FDA 510(k) Decisions During March, 1999  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K984352 03/04/1999 AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR AARON MEDICAL INDUSTRIES J. ROBERT SARON
K990297 03/22/1999 ETEST MINOCYCLINE AB BIODISK ANNE BOLMSTROM
K984491 03/09/1999 SYSTEM U3 FOR CEFUROXIME AB BIODISK ANNE BOLMSTROM
K984581 03/09/1999 SYSTEM U3 FOR CEPHALOTHIN AB BIODISK ANNE BOLMSTROM
K990685 03/26/1999 TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) AB BIODISK ANNE BOLMSTROM
K990035 03/08/1999 RF ABBOTT LABORATORIES MARK LITTLEFIELD
K990311 03/31/1999 VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER ABX DIAGNOSTICS PAT AMTOWER
K990140 03/25/1999 NORMED BONE TRANSPORT ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K990090 03/22/1999 DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE AESCULAP, INC. STEVE REITZLER
K990089 03/15/1999 SILKAM NONABSORBABLE SILK SURGICAL SUTURE AESCULAP, INC. STEVE REITZLER
K984584 03/22/1999 AIR TECHNIQUES' DENTO-VAC AIR TECHNIQUES, INC. JOSEPH CAREY
K980688 03/16/1999 INTEGRITI PATIENT MONITOR ALLIANCE INSTRUMENTS JIM ROOKS
K990453 03/09/1999 NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR ALLIANCE RUBBER PRODUCTS SDN. BHD. CHUA HOOI KOON
K984017 03/04/1999 ALLISON MEDICAL INSULIN SYRINGE (AMIS) ALLISON MEDICAL, INC. JUSTIN FERRIN
K983879 03/22/1999 ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. PAUL D SMOLENSKI
K990725 03/22/1999 NUVOLASE 532 LASER SYSTEM AMERICAN LASER CORP. DANIEL HOFFER
K990780 03/22/1999 NUVOLASE 532 CUTANEOUS LASER SYSTEM AMERICAN LASER MEDICAL DANIEL HOEFER
K983927 03/11/1999 GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT ARTERIAL VASCULAR ENGINEERING, INC. DEBORAH L HERRINGTON
K983843 03/12/1999 BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B ARTHREX, INC. SCOTT M DURLACHER
K981858 03/22/1999 ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW ATLANTIS COMPONENTS, INC. ANDREW ZIEGLER
K983794 03/23/1999 CHEMO MINI SPIKE PLUS B. BRAUN OF AMERICA, INC. MARK S ALSBERGE
K984190 03/15/1999 BACK-ON-TRAC, MODEL 101BOT BACK-ON-TRACK, INC. DAVID A SCIORTINO
K983225 03/29/1999 BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER BAUSCH & LOMB, INC. YVONNE E MIDDLEFELL
K984006 03/18/1999 GLUCOMETER ELITE XL BLOOD GLUCOSE METER BAYER CORP. GEORGE M TANCOS
K984618 03/25/1999 BCI MINI-TORR PLUS, MODEL 6004 BCI INTL., INC. DONALD ALEXANDER
K984597 03/01/1999 MODIFICATION OF CUTINOVA CAVITY DRESSING BEIERSDORF-JOBT, INC. ANGELO R PEREIRA
K984599 03/01/1999 MODIFICATION OF CUTINOVA FOAM DRESSING BEIERSDORF-JOBT, INC. ANGELO R PEREIRA
K984595 03/01/1999 MODIFICATION OF CUTINOVA HYDRO DRESSING BEIERSDORF-JOBT, INC. ANGELO R PERIERA
K984593 03/01/1999 MODIFICATION OF CUTINOVA THIN DRESSING BEIERSDORF-JOBT, INC. ANGELO R PEREIRA
K990042 03/19/1999 SILON DUAL-DRESS BIO MED SCIENCES, INC. MARK E DILLON
K984582 03/16/1999 ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX BIO-DETEK, INC. MICHAEL R DUPELLE
K990317 03/18/1999 ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 BIO-RAD ELIZABETH PLATT
K990282 03/09/1999 ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 BIO-RAD ELIZABETH PLATT
K990424 03/31/1999 ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 BIO-RAD ELIZABETH PLATT
K990391 03/15/1999 ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 BIO-RAD ELIZABETH PLATT
K990394 03/18/1999 ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 BIO-RAD ELIZABETH PLATT
K990608 03/30/1999 ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 BIO-RAD ELIZABETH PLATT
K990393 03/22/1999 ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 BIO-RAD ELIZABETH PLATT
K990513 03/17/1999 ULTIMAX CORTICAL BONE SCREWS BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K990481 03/17/1999 ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K990436 03/31/1999 ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM BIODYNAMIC TECHNOLOGIES, INC. DANNY HODGEMAN
K984583 03/15/1999 THE BIOPLATE SHUNT CONNECTOR BIOMEDICS ERIC V HOHENSTEIN
K990291 03/23/1999 LACTOSORB BONE PIN BIOMET, INC. MICHELLE L MCKINLEY
K984623 03/05/1999 MAXIM REMOVABLE MOLDED POLY TIBIA BIOMET, INC. FRED MCCLURE
K981996 03/10/1999 TITANIUM FEMORAL COMPONENT BIOMET, INC. FRED MCCLURE
K984580 03/12/1999 BIOSACA SYSTEM BIOSYS AB (PUBL) JANE B CAMPBELL
K990156 03/05/1999 MULTITAK SS BUTTONS BONUTTI RESEARCH PATRICK BALSMANN
K980351 03/05/1999 BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT BOSTON BIOMEDICA, INC. DEBRA A PETIT
K981947 03/03/1999 STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) BOSTON MEDICAL CORP. TIMOTHY F HAND
K990295 03/05/1999 BONE ANCHOR SYSTEM III (BAS III) BOSTON SCIENTIFIC CORP. Lorraine M Hanley
K983171 03/11/1999 CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM BOSTON SCIENTIFIC CORP. STEVE JWANOUSKOS
K983295 03/15/1999 BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 BRAUN AG FRANCES E HARRISON
K974393 03/19/1999 VASO PRESS SYSTEM BRITT CORP., INC. J. JAMES BRITTON
K990514 03/09/1999 MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR C.R. BARD, INC. SANDRA PERREAND
K990066 03/17/1999 CCD CAMERA, MODEL 9000 CAMTRONICS, LTD. ROBERT KRIEDERMANN
K982283 03/09/1999 WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH CARADYNE, LTD. PAUL E DRYDEN
K990009 03/16/1999 CARESIDE AST CARESIDE, INC. KENNETH B ASARCH
K990036 03/18/1999 CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 CARESIDE, INC. KENNETH B ASARCH
K990691 03/23/1999 HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. DAVID U THOMAS
K990368 03/26/1999 DUODERM HYDROACTIVE GEL WOUND DRESSING CONVATEC, A BRISTOL-MYERS SQUIBB CO. ADRIENNE MCNALLY
K984388 03/03/1999 HA ABSORBENT WOUND DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIIENNE MCNALLY
K983986 03/23/1999 CONWAY STUART MEDICAL MODEL C4 ELECTROSURGICAL GENERATOR CONWAY STUART MEDICAL, INC. THOMAS C WEHMAN
K990072 03/25/1999 BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C COOK UROLOGICAL, INC. DEBBIE SCHMIDT
K990855 03/30/1999 COOPERSURGICAL INFRARED COAGULATOR FOR ENT COOPERSURGICAL, INC. JONATHAN S KAHAN
K990606 03/15/1999 TETRAFILCON A COOPERVISION, INC. BONNIE TSYMBAL
K990805 03/15/1999 MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER CORDIS CORP. ARIEL MACTAVISH
K983483 03/24/1999 VASCULAR OCCLUSION SYSTEM CORDIS NEUROVASCULAR, INC. MARTINE D SCHNEIDER
K990657 03/26/1999 TRIFIX PEDICLE SPINAL SCREW ASSEMBLY CORIN U.S.A. CRAIG CORRANCE
K983945 03/17/1999 CORTEX DERMASCAN C ULTRASONIC SYSTEM CORTEX TECHNOLOGY APS GEORGE MYERS
K984216 03/16/1999 IMMUNO-TROL CONTROL CELLS COULTER CORP. MARION S GAIDE
K984039 03/29/1999 CRANBERRY POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESSS) CRANBERRY (M) SDN. BHD. CHONG YOON TAT
K990251 03/31/1999 DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 DADE BEHRING, INC. CATHY P CRAFT
K990554 03/22/1999 DIMENSION SPECIAL PROTEIN CALIBRATOR DADE BEHRING, INC. CATHY P CRAFT
K990551 03/25/1999 IGG FLEX REAGENT CARTRIDGE DADE BEHRING, INC. CATHY P CRAFT
K990553 03/22/1999 IGM FLEX REAGENT CARTRIDGE DADE BEHRING, INC. CATHY P CRAFT
K990552 03/25/1999 IMMUNOGLOBULIN A TEST SYSTEM DADE BEHRING, INC. CATHY P CRAFT
K990603 03/10/1999 MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM DANEK MEDICAL, INC. RICHARD W TREHARNE
K990278 03/30/1999 DAUM NEUROCUT NEUROBIOPSYNEEDLE DAUM CORP. E.J. Smith
K990448 03/23/1999 THE.R.MO.FREE DENTAMAX, INC. MARTIN A RIGUTTO
K983105 03/08/1999 CCS; COMPUTER CONTROLLED SYRINGE, MODEL #CCS-100, CCS; CARTRIDGE HOLDER (REPLACEMENTS), MODEL # CCS-100-01 DENTSPLY MIDWEST ROBERT BOOTH
K990392 03/23/1999 DEPUY ACE SPIDER PLATE DEPUY ACE MEDICAL CO. KATHLEEN DRAGOVICH
K990438 03/25/1999 DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING DERMAPHYLYX, INC. ANDREW M REED
K990379 03/04/1999 MODIFICATION TO MULTAPORT CANNULA, REDUCER AND ACCESSORIES DEXIDE, INC. JOHN CORZINE
K984062 03/24/1999 SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 DIAG CORP. TODD KORNMANN
K982468 03/12/1999 IMMULITE 2000 THYROGLOBULIN MODEL L2KTY DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K982466 03/12/1999 IMMULITE THYROGLOBULIN MODEL LKTY DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K983336 03/18/1999 PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K981812 03/04/1999 EBV-VCA IGG ELISA TEST SYSTEM DIAMEDIX CORP. NORMAN JENKINS
K984322 03/02/1999 DIDECO D920, LILLIPUT 1 TWIN RESERVOIR DIDECO S.P.A. BARRY SALL
K990049 03/12/1999 CD-DENT DIGITAL IMAGING DEVICES FOR DENTAL X-RAY SYSTEMS, MODELS 600, 1000 AND 2000 DIGIDENT LTD. MARY MCNAMARA-CULLINAME
K984466 03/16/1999 DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 DILON TECHNOLOGIES, INC. LEE H FAIRCHILD
K990019 03/15/1999 DRG MEDIUM SCREW SYSTEM DOLPHIN MEDICAL TECHNOLOGIES, INC. MARK G URBANSKI
K984591 03/26/1999 DORNIER MEDILAS H/2 DORNIER SURGICAL PRODUCTS, INC. CAROL WERNECKE
K984611 03/29/1999 DRAGER SOLA SERIES, MODELS 1000/700/500/300 DRAGER MEDIZINTECHNIK GMBH FRANK CLANZETT
K983797 03/03/1999 D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM DUTCH OPHTHALMIC USA, INC. MARK W FURLONG
K990146 03/17/1999 SURGITRON ELLMAN INTL., INC. FRANK LIN
K990516 03/31/1999 ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS EMD CHEMICALS INC. ANNA G BENTLEY
K984081 03/17/1999 EMOX EMOX 911 CC IVOR DUNCAN
K982160 03/17/1999 HINGED KNEE ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K984345 03/19/1999 AROMAPATCH ENVIS, INC. STEVE WOODY
K990573 03/11/1999 ESTECH ARTERIAL REMOTE ACCESS PERFUSION CANNULA ESTECH, INC. ARTHUR BERTOLERO
K990430 03/12/1999 ULTRACISION HARMONIC SCALPEL HAND PIECE ETHICON ENDO-SURGERY, INC. RUTH ANN WOOD
K990366 03/05/1999 EXMOOR SUCTION CLEARANCE KIT EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K990205 03/26/1999 DIGISCOPE OPHTHALMIC CAMERA EYE TEL IMAGING, INC. KEVIN T QUINN
K984539 03/01/1999 FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING FERRIS MFG. CORP. THEODORE THORSEN
K990765 03/15/1999 FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO FLEXMEDICS WILLIAM C CORRIGAN, JR.
K982414 03/26/1999 GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS GAMBRO HEALTHCARE JEFFREY R SHIDEMAN
K983318 03/01/1999 FIXATION SYSTEM GENERAL SURGICAL INNOVATIONS FEROLYN T POWELL
K983379 03/09/1999 GTI-PF4 ELISA GENETIC TESTING INSTITUTE MICHAEL MOGHADDAM
K990062 03/30/1999 SAPHLIFT GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) Ruth Forstadt
K983624 03/18/1999 GILTECH PLUS CONNECTING TUBE SET GILTECH PLUS, INC. WILLIAM J GILIAM
K990639 03/25/1999 ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING. GUIDANT CORP. MARGARET ANDERSON
K984394 03/08/1999 ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING GUIDANT CORP. MARGARET ANDERSON
K983075 03/03/1999 GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 GUIDANT CORP. SANDRA SUNDELL
K983346 03/23/1999 STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF GUIDANT CORP. MARGARET ANDERSON
K982738 03/01/1999 VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) GYNECARE, INC. Susan M Aloyan
K982739 03/12/1999 GYNEX ELECTRODES GYNEX CORP. DAVID W SCHLERF
K990601 03/31/1999 BOJRAB MICRO-TORP, MODEL 7014-5845 GYRUS ENT L.L.C. ALICIA FARAGE
K990293 03/16/1999 ALADDIN II MONITORING OXYGEN/AIR MONITOR HAMILTON MEDICAL, INC. TIMOTHY Y COWART
K990184 03/19/1999 AUTOMARQER HAMILTON THORNE RESEARCH DIARMAID DOUGLAS-HAMILTON
K990283 03/09/1999 BLUE POWDER-FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD KUAN KAM HON
K983202 03/15/1999 HARWILL MEDICAL CERVITULA CERVICAL SPATULA HARWILL MEDICAL (PTY) LTD. E.J. Smith
K983119 03/15/1999 ENTERO-TEST HP, MODEL #102-01 HDC CORP. LEN ROSS
K983572 03/19/1999 SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500 HEALTHDYNE TECHNOLOGIES, INC. BETSY CORTELLONI
K990772 03/23/1999 DIRECTFLOW ARTERIAL CANNULA HEARTPORT, INC. MARIANNE C DRENNAN
K990923 03/31/1999 TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 HEINZ KURZ DAGMAR S MAESER
K980840 03/15/1999 LOKKI DT HILLARD W. WELCH HILLARD W WELCH
K990456 03/25/1999 ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP HOLLISTER, INC. JOSEPH S TOKARZ
K990152 03/15/1999 OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER HOWMEDICA OSTEONICS CORP. KATE SUTTON
K990598 03/15/1999 OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD HOWMEDICA OSTEONICS CORP. MARYBETH NAUGHTON
K981153 03/17/1999 OSIRIS HUESTIS MEDICAL TERRY CHWALK
K983385 03/15/1999 HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS HUTCHISON INTL., INC. EDUARDO MARCH
K984502 03/04/1999 NERVE BLOCK INFUSION KIT I-FLOW CORP. ROBERT J BARD
K990242 03/03/1999 TOPOGRAPHIC IMAGING MARKER I.Z.I. MEDICAL PRODUCTS CORP. E J SMITH
K990298 03/03/1999 TOPOGRAPHIC IMAGING MARKER I.Z.I. MEDICAL PRODUCTS CORP. E.J. Smith
K984357 03/04/1999 TRANSFX EXTERNAL FIXATION SYSTEM IMMEDICA, INC. ROY BOGERT
K983835 03/15/1999 IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA IMPLEX CORP. ROBERT POGGIE
K990851 03/30/1999 INDIGO LASEROPTIC TREATMENT SYSTEM INDIGO MEDICAL, INC. JACQUELYN A HUGHES
K964235 03/02/1999 ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL INDUSTRIELLE ENTWICKLUNG MEDIZINTECHNIK UND VERTRI UWE KORTH
K984490 03/01/1999 SUTURELESS ANCHOR INNOVASIVE DEVICES, INC. KATHLEEN MORAHAN
K983742 03/15/1999 ITI DENTAL IMPLANT SYSTEM INSTITUT STRAUMANN AG LINDA JALBERT
K990086 03/31/1999 HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM INTEGRA LIFESCIENCES CORP. JUDITH E O'GRADY
K983272 03/24/1999 IBC FLOPUMP, MODEL 6000 INTERNATIONAL BIOPHYSICS CORP. H. DAVID SHOCKLEY, JR
K990131 03/02/1999 PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE INTERPORE CROSS INTL. LYNN M RODARTI
K984578 03/23/1999 SYNERGY D2 SPINAL IMPLANTS INTERPORE CROSS INTL. LYNN M RODARTI
K990664 03/31/1999 PRIMA SYSTEM - OLD, BARTELS ELISA - NEW INTRACEL CORP. CECILIA MATOS-ROSA
K982668 03/02/1999 PHORESOR II,MODEL PM900 IOMED, INC. W.TIM MILLER
K990182 03/01/1999 D-SIGN V (R&D PROJECT DW267#17) IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K990235 03/01/1999 D-SIGN VI (R&D PROJECT DW266#9) IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K990534 03/19/1999 EXCITE IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K990315 03/04/1999 MONOPAQUE IVOCLAR NORTH AMERICA, INC. PETER P MANCUSO
K984587 03/17/1999 ALLROUND-E (CODE NAME RD 1710) J.F. JELENKO & CO., INC. TRIDIB DASGUPTA
K990056 03/25/1999 JELDENT MULTICRYL J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K982641 03/29/1999 ADVANCED NIBP MODULE JOHNSON & JOHNSON MEDICAL, INC. DARLENE T KORAB
K990334 03/22/1999 KSEA ENDOSCOPE HOLDER KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN A KENNAN
K990240 03/11/1999 ELECTROGLOTTOGRAPH KAY ELEMETRICS CORP. WILLIAM D HARBESON
K990306 03/03/1999 HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 KAY SEE DENTAL MFG. CO. CLARK SMITH
K990257 03/25/1999 KEELER PULSAIR 3000 NON CONTACT TONOMETER KEELER INSTRUMENTS, INC. EUGENE R VAN ARSDALE
K983817 03/01/1999 BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) KING SYSTEMS CORP. MICHAEL A LEAGRE
K990420 03/29/1999 LAGLOVE BRAND NITRILE EXAMINATION GLOVE (POWDER FREE) LAGLOVE (M) SDN. BHD. G. BASKARAN
K990415 03/29/1999 LAGLOVE BRAND NITRILE EXAMINATION GLOVES (LIGHTLY POWDERED) LAGLOVE (M) SDN. BHD. G. BASKARAN
K984424 03/05/1999 AURA DYE LASER SYSTEM (ADLS) LASERSCOPE PAUL H HARDIMAN
K990075 03/30/1999 LPULSA SYL-9000 OPHTHALMIC YAG LASER LIGHT-MED (USA), INC. THOMAS V KEELEY
K983652 03/23/1999 ABLATOR ELECTRODE LINVATEC CORP. LAURA D SENEFF
K984102 03/18/1999 ACL/APS FACS KIT LOUISVILLE APL DIAGNOSTICS, INC. SILVIA S PIERANGELI
K980964 03/12/1999 MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS LS RUBBER SDN BHD MOHAMAD FIRDAOS BIN MOHAMED
K981955 03/15/1999 MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS LS RUBBER SDN BHD RAJIL VOHRA
K990506 03/11/1999 MABIS NB-02 ULTRASONIC NEBULIZER MABIS HEALTHCARE, INC. STEVEN M BISULCA
K983918 03/12/1999 RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) MASTEK, INC. MARCOS V MASSON
K990220 03/31/1999 MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM MEDI-GLOBE CORP. MICHELLE L FIELDS
K983500 03/17/1999 PRO2 CHECK OXYGEN INDICATOR MEDICAL TECHNOLOGY SPECIALISTS, INC. DONALD W MORROW, III
K984434 03/17/1999 MEDIVISION LAPAROSCOPE MEDIVISION SCOPE SERVICE CENTER, INC. WAYNE B STERNER
K990463 03/15/1999 MEDLINE EXCEL WHEELCHAIRS MEDLINE LARA N SIMMONS
K984418 03/11/1999 UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET MEDRAD, INC. FRANK W PELC III
K990375 03/09/1999 DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S ANN-CHRISTINE JONSSON
K984271 03/09/1999 MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 MEDTRONIC VASCULAR KAREN CROPPER
K990707 03/22/1999 MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS MEDTRONICS INTERVENTIONAL VASCULAR MARK CHARTIER
K990264 03/31/1999 COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS METRO OPTICS OF AUSTIN, INC. MARTIN DALSING
K990210 03/29/1999 POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABP MEXPO INTL., INC. TIM THAI
K982278 03/26/1999 MICRINS MICRO ANASTOMOSIS CLAMP MICRINS SURGICAL, INC. BERNHARD TEITZ
K983882 03/15/1999 MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400 MICRO-MEDICAL DEVICES, INC. JIM OHNECK
K983533 03/23/1999 ACTIWATCH MINI-MITTER CO., INC. JACK E MCKENZIE
K983126 03/08/1999 FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS MINNTECH CORP. MARK MURPHY
K984370 03/01/1999 HYPERGEL 20% HYPERTONIC SALINE GEL MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K984371 03/03/1999 MEPITEL NON ADHERENT SILICONE DRESSING MOLNLYCKE HEALTH CARE, INC. MIGUEL A NEGRON
K984628 03/17/1999 MODIFICATION OF MOSS P.E.G. TRAY MOSS TUBES, INC. HARRY SCHLAKMAN
K990389 03/22/1999 MOSS GASTROSTOMY TUBE MOSS TUBES, INC. HARRY SCHLAKMAN
K984629 03/02/1999 MOSS TUBES, INC. NASAL TUBE - MARK IV MOSS TUBES, INC. HARRY SCHLAKMAN
K983228 03/15/1999 BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 MURRAY ELECTRONICS KENT C HOFFMAN
K982173 03/11/1999 BUZBEE MWR ELECTRONICS INDUSTRIAL CO. MANFRED W ROSCHER
K982098 03/01/1999 TUTODROP 1 AND TUTODROP 2 MYCO MEDICAL SUPPLIES, INC. SANJIV KUMAR
K990388 03/29/1999 TUTOPLUS IV ADMINISTRATION SET MYCO MEDICAL SUPPLIES, INC. SANJIV KUMAR
K983476 03/01/1999 BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES NAVION BIOMEDICAL CORP. DONALD A KAY
K983164 03/05/1999 RESTORE (AKA RE/STOR) NEBL, INC. Jeffrey A Dann
K983007 03/22/1999 NEUROTUBE NEUROREGEN, L.L.C. JOHN E BARHAM
K984427 03/15/1999 EXCELSIOR PORCELAIN SYSTEM NEY DENTAL, INC. ANDREW J PIETROBONO
K990629 03/19/1999 SYMBIOCERAM NEY DENTAL, INC. ANDREW J PIETROBONO
K980737 03/23/1999 ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K981702 03/05/1999 AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300 NIHON SEIMITSU SOKKI CO., LTD. ROBERT D WAXHAM
K984287 03/01/1999 PROVISIONAL DENTAL IMPLANT SYSTEM NOBEL BIOCARE UAS INC JEFF HAUSHEER
K983576 03/23/1999 DR180-R/OXY NORTHEAST MONITORING, INC. RODNEY L CAMBRE
K990646 03/19/1999 PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K990682 03/24/1999 PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) NSK NAKANISHI, INC. HIROJI SEKIGUCHI
K983229 03/23/1999 OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM OLYMPIC MEDICAL CORP. EDWARD (TED) B WEILER
K990687 03/26/1999 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS OLYMPUS OPTICAL, CO. LAURA STORMS TYLER
K983496 03/29/1999 RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T OPTI-CENTRE LABORATORIES MARTIN DALSING
K990783 03/25/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. ANNE ZAVERTNIK
K990531 03/12/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS Ortho-Clinical Diagnostics, Inc. ANNE ZAVERTNIK
K984289 03/12/1999 VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK Ortho-Clinical Diagnostics, Inc. ANNE ZAVERTNIK
K982996 03/04/1999 POLYMER OBL SB ANCHOR / SUTURE COMBINATION ORTHOPAEDIC BIOSYSTEMS, LTD. JEFFRY B SKIBA
K982798 03/25/1999 OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM OSTEONICS CORP. KATE SUTTON
K984608 03/09/1999 GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K983360 03/19/1999 MACROPORE PROTECTIVE SHEET PACIFIC MATERIALS AND INTERFACES FLOYD G LARSON
K982980 03/04/1999 LIGHTSHEER LONG PULSE RUBY LASER PALOMAR MEDICAL PRODUCTS, INC. Marcy Moore
K981431 03/03/1999 PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW280 PANASONIC CORPORATION (PANASONIC) EDWARD M BASILE, ESQ.
K981542 03/03/1999 PANASONIC WRIST BLOOD PRESSURE METER, MODEL EW284 PANASONIC CORPORATION (PANASONIC) EDWARD M BASILE
K990557 03/22/1999 THE STELLAR TILT, MANUALLY OPERATED WHEELCHAIR PDG PRODUCT DESIGN GROUP, INC. PHIL MUNDY
K990518 03/25/1999 PEREGRINE WET SET, MODEL PD400.00 PEREGRINE SURGICAL LTD. JOHN E RICHMOND
K990249 03/22/1999 OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 PHAMATECH CARL MONGIOVI
K990860 03/30/1999 VIEWPOINT MICROSCOPE OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K990868 03/30/1999 VIEWPOINT PASSIVE TOOL OPTION PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. ELAINE K KEELER
K990423 03/15/1999 PHILIPS NICOL COLLIMATOR FAMILY PHILIPS MEDICAL SYSTEMS, INC. PETER ALTMAN
K990309 03/15/1999 PLUS FRACTURE HEAD PROSTHESIS PLUS ORTHOPEDICS HARTMUT LOCH
K984492 03/15/1999 TIGRAN HIP PROSTHESIS PONMED LTD. JEFFREY R SCHIDEMAN
K990296 03/18/1999 CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) PRECISION BIOLOGIC SANDY MORRISON
K990786 03/26/1999 ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ PRINCETON BIOMEDITECH CORP. JEMO KANG
K984449 03/19/1999 NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM PT. IRAMA DINAMIKA LATEX ANIL TANEJA
K990326 03/04/1999 OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII RADIONICS SOFTWARE APPLICATIONS, INC. KEVIN J O'CONNELL
K984552 03/05/1999 COOL-TIP RF SYSTEM RADIONICS, INC. JEFFREY R MANNION
K984494 03/23/1999 RANDOX ALBUMIN RANDOX LABORATORIES, LTD. P ARMSTRONG
K990703 03/30/1999 SPOROX II STERILIZING & DISINFECTING SOLUTION RECKITT BENCKISER, INC. SEAN MCNEAR
K984547 03/19/1999 DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS RESOUND CORP. GARY ROESEL
K983071 03/04/1999 BILICHEK NON-INVASIVE BILIRUBIN ANALYZER RESPIRONICS, INC. TIMOTHY Y COWART
K984607 03/05/1999 PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K984521 03/17/1999 RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K990050 03/26/1999 URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K990460 03/22/1999 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K990108 03/09/1999 LC FLOWFILL S & C POLYMER GMBH JURGEN ENGELRECHT
K990720 03/19/1999 SAS HCG SERUM CONTROLS SA SCIENTIFIC, INC. HARBI A SHADFAN
K990755 03/19/1999 SAS HCG URINE CONTROLS SA SCIENTIFIC, INC. HARBI A SHADFAN
K983355 03/12/1999 SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR SABRATEK CORP. J. HARVEY KNAUSS
K982136 03/24/1999 JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 SCHIFF & CO. ANNE M CESARIO
K984641 03/29/1999 FLEXISCOPE OPTOMODUL SCHOELLY FIBEROPTIC, GMBH JOSEPH RESS
K990118 03/22/1999 ISOBAR SPINAL SYSTEM SCIEN'TX USA INC. DEBBIE DE LOS SANTOS
K990208 03/25/1999 PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT SCIENCE INCORPORATED RALPH E HOGANCAMP
K990101 03/19/1999 PAIN CONTROL INFUSION PUMP SGARLATO LABORATORIES, INC. THOMAS SGARLATO
K990299 03/29/1999 POWDER FREE BLUE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. DANNY WANG
K990267 03/29/1999 POWDERED BLUE NITRILE MEDICAL EXAMINATION GLOVES SHANGHAI PALOMAR MOUNTAIN INDUSTRIES, INC. DANNY WANG
K984634 03/12/1999 3D-ANGIO SIEMENS MEDICAL CORP. MALGORZATA STANEK
K982952 03/05/1999 IMFAST SIEMENS MEDICAL SOLUTIONS USA, INC. KATHRYN B DODD
K990563 03/19/1999 SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K990192 03/12/1999 BIOPSY-DIGIT SITCO, INC. ROBERT H MCCARTHY
K984550 03/01/1999 PRE-THREADED ENDOBUTTON SMITH & NEPHEW, INC. SUSAN A FINNERAN
K990369 03/12/1999 SYNERGY CEMENTED HIP STEM SMITH & NEPHEW, INC. NEAL DEFIBAUGH
K984518 03/12/1999 SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL SONIC INNOVATIONS, INC. JEANNETTE S JOHNSON
K990806 03/26/1999 C1 ULTRASOUND SYSTEM SONOSITE,INC. HOWARD HOLMAN
K990751 03/23/1999 SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES SOUTHLAND PRODUCTS CO., LTD. NG PENG LEONG
K990746 03/23/1999 SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM SOUTHLAND PRODUCTS CO., LTD. NG PENG LEONG
K983194 03/05/1999 SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) SPORICIDIN INTL. HAROLD E PLANK
K990136 03/01/1999 ANATOMICA GLENOID COMPONENT SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K983790 03/01/1999 VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE SUN BIOMEDICAL LABORATORIES, INC. MING SUN
K984018 03/15/1999 HEMOSLEEVE, MODEL 4.0MM, 5.5MM SURGICAL LASER TECHNOLOGIES, INC. MONICA FERRANTE
K990498 03/08/1999 OPTIBOND SOLO PLUS SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K984543 03/01/1999 SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 SYNTEC SCIENTIFIC CORP. TED Y SHI
K984364 03/02/1999 SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 SYNTEC SCIENTIFIC CORP. TED Y SHI
K984602 03/05/1999 SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM SYNTEC SCIENTIFIC CORP. TED Y SHI
K990745 03/30/1999 MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM SYNTHES SPINE J0NATHAN GILBERT
K984382 03/05/1999 ACCU GUIDE TAYMAN MEDICAL, INC. VAUGHN WEEKS
K983671 03/04/1999 NATURAL BRAND ACUPUNCTURE NEEDLES TCM SUPPLY CORP. WILLIAM HUNG LEE
K984443 03/05/1999 ORBSCAN TECHNOLAS PERFECT VISION GMBH BETSY M JOHNSON
K990555 03/22/1999 TISPORT X AND TISPORT XC TISPORT SANDRA GLADSTONE
K990134 03/19/1999 MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K990490 03/02/1999 SSA-320A JUST VISION 200/ SSA-325A JUST VISION TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K982660 03/30/1999 ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM TRANSFUSION TECHNOLOGIES CORP. JOHN J SOKOLOWSKI
K990354 03/31/1999 ENDOSHEATH VISION-SCIENCES, INC. PAMELA PAPINEAU
K982816 03/17/1999 VNUS CLOSURE SYSTEM VNUS MEDICAL TECHNOLOGIES, INC. JOHN D'ANGELO
K984534 03/15/1999 PRECLUDE ACUSEAL DURA SUBSTITUTE W.L. GORE & ASSOCIATES,INC JOHN NICHOLSON
K981446 03/09/1999 WAKO AUTOKIT LP(A) WAKO CHEMICALS, USA, INC. TONYA MALLORY
K984306 03/01/1999 `THE INSEMINATOR' (PROPOSED) WALLACH SURGICAL DEVICES, INC. MICHAEL MALIS
K982600 03/12/1999 PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED) WEMBLEY RUBBER PRODUCTS (M) SDN BHD CHOW YUE WAH
K990145 03/25/1999 WILSON-COOK BIPOLAR PROBE WILSON-COOK MEDICAL, INC. PAULA JOYCE
K990556 03/26/1999 ESOPHAGEAL INTUBATION DETECTOR WOLFE TORY MEDICAL, INC. TIM WOLFE
K990708 03/30/1999 TITANIUM VERSALOK WRIGHT MEDICAL TECHNOLOGY, INC. DAN REGAN
K990578 03/09/1999 OSOM CARD II HCG-URINE TEST, MODEL 102 WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K990576 03/09/1999 OSOM CARD PREGNANCY TEST, MODEL 103 WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K990013 03/23/1999 EVERGREEN NON-STERILE POWDER-FREE, COLORED NITRILE EXAMINATION GLOVES YTY INDUSTRY (MANJUNG) SDN. BHD. E J SMITH
K984138 03/23/1999 APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K990207 03/26/1999 GLIADIN IGA ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK K KOPNITSKY
K990204 03/26/1999 GLIADIN IGG ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K983656 03/18/1999 HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM ZEUS SCIENTIFIC, INC. MARK J KOPNITSKY
K982992 03/11/1999 ZOLL M SERIES SPO2 OPTION ZOLL MEDICAL CORP. MAURA MCGUIRE
K984596 03/04/1999 VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES ZYMETX, INC. CRAIG D SHIMASAKI


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