| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K062493 |
11/17/2006 |
LAVA SOFTWARE |
3M ESPE AG DENTAL PRODUCTS |
SABINE KRISCHER |
| K062855 |
11/22/2006 |
CALCIUM |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K063173 |
11/03/2006 |
MODIFICATION TO SILVER ALGINATE II WOUND DRESSING |
ADVANCED MEDICAL SOLUTIONS LIMITED |
GRAHAME SOMERVILLE |
| K062135 |
11/07/2006 |
ART SHIELDED BREAST APPLICATOR |
ADVANCED RADIATION THERAPY, LLC |
RAYMOND J BRICAULT |
| K062510 |
11/17/2006 |
AESCULAP STERILCONTAINER SYSTEM |
AESCULAP |
MATTHEW M HULL |
| K062413 |
11/21/2006 |
AESCULAP PNEUMATIC KERRISON |
AESCULAP, INC. |
KATHY A RACOSKY |
| K062684 |
11/22/2006 |
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD |
AESCULAP, INC. |
KATHY A RACOSKY |
| K062434 |
11/13/2006 |
ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528 |
AGAMATRIX |
CONNIE HERTEL |
| K063421 |
11/22/2006 |
DX-SI |
AGFA CORP. |
JEFFERY A JEDLICKA |
| K062930 |
11/08/2006 |
LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM |
ALCON RESEARCH, LTD. |
JANET G JOHNSON |
| K062212 |
11/21/2006 |
SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S |
ANACAPA TECHNOLOGIES, INC. |
ILA DOSHI |
| K062466 |
11/29/2006 |
ARTHREX INTERFERENCE SCREW |
ARTHREX, INC. |
ANN WATERHOUSE |
| K061601 |
11/17/2006 |
ASAHI PRECIOUS GUIDE CATHETER |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K062186 |
11/09/2006 |
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K062467 |
11/22/2006 |
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 |
AXIS-SHIELD DIAGNOSTICS, LTD. |
ERICA CONWAY |
| K061639 |
11/01/2006 |
ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON |
AXON SYSTEMS, INC. |
HOWARD BAILIN |
| K063280 |
11/17/2006 |
INJEKT SYRINGE |
B. BRAUN MEDICAL, INC. |
CHRISTINE FORD |
| K062715 |
11/03/2006 |
SYNTHETIC VINYL PATIENT EXAM GLOVES POWDER-FREE, YELLOW |
BAODING GUANZHONG GLOVE CO., LTD. |
MARY A DOUCETTE |
| K062131 |
11/17/2006 |
NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB |
BARCOVIEW |
LIEVEN DE WANDEL |
| K062441 |
11/14/2006 |
BARRX HALO COAGULATION SYSTEM; GENERATOR, MODEL 90-9000; OUTPUT CABLE, MODEL 90-9010; FOOTSWITCH, MODEL 90-9020 |
BARRX MEDICAL, INCORPORATED |
JONATHAN S KAHAN |
| K062723 |
11/09/2006 |
HALO90 COAGULATION CATHETER |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K062347 |
11/22/2006 |
ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE, LLC |
MARC HENN |
| K062944 |
11/15/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
| K062945 |
11/21/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML |
BECTON, DICKINSON & CO. |
VICKI L KENNEDY |
| K062044 |
11/21/2006 |
THE 5.0 X 6.0MM DENTAL IMPLANT |
BICON, INC. |
VINCENT J MORGAN |
| K062109 |
11/09/2006 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
Angela Drysdale |
| K061567 |
11/22/2006 |
BIOHORIZONS CERAMIC ABUTMENT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K061794 |
11/21/2006 |
FIDIS TM THYRO, MODEL MX002 |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
CHRISTELLE COURIVAUD |
| K062980 |
11/22/2006 |
ACTIVASCREW |
BIORETEC LTD |
MARI RUOTSALAINEN |
| K052742 |
11/07/2006 |
HEPASPHERE MICROSPHERES |
BIOSPHERE MEDICAL, INC. |
ROSINA ROBINSON |
| K063060 |
11/29/2006 |
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP |
BLUESHINE SRL |
ALICE NOVELLI |
| K063312 |
11/30/2006 |
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 |
BOSTON SCIENTIFIC CORP. |
ROBERT Z PHILLIPS |
| K063178 |
11/21/2006 |
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 |
C.R. BARD, INC. |
STEPHANIE BAKER |
| K063240 |
11/21/2006 |
SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR |
C.R. BARD, INC. |
LYNN M KIRCHOFF |
| K061705 |
11/21/2006 |
CADWELL EASYNET NASAL PRESSURE MODULE |
CADWELL LABORATORIES, INC. |
CHRIS BOLKAN |
| K062886 |
11/06/2006 |
ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K062619 |
11/14/2006 |
DENLASER 800 PLUS |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K063193 |
11/21/2006 |
MODIFICATION TO BIOMARC TISSUE MARKER |
CARBON MEDICAL TECHNOLOGIES, INC. |
ROBERT W JOHNSON |
| K053524 |
11/16/2006 |
C-PORT DISTAL ANASTOMOSIS SYSTEM |
CARDICA, INC. |
DAVID CASAL |
| K063288 |
11/28/2006 |
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X |
CARDINAL HEALTH 303, INC. |
STACY L LEWIS |
| K062340 |
11/30/2006 |
CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM |
CARDIO-OPTICS, INC. |
LARRY BLANKENSHIP |
| K063222 |
11/14/2006 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 |
CARDIONET, INC |
JACK GAIKWAD |
| K062400 |
11/16/2006 |
IMPRESSIX, COLORCHANGE ALGINATE |
CAVEX HOLLAND B.V. |
RICHARD WOORTMAN |
| K062487 |
11/17/2006 |
APERFIX FEMORAL IMPLANT WITH INSERTER |
CAYENNE MEDICAL, INC. |
Floyd Larson |
| K063289 |
11/16/2006 |
2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC |
CHI LIN TECHNOLOGY CO., LTD. |
JUDY LIN |
| K063266 |
11/09/2006 |
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC |
CHI LIN TECHNOLOGY CO., LTD. |
JUDY LIN |
| K063291 |
11/21/2006 |
INFRARED EAR THERMOMETER, MODEL IRT-21 AND IRT-22 |
CHOICE SMART HEALTH CARE CO. LTD. |
JANICE MA |
| K062262 |
11/14/2006 |
CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS |
CIBA VISION CORPORATION |
ALICIA M PLESNARSKI |
| K063079 |
11/07/2006 |
I-STOP TRANS OBTURATOR MALE SLING |
CL MEDICAL |
VINCENT GORIA |
| K062593 |
11/22/2006 |
CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET |
COMPASS BIOSCIENCE |
CARTER GRANDJEAN |
| K061814 |
11/30/2006 |
VASOPRESS DVT SYSTEM, MODEL VP500D |
COMPRESSION THERAPY CONCEPTS, INC. |
LEONARD NASS |
| K062548 |
11/01/2006 |
MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES |
CONTAMAC LTD. |
MARTIN DALSING |
| K063252 |
11/14/2006 |
ATB ADVANCED PTA DILATATION CATHETER |
COOK, INC. |
KAREN BRADBURN |
| K061948 |
11/22/2006 |
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS |
COOPERVISION, INC. |
LISA HAHN |
| K060987 |
11/02/2006 |
OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 |
CP MEDICAL |
BETSY CORTELLONI |
| K061892 |
11/22/2006 |
PROPATCH SOFT TISSUE REPAIR MATRIX |
CRYOLIFE, INC. |
JOHN D FERROS |
| K063102 |
11/09/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) |
DADE BEHRING, INC. |
SHANNON POPSON |
| K063099 |
11/01/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) |
DADE BEHRING, INC. |
MAY MORISHIMA |
| K063101 |
11/01/2006 |
MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML |
DADE BEHRING, INC. |
MAUREEN MENDE |
| K063299 |
11/27/2006 |
MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN |
DADE BEHRING, INC. |
MAY MORISHIMA |
| K062938 |
11/20/2006 |
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K062754 |
11/02/2006 |
GAS MODULE SE, MODEL 0998-00-0481-02 |
DATASCOPE CORP. |
KATHLEEN KRAMER |
| K062469 |
11/03/2006 |
VOYAGER 12 |
DEL MAR REYNOLDS MEDICAL, LTD. |
GEORGE MYERS |
| K063188 |
11/30/2006 |
DEL-IMS |
DEL MEDICAL IMAGING CORP. |
WILLIAM J ENGEL |
| K062733 |
11/09/2006 |
TOMAS PIN SD 6, 8, AND 10 MM |
DENTAURUM |
CHARLES R BELL |
| K062828 |
11/27/2006 |
MOUTHGUARD AND ALIGNER MATERIALS |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K063273 |
11/22/2006 |
PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR |
DEPUY MILTEK, A JOHNSON & JOHNSON CO. |
KRISTINE CHRISTO |
| K062748 |
11/30/2006 |
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD |
DEPUY ORTHOPAEDICS, INC. |
ANNE M SCHULER |
| K062174 |
11/02/2006 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
MARY GRAY |
| K063156 |
11/22/2006 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K061101 |
11/20/2006 |
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT |
DIAGNOSTIC HYBRIDS, INC. |
GAIL R GOODRUM |
| K063067 |
11/03/2006 |
CONFIDENCE FENESTRATED INTRODUCER NEEDLE |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K063146 |
11/27/2006 |
ACCU-CHEK LINKASSIST |
DISETRONIC MEDICAL SYSTEMS AG |
Scott Thiel |
| K063029 |
11/02/2006 |
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 |
E-Z-EM, INC. |
TRACEY CAMPBELL |
| K061696 |
11/13/2006 |
IQQA-LIVER SOFTWARE |
EDDA TECHNOLOGY, INC. |
XIAOLAN ZENG |
| K063120 |
11/09/2006 |
COLOR LCD MONITOR, RADIFORCE, MODEL RX210 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K062507 |
11/22/2006 |
MICRO-INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K063448 |
11/30/2006 |
EMG AC/DC SUCTION UNIT |
EMG TECHNOLOGY CO., LTD. |
SALLY CHUANG |
| K063257 |
11/22/2006 |
FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K063277 |
11/30/2006 |
MAPMATE |
EP MEDSYSTEMS, INC. |
LARRY PICCIANO |
| K063207 |
11/09/2006 |
S-SCAN MRI SYSTEM |
ESAOTE, S.P.A. |
CARRI GRAHAM |
| K063204 |
11/14/2006 |
SPIDERFX EMBOLIC PROTECTION DEVICE |
EV3 INC |
David Worrell |
| K063279 |
11/29/2006 |
NOVATION SPLINED RDD FEMORAL STEMS |
EXACTECH, INC. |
MARITZA ELIAS |
| K062440 |
11/07/2006 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091 |
GEN-PROBE, INC. |
E JOSEPH MCMULLEN |
| K063006 |
11/02/2006 |
GE LOGIQ WORKS |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K063162 |
11/02/2006 |
GOLDEN LITEWAY |
GOLDEN TECHNOLOGIES, INC. |
GENE R KULON |
| K062721 |
11/21/2006 |
GREENTON ECOLITE IPL SYSTEM |
GREENTON (LONDON) LTD. |
ROBERT T HANDREN |
| K061933 |
11/16/2006 |
HAGER MIRAMATIC BOX SHARPS CONTAINER AND CAP TRAP NEEDLE RE-CAPPER |
HAGER WORLDWIDE, INC. |
JAMES DELANEY |
| K063046 |
11/17/2006 |
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN) |
HARTALEGA SDN BHD |
NURUL A KONG |
| K062515 |
11/22/2006 |
RETENTION FLOW OPAQUE |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
| K061993 |
11/03/2006 |
EQUIVITAL, MODEL EQ-01 |
HIDALGO LIMITED |
JUSTIN PISANI |
| K061608 |
11/22/2006 |
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
DOUG THISTLETHWAITE |
| K062999 |
11/03/2006 |
OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN |
HOSPIRA, INC. |
DIANE RENNPFERD |
| K062419 |
11/15/2006 |
TRIDENT LARGE DIAMETER ACETABULAR INSERTS |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
| K061848 |
11/08/2006 |
HYPERSPECTRAL TISSUE OXYGENATION MEASUREMENT SYSTEM, MODEL OXY VU1 |
HYPERMED, INC. |
CHAS BURR |
| K063234 |
11/21/2006 |
ON-Q INTRODUCERS |
I-FLOW CORP. |
SHANE NOEHRE |
| K063246 |
11/22/2006 |
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K063247 |
11/22/2006 |
XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K063039 |
11/02/2006 |
XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
| K062985 |
11/22/2006 |
IVUS ENHANCER |
INDEC SYSTEMS, INC. |
CAROL HUBLER |
| K062782 |
11/09/2006 |
INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 |
INION OY |
KATI MARTTINEN |
| K061718 |
11/13/2006 |
INNOVACON SPECTRUM II TEST CARD |
INNOVACON, INC. |
EDWARD TUNG |
| K063422 |
11/21/2006 |
BIOAGGREGATE |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
| K062589 |
11/30/2006 |
SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM |
INOLASE 2002, LTD. |
GEORGE J HATTUB |
| K062369 |
11/08/2006 |
IRIDEX OCULIGHT TX |
IRIDEX CORP. |
JOHN JOSSY |
| K062074 |
11/14/2006 |
IRIDEX WIRELESS FOOTSWITCH |
IRIDEX CORP. |
JOHN JOSSY |
| K062384 |
11/09/2006 |
CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE |
ISORAY, INC |
DAVID J SWANBERG |
| K062713 |
11/02/2006 |
ADHESIVE DC ACTIVATOR |
IVOCLAR VIVADENT, INC. |
ANDERJEET S GULATI |
| K062740 |
11/02/2006 |
JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU |
JINDELL MEDICAL INSTRUMENTS CO., LTD. |
Ke-Min Jen |
| K062614 |
11/01/2006 |
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) |
JOHNSON & JOHNSON VISION CARE, INC. |
SUSAN MORRIS |
| K060907 |
11/09/2006 |
KARL STORZ VIDEO GASTROSCOPES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
| K062412 |
11/06/2006 |
CRYOMATIC |
KEELER INSTRUMENTS, INC. |
EUGENE R VANARSDALE |
| K062671 |
11/03/2006 |
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) |
KENDALL |
KEITH MARTIN |
| K061749 |
11/22/2006 |
ECLIPSE TOTAL ANKLE IMPLANT |
KINETIKOS MEDICAL, INC. |
JOHN G STAMPINATO |
| K062857 |
11/22/2006 |
KLS MARTIN QUICK DISC |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K062021 |
11/01/2006 |
KOWA VX-10I |
KOWA CO. LTD. |
RICHARD PHILLIPS |
| K062409 |
11/08/2006 |
K-ETCHANT GEL |
KURARAY MEDICAL INC. |
KOJI NISHIDA |
| K063031 |
11/02/2006 |
PRISM VIEW, MODEL |
KYRON CLINICAL IMAGING, INC. |
JAMES L REUSS, PH.D. |
| K063161 |
11/21/2006 |
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL |
LEONHARD LANG GMBH |
ELAINE DUNCAN |
| K062643 |
11/16/2006 |
KINETIC ANTERIOR CERVICAL PLATE |
LIFE SPINE |
ERIN MALLOY |
| K062876 |
11/01/2006 |
PRIMACONNEX CERAMIC ABUTMENTS |
LIFECORE BIOMEDICAL, INC. |
BRIAN SMEKAL |
| K062571 |
11/21/2006 |
LONGPORT EPISCAN, MODEL-I-200 |
LONGPORT, INC. |
MICHAEL G FARROW |
| K061375 |
11/17/2006 |
RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730 |
LOUIS M. GERSON CO., INC. |
ROBERT BRUNELL |
| K053225 |
11/06/2006 |
CELLU M6 KEYMODULE I |
LPG ONE, INC |
JAY MANSOUR |
| K062871 |
11/14/2006 |
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE |
LYNTON LASERS LIMITED |
ANDREW J BERRY |
| K050263 |
11/21/2006 |
MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU |
M.O.C.O.M. SRL |
DANIELE TOSI |
| K063333 |
11/21/2006 |
M3 |
MAVIG GMBH |
CHRISTIAN STOIAN |
| K062474 |
11/09/2006 |
SMITHWICK CAROTID SHUNT |
MCPHERSON ENTERPRISES, INC. |
WILLIAM MCPHERSON |
| K061905 |
11/08/2006 |
HORIZON CARDIOLOGY ECG-MCKESSON'S ECG MANAGEMENT SYSTEM, MODEL 1.0 |
MEDCON LTD. |
JONATHAN S KAHAN |
| K062127 |
11/08/2006 |
MEDIC4ALL TELEMEDICINE SYSTEM, MODEL VMS-01 (NIBP) |
MEDIC4ALL (ISRAEL) LTD. |
JONATHAN S KAHAN |
| K062662 |
11/21/2006 |
TELEMEDICINE SYSTEM MODEL VMS-01 |
MEDIC4ALL (ISRAEL) LTD. |
JONATHAN S KAHAN |
| K062746 |
11/20/2006 |
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279 |
MEDICON HELLAS S.A. |
GEORGE PSICHAS |
| K062482 |
11/03/2006 |
VENTED VIAL ADAPTER TRANSFER DEVICE |
MEDIMOP MEDICAL PROJECTS, LTD. |
ARI Y SOBEL |
| K062984 |
11/13/2006 |
MEDLINE HYPODERMIC NEEDLES |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K061316 |
11/02/2006 |
MEDLINE SURGICAL SPONGE SCANNER |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K063342 |
11/30/2006 |
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS |
MEDRAD, INC. |
LISA A EWING |
| K063117 |
11/03/2006 |
MODIFICATION TO DUREPAIR DURA REGENERATION MATRIX |
MEDTRONIC NEUROSURGERY |
JEFFERY HENDERSON |
| K063083 |
11/06/2006 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
EDWARD S CHIN |
| K062807 |
11/06/2006 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
EDWARD CHIN |
| K063305 |
11/29/2006 |
STIMULATING BUR GUARD |
MEDTRONIC XOMED, INC. |
ANTOINE KOUCHAKJY |
| K063327 |
11/22/2006 |
ORTHOVIEW |
MERDIAN TECHNIQUE, LTD. |
ANTHONY THORNE |
| K062906 |
11/17/2006 |
ENA HFO COMPOSITE SYSTEM |
MICERIUM S.P.A. |
EUGENIO MICELI |
| K062153 |
11/21/2006 |
PORTABLE OXYGEN GENERATOR SYSTEM |
MOLECULAR PRODUCTS LTD. |
PAUL DRYDEN |
| K062677 |
11/15/2006 |
ELI 350 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
HARLAN VAN MATRE |
| K061829 |
11/17/2006 |
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES |
NEW LEAF MEDICAL, INC. |
RICHARD T NOCK |
| K062749 |
11/29/2006 |
SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K062241 |
11/09/2006 |
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR |
NORTH AMERICAN SCIENTIFIC, INC. |
LEIGH SPOTTEN |
| K061830 |
11/01/2006 |
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+ |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K062500 |
11/21/2006 |
FLEXPEN NEEDLE |
NOVO NORDISK INC. |
RICK SPRING |
| K062581 |
11/29/2006 |
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM |
OLYMPUS AMERICA, INC. |
DAVID DAVIS |
| K063141 |
11/29/2006 |
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K062043 |
11/07/2006 |
BODY COMPOSITION MONITOR WITH SCALE, MODEL HBF-500 |
OMRON HEALTHCARE, INC. |
DONNA DJINOVICH |
| K060054 |
11/21/2006 |
ONCOBIONIC SYSTEM |
ONCOBIONICS, INC. |
LAURIE A CLARKE |
| K063177 |
11/30/2006 |
RAPID STRAND RX |
ONCURA INC. |
SUBHASH PATEL |
| K062416 |
11/17/2006 |
RETINAL FUNCTIONAL IMAGER (RFI) |
OPTICAL IMAGING LTD. |
JONATHAN S KAHAN |
| K063144 |
11/13/2006 |
VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM |
Ortho-Clinical Diagnostics, Inc. |
SARAH C PARSONS |
| K062077 |
11/22/2006 |
VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K062123 |
11/16/2006 |
VITROS CHEMISTRY PRODUCTS COCM REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1 AND DAT PERFORMANCE VERIFIERS I, II, III, IV |
Ortho-Clinical Diagnostics, Inc. |
MICHAEL M BYRNE |
| K062637 |
11/22/2006 |
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K062094 |
11/22/2006 |
VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V |
Ortho-Clinical Diagnostics, Inc. |
Darlene J Phillips |
| K063330 |
11/22/2006 |
ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY |
ORTHOCON, INC. |
HOWARD L SCHRAYER |
| K062920 |
11/13/2006 |
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K063033 |
11/01/2006 |
MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT |
ORTHOPEDIC SCIENCES, INC |
JAMES BRANNON M.D. |
| K062908 |
11/13/2006 |
ORTHROPRO HEMI TOE |
ORTHOPRO LLC |
J.D. WEBB |
| K062051 |
11/01/2006 |
SS SYSTEM |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
| K062030 |
11/02/2006 |
US SYSTEM |
OSSTEM IMPLANT CO.,LTD |
CATHRYN N CAMBRIA |
| K062851 |
11/17/2006 |
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED |
OSTEOMED L.P. |
PIEDAD PENA |
| K052716 |
11/16/2006 |
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT |
OTSUKA PHARMACEUTICAL CO., LTD. |
CYNTHIA A SINCLAIR |
| K062403 |
11/14/2006 |
IMAX CEPH DIGITAL X-RAY SENSOR |
OWANDY |
CLAUDE D BERTHOIN |
| K063003 |
11/28/2006 |
AURORA |
PARKELL, INC. |
DANIEL R SCHECHTER |
| K062300 |
11/27/2006 |
OX-SOX, MODEL C, D, E, |
PATTIENT SAFETY INNOVATIONS, LLP |
ERIK STALHANDSKE |
| K062271 |
11/30/2006 |
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) |
PHILIPS MEDICAL SYSTEMS |
DAVID OSBORN |
| K062455 |
11/03/2006 |
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL |
PHILIPS MEDICAL SYSTEMS |
RICH MCCLEARY |
| K062605 |
11/09/2006 |
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T |
PHILIPS MEDICAL SYSTEMS |
RICH MCCLEARY |
| K062233 |
11/22/2006 |
HEARTSTART MRX MONITOR/DEFIBRILLATOR |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
MICHAEL J DOYLE |
| K063315 |
11/20/2006 |
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
ANDREAS SUCHI |
| K063344 |
11/28/2006 |
CAAS QCA 3D |
PIE MEDICAL IMAGING B.V. |
CARLA DE VRIES |
| K061944 |
11/03/2006 |
POLY-CHEM CREATININE |
POLYMEDCO, INC. |
HELEN LANDICHO |
| K062155 |
11/09/2006 |
DIGITAL MXR-D FLOWMETER |
PORTER INSTRUMENT CO., INC. |
CYNTHIA J.M. NOLTE |
| K061951 |
11/22/2006 |
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120 |
POSSIS MEDICAL, INC. |
FRANK B FREEDMAN |
| K063075 |
11/02/2006 |
NATURAL ORIFICE LINEAR CUTTER DIGITAL LOADING UNITS |
POWER MEDICAL INTERVENTIONS, INC. |
BARBARA J WHITMAN |
| K062166 |
11/21/2006 |
ENAMEL PRO |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
| K062683 |
11/21/2006 |
ENAMEL PRO VARNISH |
PREMIER DENTAL PRODUCTS CO. |
VINCE D'ALESSANDRO |
| K063389 |
11/17/2006 |
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54 |
PRIDE MOBILITY PRODUCTS CORP. |
THOMAS SCHAPPERT |
| K061517 |
11/22/2006 |
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES |
PRIME HERBS CORPORATION |
GENEVIEVE HSIA |
| K062638 |
11/22/2006 |
TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
| K062955 |
11/09/2006 |
POWDER FREE LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
PT. HALONI JANE |
EMMY TJOENG |
| K062313 |
11/30/2006 |
SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE |
PT. MAHAKARYA INTI BUANA |
VENUGOPAL NADARAJAN |
| K061233 |
11/03/2006 |
SENSTOUCH POWDER FREE EXAMINATION GLOVES, NON STERILE |
PT. MAHAKARYA INTI BUANA |
V NADARAJAN |
| K062817 |
11/22/2006 |
PTW DAVID IMRT QC VERIFICATION SYSTEM |
PTW-NEW YORK CORP. |
RICHARD D BARKER |
| K063185 |
11/17/2006 |
RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES |
RADIANT INNOVATION, INC. |
FRANK LIN |
| K062642 |
11/02/2006 |
RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100A |
RF SURGICAL SYSTEMS, INC. |
KEVIN COSENS |
| K062579 |
11/28/2006 |
OMNIPICC P.I. |
RITA MEDICAL SYSTEMS, INC. |
DAVID SMITH |
| K062399 |
11/17/2006 |
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE |
ROCKWELL MEDICAL TECHNOLOGIES, INC. |
ROB CHIOINI |
| K062934 |
11/16/2006 |
SIERRA |
SEASPINE, INC. |
DIANA SMITH |
| K063093 |
11/07/2006 |
SECTRA WORKSTATION, VERSION 11.1 |
SECTRA IMTEC AB |
CARL ALLETTO |
| K063283 |
11/17/2006 |
DEFINIUM 5000 X-RAY SYSTEM |
SEDECAL S.A. |
DANIEL KAMM |
| K061935 |
11/08/2006 |
SENSACARE SAW-102 WRIST DIGITAL BLOOD PRESSURE MONITOR |
SENSACARE LTD. |
STEVEN CHANG |
| K063302 |
11/15/2006 |
SDIF DENTAL CHAIR WITH OPERATIVE UNIT AND ACCESSORIES |
SHANGHAI DENTAL INSTRUMENT FACTORY |
MARK JOB |
| K063373 |
11/17/2006 |
FLEX LOOP COIL SET 3T |
SIEMENS AG |
RUTH SCHNEISS |
| K063507 |
11/30/2006 |
SYNGO NEURO PBV CT |
SIEMENS AG |
RALF HOFMANN |
| K063138 |
11/22/2006 |
MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING PH.D. |
| K063085 |
11/14/2006 |
MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHEILA W PICKERING |
| K062454 |
11/03/2006 |
MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES |
SIEMENS MEDICAL SOLUTIONS, INC. |
JUDITH CAMPBELL |
| K062898 |
11/13/2006 |
SBI LATERAL RHEAD IMPLANT |
SMALL BONE INNOVATIONS INC. |
ROBERT HOEHN |
| K063467 |
11/21/2006 |
SMITH & NEPHEW RF CANNULAE |
SMITH & NEPHEW, INC. |
MINNIE MILDWOFF |
| K062592 |
11/29/2006 |
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE |
SMITHS MEDICAL MD, INC. |
MELANIE HESS |
| K062323 |
11/01/2006 |
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
| K062064 |
11/09/2006 |
RIVA BOND LC |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
| K062065 |
11/15/2006 |
RIVA LUTING PLUS |
SOUTHERN DENTAL INDUSTRIES, INC. |
RAY CAHILL |
| K062341 |
11/02/2006 |
MALE REMEEX SYSTEM |
SPECIALITIES REMEEX INTERNATIONAL, S.L. |
JEFFREY R SHIDEMAN |
| K052519 |
11/30/2006 |
SPECTRAL WEST NILE VIRUS IGM STATUS TEST |
SPECTRAL DIAGNOSTICS, INC. |
NISAR A SHAIKH |
| K063010 |
11/28/2006 |
REGEN BIOCEMENT |
STEINER LABORATORIES |
GREGORY GENE STEINER |
| K063267 |
11/09/2006 |
ISITE PACS, V 4. X |
STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO. |
DEANA WISEMAN |
| K061983 |
11/21/2006 |
STIMUPLEX PEN |
STOCKERT GMBH |
DOMINIKA SCHULER |
| K062270 |
11/22/2006 |
RADIUS SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K063021 |
11/22/2006 |
PROFILER 2 |
SUN NUCLEAR CORP. |
NOEL DOWNEY |
| K062884 |
11/09/2006 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
SUQIAN GREEN GLOVE CO., LTD. |
CHU XIAOAN |
| K052599 |
11/07/2006 |
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A |
SUZHOU 66 VISION TECH CO., LTD. |
GONG BO |
| K062781 |
11/21/2006 |
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY |
SYMTIUM CORPORATION |
SEAN COMER |
| K062237 |
11/20/2006 |
CADI, VERSION 4 |
SYNCA MARKETING, INC. |
STEPHANE ARSENAULT |
| K063158 |
11/14/2006 |
SYNTHES ANTEGRA SYSTEM |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K063212 |
11/22/2006 |
CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
PI-SHIOU LI |
| K062914 |
11/02/2006 |
HEM-O-LOK LIGATION CLIP |
TELEFLEX MEDICAL |
LORI HAYS |
| K053420 |
11/15/2006 |
TENACORE SP02 SENSORS |
TENACORE HOLDINGS, INC. |
Brand Caso |
| K062597 |
11/03/2006 |
TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CHRISTINA L THOMAS |
| K062183 |
11/21/2006 |
FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K062812 |
11/28/2006 |
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N |
THUNDER TIGER CORP. |
JEN KE-MIN |
| K061617 |
11/22/2006 |
FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
RODRIGO BERTIE |
| K062081 |
11/02/2006 |
LITHOGOLD |
TISSUE REGENERATION TECHNOLOGIES, INC. |
CHERITA JAMES |
| K063081 |
11/09/2006 |
AEQUALIS SHOULDER SYSTEM |
TORNIER |
Mireille Lemery |
| K060544 |
11/13/2006 |
SALTO TALARIS TOTAL ANKLE PROSTHESIS |
TORNIER |
MIREILLE EMERY |
| K063241 |
11/09/2006 |
CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K063361 |
11/21/2006 |
EXCELART VANTAGE ATLAS, MODEL MRT-1503 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K063184 |
11/03/2006 |
MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K063189 |
11/03/2006 |
TSX-301A, AQUILION ONE CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K063130 |
11/02/2006 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K063197 |
11/30/2006 |
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K063198 |
11/30/2006 |
21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K062839 |
11/09/2006 |
MODIFICATION TO SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K062816 |
11/01/2006 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
Cynthia Knapp |
| K062523 |
11/17/2006 |
TRU-MR LARYNGOSCOPE SET |
TRUPHATEK INTERNATIONAL, LTD. |
PAUL DRYDEN |
| K061002 |
11/15/2006 |
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM |
U&I CORP. |
BETTY LIM |
| K062688 |
11/30/2006 |
POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM |
UG HEALTHCARE (USA), INC. |
KENNETH J STANTON |
| K062702 |
11/29/2006 |
ULTICARE DISPOSABLE SYRINGES AND NEEDLES |
ULTIMED, INC. |
CAROLE STAMP |
| K061288 |
11/02/2006 |
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
FRANK GIANELLI |
| K063195 |
11/29/2006 |
LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044 |
VALLEYLAB |
CHARLES COPPERBERG |
| K062734 |
11/22/2006 |
ADJUST-RIGHT FIXATION DEVICES |
VALPO ORTHOPEDIC TECHNOLOGY, INC. |
RON CLARK |
| K062822 |
11/21/2006 |
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500 |
VASCULAR SOLUTIONS, INC. |
PATRICE STROMBERG |
| K060421 |
11/03/2006 |
SONARA; SONARA/TEK |
VIASYS HEALTHCARE, INC. |
GLEN HERMANSON |
| K061908 |
11/06/2006 |
NICOLETONE SYSTEM V32 AMPLIFIER |
VIASYS NEUROCARE |
Gary Syring |
| K062422 |
11/07/2006 |
HUMERAL HEAD, MANUAL DRIVER |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K062833 |
11/30/2006 |
POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K062343 |
11/02/2006 |
GRANDIO FLOW TRY-IN |
VOCO GMBH |
MICHAEL SUES |
| K061796 |
11/02/2006 |
HEPATOSTAT SET, MODEL 760X |
VYGON CORP. |
STEPHEN GOLDNER |
| K063435 |
11/28/2006 |
GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL |
W. L. GORE & ASSOCIATES, INC. |
Michael Ivey |
| K062161 |
11/09/2006 |
GORE PROPATEN VASCULAR GRAFT |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
| K062917 |
11/02/2006 |
STERILE AND NON-STERILE POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELING CLAIM (50 |
WEAR SAFE MALAYSIA SDN. BHD. |
TK LOH |
| K061653 |
11/09/2006 |
SOYALA FULL FACE MASK |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
ECKHARDT ABERS |
| K062757 |
11/07/2006 |
XERON PACS |
XERON HEALTHCARE CORP. |
MELISSA MAHALL |
| K063303 |
11/22/2006 |
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
| K062228 |
11/08/2006 |
ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION |
ZIMMER, INC. |
PATRICIA JENKS |
