FDA 510(k) Decisions During December, 1997  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K973899 12/04/1997 UNIFINE PENTIPS *OWNE MUMFORD USA, INC.** ROBERT E SHAW
K973961 12/17/1997 3M DENT SYSTEM II PLUS 3M COMPANY LAEL J PICKETT
K973472 12/08/1997 3M CDI H/S CUVETTES WITH HEPARON TREATMENT 3M HEALTH CARE DIANA RHEA
K974032 12/22/1997 ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR A & A MEDICAL, INC. JIHAD MANSOUR
K972925 12/05/1997 ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC ACCESS RADIOLOGY CORP. ALLAN M GREEN
K973767 12/23/1997 HARMONIC IMAGING WITH CONTRAST ACUSON CORP. WILLIAM WELCH
K973355 12/05/1997 ADVANTAGE 3000 ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX ROBERT SNOW
K973736 12/29/1997 AESCULAP HILAN MOTOR SYSTEM AESCULAP, INC. MARY E HOLDEN
K970851 12/09/1997 LYOPLANT DURA SUBSTITUTE(VARIOUS) AESCULAP, INC. VICTORIA MACKINNON
K964271 12/19/1997 IGN 500 TM WATER CLEANING UNIT WITH CALBENIUM LIQUID AIREL-WEST DANIEL A KRACOV
K973332 12/02/1997 ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 ALCON LABORATORIES MICHAEL E PFLEGER
K973967 12/08/1997 AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) ALDEN OPTICAL LABS., INC. MARTIN DALSING
K973703 12/04/1997 JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN ALLEGIANCE HEALTHCARE CORP. JOSEPH A MERTIS
K973501 12/11/1997 EXPRESSE AND PREMIER POWERED BREAST PUMPS AMEDA MEDIZINTECHNIK AG JOSEPH S TOKARZ
K955893 12/30/1997 EVERYTIME TRANSFUCER COVER AMEDIC AB GINA AZARIC
K973873 12/29/1997 DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 AMERICAN TELECARE, INC. GERARD J PRUD'HOMME
K973957 12/17/1997 DBEST ONE-STEP HCG SERUM/URINE TEST AMERITEK, INC. K C YEE
K974042 12/19/1997 AMSURE CLEANSING ENEMA SET AMSINO INTL., INC. RICHARD Y LI
K974218 12/18/1997 DERMACLEAN STERILE (PROTEIN LABELING CLAIM) EXAM GLOVES ANSELL PERRY JAMES R CHATTERTON
K973461 12/09/1997 ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE ANSELL PERRY JAMES R CHATTERTON
K973893 12/19/1997 AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE APPLIED MEDICAL TECHNOLOGIES THOMAS W PARKINSON
K973950 12/12/1997 RETINAL CUBE APPLIED SPECTRAL IMAGING, LTD. MICHAEL ADEL
K970367 12/17/1997 THERMO-STAT SYSTEM AQUARIUS MEDICAL CORP. W. JEFFREY CHANDLER
K973653 12/12/1997 SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM AREEDA ASSOC., LTD. JOSEPH AREEDA
K970277 12/11/1997 URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) ASTORIA-PACIFIC,INC. RAYMOND L PAVITT
K972946 12/19/1997 AURELUX 77 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K974127 12/19/1997 HYDRA METER AUTOMATA INSTRUMENTATION, INC. LINDA V MASANO
K973638 12/23/1997 N.I.T., INC. NEEDLE GUIDING TEMPLATE AVID N.I.T., INC. JOSEPH E HARMS
K971086 12/19/1997 RADIAL AND FEMORAL ARTERY CATHETER B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K964703 12/01/1997 THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) BAYER CORP. GABRIEL J MURACA, JR.
K973616 12/05/1997 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM BAYER CORP. GABRIEL J MURACA
K973932 12/15/1997 BECKMAN CALIBRATOR 2 (CAL2) BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K973928 12/01/1997 BECKMAN URINE PROTEIN CALIBRATOR (UCAL) BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K974110 12/24/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K974452 12/17/1997 VIGIL LIPID CONTROL BECKMAN INSTRUMENTS, INC. RICHARD T ROSS
K971205 12/01/1997 TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS ANNA LONGWELL
K971339 12/24/1997 INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS BECTON DICKINSON VASCULAR ACCESS, INC. C.J. WELLE
K974069 12/15/1997 OPUS 2 - CANAL SERIES (ITC) BERNAFON-MAICO, INC. RAY ENROTH
K974152 12/15/1997 OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) BERNAFON-MAICO, INC. RAY ENROTH
K974211 12/15/1997 OPUS 2 - FULL CONCHA SERIES - ITE BERNAFON-MAICO, INC. RAY ENROTH
K973609 12/18/1997 IDA-4 AND IPT-MC BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K973706 12/24/1997 DURA-GUARD-DURAL REPAIR PATCH BIO-VASCULAR, INC. BARBARA ATZENHOEFER
K973552 12/16/1997 OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP BIO-VASCULAR, INC. JULIE SHERMAN
K973429 12/01/1997 BIODERM FOAM WOUND DRESSING BIODERM, INC. GEORGE WORTHLEY
K972064 12/01/1997 MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV BIOLOGICAL CONTROLS, INC. GARY D MESSINA
K973644 12/23/1997 FLOSTAT VASCULAR LAB BIOMEDIX, INC. DAVID LERNER
K973857 12/29/1997 FLOSTAT VASCULAR REPORT GENERATOR (VRG) BIOMEDIX, INC. DAVID LERNER
K971824 12/04/1997 REACH FEMORAL HIP COMPONENT BIOMET, INC. DEBORAH M MATARAZZO
K974461 12/10/1997 TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL, TRIAGE MYOGLOBIN CONTROL BIOSITE INCORPORATED JOHN F BRUNI
K973784 12/03/1997 TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS BIOSITE INCORPORATED JOHN F BRUNI
K973662 12/15/1997 ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS BOEHRINGER MANNHEIM CORP. MIKE FLIS
K974384 12/08/1997 ELECSYS CALCHECK FOLATE BOEHRINGER MANNHEIM CORP. PATRICIA M KLIMLEY
K974383 12/08/1997 ELECSYS CALCHECK VITAMIN B12 BOEHRINGER MANNHEIM CORP. PATRICIA M KLIMLEY
K974421 12/17/1997 ELECSYS CK-MB STAT BOEHRINGER MANNHEIM CORP. JODY J SAVAGE
K974261 12/11/1997 ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K971688 12/11/1997 IVT 0.014" PTFE-COATED TRACKWIRE BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES KEVIN E DALY
K972744 12/11/1997 COURIER ST BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. MARY P LEGRAW
K973008 12/15/1997 COURIER ST BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. MARY P LEGRAW
K973826 12/05/1997 SPHINCTEROTOME BOSTON SCIENTIFIC CORP. DANIEL J DILLON
K973818 12/16/1997 T-REX BIOPSY FORCEPS BOSTON SCIENTIFIC CORP. JOCELYN KERSTEN
K973567 12/11/1997 SOWELL COBALT-CHROME METAL ALLOY C.K. INTERNATIONAL TRADING ANNA CHIN
K973568 12/11/1997 SOWELL NICKEL-CHROME NON-PRECIOUS METAL ALLOY C.K. INTERNATIONAL TRADING ANNA CHIN
K973569 12/11/1997 SOWELL NICKEL-CHROME-MOLYBDENUM ALLOY C.K. INTERNATIONAL TRADING ANNA CHIN
K973566 12/08/1997 SOWELL PATENTED NON-PRECIOUS METAL ALLOY C.K. INTERNATIONAL TRADING ANNA CHIN
K972016 12/04/1997 AUTIMO 2.5-D AND AUTIMO 3-D C.L. MCINTOSH & ASSOC., INC. T. WHIT ATHEY
K972767 12/04/1997 CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER CANDELA CORP. JAY CAPLAN
K971775 12/29/1997 INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 CARDIAC CONTROL SYSTEMS, INC. TERRY C MCMAHON
K974638 12/18/1997 STERITITE SEALED CONTAINERS MODEL SCO4Q CASE MEDICAL, INC. LARRY R PILOT
K974325 12/08/1997 CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN CHIRON DIAGNOSTICS CORP. WILLIAM J PIGNATO
K970727 12/17/1997 MPORT FOLDABLE LENS PLACEMENT SYSTEM CHIRON VISION CORP. JUDY F GORDON
K974198 12/22/1997 TAKY-SPIKE PLUS CLINICO REINHARD HOPF
K973420 12/09/1997 CLINITEX CAST PADDING CLINITEX MEDICAL CORP. HOWELL H MICHAEL
K973417 12/09/1997 CLINITEX STOCKINETTE CLINITEX MEDICAL CORP. HOWELL H MICHAEL
K963518 12/08/1997 COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR COBE CARDIOVASCULAR, INC. MARY L ARMSTRONG
K972699 12/19/1997 "AESOP 3000 SYSTEM AND ACCESSORIES" COMPUTER MOTION, INC. DOUGLAS P BUESCHEL
K973719 12/23/1997 MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER CONTINUUM BIOMEDICAL, INC. LAURIE A RIDENER
K973688 12/23/1997 DUODERM CONTROL GEL FORMULA BORDER DRESSING CONVATEC LTD. ANDRIENNE MCNALLY
K973689 12/23/1997 DUODERM HYDROACTIVE DRESSING CONVATEC LTD. ADRIENNE MCNALLY
K973717 12/17/1997 COMBIDERM ACD CONVATEC, A BRISTOL-MYERS SQUIBB CO. ADRIENNE MCNALLY
K973716 12/17/1997 DUODERM EXTRA THIN CGF DRESSING CONVATEC, A BRISTOL-MYERS SQUIBB CO. ADRIENNE MCNALLY
K973806 12/29/1997 DUODERM HYDROACTIVE GEL CONVATEC, A BRISTOL-MYERS SQUIBB CO. ADRIENNE MCNALLY
K973807 12/23/1997 DUODERM HYDROACTIVE PASTE CONVATEC, A BRISTOL-MYERS SQUIBB CO. ADRIENNE MCNALLY
K973632 12/22/1997 DUODERM CGF CONTROL GEL FORMULA DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS ADRIENNE MCNALLY
K963013 12/19/1997 PREFERENCE 60 AND PREFERENCE 60 TORIC COOPERVISION, INC. BERNARD F HALLATT
K973595 12/19/1997 THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM CORIN U.S.A. CRAIG CORRANCE
K971920 12/04/1997 GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) CUSTOMED, INC. GLADYNELL RODRIQUEZ
K971905 12/12/1997 DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING DAKO CORP. GRETCHEN M MURRAY
K973954 12/22/1997 IMAGEN RESPIRATORY SCREEN DAKO DIAGNOSTICS LTD. ELISABETH SILVER
K974114 12/18/1997 "DASH", "VITAL GARD" DASH MEDICAL GLOVES SDN BHD ROBERT J SULLIVAN
K971650 12/04/1997 RHYTHMSTAT XL DATA CRITICAL CORP. LISA S JONES
K970078 12/11/1997 HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM DAVOL, INC., SUB. C.R. BARD, INC. ROBIN M DRAGO
K970419 12/22/1997 DAXOR MAX100 SYRINGE (MAX100) DAXOR CORPORATION RONALD H BALDRY
K973421 12/05/1997 IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT} DEJARNETTE RESEARCH SYSTEMS ERIC J FINEGAN
K971696 12/30/1997 SENTINEL RECORDER, MODELS 471/472 DEL MAR AVIONICS RAPHAEL HENKIN
K973781 12/11/1997 AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFREY LEHN
K973782 12/04/1997 AQUASIL XLV SMART WETTING IMPRESSION MATERIAL DENTSPLY INTL. P. JEFFREY LEHN
K974035 12/17/1997 CENTURY ALLOY DENTSPLY INTL. P. JEFFERY LEHN
K974223 12/18/1997 NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES DERLIN COMPANY LTD. JOHN BUCHER
K974003 12/05/1997 ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K974053 12/08/1997 AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10 DIAGNOSTIC CHEMICALS LTD. KAREN CALLBECK
K974396 12/18/1997 IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE DIAMETRICS MEDICAL, INC. STEVE BOEH
K972314 12/19/1997 PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM DIAMETRICS MEDICAL, LTD. KARIMA HEBRI
K973485 12/08/1997 CLEARVIEW BLOWER/MISTER DLP, INC. GRETCHEN HARTLAGE
K973727 12/19/1997 ELECTRODE, ELECTROCARDIOGRAPH DON TAY INDUSTRIES EDWARD ARNDT
K973291 12/19/1997 DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES DYNAMIC TECHNOLOGY CORP. ERIC LUO
K973833 12/30/1997 CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL DYNARAD CORP. RAYMOND MANEZ
K973683 12/24/1997 OMEGA 21 SYSTEM EBI ELECTRO BIOLOGY JON CAPAROTTA
K973682 12/18/1997 BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, ELECTROSCOPE, INC. JANE E JOHNSON
K973540 12/17/1997 ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS ELEKTA ONCOLOGY SYSTEMS, INC. PETER ALTMAN
K973672 12/18/1997 FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K973302 12/02/1997 FOUNDATION POROUS HIP STEM ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K973614 12/18/1997 FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K973685 12/19/1997 REVELATION POROUS HIP STEM ENCORE ORTHOPEDICS, INC. DEBBIE DE LOS SANTOS
K973686 12/22/1997 ENDOCARE CRYOCARE CRYOSURGICAL SYSTEM ENDOCARE, INC. VIN CUTARELLI
K974516 12/22/1997 ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE ENDOLAP, INC. TONY GILSTRAP
K974515 12/22/1997 ENDOLAP RESECTOSCOPE ROLLER ELECTRODE ENDOLAP, INC. TONY GILSTRAP
K973424 12/09/1997 ENFRESH TONGUE BRUSH ENFRESH PRODUCTS LLC. HOWARD M HOLSTEIN, ESG
K973576 12/09/1997 EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM EPULSE TECHNOLOGIES, INC. SANFORD DAMASCO
K973513 12/22/1997 SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER ESPE GMBH & CO. KG. BARBARA WAGNER-SCHUH
K973803 12/16/1997 FLEXVIEW CO2 BLOWER WITH MIST ETHICON ENDO-SURGERY, INC. LORRI CHAVEZ
K973384 12/05/1997 ETHICON NON-STICK BIPOLAR FORCEPS ETHICON, INC. GREGORY JONES
K974322 12/16/1997 ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM EUROPA SCIENTIFIC, LTD. ROBERT F MARTIN
K972365 12/12/1997 COMPACT OR COMP-X EUROTEC, S.R.L. CHRISTIAN BONAZZI
K963659 12/16/1997 EXEL I.V. ADMINISTRATION SET EXEL INTL. ARMAND HAMID
K974007 12/12/1997 SHAH PERMAVENT EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K971528 12/12/1997 ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) FUJINON, INC. GARY A ADLER
K971440 12/02/1997 FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH FUKUDA DENSHI USA, INC. DAVID J GERAGHTY
K970901 12/22/1997 GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEMS DAVID DUERSTELER
K970465 12/18/1997 BOUSER'S URINAL GENERAL POLYMERS MILTON N BENEKE JR.
K973411 12/04/1997 DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) GENERAL SCANNING, INC. WALTER J LESLIE
K972555 12/22/1997 CATHETER TUNNELER GERARD MEDICAL, INC. RICHARD CAYER
K973825 12/19/1997 MIDSTREAM HOME REGNANCY TEST GERMAINE LABORATORIES, INC. MARTIN O'CONNOR
K961289 12/04/1997 VAPOPHENE GERMIPHENE CORP. PETER WILK
K965016 12/02/1997 ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212) GIBECK, INC. BILL BRILEY
K973495 12/01/1997 GLENROE GLOW IN DARK ELASTOMERIC LIGATURES GLENROE JOHN BOZMAN
K972839 12/17/1997 PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET GLOBE ENT., INC. STEPHEN Y JAN
K972843 12/16/1997 PROTOS BLOOD TRANSFUSION SET GLOBE ENT., INC. STEPHEN Y JAN
K972854 12/17/1997 PROTOS I.V. ADMINISTRATION SET (15 DROPS/ML) I4070S/(60 DROPS/ML)I4670S PRELIMINARY GLOBE ENT., INC. STEPHEN Y JAN
K974227 12/12/1997 HOSPITAL'S CLAMP GPS LOUIS PAGLIARA
K974228 12/12/1997 HOSPITAL'S SPEC GPS LOUIS PAGLIARA
K973620 12/17/1997 VACUETTE MULTI-SAMPLE NEEDLE GREINER MEDITECH, INC. DOUGLAS L HARRIS
K973494 12/12/1997 HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG GUIDANT CORP. MARGARET ANDERSON
K973730 12/24/1997 DURASIL I AND DURASIL II HANSON MEDICAL, INC. GERALD HANSON
K973729 12/24/1997 POWERFLEX PEC IMPLANT HANSON MEDICAL, INC. ERIK HANSON
K973871 12/11/1997 LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM) HARTALEGA SDN BHD KUAN KAM HON
K973778 12/11/1997 POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES HARTALEGA SDN BHD KAM H KUAN
K972198 12/17/1997 DENT-TEMP ACRYLIC HEALTH-DENT INTL., INC. JASHAN SETH
K974175 12/16/1997 HEARTPORT ENDOAORTIC CLAMP CATHETER HEARTPORT, INC. MARIANNE C DRENNAN
K973491 12/04/1997 MECHANICAL FOLDING WHEEL CHAIR HEARTWAY MEDICAL PRODUCTS CO., LTD. KENNY HO
K973437 12/03/1997 HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES HEWLETT-PACKARD GMBH EGON PFEIL
K974048 12/23/1997 INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER HOLLISTER, INC. JOSEPH S TOKARZ
K973484 12/02/1997 CHIN DISTRACTOR HOWMEDICA, INC. JOHN DICHIARA
K974054 12/23/1997 DISTAL CENTRALIZER, EXETER II HIP SYSTEM HOWMEDICA, INC. FRANK MAAS
K972228 12/05/1997 MERIDIAN TITANIUM FEMORAL STEMS HOWMEDICA, INC. FRANK MAAS
K973927 12/11/1997 HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL HYUNJAE CORP. DAN MODICA
K972406 12/22/1997 ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM IMMUNO PROBE, INC. WILLIAM L BOTELER
K973510 12/08/1997 DUPLOJECT (0.5/1.0 ML, 2.0 ML, 5.0 ML) IMMUNO-U.S., INC. DAVID WEST
K972457 12/01/1997 MONOCOL/LEX-IM TEST IMMUNOSTICS, INC. DAVID MYCOCK
K972480 12/23/1997 3I BIORESORBABLE FIXATION TACK IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K973771 12/04/1997 DENTAL/SURGICAL DRILLS, BURS, TAPS IMPLANT INNOVATIONS, INC. WILLIAM G CONETY
K972470 12/11/1997 CRIT-LINE MONITOR (CLMIII) IN-LINE DIAGNOSTICS CORP. THOMAS J BOUCHARD
K963969 12/23/1997 INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB INDIGO MEDICAL, INC. SHARON STAROWICZ
K973323 12/01/1997 ACL CLIP-IN INNOVASIVE DEVICES, INC. ERIC BANNON
K973313 12/01/1997 INNOVASIVE DEVICES Y-KNOT SUTURE CLIP INNOVASIVE DEVICES, INC. ERIC BANNON
K973855 12/01/1997 IT HYDROCOLLOID WITH ZINC INNOVATIVE TECHNOLOGIES LTD. PRISCILLA WHITEHEAD COX
K971335 12/01/1997 QUANTA LITE CMV IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K971441 12/02/1997 QUANTA LITE TOXOPLASMA IGG INOVA DIAGNOSTICS, INC. BRYS C MYERS
K973755 12/17/1997 PILOT TUBE REPAIR KIT INSTRUMENTATION INDUSTRIES, INC. EDWARD C HOREY, JR.
K974125 12/17/1997 IL TEST AMYLASE INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K974337 12/17/1997 IL TEST UREA NITROGEN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K973525 12/16/1997 MAURICE WORLDWIDE SHUNT SYSTEM INTEGRA NEUROCARE LLC. LORI L HAYS, MT (ASCP)
K973468 12/08/1997 MODEL IRC 1199 SCOUT NEBULIZER INVACARE CORP. EDWARD A KROLL
K963982 12/05/1997 ACIST ANGIOGRAPHIC INJECTOR INVASATEC DOUG DUCHON
K973580 12/10/1997 INVOTEC CLEAN PAD INVOTEC INTERNATIONAL, INC. JEFFREY L AULL
K971242 12/17/1997 BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) IPAX, INC. PHIL PENNELL
K974197 12/17/1997 ELITE LIGHTWEIGHT WHEELCHAIR JAKEN CO., INC. SAMANTHA LIN
K974131 12/17/1997 ALERT JENERIC/PENTRON, INC. MURRAY C GAMBERG
K973528 12/08/1997 SUNGLASSES JEOU JEOU LONG INDUSTRIAL CO., LTD. C K LIU
K973699 12/16/1997 ULTRALON POWDER FREE LATEX SURGICAL GLOVE JOHNSON & JOHNSON MEDICAL, INC. MAGARET MARSH
K973774 12/29/1997 CODMAN HAKIM MICRO PRECISION VALVE JOHNSON & JOHNSON PROFESSIONALS, INC. JANET G JOHNSON
K971944 12/17/1997 LACTEST I JWT, INC. JAMES B JOHNSTON
K962985 12/19/1997 KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K973304 12/02/1997 MVM 3.3 MM MICROENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K973876 12/19/1997 PROPHYFLEX 2, MODEL 2012 KAVO AMERICA GREGORY W BOWMAN
K973509 12/04/1997 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH JAN L EFFLANDT
K973763 12/31/1997 KENDALL CURITY IODOFORM PACKING STRIP KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH DAVID A OLSON
K973619 12/10/1997 KENDALL CURITY NON-ADHERING DRESSING KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH DAVID A OLSON
K973511 12/16/1997 KENDALL CURITY PETROLATUM GAUZE KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH DAVID A OLSON
K973507 12/15/1997 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH DAVID A OLSON
K973853 12/19/1997 KOLPLAST VAGINAL SPECULUM KOLPLAST COMERCIAL E INDUSTRIAL LTDA E J SMITH
K974089 12/17/1997 ALLOY PRIMER KURARAY AMERICA, INC. KEJI FUJITA
K973415 12/02/1997 CURVILINEAR SUTURE PLACEMENT SYSTEM LAURUS MEDICAL CORP. RICHARD A BASLER
K973951 12/23/1997 LEVO COMPACT-EASY LCE LEVO USA THOMAS RAEBER
K963817 12/23/1997 LEVO MOBIL LCM LEVO USA THOMAS RAEBER
K972473 12/16/1997 ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK LIFESCAN, INC. JOHN E HUGHES
K973631 12/23/1997 LORAD M-III ELITE (M-III E) LORAD CORP. PHILIP G JUHAS
K973470 12/09/1997 COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS LUMENIS, INC. KAREN BAKER
K974254 12/16/1997 BENEFIT B3--- SERIES M.C. HEALTHCARE PRODUCTS, INC. R N THOMPSON
K973657 12/01/1997 ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING MAERSK MEDICAL, LTD. EVAN DICK
K972258 12/29/1997 HI-CARE CLOSED SUCTION SYSTEM MALLINCKRODT MEDICAL MICHAEL B SCHOECK
K972914 12/22/1997 SYVEK PATCH MARINE POLYMER TECHNOLOGIES, INC. SERGIO FINKIELSZTEIN
K973847 12/08/1997 AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS MARTIN DALSING MARTIN J DALSING
K973919 12/16/1997 CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) MEDENTAL INTL. DEBRA GILLASPY
K974164 12/18/1997 SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE MEDICAL DEVICE CONSULTANTS, INC. ROSINA ROBINSON
K972148 12/10/1997 B.U.S. ENDOTRON MEDICAMAT S.A. ANDREW S KRULWICH
K972887 12/11/1997 MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG MEDLINE INDUSTRIES, INC. CHRISTINE GALEA
K972081 12/17/1997 SUPERSKIN MEDLOGIC GLOBAL CORP. JUR STROBOS
K973787 12/30/1997 MEDRAD 1.5T EXTREMITY ARRAY MEDRAD, INC. MARY A GREENAWALT
K973842 12/05/1997 CARBON FIBER CONFORMAL COUCH TOP MEDTEC, INC. DONALD F RIIBE
K973146 12/04/1997 MENTOR SUPER ABSORBENT DRAPE MENTOR OPHTHALMICS, INC. DONNA A CRAWFORD
K973708 12/19/1997 TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL MERIT MEDICAL SYSTEMS, INC. DENNIS REIGLE
K973761 12/24/1997 MICRO-STRIP FOR OPIATE METABOLITES MICRODIAGNOSTICS, INC. ROY CHUNG
K973712 12/12/1997 MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT MINXRAY, INC. KEITH R KRETCHMER
K973340 12/03/1997 TWEEZER-TYPE EPILATOR MOBIT, INC. JAMES R MARSHALL
K974414 12/08/1997 MULTI MORNING CALM CORP. ALEXANDER B KIM
K971663 12/30/1997 WELLCOLEX E.COLI O157:H7 MUREX BIOTECH LTD. REBECCA VINE
K965158 12/09/1997 HEART PROTECTOR (VER 1996) N.P.N.T., INC. KEN NUSBAUM
K973621 12/17/1997 PRE-VIEW CHOLANGIOGRAPHY CLAMP NASHVILLE SURGICAL INSTRUMENTS S.S. KUMAR
K974047 12/05/1997 ACCUWELL PHENYLALANINE ASSAY NEOMETRICS, INC. DAVID SCHWARTZ
K964622 12/01/1997 MEDI-DX 7000 NEURO-DIAGNOSTIC ASSOC. JAMES HEDGECOCK
K973764 12/31/1997 TEMPERATURE DIAGNOSTIC ACCESSORY NEW STAR LASERS, INC. DAVE HENNINGS
K971582 12/22/1997 NIPRO CORELESS NEEDLE/CORELESS NEEDLE SET NIPRO MEDICAL CORP. KAELYN B HADLEY
K952267 12/02/1997 CRITERION, CRITERION I.V., MODIFIED NOVA-VENTRX BERNARD R PALUCH
K971243 12/02/1997 OHMEDA INFANT RESUSCITATION SYSTEM OHMEDA MEDICAL ALBERTO F PROFUMO
K973959 12/22/1997 OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE OLICON IMAGING SYSTEMS, INC. HERMAN OOSTERWIJCK
K973793 12/17/1997 OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE OLICON IMAGING SYSTEMS, INC. HERMAN OOSTERWIJCK
K973325 12/02/1997 BACT/ALERT FAN CULTURE BOTTLES ORGANON TEKNIKA CORP. REBECCA A RIVAS
K972698 12/16/1997 TOF-WATCH ORGANON TEKNIKA CORP. REBECCA A RIVAS
K974158 12/09/1997 ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY ORTHO DEVELOPMENT CORP. CAROL FRASIER
K973944 12/19/1997 ORTHOFIX FEMORAL NAILING SYTEM ORTHOFIX SRL ROBERT L SHERIDAN
K973438 12/09/1997 OSTEO BOS SYSTEM PRODUCT LINE EXTENSION OSTEONICS CORP. KATE SUTTON
K973406 12/08/1997 OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT OSTEONICS CORP. DONNA S WILSON
K973463 12/02/1997 OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE OTECH, INC. HERMAN OOSTERWIJCK
K973479 12/01/1997 CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K971637 12/23/1997 COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC OXOID, LTD. ANDY HOLLINGSWORTH
K973315 12/02/1997 THERAPAX DXT 300 MODEL HF-300 PANTAK, INC. GREG MOREAU
K973976 12/04/1997 EPIC-FLO PARKELL, INC. NELSON J GENDUSA
K973693 12/18/1997 AQUA PATCH PCI TECHNOLOGY ROGER LIEBELT
K972192 12/17/1997 PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM PERCEPTION, INC. SUSAN D GOLDSTEIN-FALK
K972915 12/19/1997 ERBIUM 2000 LASER FAMILY PHANTOM TECHNOLOGIES, INC. JAMES A NATIONS
K974016 12/19/1997 CERCLAGE CABLE WITH HEX BUTTON PIONEER SURGICAL TECHNOLOGY BURNS O SEVERSON
K971118 12/16/1997 ARAGO PREMIER LASER SYSTEMS, INC. LISA MOJICA
K974181 12/11/1997 ACCUSIGN DOA 2, ACCUSIGN DOA, ACCUSIGN BAR/BZO, BIOSIGN DOA 2, BIOSIGN BAR/BZO, FIRST CHECK PANEL 2 BAR/BZO, STATUS DS B PRINCETON BIOMEDITECH CORP. JEMO KANG
K974425 12/24/1997 BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST PRINCETON BIOMEDITECH CORP. JEMO KANG
K971900 12/18/1997 LATERAL FLARE INTERNAL COLLAR (LFIC) PRO-LFIC LLC. IRVING WIESEN
K972150 12/10/1997 OSMOCYTE ISLAND WOUND DRESSING PROCYTE CORP. PAUL KETTERIDGE
K972329 12/10/1997 OSMOCYTE RA WOUND DRESSING PROCYTE CORP. PAUL KETTERIDGE
K970773 12/04/1997 POWDER-FREE EXAM GLOVES PT. SARANA INDOPROTEX MD YUSOF BIN IBRAHIM
K974014 12/17/1997 PULPDENT DENTASTIC UNO PULPDENT CORP. KENNETH J BERK
K973913 12/18/1997 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE PWA INDUSTRIES SDN. BHD. AZMAN ISMAIL
K973610 12/19/1997 SKYVAL PYRAMID AIR SYSTEMS MARK MCKEE
K972230 12/02/1997 QUICKIE P90 SERIES QUICKIE DESIGNS, INC. REBECCA ANDERSEN
K973841 12/01/1997 QUICKVUE ONE-STEP HCG-COMBO QUIDEL CORP. ROBING WEINER
K974052 12/19/1997 QUICKVUE SEMI-Q HCG-COMBO QUIDEL CORP. ROBIN WEINER
K971570 12/29/1997 EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 QUINTON ELECTROPHYSIOLOGY CORP. MATTHEW HEDLUND
K973995 12/08/1997 RANDOX BILIRUBIN RANDOX LABORATORIES, LTD. P ARMSTRONG
K973988 12/22/1997 RDI HOMOGENEOUS HDL CHOLESTEROL TEST REFERENCE DIAGNOSTICS, INC. JOSEPH LAWLOR
K974257 12/12/1997 RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) RESOUND CORP. KRISTA M BUCKLES
K974081 12/12/1997 RESOUND STEALTH CIC RESOUND CORP. KRISTA M BUCKLES
K972649 12/04/1997 CARDIOCALL CARDIAC EVENT RECORDER REYNOLDS MEDICAL LTD. GEORGE MYERS
K973648 12/17/1997 MINI FORCEPS WITH HF, 3.5MM; MICRO FORCEPS WITH HF, 2MM RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K973737 12/12/1997 MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K964663 12/11/1997 FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX RMDS, INC. DELBERT L RICE
K973284 12/18/1997 COBAS INTEGRA HDL-CHOLESTEROL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC. MARIA FEIJOO
K974129 12/12/1997 HI-69E, HI-69N, HI-69P ROCKWIN CORP. KEITH TAYLOR
K972372 12/11/1997 GERM TRAPPER SUCTION TUBE HOLDER RZV MEDICAL SPECIALTIES, INC. LINDA K RUVO
K974154 12/19/1997 CHOICE ACCU-TEST PREGNANCY TEST KIT SA SCIENTIFIC, INC. HARBI SHADFAN
K974021 12/19/1997 SIGNAL PREGNANCY TEST KIT SA SCIENTIFIC, INC. HARBI SHADFAN
K974306 12/23/1997 SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA SANGUI BIOTECH, INC. JOHN J KIANG
K974262 12/24/1997 SYSCOS IDC - G, IDC, BSC, IDC - G SCANTIBODIES LABORATORY, INC. RICHARD LENART
K971735 12/02/1997 ACCUDEXA BONE DENSITOMETER SCHICK TECHNOLOGIES, INC. T. WHIT ATHEY
K973603 12/19/1997 SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM SCHWARTZ ELECTRO-OPTICS, INC. TIMOTHY J SHEA
K971362 12/04/1997 PERSONAL INFUSOR SCIENCE INCORPORATED RALPH E HOGANCAMP
K973749 12/08/1997 FRAG COMMANDER SCIERAN TECHNOLOGIES, INC. ROD ROSS
K974551 12/22/1997 SEALITE SCIENCES, INC. AQUALITE FREE T, ASSAY SEALITE SCIENCES, INC. CATHRYN N CAMBRIA
K973742 12/03/1997 SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM SENDX MEDICAL, INC. RUBEN CHAIREZ
K970795 12/18/1997 SHANG HO SHANG HO INDUSTRIAL CORP. LTD. CHENG KO LIN
K974120 12/17/1997 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANGHAI SUPER GLOVES CO., LTD. SUSAN D GOLDSTEIN-FALK
K974151 12/18/1997 VINYL PATIENT EXAMINATION GLOVES (POWDERED) SHANGHAI SUPER GLOVES CO., LTD. SUSAN D GOLDSTEIN-FALK
K973354 12/04/1997 SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) SHARPLAN LASERS, INC. GEORGE J HATTUB
K971360 12/22/1997 SYNTEX SHINEMOUND ENTERPRISE, INC. HUAN-CHUNG LI
K973630 12/05/1997 CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K971681 12/04/1997 SMC FEMORAL HIP COMPONENT SIGNAL MEDICAL CORP. LOUIS A SERAFIN
K974013 12/17/1997 EXTENSION SET WITH MICROBORE TUBING, EXTENSION SET WITH MICROBORE TUBING AND 0.2 U FILTER, EXTENSION SET WITH MICROBORE SIMS DELTEC, INC. EDWARD W NUMAINVILLE
K973862 12/29/1997 PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS SIMS DELTEC, INC. LISA STONE
K973965 12/12/1997 SMART MOTORIZED VIEWER SMARTLIGHT, LTD. DAN BEN-ZEEV
K972979 12/11/1997 SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM SMITH & NEPHEW, INC. DEBORAH J CONNORS
K971818 12/18/1997 SNOREX SNOREX (NZ) LTD. VERNON PRIBBLE
K973618 12/19/1997 SOMNOPLASTY SYSTEM SOMNUS MEDICAL TECHNOLOGIES, INC. EVE CONNER
K973798 12/03/1997 S-357 VIDEO IMAGING SYSTEM SOPRO PIERRE MONTILLOT
K973677 12/15/1997 DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH SORRENTO BIOCHEMICAL, INC. ZAK HASSANEIN
K973676 12/16/1997 PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH SORRENTO BIOCHEMICAL, INC. ZAK HASSANEIN
K973678 12/15/1997 ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH SORRENTO BIOCHEMICAL, INC. ZAK HASSANEIN
K973089 12/08/1997 FREEDOM SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K973092 12/08/1997 STAE SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K973091 12/08/1997 WAVE SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K965008 12/16/1997 BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM SPACELABS MEDICAL, INC. ANTHONY CALDERONI
K973611 12/02/1997 SPECTRASCIENCE REUSABLE BIOPSY FORCEPS SPECTRASCIENCE, INC. JOHN G YAGER
K974020 12/19/1997 SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM SPINAL CONCEPTS, INC. TEENA M AUGOSTINO
K974184 12/18/1997 HIGH RISK POLYMER LATEX EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K973904 12/17/1997 POLYMER LATEX EXAMINATION GLOVES SRI JOHANI SDN. BHD. LIM LEE AIK
K974185 12/18/1997 POLYMER NITRILE EXAMINATION GLOVES SRI JOHANI SDN. BHD. LIM LEE AIK
K974183 12/18/1997 POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K974182 12/17/1997 POWDERED NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K973903 12/17/1997 POWDERFREE NITRILE EXAMINATION GLOVES (BLUE COLOUR) SRI JOHANI SDN. BHD. LIM LEE AIK
K973324 12/03/1997 STARLIGHT PULSED DIODE ARRAY LASER SYSTEM STAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K973423 12/05/1997 STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT STERI-OSS, INC. JEFF HAUSHEER
K973433 12/05/1997 STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT STERI-OSS, INC. JEFF HAUSHEER
K973206 12/04/1997 STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY STERLING DIAGNOSTIC IMAGING, INC. ELAINE H KINDELL
K974423 12/22/1997 ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL STERLING DIAGNOSTIC IMAGING, INC. JEAN E BARLETT
K973353 12/02/1997 BONDING BASE STRAUMANN USA LINDA JALBERT
K970714 12/16/1997 STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) STRYKER INSTRUMENTS TAMMY LOUNDS
K973681 12/19/1997 NATURAL-HIP COCR OFFSET STEM SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K973675 12/19/1997 NATURAL-HIP POROUS STEM WITH OFFSET SULZER ORTHOPEDICS, INC. MITCHELL A DHORITY
K973412 12/08/1997 NATURAL-KNEE II CONSTRAINED KNEE SYSTEM SULZER ORTHOPEDICS, INC. LORI KLEINSCHRODT HOLDER
K973942 12/12/1997 SWIFT DELIVERY PRODUCT #300 SWIFT DELIVERY PRODUCTS RICHARD G LINDSAY
K973710 12/18/1997 DIGITAL ADD ON MULTI SYSTEM SWISSRAY INTERNATIONAL, INC. MORTEZA MINAEE
K973439 12/08/1997 ENDO ANALYZER, MODEL 8005 SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K974179 12/01/1997 NON-PRESCRIPTION SUNGLASSES TAIPAN OPTICAL COMPANY LTD. HENRY HSU
K972496 12/09/1997 PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER TAO & TAO TECHNOLOGYT, INC. PAULINE TAO
K972112 12/01/1997 INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 TAUT, INC. GLENN MILLER
K970163 12/10/1997 ALPHA MX (20)/ULTRA PC (30) TECHNICAL MEDICAL PRODUCTS, INC. JIM R MOORE
K973385 12/05/1997 OVAL SHAPES TECHNICAL PRODUCTS, INC. NORBERT D THOMPSON
K974068 12/22/1997 PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL TECNOL MEDICAL PRODUCTS, INC. RUTH JONES
K974300 12/19/1997 TELEMED SYSTEMS RETRIEVAL BASKET TELEMED SYSTEMS, INC. SAMUEL D WADE
K970708 12/19/1997 CLIRANS T-SERIES HOLLOW FIBER DIALYZERS TERUMO MEDICAL CORP. KEITH M SMITH
K974171 12/19/1997 COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS TEVA MEDICAL, LTD. HARRY LEINWAND
K973537 12/17/1997 PATHWAY ELECTROMYOGRAPH THE PROMETHEUS GROUP PETER A SULLIVAN
K974036 12/22/1997 PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE THE PROMETHEUS GROUP RICHARD HORTON
K973882 12/05/1997 EL-B2GP1SCR THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K972790 12/05/1997 THE THERATEST "EL-B2GP1 (IGM, IGG, IGA)" AND "EL-B2GP1SCR" THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K973453 12/09/1997 TORNIER CEMENT RESTRICTOR TORNIER DAVID W SCHLERF
K973908 12/22/1997 AUKLET CT SCANNER, TSX-003A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K974286 12/12/1997 CIRCUMCISION TRAY, CAT. NO. 70340 TRINITY LABORATORIES, INC. PARTHA BASUMALLIK
K963391 12/12/1997 SPECULITE TRYLON CORP. A. THOMAS DOYLE
K974454 12/18/1997 CLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004 TUCSON MEDICAL CORP. JIM PATKO
K973083 12/09/1997 ULTRACELL NEURO SPONGES ULTRACELL MEDICAL TECHNOLOGIES, INC. GEORGE P KORTEWEG
K972633 12/17/1997 ULTRACELL SUCTION SPONGE ULTRACELL MEDICAL TECHNOLOGIES, INC. GEORGE P KORTEWEG
K972634 12/17/1997 ULTRACELL SUCTION SPONGE ULTRACELL MEDICAL TECHNOLOGIES, INC. GEORGE P KORTEWEG
K973496 12/01/1997 THE AUTO SUTURE* MIBB** SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR CLAVELLI
K974338 12/12/1997 UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) UNITRON INDUSTRIES, INC. SUSAN ARCHER
K974339 12/12/1997 UNITRON MODEL SOUND F/XD PROGRAMMABLE UNITRON INDUSTRIES, INC. SUSAN ARCHER
K974340 12/12/1997 UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE UNITRON INDUSTRIES, INC. SUSAN ARCHER
K971790 12/17/1997 KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) UROMETRICS, INC. PHILLIP A MESSINA
K973554 12/19/1997 VALLEY FORGE BIPOLAR BALL TIP ELECTRODE VALLEY FORGE SCIENTIFIC CORP. JERRY L MALIS
K973659 12/17/1997 VASOCOR PVR 100 VASOCOR, INC. JEFFERY RAINES
K974290 12/19/1997 MICROPROTEIN STANDARD KIT VERICHEM LABORATORIES, INC. ANTHONY J DIMONTE
K973436 12/09/1997 VISTA HEAD MOUNTED DISPLAY VISTA MEDICAL TECHNOLOGIES, INC. MARTIN NEWMAN
K973594 12/17/1997 GORE RESOLUT XT REGENERATIVE MATERIAL W.L. GORE & ASSOCIATES,INC JOHN W NICHOLSON
K973432 12/09/1997 SURGIFLATOR-30 W.O.M. WORLD OF MEDICINE, GMBH ROBERT P REZNICK
K973773 12/17/1997 DAPELLE HAIR REMOVER WELLQUEST INTL., INC. STEVEN MISHAN
K971580 12/09/1997 UAS ULTRASONIC ASPIRATOR SYSTEM WELLS JOHNSON CO. BRENDA HUNT
K973370 12/02/1997 AQUAPLAST PALATAL STENT WFR/AQUAPLAST CORP. JOHN R KIRK
K972280 12/11/1997 GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES WILSON GREATBATCH TECHNOLOGIES, INC. GARY J SFEIR
K973538 12/16/1997 N-TERFACE WINFIELD LABORATORIES, INC. GARY W CUMMINGS
K973524 12/12/1997 ADVANCE MODULAR TIBIAL COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC. KIM TOMPKINS
K974240 12/22/1997 LIGHTLINE-M WUESTEC MEDICAL, INC. KRISTI WHITE
K974159 12/24/1997 OSOM HCG-URINE TEST MODEL 101 WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K973744 12/29/1997 UNICATH SP BI-PLANE (MODEL M269 & M289) XRE CORP. WAYNE V LOOMER
K974191 12/24/1997 EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE YTY INDUSTRY (MANJUNG) SDN. BHD. MOH UNG NANG
K974518 12/12/1997 NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED YTY INDUSTRY (MANJUNG) SDN. BHD. LEONARD FRIER
K973714 12/24/1997 VERSYS HIP SYSTEM BEADED HIP PROSTHESIS ZIMMER, INC. KAREN CAIN


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