FDA 510(k) Applications Received During April, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K001163 04/10/2000 DMLC IV-ERGO 3D LINE USA, INC. KAREN H RIGAMONTI
K001114 04/06/2000 3M QUIK TEMP TEMPORIZATION MATERIAL 3M COMPANY CHERI SMOKOVICH
K001245 04/18/2000 3T L. V. CONTROL VALVE 3T MEDICAL SYSTEMS, LLC. TIMOTHY J SIMMONS
K001223 04/17/2000 ACULUX, MODEL AX3001, AX3002 ACULUX KIM MARSH
K001234 04/17/2000 BIOINSULATED SILICONE PUNCTUM PLUG ADVANCED VISION SCIENCE KHALID MENTAK
K001330 04/27/2000 SOVEREIGN BIPOLAR INSTRUMENTS AESCULAP, INC. LIA S JONES
K001080 04/04/2000 SPINE SYSTEM EVOLUTION AESCULAP, INC. LIA S JONES
K001308 04/25/2000 MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW AGILENT TECHNOLOGIES GRETEL LUMLEY
K001333 04/27/2000 AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI AGILENT TECHNOLOGIES DEUTSCHLAND GMBH EGON PFEIL
K001057 04/03/2000 AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K001348 04/28/2000 ST/AR ST AND ARRHYTHMIA SOFTWARE AGILENT TECHNOLOGIES, INC. DAVE OSBORN
K001313 04/26/2000 AIRDENT II CS AIR TECHNOLOGIES, INC. JOSEPH CAREY
K001126 04/07/2000 PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST ALATEX SCIENTIFIC, INC. JANIS FREESTONE
K001157 04/10/2000 MONARCH II IOL DELIVERY SYSTEM ALCON RESEARCH, LTD. SHERRI J LAKOTA
K001214 04/14/2000 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION ALCON UNIVERSAL, LTD. MICHAEL E PFLEGER
K001235 04/17/2000 OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136 ALCON UNIVERSAL, LTD. RALPH H LARSON
K001321 04/26/2000 ALL-PRO 2010 ALL-PRO IMAGING CORP. JOSEPH CAREY
K001314 04/26/2000 MEDSCOPE ALL-PRO IMAGING CORP. JOSEPH CAREY
K001189 04/12/2000 MODIFICATION TO CONVERTORS SURGICAL GOWNS ALLEGIANCE HEALTHCARE CORP. SHARON ROBBINS
K001141 04/10/2000 POWDER FREE STERILE LATEX EXAMINATION GLOVES ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K001282 04/21/2000 AIW WATER SYSTEM FOR HEMODIALYSIS AMERICAN INDUSTRIAL WATER JOE GREENING
K001215 04/14/2000 DBEST HCG 2 IU/ML TEST KIT AMERITEK, INC. K.C. YEE
K001341 04/27/2000 DR5000 DEDICATED CHEST X-RAY SYSTEM ANALOGIC CORP. ROBERT H FRENCH
K001336 04/27/2000 DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM ANALOGIC CORP. ROBERT H FRENCH
K001306 04/25/2000 STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX ANDROMED, INC. JEAN DUMAS
K001239 04/18/2000 ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) ANSELL PERRY JAMES R CHATTERTON
K001079 04/04/2000 RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO ARJO, INC. DAVID INSCO
K001212 04/14/2000 TROJAN EXTRA LARGE LATEX CONDOM ARMKEL, LLC. STEPHEN C KOLAKOWSKY
K001302 04/24/2000 ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, PLASMA SCALPEL GS, C ARTHROCARE CORP. BRUCE PROTHRO
K001250 04/19/2000 APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) ASAHI MEDICAL CO., LTD. DAVID L WEST
K001142 04/10/2000 AUDIO TECHNOLOGIES S:R.1 AUDIO TECHNOLOGIES S.R.L. FRANCO BEONI
K001149 04/10/2000 AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K001259 04/19/2000 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM BASIC DENTAL IMPLANT SYSTEMS, INC. DAN BLACKLOCK
K001063 04/03/2000 SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 BAXTER HEALTHCARE CORP. JASON SMITH
K001344 04/27/2000 ADVIA IMS BAYER CORP. FREDRICK CLERIE
K001353 04/28/2000 MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM BIOMEDICAL ENT., INC. W. CASEY FOX
K001219 04/17/2000 MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM BIOMEDICAL ENT., INC. W. CASEY FOX
K001354 04/28/2000 MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM BIOMEDICAL ENT., INC. W. CASEY FOX
K001350 04/28/2000 PATIENT MATCHED TITANIUM ALLOY TROCHLEA BIOMET, INC. PATRICIA SANDBORN BERES
K001271 04/20/2000 SAMARCO SPIDER PLATES BIOMET, INC. MARY VERSTYNEN
K001139 04/10/2000 PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M BIOSENSE WEBSTER, INC. MARY ADAMS
K001134 04/10/2000 GAZELLE BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K001338 04/27/2000 MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. ABBY LIPMAN
K001083 04/04/2000 GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K001093 04/04/2000 CANDELA SPTL-1B PULSED DYE LASER CANDELA CORP. JOAN M CLIFFORD
K001100 04/05/2000 BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH CARDIODYNAMICS INTERNATIONAL CORP. BRIAN PARK
K001081 04/04/2000 BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810 CARDIODYNAMICS INTERNATIONAL CORP. BRIAN PARK
K001296 04/24/2000 SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM CAVENDISH SCOTT, INC. PAUL TRESE
K001244 04/18/2000 BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D CITIZEN WATCH CO., LTD. JOSEPH D EDMONDSON
K001110 04/06/2000 CRYSTAL-EEG MODEL 15 CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K001111 04/06/2000 PANORET, MODEL 1000A CMT MEDICAL TECHNOLOGIES, LTD. ILAN SHARON
K001300 04/24/2000 D. R. MEDICAL CONTROLLED PRESSURE GARMENTS CONFECTION MEDICALE D.R., INC. GUY HOUDE
K001159 04/10/2000 HYFRECATOR 2000 REUSABLE HAND-SWITCHING ACCESSORY HANDPIECE/FOOT-SWITCHING ACCESSORY HANDPIECE, HYFRECATOR PLUS REUSABL CONMEDCORP CHARLES M (MIKE) HART
K001161 04/10/2000 ULTRAPEN REUSABLE PENCIL, MODEL 130350 THROUGH 130353, REUSABLE ACCESSORY ELECTRODE KIT (FOR USE WITH ULTRAPEN PENCIL), CONMEDCORP CHARLES M (MIKE) HART
K001249 04/12/2000 QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3 CONSOLIDATED TECHNOLOGIES OF WISCONSIN RUSTY SEWELL
K001087 04/04/2000 PTA BALLOON CATHETER COOK, INC. KAREN BRADBURN
K001090 04/04/2000 METHAFILCON A COOPERVISION, INC. BONNIE TSYMBAL
K001089 04/04/2000 POLYMACON COOPERVISION, INC. BONNIE TSYMBAL
K001135 04/10/2000 6F & 7F INTRODUCING CATHETERS (MODIFICATION) CORDIS CORP. DENNIS S GRIFFIN
K001258 04/18/2000 BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM CORDIS CORP. DEAN A KNIGHT
K001136 04/10/2000 CORDIS INTRODUCER GUIDE CORDIS CORP. ARIEL MACTAVISH
K001352 04/28/2000 REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K001322 04/26/2000 PERFORMER 30 HPS CORNELIA DAMSKY, INC. CORNELIA DAMSKY
K001174 04/11/2000 COSMED QUARK COSMED S.R.L. ROBERT SCHIFF
K001173 04/11/2000 NYLON, NONABSORBABLE SURGICAL SUTURES USP CP MEDICAL PATRICK FERGUSON
K001299 04/24/2000 PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP CP MEDICAL PATRICK FERGUSON
K001172 04/11/2000 POLYESTER NONABSORBABLE SURGICAL SUTURES URP CP MEDICAL PATRICK FERGUSON
K001185 04/11/2000 POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP CP MEDICAL PATRICK FERGUSON
K001184 04/11/2000 SILK, NONABSORBABLE, SURGICAL SUTURES, USP CP MEDICAL PATRICK FERGUSON
K001106 04/05/2000 MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000 CREATIVE PLASTIC TECHNOLOGY ROBERT J BARD
K001064 04/03/2000 BEHRING COAGULATION TIMER ANALYZER (BCT) DADE BEHRING, INC. REBECCA S AYASH
K001256 04/19/2000 CONTROL PLASMA N DADE BEHRING, INC. DONNA A WOLF
K001067 04/03/2000 DADE BEHRING COAGULATION ANALYZER (BCT) DADE BEHRING, INC. REBECCA S AYASH
K001145 04/10/2000 SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 DADE BEHRING, INC. RADAMES RIESGO
K001198 04/13/2000 DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET DATASCOPE CORP. JOANN WOLF
K001317 04/26/2000 ARIA DEL MAR MEDICAL SYSTEMS, LLC. ED CRESPIN
K001269 04/20/2000 DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC DENTALMATIC TECHNOLOGIES, INC. NAOUM ARAJ
K001105 04/05/2000 MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS DEPUY ACROMED LISA GILMAN
K001340 04/27/2000 STACKABLE CAGE SYSTEM DEPUY ACROMED KAREN JURCZAK
K001277 04/21/2000 TRIFLANGE ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. MARCIA J ARENTZ
K001285 04/21/2000 AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K001286 04/21/2000 ETHANOL-L3K ASSAY, MODELS 273-30, 273-17, 273-10 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K001086 04/04/2000 FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN CLASS
K001118 04/07/2000 MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET DIASORIN, INC. JUDITH J SMITH
K001243 04/18/2000 DORNIER MEDILAS H DORNIER SURGICAL PRODUCTS, INC. JOE D BROWN
K001263 04/19/2000 SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040 E S C SHARPLAN ZVI LADIN
K001264 04/19/2000 EAGLE ENDO SPECIMEN RETRIEVAL BAG EAGLE ENDOSCOPIC, INC. JOHN MAYALL
K001358 04/28/2000 EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM EBI, L.P. PATRICIA FLOOD
K001357 04/28/2000 MODIFICATION TO OMEGA 21 SYSTEM EBI, L.P. JONAS WILF
K001253 04/19/2000 SURGITRON IEC II ELLMAN INTL., INC. FRANK LIN
K001121 04/07/2000 OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) ENGINEERED MEDICAL TECHNOLOGY, INC. DON SCHMIELEY
K001177 04/11/2000 PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI ENTERIC PRODUCTS, INC. JEFFREY PEACOCK
K001194 04/12/2000 STERICHEK TOTAL CHLORINE REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. DAVID A MORRIS
K001220 04/17/2000 ENDOPATH SURESEAL REDUCER CAP ETHICON ENDO-SURGERY, INC. TAMIMA ITANI
K001122 04/07/2000 PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH ETHICON, INC. GREGORY R JONES
K001335 04/27/2000 ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED EXACTECH, INC. LISA SIMPSON
K001166 04/10/2000 ULTRA V THERAPEUTIC ULTRASOUND EXCEL TECH. LTD. CAMERON MAHON
K001103 04/05/2000 WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) EXCEL TECH. LTD. DEBBIE DAVY
K001101 04/05/2000 XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 EXCEL TECH. LTD. DEBBIE DAVY
K001232 04/17/2000 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS FITCO DIPPED PRODUCTS PVT. LTD JOSEPH J E PEREIRA
K001216 04/14/2000 POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) FITCO DIPPED PRODUCTS PVT. LTD JOSEPH J E PEREIRA
K001107 04/05/2000 FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP) FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K001156 04/10/2000 PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET GAMBRO RENAL PRODUCTS BENITA BRADFORD
K001267 04/20/2000 GE SYSTEM FIVE GE MEDICAL SYSTEMS, INC. ALLEN SCHUH
K001359 04/28/2000 DASH 3000/4000 PATIENT MONITOR GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K001112 04/06/2000 GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K001268 04/20/2000 GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K001305 04/24/2000 MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN J. LAN MCDONALD
K001146 04/10/2000 GENYX FLEXIBLE INJECTION NEEEDLE GENY MEDICAL, INC. JUDY F GORDON
K001281 04/21/2000 GERATHERM BABYWATCH TEMPERATURE MONITOR GERATHERM AG ED HOLTER
K001125 04/07/2000 GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING GEUDER GMBH HILLARD W WELCH
K001279 04/21/2000 GT990402 DIGITAL THERMOMETER GLOBAL TREASURE LTD. BEN MA
K001222 04/17/2000 OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 GUIDANT CORP. MARGARET ANDERSON
K001224 04/17/2000 RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 GUIDANT CORP. MARGARET ANDERSON
K001270 04/20/2000 GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE GYRUS MEDICAL LTD. DAVID KAY
K001123 04/07/2000 KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111 HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR S MASER
K001242 04/18/2000 ISOLETTE INFANT INCUBATOR, MODEL C2HS HILL-ROM AIR-SHIELDS JAMES G CARPENTER
K001334 04/27/2000 HITACHI AIRIS II HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGLAS THISTLETHWAITE
K001147 04/10/2000 ENHANCED POLYETHYLENE KNEE PROSTHESES HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001272 04/20/2000 XIA SPINE SYSTEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001319 04/26/2000 XIA SPINE SYSTEM HOOKS HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K001213 04/14/2000 CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 HUDSON RESPIRATORY CARE, INC. DANA HOUGHTON
K001154 04/10/2000 I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER I-STAT CORP. PAUL VANDERWERF
K001312 04/26/2000 MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL IGC-MEDICAL ADVANCES, INC. THOMAS E TYNES
K001097 04/04/2000 ACTIVE ARRAY CATHETER, MODEL CS-2000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K001096 04/04/2000 BURR HOLE COVER, MODEL XX IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K001192 04/12/2000 SELF ADHERING NAVIGUS GUIDE IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K001248 04/18/2000 MULTI-PULSE 2000 IMAGING SCIENCES INTL., INC. ROBERT E HAY
K001228 04/17/2000 EXTERNAL FIXATION ANCHOR PIN IMMEDICA, INC. ROY BOGERT
K001084 04/04/2000 TRANS FX ADJUSTABLE PIN TO BAR CLAMP IMMEDICA, INC. ROY BOGERT
K001307 04/24/2000 CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ IMPLEX CORP. JOHN SCHALAGO
K001092 04/04/2000 GENERIC BLOOD GLUCOSE TEST STRIP INBIOS INTL., INC. ESTELA I RAYCHAUDHURI
K001349 04/28/2000 CARDIOVISE ECG INTERPRETATIVE SOFTWARE INOVISE MEDICAL, INC. DEBRA A OLSON
K001171 04/11/2000 DELTA 16 TACT INSTRUMENTARIUM IMAGING, INC. MAX LINDERT
K001211 04/14/2000 MODIFICATION TO INTRALASE 600C LASER KERATOME INTRALASE CORP. CHARLINE GAUTHIER
K001257 04/19/2000 INTRACOIL STENT INTRATHERAPEUTICS, INC. MARIA E BRITTLE
K001113 04/06/2000 IVC THREE BLASTOCYST MEDIUM, CAT # 2007 INVITROCARE, INC. ROBERT E LOVINS
K001260 04/19/2000 ALLROUND 55 LF J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K001196 04/12/2000 JEL BIOS 90 (CODE NAME RD-2401) J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K001360 04/28/2000 SIGNUM J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K001094 04/04/2000 SAFE TOUCH NATURAL RUBBER POWDERED LATEX EXAMINATION GLOVES JB STAR SDN BHD LOOI CHIN SWEE
K001218 04/17/2000 CORRECT PLUS JENERIC/PENTRON, INC. ANNMARIE TENERO
K001051 04/03/2000 RX EVEREST JENERIC/PENTRON, INC. ANNMARIE TENERO
K001361 04/28/2000 JILCO TRACTION-FLEXION CHAIR JILCO ENTERPRISES DAVID K LEONARD
K001362 04/28/2000 KARL STORZ 3D VIDEO SYSTEM KARL STORZ IMAGING, INC. TERRY FERNANDEZ
K001309 04/25/2000 HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 KAY SEE DENTAL MFG. CO. CLARK SMITH
K001058 04/03/2000 AUDIOSCREENER OAE + ABR KEDLY, INC. RANDALL J KROHN
K001190 04/12/2000 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PE KOSSAN LATEX INDUSTRIES (M) SDN. BHD. LIM KWAN HWA
K001144 04/10/2000 ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS LASERSIGHT TECHNOLOGIES, INC. SAM MIRZA
K001129 04/07/2000 PROLONG, MODELS PL50, PL100, PL150 LIFE-TECH INTL., INC. JEFF KASOFF
K001329 04/27/2000 INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET LIFEMED OF CALIFORNIA PATRICIA BRINKER
K001179 04/11/2000 SUPER NOVA, ACUBEAM LIGHT FORCE THERAPY, INC. KIM PETERSON
K001261 04/19/2000 L720 EXAMINATION CHAIR LUNEAU GYNECOLOGIE SA BERNARD HOEL
K001115 04/06/2000 ULTRA CATHETER SET LYCO ENTERPRISES, INC. ROBERT L CHILD
K001162 04/10/2000 GOLDFINGER DEVICE MALI-TECH LTD. AHAVA STEIN
K001275 04/20/2000 RETCAM II MASSIE RESEARCH LABORATORIES, INC. BERT MASSIE
K001252 04/19/2000 MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651 MAXHEALTH CORP. LEWIS WARD
K001343 04/27/2000 EUDERMIC PF POWDER-FREE SURGICAL GLOVES MAXXIM MEDICAL, INC. PALLIE STODDARD
K001052 04/03/2000 MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX MED-TEC,INC. DONALD F RIIBE
K001293 04/24/2000 MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE MEDIMOP MEDICAL PROJECTS, LTD. BRUCE F MACKLER
K001165 04/10/2000 POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) MEDIPURE CORPORATION (M) SDN. BHD. LEE SON HONG
K001066 04/03/2000 CD HORIZON ECLIPSE MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K001255 04/19/2000 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K001153 04/10/2000 MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORM MEDTRONIC SURGICAL NAVIGATION VICTORIA RENDON
K001284 04/21/2000 STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES VICTORIA RENDON
K001138 04/10/2000 AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 MEDTRONIC VASCULAR MARIE HOLM
K001120 04/07/2000 ENVOY PATIENT MONITOR MENNEN MEDICAL LTD. KEN RAICHMAN
K001347 04/28/2000 MERIDIAN-II AND MERDIAN-PLUS MERIDIAN CO., LTD. SOO-RANG LEE
K001237 04/18/2000 EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K001178 04/11/2000 CEDIA DAU 6-ACETYLMORPHINE ASSAY MICROGENICS CORP. CYNTHIA MERRELL
K001182 04/11/2000 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1 MICROLIFE CORP. SUSAN D GOLDSTEIN-FALK
K001217 04/17/2000 INSIDE VIEW MONADNOCK OPTICS, INC. LEONARD J BONNELL
K001303 04/24/2000 BREAST IMMOBILIZATION DEVICE MR-BY 160 MRI DEVICES CORP. THOMAS SCHUBERT
K001131 04/10/2000 3D HDRAULIC FINE MICROMANIPULATOR MO-188NE NARISHIGE CO., LTD. MITSUKO YONEYAMA
K001130 04/10/2000 3D MANUAL COARSE MANIPULATOR MN-188NE NARISHIGE CO., LTD. MITSUKO YONEYAMA
K001068 04/03/2000 NBS CONNECTING TUBE SET NBS PRODUCTS CO CHARLES E MEISCH
K001324 04/26/2000 SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS) NEURO SCAN LABS DAVID B JONES
K001231 04/17/2000 THE KALIX IMPLANT NEWDEAL S.A. NORMAN F ESTRIN
K001091 04/04/2000 CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01 NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC. JUAN OMAR PEREZ
K001251 04/19/2000 SNIPER, MODEL OR-3872XX SERIES NIPRO MEDICAL CORP. JACK FRAUTSCHI
K001085 04/04/2000 MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 NONIN MEDICAL, INC. RICHARD P BENNETT
K001288 04/24/2000 DR180-II NORTHEAST MONITORING, INC. RODNEY L CAMBRE
K001325 04/26/2000 FLO ASSISTANT, MODEL 4-250-00 NORTHGATE TECHNOLOGIES, INC. CASEY KUREK
K001151 04/10/2000 ELECTROSURGICAL ELECTRODE FAMILY NOVASYS MEDICAL, INC. THOMAS WEHMAN
K001150 04/10/2000 ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE NOVASYS MEDICAL, INC. THAMAS WEHMAN
K001328 04/26/2000 INTRODUCER SHEATH NOVASYS MEDICAL, INC. THOMAS C WEHMAN
K001059 04/03/2000 NORMOCARB STERILE BICARBONATE RENAL DIALYSIS NOVEX PHARMA JOSSEPH W BEYGER
K001323 04/26/2000 NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW NUVASIVE, INC. LAETITIA BERNARD
K001283 04/21/2000 LIFEMATE HEMOFILTRATION SYSTEM NXSTAGE MEDICAL, INC. JEFFREY BURBANK
K001176 04/11/2000 DISPOSABLE MICROKERATOME BLADES-PE OASIS MEDICAL, INC. YVONNE FERNANDEZ
K001326 04/26/2000 NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON OCULAR CONCEPTS LLC. KEVIN SCHOU
K001056 04/03/2000 OLYMPIC WARM-UP OLYMPIC MEDICAL CORP. JOSEPH P STEFANILE
K001339 04/27/2000 MRI FASTSYSTEM RETRACTOR SYSTEM OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. CATHERINE MILLER
K001227 04/17/2000 ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT OPTI-CENTRE LABORATORIES MARTIN DALSING
K001169 04/11/2000 OPTIVU HDVD SYSTEM OPTIMIZE, INC. KEN GONG
K001197 04/11/2000 COCAINE METABOLITE INTERCEPT MICRO-PLATE EIA ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K001133 04/10/2000 VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE SHULMAN
K001310 04/25/2000 VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A SHULMAN
K001266 04/20/2000 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITAMIN B12/FOLATE REAGENT PACK 3, PRODUCTS RED CELL FOLATE PA ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE PHILLIPS
K001254 04/19/2000 ORTHOMATRIX, INC. CERCLAGE SYSTEM ORTHOMATRIX, INC. BEN SHAPPLEY
K001167 04/10/2000 OPI BAND ORTHOMERICA PRODUCTS, INC. WILLIAM H.E. VON OEHSEN
K001274 04/20/2000 LATEX SURGEON SURGEON'S GLOVES POWDER-FREE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) P.T. MAJA AGUNG LATEXINDO EMMY TJOENG
K001180 04/11/2000 TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMAKER SURGICAL EXTENSION CABLE, MODELS 528 PACE MEDICAL ROBERT C MACE
K001331 04/27/2000 SYNERGY HEAD/NECK COIL PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K001088 04/04/2000 ULTRASIM CT SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ROBERT L TUROCY
K001069 04/03/2000 MODEL 4000 EEG MONITOR WITH PSI (PSA4000) PHYSIOMETRIX, INC. DAWN E FRAZER
K001055 04/03/2000 MODEL 4300 PSARRAY EEG ELECTRODE SET PHYSIOMETRIX, INC. DAWN E FRAZER
K001240 04/18/2000 SERAGARD INJECTION PATCH PLATINUM SERVICES, INC. NANCY Y STREET
K001175 04/11/2000 SERAGARD VASCULAR ACCESS PATCH PLATINUM SERVICES, INC. NANCY Y STREET
K001221 04/17/2000 MALE LATEX COMDOM WITH DOTTED SURFACE PLEASURE LATEX PRODUCTS SDN. BHD. KOI-YONG LIM
K001342 04/27/2000 P.O.P. PAIN KIT POST OPERATIVE PAIN MANAGEMENT CHARLES ROWLAND II
K001327 04/26/2000 POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS) PREMIER PATHWAY SDN. BHD. JANNA P TUCKER
K001108 04/05/2000 PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL PRIME DENTAL MANUFACTURING, INC. ROLANDDO MARASIGAN
K001225 04/17/2000 ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. PRINCETON BIOMEDITECH CORP. JEMO KANG
K001098 04/04/2000 PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 PRO. DUCT HEALTH, INC. ANGELA B SOITO
K001132 04/10/2000 BONE BIOPSY NEEDLE PROMEX, INC. JOSEPH L MARK
K001278 04/21/2000 SENSAIRE DIAGNOSTIC SPIROMETER QRS DIAGNOSTIC, LLC. JILL R KRALL
K001117 04/06/2000 COMFORT STIM R & D MEDICAL PRODUCTS, INC. JAMES TRAN
K001233 04/17/2000 ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D S R-GROUP INTL. KERRY ANNE KAHN
K001236 04/18/2000 RIZA BAND STRETCHER (RBS)-60000 R-MED, INC. EROL D RIZA
K001070 04/03/2000 RADIOMED SOURCE RADIOMED CORP. JOHN SCHWAMB
K001102 04/05/2000 PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E RD MEDICAL MFG., INC. CARLOS A RODRIGUEZ-GARCIA
K001208 04/14/2000 ESPIRT RESPIRONICS, INC. KATHY MOORE
K001356 04/28/2000 ONTRAK TESTCUP PRO-5, MODEL 1986678 ROCHE DIAGNOSTICS CORP. JENNIFER TRIBBETT
K001143 04/10/2000 RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER ROCHESTER MEDICAL CORP. MARY WILEN
K001298 04/24/2000 J.A.G. LIGHTWEIGHT MANUAL WHEELCHAIR ROLL-ABILITY (PTY) LTD. KEITH F MYBURGH
K001119 04/07/2000 ROVERS ENDOCERVEX-BRUSH ROVERS MEDICAL DEVICES B.V. TODD M GATES
K001295 04/24/2000 PIPER RTEK MEDICAL SYSTEMS, LLC. ROBERT C JACKSON
K001140 04/10/2000 IDS5 IMAGE DISPLAY SYSTEM SECTRA AB HERMAN OOSTERWIJK
K001128 04/07/2000 NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K001065 04/03/2000 DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR SHEEN MORE ENT. CO., LTD. KEN HUANG
K001155 04/10/2000 DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR SHEEN MORE ENT. CO., LTD. KEN HUANG
K001077 04/04/2000 LUBRIGEL PERSONAL LUBRICANT SHEFFIELD LABORATORIES, DIV. OF FARIA LIMITED, LLC KATHLEEN HACKU
K001315 04/26/2000 MODIFICATION TO KION ANESTHESIA SYSTEM SIEMENS ELEMA AB DAVE SIMARD
K001201 04/13/2000 MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. MALGORZATA STANEK
K001318 04/26/2000 CPAP SYSTEM, MODEL 102001 SIMS PORTEX, INC. BRIAN D FARIAS
K001226 04/17/2000 SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM SMITH & NEPHEW, INC. MARK KIERAS
K001160 04/10/2000 VERSABOND BONE CEMENT SMITH & NEPHEW, INC. EHAB M ESMAIL
K001287 04/24/2000 EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML SORENSON MEDICAL, INC. R. DOUGLAS JACOB
K001346 04/28/2000 ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX ST. JUDE MEDICAL, INC. PAUL CORNELISON
K001082 04/04/2000 STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 STACKHOUSE, INC. TOM GUTIERREZ
K001273 04/20/2000 STARION INSTRUMENTS POWER POINT CAUTERY CLAMP STARION INSTRUMENTS BRIAN GRIGSBY
K001262 04/19/2000 THERMAL CAUTERY FORCEPS STARION INSTRUMENTS BRIAN GRIGSBY
K001320 04/26/2000 SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM SULZER ORTHOPEDICS, INC. FRANCES E HARRISON
K001078 04/04/2000 SULZER ORTHOPEDICS MS-30 FEMORAL STEM SULZER ORTHOPEDICS, INC. FRANCES E HARRISON
K001276 04/21/2000 MEDICAL IMAGE MERGE (MIM) SYNTERMED, INC. KENNETH F VAN TRAIN
K001311 04/25/2000 SYNTHES (USA) ORIBITAL MESH PLATES SYNTHES (USA) BONNIE J SMITH
K001095 04/04/2000 OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 TELEDYNE ANALYTICAL INSTRUMENTS RAY KHAJAVI
K001127 04/03/2000 ANCA COMBI DIAGNOSTIC KIT WITH IF-AIM TECHNOLOGY THE BINDING SITE, LTD. JAY H GELLER
K001337 04/27/2000 DANIELS SHARPSMART REUSABLE SHARPS CONTAINER THE DANIELS CORP. FLOYD G LARSON
K001241 04/18/2000 EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/I THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K001203 04/13/2000 OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K001137 04/10/2000 AEROTRACH PLUS VALVED HOLDING CHAMBER ("VHC") TRUDELL MEDICAL INT'L TOM HOLBROOK
DEN000006 04/27/2000 EROS-CLITORAL THERAPY DEVICE (CTD) UROMETRICS, INC. PHILIP A MESSINA
K001210 04/14/2000 HI-RES 9000 PHASED ARRAY CAROTID COIL USA INSTRUMENTS, INC. RONY THOMAS
K001209 04/14/2000 INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL USA INSTRUMENTS, INC. RONY THOMAS
K001238 04/18/2000 LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM WALTER LORENZ SURGICAL, INC. DIANA PRESTON
K001265 04/19/2000 WELCH ALLYN INSTRUMENT INTERFACE MODULE WELCH ALLYN, INC. DAVID KLEMENTOWSKI
K001280 04/21/2000 COMFIT POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE, NON STERILE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LES WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K001148 04/10/2000 MEROGEL OTOLOGIC PACK XOMED, INC. DAVE TIMLIN


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