FDA 510(k) Applications Received During November, 2005

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


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