| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K130664 |
03/12/2013 |
HYRDROMAX HMEF |
A-M SYSTEMS |
PAUL DRYDEN |
| K130762 |
03/20/2013 |
AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K130764 |
03/20/2013 |
AUDIT MICROCV VITAMIN D LINEARITY SET |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K130590 |
03/07/2013 |
AAP CANNULATED SCREW 2.0 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K130864 |
03/28/2013 |
C-MAX+ (PLUS) |
AAT ALBER ANTRIEBSTECHNIK GMBH |
STEFANIE D BANKSTON |
| K130755 |
03/19/2013 |
HICUT HIGHSPEED INSTRUMENT |
ADEOR MEDICAL AG |
FABIO VON ZEPPELIN |
| K130627 |
03/08/2013 |
SWING-OFF SCREW |
ADVANCED INTERVENTIONAL TECHNOLOGY, LLC |
EDUARDO MARCH |
| K130625 |
03/08/2013 |
12MM AND 13MM TIBIAL NAILS |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ALLYSON PARKS |
| K130887 |
03/29/2013 |
S4C NAVIGATION INSTRUMENTS |
AESCULAP IMPLANT SYSTEM, INC. |
LISA M BOYLE |
| K130596 |
03/07/2013 |
CAIMAN SEAL AND CUT TECHNOLOGY |
AESCULAP, INC. |
DENISE ADAMS |
| K130535 |
03/01/2013 |
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION |
AGAMATRIX INC |
WILLIAM H MCGRAIL |
| K130732 |
03/18/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
AIDE PLASTIC CO., LTD. |
CHU XIAOAN |
| K130702 |
03/15/2013 |
AIRSONETT AIR-4 |
AIRSONETT, AB |
CONSTANCE G BUNDY |
| K130657 |
03/12/2013 |
LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE |
ALL MEDICUS CO., LTD |
Priscilla Chung |
| K130548 |
03/04/2013 |
EPICAGE INTERBODY FUSION DEVICE |
ALPHATEC SPINE, INC. |
NADINE SMITH |
| K130845 |
03/26/2013 |
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW |
AMBU A/S |
SANJAY PARIKH |
| K130671 |
03/12/2013 |
VENACURE EVLT NEVERTOUCH PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K130538 |
03/01/2013 |
WINX SLEEP THERAPY SYSTEM |
APNICURE, INC. |
CHRIS DANIEL |
| K130677 |
03/13/2013 |
APTUS HELI-FX AORTIC SECUREMENT SYSTEM |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
| K130730 |
03/18/2013 |
V-STICK VASCULAR ACCESS SET |
ARGON MEDICAL |
JENNIFER BONACCI |
| K130676 |
03/12/2013 |
AMBIO REMOTE HEALTH MONITORING SYSTEM |
ARRAYENT HEALTH LLC D/B/A AMBIO HEALTH |
KEVIN JONES |
| K130876 |
03/29/2013 |
CG+ ARROW PICC POWERED BY ARROW VPS STYLET |
ARROW INTERNATIONAL, INC. |
ELIZABETH DUNCAN |
| K130675 |
03/13/2013 |
ARTHREX UNIVERS II CA HEADS |
ARTHREX, INC. |
COURTNEY SMITH |
| K130859 |
03/28/2013 |
HAMMERTOE CORRECTION SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K130693 |
03/14/2013 |
AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM |
ASEPTICO, INC. |
CHERIE TREGONING |
| K130692 |
03/13/2013 |
M2 WRIST 2 MRI SYSTEM |
ASPECT IMAGING LTD |
George Hattub |
| K130576 |
03/05/2013 |
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS |
B. BRAUN INTERVENTIONAL SYSTEMS INC. |
AMBER KINGSTON |
| K130857 |
03/28/2013 |
PRONTOSAN WOUND GEL X |
B. BRAUN MEDICAL, INC. |
NANCY SKOCYPEC |
| K130531 |
03/01/2013 |
ULTRAFUSE |
BAXTER HEALTHCARE CORP. |
GRETCHEN MURRAY |
| K130760 |
03/20/2013 |
ELECTROSURGICAL GENERATOR |
BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD |
LIGANG MAO |
| K130733 |
03/18/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
BENTENG PLASTIC CO., LTD. |
CHU XIAOAN |
| K130641 |
03/11/2013 |
LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE |
BINDER BIOMEDICAL, INC |
LAWRENCE BINDER |
| K130528 |
03/01/2013 |
BIOPLEX 2200 APLS IGM |
Bio-Rad Laboratories |
Juang Wang |
| K130761 |
03/20/2013 |
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K130860 |
03/28/2013 |
VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
EBONY MCKINNIES |
| K130866 |
03/28/2013 |
BIOLIGHT BIODYNAM |
BIOLIGHT AB |
PAR OLAUSSON LIDO |
| K130681 |
03/13/2013 |
ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER |
BIOLITEC SIA |
HARRY HAYES |
| K130610 |
03/07/2013 |
SIRIUS FEMORAL STEM |
BIOMET, INC. |
BECKY EARL |
| K130537 |
03/01/2013 |
BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER |
BIOPSY SCIENCES, LLC |
SHARON ROCKWELL |
| K130616 |
03/07/2013 |
MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLES |
BIOPSYBELL S.R.L. |
WILLER GHELFI |
| K130716 |
03/15/2013 |
BIORETEC ACTIVASCREW INTERFERENCE |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K130602 |
03/07/2013 |
LASSO NAV DUO LOOP CATHETER |
BIOSENSE WEBSTER, INC. |
JOHN JIMENEZ |
| K130777 |
03/21/2013 |
INBODY |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM, P.E. |
| K130775 |
03/20/2013 |
DUET SYSTEM |
BIOVIEW LTD. |
ORLY MAOR |
| K130804 |
03/25/2013 |
UROMAX ULTRA BALLOON DILATATION CATHETER |
Boston Scientific Corporation |
LAUREN RUSSO |
| K130621 |
03/08/2013 |
BROADMASTER HEALTHCARE SYSTEM |
BROADMASTER BIOTECH CORPORATION |
ROGER LAI |
| K130831 |
03/26/2013 |
MALDI BIOTYPER CA (MBT-CA) SYSTEM |
BRUKER DALTONICS, INC |
FRAN WHITE |
| K130792 |
03/22/2013 |
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM |
C.R. BARD, INC. |
Christoph Wagner von Hoff |
| K130786 |
03/21/2013 |
SLEEK OTW PTA CATHETER |
C.R. BARD, INC. |
FIONA NI MHULLAIN |
| K130751 |
03/19/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
CABIN PLASTIC CO., LTD. |
CHU XIAOAN |
| K130678 |
03/13/2013 |
BIOMARC GOLD FIDUCIAL MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ANDREW J ADAMS |
| K130567 |
03/04/2013 |
DR LONG LENGTH IMAGING SOFTWARE |
CARESTREAM HEALTH, INC. |
CAROLYN WAGNER |
| K130648 |
03/11/2013 |
FORUM GLAUCOMA WORKPLACE |
CARL ZEISS MEDITEC AG |
MANDY AMBRECHT |
| K130549 |
03/04/2013 |
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR |
CARL ZEISS MEDITEC INC |
SARAH HARRINGTON |
| K130834 |
03/26/2013 |
R7 |
CEFLA S.C. |
Claude Berthoin |
| K130872 |
03/29/2013 |
CARDIOCEL |
CELXCEL PTY LTD |
CHRISTOPHER SLOAN |
| K130618 |
03/07/2013 |
SFI-ANCHOR |
CENDRES & METAUX SA |
TANJA BONGNI |
| K130752 |
03/19/2013 |
DYNASENSE SYSTEM |
CENTAURI MEDICAL, INC. |
LORI ADELS |
| K130551 |
03/04/2013 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM, PHARM. D. |
| K130853 |
03/28/2013 |
IDYS(TM) C |
CLARIANCE |
JANICE M HOGAN |
| K130644 |
03/11/2013 |
PEDIATRIC FOLDING WHEELCHAIR |
COLUMBIA MEDICAL MFG, LLC |
GARY WERSCHMIDT |
| K130652 |
03/12/2013 |
VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW HULL |
| K130766 |
03/20/2013 |
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE |
COOK, INC. |
DAVID LEHR |
| K130673 |
03/12/2013 |
LOSPA TOTAL KNEE REPLACEMENT SYSTEM |
CORENTEC CO., LTD |
J.S. DANIEL |
| K130634 |
03/11/2013 |
CORIN METAFIX HIP STEM |
CORIN U.S.A. |
LUCINDA GERBER |
| K130744 |
03/19/2013 |
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
COVIDIEN |
DIANE REED |
| K130796 |
03/22/2013 |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
COVIDIEN |
KELSEY LEE |
| K130782 |
03/21/2013 |
ACCUMESH DEPLOYMENT SYSTEM |
Covidien LLC |
JOSE MARQUEZ |
| K130623 |
03/08/2013 |
BARRX CHANNEL RFA ENDOSCOPIC CATHETER |
Covidien LLC |
RICHELLE HOVER |
| K130725 |
03/18/2013 |
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. |
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
DOLLY MISTRY |
| K130717 |
03/15/2013 |
ENDO GIA RELOAD |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
KATHERINE ROBERTSON |
| K130532 |
03/01/2013 |
IDRIVE ULTRA STERILIZATION TRAY |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
KATHERINE ROBERTSON |
| K130663 |
03/12/2013 |
BESTFIT2 NASAL MASK |
CURATIVE MEDICAL INC. |
AMY MCKINNEY |
| K130828 |
03/26/2013 |
K SERIES CPAP SYSTEMS |
CURATIVE MEDICAL INC. |
AMY MCKINNEY |
| K130742 |
03/19/2013 |
POWEDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
DAHOON PLASTIC CO., LTD. |
CHU XIAOAN |
| K130861 |
03/28/2013 |
MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) |
DAKO NORTH AMERICA, INC. |
JENNIFER M CHAMBERS |
| K130654 |
03/12/2013 |
CRYSTAL ULTRA |
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) |
SCOTT ATKIN |
| K130680 |
03/13/2013 |
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS |
DENTSOLL, INC. |
DAVID C FURR |
| K130862 |
03/28/2013 |
CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K130539 |
03/01/2013 |
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
JULIE VAFIDES |
| K130814 |
03/25/2013 |
RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K130571 |
03/04/2013 |
DEVON CIRONA 6100 DVT |
DEVON MEDICAL INC. |
RUTH WU |
| K130779 |
03/21/2013 |
LVIVO EF SYSTEM |
DIACARDIO, LTD |
George Hattub |
| K130534 |
03/01/2013 |
DIPLOMAT |
DIPLOMAT DENTAL S.R.O. |
STUART R GOLDMAN |
| K130722 |
03/18/2013 |
AIRCAST VENAFLOW ELITE SYSTEM |
DJO, LLC |
LORRI TROTTER |
| K130580 |
03/05/2013 |
RETRACTION PASTE |
DMG USA, INC. |
PAMELA PAPINEAU, RAC |
| K130606 |
03/07/2013 |
FMWAND FERROMAGNETIC SURGICAL SYSTEM |
DOMAIN SURGICAL, INC. |
CURTIS JENSEN |
| K130729 |
03/18/2013 |
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER |
DORNIER MEDTECH SYSTEMS |
JOHN HOFFER |
| K130711 |
03/15/2013 |
INFINITY CENTRALSTATION WITH INFINITY M300 |
Draeger Medical Systems, Inc. |
TOM OSTROWSKI |
| K130765 |
03/20/2013 |
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II |
ELITECHGROUP |
DEBRA K HUTSON |
| K130550 |
03/04/2013 |
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K130793 |
03/22/2013 |
NEWA SKIN THERAPY SYSTEM |
ENDYMION MEDICAL LTD |
YORAM LEVY |
| K130556 |
03/05/2013 |
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR |
ENEURA THERAPEUTICS |
LARRY GETLIN |
| DEN130022 |
03/05/2013 |
NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR |
ENEURA THERAPEUTICS |
LARRY GETLIN |
| K130741 |
03/19/2013 |
ERCHONIA PL5000 |
ERCHONIA MEDICAL INC |
Kevin Walls |
| K130653 |
03/12/2013 |
ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU |
ETHICON ENDO-SURGERY, LLC |
CAROL HUBBARD |
| K130723 |
03/18/2013 |
FDES106 MINI TENS&EMS DEVICE,FDES106 MULTI-FUNCTION MINI TENS&EMS DEVICE,FDES105 PAIN RELIEF PLASTER,FDES107 ABDOMINAL |
FAMIDOC TECHNOLOGY CO., LTD |
REANNY WANG |
| K130735 |
03/18/2013 |
SYNTHETIC ABSORBABLE SUTURE |
FOOSIN MEDICAL SUPPLIES INC.LTD |
Diana Hong |
| K130737 |
03/18/2013 |
SYNTHETIC ABSORBABLE SUTURE |
FOOSIN MEDICAL SUPPLIES INC.LTD |
Diana Hong |
| K130542 |
03/01/2013 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K130788 |
03/22/2013 |
CAPELLA |
FUTURE MOBILITY HEALTHCARE INC. |
ABDULSAMAD PANCHBHAYA |
| K130759 |
03/20/2013 |
HUMELOCK II CEMENTLESS SHOULDER SYSTEM |
FX SOLUTIONS |
JEAN-JACQUES MARTIN |
| K130584 |
03/05/2013 |
MONITOR B40 |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
CASARSA ROBERT |
| K130884 |
03/29/2013 |
XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS F.I. HAIFA |
ELI WERNER |
| K130626 |
03/08/2013 |
MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
PHILIP MALCA |
| K130785 |
03/21/2013 |
SEER 1000 |
GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG |
BERT SCHADOW |
| K130624 |
03/08/2013 |
CONI |
GLOBALMED |
NICHOLAS CAMPBELL |
| K130886 |
03/29/2013 |
GLOOKO DEVICE SYSTEM FOR GLOOKO LOGBOOK+ APPLICATION |
GLOOKO, INC. |
SHILPA MYDUR |
| K130781 |
03/21/2013 |
L.A.M. IPM WOUND GEL, IPM DERM GEL |
GLYCOBIOSCIENCES, INC |
OLUFEMI ADEOYE |
| K130559 |
03/04/2013 |
MOBICATH BI-DIRECTIONAL GUIDING SHEATH |
Greatbatch Medical |
DENISE THOMPSON |
| K130691 |
03/13/2013 |
ELECTROTHERAPY DEVICE (COMBO UNIT) |
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD |
FIELD FU |
| K130665 |
03/12/2013 |
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K130682 |
03/13/2013 |
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT |
HAGER & MEISINGER GMBH |
WIEBKE STOLTEN |
| K130563 |
03/04/2013 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K130564 |
03/04/2013 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K130851 |
03/27/2013 |
CASCADE HEMODIALYSIS/APHERESIS CATHETER |
HEALTH LINE INTERNATIONAL CORPORATION |
NOLA BENSTOG |
| K130736 |
03/18/2013 |
BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS |
HELIX MEDICAL, LLC |
THOMAS M VASSALLO |
| K130647 |
03/11/2013 |
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML; XANTASIL FAST SET CARTRIDGE -6 X 50ML |
HERAEUS KULZER, LLC |
JAMIE MEARNA |
| K130582 |
03/05/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HEZE CITY GREEN FOOD CO., LTD. |
CHU XIAOAN |
| K130870 |
03/29/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA AMMIRATI |
| K130685 |
03/13/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA AMMIRATI |
| K130807 |
03/25/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
HOPE PLASTIC CO., LTD. |
CHU XIAOAN |
| K130670 |
03/12/2013 |
HYDROFERA BLUE PU BACTERIOSTATIC DRESSING |
HYDROFERA, LLC. |
HEATHER S SOMERS |
| K130696 |
03/14/2013 |
CARESENS N LINK BLOOD GLUCOSE MONITORING SYSTEM; CARESENS N LINK MULTI BLOOD BLUCOSE MONITORING SYSTEM |
i-SENS, Inc. |
CHAE YUN LIM |
| K130888 |
03/29/2013 |
SONOPULSE/ SONOPULSE III |
IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI |
TARA CONRAD |
| K130591 |
03/07/2013 |
SUPERA VERITAS |
IDEV TECHNOLOGIES, INC. |
DARLENE GARNER |
| K130572 |
03/04/2013 |
INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM |
IMPLANT DIRECT SYBRON MANUFACTURING LLC |
INES ARAVENA |
| K130846 |
03/27/2013 |
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN |
INDUSTRIAL CLOTHINGS, LTD. |
S.N. HARI |
| K130719 |
03/18/2013 |
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER |
Infraredx, Inc. |
Steve Chartier |
| K130635 |
03/11/2013 |
SEVIIN SURFACE REPLACEMENT SHOULDER |
INGEN ORTHOPEDICS LLC |
PERRY A GEREMAKIS |
| K130605 |
03/07/2013 |
INOMAX DSIR (DELIVERY SYSTEM) |
INO THERAPEUTICS |
ROBERT BOVY |
| K130660 |
03/12/2013 |
AUDICOR CPAM WITH SDB (SINGLE SENSOR) |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| K130598 |
03/07/2013 |
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER |
INSPIRX, INC. |
PAUL DRYDEN |
| K130557 |
03/04/2013 |
NEURAGEN 3D |
INTEGRA LIFESCIENCES CORPORATION |
STEPHEN H BEIER |
| K130821 |
03/25/2013 |
INTEL-GE CARE INNOVATIONS CONNECT RCM |
INTEL-GE CARE INNOVATIONS LLC |
MAUREEN GLYNN |
| K130795 |
03/22/2013 |
TITAN |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K130726 |
03/18/2013 |
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK |
INTUITIVE SURGICAL, INC. |
MELISSA S GONZALEZ |
| K130856 |
03/28/2013 |
BIA / VITALITY ANALYZER |
IPGDX, LLC |
Kevin Walls |
| K130829 |
03/26/2013 |
IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS |
IQ IMPLANTS LTD. |
NATALIA DINERSTHEIN |
| K130707 |
03/15/2013 |
ISIRONA MAGELLAN |
ISIRONA, LLC |
THOMAS KROENKE |
| K130809 |
03/25/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
JEWEL PLASTIC CO., LTD. |
CHU XIAOAN |
| K130847 |
03/26/2013 |
JINTRONIX REHABILITATION SYSTEM (JRS) |
JINTRONIX INC. |
NAVNEET SEKHON |
| K130699 |
03/14/2013 |
ALEUTIAN SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K130800 |
03/22/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
KAIXUAN PLASTIC CO., LTD. |
CHU XIAOAN |
| K130560 |
03/04/2013 |
MASTERTORQUE LUX 8900 L |
KALTENBACH & VOIGT GMBH |
STEFAN TRAMPLER |
| K130599 |
03/07/2013 |
WART FREEZE |
KONINKLIJKE UTERMOHLEN NV |
KENNETH R MICHAEL |
| K130758 |
03/20/2013 |
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER |
KRONNER PROTOTYPES, INC. |
RICHARD F KRONNER, M.D. |
| K130798 |
03/22/2013 |
PRE-FORMED GUIDEWIRES |
LAKE REGION MEDICAL, INC. |
MATHEW PEXA |
| K130686 |
03/13/2013 |
NASAL COMFORT FREEDOM |
LAKEVIEW SLEEP CENTER |
ANDY BLACK |
| K130614 |
03/07/2013 |
BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERS |
LAURA CATTABRIGA |
LAURA CATTABRIGA |
| K130613 |
03/07/2013 |
CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM |
LAURA CATTABRIGA |
LAURA CATTABRIGA |
| K130630 |
03/08/2013 |
PLATEAU SPACER SYSTEM TITANIUM |
LIFE SPINE, INC |
RANDY LEWIS |
| K130817 |
03/25/2013 |
LTN - LAPAROSCOPIC SURGICAL MESH |
LIFECELL CORP. |
JOHN BLEWITT |
| K130642 |
03/11/2013 |
SMR 3-PEGS GLENOIDS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K130694 |
03/14/2013 |
JR IMPLANT SYSTEM |
LK Consulting Group USA, Inc. |
Priscilla Chung |
| K130797 |
03/22/2013 |
LUCO HYBRID OSA APPLIANCE |
LUCO HYBRID OSA APPLIANCE INC. |
KEN LUCO |
| K130878 |
03/29/2013 |
CLOUDEKG |
MAKROMED, INC. |
BARRY V ASHAR |
| K130639 |
03/11/2013 |
ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K130855 |
03/28/2013 |
PTFE SUPER SHEATH INTRODUCER |
MARTECH MEDICAL PRODUCTS |
ALEXIS ERAZO |
| K130889 |
03/29/2013 |
SPLIT CATH RG |
MEDCOMP |
TIMOTHY HOLWICK |
| K130687 |
03/13/2013 |
2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER |
MEDICAL COMPONENTS INC |
JESSICA LEO |
| K130877 |
03/29/2013 |
EXPEDIUM SPINE SYSTEM |
MEDOS INTERNATIONAL SARL |
KIRSTEN LEHMULLER |
| K130637 |
03/11/2013 |
JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM |
MEDRAD, INC. |
BRIT BAIRD |
| K130536 |
03/01/2013 |
EXPORT ADVANCE ASPIRATION CATHETER |
MEDTRONIC INC. |
COLLEEN MULLINS |
| K130608 |
03/07/2013 |
QUADCUT |
MEDTRONIC NAVIGATION, INC. |
SHARON MCDERMOTT |
| K130640 |
03/11/2013 |
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KRISTI FRISCH |
| K130646 |
03/11/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BRAD SHEALS |
| K130805 |
03/25/2013 |
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION |
MENICON CO. LTD. |
Ellen M Beucler |
| K130813 |
03/25/2013 |
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS |
MENTOR CORP. |
MARTIN SPRUNCK |
| K130566 |
03/04/2013 |
BASIXTOUCH |
MERIT MEDICAL SYSTEMS, INC. |
DAN W LINDSAY |
| K130588 |
03/07/2013 |
MERIT HYDROPHILIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
MARTHA FOLAN |
| K130791 |
03/22/2013 |
PRELUDE SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K130547 |
03/04/2013 |
ENDOFORM RECONSTRUCTIVE TEMPLATE |
MESYNTHE LTD |
RONALD WARREN |
| K130577 |
03/05/2013 |
AZUR PUSHABLE 18 & 35 SYSTEM |
MICROVENTION, INC. |
CYNTHIA VALENZUELA |
| K130784 |
03/21/2013 |
SPIROTEL |
MIR MEDICAL INTL. RESEARCH SRL |
GERDA VAN HOUTS |
| K130628 |
03/08/2013 |
PATHFAST CK-MB-II CALIBRATORS |
MITSUBISHI CHEMICAL MEDIENCE CORPORATION |
Judi Smith |
| K130603 |
03/07/2013 |
PATHFAST CTNL CALIBRATORS |
MITSUBISHI CHEMICAL MEDIENCE CORPORATION |
Judi Smith |
| K130631 |
03/08/2013 |
BUZZY |
MMJ LABS, LLC |
VALERIE STAFFEY |
| K130852 |
03/28/2013 |
AVANCE« FOAM ABDOMINAL DRESSING KIT |
MOLNLYCKE HEALTHCARE |
ANGELA L BUNN |
| K130706 |
03/15/2013 |
DUOFLEX COIL SUITE (1.5T) |
MR INSTRUMENTS, INC. |
ROBERT BECK |
| K130738 |
03/18/2013 |
ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS |
NANJING MAIDIXIN MEDICAL DEVICE CO., LTD. |
Diana Hong |
| K130609 |
03/07/2013 |
VEEDA 100% COTTON MENSTRUAL TAMPON |
NATURALENA BRANDS, INC. |
JOSH ELLIS |
| K130772 |
03/20/2013 |
MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K130770 |
03/20/2013 |
MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K130651 |
03/07/2013 |
UROLIFT SYSTEM |
NEOTRACT, INC. |
NANCY E ISAAC |
| DEN130023 |
03/07/2013 |
UROLIFT SYSTEM |
NEOTRACT, INC. |
Nancy E Isaac |
| K130816 |
03/25/2013 |
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE) |
NEURO RESOURCE GROUP, INC. |
DAVID TURNER |
| K130806 |
03/25/2013 |
NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K130570 |
03/04/2013 |
NEUROVISION MEDICAL MOTION SENSOR |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K130774 |
03/20/2013 |
UNIVERSAL DISTAL RADIUS SYSTEM |
NEWCLIP TECHNICS |
J.D. WEBB |
| K130879 |
03/29/2013 |
NEXUS IV TUBING SET WITH LUER-ACCESSBILE ONE-WAY CHECK VALVE - IV PLUS |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
| K130565 |
03/04/2013 |
SPECULAR MICROSCOPE CEM-530 |
NIDEK CO., LTD. |
Aron Shapiro |
| K130601 |
03/07/2013 |
BIOROOT RCS |
NOVOCOL, INC. |
CORA BRACHO-TROCONIS |
| K130868 |
03/29/2013 |
NUVASIVE DECADE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
Cynthia Adams |
| K130820 |
03/25/2013 |
EXPANDABLE LUMBAR INTERBODY SYSTEM |
NUVASIVE, INCORPORATED |
JEREMY MARKOVICH |
| K130669 |
03/12/2013 |
SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS |
OLSEN MEDICAL |
DALENE BINKLEY |
| K130819 |
03/25/2013 |
CLL- V1 LIGHT SOURCE |
OLYMPUS WINTER & IBE GMBH |
SHERI L MUSGNUNG |
| K130666 |
03/12/2013 |
KHAN KINETIC TREATMENT (KKT-M2) |
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION |
FARHAD GHANI |
| K130656 |
03/12/2013 |
IFUSION |
OPTOVUE, INC. |
WILLIAM "BILL" JACKSON |
| K130743 |
03/19/2013 |
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL |
ORTHO KINEMATICS, INC. |
JOHN J SMITH |
| K130643 |
03/11/2013 |
ACCELEDENT AURA |
ORTHOACCEL TECHNOLOGIES, INC |
ZAFFER SYED |
| K130825 |
03/26/2013 |
AZURE ANTERIOR CERVICAL PLATE SYSTEM |
ORTHOFIX, INC. |
ALLY BADUEL |
| K130832 |
03/26/2013 |
ORTHOHELIX STAPLE SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
BRIAN HOCKETT |
| K130655 |
03/12/2013 |
RESPONSE SPINE SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
| K130633 |
03/11/2013 |
INTRODUCER SETS, MODEL ADELANTE RADIAL |
Oscor Inc. |
MILA DOSKOCIL |
| K130843 |
03/27/2013 |
SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE |
Oscor Inc. |
MILA DOSKOCIL |
| K130662 |
03/12/2013 |
ET PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K130840 |
03/27/2013 |
SMARTBUILDER SYSTEM (SB1) |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K130672 |
03/12/2013 |
OPTIFLOW II FLOWABLE COMPOSITE, LC |
PAC-DENT INTERNATIONAL, INC. |
WENYING ZHU |
| K130718 |
03/18/2013 |
PEERSCOPE SYSTEM |
PEERMEDICAL LTD. |
TAMAR FUERST |
| K130553 |
03/04/2013 |
ABSOCLEAR |
PHARMAPLAST S.A.E. |
CYNTHIA PRITCHARD |
| K130704 |
03/15/2013 |
MICRODOSE SI |
PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB |
GUSTAV LINS |
| K130684 |
03/13/2013 |
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR |
PHILIPS MEDICAL SYSTEMS |
NANCY BURKE |
| K130842 |
03/27/2013 |
ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
JOS VAN VROONHOVEN |
| K130638 |
03/11/2013 |
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
KLIEN VAN DAM |
| K130849 |
03/26/2013 |
INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K130790 |
03/22/2013 |
LYRIC2 |
PHONAK LLC |
JOHN J SMITH |
| K130579 |
03/05/2013 |
PHYSOFT AMS |
PHYSICIANS SOFTWARE SYSTEMS, LLC |
LEWIS A MITCHELL |
| K130667 |
03/12/2013 |
POWDERFREE LATEX EXAMINATION GLOVES COATED WITH ALLOGEL |
PREVENTIVE CARE, INC. |
ANIL SEGAT |
| K130650 |
03/11/2013 |
STATUS DS OXY |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K130604 |
03/07/2013 |
UNIVERSAL PASTE STAINS AND GLAZE |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K130811 |
03/25/2013 |
PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
| K130552 |
03/04/2013 |
CT PULMONARY ANALYSIS |
QI IMAGING, LLC |
RICHARD BALL |
| K130787 |
03/21/2013 |
QUANTUM DENTAL IMPLANT SYSTEM |
QUANTUM BIOENGINEERING, LTD. |
LINDA SCHULZ |
| K130714 |
03/15/2013 |
PROGIGY SUPPORT CATHETER |
RADIUS MEDICAL, LLC |
RICHARD DEMELLO |
| K130529 |
03/01/2013 |
RAUMEDIC-PTO-MONITORING-SYSTEM |
RAUMEDIC AG |
REINER THIEM |
| K130617 |
03/07/2013 |
RAYSTATION |
RAYSEARCH LABORATORIES AB |
DAVID HEDFORS |
| K130554 |
03/04/2013 |
REDSENSE ALARM SYSTEM |
REDSENSE MEDICAL AB |
PATRIK BYHMER |
| K131080 |
03/25/2013 |
PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE |
REIMERS AND JANSSEN GMBH |
JOSEPHUS JANSSEN |
| K130773 |
03/20/2013 |
TEMPUS PRO PATIENT MONITOR |
REMOTE DIAGNOSTIC TECHNOLOGIES LTD. |
CHRIS HANNAN |
| K130858 |
03/28/2013 |
REVERSE MEDICAL MICROCATHETER |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
| K130750 |
03/19/2013 |
RHYTHMIA MAPPING SYSTEM |
RHYTHMIA MEDICAL, INC |
LEON AMARIGLIO |
| DEN130002 |
03/25/2013 |
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM |
Roche Diagnostics |
Susan Hollandbeck |
| K130778 |
03/21/2013 |
DISCOSCOPES, CERVICAL ENDOSCOPES |
RZ MEDIZINTECHNIK GMBH |
ANDRE WEINGREL |
| K130632 |
03/08/2013 |
STERISPINE PS PEDICLE SCREW |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K130803 |
03/22/2013 |
UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
| K130734 |
03/18/2013 |
SAUFLON MULTIPURPOSE SOLUTION |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
| K130763 |
03/20/2013 |
BEACON TISSUE MARKER |
SCION MEDICAL TECHNOLOGIES LLC |
JOSEPH OSTENDORF |
| K130830 |
03/26/2013 |
INTEGRA LAMINOPLASTY SYSTEM |
SEASPINE, INC. |
JEFF BRITTAN |
| K130883 |
03/29/2013 |
SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T |
SEDECAL SA |
LUISA GOMEZ DE AGUERO |
| K130848 |
03/26/2013 |
SHANGHAI PHOENIX MECHANICAL WHEELCHAIR |
SHANGHAI PHOENIX MEDICAL EQUIPMENT CO., LTD. |
Ke-Min Jen |
| K130802 |
03/22/2013 |
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
JIANPING KANG |
| K130833 |
03/26/2013 |
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
| K130695 |
03/14/2013 |
Z5 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
WU ZICUI |
| K130841 |
03/26/2013 |
SHOFU BLOCK HC |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K130698 |
03/14/2013 |
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE ENNIS |
| K130619 |
03/07/2013 |
ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K130881 |
03/29/2013 |
ACUSON S2000 AND S3000 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K130739 |
03/18/2013 |
ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K130885 |
03/29/2013 |
MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K130749 |
03/19/2013 |
SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K130754 |
03/19/2013 |
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS, INC. |
PATRICK LYNCH |
| K130659 |
03/12/2013 |
SPEQRT ULTRASOUND SYSTEM |
SIGNOSTICS PTY LTD |
VARDA SWERY |
| K130649 |
03/11/2013 |
SILK ROAD ACCESS CATHETER |
SILK ROAD MEDICAL, INC |
RICHARD M RUEDY |
| K130728 |
03/18/2013 |
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA |
SMITH & NEPHEW, INC. |
SAMEER MANSOUR |
| K130708 |
03/15/2013 |
SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K130748 |
03/19/2013 |
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K130558 |
03/04/2013 |
SOMNODENT HERBST; CLASSIC, FLEX |
SOMNOMED INC. |
KATHRYN A JAYNE |
| K130801 |
03/22/2013 |
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K130709 |
03/15/2013 |
VISI MOBILE MONITORING SYSTEM |
SOTERA WIRELESS, INC |
EBEN GORDON |
| K130757 |
03/20/2013 |
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET; KOBOLD LUER TRANSFER GUIDE TUBE SET |
SPENCER FILLMORE |
CHRISTINA BERNSTEIN |
| K130863 |
03/28/2013 |
FACET SCREW SYSTEM |
SPINAL USA |
JANICE M HOGAN |
| K130594 |
03/07/2013 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K130727 |
03/18/2013 |
ENSITE VELOCITY SYSTEM |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K130545 |
03/01/2013 |
MULTI LEAD TRIAL CABLE |
ST. JUDE MEDICAL |
Lakshmi Padmanabhan |
| K130731 |
03/18/2013 |
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW |
STABILIZ ORTHOPAEDICS, LLC |
DOUGLAS L CERYNIK, MD |
| K130724 |
03/18/2013 |
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE |
STRAUMANN USA |
ELAINE ALAN |
| K130808 |
03/25/2013 |
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS |
STRAUMANN USA |
ELAINE ALAN |
| K130874 |
03/29/2013 |
STRYKER NAV3I PLATFORM |
STRYKER CORPORATE |
LILIAN ECKERT |
| K130826 |
03/26/2013 |
PASSPORT ROBOTIC REDUCER CAP; PASSPORT STOPCOCK WITH ROTATING MALE LUER |
Stryker Endoscopy |
REBECCA GOLDBERG |
| K130869 |
03/29/2013 |
TAKE 1 ADVANCE |
SYBRON DENTAL SPECIALTIES |
Wendy Garman |
| K130541 |
03/01/2013 |
SYMMETRY KERRISON DISPOSABLE TIP RONGEURS |
SYMMETRY SURGICAL |
DALENE BINKLEY |
| K130720 |
03/18/2013 |
SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
THOMAS SHEA |
| K130689 |
03/13/2013 |
SYMPHONY RF GENERATOR |
THERMIGEN, INC. |
KEVIN O'BRIEN |
| K130850 |
03/27/2013 |
PRIMI AND SECONDI SUPPORT CATHETERS |
THERMOPEUTIX INC. |
JASON FORD |
| K130827 |
03/26/2013 |
FIRMAP CATHETER |
TOPERA, INC. |
MELISSA WALKER |
| K130533 |
03/01/2013 |
SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS |
Tornier SAS |
SEVERINE BONNETON |
| K130645 |
03/11/2013 |
AQUILION PRIME, V5.00 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K130569 |
03/04/2013 |
ND NABIL DIB INFUSION CATHETER |
Translational Research Institute |
DeAnn Dana |
| K130581 |
03/05/2013 |
KONIX STERILE GEL |
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
MICHAEL SCOTT, REGULATORY AGENT |
| K130573 |
03/04/2013 |
TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF |
TYBER MEDICAL LLC |
JEFF TYBER |
| K130585 |
03/05/2013 |
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K130794 |
03/22/2013 |
CELLTRACKS ANALYZER II SYSTEM |
VERIDEX, LLC |
KIMBERLY PRESCOTT |
| K130636 |
03/11/2013 |
TELERADPRO EDGE; TELERADPRO EDGE HD-CCD |
VIDAR SYSTEMS CORP. |
CARRIE L BRANCART |
| K130873 |
03/29/2013 |
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M |
VITAL ACCESS |
CHRISTOPHER PHILLIPS |
| K130867 |
03/28/2013 |
ENFLOW IV FLUID WARMER INSULATED STRAP |
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY |
STACIE GEFFNER-ATIYA |
| K130703 |
03/15/2013 |
VIVORTE BVF |
VIVORTE, INC |
STEPHEN J PEOPLES |
| K130753 |
03/19/2013 |
STANDARD CONTACT LENS CASE; FLIP N SLIDE CONTACT LENS CASE |
WATCHDOG GROUP, LC |
JOHN O'HARA |
| K130768 |
03/20/2013 |
JIAJIAN CMN STIMULATOR |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
| K130658 |
03/12/2013 |
ELIXBO PM545 |
XBO MEDICAL SYSTEMS CO., LTD |
JINHONG GUO |
| K130611 |
03/07/2013 |
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE |
XERIDIEM MEDICAL DEVICES |
MICHELLE LOTT |
| K130674 |
03/13/2013 |
ENTUIT THRIVE LP BALLOON RETENTION GASTROSTOMY FEEDING TUBE |
XERIDIEM MEDICAL DEVICES |
MICHELLE LOTT |
| K130810 |
03/25/2013 |
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM |
ZIMMER, INC. |
SCOTT M DURLACHER |
| K130595 |
03/07/2013 |
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
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03/12/2013 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
| K130740 |
03/19/2013 |
NIGHTINGALE MONITORING SYSTEM |
ZOE MEDICAL, INC. |
JAMES CHICKERING |
| K130690 |
03/14/2013 |
Z-800 INFUSION SYSTEM |
ZYNO MEDICAL LLC |
MEI ZHANG PHD |
