| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K053256 |
11/22/2005 |
3M TEGADERM SILVER (AG) MESH |
3M COMPANY |
AMY E SHORT |
| K053032 |
11/16/2005 |
ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST; CATALOG# AMP001000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053035 |
11/16/2005 |
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053033 |
11/16/2005 |
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053037 |
11/16/2005 |
ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053034 |
11/16/2005 |
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
| K053094 |
11/04/2005 |
ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 |
ADVANCED BIO-SURFACES, INC. |
PHILLIP B JARVI |
| K053250 |
11/30/2005 |
ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT |
ADVANCED NEUROMODULATION SYSTEMS |
DANIELLE ALARCON |
| K053158 |
11/14/2005 |
OPTILENE MESH LP |
AESCULAP, INC. |
MATTHEW M HULL |
| K053187 |
11/15/2005 |
AMPLATZER NOODLEWIRE GUIDEWIRE |
AGA MEDICAL CORP. |
PATRICIA A LAFORET |
| K053117 |
11/07/2005 |
EZ-OX PLUS |
AIR LIQUIDE HEALTHCARE AMERICA |
ANGIE BEYER |
| K053316 |
11/29/2005 |
REPROCESSED COMPRESSION SLEEVES |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K053257 |
11/22/2005 |
PARA-PRO FC50 |
ALPHA-TEC SYSTEMS, INC. |
RICHARD WILLIAMS |
| K053070 |
11/01/2005 |
CONTOUR II SPINAL SYSTEM |
ALTIVA CORP. |
JOHN KAPTIAN |
| K053142 |
11/09/2005 |
AMBU MARK IV BABY RESUSCITATOR |
AMBU A/S |
SANJAY PARIKH |
| K053140 |
11/10/2005 |
AMBU MARK IV RESUSCITATOR |
AMBU A/S |
SANJAY PARIKH |
| K053175 |
11/16/2005 |
AMEDITECH DRUGSMARTCUP |
AMEDITECH, INC. |
JOHN WU |
| K053138 |
11/17/2005 |
MYSET PREGNANCY TEST |
ANI BIOTECH OY |
FRAN WHITE |
| K053119 |
11/07/2005 |
DISTAL RADIO-ULNAR JOINT IMPLANT |
APTIS MEDICAL, LLC. |
BRYAN BABB |
| K053297 |
11/25/2005 |
ARTHROCARE 8000S COBLATOR SURGERY SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K053180 |
11/14/2005 |
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K053124 |
11/15/2005 |
BOSTON ES (ENFLUFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON XO (HEXAFOCON A) RIGID GAS PERMEABLE CONTACT LENSES |
BAUSCH & LOMB INCORPORATED |
LISA GRANEY |
| K053082 |
11/02/2005 |
BAYLIS PAIN MANAGEMENT COOLED PROBE, MODEL PMPC-18-150-6 |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K053090 |
11/02/2005 |
DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR |
BECKMAN COULTER, INC. |
ERI HIRUMI |
| K053241 |
11/18/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K053213 |
11/16/2005 |
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K053126 |
11/10/2005 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
ANGELA DRYSDALE |
| K053099 |
11/03/2005 |
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K053152 |
11/10/2005 |
BIOHORIZONS SINGLE-STAGE IMPLANT |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
WINSTON GREER |
| K053097 |
11/03/2005 |
VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN |
BIOMERIEUX, INC. |
NANCY WEAVER |
| K053186 |
11/14/2005 |
VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
NANCY WEAVER |
| K053299 |
11/25/2005 |
REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT |
BIOMET MANUFACTURING, INC. |
PATRICIA S BERES |
| K053312 |
11/28/2005 |
EASYMATE BLOOD GLUCOSE MONITORING SYSTEM |
BIOPTIK TECHNOLOGY, INC. |
ERIC LUO |
| K053194 |
11/17/2005 |
NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE |
BIOSENSE WEBSTER, INC. |
SIGI CARON |
| K053087 |
11/03/2005 |
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM |
BIOTEX, INC. |
ASHOK GOWDA |
| K053268 |
11/23/2005 |
PVS 2000 SYNCHRO2 GUIDEWIRE |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
RICK GAYKOWSKI |
| K053128 |
11/08/2005 |
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE |
BOSTON SCIENTIFIC CORP. |
NICHOLAS CONDAKES |
| K053118 |
11/07/2005 |
STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX |
BOSTON SCIENTIFIC CORP. |
MAUREEN MARY MONTBRIAND |
| K053116 |
11/07/2005 |
STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX |
BOSTON SCIENTIFIC CORP. |
MAUREEN MARY MONTBRIAND |
| K053164 |
11/14/2005 |
IPLAN FLOW |
BRAINLAB AG |
RAINER BIRKENBACH |
| K053159 |
11/14/2005 |
VECTORVISION SPINE |
BRAINLAB AG |
RAINER BIRKENBACH |
| K053127 |
11/10/2005 |
IPLAN |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K053065 |
11/01/2005 |
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) |
BRYAN KEROPIAN DDS |
BRYAN KEROPIAN |
| K053221 |
11/23/2005 |
CDMX-H |
CAMSIGHT CO., INC. |
JAY CHOI |
| K053089 |
11/02/2005 |
ASCENT PIT & FISSURE SEALANT |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K053062 |
11/03/2005 |
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 |
CARDIARC LTD. |
JONATHAN KAHN |
| K053303 |
11/28/2005 |
CARDIOCOM COMMANDER III |
CARDIOCOM LLC |
DANIEL KAMM |
| K053304 |
11/28/2005 |
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM |
CARDIOCOM LLC |
DANIEL KAMM |
| K053263 |
11/22/2005 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 |
CARDIONET, INC |
JACK GAIKWAD |
| K053301 |
11/28/2005 |
CEDARA I-RESPONSE CEDARA PET/CT |
CEDARA SOFTWARE CORP. |
CAROL NAKAGAWA |
| K053223 |
11/18/2005 |
TRITON/TRU-TRAC/TX/TRITON DTS TRACTION |
CHATTANOOGA GROUP |
MICHAEL TREAS |
| K053156 |
11/14/2005 |
MINI-WRIGHT DIGITAL, MODEL 3120001 |
CLEMENT CLARKE INTL., LTD. |
PHILIP HALLYBONE |
| K053107 |
11/04/2005 |
CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD |
CODMAN & SHURTLEFF, INC. |
SUSAN KAGAN |
| K053260 |
11/22/2005 |
OSSIX -PLUS |
COLBAR LIFESCIENCE LTD. |
JONATHAN S KAHAN |
| K052687 |
11/21/2005 |
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
PATRICK HESS |
| K053201 |
11/23/2005 |
CURAE'LASE CL1000 IR LASER SYSTEM |
CURAE'LASE INC. |
M. JOYCE HEINRICH |
| K053155 |
11/14/2005 |
VIMPLANT |
CYBERMED, INC. |
SONG NAK CHOI |
| K053157 |
11/14/2005 |
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A |
DADE BEHRING, INC. |
VICTOR M CARRIO |
| K053104 |
11/04/2005 |
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K053109 |
11/04/2005 |
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
ANDREA M TASKER |
| K053108 |
11/04/2005 |
DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 |
DADE BEHRING, INC. |
YUK-TING LEWIS |
| K053072 |
11/01/2005 |
N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K053073 |
11/01/2005 |
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K053074 |
11/01/2005 |
N ANTISERA TO HUMAN CERULOPLASMIN |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K053075 |
11/01/2005 |
N ANTISERA TO HUMAN TRANSFERRIN |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
| K053083 |
11/02/2005 |
DATRIX CARDIO WIFI ELECTROCARDIOGRAPH |
DATRIX |
LINDA GLUCKMAN |
| K052989 |
11/07/2005 |
DP240 240 HOUR DOPPLER PROBE |
DELTEX MEDICAL |
LAWRENCE BROOKFIELD |
| K053167 |
11/14/2005 |
BIOPURE MTAD ROOT CANAL CLEANSER |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K053095 |
11/10/2005 |
HONEY ALGINATE DRESSING |
DERMA SCIENCES CANADA, INC. |
SHARMINI ATHERAY |
| K053111 |
11/04/2005 |
STA-CEPHASCREEN KIT |
DIAGNOSTICA STAGO, INC. |
JIM BARROW |
| K053204 |
11/16/2005 |
INTELLIVUE GAS MODULES, MODELS G5 M1019A AND G1 M1013A |
DRAEGER MEDICAL AG & CO. KGAA |
MONICA FERRANTE |
| K053176 |
11/16/2005 |
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797 |
DUCKWORTH & KENT, LTD. |
MARTIN LOCK |
| K053114 |
11/07/2005 |
SILVERFIL |
DUNIA PERWIRA MANUFACTURING SDN. BHD. |
NARESH SANCHANA |
| K053285 |
11/25/2005 |
MAGBODY DT-1200, DT-1200T, DT-1200M, DT-1200PT, DT-1200PM |
DURTECH SYSTEM CORP. |
ADA LIN |
| K053284 |
11/25/2005 |
MAGBODY DT-600 |
DURTECH SYSTEM CORP. |
ADA LIN |
| K053248 |
11/21/2005 |
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL |
ELECTROMED, INC. |
CHET SIEVERT |
| K053281 |
11/25/2005 |
EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) |
EMAGEON INC. |
INGER L HANSON |
| K053267 |
11/23/2005 |
ENDIUS ATAVI SYSTEM |
ENDIUS, INC. |
CHRISTINE KUNTZ-NASSIF |
| K053100 |
11/08/2005 |
ESTECH COBRA BIPOLAR SYSTEM |
ENDOSCOPIC TECHNOLOGIES, INC. |
CRAIG COOMBS |
| K053078 |
11/02/2005 |
ERGOSELECT 100 K/P, ERGOSELECT 200 K/P |
ERGOLINE GMBH |
HAIKO BELL |
| K053021 |
11/03/2005 |
ESTECH CLEARVIEW MV ATRIAL DEPRESSOR |
ESTECH, INC. |
CRAIG COOMBS |
| K053195 |
11/15/2005 |
SPIDERX EMBOLIC PROTECTION DEVICE |
EV3 INC. |
BRENDA JOHNSON |
| K053058 |
11/03/2005 |
XLTEK NEUROPATH, MODEL PK1070 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
| K053120 |
11/07/2005 |
STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES |
EXCELSIOR MEDICAL CORP. |
RUBEN MARTINEZ |
| K053139 |
11/09/2005 |
FOTONA QX ND:YAG/KTP LASER SYSTEM |
FOTONA D.D. |
STOJAN TROST |
| K053121 |
11/07/2005 |
TRAM MODULE |
GE HEALTHCARE |
JOEL KENT |
| K053253 |
11/23/2005 |
HEMOCUE ALBUMIN 201 ANALYZING SYSTEM |
HEMOCUE AB |
ALLAN WHITE |
| K053258 |
11/22/2005 |
EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI MEDICAL CORP. |
DOUG THISTLETHWAITE |
| K053309 |
11/28/2005 |
ALTAIRE INTERVENTIONAL MR PACKAGE |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K053148 |
11/10/2005 |
CXR16 |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K053280 |
11/28/2005 |
PROBEAT |
HITACHI, LTD., POWER SYSTEMS GROUP |
JONATHAN KAHAN |
| K053308 |
11/29/2005 |
ABX MICROS CRP 200, OPTION IM |
HORIBA ABX |
TIM LAWTON |
| K053198 |
11/16/2005 |
SIMPLEX P SPEEDSET BONE CEMENT |
HOWMEDICA OSTEONICS CORP |
TIFFANI D ROGERS |
| K053178 |
11/17/2005 |
SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS |
HU-FRIEDY MFG. CO.,INC. |
KEITH DUNN |
| K053298 |
11/25/2005 |
ALPHASPHERE ORBITAL IMPLANT |
HYDRON PTY LIMITED |
JUDY F GORDON |
| K053079 |
11/02/2005 |
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K053110 |
11/04/2005 |
I-STAT CHEM8 + CARTRIDGE |
I-STAT CORPORATION |
PAUL VANDERWERF |
| K053106 |
11/04/2005 |
TEGO, MODEL D1000 |
ICU MEDICAL, INC. |
DALE FAIRCHILD |
| K053170 |
11/14/2005 |
PREFORMANCE POSTS |
IMPLANT INNOVATIONS, INC. |
JIM BANIC |
| K053242 |
11/18/2005 |
PITT-EASY DENTAL IMPLANT SYSTEM |
INNOVA LIFE SCIENCES CORP. |
HOWARD HOLSTEIN |
| K053191 |
11/21/2005 |
DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS |
INNOVA VISION INC. |
JENNIFER REICH |
| K053276 |
11/30/2005 |
IST PEDICLE SCREW SYSTEM |
INNOVATIVE SPINAL TECHNOLOGIES INC |
STEPHEN PALUMBO |
| K053088 |
11/03/2005 |
SLACTIVE IMPLANTS |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
| K053244 |
11/23/2005 |
LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT |
INTEGRA LIFESCIENCES CORP. |
JON CAPAROTTA |
| K053196 |
11/16/2005 |
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) |
INVERNESS MEDICAL INNOVATIONS, INC. |
JAMES M DELANEY |
| K053220 |
11/17/2005 |
VERAVIEW IC 5, MODEL XDP1 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K052574 |
11/03/2005 |
COMPACT PLUS - EXTREME - PERFECT PLUS |
J.O. SUAREZ & CIA, LTDA |
JAVIER O SUAREZ |
| K052680 |
11/09/2005 |
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
PAUL S LEE |
| K053262 |
11/22/2005 |
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
YVONNE FERNANDEZ |
| K053173 |
11/15/2005 |
DS CASSETTE |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHINICHI YAMANAKA |
| K053084 |
11/02/2005 |
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM |
KONTRON MEDICAL SYSTEMS SAS |
LARRY WALKER |
| K053149 |
11/10/2005 |
SPIRO-BALL |
LEVENTON, S.A. |
ORIOL VERNIS |
| K053098 |
11/03/2005 |
OPTIUM DBM GEL AND PUTTY |
LIFENET |
DAVID KLEMENTOWSKI |
| K053225 |
11/17/2005 |
CELLU M6 KEYMODULE I |
LPG ONE, INC |
JAY MANSOUR |
| K053247 |
11/21/2005 |
VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K053300 |
11/30/2005 |
SYVEKEXCEL |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K053269 |
11/23/2005 |
MASIMO SET RAD-8 PULSE OXIMETER |
MASIMO CORPORATION |
JIM CRONIN |
| K053137 |
11/09/2005 |
ENDOTOOL DRUG DOSE CALCULATOR |
MD SCIENTIFIC LLC |
SHADE M MECUM |
| K053092 |
11/23/2005 |
MEDCOMP VASCU-SHEATH II |
MEDCOMP |
JEAN CALLOW |
| K053227 |
11/17/2005 |
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES |
MEDICAL ILLUMINATION INTERNATIONAL, INC. |
MIKE ALCALA |
| K053235 |
11/23/2005 |
NSK PRECISION APEX LOCATOR (PAL) |
MEDICSENSE U.S.A. |
GEORGE HATTUB |
| K053177 |
11/15/2005 |
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E |
MEDTRONIC MINIMED |
STACI ELLIS |
| K053101 |
11/04/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K053252 |
11/21/2005 |
U-CLIP DEVICE, MODELS B140, B160 AND B180 |
MEDTRONIC VASCULAR |
DAVID D COX |
| K053185 |
11/29/2005 |
PRIMO NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM |
MEDWAVE, INC. |
DONNA R LUNAK |
| K053296 |
11/25/2005 |
MENTOR ARIS SUPRAPUBIC SURGICAL KIT |
MENTOR CORPORATION |
DONNA A CRAWFORD |
| K053171 |
11/14/2005 |
MERIT IMPRESS DIAGNOSTIC CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
STEPHANIE ERSKINE |
| K053229 |
11/18/2005 |
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K053230 |
11/18/2005 |
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K053255 |
11/23/2005 |
NEXUS LIGATING CLIP |
MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL |
LISA S JONES |
| K053265 |
11/22/2005 |
MICRUS GUIDE WIRE, WATUSI 0.014 |
MICRUS ENDOVASCULAR CORPORATION |
MARGARET WEBBER |
| K053160 |
11/14/2005 |
MICRUS MODIFIED MICROCOIL 18-SYSTEM, "CERECYTE", MODEL CSP & CHE |
MICRUS ENDOVASCULAR CORPORATION |
MARGARET WEBBER |
| K053086 |
11/15/2005 |
MIE - GAMMA CAMERA SYSTEMS |
MIE AMERICA, INC. |
KAY WARREN |
| K053216 |
11/18/2005 |
HEARID WIDEBAND MIDDLE EAR POWER ANALYZER |
MIMOSA ACOUSTICS, INC. |
PATRICIA S JENG |
| K053192 |
11/16/2005 |
MODEL 418 SERIES WALKERS |
MJM INTERNATIONAL CORPORATION |
MELLY MOROLES |
| K053218 |
11/17/2005 |
DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ |
| K053214 |
11/17/2005 |
THERAKNIT GARMENT ELECTRODE |
NEUROTRON MEDICAL |
JACK GULDALIAN |
| K053093 |
11/07/2005 |
KALIX II IMPLANT, MODEL 141 0XX WITH XX |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K053129 |
11/08/2005 |
NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 |
NEXUS MEDICAL, LLC |
AL BOEDEKER |
| K053029 |
11/25/2005 |
NDR+/DIVA-D |
NICAL SPA |
GERALD SILVERMAN |
| K053050 |
11/03/2005 |
PROCERA BRIDGE ALUMINA |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K053068 |
11/03/2005 |
PROCERA BRIDGE LAMINATE, MODEL 40-4002 |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K053125 |
11/07/2005 |
PROCERA BRIDGE ZIRCONIA |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K053091 |
11/03/2005 |
PROCERA IMPLANT BRIDGE ZIRCONIA |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
| K053130 |
11/08/2005 |
ONYX II FINGER PULSE OXIMETER, MODEL 9550 |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K053215 |
11/22/2005 |
SURGICAL MESH SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K053286 |
11/25/2005 |
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K053306 |
11/28/2005 |
IVIEW |
ONDEMANDSOFT |
IAN P GORDON |
| K053293 |
11/25/2005 |
ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS |
ORTHO DEVELOPMENT CORP. |
WILLIAM J GRIFFIN |
| K053261 |
11/22/2005 |
ORTHOFIX TITANIUM NAILING SYSTEMS |
ORTHOFIX SRL |
CANDACE F CEDERMAN |
| K053182 |
11/17/2005 |
DRLOCK DISTAL RADIUS VOLAR SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
EDWARD A KROLL |
| K053080 |
11/02/2005 |
GRAFTCAGE ACX |
OSTEOTECH, INC. |
CHRISTOPHER TALBOT |
| K053172 |
11/14/2005 |
UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) |
OWANDY SAS |
OLIVIER MAURIER |
| K053112 |
11/08/2005 |
BIOSIGN |
OXFORD BIOSIGNALS LIMITED |
HOWARD M HOLSTEIN |
| K053282 |
11/25/2005 |
ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIP |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K053283 |
11/25/2005 |
UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG NANOLINE SET |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K053279 |
11/30/2005 |
UROVANTAGE |
PCK ELECTRONIC INDUSTRY & TRADE CO., LTD. |
JONATHAN S KAHAN |
| K053154 |
11/15/2005 |
MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM |
PIE MEDICAL |
CARRI GRAHAM |
| K053053 |
11/07/2005 |
PACP SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K053259 |
11/22/2005 |
DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE |
PRACTICAL PROTECTIVE PLASTIC MANUFACTORY LTD. |
GEORGE SU |
| K053232 |
11/18/2005 |
PRECISION BLENDER |
PRECISION MEDICAL, INC. |
JAMES PARKER |
| K053063 |
11/03/2005 |
PRO-FLOW MULTIPURPOSE CANNULA |
PRO-TECH SERVICES, INC. |
NEIL SHELLER |
| K053305 |
11/28/2005 |
SENSTOUCH POWDERED EXAMINATION GLOVES, NON STERILE |
PT MAHAKARYA INTI BUANA |
P. SASITHARAN NAIR |
| K053146 |
11/10/2005 |
QUICKVUE INFLUENZA A + B TEST |
QUIDEL CORP. |
JOHN D TAMERIUS |
| K053153 |
11/15/2005 |
RANDOX CALIBRATION SERUM |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K053212 |
11/21/2005 |
RAVEN PROPACT |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
| K053291 |
11/25/2005 |
FERRITIN CALIBRATOR SET, CATALOG NO. 8203 |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K053211 |
11/23/2005 |
RDI HSFERRITIN KIT |
REFERENCE DIAGNOSTICS, INC. |
JOSEPH LAWLOR |
| K053102 |
11/09/2005 |
BIOGEL SKINSENSE POWDER-FREE NON-LATEX SURGEON'S GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K053205 |
11/16/2005 |
RES TRAXX DATA CENTER |
RESMED LTD. |
DAVID D'CRUZ |
| K053168 |
11/14/2005 |
BIPAP FOCUS |
RESPIRONICS (IRELAND) LIMITED |
JOHN O'DEA |
| K053203 |
11/16/2005 |
MYNEB NEBULIZER, MODEL RDD100 |
RESPIRONICS NEW JERSEY, INC. |
LAUREN ZIEGLER |
| K053287 |
11/25/2005 |
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K053289 |
11/25/2005 |
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
| K053165 |
11/14/2005 |
ISE INDIRECT NA, K, CL FOR GEN.2 |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K053322 |
11/30/2005 |
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS |
ROEI MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHN |
| K053151 |
11/10/2005 |
RUBICOR MAGIC BREAST BIOPSY DEVICE |
RUBICOR MEDICAL, INC. |
ROBERT J CHIN |
| K053236 |
11/18/2005 |
DAVID PREGNANCY TEST (MIDSTREAM) |
RUNBIO BIOTECH CO., LTD. |
JESSICA VAGATA |
| K053210 |
11/16/2005 |
MAYFIELD SCANMATE MOBILE CT SYSTEM |
SCHAERER MAYFIELD USA, INC. |
JEFFREY K SHAPIRO |
| K053207 |
11/16/2005 |
ARGUS, MODEL LCM |
SCHILLER AG |
MARKUS BUETLER |
| K053292 |
11/25/2005 |
DAVANTIS/ANTELYS VERTEBRAL BODY REPLACEMENTS |
SCIENT'X USA, INC. |
J.D. WEBB |
| K053254 |
11/23/2005 |
INFANT HEEL WARMER BY INTCO |
SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. |
JOHN ZHAO |
| K053193 |
11/15/2005 |
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN - FALK |
| K053234 |
11/18/2005 |
PM-9000 EXPRESS PATIENT MONITOR |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K052894 |
11/08/2005 |
SONOLINE G60 S ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ISKRA MRAKOVIC |
| K053133 |
11/08/2005 |
SYNGO DYNAMICS, VERSION 5.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K053166 |
11/21/2005 |
SINCLAIR ORAL RINSE |
SINCLAIR PHARMACEUTICALS LIMITED |
MICHAEL KILLEEN |
| K053161 |
11/14/2005 |
SIROLASER |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K053246 |
11/21/2005 |
PATIENT MATCHED HIP STEM |
SMITH & NEPHEW, INC. |
LAURIE JORDAN |
| K053069 |
11/01/2005 |
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) |
SONOSITE,INC. |
DAINA L GRAHAM |
| K052959 |
11/07/2005 |
DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS |
SSL AMERICAS |
CHRIS ROBINSON |
| K053217 |
11/17/2005 |
CPS AIM INNER CATHETER, MODELS 410140, 410141, 410142, 410144, 410145, 410146, 410147, 410148 |
ST. JUDE MEDICAL |
DEANNA HUGHES |
| K053277 |
11/28/2005 |
CPS DIRECT SL OUTER CATHETER |
ST. JUDE MEDICAL |
DEANNA HUGHES |
| K053188 |
11/16/2005 |
REPROCESSED BALOON INFLATION DEVICE |
STERILMED, INC. |
BRUCE R LESTER |
| K053115 |
11/07/2005 |
XIA SPINAL SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
| K052699 |
11/03/2005 |
VERSA-LINK PORCELAIN BONDING SYSTEM |
SULTAN CHEMISTS, INC. |
CLARK SMITH |
| K053240 |
11/18/2005 |
DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
| K053209 |
11/16/2005 |
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM |
SUNTECH MEDICAL, INC. |
GEORGE MYERS |
| K053208 |
11/16/2005 |
CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET |
SWEMED LAB INTERNATIONAL AB |
ANDERS JOHANSSON |
| K053105 |
11/04/2005 |
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP |
SYNTHES (USA) |
LISA M BOYLE |
| K053199 |
11/16/2005 |
SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT |
SYNTHES (USA) |
LISA BOYLE |
| K053135 |
11/08/2005 |
SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K053251 |
11/21/2005 |
TECHDEVICE GUIDEWIRE |
TECHDEVICE CORPORATION |
LEIGH HAYWARD |
| K053141 |
11/15/2005 |
NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 |
THE MAGSTIM COMPANY LTD. |
CHRIS LEWIS |
| K053228 |
11/21/2005 |
THERIGRAFT TCP PUTTY BONE VOID FILLER |
THERICS, LLC |
SUNIL SAINI |
| K053266 |
11/23/2005 |
MYOTRAC INFINITI |
THOUGHT TECHNOLOGY LTD. |
SURESH SUGIRTHARAJA |
| K053245 |
11/23/2005 |
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER |
URESIL, LLC |
MATTHEW MAHON |
| K053290 |
11/25/2005 |
COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES |
VALLEYLAB |
CHARLES M COPPERBERG |
| K053310 |
11/28/2005 |
VASCON ROAMER MICROCATHETER |
VASCON LLC |
STEPHEN F VADAS |
| K053054 |
11/04/2005 |
THROMBIX 3X3 HEMOSTATIC PAD |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| K053270 |
11/23/2005 |
IVENT 201 |
VERSAMED MEDICAL SYSTEMS, INC. |
JERRY KORTEN |
| K053183 |
11/15/2005 |
JIVE X SOFTWARE |
VISUS TECHNOLOGY TRANSFER GMBH |
STEPHEN NEUSHUL |
| K053162 |
11/15/2005 |
DEXTROSCOPE & DEXTROBEAM |
VOLUME INTERACTIONS PTE LTD |
R. FAREETH |
| K052881 |
11/07/2005 |
VYGON LATEX FREE BIONECTOR |
VYGON CORP. |
COURTNEY SMITH |
| K053202 |
11/16/2005 |
GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL |
W.L. GORE & ASSOCIATES |
MICHAEL IVEY |
| K053200 |
11/16/2005 |
GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL |
W.L. GORE & ASSOCIATES,INC |
MICHAEL IVEY |
| K053132 |
11/09/2005 |
WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K053131 |
11/09/2005 |
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 |
WAKO CHEMICALS, USA, INC. |
LORI CREASY |
| K053169 |
11/18/2005 |
RM3 RENAL PRESERVATION SYSTEM |
WATERS INSTRUMENTS, INC. |
DAVE SCHOLLMAN |
| K053136 |
11/10/2005 |
5TH METATARSAL FRACTURE SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
| K053319 |
11/30/2005 |
ALLOMATRIX CUSTOM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
BRIAN YOUNG |
| K053321 |
11/30/2005 |
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER |
XODUS MEDICAL, INC. |
CRAIG KAFOREY |
| K053274 |
11/23/2005 |
ANATOMICAL SHOULDER INVERSE/REVERSE |
ZIMMER GMBH |
DALENE T BINKLEY |
| K053189 |
11/15/2005 |
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES |
ZIMMER, INC. |
LAURA D WILLIAMS |
| K053226 |
11/17/2005 |
ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER |
ZIMMER, INC. |
CINDY J DICKEY |
