FDA 510(k) Applications Received During July, 2002

FDA 510(k) Number Submission Date Device Name Applicant Contact
K022476 07/29/2002 RELYX RMGIP 3M COMPANY KAREN O'MALLEY
K022287 07/15/2002 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS 3T MEDICAL SYSTEMS, LLC. ROBERT P EATON
K022330 07/18/2002 ALLGRAD 45 AND 90 CELL SEPARATION MEDIA INTL., INC. MICHAEL D CECCHI
K022335 07/18/2002 ALLGRAD AND ALLGRAD100 INTL., INC. MICHAEL D CECCHI
K022334 07/18/2002 HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS INTL., INC. MICHAEL D CECCHI
K022352 07/19/2002 HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) INTL., INC. MICHAEL D CECCHI
K022332 07/18/2002 LITE MINERAL OIL INTL., INC. MICHAEL D CECCHI
K022312 07/17/2002 PICCOLO PHOSPHORUS TEST SYSTEM ABAXIS, INC. ROBERT MILDER
K022203 07/05/2002 ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 ABBOTT LABORATORIES FRANK POKROP
K022180 07/03/2002 DIRECT BILIRUBIN ABBOTT LABORATORIES MICHELE SMITH-WAHEED
K022182 07/03/2002 MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM ABBOTT LABORATORIES JANET CONNOLLY
K022339 07/18/2002 TOTAL BILIRUBIN ABBOTT LABORATORIES MICHELE SMITH-WAHEED
K022200 07/05/2002 PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120 ABX DIAGNOSTICS TIM LAWTON
K022480 07/26/2002 ACMI DISPOSABLE BIPOLAR CORD, MODEL DBC ACMI CORPORATION JOHN A DELUCIA
K022428 07/25/2002 QUANTITATIVE BLOOD POOL SPECT (QBS) ADAC LABORATORIES COLEEN COLEMAN
K022222 07/09/2002 LAMITRODE S-SERIES (S4 AND S8) LEADS ADVANCED NEUROMODULATION SYSTEM,INC KATRYNA WARREN
K022441 07/25/2002 STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K022511 07/30/2002 AART CALF IMPLANT AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K022223 07/09/2002 AART SILICONE SHEETING AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K022306 07/16/2002 AART SILICONE TUBING AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K022292 07/15/2002 IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO AGFA CORP. DAVID LEDWIG
K022209 07/08/2002 ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS ALARIS MEDICAL SYSTEMS, INC. RENNE L FLUET
K022501 07/29/2002 INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K022425 07/24/2002 SCREWLINE ALTATEC BIOTECHNOLOGIES N.A., INC. ROBERT J SLOMOFF
K022226 07/10/2002 ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS ALTUS MEDICAL, INC. KATHY MAYNOR
K022298 07/16/2002 I-STETHOS LINK ANDROMED, INC. GENEVIEVE HAMEL
K022394 07/23/2002 EZMANAGER PLUS ANIMAS CORP. MICHAEL J ANDREWS
K022342 07/18/2002 EZ-SCOPE AN, EZ-SCOPE LIGHT ANZAI MEDICAL CO, LTD. T. WHIT ATHEY
K022446 07/25/2002 MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C AOMORI OLYMPUS CO., LTD. LAURA STORMS-TYLER
K022386 07/22/2002 POCKETCHEM UA AUTION STICKS 10TA ARKRAY, INC. FRAN WHITE
K022234 07/11/2002 ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B ARTHREX, INC. ANN WATERHOUSE
K022475 07/29/2002 MODIFICATION TO ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K022217 07/08/2002 AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM ASEPTICO, INC. GRANT RAMALEY
K022125 07/01/2002 PROVOX FREEHANDS HME, MODEL 7710 ATOS MEDICAL AB EDDY ABERG
K022207 07/08/2002 AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM AXYA MEDICAL, INC. HOWARD L SCHRAYER
K022408 07/24/2002 CEREC VITABLOCKS MK2 B.B.'S PROPHY SHOP HORST MICHAEL BIRKHOFF
K022258 07/12/2002 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDOCO GOMEZ
K022398 07/23/2002 REUSABLE BRONCHIAL BIOPSY FORCEPS BALLARD MEDICAL PRODUCTS CINDY ELLIS
K022128 07/01/2002 BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB INCORPORATED DEBRA L KETCHUM
K022523 07/30/2002 RAPID-FILL TUBESET, MODEL 90005 BAXA CORP. KARL STEINBECK
K022288 07/15/2002 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER CORP. KENNETH T EDDS
K022331 07/18/2002 ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K022329 07/18/2002 CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K022178 07/03/2002 CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K022177 07/03/2002 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K022161 07/03/2002 MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 BECKMAN COULTER, INC. STAN SUGRUE
K022133 07/01/2002 BD DIRECTIGEN EZ RSV KIT BECTON DICKINSON & CO. COLLEEN A KISTLER
K022426 07/25/2002 BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 BECTON DICKINSON & CO. M. WENDY BOSSHARDT
K022130 07/01/2002 BD VACUTAINER PLUS PST II TUBE BECTON DICKINSON & CO. JING ZHANG
K022172 07/03/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. MICHELLE B BANDY
K022129 07/01/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K022273 07/15/2002 CRANIAL SYMMETRY SYSTEM BEVERLY HILLS PROSTHETICS ORTHOTICS, INC. KEITH E VINNECOUR
K022529 07/31/2002 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 BIO-RAD ELIZABETH PLATT
K022525 07/31/2002 LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 BIO-RAD ELIZABETH PLATT
K022515 07/30/2002 BIOMET CALCANEAL PLATE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K022463 07/26/2002 HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K022531 07/31/2002 2MM PEDIATRIC FLEX NAIL BIOMET, INC. TRACY J BICKEL
K022360 07/19/2002 ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. BIOTRONIK, INC. JON BRUMBAUGH
K022399 07/23/2002 BLACKSTONE SPINAL FIXATION SYSTEM SPACER BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K022493 07/29/2002 EMS 400 BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K022427 07/25/2002 CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K022135 07/01/2002 URETERAL ACCESS SHEATH SET (UASS) BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K022357 07/19/2002 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 BOSTON SCIENTIFIC, TARGET GEORGE J PRENDERGAST
K022355 07/19/2002 QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61 BRANAN MEDICAL CORP. RAPHAEL WONG
K022509 07/30/2002 BRUNO ELECTRA-RIDE, MODEL SRE-2700 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K022350 07/19/2002 BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 C.R. BARD, INC. BRIAN A KANERVIKO
K022447 07/26/2002 BARD ER URETERAL STENT WITH SUTURE C.R. BARD, INC. DONNA J WILSON
K022434 07/25/2002 BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U C.R. BARD, INC. BETH A ZIS
K022236 07/11/2002 RECOVERY FILTER SYSTEM, MODEL RF-048F C.R. BARD, INC. KAY FULLER
K022149 07/02/2002 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 CAMBRIDGE HEART, INC. JOHN GREENBAUM
K022152 07/02/2002 HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS CAMBRIDGE HEART, INC. JOHN GREENBAUM
K022368 07/22/2002 DISPOSABLE POWDER FREE VINYL EXAM GLOVES, WITH VITAMIN E CANOPUS MEDICAL SUPPLY CO., LTD. RUBY LIN
K022373 07/22/2002 CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS CANTOR & NISSEL LTD. MARTIN DALSING
K022174 07/03/2002 MODIFICATION TO CARDEON AEGIS CATHETER CARDEON CORP. JANE BEGGS
K022210 07/08/2002 MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650 CARDIAC SCIENCE, INC. JOHN CARLINE
K022297 07/16/2002 GLOBAL ECG MANAGEMENT SYSTEM (GEMS) CARDIOCOMM SOLUTIONS, INC. ANGELA HALWAS
K022417 07/24/2002 CARE STIM CARE REHAB AND ORTHOPAEDIC CHRISTIAN E HUNT
K022344 07/19/2002 TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM CENTERPULSE SPINE-TECH, INC. TIM MILLER
K022232 07/10/2002 CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3 CLINIQA CORPORATION CAROL RUGGIERO
K022491 07/29/2002 LINICAL HSCRP CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K022416 07/24/2002 CONTREET FOAM ADHESIVE/NON-ADHESIVE COLOPLAST CORP. ELIZABETH BOOTS
K022224 07/10/2002 COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM COLTENE AG H.J. VOGELSTEIN
K022369 07/22/2002 COMFORT WINDJOY SCOOTER, MODEL LY-EW302 COMFORT ORTHOPEDIC CO. LTD. JEN KE-MIN
K022351 07/19/2002 DIODENT DENTAL LASER SYSTEM CONTINUUM ELECTRO-OPTICS, INC. THOMAS J HANEY
K022484 07/29/2002 COOK INJECTION NEEDLE COOK UROLOGICAL, INC. DEBBIE SCHMITT
K022387 07/23/2002 CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC CRAFTMATIC ORGANIZATION, INC. PAUL D RUBIN
K022435 07/25/2002 507EL VITAL SIGNS MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K022194 07/05/2002 TRAXX ELECTRIC WHEELCHAIR CROSSROADS DISTRIBUTION COMPANY, L.L.C. KEVIN WALLS
K022290 07/15/2002 PROTEIN S AC DADE BEHRING, INC. DONNA A WOLF
K022485 07/29/2002 DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE DATEX-OHMEDA JOEL KENT
K022507 07/30/2002 DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 DATEX-OHMEDA JOEL KENT
K022221 07/09/2002 TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS DELTEC, INC. LISA STONE
K022284 07/15/2002 SNORE-AID MAX DENTAL IMAGINEERS, LLC WILLIAM A BELFER
K022300 07/16/2002 ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V DENTAL VIPI LTDA KEVIN WALLS
K022285 07/15/2002 MODIFICATION TO ISOLA SPINAL SYSTEM DEPUY ACROMED LISA GILMAN
K022190 07/05/2002 MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM DEPUY ACROMED KAREN F JURCZAK
K022246 07/12/2002 MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM DEPUY ACROMED KAREN F JURCZAK
K022118 07/01/2002 IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K022153 07/02/2002 BLADDERSCAN BVI 6100 DIAGNOSTIC ULTRASOUND CORP. RUSS GARRISON
K022450 07/26/2002 INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY DIDECO S.P.A. BARRY SALL
K022184 07/03/2002 FLASH-LITE LED DENTAL CURING LIGHT DISCUS DENTAL, INC. GARRY L HOLLAR
K022340 07/18/2002 TRAVELAIR PORTABLE COMPRESSION SYSTEM DYNAMIC AIR, INC. BRENT KNIGHT
K022419 07/24/2002 EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM EBI, L.P. JON CAPAROTTA
K022319 07/17/2002 EBI XFIX DFS SYSTEM EBI, L.P. FREDERIC TESTA
K022119 07/01/2002 EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE ELECTRO MEDICAL SYSTEMS SA MARY MCNAMARA-CULLINANE
K022328 07/18/2002 EMS PIEZON MASTER 600 ELECTRO MEDICAL SYSTEMS SA CYNTHIA J.M. NOLTE
K022437 07/25/2002 UNI KNEE ENCORE MEDICAL, L.P. JOANNA DROEGE
K022199 07/05/2002 ENDIUS ATAVI SYSTEM ENDIUS, INC. CHRISTINE KUNTZ NASSIF
K022148 07/02/2002 INJEX 30 NEEDLE FREE INJECTION SYSTEM EQUIDYNE SYSTEMS, INC. JIM BARLEY
K022502 07/29/2002 INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000 EQUIDYNE SYSTEMS, INC. JIM BARELY
K022464 07/26/2002 EQUILASE SYSTEM EQUILASERS, INC RICHARD C SAM
K022269 07/15/2002 COATED VICRYL* (POLYGLACTIN 910) SUTURE ETHICON, INC. LEA ANN CONWAY
K022406 07/23/2002 EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET EXELINT INTL. CO. ARMAND HAMID
K022276 07/15/2002 KOKOMATE FERRARIS RESPIRATORY, INC. JIM LEWIS
K022154 07/02/2002 LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D FISCHER INDUSTRIES, INC. PHIL O'KEEFE
K022412 07/24/2002 FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR E EILINSFELD
K022510 07/30/2002 FONIX, MODEL 7000 FRYE ELECTRONICS, INC. KRISTINA FRYE
K022124 07/01/2002 GALEMED PEAK FLOW METER, MODELS 3751/3752 GALEMED CORP. BRUCE KUO
K022430 07/25/2002 ISO FUNCTIONAL GC AMERICA, INC. TERRY L JORITZ
K022397 07/23/2002 SIGNA 3.0T MAGNETIC RESONANCE SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K022193 07/05/2002 DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K022482 07/29/2002 SENSA-CUFF, MODELS INFANT, CHILD, ADULT GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K022310 07/17/2002 ADVANTAGE WINDOWS X-RAY/MR FUSION GE MEDICAL SYSTEMS, INC. LARRY KROGER
K022322 07/17/2002 INNOVA AND INNOVA 2000 S GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K022240 07/11/2002 MOBILE MILLENNIUM MG SYSTEM GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K022874 07/26/2002 GEN-PROBE APTIMA COMBO 2 ASSAY GEN-PROBE, INC. ALAN MADERAZO
K022410 07/24/2002 SAPH-LOOP LIGATING LOOP GENZYME BIOSURGERY KAREN K SYLVIA
K022495 07/29/2002 GETTIG DISPOSABLE SYRINGES GETTIG PHARMACEUTICAL INSTRUMENT CO. JAMES A BENZ
K022362 07/22/2002 GIVEN DIAGNOSTICS SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K022455 07/26/2002 SPIFE LD-12 KIT, MODEL 3338 HELENA LABORATORIES PATRICIA FRANKS
K022333 07/18/2002 SPIFE LIPPOROTEIN-12, MODEL 3344 HELENA LABORATORIES PATRICIA FRANKS
K022251 07/12/2002 PALABOND HERAEUS KULZER GMBH & CO. KG K. D. KUHN
K022305 07/16/2002 MULTIPLE LABELS, POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE HEYUAN HONGLI INDUSTRIES, INC. JANNA P TUCKER
K022390 07/23/2002 HITACHI ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K022243 07/12/2002 HORIZONS REUSABLE HOT BIOPSY FORCEPS HORIZONS INTL. CORP. RAFIC SALEH
K022268 07/15/2002 HORIZONS REUSABLE POLYPECTOMY SNARES HORIZONS INTL. CORP. RAFIC SALEH
K022461 07/26/2002 S2 FEMORAL NAIL HOWMEDICA OSTEONICS KAREN ARIEMMA
K022160 07/03/2002 XIA SPINAL SYSTEM HOWMEDICA OSTEONICS KAREN ARIEMMA
K022403 07/23/2002 GMRS PRESS FIT STEMS WITH PUREFIX HA HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K022481 07/29/2002 S2 TIBIAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K022530 07/31/2002 POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS) HYCARE INTL. CO., LTD. JANNA P TUCKER
K022294 07/16/2002 APNEACHECK IM SYSTEMS DAVID T KRAUSMAN
K022512 07/30/2002 CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 IMMUNICON CORP. PETER SCOTT
K022377 07/22/2002 THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 IMPLEX CORP. ROBERT A POGGIE
K022233 07/10/2002 HYDROBOOT INCAPPE, INC. ROBERT SHERIDAN
K022504 07/29/2002 IDI-STREP B ASSAY INFECTIO DIAGNOSTIC, INC. JUDI SMITH
K022366 07/22/2002 CELSIUS CONTROL SYSTEM INNERCOOL THERAPIES STEVE REITZLER
K022465 07/26/2002 MODIFICATION TO NASAL-AIRE INNOMED TECHNOLOGIES MARGE WALLS-WALKER
K022275 07/15/2002 DELTA 32; DELTA 32 TACT INSTRUMENTARIUM CORP. IMAGING DIVISION DARREN GREBE
K022195 07/05/2002 COAMATIC AT-400 INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K022158 07/02/2002 IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K022127 07/01/2002 AVAGEN WOUND DRESSING INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K022159 07/02/2002 PISTON SYRINGE & HYPODERMIC NEEDLE INTERNATIONAL MEDSURG CONNECTION MICHELE H VOVOLKA
K022348 07/19/2002 ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 INTERPORE CROSS INTL. PROSIE REY-FESSLER
K022143 07/02/2002 INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) INTERPORE CROSS INTL. LYNN M RODARTI
K022242 07/11/2002 INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER INTERVASCULAR AMY AULWES
K022528 07/31/2002 IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ IQ CORP. H.G. HAINES
K022228 07/10/2002 FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES IRIDEX CORP. JOHN D'ANGELO
K022384 07/22/2002 XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP ISOLUX AMERICA NIKOLAOS ANDREOULAKIS
K022147 07/02/2002 DENTA PORT J. MORITA USA, INC. KEITH A BARRITT
K022519 07/30/2002 LDL CHOLESTEROL (AUTOMATED) JAS DIAGNOSTICS, INC. DAVID JOHNSTON
K022206 07/05/2002 JENSEN GOLD FOIL JENSEN INDUSTRIES, INC. JOHN SLANSKI
K022483 07/29/2002 ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING JOHNSON & JOHNSON MEDICAL, LTD. PATRICIA FLOOD
K022486 07/29/2002 K-ASSAY HS-CRP CONTROLS KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K022490 07/29/2002 KSEA MEDI PACK KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K022346 07/19/2002 CLEANTEXX MINT FLAVOUR BLUE COLOUR POWDER-FREE BARRIER PRO COPOLYMER EXAMINATION GLOVES LATEXX MANUFACTURING SDN.BHD. TEOH CHOH SHEE
K022347 07/19/2002 MEDTEXX GREEN COLOUR POWDERED NITRILE RUBBER EXAMINATION GLOVES LATEXX MANUFACTURING SDN.BHD. TEOH CHOH SHEE
K022145 07/02/2002 OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 LEMAITRE VASCULAR, INC. JAMES ASHBY
K022327 07/18/2002 NOVUS SPECTRA LUMENIS, INC. KELLY MOHROR
K022181 07/03/2002 NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES LUMENIS, INC. KAREN L BAKER
K022413 07/24/2002 LUNEAU 3 MIRROR LENS LUNEAU SA JEAN NOEL YOUNG
K022116 07/01/2002 ELPH INJECTION SYSTEM MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ELLIS ROGERS
K022214 07/08/2002 MSI I2010 DUAL PLACE HYPERBARIC CHAMBER MECHIDYNE SYSTEMS, INC. AUDREY L AARON
K022219 07/09/2002 EXOMIO, MODEL 1.1 MEDCOM GMBH IOANNIS NOMIKOS
K022513 07/30/2002 MEDCOMP VASCU-SHEATH INTRODUCER SET MEDCOMP FLORENCE A CAIKOSKI
K022395 07/23/2002 1.5T SCANMED PV ARRAY MEDIC, INC. RANDALL W JONES
K022378 07/22/2002 PLASMALITE PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K022431 07/25/2002 MEDRAD TRANSFER SET MEDRAD, INC. FRANK W PELC III
K022141 07/02/2002 VERDICT-II MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K022272 07/15/2002 MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) MEDTRONIC CARDIAC SURGICAL PRODUCTS ROGER BRINK
K022191 07/05/2002 MODIFICATION TO TENOR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K022126 07/01/2002 CATHETER INTRODUCER FOR THE STEALTHSTATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES VICTORIA G RENDON
K022414 07/24/2002 STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES VICTORIA G RENDON
K022238 07/11/2002 MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 MEDTRONIC VASCULAR MARY ELLEN BEST
K022370 07/22/2002 FRAMELOCK; FRAMELOCK ACCESSORIES MEDTRONIC XOMED, INC. B.L. MCDERMOTT
K022168 07/03/2002 ENVOY MENNEN MEDICAL LTD. DAVID P JOHNSON
K022212 07/08/2002 PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS MENTOR MEDICAL LIMITED STEVE OGILVIE
K022117 07/01/2002 MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 MERIT MEDICAL SYSTEMS, INC. STEPHANIE A ERSKINE
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K022489 07/29/2002 SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 SUMMIT MEDICAL LTD. NEIL R ARMSTRONG
K022477 07/29/2002 SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET SUMMIT MEDICAL LTD. NEIL R ARMSTRONG
K022264 07/12/2002 CLEAN 'N' OIL SVENSKA DENTAL INSTRUMENTS AB EMMA BERGQUIST
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K022266 07/12/2002 AURORA SR SYNERON MEDICAL LTD. AMIR WALDMAN
K022146 07/02/2002 SYNTEX POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVE SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K022255 07/12/2002 MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES SYNTHES (USA) MATTHEW M HULL
K022278 07/15/2002 TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML) TAIJECT MEDICAL DEVICE CO., LTD. JIM-SON CHOU
K022336 07/18/2002 "BALDUR" BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. DAVID HU
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K022449 07/26/2002 HYSTEREOSCOPY PUMP HM4 W.O.M. WORLD OF MEDICINE AG SUSANNE RAAB
K022415 07/24/2002 BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST WAISMED LTD. DORIT WINITZ
K022453 07/26/2002 MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM WELCH ALLYN PROTOCOL, INC. DON M ABBEY
K022163 07/03/2002 WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 WELCH ALLYN, INC. DAVID KLEMENTOWSKI
K022140 07/02/2002 WHISPER WEAR BREAST PUMP WHISPER WEAR AL WEISENBORN
K022506 07/30/2002 MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM WIDEMED LTD DAVID SOLOMON
K022459 07/26/2002 AUROPAL SOLDER M-1 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022451 07/26/2002 AUROPAL SOLDER W-2 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022462 07/26/2002 BIOPORTA SOLDER 1020 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022469 07/26/2002 ECO E4 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022456 07/26/2002 PORTA IP SOLDER V-1 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022467 07/26/2002 PORTA IP SOLDER V-2 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022452 07/26/2002 PORTA OP SOLDER M-1 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022454 07/26/2002 PORTA OP SOLDER W-2 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022457 07/26/2002 PORTA OPTIMUM SOLDER 710 WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
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K022470 07/26/2002 PORTA SOLDER 1080 W WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K022389 07/23/2002 READI-LOAD SYSTEM, MODEL PSS 1820RL WORLDWIDE MEDICAL TECHNOLOGIES, LLC RICK TERWILLIGER
K022442 07/25/2002 POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS) WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K022444 07/25/2002 POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
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