FDA 510(k) Applications Received During May, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K041221 05/10/2004 ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY ACCU-STAT DIAGNOSTICS, INC. JAMES G BARRONS
K041315 05/17/2004 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY, INC. ANNE SCHLAGENHAFT
K041165 05/04/2004 FSH MENOPAUSE PREDICTOR TEST ACON LABORATORIES, INC. FRAN WHITE
K041218 05/10/2004 GRIFFIN SPECT/CT IMAGING SYSTEM ADAC LABORATORIES COLEEN A COLEMAN
K041182 05/06/2004 SYNTEGRA ADAC LABORATORIES JOY M SACMAR
K041268 05/12/2004 SILVERSITE OR CALGITROL ADRI GEORGE H SCHERR, PH.D.
K041316 05/17/2004 ANTIMICROBIAL ALGINATE DRESSING ADVANCED MEDICAL SOLUTIONS LTD. JOHN E GREENHAM
K041186 05/06/2004 CADDY AFIKIM ELECTRIC VEHICLES AVNER FISHBEIN
K041241 05/11/2004 MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 ALARIS MEDICAL SYSTEMS, INC. STACY L LEWIS
K041376 05/24/2004 C1 SERIES PATIENT MONITOR, MODELS 863051, 863052, 863053, 863054; OPTIONAL PRINTER FOR CI, MODEL M3925A ANALOGIC CORP. DONALD J SHERRATT
K041434 05/28/2004 C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS ANALOGIC CORP. DONALD J SHERRATT
K041420 05/28/2004 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K041279 05/13/2004 IMPLANTEO IMPLANTOLOGY MOTOR ANTHOGYR ERIC GENEVE
K041303 05/17/2004 LED TURBO-PEN APOZA ENTERPRISE CO. LTD. SHIN MIN TEH
K041152 05/03/2004 THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A APPLIED DIABETES RESEARCH, INC. JIM BARLEY
K041263 05/11/2004 NEUROGUIDE ANALYSIS SYSTEM APPLIED NEUROSCIENCE INC. ROBERT W THATCHER
K041427 05/28/2004 THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS ARKRAY, INC. HELEN LANDICHO
K041153 05/03/2004 SHARPSAWAY II LOCKING DISPOSABLE CUP ARROW INTL., INC. ELIZABETH PRICE
K041356 05/20/2004 ARTHREX TENODESIS SCREW FAMILY ARTHREX, INC. ANN WATERHOUSE
K041189 05/06/2004 ARTHREX TRIMIT FAMILY ARTHREX, INC. ANN WATERHOUSE
K041261 05/11/2004 FEMORAL HOOK ARTHROTEK, INC. GARY BAKER
K041274 05/12/2004 RESORBABLE INTERFERENCE SCREW ARTHROTEK, INC. GARY BAKER
K041158 05/03/2004 ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM ATRION MEDICAL PRODUCTS, INC. DAN CLARK
K041269 05/12/2004 ATRIUM MEDICAL CORPORATION ICAST COVERED STENT ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K041415 05/27/2004 EVA TPN CONTAINER B. BRAUN MEDICAL, INC. AMY SMITH
K041222 05/10/2004 PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET B. BRAUN MEDICAL, INC. LINDA MORGAN
K041172 05/04/2004 BASBA E-MACHINE BASBA INC. M. JOYCE HEINRICH
K041428 05/28/2004 ACCUSOL DIALYSIS SOLUTION BAXTER HEALTHCARE CORP. DAVID E CURTIN
K041191 05/06/2004 COLLEAGUE VOLUMETRIC INFUSION PUMPS BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K041384 05/25/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K041432 05/28/2004 ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT BIOFILM, INC. ROBERT L DE ARMOND
K041238 05/11/2004 HELICOBACTER PYLORI IGG ELISA BIOHIT PLC ROBERT P GEARTY
K041388 05/25/2004 COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K041352 05/20/2004 COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM BIOMET, INC. GARY BAKER
K041331 05/19/2004 BIOPSY SCIENCES, LLC, LUNG BIOPSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K041293 05/14/2004 BIOPORE BALLOON DILATION CATHETER BIPORE, INC. KEITH PALUCH
K041430 05/28/2004 BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 BLEASE MEDICAL EQUIPMENT LTD. ARTHUR J WARD
K041359 05/21/2004 BODY CLOCK STIMPLUS AND STIMPLUS PRO BODY CLOCK HEALTH CARE LTD RASHELLE PRESTON
K041330 05/19/2004 IPLAN! FLOW BRAINLAB AG RAINER BIRKENBACH
K041169 05/04/2004 PIESOMETER, MODEL MK-1 CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. DANIEL KAMM
K041242 05/11/2004 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K041414 05/27/2004 CRONO AND CRONO, MODEL 30 CANE S.R.L. DANIEL KAMM
K041392 05/25/2004 SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US CAO GROUP, INC. ROBERT K LARSEN
K041418 05/27/2004 AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER Cardinal Health LAVENIA FORD
K041294 05/14/2004 BIOZDX HEMODYNAMIC MONITOR CARDIODYNAMICS INTERNATIONAL CORP. DENNIS HEPP
K041180 05/06/2004 QUANTIX OR VESSEL STABILIZER DEVICE CARDIOSONIX, LTD. AHAVA STEIN
K041363 05/21/2004 AOC BONE WAX CEREMED INC. TADEUSZ WEKKUSZ MD
K041296 05/14/2004 MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI Codman & Shurtleff, Inc. KATHRYN WUNDER
K041146 05/03/2004 CONTROL SOLUTIONS, INC., MODEL CS3102 HVG CONTROL SOLUTIONS, INC. BRETT WALACH
K041229 05/10/2004 MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL) COSMEDENT, INC. JAMES L SANDRIK
K041417 05/27/2004 DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 DADE BEHRING, INC. RICHARD M VAUGHT
K041150 05/03/2004 MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERT EUSEBIO
K041281 05/13/2004 DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES DATASCOPE CORP. JOANN TAYLOR
K041368 05/24/2004 DENTIUM CO., LTD. IMPLANTIUM DENTIUM CO., LTD. CATHRYN N CAMBRIA
K041335 05/18/2004 PTM SYSTEM DENTSPLY INTERNATIONAL P JEFFERY LEHN
K041372 05/24/2004 SMARTLITE PS PEN-STYLE LED CURING LIGHT DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K041343 05/20/2004 XENO NM LIGHT CURED DENTAL ADHESIVE DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K041272 05/12/2004 DYRACT CEM PLUS CEMENT DENTSPLY INTL. P. JEFFERY LEHN
K041205 05/07/2004 EXPEDIUM ANTERIOR SPINE SYSTEM DEPUY SPINE, INC. JENNIFER MOONEY
K041203 05/07/2004 SUMMIT OCT SPINAL SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K041416 05/27/2004 EXAC-TEMP FOLEY CATHETER AND CLINI-TEMP FOLEY CATHETER DEROYAL SHARON COOK
K041390 05/25/2004 DIAMOND MEDISTIM DIAMOND SYSTEMS USA, INC. DONNA LOPE
K041213 05/10/2004 3DSCOPE DIREX SYSTEMS CORP. LARISA GERSHTEIN
K041178 05/05/2004 EMPOWER TRANSFER SET, (CAT. NO. 7725) E-Z-EM, INC. JUDY HAUSER
K041198 05/07/2004 NIC36 AMPLIFIER EB NEURO, S.P.A. CARRI GRAHAM
K041597 05/25/2004 MONOCHROME LCD MONITOR, MODEL RADIFORCE G22 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K041264 05/12/2004 ELEKTA OY ELEKTA NEUROMAG OY BIRGITTA FAGERSTROM
K041145 05/03/2004 MODIFICATION TO E-SCAN XQ MRI SYSTEM ESAOTE S.P.A. CARRI GRAHAM
K041325 05/18/2004 DISPOSABLE COLORED VINYL SYNTHETIC EXAM GLOVE, POWDER FREE EST INTERNATIONAL CORPORATION ELIZABETH DENG
K041280 05/13/2004 HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500 FELTON INTERNATIONAL, INC. JIM STANLEY
K041240 05/11/2004 SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED FERTILITY SOLUTIONS, INC. SUSAN A ROTHMANN, PH.D., HCLD
K041192 05/06/2004 ARCHITECT STAT TROPONIN-I IMMUNOASSAY FISHER DIAGNOSTICS JOSEFINA INFANTAS
K041224 05/10/2004 FOOTHILLS SURGICAL DRAPES FOOTHILLS INDUSTRIES, INC. JOY SHUFORD
K041400 05/26/2004 FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 FORTIFIER INTERNATIONAL CO., LTD. Ke-Min Jen
K041164 05/03/2004 L-TENS FUJI DYNAMICS LIMITED ANTHONY AH YIN, SHUM
K041398 05/26/2004 GC FUSION GC AMERICA, INC. TERRY L JORITZ
K041220 05/10/2004 GE DISCOVERY ST SYSTEM GE MEDICAL SYSTEMS DAVID DUERSTELER
K041206 05/07/2004 EPITOME SYSTEM GEBAUER MEDIZINTECHNIK GMBH KIMBERLEY DONEY
K041267 05/12/2004 CARDIQ ANALYSIS III GENERAL ELECTRIC MEDICAL SYSTEMS LARRY A KROGER
K041270 05/12/2004 CT COLONOGRAPHY II GENERAL ELECTRIC MEDICAL SYSTEMS LARRY A KROGER
K041239 05/11/2004 GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 GENESIS MEDICAL TECHNOLOGY, INC. THOMAS KROENKE
K041232 05/10/2004 GETTIG UNIVERSAL VIAL ACCESS PIN GETTIG PHARMACEUTICAL INSTRUMENT CO. JAMES A BENZ
K041149 05/03/2004 GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE GIVEN IMAGING LTD. SHOSH FRIEDMAN
K041341 05/20/2004 GOLDEN SPYDER, MODEL GS-300 GOLDEN TECHNOLOGIES, INC. GENE R KULON
K041188 05/06/2004 GRAND WORK PLASTICS PRODUCTS CO., LTD., SYNTHETIC VINYL PATIENT EXAMINATION GLOVES - POWDERED GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K041225 05/10/2004 SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES-POWERED GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K041340 05/20/2004 GUIDANT MICROWAVE ABLATION SYSTEM GUIDANT CORPORATION, CARDIAC SURGERY NANCY GALLO
K041237 05/11/2004 ECHOSAMPLER GYNETICS MEDICAL PRODUCTS NV GRACE HOLLAND
K041285 05/13/2004 GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) GYRUS MEDICAL LTD. ANDREW DZIMITROWICZ
K041157 05/03/2004 MODIFICATION TO SMALL BONE FIXATION SYSTEM HAND INNOVATIONS, INC. AL WEISENBORN
K041391 05/25/2004 FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD TITO ALDAPE
K041360 05/21/2004 ALDAHOL III HIGH-LEVEL DISINFECTANT HEALTHPOINT, LTD. NORM MINER, PHD
K041230 05/10/2004 CLINICAL LABORATORY ANALYZING SYSTEM HEMOCUE, INC. R.J. SLOMOFF
K041234 05/10/2004 HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM HEMOCUE, INC. R.J. SLOMOFF
K041266 05/12/2004 PEDIATRIC REFERENCE DATABASE HOLOGIC, INC. ANA RANDALL
K041160 05/03/2004 AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K041170 05/04/2004 SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K041233 05/10/2004 ARTHROJET XT HYDROCISION, INC. DEBBIE IMAMPIETRO
K041313 05/17/2004 STABIL-O-GRAPH I.E.M. GMBH GUENTER GINSBERG
K041349 05/20/2004 LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM IBL GMBH Gary Lehnus
K041410 05/27/2004 PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118 ICU MEDICAL INC DALE FAIRCHILD
K041374 05/24/2004 AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 IDEV TECHNOLOGIES, INC. LYNNE A DAVIES
K041185 05/06/2004 TORSO ARRAY COIL, MODEL 558GE-64 IGC-MEDICAL ADVANCES, INC. ANTHONY DIETZLER
K041402 05/26/2004 MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS IMPLANT INNOVATIONS, INC. JEANNETTE G DAILEY
K041405 05/26/2004 ASPIRATION PUMP, MODEL IMD-020 INDUSTRIAL & MEDICAL DESIGN, INC. YEVGENIY KUKLIN
K041409 05/27/2004 MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 INOMED GMBH ANDERS SKOGLUND
K041201 05/07/2004 ULTRACLIP II MR INRAD MELISSA LALOMIA
K041295 05/14/2004 RN SYNOCTA UCLA GOLD ABUTMENT FOR THE STRAUMANN DENTAL IMPLANT INSTITUT STRAUMANN AG JOHN KING
K041407 05/27/2004 TITANIUM MESH IMPLANT INTERPORE CROSS INTL. WENDY SPIELBERGER
K041163 05/03/2004 ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES ISOPURE CORP. KEVIN GILLESPIE
K041344 05/20/2004 OPEN BORE SYRINGE ISOTIS NV ELIANE SCHUTTE
K041433 05/28/2004 BRIGHT GOLD XH IVOCLAR VIVADENT, INC. ANDERJEET GULATI
K041159 05/03/2004 JMS ABSORBABLE ANCHOR AND APPLICATOR JMS, INC. JOHN I SHIPP
K041353 05/20/2004 FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM JRI MANUFACTURING LTD E.J. Smith
K041151 05/03/2004 KERBEROS OCCLUDING GUIDE CATHETER AND ACCESSORIES KERBEROS PROXIMAL SOLUTIONS, INC. MICHAEL A DANIEL
K041291 05/14/2004 RINSPIRATION SYSTEM KERBEROS PROXIMAL SOLUTIONS, INC. TOM MASON
K041334 05/19/2004 ALCOMATE, MODEL CA2000 KHN SOLUTIONS, LLC DANIEL KAMM
K041378 05/24/2004 BIO 60 KODENT, INC. DAE KYU CHANG
K041262 05/11/2004 DURALITE-GL LASER SCIENTIFIC JOHN CROWNOVER
K041324 05/18/2004 CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER LIFECORE BIOMEDICAL, INC. KIM E AVES
K041288 05/13/2004 MODIFICATION TO SMARTPIN LINVATEC BIOMATERIALS, INC. TUIJA ANNALA
K041223 05/10/2004 MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E MAQUET CRITICAL CARE AB JAMIE YIEH
K041204 05/07/2004 NC SP02 ADAPTER CABLE MASIMO CORP. JAMES J CRONIN
K041332 05/19/2004 JOEY CLAMP OPENING TOOL MATERNUS, INC. RONALD B HICKS
K041327 05/18/2004 MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES MED2000 S.R.L. SUSAN D GOLDSTEIN-FALK
K041177 05/05/2004 SYNTHACER; SYNTRICER MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG HANS-PETER WETTL
K041326 05/18/2004 MEDCOMMONS OPEN RADIOLOGY GATEWAY MEDCOMMONS, INC. CHAS BURR
K041179 05/06/2004 MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR MEDEGEN MEDICAL MANUFACTURING SERVICES, INC. TIM TRUITT
K041194 05/06/2004 ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H MEDICAL ANALYSIS SYSTEMS, INC. MARY THORSNESS
K041419 05/28/2004 LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM MEDICAL ENERGY, INC. DAVID P LEWING
K041284 05/13/2004 MEDICULT IVM SYSTEM MEDICULT A/S RONALD G LEONARDI
K041162 05/03/2004 ORTHO-CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K041345 05/20/2004 PROTECTIV JELCO SAFETY I.V. CATHETER, MODEL 3600 SERIES MEDIX, INC. BARBARA LAW
K041318 05/18/2004 MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP MEDTRONIC MINIMED MARK J FAILLACE
K041317 05/18/2004 MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP MEDTRONIC MINIMED MARK J FAILLACE
K041197 05/07/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K041217 05/10/2004 MODIFICATION TO BONE GRAFT WASHER MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K041282 05/13/2004 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K041338 05/20/2004 MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES MEDTRONIC VASCULAR SCOTT CUNDY
K041244 05/11/2004 POLYGRAM NET BIOFEEDBACK APPLICATION MEDTRONIC VASCULAR JULIE GOODE
K041381 05/25/2004 MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT MEDTRONIC XOMED, INC. DAVID S DODD
K041413 05/27/2004 XPS 3000 SYSTEM MEDTRONIC XOMED, INC. MARTIN D SARGENT
K041302 05/14/2004 REFUGE SOUND GENERATOR MICRO-EAR TECHNOLOGY, INC. DEBORAH SHAFFER
K041411 05/27/2004 MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP MICROLIFE CORP. SUSAN D GOLDSTEIN
K041364 05/21/2004 ML830 LASER SYSTEM MICROLIGHT CORPORATION OF AMERICA FRED A SIMPSON
K041435 05/28/2004 THE STRIPPER PGD MID-ATLANTIC DIAGNOSTICS, INC. SUSAN J BUSH
K041200 05/07/2004 THERMASSAGE ENEGRY PRODUCT, MODEL HY-7000 MIGUN MEDICAL INSTRUMENT CO. LTD. EDWARD A KROLL
K041286 05/13/2004 DYNACAD V1.0 MRI DEVICES CORP. TOM TYNES
K041228 05/10/2004 MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 MYTECH TECHNOLOGY CO., LTD. JEN KE-MIN
K041212 05/10/2004 HOUVA 3 PHOTOTHERAPY SYSTEM NATIONAL BIOLOGICAL CORP. LORETTA MOONEY
K041347 05/20/2004 MODIFICATION TO EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORP. SHERRIE COVAL-GOLDSMITH
K041320 05/18/2004 MODIFICATION TO NC-STAT NEUROMETRIX, INC. JOSEPH F BURKE
K041323 05/18/2004 PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA NEW STAR LASERS, INC. DONALD V JOHNSON
K041406 05/26/2004 NEWPORT C250 AIR COMPRESSOR MODEL C250 NEWPORT MEDICAL INSTRUMENTS RICHARD WATERS
K041283 05/13/2004 PROCERA BRIDGE ZIRCONIA NOBEL BIOCARE AB ELIZABETH J MASON
K041236 05/11/2004 PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 NOBEL BIOCARE AB ELIZABETH J MASON
K041312 05/17/2004 NOBELRONDO DENTAL CERAMIC-ALUMINA NOBEL BIOCARE UAS INC ELIZABETH J MASON
K041275 05/12/2004 PROCERA ABUTMENT OCTAGON NOBEL BIOCARE UAS INC ELIZABETH J MASON
K041156 05/03/2004 AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 NONIN MEDICAL, INC. JOHN R DALPEE
K041371 05/24/2004 BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN NOVAMIN TECHNOLOGY, INC. DAVID C GREENSPAN
K041184 05/06/2004 NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION NTI-TSS, INC. JAMES BOYD
K041306 05/17/2004 NUMED PTS X SIZING BALLOON CATHETER NUMED, INC. NICHELLE LAFLESH
K041424 05/28/2004 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. NORMA LEMAY
K041161 05/03/2004 MICROCYN WOUND CARE DRESSING OCULUS INNOVATIVE SCIENCES, INC. MANISHA S DESHMUKH
K041370 05/24/2004 LIFESTENT LP SDS BILIARY ENDOPROSTHESIS ORBUS MEDICAL TECHNOLOGIES JIM CLOSSICK
K041322 05/18/2004 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. SARAH PARSONS
K041369 05/24/2004 NAVITRACK SYSTEM - S&N IMAGE FREE HIP, MODEL PRO-03017 ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K041382 05/25/2004 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER, PH.D.
K041148 05/03/2004 POCONE INFRARED SPECTROPHOTOMETER OTSUKA PHARMACEUTICAL CO., LTD. CYNTHIA A SINCLAIR, RAC
K041215 05/10/2004 CRANIAL HELMET OTTO BOCK HEALTH CARE, LP SHELLEY STOCKMAN
K041208 05/10/2004 POWERED WHEELCHAIR, MODEL B-500 OTTO BOCK HEALTH CARE, LP BOB CLARKE
K041210 05/10/2004 POWERED WHEELCHAIR, MODEL B-600 OTTO BOCK HEALTH CARE, LP BOB CLARKE
K041211 05/10/2004 POWERED WHEELCHAIR, MODEL C-1000 OTTO BOCK HEALTH CARE, LP BOB CLARKE
K041231 05/10/2004 WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M PANBIO LIMITED CRAIG BREADMORE
K041214 05/10/2004 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K041393 05/24/2004 FASSIER-DUVAL TELSCOPIC IM SYSTEM PEGA MEDICAL INC. ARIEL R DUJOVNE
K041395 05/26/2004 EG-3630UR PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K041397 05/26/2004 EG-3830UT PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K041396 05/26/2004 FG-36UX FIBER ULTRASOUND GASTROSCOPE PENTAX PRECISION INSTRUMENT CORP. PAUL SILVA
K041219 05/10/2004 ELECTRO PERMOBIL A.B. JAN' ASTROM
K041401 05/26/2004 MODIFICATION TO M2376A DEVICELINK SYSTEM PHILIPS MEDICAL SYSTEMS HERBERT VAN DYK
K041235 05/11/2004 PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH MARKUS STACHA
K041167 05/04/2004 PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K041408 05/27/2004 POLYMEDCO OC AUTO MICRO 80 FOB TEST POLYMEDCO, INC. HELEN LANDICHO
K041297 05/14/2004 POLYMEDCO OC LIGHT FOBT TEST POLYMEDCO, INC. HELEN LANDICHO
K041346 05/20/2004 SYNERGY ULTIMATE PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K041337 05/19/2004 PRO WALKER ML-300 FOLDABLE WHEELCHAIR PRO WALKER INC. JEN KE-MIN
K041336 05/19/2004 PRO WALKER PL-200 POWER WHEELCHAIR PRO WALKER INC. JEN KE-MIN
K041380 05/25/2004 IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR R2 TECHNOLOGY, INC. Kathy O'Shaughnessy
K041361 05/21/2004 RANDOX TRI LEVEL CARDIAC CONTROL RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K041386 05/25/2004 RAVEN PROTEST - STEAM RAVEN BIOLOGICAL LABORATORIES, INC. WENDY ROYALTY-HANN
K041366 05/24/2004 IPACS ORTHO REAL TIME IMAGE INC. CARL ALLETTO
K041362 05/20/2004 RESMED HOSPITAL FULL FACE MASK RESMED LTD. DAVID D'CRUZ
K041209 05/10/2004 RESMED S8 PIONEER CPAP SYSTEM RESMED LTD. DAVID D'CRUZ
K041412 05/27/2004 ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. MARY FUNK
K041321 05/18/2004 VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
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