FDA 510(k) Decisions During December, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K052307 12/16/2005 BEAMER PAINLOW INFRARED LIGHT TREATMENT SYSTEM BEAMLINE CORPORATION DAVID R BALZER
K053256 12/16/2005 3M TEGADERM SILVER (AG) MESH 3M COMPANY AMY E SHORT
K051041 12/23/2005 INSULIN PUMP ABBOTT DIABETES CARE INC. MARY ROSE
K053330 12/16/2005 ARCHITECT B12 CALIBRATORS ABBOTT LABORATORIES MARGARET PROCHNIAK
K052744 12/16/2005 C2000 AUTOMATED MANIFOLD KIT ACIST MEDICAL SYSTEMS, INC. A; SAALABI
K053250 12/15/2005 ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K052087 12/14/2005 BREATHING FILTER BACTERIAL/VIRAL, MODEL AG7178 AG INDUSTRIES IAN GORDON
K053440 12/30/2005 AMPLATZER SIZING BALLOON II AGA MEDICAL CORP. AMANDA JOHNSON
K053458 12/22/2005 WEB1000 AGFA CORP. PHIL CUSCUNA
K052023 12/08/2005 CADIMAS VERSION 1.0 ALAN PENN & ASSOCIATES., INC. ROGER H SCHNEIDER
K051101 12/06/2005 VERIFY FLASH INTEGRATOR ALBERT BROWNE LTD. CYNTHIA J M. NOLTE
K052340 12/09/2005 DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM ALFA TECH MEDICAL SYSTEMS, LTD. SUSAN D GOLDSTEIN-FALK
K051275 12/09/2005 LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K052733 12/22/2005 ALMITECH INC. DENTAL IMPLANT SYSTEM ALMITECH INC. ALEX BREYTMAN
K053142 12/20/2005 AMBU MARK IV BABY RESUSCITATOR AMBU A/S SANJAY PARIKH
K053140 12/23/2005 AMBU MARK IV RESUSCITATOR AMBU A/S SANJAY PARIKH
K053175 12/08/2005 AMEDITECH DRUGSMARTCUP AMEDITECH, INC. JOHN WU
K051903 12/27/2005 FETALGARD LITE-NIBP, MODEL FGL-NIBP ANALOGIC CORPORATION JANET KWIATKOWSKI
K053119 12/07/2005 DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. BRYAN BABB
K052901 12/12/2005 ARTHREX TENSIONLOK ARTHREX, INC. ANN WATERHOUSE
K052776 12/13/2005 TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD ARTHREX, INC. SALLY FOUST
K053297 12/06/2005 ARTHROCARE 8000S COBLATOR SURGERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K053447 12/27/2005 ARTHROCARE PERC-D SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K052845 12/16/2005 B-CARE POWDERED LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD. KEVIN WALLS
K052772 12/20/2005 BARRIERPLUS GOLD ORTHO POWDER-FREE SYNTHETIC POLYISOPRENE ORTHOPEDIC SURGICAL GLOVES BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K051693 12/07/2005 MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM BAYER HEALTHCARE, LLC ANDREA HOLLE
K053020 12/30/2005 TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K052503 12/14/2005 TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM BAYER HEALTHCARE, LLC ANDRES HOLLE
K053090 12/16/2005 DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR BECKMAN COULTER, INC. ERI HIRUMI
K053241 12/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K053011 12/14/2005 PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 BIO PROTECH, INC. E.J. SMITH
K053152 12/02/2005 BIOHORIZONS SINGLE-STAGE IMPLANT BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K051030 12/23/2005 COAG-A-MATE MTX III BIOMERIEUX, INC. JOHN CUSACK
K053097 12/14/2005 VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN BIOMERIEUX, INC. NANCY WEAVER
K053186 12/01/2005 VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. NANCY WEAVER
K052888 12/06/2005 POROUS TITANIUM ACETABULAR AUGMENTS BIOMET MANUFACTURING CORP. ALLISON KOSKEY
K052990 12/16/2005 STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM BIOMET, INC. LESTER F PADILLA
K043598 12/16/2005 FC 1400 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K043597 12/16/2005 FC 700 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K052625 12/05/2005 BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 BIONICARE MEDICAL TECHNOLOGIES, INC. KENT HOFFMAN
K052646 12/16/2005 BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 BIOSPACE CORPORATION LIMITED DANIEL KAMM
K052289 12/13/2005 DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE BIOWAVE CORPORATION MARY MCNAMARA-CULLINANE
K051513 12/07/2005 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER BIPORE, INC. KEITH PALUCH
K052799 12/16/2005 MULTITAK 6.0 MM ABSORBABLE ANCHOR SYSTEM BONUTTI RESEARCH, INC. PATRICK BALSMANN
K053118 12/16/2005 STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX BOSTON SCIENTIFIC CORP. MAUREEN MARY MONTBRIAND
K053116 12/16/2005 STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX BOSTON SCIENTIFIC CORP. MAUREEN MARY MONTBRIAND
K052779 12/20/2005 BRECOMP BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052781 12/09/2005 BREFORMANCE BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052780 12/21/2005 DENTAPLAST HOT, MODEL 16-XXX BREDENT-PRODUCTS FOR THE DENTAL TECHNICIAN LABORAT MARKUS DENK
K052862 12/30/2005 FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) BRYAN KEROPIAN DDS BRYAN KEROPIAN
K053031 12/07/2005 EXTENDSURE HBFASC CONTROL CANTEBURY SCIENTIFIC LTD. MAURICE OWEN
K053089 12/20/2005 ASCENT PIT & FISSURE SEALANT CAO GROUP, INC. ROBERT K LARSEN
K053395 12/23/2005 BP PRO BLOOD PRESSURE MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K052790 12/23/2005 SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K053303 12/30/2005 CARDIOCOM COMMANDER III CARDIOCOM LLC DANIEL KAMM
K053304 12/30/2005 COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM CARDIOCOM LLC DANIEL KAMM
K051257 12/22/2005 ADULT CEREBRAL OXIMETER, MODEL 2040 CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K051896 12/16/2005 MODEL 750E SERIES MONITOR CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K052725 12/28/2005 PROTECTOR NEEDLE SHEATH PROP CERTOL INTERNATIONAL, LLC LEWIS WARD
K050758 12/22/2005 CHEMPAQ XBC ANALYZER CHEMPAQ A/S JONATHAN S KAHAN
K052963 12/05/2005 MEDIQ VERSION 1.0 CLARIO MEDICAL IMAGING, INC. PATRICIA A MILBANK
K051964 12/01/2005 POWERNEB COMEDICA , INC. KRISTA OAKES
K052539 12/09/2005 COOK FORMULA 418 BILIARY STENT SYSTEM COOK, INC. KAREN BRADBURN
K052841 12/08/2005 MIRA-FLEX 18 MICROCATHETER COOK, INC. THALIA BRINE
K052560 12/06/2005 BIOFINITY (COMFILCON A) SOFT CONTACT LENS COOPERVISION, INC. JACK P DOUGLAS
K053197 12/15/2005 TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION CORDIS NEUROVASCULAR, INC. AMARILYS MACHADO
K052263 12/16/2005 MULTIPLE (TOOTH DESENSITIZER) COSMEDENT, INC. JAMES L SANDRIK
K053201 12/09/2005 CURAE'LASE CL1000 IR LASER SYSTEM CURAE'LASE INC. M. JOYCE HEINRICH
K051911 12/06/2005 GELITA-SPON CURAMEDICAL, BV WILLIAM GREENROSE
K052135 12/20/2005 CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER CYBERSONICS, INC. WILLIAM A STOLL
K053157 12/09/2005 AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A DADE BEHRING, INC. VICTOR M CARRIO
K053104 12/23/2005 DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR DADE BEHRING, INC. ANDREA M TASKER
K053109 12/23/2005 DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE DADE BEHRING, INC. ANDREA M TASKER
K052303 12/16/2005 READMYHEART, MODEL RMH2.0 DAILYCARE BIOMEDICAL INC DANIEL J. H. CHANG
K052688 12/12/2005 ELLIPSE FLEX PPT, MODEL 9ESF7255 DANISH DERMATOLOGIC DEVELOPMENT A/S OLE KOFOD
K053167 12/08/2005 BIOPURE MTAD ROOT CANAL CLEANSER DENTSPLY INTL., INC. HELEN LEWIS
K052840 12/16/2005 IGI-SYSTEM DENX ADVANCED DENTAL SYSTEMS RACHEL WEISSBROD
K051714 12/07/2005 TOTAL BILE ACIDS ASSAY, MODEL DZ042A DIAZYME LABORATORIES HUAN TRAN
K051487 12/22/2005 DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE DOCTOR'S RESEARCH GROUP, INC. MAHMUD AHMED
K051733 12/07/2005 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL DRG INTL., INC. GARY LEHNUS
K052445 12/05/2005 DUOPROSS NEEDLE DUOPROSS MEDITECH CORPORATION FRANK FERGUSON
K052743 12/22/2005 DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921 DYNAREX CORP. JAMES HURLMAN
K052343 12/07/2005 E-SAN BLUETOOTH CRADLE E-SAN LIMITED KRISTIN M ZIELINSKI
K053008 12/27/2005 E-Z-EM ENDOSCOPIC CO2 REGULATOR E-Z-EM, INC. ROBERT WILLIAMS
K050921 12/12/2005 EASYSTIM NMS-28 EASYMED INSTRUMENT CO., LTD. JEFFERY WU
K053404 12/21/2005 LIFESTENT FLEXSTART BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K053016 12/30/2005 WIRELESS PHYSIOLOGIC MONITORING SYSTEM EDWARDS LIFESCIENCES, LLC. DIANE PETERSON
K053432 12/30/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K053248 12/01/2005 SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL ELECTROMED, INC. CHET SIEVERT
K053281 12/07/2005 EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) EMAGEON INC. INGER L HANSON
K052320 12/30/2005 ENCORE CLP OFFSET TOTAL HIP SYSTEM ENCORE MEDICAL CORPORATION SAM SON
K053100 12/19/2005 ESTECH COBRA BIPOLAR SYSTEM ENDOSCOPIC TECHNOLOGIES, INC. CRAIG COOMBS
K052081 12/16/2005 REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA ESTECH, INC. CRAIG COOMBS
K052233 12/13/2005 TRACHEOSCOPIC VENTILATION TUBE (TVT) SYSTEM ETVIEW LTD. YORAM LEVY
K052133 12/12/2005 IMMUNOSCAN RA ANTI-CCP TEST SYSTEM EURODIAGNOSTICA WILLIAM L BOTELER JR.
K052787 12/27/2005 ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) EXACTECH, INC. MARITZA ELIAS
K051858 12/01/2005 ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM EXACTECH, INC. LISA SIMPSON
K053120 12/09/2005 STERILE FIELD SALINE AND HEPARIN LOCK FLUSH SYRINGES EXCELSIOR MEDICAL CORP. RUBEN MARTINEZ
K051294 12/21/2005 FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1 FEMSPEC L.L.C. CARL YOUNGMANN
K052115 12/29/2005 FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY FIRST CHECK DIAGNOSTICS LLC KEVIN J GADAWSKI
K052531 12/14/2005 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER FU HONG INDUSTRIES LTD. KEVIN WALLS
K052889 12/20/2005 VITROS CA 19-9 FUJIREBIO DIAGNOSTICS, INC. DIANA L WOLANIUK
K051520 12/09/2005 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K052972 12/29/2005 DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 GE HEALTHCARE JOEL KENT
K053435 12/16/2005 GE VOLUSON I GENERAL ELECTRIC CO. ALLEN SMITH
K053066 12/19/2005 SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH GENZYME CORPORATION LISA D CROCKETT
K053055 12/22/2005 ORTHODONTIC POLYMER COMPOSITE BRACKET GESTENCO INTERNATIONAL AB GORAN STEEN
K052184 12/01/2005 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K052923 12/21/2005 GREAT GLOVE POWDER FREE VINYL EXAMINATION GLOVES GREAT GLOVE (CHINA), INC. K.M. LEE
K052922 12/20/2005 GREAT GLOVE POWDERED VINYL EXAMINATION GLOVES GREAT GLOVE (CHINA), INC. K.M. LEE
K052956 12/21/2005 NITRILE BLUE POWDER FREE EXAMINATION GLOVE GREAT GLOVE SDN BHD LIM WEE-CHAI
K052177 12/09/2005 POWDER FREE STERILE LATEX SURGICAL GLOVES HARTALEGA SDN BHD NURUL AISYAH KONG
K052471 12/23/2005 HDC SPIDER SCREW HDC S.R.L. MILLIE LYNN BENTLEY
K052120 12/16/2005 LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50 HEEYOUNG CO., LTD. DANIEL KAMM
K053258 12/09/2005 EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL CORP. DOUG THISTLETHWAITE
K052597 12/16/2005 BREATHEX OMEGA CPAP DEVICE, MODEL 322 HOFFMAN LABORATORIES, LLC KEITH BOSECKER
K053308 12/29/2005 ABX MICROS CRP 200, OPTION IM HORIBA ABX TIM LAWTON
K052007 12/16/2005 ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER (OPTION: I.S.E. MODULE) HORIBA ABX TIM LAWTON
K053349 12/09/2005 HOFFMANN II ROD TO WIRE COUPLING HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K052917 12/27/2005 STRYKER COMPARTMENTAL KNEE SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K052748 12/02/2005 SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K052811 12/21/2005 HSINER JET NEBULIZER, MODEL HS-31100 HSINER CO., LTD. TOM SHANKS
K053369 12/22/2005 MEDILOG DARWIN HOLTER ANALYSIS HUNTLEIGH HEALTHCARE JAMES PARDEY
K051472 12/23/2005 BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR HYPHEN BIOMED OLA ANDERSON
K050365 12/27/2005 BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 HYPHEN BIOMED OLA ANDERSON
K051433 12/15/2005 I-STAT CREATINE KINASE MB (CK-MB) I-STAT CORPORATION SUE KENT
K052865 12/22/2005 HOSPIRA CATH LAB CONVENIENCE KITS ICU MEDICAL, INC. TOM KOZMA
K052694 12/16/2005 ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. IND DIAGNOSTIC INC. JASON PENG
K053276 12/27/2005 IST PEDICLE SCREW SYSTEM INNOVATIVE SPINAL TECHNOLOGIES INC STEPHEN PALUMBO
K052562 12/23/2005 ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS. INTERACOUSTICS AS DANIEL EGGAN
K051371 12/06/2005 INTERBODY INNOVATIONS CEMENT RESTRICTOR INTERBODY INNOVATIONS LLP IAN GORDON
K053196 12/16/2005 ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) INVERNESS MEDICAL INNOVATIONS, INC. JAMES M DELANEY
K050642 12/05/2005 ORTHOBLAST II PUTTY AND PASTE ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K052587 12/27/2005 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF J. MORITA USA, INC. KEITH A BARRITT
K052398 12/07/2005 MESA SPINAL SYSTEM K2M, LLC RICHARD W WOODS
K051300 12/08/2005 ROBIN HOOD VEST KAMBER CORPORATION DAVID J BLOCH
K050944 12/23/2005 K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K053262 12/19/2005 KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. YVONNE FERNANDEZ
K053173 12/15/2005 DS CASSETTE KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K052467 12/20/2005 BRAIN VIEWRX VIEWER, VERSION 1.0 KYRON CLINICAL IMAGING, INC. JAMES L REUSS
K052604 12/16/2005 STARLITE 2006 LASER DENTAL INNOVATIONS HOWARD FEINBERG
K053149 12/13/2005 SPIRO-BALL LEVENTON, S.A. ORIOL VERNIS
K052397 12/22/2005 CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) LIFE-SHIELD PRODUCTS, INC KE-MIN JEN
K052735 12/28/2005 ALLOCRAFT DBM LIFECELL CORP. HOWARD M HOLSTEIN
K052678 12/27/2005 AQ-830 SLIM BODY, BODY FAT MONITOR LIMAX ELECTRONICS CO., LTD. JENNIFER REICH
K051926 12/12/2005 LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP LIMERICK, INC. PAUL KRUMM
K052715 12/22/2005 CALM CURVE, VERSION 01.00 LMS MEDICAL SYSTEMS (CANADA), LTD. PAMELA HASWELL
K052728 12/05/2005 POWDER FREE LATEX STERILE PATIENT EXAMINATION GLOVES M/S. KANAM LATEX INDUSTRIES PVT. LTD. RAVI ABRAHAM
K052846 12/22/2005 TEWA CJ-TYPE, PJ-TYPE, CB-TYPE AND PB-TYPE ACUPUNCTURE NEEDLES FOR SINGLE USE MAANSHAN MEDICAL INSTRUMENTS CO., LTD. KEVIN WALLS
K052622 12/09/2005 MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT MACAN ENGINEERING CO. MICKEY ALBERGO
K050150 12/05/2005 MANI NEEDLE & SUTURE PACK MANI, INC. DAVID J BLOCH
K052606 12/15/2005 MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS MARIETTA VISION MARTIN DALSING
K053269 12/21/2005 MASIMO SET RAD-8 PULSE OXIMETER MASIMO CORPORATION JIM CRONIN
K051324 12/05/2005 MEDI BUTLER MEDI USA, LP GARY L YINGLING
K051694 12/21/2005 CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. OYTIP KUNWUNLOP
K052338 12/15/2005 SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K052751 12/23/2005 VENTLINK SYSTEM MEDISERVE INFORMATION SYSTEMS, INC. MARK OFORI-KYEI
K052615 12/09/2005 MEDISIZE GOLD MEDISIZE BV SOPIHA LAM
K050933 12/09/2005 FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 MEDISURG LTD. RICHARD J FUGO
K053325 12/07/2005 MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 MEDIWATCH LTD ANDREW HOPKINS
K042404 12/22/2005 LIFEPAK, MODEL 1000 MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. SHERRI POCOCK
K052386 12/16/2005 MEDTRONIC M2 MAGNET ADJUSTMENT TOOL MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K051386 12/16/2005 MASTERGRAFT PUTTY BONE VOID FILLER MEDTRONIC VASCULAR RICHARD TREHARNE
K053252 12/16/2005 U-CLIP DEVICE, MODELS B140, B160 AND B180 MEDTRONIC VASCULAR DAVID D COX
K052288 12/20/2005 VITALOGIK MENNEN MEDICAL LTD. MICHA OESTEREICH
K053414 12/27/2005 MENTOR NOVASILK MESH MENTOR CORP. DONNA A CRAWFORD
K053296 12/15/2005 MENTOR ARIS SUPRAPUBIC SURGICAL KIT MENTOR CORPORATION DONNA A CRAWFORD
K053160 12/07/2005 MICRUS MODIFIED MICROCOIL 18-SYSTEM, "CERECYTE", MODEL CSP & CHE MICRUS ENDOVASCULAR CORPORATION MARGARET WEBBER
K053192 12/05/2005 MODEL 418 SERIES WALKERS MJM INTERNATIONAL CORPORATION MELLY MOROLES
K052451 12/08/2005 MPS ACACIA MEDFLO ELASTOMERIC PUMP MPS ACACIA FERGIE FERGUSON
K052946 12/08/2005 MPS ACACIA NERVE BLOCK NEEDLE MPS ACACIA FERGIE F FERGUSON
K052942 12/27/2005 21.3INCH MONOCHROME LCD MONITOR NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP. SHUICHI KINO
K053214 12/20/2005 THERAKNIT GARMENT ELECTRODE NEUROTRON MEDICAL JACK GULDALIAN
K053093 12/07/2005 KALIX II IMPLANT, MODEL 141 0XX WITH XX NEWDEAL S.A. JUDITH E O'GRADY
K053408 12/22/2005 NEXA BONE PLATE AND SCREW SYSTEM NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K053394 12/14/2005 NEXA BONE SCREW SYSTEM NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K053129 12/08/2005 NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 NEXUS MEDICAL, LLC AL BOEDEKER
K051828 12/15/2005 NIPRO SUREFUSER AMBULATORY INFUSION PUMP NIPRO MEDICAL CORPORATION KAELYN HADLEY
K052885 12/23/2005 ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 NOBEL BIOCARE USA LLC HERBERT CRANE
K050726 12/05/2005 SILVERSEAL SILVERAID WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. PATRICIA DAVIDSON
K052669 12/23/2005 AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 NONIN MEDICAL, INC. LORI M ROTH
K052490 12/08/2005 ENDOSSEOUS DENTAL IMPLANT SYSTEM NORTHERN IMPLANTS, LLC GRETA M HOLS
K053470 12/21/2005 NOVOFINE 32G TIP NOVO NORDISK INC. JOHN SIGNORIN
K052700 12/20/2005 PANA-SPRAY NSK AMERICA CORP. HIROHIKO MURASE
K052210 12/12/2005 NUVASIVE COROENT EXTENSURE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K053286 12/22/2005 MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION NXSTAGE MEDICAL, INC. NORMA LEMAY
K052804 12/09/2005 BREATHKEY MODEL G10/BREATHKEY MODEL G30X OMEGAPOINT SYSTEMS, LLC BARBARA S FANT
K052428 12/08/2005 RESOLUTION ENDOVASCULAR SYSTEM OMNISONICS MEDICAL TECHNOLOGIES ANNE M KULIS
K052645 12/14/2005 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; ORTHO-CLINICAL DIAGNOSTICS MICHAEL M BYRNE
K052819 12/23/2005 VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K052867 12/23/2005 VITROS CHEMISTRY PRODUCTS DTIBC REAGENT ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K053261 12/12/2005 ORTHOFIX TITANIUM NAILING SYSTEMS ORTHOFIX SRL CANDACE F CEDERMAN
K053080 12/01/2005 GRAFTCAGE ACX OSTEOTECH, INC. CHRISTOPHER TALBOT
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K052586 12/09/2005 A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P TAIWAN AN I CO.,LTD. KEVIN WALLS
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K052635 12/13/2005 TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW TEH LOONG CORP. CHIEN LIN
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K052864 12/22/2005 TYRX SURGICAL MESH, MODEL SMPC-0501 TYRX PHARMA INC MASON W DIAMOND
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K051638 12/06/2005 INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC UNIPATH LTD. LOUISE ROBERTS
K053245 12/20/2005 GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER URESIL, LLC MATTHEW MAHON
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K053503 12/28/2005 VAX-D GENESIS SYSTEM (THERAPEUTIC TABLE) VAX-D MEDICAL TECHNOLOGIES USA, L.C. LAWRENCE DYER
K052738 12/06/2005 INFUSIONCATH PERIPHERAL INFUSION CATHETER, MODELS VF0012, VF0016, VF0024, VF0028, VF0032, VF0036, VF0040, VF0044 VEINRX INC. GREGORY J MATHISON
K052632 12/15/2005 VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE VITAL IMAGES, INC. TIMOTHY J KAPPERS
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K052348 12/02/2005 IN VISION GOLD WITH SPIN VISION, MODEL 891 SV VOLCANO CORPORATION JENNIFER M MOTTO
K052395 12/01/2005 STERILE EQUIPMENT COVERS VOLCANO CORPORATION MICHELLE J BADAL
K053162 12/09/2005 DEXTROSCOPE & DEXTROBEAM VOLUME INTERACTIONS PTE LTD R. FAREETH
K053202 12/07/2005 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES MICHAEL IVEY
K053200 12/07/2005 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC MICHAEL IVEY
K053132 12/30/2005 WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 WAKO CHEMICALS, USA, INC. LORI CREASY
K053131 12/30/2005 WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 WAKO CHEMICALS, USA, INC. LORI CREASY
K052160 12/16/2005 ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) WELCH ALLYN, INC. JOHN E SAWYER
K051242 12/13/2005 WINNER SELF SEAL STERILIZATION POUCH WINNER MEDICAL (USA), INC. MING XIE
K052026 12/05/2005 LINEAGE A-CLASS POLY LINER WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K052847 12/12/2005 CAPLESS PEDICLE SCREW SYSTEM X-SPINE SYSTEMS, INC. FLOYD G LARSON
K050843 12/22/2005 AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM XOFT, INC. KATHY O'SHAUGHNESSY
K052328 12/22/2005 ZAN LUNG-FUNCTION LAB ZAN MESSGERATE GMBH JIM LEWIS
K051484 12/05/2005 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. ZEUS SCIENTIFIC, INC. MARK K KOPNITSKY
K052912 12/15/2005 YUSHENG DISPOSABLE VAGINAL SPECULUM ZHEJIANG YUSHENG MEDICAL INSTRUMENT CO. LTD. PEIFANG XING
K053189 12/09/2005 COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES ZIMMER, INC. LAURA D WILLIAMS
K052425 12/28/2005 ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION ZIMMER, INC. STEPHEN H MCKELVEY
K052906 12/19/2005 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM ZIMMER, INC. DALENE T BINKLEY


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