global HP LifeGlobal Group, LLC MICHAEL D CECCHI
K143509 12/11/2014 MasterSL femoral stem LIMACORPORATE S.P.A. STEPHEN J PEOPLES
K143531 12/12/2014 Rapid Therapy System MAGSTIM COMPANY LIMITED Charles Hounsell
K143635 12/22/2014 KINETIS Total Knee System MAKO SURGICAL JONATHAN REEVES
K143752 12/31/2014 Total Knee Application (TKA) MAKO SURGICAL CORP. JONATHAN REEVES
K143567 12/16/2014 NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for l MARVAO MEDICAL DEVICES, LTD. CHRISTOPHER DAVEY
K143453 12/03/2014 Mpact Double Mobility System Medacta International Adam Gross
K143662 12/23/2014 Bissinger Monopolar Forceps and Cables MEDAGENT, INC Franz Menean
K143688 12/24/2014 ASFORA ANTERIOR CERVICAL PLATE SYSTEM MEDICAL DESIGNS, LLC KRISTI VONDRA
K143485 12/08/2014 iGuide 2.1 MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K143447 12/02/2014 Dilapan-S Medicem Technology s.r.o. Adam Vlcek
K143634 12/22/2014 MUSE System MEDIGUS LTD. SHARON KANETY DERESH
K143529 12/12/2014 UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer MEDLINE INDUSTRIES, INC. JENNIFER MASON
K143480 12/08/2014 Euphora Rapid Exchange Balloon Dilatation Catheter MEDTRONIC INC. John Kilmartin
K143569 12/16/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC GREGORY MASCHEK
K143628 12/22/2014 Navigated Vertex Select Instruments MEDTRONIC SOFAMOR DANEK USA, INC Tejas Patel
K143471 12/05/2014 VERTEX Reconstruction System Medtronic Sofamor Danek USA, Inc Lee Grant
K143583 12/18/2014 Cathivex ?GV filter units MERCK MILLIPORE LTD. CHRIS PARR
K143429 12/01/2014 Passage Hemostasis Valve MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K143426 12/01/2014 Wound Matrix TF MIROMATRIX MEDICAL INC. Jeff Ross
K143457 12/03/2014 NeuroBlate System MONTERIS MEDICAL, INC. Brooke Ren
K143622 12/22/2014 dynaMX Compression Staple MX Orthopedics, Corp. Howard L. Schrayer
K143653 12/23/2014 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) NANOSPHERE, INC Noah Lermer
K143706 12/29/2014 FortiBridge Anterior Cervical Plate System Nanovis Spine LLC Matthew Hedrick
K143433 12/01/2014 Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm Natus Manufacturing Limited Michael Galvin
K143440 12/02/2014 Natus Quantum NATUS MEDICAL INCORPORATED SANJAY MEHTA
K143607 12/19/2014 I-Portal NOTC, VNG and VOG NEURO KINETICS, INC. J. Howison Schroeder
K143458 12/04/2014 Neurosplint Neurospectrum LLC David Kernan
K143507 12/10/2014 NFANT Feeding Solution NFANT Labs, LLC Lou Malice
K143703 12/29/2014 NICAL SMART MICRO CR system for intraoral dental images NICAL SPA ROBERTO NICCOLUCCI
K143678 12/24/2014 NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory NINEPOINT MEDICAL, INC. SCOTT BLOOD
K143608 12/19/2014 NovaCross Microcatheter Nitiloop Ltd. Michael A Daniel
K143523 12/12/2014 Airlock osteosynthesis plate system NOVASTEP Gilles AUDIC
K143684 12/24/2014 NuVasive Reline System NUVASIVE INCORPORATED OLGA LEWIS
K143641 12/22/2014 NuVasive NVM5 System NuVasive, Incorporated Jeremy Markovich
K143579 12/18/2014 NuVasive Sterilization Trays NuVasive, Incorporated Olga Lewis
K143595 12/18/2014 NuVasive(R) CCX-L Interbody System NuVasive, Incorporated Cynthia Adams
K143561 12/16/2014 ELM PTA Balloon Dilatation Catheter O'CONNELL REGULATORY CONSULTANTS, INC. Maureen O'Connell
K143590 12/18/2014 Alevicyn SG Antipruritic Gel OCULUS INNOVATIVE SCIENCES Brian W Martin
K143609 12/19/2014 Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter OLYMPUS SURGICAL TECHNOLOGIES AMERICA MARY ANNE PATELLA
K143463 12/04/2014 IS4/DF4 Port Plug Oscor Inc. Dorit Segal
K143572 12/17/2014 Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK Osteomed Implantes, LTDA Niderdani Ragonha
K143696 12/24/2014 Spirit PELTON & CRANE Frank Ray
K143606 12/19/2014 MultiBand SENSE PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Jan van de Kerkhof
K143488 12/08/2014 InFill Graft Delivery System PINNACLE SPINE GROUP, LLC Rebecca K Pine
K143435 12/01/2014 Planmed Verity PLANMED OY Lars Moring
K143515 12/11/2014 Inclusive« Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants PRISMATIK DENTALCRAFT, INC. Brandon Shepard
K143533 12/12/2014 FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE PROSIDYAN, INC. CHARANPREET S BAGGA
K143474 12/05/2014 Artemis Hand Held Imaging System QUEST MEDICAL IMAGING MARTIN HEUVELMANS
K143753 12/31/2014 Digital Dental Intra Oral Sensor, EzSensor Soft, EzSensor Bio Rayence Co., Ltd Kevin Kim
K143671 12/23/2014 Propeller Model 2014-D Sensor Reciprocal Labs David Hubanks
K143511 12/11/2014 K-Y BRAND TOUCH All-in-one Warming Caressing Creme and Personal Lubricant RECKITT BENCKISER ELIZABETH TORRE
K143532 12/12/2014 Durex Silicone Reckitt Benckiser LLC Elizabeth Torre
K143466 12/04/2014 Hemogrip Patch REMEDIUM TECHNOLOGIES, INC. JOHN GUSTIN
K143647 12/22/2014 Renovis Surgical Hip Replacement System Renovis Surgical Technologies, Inc. Anthony DeBenedictis
K143603 12/18/2014 Darlinghurst Vented, Darlinghurst NV-AAV RESMED LTD. Jean-Nicholas Boudaud
K143623 12/22/2014 Narval Brux RESMED SAS Larissa D'Andrea
K143694 12/24/2014 Rhondium One-Visit-Crown(OVC) Rhondium, Ltd. Greer Fricker
K143481 12/08/2014 IntellaMap Orion High Resolution Mapping Catheter RHYTHMIA MEDICAL, INC FRANK JURCZAK
K143476 12/05/2014 Digi-One RIMED LTD. AHAVA STEIN
K143446 12/02/2014 Accu-Chek FlexLink Plus infusion set Roche Diagnostics GmbH Alexander Ruegner
K143691 12/24/2014 LDLC3 LDL-Cholesterol Gen.3 Roche Diagnostics Operations (RDO) Noel B Mencias
K143534 12/12/2014 Elecsys CA-125 II assay ROCHE PROFESSIONAL DIAGNOSTICS LINDA MCCAMMACK
K143744 12/31/2014 MicroCross Catheter ROXWOOD MEDICAL, INC. GRACE LI
K143700 12/24/2014 CPAP Cannulaide Salter Labs Aurelia Brownridge
K143673 12/24/2014 CMOS Video Nasopharyngoscope System Schoelly Fiberoptic Gmbh Dr. Sandra Baumann
K143483 12/08/2014 MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING SEBIA Karen Anderson
K143585 12/18/2014 Electric Breast Pump SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD Jun Deng
K143472 12/05/2014 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K143655 12/23/2014 SICAT OPTIMOTION SICAT GMBH & CO. KG MANFRED BREUER
K143720 12/29/2014 Dimension Vista MMB Assay Siemens Healthcare Diagnostics Kathleen Dray-Lyons
K143639 12/22/2014 IMMULITE 2000 CEA Calibration Verification Material Siemens Healthcare Diagnostics Asha Gartland
K143504 12/10/2014 IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material Siemens Healthcare Diagnostics Inc. Sara Kastrup
K143687 12/24/2014 ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Fatima Pacheco
K143680 12/24/2014 ADVIA Centaur IgE Master Curve Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Fatima Pacheco
K143636 12/22/2014 IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. Donna Velasquez
K143493 12/09/2014 SignosRT Bladder Ultrasound System Signostics Ltd Stewart Bartlett
K143459 12/04/2014 Silk Road Acccess Catheter SILK ROAD MEDICAL, INC RICHARD M RUEDY
K143624 12/22/2014 Headless Compression Screw System SKELETAL DYNAMICS, LLC Ana M. Escagedo
K143512 12/11/2014 ActiSpec Activity Monitor SLEEP MODUS, INC. STANFORD P HUDSON
K143739 12/30/2014 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA SMITH & NEPHEW, INC. JEFF SPRAGUE
K143448 12/02/2014 Sonendo GentleWave System Sonendo, Inc. JENNY FAM
K143601 12/18/2014 U-Lite Sonoscanner SARL Bruno Richard
K143751 12/31/2014 Visi Mobile Monitoring System Sotera Wireless, Inc. Eben Gordon
K143683 12/24/2014 APEX-DL Spine System SPINECRAFT LLC AMI AKALLAL-ASAAD
K143562 12/16/2014 Reprocessed Cordless Ultrasonic Dissection Device STERILMED, INC. Nicole Boser
K143661 12/23/2014 DirectInject STRYKER Nathan VanSweden
K143597 12/18/2014 Navigated XIA 4.5 Polyaxial Screwdriver STRYKER CORPORATE BECKY DITTY
K143616 12/19/2014 AccuLIF TL and PL Cage STRYKER CORPORATION Aakash Jain
K143546 12/15/2014 Imbibe Aspirating XIA Taps Stryker Corporation Soraya King
K143540 12/15/2014 Stryker MIS Attachments and Cutting Accessories STRYKER CORPORATION Mairead Twomey
K143588 12/18/2014 Surefire Infusion System 021 SUREFIRE MEDICAL, INC Lynne Aronson
K143728 12/29/2014 Minhua Disposable Blood Pressure Cuff SUZHOU MINHUA MEDICAL APPARATUS Ji Dong Yang
K143444 12/02/2014 SynePure Wound Cleanser Synedgen Inc. Shenda Baker
K143589 12/18/2014 GEM Flow COUPLER Device and System Synovis Life Technologies, Inc. Jodi Jorgenson
K143467 12/04/2014 FORA GD43 Blood Glucose Monitoring System TaiDoc Technology Corporation C. W. CHEN
K143692 12/24/2014 GranOSTM - beta tricalcium phosphate synthetic bone granules TCM ASSOCIATES LTD IAIN ALLIGAN
K143581 12/18/2014 Arrow Epidural Catheter Kit Teleflex Medical, Inc. Angela Bouse
K143469 12/05/2014 SOFTECH Plus ETCO2 Cannula TELEFLEX MEDICAL, INC. Brian Gall
K143592 12/18/2014 GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC THE SURGEON GENERAL, DEPARTMENT OF THE ARMY Kenneth A. Bertram
K143526 12/12/2014 The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) Thermo Fisher Scientfic Cynthia Knapp
K143479 12/08/2014 Bluefin Interbody System Tides Medical J. Doug Payne
K143552 12/15/2014 Simpliciti Shoulder System TORNIER, INC. Loucinda Bjorklund
K143717 12/29/2014 Treace Medical Concepts(TMC) Plating System Treace Medical Concepts, INc. Joe Ferguson
K143631 12/22/2014 Benefix Interspinous Fixation System U & I Corporation Young-Geun Kim
K143629 12/22/2014 U&U Bowie-Dick Test Pack U&U MEDICAL TECHNOLOGY CO., LTD GARFIELD WANG
K143637 12/22/2014 U&U Sterilization Pouch and Roll U&U Medical Technology Co.,Ltd Garfield Wang
K143664 12/23/2014 HeartSee UNIVERSITY OF TEXAS MEDICAL SCHOOL AT HOUSTON K Lance Gould
K143424 12/01/2014 UTAH CVX-RIPE UTAH MEDICAL PRODUCTS, INC. Ben Shirley
K143652 12/23/2014 Vector PTA Balloon Dilatation Catheter Vector Corporation LLC Jay Sturm
K143554 12/15/2014 Venus Legacy CX Venus Concept Ltd. Orit Ron Edoute
K143685 12/24/2014 Hedgehog Cervical Interbody Fusion Device Vertera, Inc. Stephen Laffoon
K143549 12/15/2014 Vivorte Trabexus VIVORTE, INC ROBERT BURDEN
K143547 12/15/2014 Vivorte Trabexus EB VIVORTE, INC Robert Burden
K143486 12/08/2014 Ufi Gel hard C VOCO GMBH M.Th. Plaumann
K143701 12/24/2014 EAGLE EYE PLATINUM CATHETER, EAGLE EYE PLATINUM SHORT TIP CATHETER, VISIONS PV .014 PLATINUM VOLCANO CORPORATION MARCUS GARCIA
K143724 12/29/2014 COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit WILLIAM A. COOK AUSTRALIA PTY, LTD. Gordana Pozvek
K143460 12/04/2014 Cannulated Screw System WRIGHT MEDICAL TECHNOLOGY, INC. Tara Conrad
K143741 12/31/2014 Lipofina Laser System YOLO MEDICAL, INC. Robert J Krznaric
K143528 12/12/2014 Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System ZIMMER DENTAL INC. CHRISTINA BOYDSTON
K143505 12/10/2014 Zimmer Patient-Specific Abutment, Internal Hex, Titanium Zimmer Dental, Inc. Christina Boydston
K143626 12/22/2014 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Sele Zimmer Spine, Inc. Donna M. Semlak
K143618 12/19/2014 Kirschner Wires, Steinmann Pins ZIMMER, INC. PATRICK MCCULLAGH


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