FDA 510(k) Decisions During February, 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
K970168 02/27/1997 3M QUIKPLUS SYSTEM 3M COMPANY ANY FOWLER
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
K965116 02/20/1997 ABBOTT TESTPACK PLUS HCG COMBO WITH OBC ABBOTT LABORATORIES KAREN L GATES
K961552 02/10/1997 CVP POLYURETHANE CATHETER ABBOTT LABORATORIES DAVID GUZEK
K963351 02/26/1997 LIFESHIELD BLUNT CANNULA ABBOTT LABORATORIES JILL N SACKETT
K972925 12/05/1997 ACCESS RADIOLOGY (FRAMEWAVE) TELERADIOLOGY IMAGE ACQUISITION AND DISTRIBUTION SYSTEM WITH PICTURE AND ARCHIVING COMMUNIC ACCESS RADIOLOGY CORP. ALLAN M GREEN
K953978 02/19/1997 ANTERIOR DYNAMIZED SYSTEM ACROMED CORP. GREGORY CANNEDY
K965029 02/19/1997 STABLELOC II EXTERNAL FIXATOR ACUMED, INC. SHARI L JEFFERS
K973767 12/23/1997 HARMONIC IMAGING WITH CONTRAST ACUSON CORP. WILLIAM WELCH
K964697 02/11/1997 AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION ADVANCE MEDICAL DEVICE, INC. BRIAN W PETERSEN
K965036 02/20/1997 THE ADVANCED OSMOMETER (3900) ADVANCED INSTRUMENTS, INC. DOUGLAS GUERETTE
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
K960309 02/28/1997 AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION) AIRSEP CORP. EDWARD E VRANA
K964840 02/11/1997 BEAM BLOCK TRAYS AKTINA MEDICAL PHYSICS CORP. JOAN ZACHAROPOULOS
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
K964783 02/12/1997 EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT ALEXANDER MEDICAL, INC. KENNETH A PALMER
K964864 02/04/1997 PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY ALEXON BIOMEDICAL, INC. SUSAN TURNER, PH.D.
K973703 12/04/1997 JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN ALLEGIANCE HEALTHCARE CORP. JOSEPH A MERTIS
K970225 02/14/1997 ALPHA MICRON 20/40 MICROAGGREGATE FILTER ALPHA THERAPEUTIC CORP. M. SUE PRESTON
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
K964656 02/10/1997 TEFGEN GUIDED TISSUE MEMBRANE AMERICAN CUSTOM MEDICAL, INC. BRUCE G RUEFER
K963808 02/12/1997 CHOICE POWERED WHEELCHAIR AMERICAN MEDICAL TECHNOLOGY, INC. J.R. MCLAUGHLIN
K964358 02/14/1997 AMSEAL SURGICAL FACE MASK AMERICAN SEAL CO. LISA CHEN
K963678 02/24/1997 CARETONE II AMERICAN TELECARE, INC. GERARD J PRUD'HOMME, ESQ.
K973873 12/29/1997 DIGITAL PERSONAL TELEMEDICINE MODULE, DIGITAL PTM 1 AMERICAN TELECARE, INC. GERARD J PRUD'HOMME
K964614 02/06/1997 ULTRAFERA WOUND DRESSING AMERICAN WHITE CROSS, INC. PAUL B CALLAHAN
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
K964037 02/20/1997 FLEXIBLE CYSTOSCOPE APPLIED FIBEROPTICS, INC. GRAHAM BAILLIE
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
K965216 02/27/1997 ARGI-SATIN OR OPTI0-STAR ARGEN PRECIOUS METALS, INC. PAUL J CASCONE
K964629 02/10/1997 VINYL PATIENT EXAMINATION GLOVES ARISTA MEDI PRIMA HADY SUYANTHO
K962558 02/24/1997 CHLAMYDIA IGG ELISA TEST SYSTEM ARMKEL, LLC. WILLIAM L BOTELER
K963645 02/04/1997 HERPES GROUP IGG ELISA TEST SYSTEM ARMKEL, LLC. WILLIAM L BOTELER, JR.
K963104 02/04/1997 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM ARROW INTL., INC. THOMAS D NICKEL
K970277 12/11/1997 URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) ASTORIA-PACIFIC,INC. RAYMOND L PAVITT
K961073 02/19/1997 ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) ATLANTIS DIAGNOSTICS INTL., INC. TERRENCE J SWEENEY
K972946 12/19/1997 AURELUX 77 AUREX PRECIOUS METAL INDUSTRIES (PTY)LTD J.D. DAVIS
K970057 02/26/1997 AHS OMEGA SP AUTHORIZED HEARING SYSTEMS, INC. HENRY SMITH
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
K962084 02/10/1997 OMNICAN SYRINGE B. BRAUN MEDICAL AG MARK S ALSBERGE
K971086 12/19/1997 RADIAL AND FEMORAL ARTERY CATHETER B. BRAUN MEDICAL, INC. MARK S ALSBERGE
K964369 02/11/1997 TRACH CARE SET WITH MICROBAN BALLARD MEDICAL PRODUCTS E. MARTIN CHAMBERLAIN, JR.
K970110 02/19/1997 BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019) BARD MEDICAL DIV. DONNA J WILSON
K964850 02/25/1997 SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER BAXTER HEALTHCARE CORP. MARY E SNYDER
K964630 02/10/1997 GLUCOMETER ELITE BLOOD GLUCOSE METER BAYER CORP. ROSANNE M SAVOL
K964004 02/10/1997 GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS BAYER CORP. ROSANNE M SAVOL, R.A.C.
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
K961968 02/04/1997 BBLCRYSTAL GRAM-POSITIVE ID SYSTEM BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC VIRGINIA C WEINKNECHT
K965202 02/10/1997 VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC EILEEN SCHWEIGHARDT
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
K964010 02/10/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT BECKMAN INSTRUMENTS, INC. MARGIE GEORGE
K964009 02/11/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K963868 02/10/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K964260 02/10/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG BECKMAN INSTRUMENTS, INC. ANNETTE HELLIE
K963673 02/04/1997 IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS 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
K965159 02/04/1997 CETIBUTEN, 30MCG, SENSI-DISC BECTON DICKINSON MICROBIOLOGY SYSTEMS ROBERT E JAMES
K961730 02/04/1997 RAPID GRAM-POSITIVE ID SYSTEM BECTON DICKINSON MICROBIOLOGY SYSTEMS VIRGINIA C WEINKNECHT
K971339 12/24/1997 INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS BECTON DICKINSON VASCULAR ACCESS, INC. C.J. WELLE
K964863 02/28/1997 MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN BELL INTL., INC. DEWEY BELL
K964858 02/11/1997 BEMIS TWO GALLON CHEMOTHERAPY CONTAINER BEMIS MFG. CO. JOHN B HOWELL
K965248 02/14/1997 BEMIS TWO GALLON SHARPS CONTAINER BEMIS MFG. CO. JOHN B HOWELL
K962666 02/27/1997 BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN BEMISS-JASON CORP., TRIAD MEDICAL DIV. SANDRA MCGEE
K964736 02/27/1997 BERGEN 610 BIPOLAR COAGULATOR BERGEN MFG. ROGER OOSTEN
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
K964963 02/20/1997 LYPHOCHEK COAGULATION CONTROL BIO-RAD ELIZABETH PLATT
K960850 02/04/1997 ACCESS CHLAMYDIA ASSAY BIO-RAD LABORATORIES, INC. CAROLE STAMP
K970126 02/25/1997 ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) BIO-RAD LABORATORIES, INC. SANDRA F SCHWARTZ, PH.D.
K973609 12/18/1997 IDA-4 AND IPT-MC BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K961862 02/26/1997 MODELS IDA-2 PLUS AND IPT-1 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
K962717 02/12/1997 6 FRENCH, 7 FRENCH, AND 8 FRENCH GUIDING CATHETERS WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING BIOCOMPATIBLES CARDIOVASCULAR, INC. NANCY F TEAGUE
K973429 12/01/1997 BIODERM FOAM WOUND DRESSING BIODERM, INC. GEORGE WORTHLEY
K964561 02/11/1997 ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA BIOENTERICS CORP. KEITH LOWREY
K972064 12/01/1997 MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV BIOLOGICAL CONTROLS, INC. GARY D MESSINA
K964472 02/03/1997 RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT BIOLOGICALLY ORIENTED PROSTHESES VALERIE GARDNER
K973644 12/23/1997 FLOSTAT VASCULAR LAB BIOMEDIX, INC. DAVID LERNER
K973857 12/29/1997 FLOSTAT VASCULAR REPORT GENERATOR (VRG) BIOMEDIX, INC. DAVID LERNER
K960363 02/18/1997 BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 BIOMET, INC. PATRICIA S BERES
K971824 12/04/1997 REACH FEMORAL HIP COMPONENT BIOMET, INC. DEBORAH M MATARAZZO
K970008 02/18/1997 ADVANCED QUALITY PREGNANCY TEST BIONIKE, INC. JANIS FREESTONE
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
K963662 02/26/1997 GALILEO EVOKED POTENTIALRE BIOSOUND, INC. WAYNE NETHERCUTT
K964931 02/10/1997 WHITE CORE BISCO, INC. JAMES L SANDRIK
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
K964372 02/10/1997 CARDIAC T TROPONIN T RAPID ASSAY BOEHRINGER MANNHEIM CORP. JOHN D STEVENS
K970148 02/10/1997 ELECSYS CALCHECK ESTRADIOL BOEHRINGER MANNHEIM CORP. Yvette Lloyd
K974384 12/08/1997 ELECSYS CALCHECK FOLATE BOEHRINGER MANNHEIM CORP. Patricia M Klimley
K970147 02/10/1997 ELECSYS CALCHECK PROLACTIN BOEHRINGER MANNHEIM CORP. Yvette Lloyd
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
K965109 02/18/1997 ELECSYS ESTRADIOL ASSAY BOEHRINGER MANNHEIM CORP. Yvette Lloyd
K964532 02/03/1997 MULTITAK SS SUTURE SYSTEM BONUTTI RESEARCH LYNNETTE WHITAKER
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
K964079 02/13/1997 SPEEDBAND MULTIPLE BAND LIGATOR BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K973826 12/05/1997 SPHINCTEROTOME BOSTON SCIENTIFIC CORP. DANIEL J DILLON
K973818 12/16/1997 T-REX BIOPSY FORCEPS BOSTON SCIENTIFIC CORP. JOCELYN KERSTEN
K970054 02/10/1997 TANDEMRX BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
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
K964780 02/26/1997 BARD DIRECTOR GUIDEWIRE (000560) C.R. BARD, INC. BETH A ROCHETTE, R.A.C.
K962576 02/10/1997 SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM CALCITEK, INC. DONNA K HOWARD
K963326 02/12/1997 BREATHE FIT CAMBRIDGE ASSOC. FRAN WHITE
K972767 12/04/1997 CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER CANDELA CORP. JAY CAPLAN
K970248 02/11/1997 CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM CANYON DIAGNOSTICS, INC. ANTHONY FALKOWSKI
K964665 02/19/1997 VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) CARBOMEDICS, INC. TEENA M AUGOSTINO
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
K964735 02/05/1997 DENTINSENSE CENTRIX, INC. JOHN DISCKO
K965138 02/14/1997 DENTINSENSE B/C CENTRIX, INC. JOHN DISCKO
K964497 02/06/1997 CERALAS DIODE LASER SYSTEM (CERALAS D15) CERAMOPTEC, INC. JONATHAN S KAHAN
K964751 02/21/1997 CERALAS DIODE LASER SYSTEM (CERALAS D2) CERAMOPTEC, INC. JONATHAN S KAHAN
K965099 02/20/1997 ACCUMETER H. PYLORI TEST CHEMTRAK, INC. RODGER J RICHEAL
K964765 02/14/1997 CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY CHIRON DIAGNOSTICS CORP. William J Pignato
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
K963544 02/20/1997 SUPREME II METER CHRONIMED, INC. JEFFREY P HEATON
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
K954003 02/06/1997 COBE HEMODYNAMIC RECIRCULATION MONITOR COBE RENAL CARE, INC. MATTHEW M HULL
K946279 02/10/1997 PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) COBE RENAL CARE, INC. MATTHEW M HULL
K964975 02/24/1997 COHORT DISCECTOMY SYSTEMS (CDS) COHORT MEDICAL PRODUCTS GROUP, INC. RONALD C ALLEN
K972699 12/19/1997 AESOP 3000 SYSTEM AND ACCESSORIES COMPUTER MOTION, INC. DOUGLAS P BUESCHEL
K964994 02/21/1997 CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR CONTEMPORARY PRODUCTS, INC. BARRY A SCHWARTZ
K964827 02/14/1997 PROD. NO. 01-132 - SUTURE REMOVAL KIT CONTINENTAL MEDICAL LABORATORIES, INC. JOSEPH DUNN
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
K962765 02/21/1997 CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) CORDIS CORP. Lisa Wells
K963000 02/20/1997 MAXI LD PTA BALLOON CATHETER CORDIS CORP. TAMARA YOUNT
K973595 12/19/1997 THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM CORIN U.S.A. CRAIG CORRANCE
K964812 02/10/1997 NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER AND I.V. SET CRITICAL DEVICE CORP. DAN HYUN
K962874 02/25/1997 RESPIFLO/S CURTIN & ASSOCIATES INTERNATIONAL , INC. WILLIAM D CURTIN
K971920 12/04/1997 GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) CUSTOMED, INC. GLADYNELL RODRIQUEZ
K970396 02/20/1997 HUMAN CHORIONIC GONADOTROPIN CALIBRATOR DADE CHEMISTRY SYSTEMS, INC. REBECCA S AYASH
K970343 02/14/1997 MMB METHOD DADE CHEMISTRY SYSTEMS, INC. CATHY P CRAFT
K970389 02/18/1997 THYROID CALIBRATOR DADE CHEMISTRY SYSTEMS, INC. CATHY P CRAFT
K965213 02/10/1997 STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY DADE INTL., INC. RADHA GOOLABSINGH
K964139 02/06/1997 SYSMEX CA-6000 DADE INTL., INC. RADAMES RIESGO
K964862 02/10/1997 TROPONIN-I TEST SYSTEM DADE INTL., INC. RADHA GOOLABSINGH
K965249 02/21/1997 SPYGLASS ANGIOGRAPHIC CATHETER DAIG CORP. JOHN C HEINMILLER
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
K953175 02/06/1997 AS/3 ESTPR MODULE DATEX DIVISION INSTRUMENTARIUM CORP. VINCENT RAUSHER
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
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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
K964628 02/10/1997 NITRILE POWDER-FREE EXAMINATION GLOVES SHEN WEI (USA), INC. BELLE L CHOU
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
K964747 02/10/1997 SOMATOM PLUS 4 CT SCANNER 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
K963729 02/13/1997 SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD) SKYLARK DEVICE CO., LTD. GEORGE CHEN
K973965 12/12/1997 SMART MOTORIZED VIEWER SMARTLIGHT, LTD. DAN BEN-ZEEV
K964935 02/25/1997 SUTURE LOCK SMITH & NEPHEW ENDOSCOPY, INC. SUSAN A FINNERAN
K965073 02/27/1997 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW SMITH & NEPHEW, INC. DAN W MILLER
K972979 12/11/1997 SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM SMITH & NEPHEW, INC. DEBORAH J CONNORS
K970351 02/28/1997 GLOBAL TAPER SPECTRON HIP STEMS SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. THOMAS L CRAIG
K970337 02/28/1997 HA GLOBAL TAPER (GT) TAPERED HIP STEM SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. THOMAS L CRAIG
K971818 12/18/1997 SNOREX SNOREX (NZ) LTD. VERNON PRIBBLE
K964623 02/06/1997 TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHAME, PH.D.
K962708 02/06/1997 TITANIUM CD HORIZON SPINAL SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K953076 02/28/1997 TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM SOFAMOR DANEK USA,INC. RICHARD W TREHARNE
K973618 12/19/1997 SOMNOPLASTY SYSTEM SOMNUS MEDICAL TECHNOLOGIES, INC. EVE CONNER
K964658 02/14/1997 OASIS SONOTECH, INC. MARGARET J LARSON
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
K965168 02/04/1997 STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002) SPECIALIZED ASSAYS, INC. RICHARD A KAUFMAN
K965169 02/06/1997 STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003) SPECIALIZED ASSAYS, INC. RICHARD A KAUFMAN
K965166 02/04/1997 STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001) SPECIALIZED ASSAYS, INC. RICHARD A KAUFMAN
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
K970040 02/28/1997 SPINE-TECH BONE HARVESTER SPINE-TECH, INC. DAVID A CANNISTRACI
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
K961246 02/14/1997 SJM SEGUIN ANNULOPLASTY RING MODEL SAR-M ST. JUDE MEDICAL, INC. JONAS RUNQUIST
K973324 12/03/1997 STARLIGHT PULSED DIODE ARRAY LASER SYSTEM STAR MEDICAL TECHNOLOGIES, INC. Marcy Moore
K964245 02/04/1997 PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS STARKEY LABORATORIES, INC. SHARI L SWIDEN
K964944 02/10/1997 ROUND DENTAL BUR STERI-OSS, INC. JEFF AHUSHEER, PH.D.
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
K963945 02/11/1997 STERI-OSS GOLD ATTACHMENT SYSTEM STERI-OSS, INC. DON KENNARD
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
K965006 02/05/1997 AT 62 EEG (A.K.A THE A;PHA-THETA TRAINER) STOELTING CO. JOHN ZIOBRO
K964743 02/03/1997 STORZ E8010 ERGOTEC/PREMIERE ADAPTOR STORZ INSTRUMENT CO. PATRICK G BALSMANN
K973353 12/02/1997 BONDING BASE STRAUMANN USA LINDA JALBERT
K964930 02/28/1997 STRYKER SAPHENOUS VEIN HARVEST SCOPE Stryker Endoscopy BOB DAHLA
K970714 12/16/1997 STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) STRYKER INSTRUMENTS TAMMY LOUNDS
K964768 02/25/1997 THREADLOC DENTAL IMPLANT SYSTEMS SULZER CALCITEK, INC. JOSEPH S SHAN
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
K964964 02/07/1997 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SUNMAX ENTERPRISE SHANGHAI CO. LTD. SUSAN D GOLDSTEIN-FALK
K964696 02/20/1997 SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS SUNSOFT CORP. JAMES B WILLIAMS
K962737 02/07/1997 AMBIDERM (COLOR POW LATEX EXAM GLOVES W/ PROTEIN) SUPERTEX INDUSTRIAL, S.A. DE C.V. JAMES F LOGAN
K963866 02/10/1997 AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN) SUPERTEX INDUSTRIAL, S.A. DE C.V. JAMES F LOGAN
K964181 02/26/1997 SPONGETRAC SURGITRAC CORP. JONATHAN S KAHAN
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
K964981 02/10/1997 TEMPFIL C&B SYBRON DENTAL SPECIALTIES, INC. WILLIAM R PIKE
K963045 02/13/1997 SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM SYNTHES (USA) DIANE T BROWN
K963654 02/28/1997 QUIKSTRIP ONESTEP MARIJUANA (THC) TEST SYNTRON BIORESEARCH, INC. CLEVE W LAIRD
K974179 12/01/1997 NON-PRESCRIPTION SUNGLASSES TAIPAN OPTICAL COMPANY LTD. HENRY HSU
K964137 02/03/1997 RTA RETINAL THICKNESS ANALYZER TALIA TECHNOLOGY LTD. JONATHAN S KAHAN
K972496 12/09/1997 PENCIL-GRIP FNA SYRINGE HOLDER AND EFFORTLESS NEEDLE REMOVER TAO & TAO TECHNOLOGYT, INC. PAULINE TAO
K964112 02/26/1997 BERENSTEIN COIL TARGET THERAPEUTICS LARAINE PANGELINA
K972112 12/01/1997 INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 TAUT, INC. GLENN MILLER
K963302 02/06/1997 TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM TAYMAN MEDICAL, INC. JAMES TAYLOR
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
K964461 02/11/1997 ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST TECO DIAGNOSTICS ANDREW REAMS
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K964462 02/11/1997 ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST TECO DIAGNOSTICS ANDREW REAMS
K974300 12/19/1997 TELEMED SYSTEMS RETRIEVAL BASKET TELEMED SYSTEMS, INC. SAMUEL D WADE
K963505 02/14/1997 TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM TENET MEDICAL ENGINEERING KEN MOORE
K962981 02/25/1997 CAPIOX SP PUMP HEAD TERUMO MEDICAL CORP. SANDI HARTKA
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
K963680 02/06/1997 TARGET MYOGLOBIN TEST TEXAS IMMUNOLOGY, INC. CHRALES W GILL
K965069 02/12/1997 ANSPACH SUTURE ANCHOR THE ANSPACH EFFORT, INC. WLLIAM E ANSPACH III M.D.
K963568 02/25/1997 MASK SURGICAL THE INNOVATIVE APPROACH, CORP. ELISA N PEREZ
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
K964322 02/26/1997 VIPOR UNIT TILANE CORP. TIMOTHY G LANE MD, PH.D.
K963683 02/12/1997 TRU-PULSE LASER (MODIFIED) TISSUE TECHNOLOGIES, INC. CONNIE WHITE
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
K964608 02/04/1997 MRT-35A V9.0 TOSHIBA AMERICA MRI, INC. STEVEN M KAY
K962475 02/20/1997 ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM TRANSFUSION TECHNOLOGIES CORP. JOHN J SOKOLOWSKI
K960817 02/11/1997 HD01-SERIES TRANSONIC HEMODIALYSIS MONITOR (R%,QA,CO,QB,QB2) TRANSONIC SYSTEMS, INC. CORNELIS J DROST
K974286 12/12/1997 CIRCUMCISION TRAY, CAT. NO. 70340 TRINITY LABORATORIES, INC. PARTHA BASUMALLIK
K965201 02/14/1997 O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE 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
K964174 02/10/1997 MINERAL TRIOXIDE AGGREGATE (MTA) TULSA DENTAL PRODUCTS, LTD. H. N. DUNNING
K962872 02/25/1997 RESPIFLO TYCO HEALTHCARE DEUTSCHALAND GMBH WILLIAM D CURTIN
K964888 02/28/1997 HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II TZ MEDICAL, INC. D. JADEEN HAILEY
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
K964810 02/10/1997 DERMADAM ULTRADENT PRODUCTS, INC. CHESTER MCCOY
K964808 02/26/1997 SPETEMP ULTRADENT PRODUCTS, INC. CHESTER MCCCOY
K970066 02/18/1997 UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE UNIMED SURGICAL PRODUCTS, INC. RONALD R FROEMMING
K964490 02/07/1997 AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964489 02/07/1997 CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964495 02/07/1997 CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964496 02/06/1997 CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC UNIPATH LTD. FRAN WHITE
K964512 02/06/1997 CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964492 02/07/1997 CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964487 02/07/1997 IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964491 02/07/1997 NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964493 02/06/1997 OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K964501 02/06/1997 SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC UNIPATH LTD. FRAN WHITE
K973496 12/01/1997 THE AUTO SUTURE* MIBB** SYSTEM UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR CLAVELLI
K963115 02/12/1997 TROCAR CANNULA UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JANET G JOHNSON
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
K935706 02/11/1997 EPI 2 UNIVERSAL H.R. SYSTEM, INC. WILLIAM H SIMPSON
K964968 02/27/1997 MR EXTENSION SET (001) UNIVERSITY OF MICHIGAN MARTIN R PRINCE, MD, PH.D.
K971790 12/17/1997 KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) UROMETRICS, INC. PHILLIP A MESSINA
K964753 02/11/1997 MATRIX 3000 FLEXIBLE SPINE COIL US ASIA INSTRUMENTS, INC. RONY THOMAS
K964820 02/28/1997 MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A US ASIA INSTRUMENTS, INC. RONY THOMAS
K964526 02/10/1997 LIBERTY RECTAL PELVIC FLOOR EXERCISER UTAH MEDICAL PRODUCTS, INC. JOHN W SMITH
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
K941397 02/10/1997 ANTI-VIMENTIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. STEPHEN A TILLSON
K941604 02/14/1997 VENTANA ANTI-CD4 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. STEPHEN A TILLSON
K941784 02/14/1997 VENTANA ANTI-CD8 PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. STEPHEN TILLSON
K941516 02/10/1997 VENTANNA ANTI-DESMIN PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. STEVE TILLSON
K974290 12/19/1997 MICROPROTEIN STANDARD KIT VERICHEM LABORATORIES, INC. ANTHONY J DIMONTE
K965021 02/25/1997 NON-PRESCRIPTION SUNGLASSES VICTORY EYEWEAR CO., LTD. DAVID HSU
K963375 02/28/1997 CARDIACMONITOR VISION ELECTRONICS SHAWN P WOOD
K973436 12/09/1997 VISTA HEAD MOUNTED DISPLAY VISTA MEDICAL TECHNOLOGIES, INC. MARTIN NEWMAN
K964876 02/28/1997 SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET VLV ASSOCIATES, INC. VINCENT VAILLANCOURT
K963981 02/14/1997 VYGON BIONECTOR WITH EXTENSION SET VYGON CORP. ANNE MARIE CESARIO
K964061 02/20/1997 GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) W.L. GORE & ASSOCIATES,INC DAWN LOPEZ
K973594 12/17/1997 GORE RESOLUT XT REGENERATIVE MATERIAL W.L. GORE & ASSOCIATES,INC JOHN W NICHOLSON
K965038 02/06/1997 GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE W.L. GORE & ASSOCIATES,INC R. LARRY PRATT
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
K960640 02/14/1997 S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION) WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH JAY SULLIVAN
K973524 12/12/1997 ADVANCE MODULAR TIBIAL COMPONENT WRIGHT MEDICAL TECHNOLOGY, INC. KIM TOMPKINS
K964786 02/06/1997 ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. CRISTIE MANUEL
K960659 02/06/1997 CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) WRIGHT MEDICAL TECHNOLOGY, INC. CLIFF R KLINE, II
K960534 02/06/1997 METALLIC SPHERICAL CMC IMPLANT WRIGHT MEDICAL TECHNOLOGY, INC. CLIFF R KLINE II
K974240 12/22/1997 LIGHTLINE-M WUESTEC MEDICAL, INC. KRISTI WHITE
K965227 02/04/1997 OSOM CLASSIC HCG-URINE TEST (115) WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K974159 12/24/1997 OSOM HCG-URINE TEST MODEL 101 WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K965184 02/04/1997 PERFECTA PREGNANCY TEST 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
K965098 02/28/1997 INTRAMEDULLARY NAIL SYSTEM ZIMMER, INC. KAREN CAIN
K963148 02/13/1997 NEXGEN COMPLETE KNEE SOLUTION ZIMMER, INC. RUTH ANN WOOD
K973714 12/24/1997 VERSYS HIP SYSTEM BEADED HIP PROSTHESIS ZIMMER, INC. KAREN CAIN
K964769 02/13/1997 VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS ZIMMER, INC. KAREN CAIN


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