FDA 510(k) Applications Received During September, 2014

FDA 510(k) Number Submission Date Device Name Applicant Contact
K142770 09/25/2014 Powered Wheelchair AAT ALBER ANTRIEBSTECHNIK GMBH Mrs.Stefanie D Bankston
K142820 09/30/2014 BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric M ABB Optical Group, LLC John Kenyon
K142816 09/29/2014 AbbVie J ABBVIE INC. Katherine Wortley
K142792 09/26/2014 AbbVie NJ ABBVIE INC. Katherine Wortley
K142793 09/26/2014 AbbVie PEG AbbVie Inc. Katherine Wortley
K142467 09/03/2014 IntelAir Nasal Airway Support System ABEON MEDICAL CORPORATION ALLISON SLAGA
K142527 09/08/2014 Extension Set with BD Q-Syte Luer Access Split Septum ACACIA, INC. DAN HYUN
K142543 09/10/2014 Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine Control ACON LABORATORIES, INC. Qiyi Xie
K142454 09/02/2014 STERRAD NX Sterilizer, STERRAD 100NX Sterilizer ADVANCED STERILIZATION PRODUCTS SUN CHOI
K142686 09/22/2014 StimPad OTC AEMED, INC. John K Burke
K142707 09/22/2014 AIS Odontoid Fracture Fixation System AESCULAP IMPLANT SYSTEM, INC. Lisa M Boyle
K142528 09/09/2014 AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm Agent Medical, LLC Scott Munday
K142672 09/19/2014 AliveCor Heart Monitor ALIVECOR, INC. Albert Boniske
K142743 09/24/2014 AliveCor Heart Monitor AliveCor, Inc. Albert Boniske
K142651 09/18/2014 The Moses Express appliance ALLEN J. MOSES, DDS, LTD. ALLEN J. MOSES, DDS
K142557 09/11/2014 Anker Dental Implant System - SB-III, ST and AT series Alliance Global Technology Co., Ltd. Yayuan Chang
K142733 09/23/2014 E-CUBE 5 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K142607 09/15/2014 AngioVac Circuit ANGIODYNAMICS Gary Barrett
K142614 09/16/2014 AngioDynamics VenaCure EVLT TreÆ Sheath and VenaCure EVLT NeverTouch Procedure Kits AngioDynamics, Inc. Teri Juckett
K142593 09/15/2014 AngioVac Cannula AngioDynamics, Inc. Wanda Carpinella
K142689 09/22/2014 GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring System Apex BioTechnology Corp. Hsue-mei Lee
K142569 09/12/2014 Aptis Medical Distal Radio Ulnar Joint Implant APTIS MEDICAL, LLC. Bryann Babb
K142641 09/17/2014 Intelliwave4 ART OPTICAL CONTACT LENS, INC. MICHAEL JOHNSON
K142619 09/16/2014 Snap Insulin Pump System ASANTE SOLUTIONS, INC EDWARD SINCLAIR
K142441 09/02/2014 cryoICE croablation probe ATRICURE, INC. Jonathan McElwee
K142596 09/15/2014 Infusomat Space Volumetric Infusion Pump B. Braun Medical Inc. Gary Johnson
K142577 09/12/2014 PANTHER Endo Linear Cutter Staplers with Single Use Loading Units B.J.Z.H.F. Panther Medical Equipment Co. Ltd. Liu Yu
K142600 09/15/2014 VIAL-MATE Adaptor BAXTER HEALTHCARE CORPORATION GARY CHUMBIMUNE
K142480 09/04/2014 OsteoCool V-2 RF Ablation System BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K142640 09/17/2014 Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator BIO COMPRESSION SYSTEMS, INC. Barbara Whitman
K142657 09/18/2014 XEROSTOM SALIVA SUBSTITUTE GEL BIO COSMETICS, S.L. SUSANA SARDON
K142448 09/02/2014 VARIANT II TURBO HbA1c Kit - 2.0 Bio-Rad Laboratories, Inc. Jackie Buckley
K142463 09/02/2014 Bio2 CLM BG Bioactive Scaffold Bio2 Technologies, Inc. Janet Krevolin, PhD
K142813 09/29/2014 Biogensis Implant System-Kisses BIOGENESIS CO., LTD. Haeyong Lee
K142828 09/30/2014 osteoSPAN Morpheus BIOGENNIX Edwin Clayton Shors
K142658 09/18/2014 Biomet Headless Compression and Twist-off Screws BIOMET MANUFACTURING CORP. Victoria Scheitlin
K142814 09/29/2014 Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial BIOMET MANUFACTURING LLC TRACY BICKEL JOHNSON
K142746 09/24/2014 G7 Finned Acetabular Shell BIOMET MANUFACTUTING CORP. TRACY JOHNSON
K142823 09/30/2014 Biomet Microfixation Thoracic Fixation System BIOMET MICROFIXATION Lauren Jasper
K142634 09/17/2014 Biomet Spine Fusion System BIOMET SPINE, LLC. Mike Medina
K142799 09/29/2014 Model BT-220L and BT-220C Bistos Co., Ltd. Young Chi
K142513 09/08/2014 Barricade Embolization Coil System BLOCKADE MEDICAL Rebecca K Pine
K142677 09/19/2014 MALDI Biotyper CA System BRUKER DALTONICS, INC Ken Hirakawa
K142818 09/29/2014 Phasix Mesh C.R. Bard Steve Keenan
K142706 09/22/2014 Modified ONFLEX Mesh C.R. Bard Inc. Mariya Buharin
K142711 09/22/2014 ONFLEX Mesh C.R. Bard Inc. Mariya Buharin
K142443 09/02/2014 Site-Rite 6 Ultrasound System with Pinpoint GT Technology C.R. Bard, Inc Kerrie Hamblin
K142575 09/12/2014 Bard RiteCath Intermittent Urinary Catheter C.R. Bard, Inc. Michele Davis
K142445 09/02/2014 PINPOINT GT SAFETY INTRODUCER NEEDLE C.R. BARD, INC. AMY MCMANUS
K142586 09/15/2014 Captiva Spine FuselOX Cervical IBF System CAPTIVA SPINE Tamala J Wampler
K142468 09/03/2014 Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth System CARDIAC INSIGHT, INC. BRAD HARLOW
K142529 09/09/2014 Genesis Reusable Rigid Container System CareFusion 2200 Inc Jane Weber
K142490 09/04/2014 ProxiFuse Hammer Toe Device Cartiva, Inc. Richard Knostman
K142806 09/29/2014 DualCap CATHETER CONNECTIONS, INC. Mark Endo
K142501 09/05/2014 Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System CEPHEID KERRY J. FLOM
K142751 09/24/2014 Chang Gung ComMed Series Dental Implant System Chang Gung Medical Technology Co., Ltd. Chao-Chun Chiu
K142580 09/15/2014 Chemtrue Multi-Panel DOA DIP Card Tests CHEMTRON BIOTECH, INC. Jane Zhang
K142469 09/03/2014 2D Mercy TAPE & 3D Mercy TAPE Children's Mercy Hospital Susan Abdel-Rahman
K142655 09/18/2014 CB PROT II Posterior Spinal System CHIN BONE TECHNIQUE CORP CHENG-KUNG CHENG
K142800 09/29/2014 Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard Co-Innovation Biotech Co., Ltd. Hong Feng
K142745 09/24/2014 125mL CT Syringe COEUR, INC. Erin Rheinscheld
K142496 09/05/2014 Collagen Dental Membrane - Conformable IIBP COLLAGEN MATRIX, INC. GLORIA ZUCLICH
K142535 09/09/2014 ConMed Mixing and Delivery Kit CONMED CORPORATION Dionne Sanders
K142464 09/02/2014 Entriport CONMED CORPORATION Anna D'Lima
K142716 09/23/2014 VCARE CONMED CORPORATION ANNA D'LIMA
K142825 09/30/2014 Zmachine CONSOLIDATED RESEARCH OF RICHMOND, INC Richard Kaplan
K142829 09/30/2014 Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification; Flexor Check-Flo Introducer, Ansel Modification; Flexor Check-Flo Introducers, Ansel Modification with High-Flex Dilator and Hydrophilic Coating; Flexor Check-Flo Introducer Balkin Up and Over Co Cook Incorporated Sarah Reeves
K142819 09/29/2014 Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set COOK INCORPORATED STEVEN LAWRIE
K142688 09/22/2014 Echotip Procore HD Ultrasound Biopsy Needle COOK IRELAND LTD Nora O'Connor
K142761 09/25/2014 Corin TaperFit Hip Stem CORIN USA Diana L Nader-Martone
K142547 09/10/2014 Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm COVIDIEN MARY MELLOWS
K142656 09/18/2014 Surgical Gut Suture COVIDIEN Mary Mellows
K142695 09/22/2014 Cytosponge Cell Collection Device Covidien LLC Richelle Hover
K142654 09/18/2014 Fortrex 0.035 OTW PTA Balloon Catheter Covidien LLC Rupali Gupta
K142839 09/30/2014 GenCut Core Biopsy System Covidien LLC Jenny Jiang
K142865 09/30/2014 Nellcor Bedside SpO2 Patient Monitoring System Covidien LLC Megan Fessenden
K142808 09/29/2014 CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners CR BARD INC Andrew Harrell
K142545 09/10/2014 SonoFlow Sonohysterography and Sonohysterosalpingography Device CrossBay Medical, Inc. Piush Vidyarthi
K142643 09/17/2014 Stabilynx PEEK Suture Anchor D3 DC, LLC /Stabilynx, Inc Mike Rosenthal
K142679 09/19/2014 CARESCAPE R860 Datex-Ohmeda, Inc. Trishia Dwyer
K142531 09/09/2014 F1-Modular Pedicle Screw System Degen Medical Craig Black
K142517 09/08/2014 SolfVue DELPHINUS MEDICAL TECHNOLOGIES, INC Andrea N Wallen-Gerding
K142666 09/18/2014 Scrambler Therapy MC-5 A Device Delta International Services & Logistics S.r.l Donatella Ruscito
K142574 09/12/2014 4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, DEPUY MITEK, A JOHNSON & JOHNSON COMPANY TRACEY HANNON
K142587 09/15/2014 Vertical Expandable Prosthetic Titanium Rib Depuy Synthes Spine, Inc. Catherine Kilshaw
K142494 09/05/2014 ViMove dorsaVi Ltd. Dan Ronchi
K142475 09/03/2014 EVS 4343 DRTECH Corporation Choul-Woo Shin
K142514 09/08/2014 UniWeb 8.0 EBM Technologies Incorporated John Su
K142511 09/08/2014 U50 Diagnostic Ultrasound System EDAN INSTRUMENTS, INC. CHERRY SUN
K142749 09/24/2014 TruWave Disposable Pressure Transducer EDWARDS LIFESCIENCES, LLC. ANDREW S. MAZURKIEWICZ
K142576 09/12/2014 Spinal System EISERTECH, LLC Lukas Eisermann
K142518 09/08/2014 HumaPen Luxura ELI LILLY AND COMPANY LeeAnn Chambers, MS., RAC
K142599 09/15/2014 PRECISE Trauma Nail System Ellipse Technologies, Incorporated Rebecca Shelburne
K142692 09/22/2014 Occlusion Balloon Catheter EMBOLX, INC. Michael P Allen
K142773 09/25/2014 EOS System EOS IMAGING Karine Chevrie
K142822 09/30/2014 PLIASURE Polyglycolide Synthetic Absorbable Suture ETHICON, Inc. Susan Lin
K142732 09/23/2014 T3 Software Etiometry, Inc. Dimitar Baronov
K142571 09/12/2014 Powder Free Vinyl Patient Examination Gloves EVER LIGHT PLASTIC PRODUCTS CO., LTD. ZHANG LITAO
K142570 09/12/2014 Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) EVER LIGHT PLASTIC PRODUCTS CO., LTD. ZHANG LITAO
K142794 09/29/2014 Everyway Facial MENS EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K142446 09/02/2014 Fixtemp Cement EXACTA DENTAL DIRECT, INC JOHN PANKUCH
K142620 09/16/2014 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe Excelsior Medical Corporation John Linfante
K142776 09/26/2014 Flow-Screw Flow-FX, LLC PATRICK J. SWEENEY
K142810 09/29/2014 WEGO-PGCL Absorbable Surgical Monofilament Suture FOOSIN MEDICAL SUPPLIES INC.LTD Suxia Zhao
K142778 09/26/2014 ARROW Reverse Shoulder long keel and short keel glenoid base Fournitures Hospitalieres Industrie Patricia Donnard
K142629 09/16/2014 EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes FUJIFILM MEDICAL SYSTEM U.S.A., INC. Mary Moore
K142521 09/08/2014 Synapse 3D Liver and Kidney Analysis FUJIFILM MEIDCAL SYSTEMS U.S.A.,INC. JYH-SHYAN LIN
K142456 09/02/2014 GPS Spacers G SURGICAL, LLC Donald Grafton
K142801 09/29/2014 Triton Canister System Gauss Surgical, Inc. Peggy McLaughlin
K142719 09/23/2014 E-App GC MEDTECH, LLC Robert Ramirez
K142840 09/30/2014 Unity Network ID GE HEALTHCARE Robert Casarsa
K142472 09/03/2014 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems GE Healthcare Tracey Ortiz
K142646 09/17/2014 XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and Genadyne Biotechnologies, Inc Chien Ming
K142846 09/30/2014 BBX1, BBX2, BBX1MO, BBX1MC GLOBALDENTAL, INC. EBLESS V BAEZ ALERS
K142498 09/05/2014 MAGNIFY and MAGNIFY-S Spacers GLOBUS MEDICAL INC. KELLY J BAKER
K142726 09/23/2014 O Glide Personal Lubricant Grafenberg Labs Manny Frankl
K142478 09/03/2014 opti-Toe Graham Medical Technologies, L.L.C. (d.b.a.GraMedica) Michael Graham
K142534 09/09/2014 HyProCure II Graham Medical Technologies, L.L.C. dba GraMedica ANGELA RECCHIA
K142609 09/16/2014 CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine Guangzhou Wondfo Biotech Co., Ltd. Ben Chen
K142700 09/22/2014 InsufflatOR Needle GYNETECH PTY. LTD. Kevin MacDonald
K142759 09/25/2014 PK Cutting Forceps for ESG-400 Workstation GYRUS ACMI, INC. DOLAN MILLS
K142824 09/30/2014 LX-100 Hair Growth Stimulation System Hairlabs International Inc James Britt
K142764 09/25/2014 KYOLING CPR Mask with Oxygen Port and Without Oxygen Port HANGZHOU JINLIN MEDICAL APPLIANCES CO., LTD. Lydia HE
K142805 09/29/2014 Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) HARTALEGA SDB. BHD. KUAN KAM HON
K142588 09/15/2014 Nitrile Powder Free Examination Glove (Blue) HARTALEGA SDN BHD KUAN KAM HON
K142476 09/03/2014 Master Caution Device MCD HealthWatch Ltd. Yoram Levy
K142709 09/22/2014 samaritan PAD 450P HEARTSINE TECHNOLOGIES, INC. Paul Phillips
K142783 09/26/2014 HEARTWAY Electrically Powered Wheelchair P27 HEARTWAY Medical Products Co., Ltd. JEN KE-MIN
K142731 09/23/2014 HEARTWAY Electrically Powered Wheelchairs HEARTWAY Medical Products Co., Ltd. Dr. Ke-Min Jen
K142703 09/22/2014 Powder-free PVC Vinyl Exam Gloves Hebei Grandeast Plastic Products Co., Ltd. Wei Liu
K142486 09/04/2014 HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 HEINE Optotechnik GmbH & Co. KG Bettina Seim
K142837 09/30/2014 HEINE SIGMA 250 & HEINE SIGMA 250 M2 HEINE Optotechnik GmbH & Co. KG Bettina Seim
K142631 09/17/2014 Hermes Medical Imaging Suite v5.5 HERMES MEDICAL SOLUTIONS, AB Joakim Arwidson
K142551 09/10/2014 QANS (Quantitative Autonomic Nervous System) Monitoring System HHSsystems, LLC HOWARD G. HINDIN
K142482 09/04/2014 The Vest Airway Clearance System Hill-Rom Services Private Limited Christina Miracle
K142618 09/16/2014 Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System Hitachi Aloka Medical America, Inc. Angela Van Arsdale
K142734 09/23/2014 TRILLIUM Oval MR System HITACHI MEDICAL SYSTEMS AMERICA, INC. Doug Thistlethwaite
K142622 09/16/2014 IV Administration HOSPIRA, INC. DAVID BLONSKI
K142769 09/25/2014 Fetal Doppler iCare Newlife Technologies, Inc. BO XIAO
K142781 09/26/2014 ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA IMMCO DIAGNOSTICS, INC. Kevin Lawson
K142519 09/08/2014 InterActive Complete Surgical Tray Implant Direct Sybron Manufacturing , LLC Debleena Sinha
K142638 09/17/2014 ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) InnovaQuartz LLC Stephen Griffin
K142477 09/03/2014 Intact Advance and Intact Excision XL, Intact BLES INTACT MEDICAL CORPORATION JOHN VACHA
K142766 09/25/2014 I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear INTEROJO INC. Si-Chul Rho
K142503 09/05/2014 IMED-Z FLUID STATUS MONITOR INTERSECTION MEDICAL, INC. WARREN CRAYCROFT
K142668 09/19/2014 Lesion-Loc Iodine I-125 Seed/Needle Intramedical Imaging, LLC Farhad Daghighian
K142683 09/19/2014 12 mm Endoscopes and Accessories INTUITIVE SURGICAL, INC. Crystal Ong
K142681 09/19/2014 ZEUS (ZIO ECG Utilization Service) System iRhythm Technologies, Inc. Rich Laguna
K142549 09/10/2014 Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste J.C.E.C. Company, Inc. (doing business as Fountain Health Ca John Canvin
K142484 09/04/2014 Sternal Closure System JACE Medical LLC Justin May
K142833 09/30/2014 INTRAGen JEISYS MEDICAL, INC. Kyung Won Hwang
K142797 09/29/2014 I.V. Catheter Jiangxi Sanxin Medtec Co., Ltd Bingrong Liu
K142564 09/11/2014 JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) JMS North America Corporation Sho Hosoki
K142460 09/02/2014 EXPEDIUM Spine System/Synapse System JOHNSON AND JOHNSON Jaclyn Porsolt
K142536 09/09/2014 21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K142540 09/09/2014 24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244) JVC KENWOOD CORPORATION Tsukasa Tashiro
K142760 09/25/2014 Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles K.S. Choi Corporation Kak Soo Choi
K142558 09/11/2014 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2M Nancy Giezen
K142487 09/04/2014 Chesapeake Stabilization System K2M Inc. Nancy Giezen
K142556 09/11/2014 Flexible Video-Uretero-Choledochoscope System KARL STORZ ENDOSCOPY-AMERICA, INC. Mike Samuels
K142782 09/26/2014 KIMGUARD ONE-STEP Sterilization Wrap Kimberly-Clark Health Care Thomas Kozma
K142625 09/16/2014 PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) KURARAY NORITAKE DENTAL INC. Michio Takigawa
K142623 09/16/2014 PANAVIA SA Cement Plus Handmix KURARAY NORITAKE DENTAL, INC. Michio Takigawa
K142645 09/17/2014 Avenue T TLIF Cage LDR SPINE USA INC. BRADLEY W. STRASSER
K142660 09/18/2014 Antegrade LeMills Valvulotome LeMaitre Vascular, Inc. Xiang (Vic) Zhang
K142803 09/29/2014 Skintact, various other tradenames Leonhard Lang GmbH Burrhus Lang
K142573 09/12/2014 HairMax LaserComb, HairMax LaserComb LEXINGTON INTERNATIONAL, LLC DAVID MICHAELS
K142757 09/25/2014 LiNA PowerBlade Plus HC LiNA Medical ApS Louisa Memborg
K142538 09/09/2014 LiNA SafeAir Smoke Pencil LINA MEDICAL APS Louisa Memborg
K142682 09/19/2014 The Lipogems System Lipogems International SpA Carlo Russo
K142561 09/11/2014 LM-9300 ELMA Lithotripter LITE-MED INC. WALT HSU
K142722 09/23/2014 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 Livetec GMBH Klaus Reichenbach
K142567 09/12/2014 RETeval Visual Electrodiagnostic Device LKC Technologies, Inc Quentin Davis
K142705 09/22/2014 LeadCare Plus Blood Lead Testing System Magellan Diagnostics Reba Daoust
K142606 09/15/2014 Trident« Tritanium« PST« Acetabular Shells MAKO Surgical Corp. Jonathan Reeves
K142530 09/09/2014 Partial Knee Application (PKA) MAKO SURGICAL CORPORATION Jonathan Reeves
K142850 09/30/2014 McKesson Radiology Mammography Plus MCKESSON MEDICAL IMAGING COMPANY GILBERT WONG
K142744 09/24/2014 Mecta-C TiPEEK Medacta International Adam Gross
K142581 09/15/2014 APTUS Foot System MEDARTIS AG ANDREA SCHWEIZER
K142626 09/16/2014 Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters MEDELA, AG Orlando Antunes
K142728 09/23/2014 ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) Medical Compressions System (DBN) Ltd. Eyal Sandach
K142548 09/10/2014 MIDSLEEVE MEDICAL INNOVATION DEVELOPMENT Melanie Fouilland
K142798 09/29/2014 PASS LP Spinal System MEDICREA INTERNATIONAL S.A. Audrey VION
K142702 09/22/2014 Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad MEDIVANCE, INC. Stacci Cronk
K142635 09/17/2014 Medline Silicone Foley Catheter MEDLINE INDUSTRIES, INC. Matt Clausen
K142684 09/19/2014 FlexCath Select Steerable Sheath (10 French) Medtronic CryoCath LP Vanessa Ware
K142847 09/30/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANCK USA, INC. LAVEEDA LEFLORE
K142450 09/02/2014 DIVERGENCE Anterior Cervical Fusion System MEDTRONIC SOFAMOR DANEK USA, INC Shweta Sharma
K142591 09/15/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. LILA JOE
K142559 09/11/2014 ELEVATE Spinal System Medtronic Sofamor Danek USA, Inc. Becky Ronner
K142648 09/17/2014 SPINEDESIGN Spine Surgery Planning (Software Application) MEDTRONIC SOFAMOR DANEK USA, INC. Lila Joe
K142611 09/16/2014 TYRX Neuro Absorbable Antibacterial Envelope MEDTRONIC TYRX, INC. REGINA NOVAK
K142784 09/26/2014 Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface Medtronic, Inc Lisa Stone
K142673 09/19/2014 Bio-Medicus Adult Cannulae and Introducer Medtronic, Inc Bruce Backlund
K142835 09/30/2014 Iliad Pedicle Screw System and Zenius Pedicle Screw System MEDYSSEY USA, INC. JOHN KUCZYNSKI
K142772 09/25/2014 Phlebo Press DVT 603 Mego Afek AC Ltd. Aharon Cohen
K142451 09/02/2014 OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K142636 09/17/2014 Merit 10mL Syringe Merit Medical Systems, Inc. Mridi Kumathe
K142597 09/15/2014 Vienna System MICK RADIO-NUCLEAR INSTRUMENTS, INC. Chuck Smith
K142449 09/02/2014 Headway 27 Microcatheter MICRO VENTION, INC. Cynthia Valenzuela
K142550 09/10/2014 EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments MICROPORT ORTHOPEDICS INC. Caroline Fryar
K142541 09/10/2014 POCKET NEB MicroVaper Devices Scott Faris
K142647 09/17/2014 mint Lesion MINT MEDICAL GMBH Jochen Neuhaus
K142505 09/05/2014 ClearPoint System MRI INTERVENTIONS, INC. E F Waddell
K142459 09/02/2014 Ebony PTA 0.014 RX Peripheral Dilatation Catheter NATEC MEDICAL LTD Xavier de Buchere
K142616 09/16/2014 PICC Maximal Barrier Nursing Kit NAVILYST MEDICAL, INC. WANDA CARPINELLLA
K142470 09/03/2014 E-Shield Multi-paried Subdermal Needle Electrodes NEUROINVENT INC. CHAO SHENT-CHAO
K142697 09/22/2014 NExCT 7 NEUROLOGICA CORPORATION Ninad Gujar
K142774 09/26/2014 Polysmith Sleep System Neurotronics, Inc. David Pezet
K142834 09/30/2014 DiscoverEEG System, Model DE-401 NeuroWave Systems Inc. Tatjana Zikov
K142502 09/05/2014 ALIANS ULNA LOCKING PLATING SYSTEM NEWCLIP TECHNICS Ga?lle LUSSORI
K142590 09/15/2014 All Safe Huber Safety Infusion Set NEXUS MEDICAL, LLC Heather Turner
K142717 09/23/2014 Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case Ni Hau Industrial Co., Ltd. Lyn Chiu
K142624 09/16/2014 Neuromaster G1 MEE200 Nihon Kohden Corporation Natalie Kennel
K142712 09/22/2014 Dental Collagen Wound Dressing (Nova Tape and NovaPlug) NovaBone Products, LLC Lisa Simpson
K142737 09/23/2014 MAS PLIF Fixation system NUVASIVE, INCORPORATED OLGA LEWIS
K142499 09/05/2014 Reline System NUVASIVE, INCORPORATED Olga Lewis
K142594 09/15/2014 nva, nvp, nvt NVISION BIOMEDICAL TECHNOLOGIES, LLC Brian Kieser
K142583 09/15/2014 LaborView LV1000 OBMedical Company Suha Jhaveri
K142785 09/26/2014 PRODIGY iConnect Blood Glucose Monitoring System OK BIOTECH CO., LTD. Jen Ke-Min
K142680 09/19/2014 ENDOCAPSULE SOFTWARE 10; ENDOCAPSULE SOFTWARE 10 LIGHT OLYMPUS MEDICAL SYSTEMS CORP. Daphney Germain-Kolawole
K142525 09/08/2014 PK Lap Loop Olympus Winter & Ibe GmbH Graham A.L. Baillie
K142855 09/30/2014 Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) Omega Laboratories, Inc. William Corl
K142671 09/19/2014 ONEFIT HIP PLANNER ONEFIT MEDICAL JULIEN SIMON
K142786 09/26/2014 Ontex Unscented Tampons with Colored Plastic Applicators ONTEX BVBA Henri Lesage
K142830 09/30/2014 Ophthalmed Bending Laser Probes OPHTHALMED LLC JAY MANSOUR
K142598 09/15/2014 Opto Wire and OptoMonitor System Opsens, Inc. Vanessa Mootoosamy
K142639 09/17/2014 StitchKit ORIGAMI SURGICAL LLC Patrick Culligan
K142595 09/15/2014 VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II ORTHO CLINICAL DIAGNOSTICS Bradley P Boyer
K142727 09/23/2014 CrossCLIP Implant System OrthoDiscovery Group LLC(D.B.A. CrossRoads Extremity Systems Vernon Hartdegen
K142678 09/19/2014 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm OTICON MEDICAL AB Carolina Anker Wessling
K142848 09/30/2014 EAZY PRIMER Parkell, Inc. David Mott
K142458 09/02/2014 Penumbra System ACE PENUMBRA, INC. Michaela Mahl
K142698 09/22/2014 PerkinElmer, XRpad 4343 F MED Flat Panel Detector PerkinElmer, Inc Dawn Spooner
K142708 09/22/2014 VERADIUS UNITY PHILIPS MEDICAL SYSTEMS NETHRLANDS BV Jeanette Becker
K142821 09/30/2014 PAXgene Blood DNA Tube PREANALYTIX GMBH Pasquale Amato
K142471 09/03/2014 Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip Pressure Point Inc. Joseph DiLustro
K142729 09/23/2014 Chi Lites Orthodontic Sapphire Bracket PROGRESSIVE TECHNOLOGY, INC. Shannon Rogers
K142738 09/23/2014 artus HSV-1/2 QS-RGQ MDx Kit QIAGEN Lindsey Howard
K142802 09/29/2014 Atlas SPEEDER Head/Neck Quality Electrodynamics, LLC Kathleen Aras
K142718 09/23/2014 Radlink GPS RADLINK, INC. Brian Kordich
K142516 09/08/2014 Propeller System RECIPROCAL LABS CORPORATION David Hubanks
K142755 09/25/2014 Siemens 3.0 Blanket Array Coil RESONANCE INNOVATIONS LLC Randall Jones
K142676 09/19/2014 Siemens 3.0T PROCURE Array Coil RESONANCE INNOVATIONS LLC RANDALL JONES
K142554 09/11/2014 Revolution Full Face Mask Respironics, Inc. Amy Macevoy
K142721 09/23/2014 cobas MRSA/SA Test ROCHE MOLECULAR SYSTEMS, INC. Wilk von Gustedt
K142789 09/26/2014 A1c iGear System Sakae Corporation Shinji Nakayama
K142701 09/22/2014 SMD Sr90-1 Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. Laurence Marsteller
K142492 09/04/2014 GM60A-32S, GM60A-40S SAMSUNG ELECTRONICS CO., LTD. KIM CHULSIN
K142466 09/02/2014 UGEO PT60A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD PARK KYEONG-MI
K142488 09/04/2014 SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene SeaSpine, Inc. Michelle Willis
K142715 09/22/2014 Sensor Medical Family of Vitrectomy Lenses and Products Sensor Medical Technology, LLC Louise Culham
K142675 09/19/2014 CI../..X liner for NOVAE Dual Mobility Acetabular Cup SERF Jean-Luc AURELLE
K142687 09/22/2014 Pulse Oximeter Shanghai Berry Electronic Tech Co., Ltd Xuezhi Yin
K142601 09/11/2014 Panorama Patient Monitoring Network Shenzhen Mindray Bio-Medical Electronics Co. Diane Arpino
K142552 09/10/2014 A7 Anesthesia System ShenZhen Mindray Bio-Medical Electronics Co., Ltd Tang Hao
K142685 09/22/2014 NITRILE EXAMINATION GLOVES WITH ALOE & VITAMIN E, POWDER- FREE SIAM SEMPERMED CORP., LTD ANAN PRUKSANUSAK
K142723 09/23/2014 ADVIA Centaur Cortisol (COR) Assy Siemens Healthcare Diagnostics Inc. Fatima Pacheco
K142811 09/29/2014 IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) Siemens Healthcare Diagnostics Inc. Asha Gartland
K142758 09/25/2014 ADVIA Centaur HAV total assay SIEMENS HEALTHCARE DIAGNOSTICS, INC. Philip Liu
K142826 09/30/2014 ADVIA Centaur Toxoplasma M (Toxo M) SIEMENS HEALTHCARE DIAGNOSTICS, INC. Matthew Gee
K142584 09/15/2014 iMAR Siemens Medical Solutions USA, Inc. Eve Davis
K142515 09/08/2014 MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra Siemens Medical Solutions USA, Inc. Cordell L. Fields
K142628 09/16/2014 Acuson SC2000 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS, INC. Kevin Kong
K142592 09/15/2014 CleanSmart Wound Cleanser SIMPLE SCIENCE, LLC Justin Scanlan
K142779 09/26/2014 SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED SIMPLEWARE LTD. GARETH JAMES
K142473 09/03/2014 Lubricating Jelly SION BIOTEXT MEDICAL LTD NADAV REUBEN
K142520 09/08/2014 Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software Smith & Nephew, Inc Martin Ostmann
K142807 09/29/2014 ANTHEM PS Total Knee System Smith & Nephew, Inc. Samir Ibrahim
K142474 09/03/2014 S12 Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED TOKI WU
K142815 09/29/2014 S22 Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED Toki Wu
K142714 09/22/2014 S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED Toki Wu
K142710 09/22/2014 S9 Portable Digital Color Doppler Ultrasound System SONOSCAPE COMPANY LIMITED TOKI WU
K142827 09/30/2014 Visi Mobile Monitoring System, Visi Mobile Chest Sensor Sotera Wireless, Inc. Eben Gordon
K142791 09/26/2014 Spectra Soft Tissue Biopsy Needles SPECTRA MEDICAL DEVICES Agustin Turriza
K142546 09/10/2014 TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath SPECTRANETICS, INC. Christopher McLellan
K142661 09/18/2014 Bi-Portal Bone Graft Delivery Device Spinal Surgical Strategies, LLC Jeffrey Kleiner
K142504 09/05/2014 SpineFrontier Lumbar Interbody Fusion Device System SpineFrontier, Inc. Manthan Damani
K142667 09/19/2014 Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm Sterngold Dental, LLC Maria Rao
K142568 09/12/2014 Stryker MEDPOR TITAN 3D Orbital Floor Implant Stryker Julie Schoell
K142699 09/22/2014 LITe Plate System STRYKER CORPORATION KRISTEN MEANY
K142741 09/24/2014 OASYS System STRYKER CORPORATION Garry T Hayeck
K142603 09/15/2014 Stryker Precision HD Camera System Stryker Endoscopy Angela Wong
K142565 09/12/2014 Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter Stryker Neurovascular Yoko Enrile
K142462 09/02/2014 Restoration Anatomic Shell STRYKER ORTHOPAEDICS Denise Daugert
K142754 09/25/2014 Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test Sugentech, Inc. Mijin Sohn
K142630 09/17/2014 Instru-Safe Instrument Protection System Summit Medical Inc. Nicole Dove
K142768 09/25/2014 Instru-Safe Instrument Protection System SUMMIT MEDICAL, INC. NICOLE DOVE
K142617 09/16/2014 ArcCHECK SUN NUCLEAR CORPORATION Noel Downey
K142457 09/02/2014 Quickie, Zippie Sunrise Medical (US) LLC Laurie Roberts
K142510 09/08/2014 UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens Synergeyes, Inc. Steven L. Ziemba
K142461 09/02/2014 VASCU-GUARD Peripheral Vascular Patch Synovis Life Technologies Inc. Jodi Jorgenson
K142447 09/02/2014 PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch Synovis Life Technologies. Inc. Jodi Jorgenson
K142838 09/30/2014 Synapse Occipital-Cervical-Thoracic (OCT) System SYNTHES USA PRODUCTS, LLC KATE LAROSE
K142653 09/18/2014 G-Lok and G-Lok XL Extender T.A.G. Medical Products Corporation, Ltd Tomer Alon
K142664 09/18/2014 URight Hemoglobin A1c system, FORA A1c System TAIDOC TECHNOLOGY CORPORATION C.W. Chen
K142777 09/26/2014 Weck Hem-o-lok Auto Endo5 Ligating Clip Applier Teleflex Medical, Inc. Ashlea Ricci
K142506 09/08/2014 TensCare KegelFit TENSCARE LTD. Andrew Brown
K142500 09/05/2014 One Way Soft Valve Terumo Cardiovascular Systems Corporation Suzanne Grenier
K142817 09/29/2014 IntraNovo 25 Microcatheter TEXAS MEDICAL TECHNOLOGIES, INC. Aaron Chiu
K142790 09/26/2014 OneTouch Lubricant Gel THAI NIPPON RUBBER INDUSTRY CO., LTD. Pisut Chanwatarungkull
K142735 09/23/2014 The Optilite IgG3 kit THE BINDING SITE GROUP LTD Andrea Thomas
K142649 09/17/2014 Progressive Orthopedic Total Knee System The Progressive Orthopaedic Company, LLC Scott Keiser
K142767 09/25/2014 ThinkMed Intermittent Catheter with/without Hydrophilic Coating ThinkMed Medical Technology Co., Ltd. Garfield Wang
K142765 09/25/2014 TM SAFETY NEEDLE ThinkMed Medical Technology Co., Ltd. Garfield Wang
K142589 09/15/2014 Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL TITAN SPINE, LLC Jane Rodd
K142465 09/02/2014 Aquilion ONE Vision, v7.0 TOSHIBA MEDICAL SYSTEMS CORPORATION Paul Biggins
K142736 09/23/2014 XIDF-AWS801, Angio Workstation, v5.31 Toshiba Medical Systems Corporation Paul Biggins
K142483 09/04/2014 TurboSEAL Nasogastric Aspiration Tube TurboSEAL, L.P. DORON BESSER
K142851 09/30/2014 CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens Unilens Corp., USA Alan J. Frazer
K142832 09/30/2014 Unimed Disposable and Reusable SPO2 Sensors UNIMED MEDICAL SUPPLIES INC. Xinmei Tan
K142489 09/04/2014 Unimed Disposable ECG lead wires UNIMED MEDICAL SUPPLIES INC. Tan Xinmei
K142553 09/10/2014 UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle UNISIS CORP. Tadashi Yasuda
K142560 09/11/2014 Varian Head Frame VARIAN MEDICAL SYSTEMS, INC. Peter J Coronado
K142512 09/08/2014 Personalized Physiology Analytics Engine software VGBio, Inc (DBA PhysIQ) Gary Conkright
K142775 09/26/2014 Neuwater TM (HydrocynTM aqua) Vigilenz Medical Devices Shudipta Choudhury
K142750 09/24/2014 JiveX VISUS TECHNOLOGY TRANSFER GMBH Axel Schreiber
K142642 09/17/2014 Vitalograph Model 6600 Compact VITALOGRAPH(IRELAND) LTD. Tom J Healy
K142812 09/29/2014 Vitalograph Model 6800 Pneumotrac VITALOGRAPH(IRELAND) LTD. Tom J Healy
K142563 09/11/2014 Well Lead PVC Urethral Catheter WELL LEAD MEDICAL CO., LTD. Han Guang Yuan
K142670 09/19/2014 Vericore Zirconia Blanks WHIP MIX CORPORATION JOHN WATERS
K142724 09/23/2014 BIOFOAM Bone Wedge WRIGHT MEDICAL TECHNOLOGY, INC. Val Myles
K142585 09/15/2014 PhaLinx Hammertoe System WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K142602 09/15/2014 VALOR Hindfoot Fusion Nail System WRIGHT MEDICAL TECHNOLOGY, INC. VAL MYLES
K142845 09/30/2014 SILKPRO laser hair removal system Wuhan Lotuxs Technology Co., Ltd Wu Na
K142479 09/04/2014 MEGNA BREAST PUMPS WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. ANNE CHEN
K142771 09/25/2014 Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) Xuanhua Metallurgical Industry CO., LTD Yanlong Dong
K142491 09/04/2014 ZEL TIQ CoolSculpting System ZELTIQ AESTHETICS, INC. SHRUTI JAYAKUMAR
K142539 09/09/2014 EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set ZEVEX, INC. Dianne Batch
K142508 09/08/2014 Powder Free Yellow Vinyl Patient Examination Gloves ZIBO HUAQI TRADING Co., Ltd Jing Li
K142740 09/24/2014 Ziehm Vision RFD 3D ZIEHM IMAGING GMBH STEFAN FIEDLER
K142572 09/12/2014 Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System Zimmer Dental, Inc. Christina Boydston
K142752 09/24/2014 Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360? Spinal Fixatoin System, Title 2 Polyaxial Spinal System ZIMMER SPINE, INC. DONNA M. SEMLAK
K142442 09/02/2014 MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM ZIMMER, INC. PATRICK MCCULLAGH
K142579 09/15/2014 Zimmer Periarticular Plating System ZIMMER, INC. Patrick McCullagh
K142787 09/26/2014 Zimmer Persona Personalized Knee System ZIMMER, INC. KEITH PROCTOR
K142836 09/30/2014 Zimmer Plates and Screws (ZPS), Forte Screws ZIMMER, INC. PATRICK MCCULLAGH
K142693 09/22/2014 ZywieAI Software Library Zywie, Inc. Latha Ganeshan


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