FDA 510(k) Applications Received During April, 2001

FDA 510(k) Number Submission Date Device Name Applicant Contact
K011255 04/24/2001 3D LINE STEROTACTIC HARDWARE ACCESSORIES 3D LINE USA, INC. KAREN H RIGAMONTI
K011200 04/19/2001 GILB, MODEL 8010 3M COMPANY KAREN O'MALLEY
K011167 04/16/2001 XSE 3M COMPANY KAREN O'MALLEY
K011096 04/10/2001 ABBOTT ACCLAIM ENCORE, MODEL 12237 ABBOTT LABORATORIES FRANK POKROP
K011217 04/20/2001 CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT ABBOTT LABORATORIES THOMAS P SAMPOGNA
K011024 04/04/2001 CYBERKNIFE SYSTEM ACCURAY, INC. E. BRUCE FLOYD
K011189 04/18/2001 VIADUCT MICROENDOSCOPE AND ACCESSORIES ACUEITY, INC. MARYBETH FECTEAU
K011248 04/23/2001 CW DISPOSABLE ACUPUNCTURE NEEDLE ACUSUPPLY, INC. FERES DAGER
K011247 04/23/2001 HOLY DRAGON STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE ACUSUPPLY, INC. FERES DAGER
K011242 04/23/2001 HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE ACUSUPPLY, INC. FERES DAGER
K011265 04/25/2001 ULTRASOUND TRANSDUCER COVER ADVANCE MEDICAL DESIGNS, INC. BILL GILL
K011183 04/18/2001 OMNIPORT HAND AND INSTRUMENT ACCESS DEVICE ADVANCED SURGICAL CONCEPTS (ASC) MARY MCNAMARA-CULLINANE
K011224 04/20/2001 HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY ADVANCED TECHNOLOGY LABORATORIES, INC. TERRENCE J SWEENEY
K011030 04/05/2001 AESCULAP -MIETHKE SHUNT SYSTEM AESCULAP, INC. JOYCE THOMAS
K011102 04/11/2001 ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM AESCULAP, INC. LISA M MILLINGTON
K011093 04/10/2001 AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K010965 04/02/2001 A-LINE AEP MONITOR ALARIS MEDICAL SYSTEMS, INC. RENEE FLUET
K010966 04/02/2001 MEDLEY SP02 MODULE, MODEL 8220 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K011132 04/13/2001 AIRLIFE HEPA FILTER ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K011078 04/09/2001 MALLEABLE SHAFT CLAMP ALLEGIANCE HEALTHCARE CORP. LANCE MARCONI
K011186 04/18/2001 POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K011192 04/19/2001 COMPRESSIBLE LIMB SLEEVE ALLIANCE MEDICAL CORP. DON SELVEY
K011314 04/30/2001 OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM ALOKA CO., LTD. KELVIN BURROUGHS
K011315 04/30/2001 SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 ALOKA CO., LTD. KELVIN BURROUGHS
K011234 04/23/2001 BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L AMERICAN BIOCURVE, INC. MARTIN DALSING
K011316 04/30/2001 BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T AMERICAN CONTACT LENS, INC. MARTIN DALSING
K011201 04/19/2001 ALPCO MILENIA ANTI-TPO ELISA AMERICAN LABORATORY PRODUCTS CO., LTD. RICHARD E CONLEY
K010990 04/03/2001 AMS SLING FIXATION SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K011251 04/24/2001 SPARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. GINGER S GLASER
K011006 04/04/2001 AMYSEAT TILT/RECLINE SEATING AMYSYSTEMS SYLVAIN DUGAS
K011304 04/30/2001 OB-1 FETAL MONITOR ANALOGIC CORP. STEVEN A CLARKE
K011077 04/09/2001 ANDERSEN INTESTINAL TUBE, MILLER-ABBOTT TYPE (AN 22) ANDERSEN PRODUCTS, INC. WENDY HEDRICK
K011233 04/23/2001 MODIFICATION TO GLUCOSURE BGM SYSTEM, MODEL 221100 APEX BIOTECHNOLOGY CORP. BRUCE A MACFARLANE
K011264 04/25/2001 MESH URETERAL STENT APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K011236 04/23/2001 MODIFICATION TO IMPLANTABLE CLIP APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K011212 04/20/2001 FILTERFLO H ARC MEDICAL, INC. HAL NORRIS
K011056 04/06/2001 ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD ARROW INTL., INC. THOMAS D NICKEL
K011172 04/17/2001 ARTHREX BIO-TRANSFIX ARTHREX, INC. VERNON BROWN
K011007 04/04/2001 TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 ARTHREX, INC. ANN WATERHOUSE
K011083 04/10/2001 ARTHROCARE SYSTEM 2000 CONTROLLER, CABLE, FOOTSWITCH, POWER CORD & ARTHROCARE ARTHROWAND ARTHROCARE CORP. BRUCE PROTHRO
K011279 04/27/2001 ENTEC EVAC PLASMA WAND ARTHROCARE CORP. BRUCE PROTHRO
K011273 04/26/2001 SI ASCOPE ASTRON CLINICA LIMITED E.J. Smith
K011199 04/19/2001 PROVIEW EYE PRESSURE MONITOR BAUSCH & LOMB, INC. DOUGLAS J FORTUNATO
K011317 04/30/2001 MULTIRATE INFUSOR SV; MULTIRATE INFUSER LV; BAXTER PAIN MATE PAIN MANAGEMENT SYSTEM BAXTER HEALTHCARE CORP. VICKI L DREWS
K011156 04/16/2001 BCI 3403 SLEEP SCREENING PULSE OXIMETER BCI, INC. DONALD ALEXANDER
K011177 04/17/2001 BCI ADVISOR VITAL SIGNS MONITOR (9200) BCI, INC. DONALD J ALEXANDER
K011103 04/11/2001 BD SPRING BASED SYRINGE BD GREG W MORGAN
K011213 04/20/2001 MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM BECKMAN COULTER, INC. ANNETTE HELLIE
K011222 04/20/2001 PORTABELL, MODEL 4200 BELL DENTAL PRODUCTS, LLC. DAN BELL
K011041 04/05/2001 WATERLASE, MILLENNIUM BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K011219 04/20/2001 ASCENT KNEE SYSTEM BIOMET, INC. DALENE T BINKLEY
K011237 04/23/2001 LACTOSORB PLATES, MESHES, AND PANELS/SHEETS BIOMET, INC. DALENE T BINKLEY
K011139 04/13/2001 LORENZ LACTOSORB PANELS AND FASTENERS BIOMET, INC. TRACY J BICKEL
K011110 04/11/2001 M2A ACETABULAR SYSTEM BIOMET, INC. MICHELLE L MCKINLEY
K011138 04/13/2001 OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT BIOMET, INC. PATRICIA S BERES
K011137 04/13/2001 RESORBABLE HAMMERTOE PIN BIOMET, INC. SARA A BAILEY
K011216 04/20/2001 PVC FREE INTRAVASCULAR ADMINISTRATION SET BIOMETRIX LTD. MIRIAM ABUTBUL
K010983 04/02/2001 PLLA PIN BIONX IMPLANTS, INC. TUIJA ANNALA
K011075 04/09/2001 EASYBELL BIOPSYBELL S.A.S. LUCIO IMPROTA
K011104 04/11/2001 OSTEOBELL BIOPSYBELL S.A.S. LUCIO IMPROTA
K011208 04/19/2001 BIOVER BIOVER AG HEINZ E WICK
K011159 04/11/2001 ONE-STEP PLUS BISCO, INC. CYNDY ORIS
K010993 04/03/2001 ALIEN RX MICRO CANNULA, MODEL 4530 BOSTON SCIENTIFIC CORP. LIAS M QUAGLIA
K010968 04/02/2001 VECTORVISION CT/FLUORO BRAINLAB, AG RAINER BIRKENBACH
K011267 04/26/2001 EXHALE RF PROBE BRONCUS TECHNOLOGIES, INC. TIM R WILLIAMS
K011227 04/23/2001 REGAL MOTOTRIZED 3 WHEELED VEHICLE BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD A KELLER
K011015 04/04/2001 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. PEGGY KEIFFER
K010974 04/02/2001 RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K011092 04/10/2001 CANDELA SPTL-1E PULSED DYE LASER CANDELA CORP. JOAN CLIFFORD
K011147 04/16/2001 CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT) CAVITAT MEDICAL TECHNOLOGIES, INC. LARRY R PILOT
K011054 04/06/2001 RADS CHASON HEALTHCARE, LLC. CHARLES F NEILSON
K011243 04/23/2001 CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 CHATTANOOGA GROUP, INC. CHERYL L BAGWELL
K011180 04/17/2001 CT/MASTER, VERSION 1.0 COLUMBIA SCIENTIFIC, INC. CHARLES D STOCKHAM
K011012 04/04/2001 POWDER FREE NITRILE EXAMINATION GLOVE CONTRACT LATEX DIPPERS SDN BHD VINAYAGAN RAMALINGAM
K011157 04/16/2001 COOK IVF CRYOPRESERVATION KIT AND THE COOK IVF THAW KIT COOK UROLOGICAL, INC. BRENDA DAVIS
K011239 04/23/2001 GINDA GUARD COSMEDENT, INC. MICHAEL O'MALLEY
K011131 04/13/2001 METHADONE MICROPLATE EIA URINE APPLICATION COZART BIOSCIENCE LTD. LESLY MOORE
K011073 04/09/2001 CRYOPLAN SYSTEM CRYOMEDICAL SCIENCES, INC. E.J. Smith
K011112 04/11/2001 CYCLOSPORINE CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K011035 04/05/2001 DIMENSION DRUG CALIBRATOR, MODEL DC22B DADE BEHRING, INC. RICHARD M VAUGHT
K011033 04/05/2001 DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 DADE BEHRING, INC. RICHARD M VAUGHT
K011235 04/23/2001 SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 DADE BEHRING, INC. RADAMES RIESGO
K011069 04/09/2001 AQUASENS FLUID MONITORING SYSTEM DAVOL, INC., SUB. C.R. BARD, INC. LUCINDA L FOX
K011179 04/17/2001 DELDENT ULTRASONIC INSERTS DELDENT LTD. ALAN EDEL
K011009 04/04/2001 WHITE MTA MATERIAL DENTSPLY INTERNATIONAL P.JEFFERY LEHN
K011020 04/04/2001 DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER DENVER BIOMEDICALS, INC. NANCY SAUER
K010972 04/02/2001 ISOLA BAND CLAMP DEPUY ACROMED LISA GILMAN
K011182 04/18/2001 MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS DEPUY ACROMED LISA GILMAN
K011048 04/06/2001 BSM BONE SUBSTITUTE MATERIAL DEPUY ORTHOPAEDICS, INC. LYNNETTE WHITAKER
K011047 04/06/2001 GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT DEPUY ORTHOPAEDICS, INC. MARCIA ARENTZ
K011099 04/11/2001 GLOBAL FX POROUS-COATED HUMERAL STEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K011004 04/04/2001 NEEDLELOK HYPODERMIC NEEDLE PROTECTION DIASOL, INC. MONICA ABELES
K011003 04/04/2001 SAFESTING AND SAFESTING HUB DIASOL, INC. MONICA ABELES
K010988 04/02/2001 FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K011211 04/19/2001 FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW DMG USA, INC. PAMELA PAPINEAU
K011119 04/12/2001 BRACHYSEED PD-103 MODELS #PD1 DRAXIMAGE, INC. RICHARD J FLANAGAN
K011160 04/16/2001 E-Z EM PERCUPUMP 2001 CT INJECTOR E-Z-EM, INC. BOB WILLIAMS
K011040 04/05/2001 CRYOCARE CARDIAC SURGICAL SYSTEM ENDOCARE, INC. VINCENT CUTARELLI
K011074 04/09/2001 CRYOCARE SURGICAL SYSTEM ENDOCARE, INC. VINCENT CUTARTELLI
K011154 04/16/2001 ELIPAR FREELIGHT ESPE DENTAL AG ANDREAS PETERMANN
K011257 04/24/2001 ENDOPATH NON-BLADED OBTURATOR TROCAR SYSTEM (5 MM) ETHICON ENDO-SURGERY, INC. KATIE FORDYCE
K011114 04/12/2001 ETYMOTIC RESEARCH ER-10D OAE PROBE ETYMOTIC RESEARCH ERIK GUNDERSEN
K011218 04/20/2001 ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 EXACTECH, INC. GARY J MILLER
K011081 04/10/2001 ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS EXACTECH, INC. GARY J MILLER
K011291 04/27/2001 TEMPORALSCANNER THERMOMETER, SENSORTOUCH EXERGEN CORP. WILLIAM HARE
K011309 04/30/2001 LUTE VLC; CORE VLC FIRST SCIENTIFIC LIMITED ADE AKINMADE
K011295 04/30/2001 RESTORE-PF VIC; RESTORE-PF VLC CAPSULE FIRST SCIENTIFIC LIMITED ADE AKINMADE
K011174 04/17/2001 PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES FOTONA D.D. MOJCA VALJAVEC
K010991 04/03/2001 SEEDNET, MODELS FP6T5, FP5T5, FP5T3 GALIL MEDICAL LTD. JOHATHAN S KAHAN
K010985 04/02/2001 GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L GAMBRO RENAL PRODUCTS JEFFREY R SHIDEMAN
K011221 04/20/2001 PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET GAMBRO RENAL PRODUCTS SUZANNE DENNIS
K011188 04/18/2001 GE LOGIQ 9, MODEL 2188900-X GE MEDICAL SYSTEMS ALLEN SCHUH
K011072 04/09/2001 GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS GELFLEX PETER G BRYANT
K011000 04/03/2001 TRAM 2001 MODULE GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KAREN WEBB
K011055 04/06/2001 THE O'NEIL STERILE FIELD URINARY CATHETER KIT WITH PREP PADS GO MEDICAL INDUSTRIES PTY. LTD. GEORGE O'NEIL
K011153 04/16/2001 ALANTE, BATTERY OPERATED POWER WHEELCHAIR GOLDEN TECHNOLOGIES, INC. FRED KIWAK
K011039 04/05/2001 OMNILINK .018 BILIARY STENT SYSTEM GUIDANT CORP. CURTIS TRUESDALE
K011086 04/10/2001 HARDYDISK BACITRACIN, 10MCG, MODEL Z927 HARDY DIAGNOSTICS MELISSA M TRAYLOR
K011032 04/05/2001 SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA HARVEST TECHNOLOGIES, CORP. ANNETTE FAGNANT
K011115 04/12/2001 KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010 HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR MASER
K011126 04/13/2001 RAICHEM CREATININE URINE STANDARD HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K011130 04/13/2001 PREMIUM HERAEUS KULZER, INC. RAPHAEL JUDKINS
K011036 04/05/2001 RD-3008 HERAEUS KULZER, INC. RAPHAEL JUDKINS
K011252 04/24/2001 EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM HITACHI MEDICAL CORP. WALTER WEYBURNE
K011136 04/13/2001 APEX FIXATION PINS HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K011125 04/13/2001 NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI HUDSON RESPIRATORY CARE, INC. JEANNIE L DENNING
K011134 04/13/2001 OXYGEN SUPPLY TUBING, MODEL 1115 HUDSON RESPIRATORY CARE, INC. JEANNIE K DENNING
K010973 04/02/2001 DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 HYPOGUARD USA, INC. BRUCE MACFARLANE
K011155 04/16/2001 INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S IBT, INC. RUTH FEICHT
K011181 04/18/2001 ICS MEDICAL CHARTR OAE WITH TYMP ICS MEDICAL CORP. DELMAR F BLOEM
K011173 04/17/2001 TELEPAX IMED SYSTEMS & CONSULTING, LLC. KENNETH P BONNER
K010997 04/03/2001 PAM-RL INDIVIDUAL MONITORING SYSTEMS, INC. DAVID T KRAUSMAN
K011140 04/13/2001 QUANTA PLEX ENA PROFILE 4 INOVA DIAGNOSTICS, INC. BRYS C MYERS
K011196 04/19/2001 IQUANTIFY, VERSION 1.0 INSIGHTFUL CORPORATION BRADLEY T WYMAN
K011168 04/17/2001 NEUROGEN NERVE GUIDE INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K011169 04/17/2001 HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONTROL LEVEL 3 INTERNATIONAL ENZYMES, INC. CAROL RUGGIERO
K010989 04/03/2001 TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 INTERPORE CROSS INTL. LYNN R RODARTI
K011148 04/16/2001 ULTRACONCENTRATOR SYSTEM INTERPORE CROSS INTL. PROSIE REY-FESSLER
K011184 04/18/2001 INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS INTRATHERAPEUTICS, INC. AMY PETERSON
K011002 04/03/2001 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 INTUITIVE SURGICAL, INC. DAVID CASAL
K011281 04/27/2001 INTUITIVE SURGICAL ULTRASONIC SHEARS INTUITIVE SURGICAL, INC. MICHAEL YRAMATEGUI
K011095 04/10/2001 MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM IODP SA DANIEL KAMM
K011205 04/19/2001 ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125 ISOAID ART WARD
K011022 04/04/2001 BIOUNIVERSAL PDF IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K011023 04/04/2001 D.SIGN 96 IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K011079 04/09/2001 K-ASSAY HS-CRP CONTROLS KAMIYA BIOMEDICAL CO. COLIN GETTY
K010987 04/02/2001 KSEA MINIATURE TELESCOPE AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K010994 04/03/2001 TAKE ONE BITE MODIFIED KERR CORP. COLLEEN BOSWELL
K011312 04/30/2001 BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR W T WORKMAN
K011084 04/10/2001 MANDREL GUIDEWIRE ASSEMBLY LAKE REGION MFG., INC. JIM KLOSTERMAN
K010998 04/03/2001 LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 LANGHAM OPHTHALMIC TECHNOLOGIES MAURICE E LANGHAM
K011207 04/19/2001 LASER PERIPHERALS REUSABLE HOLMIUM FIBER LASER PERIPHERALS, LLC. NANCY ARNOLD
K011176 04/17/2001 REUSABLE GLASS SYRINGES LOCKETT MEDICAL CORP. WILLIAM LOCKETT III
K011016 04/04/2001 LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT LSI SOLUTIONS CHRISTINE E EHMANN
K011197 04/19/2001 DERMACLEAR UV-B PHOTOTHERAPY SYSTEM LUMENIS C. ROBERT PAYNE JR.
K010986 04/02/2001 LUNAPADS LUNAPADS INTERNATIONAL PRODUCTS LTD SUZANNE SIEMENS
K011071 04/09/2001 PARADIGM QUICK-SET INFUSION SET MAERSK MEDICAL A/S GERDA RESCH
K011209 04/19/2001 MANAN SPRITACRE SPINAL NEEDLES MANAN MEDICAL PRODUCTS, INC. ROBBIE PALADUGU
K011284 04/27/2001 THIN FILM DRESSING FOR ULTRASOUND EXAM MARTIN E. WENDELKEN MARTIN E WENDELKEN
K011198 04/19/2001 SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL MAXXIM MEDICAL, INC. JAMAL S ALNASER
K011246 04/23/2001 DCM 1.0 MDS NORDION E.S. MARTELL
K011085 04/10/2001 GUIDEWIRE INTRODUCER SAFETY NEEDLE MEDAMICUS, INC. DENNIS S MADISON
K011261 04/25/2001 STONE EXTRACTOR BALLOON CATHETER MEDI-GLOBE CORP. SCOTT KARLER
K011053 04/06/2001 OPTIMA MEDICAL INDUSTRIES AMERICA, INC. LEE SMITH
K011202 04/19/2001 MSI BIPOLAR SHEATH MEDICAL SCIENTIFIC, INC. PAUL NARDELLA
K011240 04/23/2001 EVENCARE BLOOD GLUCOSE MONITORING SYSTEM MEDLINE INDUSTRIES, INC. STACEY L BOLEN
K010981 04/02/2001 GSA GENITO SENSORY ANALYZER MEDOC LTD. ADVANCED MEDICAL SYSTEMS ANN QUINLAN-SMITH
K011080 04/09/2001 BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM MEDTRONIC AVE, INC. JOHN RIOLO
K011144 04/16/2001 LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATOR MEDTRONIC PHYSIO-CONTROL CORP. SHERRI L POCOCK
K011029 04/05/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K011067 04/09/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K011098 04/11/2001 REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR MEDTRONIC VASCULAR STACEY P WESSMAN
K011191 04/19/2001 MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES MEDTRONIC XOMED, INC. DIANA TAYLOR
K011321 04/27/2001 MODIFICATION TO XPS 3000 SYSTEM MEDTRONIC XOMED, INC. MARTIN D SARGENT
K011152 04/16/2001 VASOTRAC APM205A MEDWAVE, INC. DONNA R LUNAK
K011058 04/06/2001 TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII MERIDIAN MEDICAL TECHNOLOGIES LTD. RHONA LOVE
K011254 04/24/2001 EAR THERMOMETER, MODELS ST613C AND ST613F MESURE TECHNOLOGY PHIL ZULUETA
K011238 04/23/2001 RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEM METRACOR TECHNOLOGIES, INC. GEORGE F MCHUGH
K011150 04/16/2001 DRIDAU OPIATE ASSAY MICROGENICS CORP. SHERRIE RINNE
K011111 04/11/2001 MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) MODULAR X-RAY DEVICES S.B.B. DESEMBERG
K011070 04/09/2001 DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR MOOR INSTRUMENTS LTD. DAVID BOGGETT
K011117 04/12/2001 MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS MPS ACACIA FERGIE F FERGUSON
K011293 04/30/2001 POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES MULTISAFE SDN BHD ABD HADI BIN HUSIN
K011241 04/23/2001 NEUROSOFT'S SOURCE NEUROSOFT, INC. ELVIRA GARCIA
K011262 04/25/2001 MODIFICATION TO THE BOLD SCREW NEWDEAL S.A. NORMAN F ESTRIN
K011128 04/13/2001 NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT) NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K011135 04/13/2001 GSI AUDERA NICOLET BIOMEDICAL DAVID W WAGNER
K011310 04/30/2001 NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1 NIEN MADE ELECTRNICS CORP. JAMES M DELANEY
K011204 04/19/2001 NEUROFAX, MODELS EEG-1100A, EEG-9100A NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K011286 04/27/2001 POWDER-FREE NITRILE EXAM GLOVE, BLUE NINGBO YUJIANG PLASTIC & RUBBER CO. LTD. JANNA P TUCKER
K011120 04/12/2001 GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES NIPRO DIABETES SYSTEMS, INC. KAELYN B HADLEY
K011297 04/30/2001 NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET NIPRO MEDICAL CORP. KAELYN B HADLEY
K011269 04/26/2001 LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR NXSTAGE MEDICAL, INC. KAREN ST. ONGE
K011057 04/06/2001 INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX ORASURE TECHNOLOGIES, INC. R.SAM NIEDBALA
K011026 04/04/2001 FORTADERM WOUND DRESSING ORGANOGENESIS, INC. PATRICK R BILBO
K011025 04/05/2001 FORTAFLEX SURGICAL MESH ORGANOGENESIS, INC. PATRICK R BILBO
K011027 04/05/2001 FORTAFLEX SURGICAL SLING ORGANOGENESIS, INC. PATRICK R BILBO
K011050 04/06/2001 MICROSTREAM ORAL NASAL CANNULA FILTERLINE ORIDION MEDICAL 1987 LTD. SANFORD BROWN
K011250 04/24/2001 VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS Ortho-Clinical Diagnostics, Inc. ANN QUINN
K011087 04/10/2001 ORTHOVITA PISTON SYRINGE OR IMBIBE BONE MARROW ASPIRATION SYRINGE ORTHOVITA, INC. ANGIE IDE
K011043 04/05/2001 OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) OSMETECH JOHN PLANT
K011118 04/12/2001 NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM OSTEOMEDICS ALBERT ENAYATI
K011052 04/06/2001 OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE OSTEX INTL., INC. NANCY JS MALLINAK
K011308 04/30/2001 MULTISTIM PAJUNK GMBH LYNETTE HOWARD
K010967 04/02/2001 LIVESURE COCAINE SCREEN TEST PAN PROBE BIOTECH, INC. ALICE H YU
K011011 04/04/2001 LIVESURE MORPHINE SCREEN TEST PAN PROBE BIOTECH, INC. ALICE H YU
K011206 04/19/2001 PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES PARALLAX MEDICAL, INC. RICHARD M RUEDY
K011223 04/20/2001 QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM PAXMED INTERNATIONAL FLOYD G LARSON
K011106 04/11/2001 STONELITH, MODEL V5 PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD CENGIZ KABAKCI
K011311 04/30/2001 UROLOGIC PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD CENGIZ KABAKCI
K011271 04/26/2001 POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHAN
K011296 04/30/2001 INFINION ENHANCEMENT PACKAGE PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. DUANE PRASCHAN
K011258 04/24/2001 TC-PLUS POROUS FEMORAL COMPONENTS PLUS ORTHOPEDICS HARTMUT LOCH
K011288 04/27/2001 TC-PLUS POROUS TIBIAL COMPONENTS PLUS ORTHOPEDICS HARTMUT LOCH
K011193 04/19/2001 NAC PLUS NEEDLELESS ACCESS CONNECTOR POREX MEDICAL PRODUCTS TIM TRUITT
K011171 04/17/2001 TAMPAX SCENTED & SATIN SCENTED TAMPAX-JUNIOR, REGULAR, SUPER & SUPER PLUS PROCTER & GAMBLE CO. MARK M ANDERSON
K011270 04/26/2001 AUTOMATED CORE BIOPSY DEVICE PROMEX, INC. JOSEPH L MARK
K011231 04/23/2001 CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN PROTECTION GLOVES SDN. BHD. RICHARD CHOOI
K011185 04/18/2001 PSYCHEMEDICS RIA METHAMPHETAMINE AND MDMA ASSAY PSYCHEMEDICS CORP. WILLIAM R TISTLE
K011275 04/26/2001 PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY PSYCHEMEDICS CORP. THOMAS CAIRNS
K011005 04/04/2001 PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS PURE WATER SOLUTIONS, INC. JOHN BOWER
K011105 04/11/2001 SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE QRC CONSULTING DEBBIE IAMPIETRO
K011097 04/11/2001 QUICKVUE DIPSTICK STREP A QUIDEL CORP. Robin Weiner
K011059 04/06/2001 INFARED EAR THERMOMETER, MODEL TH8 SERIES RADIANT INNOVATION, INC. SUSAN D GOLDSTEIN-FALK
K011220 04/20/2001 LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE RADIOTHERAPEUTICS CORP. GARY CURTIS
K011287 04/27/2001 RADIUS COUGAR WIRE RADIUS MEDICAL TECHNOLOGIES, INC. DEBBIE IAMPIETRO
K011302 04/30/2001 RANDOX DIGOXIN RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K011303 04/30/2001 RANDOX PHENOBARBITAL RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K011107 04/16/2001 MODIFICATION TO SOLO RANGER ALL SEASON CORP. RON STEWART
K011017 04/04/2001 PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT REHABILICARE, INC. EDWARD F VALDEZ
K011046 04/06/2001 AUTOPULSE, MODEL 100 REVIVANT CORP. BOB KATZ
K011068 04/09/2001 RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L RHIGENE, INC. DAVID KOLESAR
K011065 04/09/2001 INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K011226 04/20/2001 CALIBRATOR FOR AUTOMATED SYSTEMS ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K011143 04/13/2001 TINA-QUANT D-DIMER TEST SYSTEM ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K011122 04/12/2001 BALLPEN SPINAL NEEDLE W/WO INTRODUCER RUSCH INTL. JULIE A BEAUMONT
K011121 04/12/2001 RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS RUSCH INTL. JULIE A BEAUMONT
K011210 04/19/2001 THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY RUSCH INTL. JULIE A BEAUMONT
K011064 04/06/2001 CLASSIC CEM S & C POLYMER GMBH JURGEN ENGELBRECHT
K011277 04/26/2001 HARD RELINER S & C POLYMER GMBH JURGEN ENGELBRECHT
K011082 04/10/2001 TPO IGG ANTIBODY EIA TEST SCIMEDX CORP. Gary Lehnus
K011113 04/11/2001 HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) SEBIA BOREK JANIK
K011407 04/19/2001 LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO SEMPERMED USA, INC. KATIE LEVINSON
K011045 04/05/2001 TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM SHEN WEI (USA), INC. BELLE CHOU
K011044 04/05/2001 TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER SHEN WEI (USA), INC. BELLE L CHOU
K011141 04/13/2001 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800TC SHIMADZU CORP. MICHAEL FISHBACK
K011129 04/13/2001 SIGN IM NAIL SIGN, INC. JEANNE DILLNER
K011066 04/09/2001 STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) SMART GLOVE CORP. SDN BHD NG-YEW SOON
K011299 04/30/2001 SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR SMITH & NEPHEW, INC. TIM CRABTREE
K011256 04/24/2001 TORIC LITE LENS SOFLEX CONTACT LENS INDUSTRIES LTD. Kevin Walls
K011089 04/10/2001 SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C SPECIALTY ULTRAVISION, INC. DEBBIE MCINTIRE
K011187 04/18/2001 SIMPLICITY SOFT YP INFUSION SET FOR USE WITH THE MINIMED PARAGIGM INFUSION PUMPS STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K011088 04/10/2001 SIII ALARM AMPLIFIER STOCKERT INSTRUMENTE GMBH ROSINA ROBINSON
K010969 04/02/2001 NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES STRYKER INSTRUMENTS ROBIN L ROWE
K011245 04/23/2001 ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM SULZER DENTAL, INC. FOSTER BOOP
K011028 04/05/2001 SCREW-VENT DENTAL IMPLANT SYSTEM SULZER DENTAL, INC. DIANA SMITH
K011038 04/05/2001 TAPER-LOCK DENTAL IMPLANT SYSTEM SULZER DENTAL, INC. DIANA SMITH
K011229 04/23/2001 DEVILBISS 9000 SERIES CPAP, MODEL 9001 SUNRISE MEDICAL HHG, INC. JIM FROEHLICH
K011268 04/26/2001 BREEZY WHEELCHAIR, MODEL 300 SUNRISE MEDICAL, INC. JOHN GERHOLD
K011195 04/19/2001 PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB SURGIN SURGICAL INSTRUMENTATION, INC. DON HAAR
K011190 04/19/2001 SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM) SURX, INC. ALAN CURTIS
K011034 04/05/2001 SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM SYNTHES (USA) BONNIE J SMITH
K011170 04/17/2001 SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE SYNTHES (USA) THOMAS M MAGUIRE
K011037 04/05/2001 VERTEBRAL SPACER SYNTHES (USA) JONATHAN GILBERT
K010984 04/02/2001 EMIT 2000 GENTAMICIN PLUS ASSAY SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K011306 04/30/2001 EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 SYVA CO., DADE BEHRING, INC. CYNTHIA ARREDONO
K011300 04/30/2001 EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229 SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K011289 04/27/2001 EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 SYVA CO., DADE BEHRING, INC. SUSAN COLLINS
K011166 04/16/2001 MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229 SYVA CO., DADE BEHRING, INC. VIRGINIA SINGER
K011162 04/16/2001 MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAY SYVA CO., DADE BEHRING, INC. SUSAN COLLINS
K011164 04/16/2001 MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229 SYVA CO., DADE BEHRING, INC. CYNTHIA ARREDONDO
K011161 04/16/2001 MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229 SYVA CO., DADE BEHRING, INC. SUSAN COLLINS
K011163 04/16/2001 MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229 SYVA CO., DADE BEHRING, INC. SUSAN COLLINS
K011018 04/04/2001 TAUT BALLOON CATHETER, MODEL 50640 TAUT, INC. RON KENSETH
K011142 04/13/2001 AQUARIUS WORKSTATION TERARECON, INC. DAVID W SCHLERF
K011253 04/24/2001 FLAVORED MALE LATEX CONDOM THAI NIPPON RUBBER INDUSTRY CO., LTD. ELI J CARTER
K011283 04/27/2001 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE THE KENDALL COMPANY DAVID A OLSON
K011149 04/16/2001 DISPOSABLE BENDING CANNULA PR-233Q THE OLYMPUS OPTICAL CO. LAURA STOMS-TYLER
K011151 04/16/2001 EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K010975 04/02/2001 ECLIPSE 6.5 VARIAN MEDICAL SYSTEMS, INC. LINDA NASH
K011049 04/06/2001 EXPRESSSUITE VIDAR SYSTEMS CORP. MARY HARP
K011031 04/05/2001 VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT VYSIS RUSSEL K ENNS
K011061 04/06/2001 SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 W & H DENTALWERK BUERMOOS GMBH HERBERT TRASCHWANDTNER
K011175 04/17/2001 W.O.M. LASER U100 W.O.M. WORLD OF MEDICINE, GMBH MICHAEL MCGRAIL
K011076 04/09/2001 LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW WALTER LORENZ SURGICAL, INC. KIM REED
K011178 04/17/2001 WILSON-COOK THRU-THE-SCOPE MECHANICAL LITHOTRIPTOR WILSON-COOK MEDICAL, INC. MARGARET J POSNER
K011290 04/27/2001 PROGNOST ES, MODEL 0302 0000 XMAR CORP. NEIL BARRETT
K011021 04/04/2001 LASER 20 YA-MAN LTD ROBERT T HANDREN
K011244 04/23/2001 ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K011292 04/30/2001 ZIEHM VISION ZIEHM INTERNATIONAL, INC. LANELL SAMANIEGO


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