| 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 |
