FDA 510(k) Decisions During March, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K051719 03/21/2006 A.B. DENTAL DEVICES A.B. DENTAL DEVICES, LTD. BENNY ARAZY
K051839 03/09/2006 FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 ABBOTT DIABETES CARE INC. DHRUMA SHAH
K060009 03/06/2006 ABBOTT SPINE UNIVERSAL CLAMP SYSTEM ABBOTT SPINE, INC. LISA PETERSON
K060634 03/31/2006 NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES ABBOTT SPINE, INC. NOAH BARTSCH
K060269 03/31/2006 ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM ACMI CORPORATION TERRENCE E SULLIVAN
K060173 03/17/2006 ACON 30 SECOND RELIABLE DIGITAL THERMOMETER, ACON DIGITAL THERMOMETER PROBE COVERS ACON LABORATORIES, INC. EDWARD TUNG
K053495 03/16/2006 EQUIPMENT SLUSH DRAPE ADVANCE MEDICAL DESIGNS, INC. WILLIAM SLEVIN
K053360 03/23/2006 AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C AEROVECTRX CORPORATION DAVE PIPER
K060528 03/28/2006 AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE AESCULAP, INC. MATTHEW M HULL
K060437 03/22/2006 EXCIA TOTAL HIP SYSTEM WITH U-CAP AESCULAP, INC. KATHY A RACOSKY
K060103 03/07/2006 ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K060066 03/24/2006 VERIFY 3-10 MIN FLASH INTEGRATOR ALBERT BROWNE LTD. CYNTHIA J M. NOLTE
K060239 03/22/2006 ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM ALVEOLUS, INC. DON CANAL
K060023 03/09/2006 ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER ANGIODYNAMICS, INC. TERI JUCKETT
K053138 03/01/2006 MYSET PREGNANCY TEST ANI BIOTECH OY FRAN WHITE
K060134 03/21/2006 APOLLO IR HEAT LAMP SYSTEM APOLLO PHYSICAL THERAPY PRODUCTS INTERNATIONAL M. JOYCE HEINRICH
K060534 03/13/2006 INTUITIVE SURGICAL SEAL APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K060673 03/29/2006 PEDIATRIC URETERAL STENT APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K053645 03/09/2006 MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS ARIZANT HEALTHCARE INC. DAVID WESTLIN
K053401 03/24/2006 SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS ARKRAY, INC. HELEN LANDICHO
K053567 03/06/2006 ATHROCARE TOPAZ ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K060127 03/16/2006 HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS ARTHROSURFACE, INC. STEVEN W EK
K060455 03/20/2006 MULTISTAR ASCLEPION LASER TECHNOLOGIES GMBH REINHARD THIEME
K060457 03/20/2006 QUADROSTAR 532 ASCLEPION LASER TECHNOLOGIES GMBH REINHARD THIEME
K060459 03/20/2006 QUADROSTAR 980 ASCLEPION LASER TECHNOLOGIES GMBH REINHARD THIEME
K053384 03/24/2006 FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM ASTRA TECH, INC. FLOYD G LARSON
K053450 03/03/2006 ATLANTIS ABUTMENT FOR ZIMMER INTERFACE ATLANTIS COMPONENTS, INC. BETSY A BROWN
K060124 03/30/2006 ATRIUM FLIXENE GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K050311 03/31/2006 ATRIUM MEDICAL CORPORATION C-QUR MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K060453 03/09/2006 AZE VIRTUALPLACE AZE, LTD. CAROLE STAMP
K053355 03/14/2006 BTI INTERNA DENTAL IMPLANT SYSTEM B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDO GOMEZ MENGOD
K060505 03/29/2006 VOXAR 3D ENTERPRISE, MODEL 6.1 BARCOVIEW MIS EDINBURGH NEIL PHILLIPS
K060074 03/29/2006 INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K051670 03/30/2006 RF TUNNELER WIRE BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K060464 03/28/2006 COULTER 5C CELL CONTROL BECKMAN COULTER, INC. NANCY NADLER
K060007 03/23/2006 BD AUTOSHIELD PEN NEEDLE BECTON DICKINSON & CO. JAMES W HAYNES
K060218 03/17/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K060493 03/29/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. BECTON, DICKINSON & CO. MONICA E GUIGUERE
K060214 03/09/2006 BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K053611 03/15/2006 SMOOTHSHAPES BICELLULASE, INC. ROBERT NAGEL
K060285 03/16/2006 BONEGEN - TR BIO-LOK INTL., INC. HAROLD ALEXANDER
K051675 03/16/2006 BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER BIODYNAMICS CORP. EDWARD M RIFKIN
K053383 03/29/2006 FIDIS CELIAC BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K053653 03/13/2006 FIDIS CONNECTIVE 10, MODEL MX006 BIOMEDICAL DIAGNOSTICS (BMD) SA CHRISTELLE COURIVAUD
K053012 03/02/2006 FIDIS VASCULITIS, MODEL MX007 BIOMEDICAL DIAGNOSTICS (BMD) SA CHRISTELLE COURIVAUD
K060121 03/21/2006 BIOMET PRE-CALIBRATED COMPUTER AIDED SURGERY NAVIGATION INSTRUMENTS FOR HIP APPLICATIONS BIOMET MANUFACTURING CORP. LESTER F PADILLA
K060303 03/30/2006 VANGUARD PS OPEN BOX POROUS FEMORAL COMPONENTS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K053312 03/01/2006 EASYMATE BLOOD GLUCOSE MONITORING SYSTEM BIOPTIK TECHNOLOGY, INC. ERIC LUO
K053194 03/09/2006 NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE BIOSENSE WEBSTER, INC. SIGI CARON
K060304 03/21/2006 PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940 BIOTEX, INC. MATTHEW FOX
K053087 03/01/2006 VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM BIOTEX, INC. ASHOK GOWDA
K052122 03/29/2006 BISCO LED BISCO, INC. BENJAMIN LICHTENWALNER
K060277 03/03/2006 BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM BOEHRINGER LABORATORIES CHRISTOPHER RADL
K053268 03/13/2006 PVS 2000 SYNCHRO2 GUIDEWIRE BOSTON SCIENTIFIC - PRECISION VASCULAR RICK GAYKOWSKI
K060419 03/13/2006 CONCERTO BIPOLAR NEEDLE ELECTRODE BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K060175 03/24/2006 ISIGHT IMAGING CATHETER, MODEL 38986 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K060572 03/15/2006 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM BOSTON SCIENTIFIC CORPORATION ELAINE APLAON
K053164 03/23/2006 IPLAN FLOW BRAINLAB AG RAINER BIRKENBACH
K060468 03/20/2006 VECTORVISION HIP BRAINLAB AG RAINER BIRKENBACH
K060344 03/29/2006 O-ARM IMAGING SYSTEM BREAKAWAY IMAGING, LLC RICK GRANT
K053607 03/16/2006 BREAS VIVO 40 SYSTEM BREAS MEDICAL AB KARL-JOHAN HOLM
K052898 03/28/2006 IQMARK EZ STRESS BRENTWOOD MEDICAL TECHNOLOGY CORP. RUOMEI ZHANG
K060433 03/10/2006 DIGITAL RADIOGRAPHY CXDI-50C CANON INC. SHEILA DRISCOLL
K052598 03/16/2006 IMMOCARE CARE DIAGNOSTIC, INC. ARACELI FANCHER-FERREIRA
K060543 03/28/2006 ESENSOR CYSTIC FIBROSIS CARRIER DETECTION SYSTEM, MODEL ESENSOR 4800 CLINICAL MICRO SENSORS, INC. WILLIAM COTY
K060322 03/21/2006 CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED CLINIQA CORPORATION CAROL RUGGIERO
K053039 03/01/2006 CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF CLINTON ELECTRONICS CORP. RANDALL J SCHROEDL
K060440 03/16/2006 CODONICS HORIZON XL DIGITAL DIRECT LONG FILM IMAGER; CODONICS HORIZON XL-X LONG FILM IMAGER CODONICS, INC. ALAN DESANTIS
K060547 03/29/2006 ACCESS BREAST COIL 4/SMS CONFIRMA, INC. PATRICIA A MILBANK
K053488 03/09/2006 CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. PATRICK HESS
K060224 03/06/2006 MODIFICATION TO MIRA-FLEX 18 MICROCATHETER COOK INCORPORATED THALIA BRINE
K060523 03/28/2006 NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM CYBERKINETICS, INC. GARY SYRING
K060035 03/09/2006 MDXNET CYBERMDX, INC. JOHN COLEMAN
K052525 03/29/2006 CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS D.F.I. CO LTD ASAD R ZAIDI
K060266 03/09/2006 DIMENSION IRON CALIBRATOR DADE BEHRING, INC. ANDREA M TASKER
K060264 03/08/2006 DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) DADE BEHRING, INC. ANDREA M TASKER
K053531 03/03/2006 DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K060312 03/23/2006 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K053072 03/28/2006 N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K053073 03/28/2006 N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K053074 03/16/2006 N ANTISERA TO HUMAN CERULOPLASMIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K053075 03/16/2006 N ANTISERA TO HUMAN TRANSFERRIN DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K052788 03/29/2006 N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K060371 03/09/2006 THE EMIT 2000 TACROLIMUS CALIBRATORS DADE BEHRING, INC. UK-TING LEWIS
K052989 03/08/2006 DP240 240 HOUR DOPPLER PROBE DELTEX MEDICAL LAWRENCE BROOKFIELD
K060086 03/03/2006 FENIIIIIIX COLORATION KIT DENTAL ARTE, INC. MASSIMO SASSO
K053580 03/03/2006 DOCTOR'S NIGHTGUARD DENTAL CONCEPTS LLC. HOWARD M HOLSTEIN
K053368 03/29/2006 INTERPROXIMAL REDUCTION SYSTEM DENTSPLY INTERNATIONAL HELEN LEWIS
K053569 03/31/2006 AGILITY LP TOTAL ANKLE PROSTHESIS DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K060515 03/23/2006 DEPUY PFC SIGMA KNEE PROSTHESIS DEPUY ORTHOPAEDICS, INC. STEVEN J WENTWORTH
K060206 03/21/2006 MISSION COMPLETE DIAMOND DIAGNOSTICS, INC. RANDOLPH QUINN
K052794 03/31/2006 ETI-MAX 3000 DIASORIN, INC. CAROL A DEPOUW
K053640 03/01/2006 INTEGRA DIREX SYSTEMS CORP. LARISA GERSHTEIN
K052212 03/10/2006 MIGUE DIREX SYSTEMS CORP. LARISA GERSHTEIN
K060171 03/29/2006 CLEANSE S+ ULTRASONIC SCALER DMETEC CO., LTD. CAROLANN KOTULA
K052800 03/07/2006 PROVISIONAL INLAY/ONLAY KIT DMG USA, INC. PAMELA PAPINEAU
K053284 03/10/2006 MAGBODY DT-600 DURTECH SYSTEM CORP. ADA LIN
K060255 03/31/2006 E SURGICAL ELECTROSURGICAL PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD AND ELECTROSURGICAL PATIENT RETURN ELECTRODE E SURGICAL, LLC LEWIS WARD
K060550 03/31/2006 KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 EASTMAN KODAK COMPANY CHRISTINE E EHMANN
K060137 03/16/2006 KODAK ECLIPSE IMAGE PROCESSING SOFTWARE EASTMAN KODAK COMPANY LINDA STEWART
K060379 03/06/2006 EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. JENNIFER P HARAKAL
K060148 03/13/2006 EBI VERTEBROPLASTY SYSTEMS EBI, L.P. BARRY E SANDS
K060487 03/23/2006 LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K060422 03/09/2006 MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K053507 03/15/2006 ELITE ELECTROMED L.I.T.E. 4/1 ELITE ELECTROMEDICAL GARY HUDDLESTON
K052777 03/16/2006 LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D ELLEX MEDICAL PTY. LTD. KEVIN HOWARD
K050239 03/16/2006 EMD THERMOGRAPHY SYSTEM EM DIAGNOSTICS, INC. RICHARD KEEN
K060216 03/16/2006 ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM ENERGIST, LTD. PETER SMITH
K060484 03/16/2006 ERBE VIO ESU, MODEL VIO 300 D ERBE USA, INC. JULIE STEPHENS
K052953 03/06/2006 NUVANCE* FACIAL REJUVENATION SYSTEM ETHICON, INC. JENNIFER M PAINE
K052999 03/22/2006 SEMPERFLO INFUSION SYSTEM ETHICON, INC. JENNIFER M PAINE
K060215 03/24/2006 ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 EUROTROL B.V. ALLAN WHITE
K060057 03/08/2006 PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM EV3 INC. MELISSA SOMMERFELD
K051684 03/17/2006 EYEPORT VISION TRAINING SYSTEM EXERCISE YOUR EYES, INC. JACOB LIBERMAN
K053494 03/23/2006 OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE FERTI PRO N.V. GRACE HOLLAND
DEN050007 03/27/2006 HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL FMG INNOVATIONS, INC. LINDA D BENTLEY
K051653 03/27/2006 HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL FMG INNOVATIONS, INC. LINDA D BENTLEY
K060075 03/30/2006 FIBER-METAL POST FOREMOST DENTAL LLC. PAMELA PAPINEAU
K052839 03/10/2006 CT PERFUSION 4 GE HEALTHCARE LARRY KROGER
K060178 03/10/2006 VIX WIN PRO GENDEX DENTAL SYSTEMS DANIEL KAMM
K060542 03/31/2006 GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX GENERAL ELECTRIC CO. ALLEN SCHUH
K053463 03/07/2006 AIM ACCURACY IN MARKING SYSTEM GEORGENE AUSTRIA GEORGENE AUSTRIA
K060104 03/15/2006 PRISMATIK CLINICAL ZIRCONIA GLIDEWELL LABORATORIES KEITH D ALLRED
K053573 03/08/2006 GSS PEDICLE SCREW SYSTEM GS MEDICAL CO., LTD. SUN-EUN JUNG
K053019 03/03/2006 ACUITY STEERABLE STYLET ACCESSORY GUIDANT CORPORATION JENNIFER X TANG
K053454 03/06/2006 RX HERCULINK ELITE BILIARY STENT SYSTEM GUIDANT CORPORATION KEITH KROHN
K060294 03/22/2006 DIAPHYSEAL PLATE HAND INNOVATIONS, LLC. ERNESTO HERNANDEZ
K052891 03/23/2006 HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM HAWKEN INDUSTRIES GEORGE MYERS
K053280 03/09/2006 PROBEAT HITACHI, LTD., POWER SYSTEMS GROUP JONATHAN KAHAN
K060360 03/15/2006 HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K060514 03/17/2006 STRYKER PLATING SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K053466 03/22/2006 HSINER RESUSCITATOR HSINER CO., LTD. TOM SHANKS
K060230 03/23/2006 DOPPLEX CENTRALE HUNTLEIGH HEALTHCARE LTD. HUW JONES
K053079 03/28/2006 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 HYPOGUARD USA, INC. BRUCE A MACFARLANE
K060156 03/20/2006 STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K060504 03/14/2006 IDEAL LIFE BP-MANAGER, MODEL BPM 0001; IDEAL LIFE POD, MODEL ILP 0001 IDEAL LIFE INC. DIANE MANDELL
K060110 03/16/2006 CELLTRACKS ANALYZER II IMMUNICON CORP. PETER SCOTT
K060267 03/17/2006 VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE IMPLANT LOGIC SYSTEMS, LTD. DANIEL KAMM
K052207 03/09/2006 ACCUREX GLUCOSE TEST STRIP INCLINE MEDICAL, LLC GREG HOLLAND
K060393 03/13/2006 INION HEXALON BIODEGRADABLE ACL/PCL SCREW INION LTD. HANNA MARTTILA
K051197 03/28/2006 ACULIFE, MODEL SMW-01 INNO-HEALTH TECHNOLOGY, INC. TERRY C CHIANG
K052383 03/29/2006 INNOCURE IMRT FILTER (COMPENSATORS) INNOCURE, LLC DONALD W COLLINS
K051907 03/02/2006 INNOCOR INNOVISION A/S RICHARD O WOOD
K060368 03/14/2006 INSPIRSTAR IS02 MICROCURRENT STIMULATOR INSPIRSTAR, INC. NING WU
K060582 03/16/2006 INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIR INVACARE CORPORATION CARROLL MARTIN
K060236 03/31/2006 MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE IOMED, INC. CURTIS JENSEN
K053622 03/15/2006 SURGISIS OCULAR GRAFT IOP, INC. JASON MALECKA
K053582 03/21/2006 INQUIRY AFOCUS II DIAGNOSTIC CATHETER IRVINE BIOMEDICAL, INC. ELVIA ZAVALA
K060306 03/27/2006 ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY ISOTIS NV ELIANE SCHUTTE
K060332 03/29/2006 ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY ISOTIS NV ELIANE SCHUTTE
K060092 03/09/2006 QUICKCAT EXTRACTION CATHETER KENSEY NASH CORP. DEBORAH L JACKSON
K060292 03/03/2006 KODAK MODELS 2100 AND 2200 KODAK-TROPHY MARIE-PIERRE LABAT-CAMY
K060454 03/24/2006 TITAN GUIDEWIRE LAKE REGION MFG., INC. KAREN MORTENSEN
K060068 03/08/2006 AVANTICARE, MODEL SA4021 LERADO CHINA LIMITED JEFF CHANG
K060481 03/09/2006 LIBERTY GLUCOSE CONTROL SOLUTION LIBERTY HEALTHCARE GROUP, INC. JOHN C GORMLEY
K060426 03/09/2006 LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041 LIBERTY HEALTHCARE GROUP, INC. JOHN C GORMLEY
K060208 03/10/2006 CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C, LIFE-SHIELD PRODUCTS, INC CHAO-HUA SHIH
K051058 03/29/2006 METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K050945 03/29/2006 ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K053510 03/20/2006 IR WIRELESS FOOT SWITCH LINEMASTER SWITCH CORP. MIKE SZOSTEK
K060338 03/09/2006 FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO LUMENIS, INC. CONNIE HOY
K053636 03/14/2006 MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) MANI, INC. DAVID J BLOCH
K053300 03/28/2006 SYVEKEXCEL MARINE POLYMER TECHNOLOGIES, INC. SERGIO FINKIELSZTEIN
K053477 03/16/2006 MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS MASIMO CORPORATION JAMES J CRONIN
K060234 03/15/2006 MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM MCCUE PLC STEVEN PEACH
K053485 03/09/2006 THERATRON EQUINOX, MODELS 80 CM AND 100 CM MDS NORDION INC. ROSS KACHANIWSKY
K053123 03/29/2006 PD CATH MED-CONDUIT, INC. GERALD G BOUSQUET
K053345 03/17/2006 PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D MEDCOMP JEAN CALLOW
K060146 03/08/2006 ACTIVECARE ++ SYSTEM MEDICAL COMPRESSION SYSTEMS (DBN) LTD. DORIT WINITZ
K052424 03/31/2006 MAXILIM MEDICIM NV JOSEPH AZARY
K051875 03/13/2006 BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS MEDITECH INTERNATIONAL, INC. RICHARD KEEN
K060401 03/15/2006 MEDRAD 3.0T ECOIL IMAGING SYSTEM MEDRAD, INC. LISA A EWING
K053431 03/16/2006 ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM MEDTRONIC IRELAND MICHELLE NIVALA
K052623 03/02/2006 IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM MEDTRONIC NAVIGATION, INC. TINA DREILING
K060418 03/15/2006 8F SHERPA NX GUIDE CATHETER MEDTRONIC VASCULAR MARK PUOPOLO
K053430 03/03/2006 TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER MEDTRONIC XOMED, INC. PENNY LAYMAN
K053335 03/10/2006 PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K060403 03/28/2006 PTA (PROGRESSIVE TIBIAL ALIGNMENT) MERIDIAN MEDICAL GRACE HOLLAND
K053229 03/23/2006 MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K060212 03/07/2006 MERITS MODEL E SERIES LIFT CHAIRS MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K051477 03/10/2006 MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) MI GWANG CONTACT LENS CO., LTD. MARTIN DALSING
K053255 03/14/2006 NEXUS LIGATING CLIP MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL LISA S JONES
K052140 03/16/2006 SPIROLAB, SPIROLAB II MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K060161 03/21/2006 AFT ALLOGRAFT FILLER TUBE MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ
K053339 03/16/2006 ALLOFIX ANCHOR MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY L BENNEWITZ
K050975 03/02/2006 NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN NANO-DITECH CO. SUSAN D GOLDSTEIN-FALK
K051596 03/13/2006 STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 NANOGEN, INC. VAN N SCHRAMM
K053626 03/29/2006 INTERX500 FLEXIBLE ARRAY ELECTRODE NEURO RESOURCE GROUP, INC. KRISTA OAKES
K050123 03/30/2006 P-STIM SYSTEM NEUROSCIENCE THERAPY CORP. JAN MCCOMB
K051617 03/06/2006 NOVABONE PUTTY - RESORBABLE BONE VOID FILLER NOVABONE PRODUCTS, LLC DAVID M GAISSER
K060349 03/10/2006 PROGUIDE NEEDLE SET NUCLETRON CORPORATION LISA DIMMICK
K060296 03/31/2006 NXSTAGE DIALYSATE PREPARATION MODULE NXSTAGE MEDICAL, INC. NORMA LEMAY
K060475 03/17/2006 EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8 OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
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