FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K062292 |
10/25/2006 |
UNICEM |
3M ESPE DENTAL PRODUCTS |
SABINE KRISCHER |
K062305 |
10/18/2006 |
CLARITY MODIFIED CERAMIC BRACKETS |
3M UNITEK |
L MARLYN SCHEFF |
K062668 |
10/16/2006 |
AUDIT MICROCV IMMUNOASSAY LINEARITY SET |
AALTO SCIENTIFIC LTD. |
ALAN VEKICH |
K062337 |
10/05/2006 |
MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR |
AARON MEDICAL INDUSTRIES |
RICHARD A KOZLOFF |
K062843 |
10/17/2006 |
FOX SV PTA CATHETER |
ABBOTT LABORATORIES |
KATHRYN MARCHEL |
K063078 |
10/24/2006 |
MICROENDOSCOPE |
ACCLARENT, INC. |
DEBBIE COGAN |
K062967 |
10/30/2006 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY, INC. |
ANNE SCHLAGENHAFT |
K061232 |
10/06/2006 |
ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 |
ACRYMED, INC. |
BRUCE GIBBINS |
K061661 |
10/18/2006 |
STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20 |
ADVANCED INFUSION, INC. |
JAMES CHRISTENSEN |
K062686 |
10/05/2006 |
UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM |
ADVANCED SPINE TECHNOLOGY, INC. |
J.D. WEBB |
K061899 |
10/26/2006 |
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH M ASCENZI |
K062461 |
10/25/2006 |
C. ALBICANS PNA FISH |
ADVANDX, INC. |
Amy Aulwes |
K062742 |
10/13/2006 |
CR 85-X |
AGFA CORPORATION |
JUDITH HARBOUR |
K062143 |
10/24/2006 |
KOZY COMFORT INFANT POSITIONER |
ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING |
ARMAN H NADERSHAHI |
K062080 |
10/18/2006 |
RESUSCITATION TIMER, MODEL L770-CPR |
ALLIED HEALTHCARE PRODUCTS, INC. |
WAYNE KARCHER |
K053550 |
10/25/2006 |
AMBU BLUE SENSOR NEO AND NEO X |
AMBU A/S |
SANJAY PARIKH |
K052944 |
10/25/2006 |
AMBU WHITE SENSOR CFM, CFL |
AMBU A/S |
SANJAY PARIKH |
K062477 |
10/27/2006 |
AMICAS VISION SERIES PACS, MODEL 4.3 |
AMICAS, INC. |
PATRICE JC NEDELEC |
K062609 |
10/06/2006 |
MODIFICATION TO ANGIODYNAMICS PROFILER PTA BALLOON CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
K062157 |
10/13/2006 |
CONFORM |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
K061651 |
10/20/2006 |
FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158 |
APPLE MEDICAL CORP. |
JOHN C PULFORD |
K061005 |
10/04/2006 |
ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS |
APPLIED DNA TECHNOLOGIES, INC. |
Feng-Yu Lee |
K053590 |
10/06/2006 |
SILVERLON CA (CALCIUM ALGINATE) |
ARGENTUM MEDICAL, LLC. |
WILLIAM A CLEMNTI |
K061863 |
10/19/2006 |
ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY |
ARTHREX, INC. |
ANN WATERHOUSE |
K061925 |
10/31/2006 |
MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS |
ARTHREX, INC. |
SALLY FOUST |
K062244 |
10/02/2006 |
OPUS SMARTSTICH SUTURE DEVICE WITH PERFECTPASSER CONNECTOR |
ARTHROCARE CORP. |
LAURA KASPEROWICZ |
K061984 |
10/05/2006 |
TREASURE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K062861 |
10/31/2006 |
ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
GLEN NEALLY |
K053585 |
10/11/2006 |
VANGUARD REPROCESSED SUTURE PASSER |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON |
K060158 |
10/13/2006 |
NET-2000 MICROCURRENT STIMULATOR |
Auri-Stem Medical Inc. |
LEWIS WARD |
K062700 |
10/26/2006 |
INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
SCOTT PEASE |
K062699 |
10/26/2006 |
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
SCOTT PEASE |
K062887 |
10/26/2006 |
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F |
BARD PERIPHERAL VASCULAR |
GENEVIEVE BALUTOWSKI |
K062079 |
10/19/2006 |
XENIUM DIALYZER, MODELS 110, 130, 150, 170, 190 AND 210 |
BAXTER HEALTHCARE CORPORATION |
DAVID E CURTIN |
K060538 |
10/10/2006 |
BEAVERITE BODY FAT SCALES, MODELS 8901, 8903, 8905, 8909, 8911, 8915, 9563 AND 9568 |
BEAVERITE INTERNATIONAL LIMITED |
PATSY J TRISLER |
K052223 |
10/06/2006 |
ACCESS EPO ASSAY |
BECKMAN COULTER, INC. |
LYNN WEIST |
K062516 |
10/05/2006 |
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) |
BECKMAN COULTER, INC. |
TYLER FOUTCH |
K061616 |
10/04/2006 |
COULTER LH 780 HEMATOLOGY ANALYZER |
BECKMAN COULTER, INC. |
NANCY NADLER |
K062680 |
10/05/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML |
BECTON, DICKINSON & CO. |
VICKI L KENNEDY |
K062687 |
10/24/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K062774 |
10/19/2006 |
BELMONT BUDDY PLUS FLUID WARMER |
BELMONT INSTRUMENT CORP. |
URAIWAN P LABADINI |
K062730 |
10/05/2006 |
NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOMS |
BIOGREEN MEDICAL SDN. BHD. |
SRI MAHENDRA SATHIACAMA |
K062830 |
10/20/2006 |
BIOLUCENT APPLICATOR KIT |
BIOLUCENT, INC. |
DAVE CAMPBELL |
K063002 |
10/31/2006 |
ALTRA PRESS-FIT HIP SYSTEM |
BIOMET MANUFACTURING CORP. |
GARY BAKER |
K062995 |
10/31/2006 |
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT |
BIOMET MANUFACTURING CORP. |
PATRICIA S BERES |
K061681 |
10/19/2006 |
REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT |
BIOMET MANUFACTURING CORP. |
LESTER F PADILLA |
K063107 |
10/27/2006 |
3DNET SUITE |
BIOTRONICS3D, LTD. |
HARALAMBOS HATZAKIS |
K060756 |
10/30/2006 |
MEDLOG, MODEL 1-0-10 |
BMC GESELLSCHAFT FUR MEDIZINTECHNIK MBH |
ANGELIKA M BERGER |
K062387 |
10/05/2006 |
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM |
BOSTON SCIENTIFIC |
ANGIE BYLAND |
K062202 |
10/20/2006 |
OCCLUSION BALLOON |
BOSTON SCIENTIFIC CORP. |
CHRISTINE M CAMERON |
K062832 |
10/20/2006 |
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 |
C.R. BARD, INC. |
GLENN NORTON |
K061428 |
10/16/2006 |
PMP4 APPLICATION |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K061046 |
10/12/2006 |
CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 |
CARDIOMEMS, INC. |
CAROL VIERLING |
K062808 |
10/13/2006 |
LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT |
CATCH INCORPORATED |
Cindy Green |
K063037 |
10/18/2006 |
CENTARISONE RIS/PACS |
CENTARISONE, LLC |
SCOTT SHANNON |
K062476 |
10/31/2006 |
CERAGEM RH1 AUTOMATIC THERMAL MASSAGER |
CERAGEM INTERNATIONAL, INC. |
SUSAN ONEL |
K060927 |
10/06/2006 |
CERES PTA CATHETER MODELS PTA018,PTA035 VARIOUS SIZES |
CERES MEDICAL SYSTEMS, L.L.C. |
CORRINE BONFIGLIO |
K062240 |
10/16/2006 |
CAREVENT |
CHIEF MEDICAL LLC |
SCOTT HORN |
K062016 |
10/27/2006 |
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES |
CHOICE SMART HEALTH CARE CO. LTD. |
JANICE MA |
K062015 |
10/31/2006 |
CHRONOS VISION EYE TRACKING DEVICE (C-ETD) |
CHRONOS VISION |
MAUREEN O'CONNELL |
K062916 |
10/23/2006 |
CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 |
CLINIQA CORPORATION |
CAROL RUGGIERO |
K061876 |
10/16/2006 |
CODMAN VPV SYSTEM, MODEL 82-3192 |
Codman & Shurtleff, Inc. |
SUSAN KAGAN |
K062846 |
10/13/2006 |
COLLAGEN DENTAL MEMBRANE III |
COLLAGEN MATRIX, INC. |
PEGGY HANSON |
K062881 |
10/11/2006 |
COLLAGEN DENTAL MENBRANE - CONFORMABLE II |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
K052229 |
10/13/2006 |
COLOPLAST OSTOMY ROD, MODEL 12814 |
COLOPLAST CORP. |
ELIZABETH BOOTS |
K063032 |
10/16/2006 |
COMFORT SCOOTER, MODEL LY-EW415 |
COMFORT ORTHOPEDIC CO. LTD. |
Ke-Min Jen |
K062215 |
10/16/2006 |
CONFIDANT 2.0 |
CONFIDANT INC. |
DANIEL R PLONSKI |
K052992 |
10/16/2006 |
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY |
CONMED LINVATEC |
ELIZABETH PAUL |
K062697 |
10/13/2006 |
SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT |
COOK BIOTECH, INC. |
MARY A FADERAN |
K062320 |
10/02/2006 |
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100 |
COOK BIOTECH, INC. |
MARY A FADERAN |
K062729 |
10/10/2006 |
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG |
COOK BIOTECH, INC. |
DANIEL J DILLON |
K062696 |
10/13/2006 |
SURGISIS, SURGISIS ES |
COOK BIOTECH, INC. |
MARY A FADERAN |
K062438 |
10/27/2006 |
BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 |
COOK OB/GYN |
CINDY RUMPLE |
K053538 |
10/10/2006 |
MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER |
CURAPHARM, INC. |
THOMAS M HNAT |
K062321 |
10/31/2006 |
SMARTLIPO ND:YAG LASER |
CYNOSURE, INC. |
GEORGE CHO |
K062035 |
10/04/2006 |
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND CONTROL |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062927 |
10/12/2006 |
MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) |
DADE BEHRING, INC. |
MAY MORISHIMA |
K063064 |
10/26/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K063053 |
10/26/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) |
DADE BEHRING, INC. |
SHANNON POPSON |
K062375 |
10/26/2006 |
MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K063065 |
10/27/2006 |
MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062923 |
10/13/2006 |
MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) |
DADE BEHRING, INC. |
LIBBY WARRINER |
K062777 |
10/10/2006 |
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062773 |
10/13/2006 |
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN |
DADE BEHRING, INC. |
LIBBY WARRINER |
K062705 |
10/20/2006 |
SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
K062103 |
10/25/2006 |
DARCO FORCE TITANIUM COMPRESSION SCREW |
DARCO INTERNATIONAL, INC. |
MARK S COOPER |
K061754 |
10/23/2006 |
BARD COMPOSITE L/P MESH |
DAVOL INC., SUB. C.R. BARD, INC. |
GAIL DOW |
K062732 |
10/25/2006 |
TOMAS PIN 6 MM |
DENTAURUM |
CHARLES R BELL |
K060836 |
10/27/2006 |
VISTADENT OC - VERSION 4 |
DENTSPLY INTL., INC. |
HELEN LEWIS |
K062301 |
10/13/2006 |
DEPUY LPS PROXIMAL TIBIAL COMPONENT |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
K062148 |
10/24/2006 |
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER |
DEPUY ORTHOPAEDICS, INC. |
ANNE M SCHULER |
K062352 |
10/19/2006 |
FRS SCREW |
DEPUY ORTHOPAEDICS, INC. |
REBECCA LENNARD |
K062495 |
10/13/2006 |
HEALOS FX BONE GRAFT SUBSTITUTE AND GRAFT MIXING AND DELIVERY SYSTEM |
DEPUY SPINE, INC. |
MELANIE ARCHER |
K060653 |
10/24/2006 |
THERMACLEAR |
DERMACARE, INC. |
HEIDI STARK |
K062959 |
10/16/2006 |
DMS 300-2, 300-3 AND 300-4 |
DIAGNOSTIC MONITORING SOFTWARE |
WILLIAM PARSONS |
K060204 |
10/18/2006 |
LIAISON EA IGG |
DIASORIN, INC. |
DAVID M IKEDA |
K062032 |
10/05/2006 |
ACCUSOFT, ACCUSOFT XL |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K062147 |
10/20/2006 |
INTEGRA SL |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K062267 |
10/31/2006 |
OXYLOG 3000 |
DRAGER MEDICAL B.V. |
BRYAN OVERTON |
K062895 |
10/13/2006 |
XENON BRIGHTSTAR ILLUMINATION SYSTEM, MODEL 1266.XIII |
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV |
F CARLETON |
K061878 |
10/24/2006 |
ELECTRODE COATED BALL, MODEL AB302C; NEEDLE, MODEL AN301C; BLADE, MODEL AE301HC |
E SURGICAL, LLC |
LEWIS WARD |
K061996 |
10/03/2006 |
SANDMAN POCKET |
EB NEURO, S.P.A. |
CARRI GRAHAM |
K062685 |
10/06/2006 |
EBI ARAY SPINAL SYSTEM |
EBI, L.P. |
DEBRA BING |
K062494 |
10/19/2006 |
EBI OPTILOCK UPPER EXTREMITY PLATING SYSTEM |
EBI, L.P. |
DEBRA BING |
K062810 |
10/17/2006 |
SOLITAIRE ANTERIOR SPINAL SYSTEM |
EBI, L.P. |
DEBRA BING |
K062716 |
10/27/2006 |
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 |
ECO-RX, INC. |
CONSTANCE R BROWN, ESQ. |
K062054 |
10/06/2006 |
5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K060781 |
10/03/2006 |
MEDICAL COMPRESSOR, MODELS DK50 D AND DM |
EKOM S.R.O. |
ESTHER SALTZ |
K062743 |
10/31/2006 |
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0 |
ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM) |
JEFFREY CHERN |
K062888 |
10/24/2006 |
MIDDLE WHEEL DRIVE POWER CHAIR, CWD01 |
EMG TECHNOLOGY CO., LTD. |
Ke-Min Jen |
K063113 |
10/27/2006 |
EP-WORKMATE |
EP MEDSYSTEMS |
LARRY PICCIANO |
K062598 |
10/31/2006 |
IMT.LAB SOFTWARE |
ESAOTE EUROPE B.V. |
CARRI GRAHAM |
K061614 |
10/06/2006 |
TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS |
ESCADA INTERNATIONAL, INC. |
MARY MCNAMARA-CULLINANE |
K062209 |
10/10/2006 |
BASX BLADELESS TROCAR |
ETHICON ENDO-SURGERY, LLC |
DENNIS HAHN |
K061804 |
10/06/2006 |
ZERION ALPHA, ; ZERION BETA |
ETKON INTERNATIONAL GMBH |
MATTHIAS ZITZMANN |
K061408 |
10/05/2006 |
EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT |
EUROIMMUN US LLC |
KATHRYN KOHL |
K062549 |
10/04/2006 |
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
K061188 |
10/23/2006 |
SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM |
FOXHOLLOW TECHNOLOGIES, INC. |
MELISSA S MURPHY |
K062090 |
10/18/2006 |
PRISMA SYSTEM R03.10A |
GAMBRO RENAL PRODUCTS |
THOMAS B DOWELL |
K061413 |
10/13/2006 |
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM |
GEN-PROBE, INC. |
BRIAN J SHEA |
K061509 |
10/04/2006 |
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196 |
GEN-PROBE, INC. |
BRIAN J SHEA |
K062312 |
10/16/2006 |
AXIOM PULSED LIGHT SYSTEM |
GENERAL PROJECT S.R.L. |
CORNELIA DAMSKY |
K061417 |
10/10/2006 |
GENICON DISPOSABLE ELECTROSURGICAL INSTRUMENTATION, MODEL 533-005-910 |
GENICON |
GARY HABERLAND |
K062786 |
10/18/2006 |
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
K062010 |
10/27/2006 |
RAPID DIGITAL THERMOMETER, MODEL RDT -18 SERIES |
GLOBAL TREASURE INDUSTRIES LTD. |
JANICE MA |
K061234 |
10/30/2006 |
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM |
GLUCOPLUS INC |
JEFFREY FLEISHMAN |
K062672 |
10/24/2006 |
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES |
Grace Medical, Inc. |
JEFF COBB |
K061153 |
10/27/2006 |
GYNESONICS EC6 TRANSDUCER |
GYNESONICS, INC. |
JESSICA GROSSMAN, MD |
K062801 |
10/04/2006 |
SMARTSUCTION SOLO DEVICE |
HAEMONETICS CORP. |
GABRIEL J MURACA |
K061070 |
10/13/2006 |
HANSEN MEDICAL TRANSSEPTAL NEEDLE AND DILATOR |
HANSEN MEDICAL, INC. |
NINA PELED |
K060669 |
10/13/2006 |
MEDRELIEF ST SERIES, MODELS RT-50, ST-100, ST 150, ST-200, ST-300 |
HEALTHONICS, INC. |
JAMES W KRONBERG |
K063191 |
10/31/2006 |
HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT |
HEIDELBERG ENGINEERING |
GERHARD ZINSER |
K062556 |
10/05/2006 |
ECHELON SHOULDER COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLEWAITE |
K062180 |
10/02/2006 |
ABX PENTRA AMYLASE CP; MULTICAL; N CONTROL; P CONTROL; CLEAN-CHEM CP; CLEAN-CHEM 99 CP |
HORIBA ABX |
TIM LAWTON |
K061585 |
10/05/2006 |
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER |
HOSPIRA, INC. |
NICOHL WILDING |
K062498 |
10/25/2006 |
PROFYLE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
K062113 |
10/03/2006 |
SOLAR REUNION FRACTURE STEM |
HOWMEDICA OSTEONICS CORP. |
FRANCISCO HARO |
K062634 |
10/06/2006 |
ORTHOXP |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K051436 |
10/13/2006 |
PRE' VAGINAL LUBRICANT |
INGFERTLITY, LLC |
DENNIS CLIFTON |
K062617 |
10/04/2006 |
MODIFICATION TO INION OTPS BIODEGRADABLE FIXATION SYSTEM |
INION LTD. |
KATI MARTINEN |
K061746 |
10/02/2006 |
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
K062361 |
10/23/2006 |
INNOVACON HCG UKTRA TEST DEVICE |
INNOVACON, INC. |
EDWARD TUNG |
K061842 |
10/18/2006 |
QUANTA LITE PBC SCREEN IGG/IGA ELISA |
INOVA DIAGNOSTICS, INC. |
GARY L NORMAN |
K062665 |
10/24/2006 |
INOVEL HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS |
INOVEL LLC |
WILLIAM WAWRZYNIAK |
K062129 |
10/20/2006 |
P.0004 IMPLANTS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
K062068 |
10/27/2006 |
INTELWAVE HEART RATE VARIABILITY SYSTEM, VERSION 1.0 |
INTELWAVE, LLC |
ALEXANDER RIFTINE |
K062809 |
10/18/2006 |
ADMIRAL XTREME PTA CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES |
David Worrell |
K062735 |
10/27/2006 |
TUTU 7, MODEL IV-T22 |
INVISIBLE TECHNOLOGY CO., LTD. |
Allison Scott |
K062767 |
10/13/2006 |
CTL-63 AND CTL-128 SPINE ARRAY COILS |
INVIVO CORPORATION |
THOMAS SCHUBERT |
K062144 |
10/12/2006 |
ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 |
INVIVO CORPORATION |
RUSTY KELLY |
K061549 |
10/18/2006 |
AMNIOSTAT-FLM-PG |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE, PHARM. D |
K061679 |
10/13/2006 |
WALLACE ARTIFICIAL INSEMINATION CATHETER |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K062520 |
10/11/2006 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
JIANGSU JAYSUN GLOVE CO., LTD. |
CHU XIAOAN |
K062311 |
10/04/2006 |
KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800 |
KARMA MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K062309 |
10/10/2006 |
KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105 |
KARMA MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
K062227 |
10/04/2006 |
V.A.C. THERAPY SYSTEM |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
MARGARET MARSH |
K062870 |
10/20/2006 |
TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 |
KENSEY NASH CORP. |
ROBIN M FATZINGER |
K062519 |
10/19/2006 |
NEXUS 3 |
KERR CORPORATION |
COLLEEN BOSWELL |
K062660 |
10/24/2006 |
CATALYSY |
KI MOBILITY LLC |
DOUGLAS MUNSEY |
K061465 |
10/05/2006 |
KMI CEMENT RESTRICTOR IMPLANT |
KINETIKOS MEDICAL, INC. |
JOHN G SPAMPINATO |
K062570 |
10/31/2006 |
PATIENT CONTOURED MESH (PCM) |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K060414 |
10/23/2006 |
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE |
KMI KOLSTER METHODS, INC. |
JEFFREY A KOLSTER |
K060458 |
10/12/2006 |
MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR |
LANGFORD IC SYSTEMS, INC. |
JIMMIE T JOHNSTON |
K062831 |
10/19/2006 |
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM |
LIFE SPINE |
ERIN MALLOY |
K063024 |
10/30/2006 |
LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHETAMINE ORAL FLUID CALIBRATORS AND CONTROLS |
Lin-Zhi International, Inc. |
MARIE LIN |
DEN060007 |
10/12/2006 |
INTROL CF PANEL I CONTROL |
MAINE MOLECULAR QUALITY CONTROLS, INC. |
JOAN GORDON |
K062864 |
10/18/2006 |
MASTALEX -MRSA, MODEL RST501 |
MAST GROUP LTD. |
BARBARA A LEE |
K063047 |
10/19/2006 |
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM |
MEDHOT THERMAL IMAGING, INC. |
SID MATHUR |
K062136 |
10/06/2006 |
PASS 2 SPINAL SYSTEM |
MEDICREA |
J.D. WEBB |
K061145 |
10/02/2006 |
SPERMSLOW |
MEDICULT A/S |
RONALD G LEONARDI |
K062386 |
10/05/2006 |
QANGIO CT |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
J.I. HOLLANDER |
K062295 |
10/20/2006 |
IRI INTEGRATED RETINAL IMAGER |
MEDIVISION MEDICAL IMAGING, LTD. |
AHAVA STEIN |
K060772 |
10/16/2006 |
MANUEL SAFTEY SYRINGE PARTS 1 & 2 |
MEDSAFE ASA |
NILS GUNNARSSON |
K060615 |
10/25/2006 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K062727 |
10/11/2006 |
CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE |
MEDTRONIC VASCULAR |
SCOTT CANDY |
K061416 |
10/25/2006 |
SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 |
MEDTRONIC VASCULAR |
MICHELLE NIVALA |
K062421 |
10/10/2006 |
MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER |
MENTOR CORPORATION |
NICOLA SELLEY |
K062490 |
10/27/2006 |
VISAGE PACS/CS, RELEASE VERSION 4.1 |
MERCURY COMPUTER SYSTEMS, INC |
RICHARD GLASHEEN |
K062302 |
10/06/2006 |
MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM |
MILLICORE AB |
ROSINA ROBINSON |
K050197 |
10/06/2006 |
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 |
MINITUBE OF AMERICA, INC |
FREDERICK T RIKKERS |
K062471 |
10/26/2006 |
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF |
MISONIX, INC. |
RONALD R MANNA |
K062663 |
10/11/2006 |
MOLDEX HEALTH CARE N95 PARTICULATE RESPIRATORS AND SURGICAL MASKS |
MOLDEX/METRIC, INC. |
WILLIAM WAWRZYNIAK |
K062138 |
10/05/2006 |
POWDER FREE STERILE NITRILE EXAMINATION GLOVES, BLUE; POWDER FREE POLYCHLOROPRENE STERILE EXAMINATION GLOVE |
MOLNLYCKE HEALTH CARE, INC. |
STEVE DOWDLEY |
K061700 |
10/26/2006 |
NEOTRACT ANCHOR |
NEOTRACT, INC. |
KEVIN MACDONALD |
K062860 |
10/27/2006 |
MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
K062779 |
10/05/2006 |
DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) |
NEW WAVE SURGICAL CORPORATION |
SID MATHUR |
K061359 |
10/18/2006 |
DENSHIELD TREATMENT FOR SENSITIVE TEETH |
NOVAMIN TECHNOLOGY, INC. |
DAVID C GREENSPAN |
K062456 |
10/16/2006 |
NOVASPINE POWERED SUCTION PUMP PRO-1 |
NOVASPINE LLC |
DINA L WEISSMAN |
K061575 |
10/05/2006 |
OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 |
OLYMPUS AMERICA, INC. |
BEV HARDING |
K062647 |
10/20/2006 |
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 |
OMEGA MEDICAL IMAGING, INC. |
JAMES A PRINCEHORN |
K060971 |
10/24/2006 |
OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS |
OMI MANUFACTURING PTY., LTD. |
DANIEL KAMM |
K062336 |
10/19/2006 |
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE |
OPTIMEDICA CORPORATION |
JUDY F GORDON |
K062552 |
10/06/2006 |
RTVUE |
OPTOVUE, INC. |
JAY WEI |
K062260 |
10/26/2006 |
OSTEOBOOST-BMA |
ORTHOS LIMITED |
ALAN RORKE |
K062156 |
10/20/2006 |
SUPER ORTHODONTIC SCREW |
OSSTEM IMPLANT CO LTD |
CATHRYN CAMBRIA |
K062863 |
10/31/2006 |
OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM |
OSTEOMED L.P. |
DAWN D TINDALL |
K062047 |
10/05/2006 |
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K061172 |
10/17/2006 |
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
LYNETTE L HOWARD |
K062097 |
10/13/2006 |
VERESS CANNULA AND MODULAR VERESS CANNULA |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K062653 |
10/27/2006 |
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 |
PARNELL PHARMACEUTICALS, INC. |
FRANCIS W PARNELL |
K052907 |
10/16/2006 |
POLARCOAT |
PATTON SURGICAL CORP. |
VIKKI BALLESTEROS |
K060889 |
10/27/2006 |
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE |
PENTRON CLINICAL TECHNOLOGIES |
GREG MOREAU |
K060163 |
10/11/2006 |
CARDIOFLON, CARDIOXYL |
PETERS SURGICAL |
ANNIE LASSERRE |
K062366 |
10/02/2006 |
OPTIME, SINUSORB PGA |
PETERS SURGICAL |
ANNIE LASSERRE |
K062338 |
10/25/2006 |
TELEVISIT |
PHD MEDICAL |
NANCY RUTH |
K062268 |
10/18/2006 |
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
DAVID OSBORN |
K062481 |
10/16/2006 |
SERENO ELECTRONIC STETHOSCOPE |
PISHON HIGH TECH CO., LTD. |
DANIEL KAMM |
K061362 |
10/06/2006 |
PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEM |
PLUS ORTHOPEDICS AG |
PAMELA J WEAGRAFF |
K062540 |
10/18/2006 |
NASOPORE EAR, MODELS ND04, ND05 |
Polyganics BV |
JAN NIEUWENHUIS |
K062061 |
10/05/2006 |
URASSIST |
PREFERRED MEDICAL DEVICES, INC. |
PENELOPE GRECO |
K061998 |
10/04/2006 |
PREMIER SELF-ETCHING BOND ENHANCER |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K061997 |
10/04/2006 |
PREMIER SELF-ETCHING ENAMEL SEALANT |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
K062751 |
10/03/2006 |
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER |
QUANTIMETRIX CORP. |
BERNICE NAVARRO |
K062942 |
10/30/2006 |
QUANTIMETRIX NICOSURE COTININE URINE CONTROL |
QUANTIMETRIX CORP. |
BERNICE NAVARRO |
K051968 |
10/16/2006 |
ABL8X7 FLEX |
RADIOMETER MEDICAL APS |
LENE MEINECHE MARNAES |
K060265 |
10/25/2006 |
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR |
REMCORE, INC. |
KEVIN JORCZAK |
K062376 |
10/27/2006 |
DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI |
RF SYSTEMS LAB. |
CLAUDE D BERTHOIN |
K062935 |
10/13/2006 |
HABIB 4X LAPAROSCOPIC |
RITA MEDICAL SYSTEMS |
DARRIN R UECKER |
K062972 |
10/13/2006 |
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS |
ROCHE DIAGNOSTICS CORP. |
KERWIN L KAUFMAN |
K062695 |
10/20/2006 |
SAGEMAX Z-BLANK |
SAGEMAX BIOCERAMICS, INC. |
LARRY DANG |
K062418 |
10/19/2006 |
K-SPRAY, MODEL 085-2715 |
SCICAN |
BRENDA MURPHY |
K061342 |
10/25/2006 |
MALIBU SPINAL SYSTEM |
SEASPINE, INC. |
DIANA SMITH |
K061922 |
10/30/2006 |
BREATH ALCOHOL TEST SYSTEM, MODEL AL-5000 |
SENTECH KOREA CORP. |
DANIEL PARK |
K063110 |
10/26/2006 |
CST61 HIGH SPEED TURBINE HANDPIECE |
SHANGHAI DENTAL INSTRUMENT FACTORY |
JAY MANSOUR |
K062360 |
10/05/2006 |
BRANSIST SAFIRE |
SHIMADZU CORP. |
RANDAL WALKER |
K062351 |
10/05/2006 |
SYNGO DUAL ENERGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GARY JOHNSON |
K063877 |
10/18/2006 |
SYNGO LUNG CAD |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MORTEZA MINAEE |
K050158 |
10/11/2006 |
SINCLAIR SEBORRHEA EMULSION |
SINCLAIR PHARMACEUTICALS, LTD. |
MICHEAL KILLEEN |
K062903 |
10/20/2006 |
SBI CARPAL FUSION PLATE |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
K062040 |
10/03/2006 |
SBI TRIHEDRON MTP HEMI GT |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
K052055 |
10/26/2006 |
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 |
SMISSON-CARTLEDGE BIOMEDICAL LLC |
JULIE STEPHENS |
K062005 |
10/18/2006 |
PORTEX EPIDURAL CATHETER |
SMITHS MEDICAL ASD, INC. |
CYNTHIA ENGELHARDT |
K062472 |
10/31/2006 |
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 |
SOURCE-RAY, INC. |
RAY MANEZ |
K062450 |
10/20/2006 |
D-SPECT CARDIAC SCANNER SYSTEM |
SPECTRUM DYNAMICS LTD. |
AHAVA STEIN |
K062496 |
10/19/2006 |
OSTEOPORE TCP |
SPINECRAFT, INC. |
AMI AKALLAL-ASSAD |
K062805 |
10/13/2006 |
MODIFICATION TO ENDO-EASE |
SPIRUS MEDICAL, INC. |
PAMELA PAPINEAU |
K062251 |
10/20/2006 |
REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804 |
ST. JUDE MEDICAL |
GLENN JACQUES |
K062257 |
10/10/2006 |
STARION INSTRUMENTS THERMAL LITIGATING SHEARS |
STARION INSTRUMENTS |
BRIAN GRIGSBY |
K061544 |
10/13/2006 |
STELLARTECH 100 COAGULATION SYSTEM |
STELLARTECH RESEARCH CORP. |
JAMES R SANTOS |
K060967 |
10/19/2006 |
NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION |
STEREOTAXIS, INC. |
DENNIS POZZO |
K061725 |
10/26/2006 |
STRYKER ARIA PNEUMATIC SYSTEM |
STRYKER INSTRUMENTS |
VALERIE FRANCK |
K061660 |
10/10/2006 |
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE |
STRYKER INSTRUMENTS |
JENNIFER HOFFMAN |
K062853 |
10/24/2006 |
MODIFICATION TO STRYKER SPINE OASYS SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K062698 |
10/11/2006 |
TRIO + SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K061626 |
10/05/2006 |
VASORING* VRC VASCULAR RING CONNECTOR |
SUNWEI TECH CO. LTD. |
JOSEPH J CHANG |
K062882 |
10/20/2006 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
SUQIAN GREEN GLOVE CO., LTD. |
CHU XIAOAN |
K062949 |
10/18/2006 |
ENSEAL PTC TISSUE SEATING SEALING DEVICE |
SURGRX INC |
LINDA OLESON |
K063097 |
10/18/2006 |
ENSEAL PTC TISSUE SEALING DEVICE |
SURGRX, INC. |
LINDA OLESON |
K062125 |
10/19/2006 |
SUPERSTITCH 5F, 12F, AND EL |
SUTURA, INC. |
GERARD J PRUD'HOMME |
K062564 |
10/19/2006 |
SYNTHES LCP DISTAL FEMUR PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K062818 |
10/06/2006 |
FLEXITOUCH SYSTEM |
TACTILE SYSTEMS TECHNOLOGY INC |
PHILLIP R ROSE |
K062529 |
10/05/2006 |
BELMAX CM MODEL X168 |
TAKARA BELMONT USA, INC. |
ROBERT SCHIFF |
K062858 |
10/20/2006 |
MODIFICATION TO GLIDESHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K062446 |
10/23/2006 |
MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
K061001 |
10/12/2006 |
THERMASSAGE |
THERMAGE, INC. |
PAMELA M BUCKMAN |
K052267 |
10/27/2006 |
SUPERCATH V |
TOGO MEDIKIT CO., LTD. |
FUMIAKI KANAI |
K061645 |
10/31/2006 |
MAGPRO, MODEL R30 |
TONICA ELEKTRONIK A/S |
LISE TERKELSEN |
K061411 |
10/18/2006 |
TORBOT VASCULAR COMPRESSION GARMENTS |
TORBUT GROUP, INC. |
Greg Johnson |
K062722 |
10/20/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K062783 |
10/26/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K062681 |
10/13/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, LTD. |
CYNTHIA C KNAPP |
K062829 |
10/10/2006 |
DIACHEX BLOOD GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
K062850 |
10/23/2006 |
AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
FRANK GIANELLI |
K061219 |
10/06/2006 |
D-STAT DRY HEMOSTATIC BANDAGE |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
K062344 |
10/02/2006 |
GRANDIO SEAL |
VOCO GMBH |
MICHAEL SUES |
K062778 |
10/27/2006 |
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED |
WEAR SAFE MALAYSIA SDN. BHD. |
LIM L BUNG |
K063007 |
10/17/2006 |
POWERTOME PERIOTOME |
WESTPORT MEDICAL, INC. |
RALPH WELLS |
K062790 |
10/11/2006 |
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E |
WU'S TECH CO., LTD. |
Ke-Min Jen |
K061847 |
10/12/2006 |
ZIMMER CONTOUR CERAMIC ABUTMENT, MODELS ZRA341S, ZRA342S, KRA451S, ZRA452S |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
K062029 |
10/31/2006 |
ANATOMICAL SHOULDER FRACTURE SYSTEM |
ZIMMER GMBH |
MASON W ROBBINS |
K062768 |
10/13/2006 |
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |