FDA 510(k) Decisions During May, 1991  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K905539 05/28/1991 3M 6830 ELECTRODE 3M HEALTH CARE JULIA L WANNAMAKER
K911227 05/29/1991 NEW STERILITY CHARACTER/SARNS OXYGENATOR PRODUCTS 3M HEALTH CARE, SARNS CATHY L SIMPSON
K911072 05/15/1991 SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR A & F PRODUCTS EULER FERRER
K911401 05/28/1991 ABBOTT LIFECARE 5000 PUMP ABBOTT LABORATORIES FREDERICK GUSTAFSON
K910919 05/23/1991 ABBOTT LIFECARE 5000 PUMP MODIFIED ABBOTT LABORATORIES FREDERICK GUSTAFSON
K905456 05/28/1991 L328 TRANSDUCER ACUSON CORP. SHEILA W PICKERING
K911092 05/22/1991 OSMOMETER MODEL 2400 ADVANCED INSTRUMENTS, INC. DOUGLAS GUERETTE
K905782 05/06/1991 FHT (FECAL HEME TEST) AERSCHER, INC. ROBERT SCHREIBER
K911774 05/03/1991 ALADAN LATEX MEDICAL GLOVE ALADAN CORP. CARL COOPER
K911391 05/08/1991 ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME) ALAMAR MICHAEL V LANCASTER
K911390 05/08/1991 ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM) ALAMAR MICHAEL V LANCASTER
K911392 05/08/1991 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN ALAMAR MICHAEL V LANCASTER
K911389 05/08/1991 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM) ALAMAR MICHAEL V LANCASTER
K911558 05/15/1991 ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN ALAMAR BIOSCIENCES LABORATORY, INC. MICHAEL V LANCASTER
K910679 05/07/1991 GENESIS I AUTOMATED CELL COUNTER ALICIA DIAGNOSTICS, INC. TOBIN, JR.
K904813 05/31/1991 VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. ALPHA-DENT GEORGE NICOLAE
K904920 05/28/1991 AMBU MATIC AUTOMATIC RESUSCITATOR AMBU, INC. DAVID LEE
K910040 05/28/1991 AMBU SIR 2 (SILICONE RESUSCITATOR), ADULT AMBU, INC. DAVID LEE
K911167 05/01/1991 ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL II ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K911168 05/01/1991 ACS THERAPEUTIC DRUG MONIT CONTR, SET I, LEVEL III ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K911171 05/01/1991 ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K911169 05/01/1991 ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K910930 05/01/1991 ACS THERAPEUTIC DRUG MONITORING CONTROL SET I LE.1 ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K911176 05/01/1991 ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL I ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K911177 05/01/1991 ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL II ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K911178 05/01/1991 ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K911170 05/01/1991 THERAPEUTIC DRUG MONIT CONTROL, SET II, LEVEL II ANALYTICAL CONTROL SYSTEMS, INC. PAULINE W BONDERMAN
K905464 05/31/1991 MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING ANGIOSYSTEMS, INC. ALAN P SCHWARTZ
K911080 05/20/1991 HYGIENA-TRACH APDYNE MEDICAL CO. MICHAEL W WALSH
K902102 05/30/1991 COM-TENS: A NEUROSTIMULATOR APEX MEDICAL, INC. THOMAS DAIGLE
K910584 05/23/1991 ONE STEP BUTTON(TM) APPLIED MEDICAL TECHNOLOGIES PAT GILPIN
K910339 05/29/1991 AVD INTIMAX OCCLUSION CATHETER APPLIED VASCULAR DEVICES, INC. JO STEGWELL
K910659 05/17/1991 AUGUSTINE STYLET AUGUSTINE MEDICAL, INC. SCOTT D AUGUSTINE
K911332 05/06/1991 SPECTACLE FRAME AUSTRALIAN OPTICAL CO., INC. DEBRA L ALDRIDGE
K911289 05/21/1991 EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP BAXTER HEALTHCARE CORP. DIANE T ADINOLFO
K911106 05/28/1991 MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG BAXTER HEALTHCARE CORP. DAVID C ROSS
K911712 05/15/1991 STRATUS(R) AUTOMATED SAMPLE HANDLER BAXTER HEALTHCARE CORP. NANCY A HORNBAKER
K910024 05/31/1991 VOLUMETRIC INFUSION PUMP BAXTER HEALTHCARE CORP. PATRICIA BARSANTI
K910873 05/29/1991 BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC D. A CUTSHALL
K911913 05/13/1991 PRECISION GLIDE - ENHANCED SURGICAL BLADE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC J ARNSBERGER
K910834 05/07/1991 QBC AUTOREADER BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC RUSSELL ARNSBERGER
K901485 05/20/1991 ENZYGNOST ANTI-CMV/IGG + IGM BEHRING DIAGNOSTICS, INC. JOHN E HUGHES
K911651 05/30/1991 ZEFON BATERIAL/VIRAL FILTER BILL OLSON CORP. MICHAEL BYRNE
K911954 05/23/1991 REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION BIO-RAD SHARON K SMITH
K911438 05/23/1991 TURBO ACCELERATOR W/CLIN DIAG SOFTWARE CARTRIDGE BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K910682 05/08/1991 ROBICSEK PROBE/RETRACTOR BIO-VASCULAR, INC. SHERYL A KRATTLEY
K910635 05/15/1991 TOTAL BILIRUBIN REAGENT SET BIOCHEMICAL TRADE, INC. ALEJO V ROY
K904310 05/31/1991 RHEUMAGEN RF T-CONTROL BIOKIT USA, INC. ODRIOZOLA
K905571 05/08/1991 ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K911755 05/22/1991 CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE BIONOSTICS, INC. BRUCE WILLIAMS
K905657 05/15/1991 SONOPAK/QS, SONOPAK BIORESEARCH JOHN RADKE
K910721 05/06/1991 BIOTROL PROTEIN MULTILEVEL STANDARDS BIOTROL, USA, INC. ALLAN C MURPHY
K905087 05/07/1991 TRIOS 02 BIOTRONIK, GMBH & CO. RICHARD R STOUT
K910794 05/23/1991 SMALL INSTRUMENT STERILIZATION/BUR BOX BREVET, INC. TIMOTHY DIAMOND
K911596 05/15/1991 VISION BG MONITOR BRITISH-AMERICAN MEDICAL, INC. THOMAS L BUCKLEY
K910371 05/15/1991 URODYNAMIC MEASURING SYSTEM BROWNE MEDICAL SYSTEMS, INC. DEBORAH HALL
K901881 05/31/1991 VIBROMETRY SYSTEM BRUEL & KJAER INSTRUMENTS, INC. FRED F FEY
K912214 05/30/1991 BARD SINGULAR BIOPSY FORCEPS C.R. BARD, INC. MATTHEW NOWLAND
K911140 05/07/1991 BARD(R) ENDOCARDIAL BALLOON ARRAY C.R. BARD, INC. ERNEST MANFREDO
K911329 05/28/1991 BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE C.R. BARD, INC. DONNA J WILSON
K910653 05/06/1991 TOUCHLESS II INTERMITTENT CATHETER C.R. BARD, INC. JOHN HOFFER
K905824 05/16/1991 MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE CARDIAC CONTROL SYSTEMS, INC. ROBERT R BROWNLEE
K910661 05/02/1991 MODEL 205 SHOCK-TRODE CARDIOTRONICS, INC. TIM J WAY
K910440 05/10/1991 DOCUMENT REFLECTANCE II LINEARITY TEST SET CASCO STANDARDS THOMAS M HAPPE
K905310 05/28/1991 MINIOX V PULSE OXIMETER CATALYST RESEARCH CORP. DEVAN WOLF
K911132 05/06/1991 MULTIPLE, SURGICAL DRAPE PACK CENTRAL GEORGIA ANCILLARY HEALTH SYSTEMS JACK HERNDON
K910788 05/09/1991 CMI TENDER TOUCH VE #303TT AND 404TT CHALLENGE MFG., INC. EMILY SMITH
K911578 05/15/1991 CHOLESTECH L.D.X. LIPID ANALYZER, MODIFICATION CHOLESTECH CORP. LYNN BANFIELD
K910684 05/01/1991 CIBA CORNING ACS FT4 IMMUNOASSAY CIBA CORNING DIAGNOSTICS CORP. WILLIAM J PIGNATO
K910327 05/16/1991 WARMAIR SYSTEM CINCINNATI SUB-ZERO PRODUCTS, INC. DOUGLAS CLARK
K910587 05/13/1991 MINISCOPE CITATION MEDICAL CORP. F WADDELL
K911037 05/03/1991 SAFETY NEEDLE SHEATH, MODIFICATION CONCORD/PORTEX ROBERT WHEELER
K910678 05/08/1991 TRO-GARD CONMED CORP. WILLIAM W ABRAHAM
K905471 05/09/1991 TROCAR ACCESS SHEATH COOK OB/GYN MICHELLE YOUNG
K910876 05/28/1991 AUTOCATH(TM) SET COOK UROLOGICAL, INC. MICHELLE YOUNG
K910688 05/16/1991 CORDIS PEEL-AWAY INSERTION TOOL CORDIS CORP. RALPH JUGO
K902968 05/15/1991 BIO-VENT-X ENDOSSEOUS HA COATED DENTAL IMPLANTS CORE-VENT CORP. PATRICK, DDS
K904889 05/14/1991 TENS CONDUCTIVE MEDIA PAD CREATIVE DESIGN SYSTEMS, INC. JOHN L ESSMYER
K910770 05/14/1991 504US PULSE OXIMETER CRITICARE SYSTEMS, INC. DER RUHR
K910048 05/17/1991 ECAT SCANNER CTI PET SYSTEMS, INC. MARK S ANDREACO
K910861 05/07/1991 PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK DAIG CORP. J FLEISCHHACKER
K905071 05/28/1991 MX CYCLER DAKMED, INC. DENNIS A KWACZALA
K902607 05/14/1991 DANTEC MAGNETIC STIMULATOR MAG 2 ("MAG 2") DANTEC MEDICAL, INC. RICHARD MANTHEI
K910620 05/07/1991 CARDIOCAP DR-124 RECORDER DATEX DIVISION INSTRUMENTARIUM CORP. HANNU AHJOPALO
K905140 05/28/1991 SATLITE PLUS PULSE OXIMETER DATEX DIVISION INSTRUMENTARIUM CORP. HANNU AHJOPALO
K911821 05/30/1991 THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST DENTECON, INC. JOHN YAVROUIAN
K910941 05/09/1991 LIFELINER SURGICAL GLOVE DEPUY-RAYNHAM DAVID A KOTKOVETZ
K911369 05/13/1991 QUALTEX LIGHT HANDLE AND LIGHT HANDLE COVER DEROYAL INDUSTRIES, INC. DEBRA F MANNING
K911204 05/08/1991 QUALTEX SKIN STAPLE EXTRACTOR DEROYAL INDUSTRIES, INC. DEBUSK LANE
K911895 05/08/1991 QUALTEX SUTURE BOOTIES DEROYAL INDUSTRIES, INC. DEBRA F.MANNING
K904344 05/01/1991 SLEEPER MASK SYSTEM DEVILBISS HEALTH CARE, INC. DAVID GAST
K910239 05/22/1991 NEBU-SOL METERED DOSE DISPENSER (TM) DEY LABORATORIES, INC. ALLAN M RAFF
K910645 05/07/1991 DISPOSABLE PATIENT CABLE DIAG CORP. J FLEISCHHACKER
K911512 05/22/1991 MILENIA PROGESTERONE DIAGNOSTIC PRODUCTS CORP. KENNETH B ASARCH
K910596 05/29/1991 DCW MODULAR DISTAL FEMORAL SYSTEM DOW CORNING WRIGHT DIANE D PATTON
K911652 05/15/1991 MIRCOLINE SCREEN FOR COCAINE DRUG SCREENING SYSTEMS, INC. KENNETH S CORPENTER
K911724 05/22/1991 ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION E.I. DUPONT DE NEMOURS & CO., INC. CHRISTOPHER BENTSEN
K911437 05/17/1991 KODAK EKTASCAN CABLE EXTENSION EASTMAN KODAK COMPANY NORMAN H GEIL
K911705 05/17/1991 CHAMPION, BEHIND-THE-EAR HEARING AID ELECTONE, INC. JIM NEE
K911706 05/17/1991 MODEL 800, BEHIND-THE-EAR HEARING AID ELECTONE, INC. JIM NEE
K911708 05/17/1991 MODEL E-50, IN-THE-EAR HEARING AID ELECTONE, INC. JIM NEE
K911707 05/17/1991 REGAL, BEHIND-THE-EAR HEARING AID ELECTONE, INC. JIM NEE
K911709 05/17/1991 STOCK CANAL, IN-THE-EAR HEARING AID ELECTONE, INC. JIM NEE
K910935 05/16/1991 MODIFIED PYROGEN TESTING ELECTROMEDICS, INC. HAROLD W BRYAN
K905658 05/08/1991 SYSTEMATE CREATININE (EPOS APPLICATION) #65413 EM DIAGNOSTIC SYSTEMS, INC. ANNA BENTLEY
K910200 05/09/1991 LASER-35 ENDO TECHNIC CORP. PHILIPPE C LEVY
K904870 05/23/1991 MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON ENDOTEC, INC. MICHAEL J PAPPAS
K910518 05/09/1991 GLOVE-N-GEL AMNIOTOMY KIT EPCOM MEDICAL SYSTEMS, INC. PAUL ULBRICH
K902853 05/09/1991 GRAVITY PLUS CONTROLLER/COMPOUNDER FERGY CORP. DAVE STOKES
K910627 05/29/1991 ALPHA-FIL, ALPHA-BASE & ALPHA-SILVER, MODIFICATION FOREMOST MFG., INC. TIM WOLF
K905038 05/06/1991 OLYMPUS PK-TP ABSORBENT KIT FUJIREBIO AMERICA, INC. RICHARD H ARNETTE
K904200 05/22/1991 SPIROSIFT 500A FUKUDA DENSHI USA, INC. ROBERT J STEURER
K911109 05/01/1991 OPHTA SIL (R), LACHRYMAL INTUBATION SETS G.W.B. INTL., LTD. GEORG W BOHSACK
K911108 05/13/1991 OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS G.W.B. INTL., LTD. GEORGE W BOHSACK
K911766 05/22/1991 SUNGLASSES-NONPRESCRIPTION INCLUDING PHOTOSEN. GALL'S, INC. RICHARD K BROOKING
K905653 05/15/1991 ADVANTX AFM ANGIO SYSTEM S1808 GE MEDICAL SYSTEMS LARRY A KROGER
K911387 05/09/1991 CT SYTEC 4000 GE MEDICAL SYSTEMS LARRY KROGER
K911848 05/07/1991 IMMUNOWELL RNP/SM ANTIBODY TEST GENERAL BIOMETRICS, INC. BRYAN L.KIEHL,PHD.
K911849 05/07/1991 IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST GENERAL BIOMETRICS, INC. L.KIEHL PHD.
K911851 05/07/1991 IMMUNOWELL SM ANTIBODY TEST GENERAL BIOMETRICS, INC. BRYAN L.KIEHL,PH.D.
K911850 05/07/1991 IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST GENERAL BIOMETRICS, INC. L.KIEHL PH.D.
K911406 05/22/1991 HDL CHOLESTEROL REAGENT GENZYME CORP. RUSSELL H HERNDON
K911519 05/22/1991 CATHCAP, CAT. NO. CC100 SERIES GISH BIOMEDICAL, INC. DEBI KRIDNER
K903394 05/06/1991 GLOBALCARE MICRO 11 AND MICROCARE (TENS) GLOBALCARE INTL., INC. JOHN DUNN
K911042 05/29/1991 GAMMAT ELECTROFORMED GOLD COPING GRAMM SURFACE TECHNOLOGY, INC. KATHARINA G EVERETT
K905480 05/06/1991 SPIROSCOPE GRANDCOR MEDICAL SYSTEMS SPERO M ALEX
K910813 05/07/1991 MET-ETCH GRESCO PRODUCTS, INC. CLINTON D VAUPEL
K910954 05/28/1991 HSV-1 IGG ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD
K910955 05/28/1991 HSV-1 IGM ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD
K910952 05/28/1991 HSV-2 IGG ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD
K910953 05/28/1991 HSV-2 IGM ELISA TEST GULL LABORATORIES, INC. FRED W RACHFORD
K904650 05/21/1991 WHEELCHAIR CONVERSION KIT HADCO MARKETING SERVICES, INC. ISAAC RODAN
K905803 05/21/1991 HALE SUN SURGICAL TOWEL OR O.R. TOWEL HALE SUN INDUSTRIES, LTD. LOCKETT III
K910800 05/20/1991 ADP REAGENT HELENA LABORATORIES PAT FRANKS
K910706 05/20/1991 COLLAGEN REAGENT CAT. NO. 5368 HELENA LABORATORIES PAT FRANKS
K910680 05/20/1991 EPINEPHRINE REAGENT, CAT. NO. 5367 HELENA LABORATORIES PAT FRANKS
K911141 05/08/1991 HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER HEMOCUE, INC. R. J SLOMOFF
K910496 05/06/1991 CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL. HERAEUS LASERSONICS, INC. ROBERT MILDER
K910805 05/24/1991 ND:YAG LASER SYSTEMS (VARIOUS MODELS) HERAEUS LASERSONICS, INC. LISA MCGRATH
K910754 05/08/1991 MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION HEWLETT-PACKARD CO. MONICA FERRANTE
K910898 05/31/1991 SURGICA(TM) H HGM MEDICAL LASER SYSTEMS, INC. DENNIS REIGLE
K911803 05/15/1991 HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED HICHEM DIAGNOSTICS BENTLEY TAM
K911667 05/30/1991 HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE HITACHI MEDICAL SYSTEMS AMERICA, INC. ROBERT MCCARTHY
K911642 05/30/1991 MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION HITACHI MEDICAL SYSTEMS AMERICA, INC. ROBERT H MCCARTHY
K905691 05/15/1991 QDR-1000 AND WITH X-RAY BONE DENSITOMETER HOLOGIC, INC. VON STETTEN
K910500 05/06/1991 HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM HOWMEDICA CORP. ROBERT E SMITH
K910869 05/23/1991 HOWMEDICA(R) CEMETED FEMORAL COMPONENT HOWMEDICA CORP. ROBERT E SMITH
K910188 05/28/1991 FLOWPLUS AC330 PUMP GARMENTS HUNTLEIGH TECHNOLOGY, INC. AUDREY WITKO
K911601 05/21/1991 REDDICK TROCAR AND CANNULA IDEAL MEDICAL, INC. LORNA K LINVILLE
K911060 05/08/1991 IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM IMMUNOMATRIX LANCE A LIOTTA
K911701 05/15/1991 G-FLOSS & G-FLOSS II IMPLANT INNOVATIONS INTERNATIONAL, INC. WILLIAM G CONETY
K905590 05/10/1991 UCEZ - STERILE LENS FOG REDUCTION DEVICE INMAN LIEBELT CORP. ROGER LIEBELT
K904237 05/09/1991 RAPID IMMOBILIZATION DEVICE OR R.I.D. SYSTEM INNOVATIVE MEDICAL TECHNOLOGIES, INC. RICHARD VOLLO
K904355 05/23/1991 CARDIOCAP II TM CH-RESP MONITORS INSTRUMENTARIUM CORP. HANNU AHJOPALO
K896596 05/30/1991 ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL INSTRUMENTARIUM IMAGING, INC. GERRY BUSS
K910920 05/15/1991 PROTEKT GLOVES INTERMEDICS ORTHOPEDICS THOMAS L CRAIG
K911122 05/16/1991 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS INTERMEDICS, INC. ALAINE MEDIO
K910181 05/10/1991 HITT BY HEMOCHRON(R) INTERNATIONAL TECHNIDYNE CORP. LES HEIMANN
K910646 05/10/1991 SUPERSERUM REAGENT (SSR) INTERNATIONAL TECHNIDYNE CORP. LES HEIMANN
K910281 05/13/1991 INTRAVASCULAR IMAGING SYSTEM/MODIFIED INTERTHERAPY, INC. THOMAS P SCHROEDER
K910845 05/21/1991 ITC ROTATING HEMOSTATIC VALVE CAT. NO. MX 1012 INTERVENTIONAL THERAPEUTICS CORP. LUANNE TERMEER
K911466 05/23/1991 INNOFLUOR VALPROIC ACID CALIBRATOR SET INTL. BIOCLINICAL, INC. CRAIG SMART
K911039 05/13/1991 INVOTEC EAR DRAPE INVOTEC INTERNATIONAL, INC. JEFFREY L AULL
K911076 05/30/1991 JAIN QUICK COUNT JAIN SURGICAL EQUIPMENT, INC. MELISA M ROOT
K911077 05/31/1991 JAIN SUTURE PACKAGE COUNTER JAIN SURGICAL EQUIPMENT, INC. MELISA M ROOT
K910563 05/23/1991 P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL JOHNSON & JOHNSON ORTHOPAEDICS, INC. MARSHA J STONE
K905258 05/21/1991 S-ROM OBLONG ACETABULAR CUP JOINT MEDICAL PRODUCTS CORP. DEBRA L BING
K910021 05/22/1991 CARDIOPULMONARY BYPASS PUMP TUBING JTL MEDICAL CORP. JAMES LICHTE
K905413 05/17/1991 JUZO-RESPIRA ANTI-EMBOLISM STOCKING JULIUS ZORN, INC. VICKI L CRESAP
K910415 05/01/1991 SUNGLASSES K.M OPTICAL CO. LEE
K910791 05/17/1991 CURITY(R) CALIB TUOHY TYPE EPIDUR NEEDLE FIX WING KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH STEPHEN J TAMSETT
K911470 05/15/1991 BUFFING FLOSS LAMAR INDUSTRIES LARRY L RINGLE
K911212 05/23/1991 LM-150HT LIGHT SOURCE LEISEGANG MEDICAL, INC. DOUGLAS DWART
K911921 05/13/1991 DISPOSABLE ISOLATION GOWN LIAONING-USA CORP. JAY A BROWN
K910432 05/01/1991 HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER LIFECORE BIOMEDICAL, INC. BRUCE F MACKLER
K910142 05/14/1991 SPARK KIT(R), MODIFICATION LYPHOMED, INC. DONALD E BAKER
K911174 05/09/1991 NHS 2009SP HEARING AID MAGNATONE HEARING AID CORP. TONY QUICK
K911182 05/09/1991 NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS MAGNATONE HEARING AID CORP. TONY QUICK
K905789 05/20/1991 FRANKLIN 9000 WALL STAND MALLINCKRODT GROUP, INC. THOMAS DONOHUE
K910577 05/09/1991 EDWARDS-WALLACE BOURNE HALL CATHETER MARLO SURGICAL TECHNOLOGY SCOTT C MARLOW
K910907 05/13/1991 PUMP VAC PLUS MARLO SURGICAL TECHNOLOGY SCOTT C MARLOW
K904789 05/22/1991 SERIES 7000 CARBON DIOXIDE MODULE MARQUETTE ELECTRONICS, INC. SANDRA SCHICK
K905374 05/31/1991 IV EXTENSION SETS WITH .22 MICRON FILTER MARQUETTE MEDICAL, INC. MARQUETTE JR
K910532 05/28/1991 URAM OPHTHALMIC LASER ENDOSCOPE MARTIN S. KNOPF ASSOC., INC. MARTIN S KNOPF
K910663 05/09/1991 BOVIE MODEL X-10, X-10I, ELECTROSURGICAL GENERATOR MDT CORP., INC. MARK SMITH
K904264 05/09/1991 MODEL SW-103 SOLITANS STIMULATOR MEDICAL CONSULTANTS INTL. LTD. SAUL LISS
K911145 05/10/1991 BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. DAVID A WALL
K910367 05/30/1991 COMPUTE-RX-COMP (TM) MEDICALIBRATION PHYSICS CONSULTANT SERVICES, INC. RALPH H RYDMAN
K910450 05/07/1991 CARD GUARD-3000 ECG TELEPHONE ADAPTER MEDTECH INDUSTRIES, INC. JONATHAN S KAHAN
K905404 05/13/1991 MEDTRONIC SULLIVAN NASAL CPAP SYSTEM MEDTRONIC VASCULAR LINDA S ALEXANDER
K910595 05/07/1991 MODEL 5311B A-V PACING SYSTEM ANALYZER MEDTRONIC VASCULAR BECKY SAVAGEAU
K910564 05/06/1991 VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY MENLO CARE, INC. JOCK M WALKER
K910790 05/03/1991 MENTOR LUBRICATING JELLY MENTOR CORP. LYNN R BRECKENRIDGE
K910637 05/13/1991 MENTOR(R) SUR-E-TROL(R) MENTOR O & O, INC. RICHARD L FOLLETT
K911160 05/02/1991 MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 MENTOR O & O, INC. RICHARD L FOLLETT
K911622 05/20/1991 CPR BAG MERCED MEDICAL, INC. JEFF RATNER
K911068 05/15/1991 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM MICRO MOTORS, INC. RUSS REINSCH
K911941 05/15/1991 CEDIA(R) DIGOXIN R' ASSAY MICROGENICS CORP. PATRICIA M KLIMLEY
K910781 05/15/1991 #491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES MIDMARK CORP. JOHN OLDIGES
K904430 05/13/1991 MENS FREEDOM MICRO MONAD CORP. MARK HANKINS
K904288 05/13/1991 MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS MONAD CORP. MARK HANKINS
K904235 05/13/1991 MENS-O-MATIC 2000 MONAD CORP. MARK HANKINS
K904260 05/13/1991 MENS-O-MATIC 3000 MONAD CORP. MARK HANKINS
K904234 05/13/1991 MENS-O-MATIC I MONAD CORP. MARK HANKINS
K904258 05/13/1991 MICRO DERM MONAD CORP. MARK HANKINS
K900576 05/13/1991 MODIFIED AEROCHAMBER WITH MASK MONAGHAN MEDICAL CORP. JAMES A COCHIE
K910912 05/28/1991 MOSS NASAL TUBE MARK IV MOSS MEDICAL PRODUCTS HARRY A SCHLAKMAN
K910911 05/03/1991 MOSS P.E.G. TRAY MOSS MEDICAL PRODUCTS HARRY A SCHLAKMAN
K911261 05/31/1991 ERA 2000A NEOTRONICS, INC. JOE LAMBARDO
K901811 05/28/1991 ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLE NEURO TECHNOLOGY COOMBS, MD
K901810 05/30/1991 MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLE NEURO TECHNOLOGY COOMBS, MD
K910629 05/14/1991 AP-860PA NIBP MODULE NIHON KOHDEN AMERICA, INC. MIKE DASHEFSKY
K904135 05/15/1991 FOUNDATION HYBRID COMPOSITE NULITE SYSTEMS RESEARCH CHRISTOPHER P DOUBE
K910601 05/14/1991 PATHFINDER NURION INDUSTRIES WILLIAM P ROSEN
K904165 05/28/1991 SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT OCCUPATIONAL PREVENTIVE DIAGNOSTICS, INC. CLIFTON, JR
K910847 05/03/1991 OHMEDA 7810 ANESTHESIA VENTILATOR OHMEDA MEDICAL TIMOTHY M DAVIS
K905635 05/03/1991 OHMEDA MODULUS CD ANESTHESIA SYSTEM OHMEDA MEDICAL TIMOTHY M DAVIS
K911266 05/07/1991 MODIFIED PK TP CONTROL OLYMPUS CORP. STORMS TYLER
K911775 05/08/1991 OMNICATH IMPLANTED CATHETER AND DEPOT OMNITRON INTL., INC. LISA S JONES
K904332 05/01/1991 MSTIM-2000 EMS OMS MEDICAL SUPPLIES, INC. THOMAS RIIHIMAKI
K910617 05/15/1991 NATIVE PROTHROMBIN ANTIGEN EIA ORGANON TEKNIKA CORP. ANN M QUINN
K904253 05/20/1991 ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY ORTHO DIAGNOSTIC SYSTEMS, INC. PATRICK ROCHE
K911197 05/23/1991 PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM ORTHOMET, INC. DENNIS H CRANE
K911198 05/23/1991 TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY ORTHOMET, INC. DENNIS H CRANE
K910736 05/21/1991 JACKSON MULTIPURPOSE OPERATING TABLE ORTHOPEDIC SYSTEMS, INC. ROBERT MOORE
K905182 05/07/1991 OSCOR MEDICAL CORP. PERMANENT PACING PAD OSCOR MEDICAL CORP. RONALD NIEUWENHOF
K905300 05/07/1991 PERMANENT PACING LEAD OSCOR MEDICAL CORP. RONALD NIEUWENENHOF
K910662 05/13/1991 PS OMNIFIT NORMALIZED HIP STEM SERIES OSTEONICS CORP. PAT KRAMER
K910903 05/08/1991 INFLATE-A-CUFF #7014 PA MEDICAL CORP. BAILEY VAUGHN
K905235 05/03/1991 VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS PERCUSSIONAIRE CORP. FORREST M BIRD
K911292 05/01/1991 SCHNEIDER WALLSTENT(R) PFIZER HOSPITAL PRODUCTS GROUP, INC. STEVE JWANOUSKOS
K910767 05/23/1991 TL100W/01 UVB LAMP PHILIPS LIGHTING CO. TONI J HONKISZ
K910370 05/28/1991 PHILIPS INTEGRIS V3000 AND V4000 PHILIPS MEDICAL SYSTEMS, INC. WILLIAM G MCMAHON
K910712 05/21/1991 VILLAN (VIDEO LIFT LINK ANALYSIS) PHYSIO SYSTEMS, INC. DAVID E LEIBERMAN
K910067 05/06/1991 PTI STERNAL CLOSURE WIRE SUTURE PIONEERING TECHNOLOGIES, INC. WRIGHT
K905779 05/23/1991 ALDETECT POCHEMCO, INC. JERRY POCH
K911792 05/15/1991 FIRST CHOICE(TM), MODIFICATION POLYMER TECHNOLOGY CORP. TERRY G.KELLEY
K911397 05/20/1991 HYPODERMIC NEEDLES, SINGLE LUMEN POPPER & SONS, INC. JOSEPH A POPPER
K911275 05/09/1991 POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM POSITRON RICHARD E HITCHENS
K910882 05/08/1991 PROPAQ 102EL, 104EL AND 106EL PROTOCOL SYSTEMS, INC. JAMES W SANDBERG
K911284 05/30/1991 PULPDENT DIAMOND POLISH PULPDENT CORP. KENNETH J BERK
K911281 05/15/1991 PULPDENT PIC N STIC PULPDENT CORP. KENNETH J BERK
K910194 05/13/1991 COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM PURITAN BENNETT CORP. MARSHALL SMITH
K905397 05/14/1991 PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM PURITAN BENNETT CORP. MARSHALL SMITH
K911664 05/31/1991 DIRECTIGEN 1-2-3 PREGNANCY CONTROLS QUIDEL CORP. CRAIG WATSON
K905049 05/07/1991 QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR QUIDEL CORP. CRAIG E WATSON
K911751 05/29/1991 MEDTRACK TREADMILL QUINTON, INC. RON DUCK
K911900 05/09/1991 RAICHEM SPIA C3 REAGENT REAGENTS APPLICATIONS, INC. ALFRED E.PEACOCK
K911899 05/09/1991 RAICHEM SPIA C4 REAGENT REAGENTS APPLICATIONS, INC. ALFRED E.PEACOCK,JR.
K911898 05/08/1991 RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT REAGENTS APPLICATIONS, INC. ALFRED E.PEACOCK,JR.
K910180 05/10/1991 BACTI-SWAB REMEL CO. ANN SILVIUS
K905114 05/07/1991 A.P.GRAPH III(TM) CARDIOVASCULAR ANALYZER RESEARCH CONSULTANTS, INC. RAOUL DESJARDINS
K910221 05/16/1991 RMI VASCULAR TOURNIQUET KIT RESEARCH MEDICAL, INC. MICHAEL N KELLY
K911327 05/21/1991 CELL SWEEP REZA S MOHAJER, M.D. C/O KRASS & YOUNG RONALD W CITKOWSKI
K910708 05/21/1991 RICH-MAR MODEL X ULTRASOUND THERAPY DEVICE RICH-MAR CORP. DAVID RICHARDS
K905437 05/30/1991 RIVER MEDICAL MICRODRILL SYSTEM RIVER MEDICAL, INC. GEORGE MURRAY
K910553 05/08/1991 ROCHE APOLIPOPROTEIN STANDARD ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K910551 05/07/1991 ROCHE REAGENT FOR APOLIPOPROTEIN A-1 ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K910552 05/07/1991 ROCHE REAGENT FOR APOLIPOPROTEIN B ROCHE DIAGNOSTIC SYSTEMS, INC. CAROL L KRIEGER
K910731 05/07/1991 DISPOSABLE RETRACTABLE NEEDLE SYRINGE SAFE TECH MEDICAL PRODUCTS, INC. MICHAEL L HAINING
K911950 05/21/1991 MEDI GUARD DRAPES SANCELLA, INC. DOREEN EDEY
K911948 05/28/1991 MEDI GUARD PILLOWCASE SANCELLA, INC. DOREEN EDEY
K911953 05/28/1991 MEDI GUARD SHEETS/UNDERLAYS SANCELLA, INC. DOREEN EDEY
K911952 05/28/1991 MEDI GUARD UNDERPAD SANCELLA, INC. DOREEN EDEY
K910241 05/03/1991 STATIM CASSETTE AUTOCLAVE SCICAN DUNCAN NEWMAN
K910178 05/22/1991 ACTH IRMA KIT "MITSUBISHI YUKA" SCIENCE REGULATORY SERVICES INTL. MICHAEL G FARROW
K910987 05/29/1991 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE SCIMED DAVID A TEICHER
K905439 05/29/1991 HYPERGEL PROTECTIVE WOUND GEL SCOTT HEALTH CARE RICHARD HAMER
K910320 05/01/1991 SERIM PERACETIC ACID REAGENT STRIPS SERIM RESEARCH CORP. MICHAEL MCKENNA
K911396 05/28/1991 SR1 ESTRADIOL ENZYME IMMUNOASSAY SERONO-BAKER DIAGNOSTICS, INC. DAVID B THOMAS
K910737 05/01/1991 SRI T3 IMMOENZYMETRIC ASSAY SERONO-BAKER DIAGNOSTICS, INC. DAVID B THOMAS
K910837 05/24/1991 SRI TSH IMMUNENZYMETRIC ASSAY SERONO-BAKER DIAGNOSTICS, INC. DAVID B THOMAS
K905795 05/29/1991 SGARLATO FLEXIBLE HINGE TOE IMPLANT SGARLATO LABORATORIES, INC. THOMAS E SGARLATO
K910867 05/31/1991 T600 TREADMILL SIEMENS BURDICK, INC. FRANCIS I DOMINY
K910971 05/03/1991 Z XT RADIATION THERAPY TREATMENT TABLE SIEMENS MEDICAL LABORATORIES, INC. MORTON, JR
K910859 05/17/1991 COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. LINDA J JALBERT
K911082 05/01/1991 REAL TIME X-RAY IMAGING SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. STEPHEN K DEOL
K910980 05/22/1991 SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE SITE MICROSURGICAL SYSTEMS, INC. JAMES K MCCRACKEN
K911633 05/09/1991 PERRY(R) ENCORE CHEMOTHERAPY GLOVE SMITH & NEPHEW PERRY JAMES R CHATTERTON
K910570 05/31/1991 SPLINTER TWEEZERS SOLAN SCISSORS SALES JOHN W SOLAN
K910671 05/10/1991 MODEL GS-4700 COMMON DUCT STONE REMOVING KIT SOLOS ENDOSCOPY, INC. WILLIAM F MEYER
K904853 05/15/1991 MODEL STT-100 SONOCARE, INC. UDO W DREWS
K910896 05/08/1991 DISPOSABLE ANESTHESIA BREATHING CIRCUIT SPECIALTY PACKAGING PRODUCS, INC. EDWARD F VALDEZ
K911020 05/29/1991 LIGAMENTOPLASTIC STAPLE OF L'UNION SPORT SERVICE, INC. J-P LACLAU
K911021 05/29/1991 PLATE BLADE WITH CURSOR OF L'UNION SPORT SERVICE, INC. J-P LACLAU
K911026 05/29/1991 STAPLE BLADE FOR TIBIAL OSTEO/STAPLE BLADE L'UNION SPORT SERVICE, INC. J-P LACLAU
K911031 05/29/1991 THE TRAMOND PIN SPORT SERVICE, INC. J-P LACLAU
K910515 05/06/1991 FREEDOM MARK III SURGICAL HELMET SYSTEM STACKHOUSE ASSOC. GREEN, JR.
K911579 05/07/1991 STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS STARKEY LABORATORIES, INC. JERROLD LANG
K911269 05/15/1991 MERCURY AND GLASS FEVER THERMOMETER STERIDYNE CORP. MARK P PONCY
K911843 05/30/1991 ZERO-G(TM) GEL/FOAM MATTRESS TOPPER STERIDYNE CORP. MARK P PONCY
K911062 05/22/1991 QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY STORZ INSTRUMENT CO. MICHAEL T TAGGART
K911582 05/28/1991 STAK-CHEX STRECK LABORATORIES, INC. HALVOR SORNSON
K910858 05/23/1991 STRYKER ARTHROSCOPIC INFUSION PUMP STRYKER CORP. HARMON WOODWORTH
K910831 05/31/1991 ENDOPATH SURGICAL INSTRUMENTS SYMBIOSIS CORP. KEVIN W SMITH
K910964 05/02/1991 HOT BIOPSY FORCEPS SYMBIOSIS CORP. KEVIN W SMITH
K911089 05/29/1991 STEALTH CATHETER SYSTEM TARGET THERAPEUTICS CHARLES T MARONEY
K911151 05/29/1991 POWER WHEELCHAIR - TILT & RECLINE SEATING SYSTEM TARSYS ENGINEERING, INC. NELSON PANG
K904934 05/21/1991 AUTOMASTER TEAM MFG., INC. RANDOLPH HAROD
K910844 05/31/1991 INFUSION PUMP TECHNOLOGY TRANSFER INTL., INC. CAESAR A ROY
K910758 05/30/1991 MICREL LTD - PORTABLE INFUSION MICROPUMP-MP11 TECHNOLOGY TRANSFER INTL., INC. CAESAR A ROY
K910350 05/30/1991 MICREL LTD-PORTABLE INFUSION PUMP-MP20Q TECHNOLOGY TRANSFER INTL., INC. CAESAR A ROY
K910901 05/30/1991 FACEPLATE ITE HEARING AID MODEL 28A TELEX COMMUNICATIONS, INC. HARRY TEDER
K910900 05/30/1991 FACEPLATE ITE HEARING AID MODEL TCA TELEX COMMUNICATIONS, INC. HARRY TEDER
K910969 05/16/1991 TORQUE DEVICE FOR A GUIDE WIRE TERUMO CORP. MIKE ICHIYANAGI
K910073 05/21/1991 TARGET ASO TEST TEXAS IMMUNOLOGY, INC. CHARLES W GILL
K910851 05/15/1991 TASSI MK3 (TURNAIR) THERAPY AIR SUPPORT SYSTEMS, INC. BILL ROSS
K911524 05/29/1991 PALFIQUE ESTELITE TOKUYAMA AMERICA, INC. EMALEE G MURPHY
K911525 05/15/1991 TOKUSO LIGHT BOND TOKUYAMA AMERICA, INC. EMALEE G MURPHY
K910091 05/30/1991 ULTRALITE PANELITE ULTRALITE WILLIAM C MCMILLAN
K910317 05/01/1991 UNI-SEM(TM) UNIMAR, INC. EDWARD C VOLLMER
K911566 05/06/1991 CLEARBLUE EASY UNIPATH LTD. MARK GITTINS
K905741 05/15/1991 CLEARVIEW HCG SERUM/URINE UNIPATH LTD. MARK GITTINS
K910951 05/06/1991 OPTHLAMIC FRAMES UNITED OPTICAL, SPA DAVID JAMES
K911271 05/29/1991 ADHESIVE PRECOATED BRACKETS UNITEK CORP. MARLYN SCHEFF
K901932 05/03/1991 VARIAN ELECTRONIC PORTAL IMAGING SYSTEM VARIAN ASSOC., INC. MILTON D SIEGEL
K911986 05/31/1991 RAMP RAT VEHICLE DYNAMICS BLAINE M HOBSON
K901454 05/29/1991 VENA CAVA FILTER VENA-TECH, INC. PAUL O'CONNELL
K910499 05/01/1991 IMMUNODIAGNOSTIC ASSAY SYSTEM HERPES SIMPLEX VIRUS VITEK SYSTEMS, INC. WINTERS HEARD
K910909 05/20/1991 MUCAID VYGON CORP. HARRY A SCHLAKMAN
K910908 05/20/1991 MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING VYGON CORP. HARRY A SCHLAKMAN
K910491 05/21/1991 WALLACH COLD SOAKER WALLACH SURGICAL DEVICES, INC. VINCENT FRAZZETTA
K910802 05/09/1991 POWER SCAN 1000 WEBB RESEARCH, INC. STEVEN KRUPNICK
K904738 05/07/1991 PYLORI STAT TEST KIT WHITTAKER BIOPRODUCTS, INC. LEIF E OLSEN
K905468 05/07/1991 PYLORI-G FIAX TEST KIT WHITTAKER BIOPRODUCTS, INC. LEIF E OLSEN
K912169 05/28/1991 WIDEX MODEL QX IN-THE-EAR HEARING AID WIDEX HEARING AID CO., INC. RON MELTSNER
K904868 05/16/1991 XEMEX TEMPORARY PACING CATHETER A ZEON MEDICAL CORP. BURNS, JR.
K910949 05/17/1991 LATEX EXAM GLOVES-POWDER FREE ZHONGMIN (FUJIAN) MACHINERY & ELECTRICAL EQUIPMENT
K910694 05/17/1991 ZINETICS INTERNAL REFERENCE PROBE ZINETICS MEDICAL, INC. RUSS GARRISON


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