FDA 510(k) Decisions During October, 1995  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K954044 10/13/1995 SIDEKICK POWER WHEELCHAIR 21ST CENTURY SCIENTIFIC, INC. RONALD E PRIOR
K944719 10/05/1995 W&H 100 SERIES LOW SPEED A-DEC, INC. PATRICK RIDENOUR
K944718 10/05/1995 W&H 900 INCOLIGHT LT HANDPIECE A-DEC, INC. PATRICK RIDENOUR
K945734 10/05/1995 W&H ROTO QUICK COUPLINGS A-DEC, INC. PATRICK RIDENOUR
K954074 10/07/1995 AALTO SCIENTIFIC LIQUID CARDIAC CONTROL AALTO SCIENTIFIC LTD. KEVIN JONES
K953115 10/06/1995 AXSYM AMPHETAMINE/METHAMPHETAMINE II ABBOTT LABORATORIES DOUG KENTZ
K953534 10/26/1995 AXSYM PHENCYCLIDINE II ABBOTT LABORATORIES DOUG KENTZ
K951496 10/19/1995 CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER ABBOTT LABORATORIES JANICE E BROWN
K953584 10/24/1995 LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG ABBOTT LABORATORIES JILL N SACKETT
K953660 10/17/1995 PLUM XL INFUSION PUMP (MODIFICATION) ABBOTT LABORATORIES DAVID GUZEK
K954029 10/05/1995 TESTPACK PLUS HCG URINE ABBOTT LABORATORIES JOY C SONSALLA
K953656 10/03/1995 ABBOTT IMX PROLACTIN(MODIFICATION) ABBOTT MFG., INC. JOY C SONSALLA
K954485 10/31/1995 6.5MM SOLID CANCELLOUS BONE SCREW ACE MEDICAL CO. NANCY GIEZEN
K954069 10/12/1995 ACE CERVICAL TRACTION HALOZS, TONGS & PINS ACE MEDICAL CO. NANCY GIEZEN
K953276 10/05/1995 ACUFEX TAG DELIVERY SYSTEM ACUFEX MICROSURGICAL, INC. JEFF HENDERSON
K952330 10/05/1995 EXTERNAL FIXATOR ACUMED, INC. SHARI L JEFFERS
K950004 10/24/1995 HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER AEROTEL, LTD. GEORGE MYERS
K945642 10/25/1995 AGEN DIMERTEST GOLD EIA AGEN BIOMEDICAL LTD. RUSSELL RICHARDS
K951882 10/16/1995 ECO CHECK (ECOVALVE AND OXYGEN MONITOR) AIRSEP CORP. EWWARD E VRANA
K952929 10/07/1995 LD GENERAL PURPOSE DISINFECTANT ALCIDE CORP. JOHN P RICHARDS
K952553 10/03/1995 ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE ALPHA MEDICA MAKRAM A BISHARA
K952983 10/05/1995 ALTR NOVA 110 HEMODIALYZER ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL MARY LANE
K952978 10/05/1995 ALTRA FLUX 110 HEMODIALYZER ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL MARY LANE
K952982 10/05/1995 ALTREX 110 HEMODIALYZER ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL MARY LANE
K953536 10/30/1995 SLANT/FIN HEPA CLEAR AMCOR, LTD. BENJAMIN LEVY
K952937 10/23/1995 NIOMED NON-SKID SHOE COVERS AMERASIA CORP. DAVID X SONG
K952897 10/23/1995 NIOMED SHOE COVERS AMERASIA CORP. DAVID SONG
K953889 10/18/1995 AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD AMERICAN BIOSURGICAL, INC. MICHAEL SOCOLOFF
K954405 10/30/1995 AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954406 10/30/1995 AMERICAN DENTAL PRODUCTS COMPOSITE RESIN CORE PASTE WITH FLUORIDE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954461 10/16/1995 AMERICAN DENTAL PRODUCTS CORE BUILDUP PASTE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954408 10/30/1995 AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE BUILDUP BLUE PASTEE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954244 10/12/1995 AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOALE
K954333 10/12/1995 AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954374 10/19/1995 AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954373 10/19/1995 AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954701 10/30/1995 AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954372 10/17/1995 AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954133 10/30/1995 AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954407 10/30/1995 AMERICAN DENTAL PRODUCTS WHITE COMPOSITE RESIN CORE PASTE WITH FLUORIDE AMERICAN DENTAL PRODUCTS, INC. GEORGE NICOLAE
K954521 10/24/1995 MAMMOSPOT PADDLE AMERICAN MAMMOGRAPHICS, INC. GORDON L HIXSON
K953744 10/25/1995 AMITA CORPORATION VARIOUS MODELS OF SUNGLASSES AMITA CORP. SOON KYUNG LEE
K952736 10/18/1995 PERCENT OXYGEN SENSOR ANALYTICAL INDUSTRIES, INC. PATRICK J PRINDIBLE
K954377 10/26/1995 FORCEPS, GRASPING, FLEXIBLE ENDOSCOPIC ANNEX MEDICAL, INC. EUGENE C KARLES
K945618 10/12/1995 GASTROINTESTINAL TUBES & ACCESSORIES APPLIED MEDICAL TECHNOLOGIES DONNA BRESSAN
K953937 10/31/1995 LIAISON COMPUTER ACCESS & ENVIRONMENTAL CONTROL SYSTEM APT TECHNOLOGY, INC. LARRY T SHIRER
K953416 10/03/1995 BRYAN POSTERIOR SPINAL FIXATOR (BPSF) ARCAN ORTHOPAEDIC CORP. DONALD W BRYAN
K954368 10/07/1995 ARGEDENT BIO 87 PF ARGEN PRECIOUS METALS, INC. MANOHAR LAR MALHOTRA
K954361 10/07/1995 ARGENCO 68M ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K954358 10/07/1995 ARGENDENT GIO 86 FR ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K954360 10/07/1995 ARGESOL 600 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K954362 10/12/1995 ARGISTAR 74 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K954367 10/07/1995 ARGISTAR BIO 75PF ARGEN PRECIOUS METALS, INC. MANOHAR LAR MALHORTRA
K954404 10/07/1995 AUROLITE 45 ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K954359 10/07/1995 SILFREE 80SF+ ARGEN PRECIOUS METALS, INC. MANOHAR LAL MALHOTRA
K954371 10/07/1995 SUREFIRE S ARGEN PRECIOUS METALS, INC. MANOHAR LAR MALHOTRA
K953581 10/03/1995 FIRST RESPONSE OVULATION PREDICTOR TEST ARMKEL, LLC. MAUREEN GARNER
K953081 10/30/1995 BEAMER PLUS ASPEN LABORATORIES, INC. CHARLES M HART
K936067 10/27/1995 ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM ATLANTIS DIAGNOSTICS INTL., INC. TERRENCE J SWEENEY
K952532 10/06/1995 AFFINITY ARTERIAL BLOOD FILTER AVECOR CARDIOVASCULAR, INC. DENNIS E STEGER
K954018 10/05/1995 AVL OMNI ANALYZER AVL SCIENTIFIC CORP. RANDY BYRD
K945850 10/06/1995 BRAUN DIACAN(R) FISTULA NEEDLES B. BRAUN OF AMERICA, INC. MARK S ALSBERGE
K953415 10/19/1995 6200 VITAL SIGNS MONITOR BCI INTL., INC. DONAL ALEXANDER
K951919 10/24/1995 B-D PEN ULTRA BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PETER ZURLO
K953467 10/27/1995 B-D SPINAL ANESTHESIA TRAY SPINAL BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC GREGORY W MORGAN
K951542 10/20/1995 DIRECTIGEN 1-2-3 GROUP A STREP TEST BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC JUDITH J SMITH
K951254 10/07/1995 SAFETYGLIDE NEEDLE BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC KAREN L ROSENCRANS
K945983 10/18/1995 BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS BEBIG TRADE, INC. PETER U NILSEN
K953979 10/03/1995 APOLIPOPROTEIN CALIBRATOR (APO-CAL) BECKMAN INSTRUMENTS, INC. DON W HART
K953340 10/05/1995 QBC ACCUTUBE BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEMS DENNIS MERTZ
K954144 10/06/1995 OPUS HCG CONTROLS BEHRING DIAGNOSTICS, INC. NANCY M JOHANSEN
K954278 10/02/1995 BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005 BETA MEDICAL PRODUCTS, INC. KEVIN BENOIT
K954680 10/20/1995 ACCESS PROLACTIN ASSAY (MODIFICATION) BIO-RAD LABORATORIES, INC. DENNIS GRIFFIN
K953572 10/19/1995 ELX800UV BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K953710 10/25/1995 ELX808 AUTOMATED MICROPLATE READERS BIO-TEK INSTRUMENTS, INC. MICHAEL N SEVIGNY
K953194 10/31/1995 LACTOSORB BONE PIN BIOMET, INC. MARY VERSTYNEN
K953399 10/30/1995 NEEDLE OR CUTTER BIOPHYSIC MEDICAL, INC. MARK A COLE
K953430 10/24/1995 ULTRASOUND PROBE BIOPSY ACCESSORIES BIOSOUND, INC. WAYNE NETHERCUTT
K951010 10/07/1995 CHLAMYDIA OIA BIOSTAR, INC. DAN W CHILDERS
K950150 10/27/1995 CHEMMATE(TM) KAPPA BIOTEK SOLUTIONS, INC. DEBORAH D HINMAN
K950151 10/04/1995 CHEMMATE(TM) L26 (CD20) BIOTEK SOLUTIONS, INC. DEBORAH D HINMAN
K950152 10/27/1995 CHEMMATE(TM) UCHL1 (CD45-RO) BIOTEK SOLUTIONS, INC. DEBOTAH D HINMAN
K942025 10/27/1995 BURGET NASAL STENT BIVONA MEDICAL TECHNOLOGIES H. M KAUFMAN
K952700 10/31/1995 SUPERSLICK BIVONA MEDICAL TECHNOLOGIES HARRY M HAUFMAN
K954636 10/25/1995 BLINDE OPTICS BLINDE EYEWEAR, INC. RACHELLE WALKER
K953802 10/24/1995 TYMPANOSTOMY TUBE BLUFF CITY MEDICAL TECHNOLOGIES, INC. ANTHONY D PRESCOTT
K945445 10/17/1995 BOBES SLIT LAMP BOBES S.A. FRANCISCO J BOBES NAVES
K945775 10/19/1995 BOEHRINGER AUTOVAC(R) 7900 SERIES BOEHRINGER LABORATORIES JOHN KARPOWICZ
K954024 10/23/1995 CHEMSTRIP CRITERION URINE ANALYZER BOEHRINGER MANNHEIM CORP. JOHN D STEVENS
K954346 10/26/1995 CHEMSTRIP MICRAL URINE TEST STRIPS BOEHRINGER MANNHEIM CORP. MICHAEL FLIS
K953602 10/18/1995 SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. MARY P LEGRAW
K950755 10/05/1995 FLEXMATE K500 BREG, INC. BARBER
K951117 10/18/1995 LIHTAN 532 LASER BUCKMAN CO., INC. DAVID W SCHLERF
K940003 10/19/1995 VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT BUCKMAN CO., INC. LAURIE A RIDENER
K954299 10/19/1995 BUHLMANN ANGIOSTENSIN II RIA BUHLMANN LABORATORIES AG RICHARD E CONLEY
K952117 10/19/1995 EPILATOR BURKE NEUTECH, INC. ROBERT E BURKE
K946311 10/04/1995 INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM CALCITEK, INC. CAROL WHITE
K953294 10/18/1995 CANDELA CRYOSYSTEM CS-5 CANDELA LASER CORP. JONATHAN S KAHAN
K953412 10/24/1995 CANDELA MODEL PLTL-1 LASER SYSTEM CANDELA LASER CORP. JONATHAN S KAHAN
K951603 10/05/1995 CARDIMA, INC. FORERUNNER CARDIMA, INC. J. D STEVENS
K943412 10/16/1995 VENTURI VENTILATOR CARDIOPULMONARY CORP. JAMES W BIONDI
K953423 10/11/1995 CASRRASYN ORAL WOUND DRESSING CARRINGTON LABORATORIES, INC. DENNIS R SPARKMAN
K942651 10/19/1995 BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS CASA FUTURA TECHNOLOGIES THOMAS DAVID KEHOE
K953219 10/06/1995 22MM STAINLESS STEEL DISC ELECTRODE, WITH PIN CHALGREN ENTERPRISES, INC. RICHARD KAISER
K953220 10/06/1995 32MM NICKEL PLATED DISC ELECTRODE CHALGREN ENTERPRISES, INC. RICHARD KAISER
K953887 10/31/1995 RE-USABLE CONCENTRIC NEEDLE CHALGREN ENTERPRISES, INC. RICHARD KAISER
K953886 10/31/1995 RE-USABLE MONOPOLAR NEEDLE CHALGREN ENTERPRISES, INC. RICHARD KAISER
K953614 10/27/1995 FORTE CHATTANOOGA GROUP, INC. GRAHAME R WATTS
K953615 10/27/1995 FORTE ES-400 CHATTANOOGA GROUP, INC. GRAHAME R WATTS
K953808 10/25/1995 CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES CHENG CHEN HSING ENTERP. & FACT. CO. LTD. CHEN-CHUNG CHIU
K954565 10/27/1995 EXPLOR-X (AZTEH) HF CHICAGO X-RAY SYSTEMS, INC. AL SOSA
K953393 10/06/1995 TOX PERFECT A TUBE CHIMERA RESEARCH & CHEMICAL, INC. CHARLES A HAY
K944993 10/12/1995 IOLAB.SITE CD PHACOEMULSIFICATION MODULE CHIRON VISION CORP. DONNA A CRAWFORD
K944995 10/05/1995 IOLAB/SITE PERISTALTIC MODULE CHIRON VISION CORP. DONNA A CRAWORD
K953685 10/12/1995 INSTRUMENT SCOPE CLARUS MEDICAL SYSTEMS, INC. JOHN VANDEN HOEK
K951981 10/12/1995 RXAIR 3000 CLEAN AIR RESEARCH & DEVELOPMENT CHARLES D HARRIS
K954670 10/30/1995 PRESSORE MONITOR CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K953772 10/20/1995 BREATHE RIGHT NASAL STRIP CNS, INC. M.W. ANDY ANDERSON
K935456 10/13/1995 REGULUS MEASUREMENT UNIT COMPASS INTL., INC. BRUCE A KALL
K954633 10/23/1995 CONMED ELECTROSURGICAL GROUNDING PAD CONMED CORP. IRA D DUESLER
K952483 10/06/1995 LEEP SYSTEM 1000 COOPERSURGICAL, INC. SHEILA HEMEON-HEYER
K954252 10/18/1995 EASY BREATHING NASAL STRIPS CORBETT LAIR, INC. JOE IERULLI
K944595 10/19/1995 CORDIS HORIZONTAL-VERICAL VALVE SYSTEM CORDIS CORP. MARVIN L SUSSMAN
K954251 10/23/1995 5F ENVOY GUIDING CATHETER (MODIFICATION) CORDIS NEUROVASCULAR, INC. MARLENE WRIGHT VALENTI
K953409 10/16/1995 LAPAROSCOPIC TROCAR CORE DYNAMICS, INC. PATRICIA H PICKETT
K953903 10/20/1995 LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM CORE DYNAMICS, INC. BILL DENNIS
K952308 10/06/1995 COULTER Z 1 COULTER CORP. BENITA BRADFORD-BOURQUE
K950709 10/25/1995 SYNERGY TI ANTERIOR SPINAL SYSTEM CROSS MEDICAL PRODUCTS, INC. DAVID W SCHLERF
K952895 10/24/1995 CMS URETHRAL WARMER CRYOMEDICAL SCIENCES, INC. CLAUDE C CRAWFORD
K953749 10/19/1995 MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS CURWOOD, INC. MATTHEW A MIELKE
K953678 10/02/1995 STERIMED STERIZATION WRAPPER (NON-STERILE) CUSTOMED, INC. FELIXX B SANTOS
K954321 10/13/1995 ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) CYTOCARE, INC. PAUL MIKUS
K954128 10/02/1995 SNOREMASTER D D S, INC. VIRGINIA PERRY
K953640 10/27/1995 DUNA II PENILE PROSTHESIS DACOMED CORP. MARY M WILEN
K950996 10/03/1995 DORNIER THERMAFOCUS 360 FIBER DAIMLER-BENZ AEROSPACE DEBORAH MOORE
K953504 10/03/1995 MICROPRIME DANVILLE ENGINEERING, INC. CRAIG R BRUNS
K951773 10/26/1995 PODOSPRAY DRILL SYSTEM DARCO INTL., INC. KEVIN M O'BRIEN
K952437 10/03/1995 DMA GLUCOSE HEXOKINASE U.V. PROCEDURE DATA MEDICAL ASSOCIATES, INC. C. H MORRIS
K953403 10/06/1995 DEROYAL INDUSTRIES, INC. POLYDERM & POLYDERM BORDER FOAM WOUND DRESSINGS DEROYAL INDUSTRIES, INC. DEBRA F MANNING
K952775 10/06/1995 DEROYAL WOUND CARE MULTIDEX GEL WOUND DRESSING DEROYAL INDUSTRIES, INC. DEBRA F MANNING
K954414 10/23/1995 CENTRALITE BACKPOINTER DIACOR, INC. GLENN N WATERMAN
K952178 10/20/1995 PH-DETECT TEST DIAGNOSTIC REAGENTS, INC. YUH-GENG TSAY
K954312 10/07/1995 ACTIVE THYROXINE RIA DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN WILLIS
K953605 10/02/1995 ULTRA-SENSITIVE ESTRADIOL DIAGNOSTIC SYSTEMS LABORATORIES, INC. JOHN WILLIS
K951684 10/06/1995 AIRPERFECT 1000 (SINGLE-USER SYSTEM), AIRPERFECT 2000 (MULTI-USER SYSTEM) DIGITAL AIR CORP. STAN E TILLMAN
K943952 10/07/1995 DISETRONIC D-MODEM DISETRONIC MEDICAL SYSTEMS JAMES J MYERS
K954345 10/18/1995 DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR DOOSAN CORP. BRENDA M KELLY
K954484 10/18/1995 KODAK AUTOMIXER II PLUS EASTMAN KODAK COMPANY DENNIS E SNEDDON
K952628 10/19/1995 ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS ELASTOMADE ACCESSORIES SDN BHD ONG L MAU
K953406 10/31/1995 EBI X FIX DYNAFIX SYSTEM (DFS) ELECTRO-BIOLOGY, INC. JONATHAN S KAHAN
K953532 10/04/1995 EBICE ELECTRO-BIOLOGY, INC. SHARON A STAROWICZ
K951187 10/02/1995 VARELISA CARDIOLIPIN ABS SCREEN ELIAS USA, INC.
K954212 10/23/1995 CONTAMINATION CONTAINMENT DRAPE ENGINEERING CONTROLS FOR MEDICINE JOHN BUSCH
K954197 10/26/1995 DISPOSABLE FLEX TUBE ENGSTROM MEDICAL WULF TREPTE
K954194 10/20/1995 DISPOSABLE HME/FILTER ENGSTROM MEDICAL PAUL E DRYDEN
K942431 10/11/1995 LAPOROSCOPIC SCISSORS ENTERPRISE MEDICAL CORP. REUBEN MARGOLIASH
K953738 10/16/1995 ERBOTOM ICC 300 ERBE ELECTROMEDIZIN GMBH MICHAEL A CLARK
K953159 10/04/1995 ERBOTOM ICC BIPOLAR ERBE USA, INC. MICHAEL A CLARK
K954162 10/30/1995 ERGOSEAT SYSTEM ERGO-AIR, INC. MARGARET N WAINWRIGHT
K953949 10/16/1995 HUMIDIFIER & ACCESSORIES FISHER & PAYKEL ELECTRONICS LTD. ADELE YEE
K953740 10/12/1995 FOR MED HIGH RISK FOR MED, INC. MARY THERESE WEITMAN
K951373 10/27/1995 FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ FUJIFILM MEDICAL SYSTEM U.S.A., INC. ROBERT A UZENOFF
K954217 10/23/1995 ARTHROPLAST & ARTHRO-CUTTER FUTURE MEDICAL SYSTEMS, INC. PATRICK JANIN
K954094 10/05/1995 OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) G.W.B. INTL., LTD. ANNE BOHSACK
K953514 10/07/1995 COURIER II GAMMEX, INC. THOMAS A DEMKE
K945506 10/12/1995 ACRYLIC DIPPED LATEX EXAMINATION GLOVES GANZ INDUSTRIES SDN. BHD.
K953595 10/27/1995 MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY GE MEDICAL SYSTEMS LARRY A KROGER
K954356 10/07/1995 COMPAX 90/15E GENERAL ELECTRIC CO. LARRY A KROHER
K945855 10/24/1995 A-FACT, ABNORMAL FACTOR ASSAY CONTROL GEORGE KING BIO-MEDICAL, INC. JUDITH A GILLISSEN
K945854 10/24/1995 B-FACT, BORDERLINE FACTOR ASSAY CONTROL GEORGE KING BIO-MEDICAL, INC. JUDITH A GILLISSEN
K945856 10/05/1995 POSITIVE LUPUS ANTICOAGULANT PLASMA GEORGE KING BIO-MEDICAL, INC. JUDITH A GILLISSEN
K945857 10/20/1995 PROTEIN C DEFICIENT PLASMA GEORGE KING BIO-MEDICAL, INC. JUDITH A GILLISSEN
K950566 10/19/1995 DECOMAT 4656 GETINGE DISINFECTION, INC. VINCENT J KOREN
K953571 10/02/1995 VASPORT VASCULAR ACCESS PORT GISH BIOMEDICAL, INC. DEBRA J KRIDNER
K954041 10/16/1995 G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) GLAXO, INC. JAMES E MURRAY
K943101 10/18/1995 GALVANIC SKIN RESPONSE DEVICE GLOBAL ENT. KATHYRN C COOK
K952275 10/11/1995 GLOBAL MEDICAL PRODUCTS TUOHY & CRAWFORD EPIDURAL NEEDLE W/PLASTIC HUB GLOBAL MEDICAL PRODS, INC. DONALD F RYAN
K953684 10/27/1995 GSI 61 CLINICAL AUDIOMETER GRASON-STADLER, INC. JANICE E PAINTER
K951769 10/16/1995 CRYOPRESS GRIMM SCIENTIFIC INDUSTRIES, INC. JOSEPH E GRIMM
K951754 10/16/1995 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST HARDY DIAGNOSTICS MELISSA M TAYLOR
K950760 10/31/1995 ANALYST, MODEL DSP 300 HEART SOUNDS, INC. HART KATZ
K951820 10/20/1995 THROMBOPLASTIN-LI REAGENT HELENA LABORATORIES PAT FRANKS
K953743 10/02/1995 PALASPLINT HERAEUS KULZER, INC. SHARON PARKER
K953917 10/26/1995 LASESONICS LOW POWER CO2 LASER SYSTEM HERAEUS SURGICAL, INC. ROBERT MILDER
K950821 10/03/1995 HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24 HEWLETT-PACKARD CO. RAY STELTING
K945795 10/27/1995 EUB-555A+ HITACHI MEDICAL CORP. OF AMERICA CHARLES F HOTTINGER
K953248 10/23/1995 IRIS BILATERAL TMJ HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES JOCHEN ROGERS
K953262 10/17/1995 QD BILATERAL BREAST COIL HITACHI MEDICAL SYSTEMS AMERICA, INC. JAMES JOCHEN ROGERS
K954235 10/06/1995 HOLLISTER HYDROCOLLOID WOUND DRESSING HOLLISTER, INC. JOSEPH S TOKARZ
K930530 10/17/1995 INCARE PRS 9300 PELVIC FL THERA SYST/TREAT URI INC HOLLISTER, INC. JOSEPH S TOKARZ
K954621 10/23/1995 RECLOSABLE WOUND COVER HOLLISTER, INC. JOSEPH S TOKARZ
K953818 10/12/1995 DALL-MILES SUTURE/BEADED CABLE HOWMEDICA CORP. ROBERT E SMITH
K954001 10/26/1995 SPETZLER PIN HOWMEDICA CORP. JOHN DICHIARA
K953664 10/23/1995 VITALOCK SPIKED ACETABULAR SHELL HOWMEDICA CORP. MARY C SPICER
K953919 10/07/1995 DENTAL ULTRASONIC SCALER INSERTS HU-FRIEDY MFG. CO.,INC. BETSY A BROWN
K953418 10/07/1995 ELECTROCAUTERY SHROUD I.C. MEDICAL, INC. KURT HASPER
K953573 10/07/1995 ICU STOPCOK WITH EXTENSION TUBING ICU MEDICAL, INC. RICHARD WATERS
K954055 10/24/1995 HDX DIGITAL IMAGING SYSTEM IMACOM, INC. JASON CHOU
K952032 10/31/1995 IMAGYN HYSTEROSCOPE SHEATHS IMAGYN MEDICAL, INC. DEBRA A RINDERER
K951363 10/13/1995 CARDIOLIPIN IGG,M,A EIA TEST SYSTEM IMMUNO PROBE, INC. EDWARD C WILSON
K946335 10/20/1995 OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES IMMUNOTECH, INC. JAMES W CHAMPLIN
K952996 10/31/1995 HA/TP COATED CYLINDER IMPLANT 3.3,4.0 IMPLANT CENTER OF THE PALM BEACHES JACK T KRAUSER
K952997 10/31/1995 PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLED IMPLANT CENTER OF THE PALM BEACHES JACK T KRAUSER
K952992 10/31/1995 PROSTHETICS 4MM IMPLANT CENTER OF THE PALM BEACHES JACK T KRAUSER
K952998 10/31/1995 TP SCREW IMPLANT 3.75, 4.0-B5 IMPLANT CENTER OF THE PALM BEACHES JACK T KRAUSER
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K952917 10/16/1995 STERI-OSS IMMEDIATE PLACEMENT IMPLANT STERI-OSS, INC. PAUL GASSER
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K953105 10/05/1995 VISUALINE II BENZODIAZEPINES SUN BIOMEDICAL LABORATORIES, INC. MING SUN
K942987 10/30/1995 NUCLEOTOME L KIT SURGICAL DYNAMICS, INC. CHARMAINE HENDERSON
K954193 10/23/1995 SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET SURGICAL DYNAMICS, INC. CHARMAINE HENDERSON
K952661 10/06/1995 SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 SURGICAL LASER TECHNOLOGIES, INC. RICHARD G JONES
K946136 10/02/1995 INFINITECH LIGHTED INFUSION CANNULA SURGICAL TECHNOLOGIES, INC. ALAN T BECKMAN
K954689 10/30/1995 CONNECT SYBRON DENTAL SPECIALTIES, INC. JEFFREY A ANDERSON
K954708 10/30/1995 SILANE PRIMER SYBRON DENTAL SPECIALTIES, INC. JEFFERY A ANDERSON
K954643 10/19/1995 TRY-IN GEL SYBRON DENTAL SPECIALTIES, INC. JEFFERY A ANDERSON
K953242 10/06/1995 SYMBIOSIS MONOPLAR ELECTROSURGICAL ELECTRODES SYMBIOSIS CORP. JOHN W BOX
K953334 10/31/1995 SYNTHES FLEXNAIL SYNTHES (USA) ANGELA J SILVESTRI
K954081 10/30/1995 PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) TAN CHONG RUBBER GLOVES SDN BHD GAN BOON CHENG
K953533 10/18/1995 RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL TERUMO MEDICAL CORP. KEITH M SMITH
K953475 10/07/1995 CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING THE DU PONT CO. JEAN E BARTLETT
K953477 10/07/1995 MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING THE DU PONT CO. JEAN E BARTLETT
K943872 10/26/1995 COMMANDER MARK II HAIR REMOVAL SYSTEM THE HELENE EDGAR CORP. KEITH EDGAR
K954539 10/30/1995 LG HEX PROSTHETICS THE IMPLANT CENTER OF THE PALM BEACHES JACK T KRAUSER
K952936 10/30/1995 THE TULIP COMPANY BRANSON ANTERIOR ELEVATOR THE TULIP MFG. CO. RICHARD S HUNTER
K952956 10/30/1995 THE TULIP COMPANY BRANSON DOUBLE-ENDED DISSECTOR THE TULIP MFG. CO. RICHARD S HUNTER
K952934 10/30/1995 THE TULIP COMPANY BRANSON RECURVED DISSECTOR THE TULIP MFG. CO. RICHARD S HUNTER
K952900 10/30/1995 THE TULIP COMPANY BRANSON SOFT TISSUE RETRACTOR THE TULIP MFG. CO. RICHARD S HUNTER
K952955 10/30/1995 THE TULIP COMPANY BRANSON STRAIGHT DISSECTOR THE TULIP MFG. CO. RICHARD S HUNTER
K952954 10/30/1995 THE TULIP COMPANY WEIL-BLAKESLEY FORCEPS THE TULIP MFG. CO. RICHARD S HUNTER
K952957 10/30/1995 THE TULIP INSULATED GRASPERS THE TULIP MFG. CO. RICHARD S HUNTER
K952899 10/30/1995 THE TULIP INSULATED SCISSORS THE TULIP MFG. CO. RICHARD S HUNTER
K945853 10/05/1995 THERMOTEK H-300 THERMOTEK, INC. JOHN F SKINNER
K952806 10/26/1995 MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 THOMAS INDUSTRIES DAN PFISTER
K941279 10/12/1995 LOWER BOWEL EVACUATION SYSTEM TILLER MIND BODY, INC. JERI C TILLER
K945838 10/25/1995 CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY TOSHIBA AMERICA MEDICAL SYSTEMS, INC. JAVAD SEYEDZADEH
K954309 10/06/1995 ANGIOREX TOSHIBA MEDICAL SYSTEMS JAVAD SEYEDZADEH
K954310 10/18/1995 BLA-800A TOSHIBA MEDICAL SYSTEMS JAVAD SEYEDZADEH
K952410 10/05/1995 CARBON DIOXIDE - DST TRACE AMERICA, INC. DAVID JOHNSTON
K952488 10/13/1995 TRACE COBAS MIRA RANGE TRACE SCIENTIFIC LTD. DAVID JOHNSTON
K954715 10/27/1995 MICRO-PLANER HANDPIECE TREBAY MEDICAL CORP. DAN H TREACE
K954517 10/27/1995 TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT TREBAY MEDICAL CORP. DAN H TREACE
K954518 10/27/1995 TREBAY TOTAL RECTANGULAR HEAD TREBAY MEDICAL CORP. DAN H TREACE
K953284 10/06/1995 TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM TREND SCIENTIFIC, INC. MARIELLYN TRUAX
K953359 10/17/1995 TRI-STAR UNIVERSAL I/A PHACO PAK TRI-STAR OPHTHALMIC MIKE ANDERSON
K950783 10/27/1995 4000+ U.S. THERAPY PRODUCTS, INC. JACK BAUMGARTEN
K954693 10/23/1995 MEHTA BRONCHIAL BIOSPY DRILL UNITED STATES ENDOSCOPY GROUP, INC. GRETCHEN YOUNKER
K952239 10/03/1995 AUTO SUTURE* MODIFIED LINEAR STAPLER** UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JANET G JOHNSON
K954108 10/17/1995 MODIFIED VERSAPORT UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC VICTOR CLAVELLI
K953173 10/03/1995 NONPOWERED NEUROSURGICAL INSTRUMENT UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JANET G JOHNSON
K953869 10/18/1995 POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JONATHAN GILBERT
K953727 10/07/1995 UNITRON MODEL IKON AOHPD UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K954430 10/06/1995 UNITRON MODEL SOUND F/X UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K954516 10/07/1995 UNITRON MODEL SOUND F/X II UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K953932 10/07/1995 UNITRON MODEL SOUND F/XD UNITRON INDUSTRIES, INC. JERRY G JOHNSON
K943440 10/06/1995 PROFILE 7000 C-SPINE COIL US ASIA INSTRUMENTS, INC. ELIZABETH M RICHARDS
K953394 10/12/1995 VISITEC COLLAR BUTTON CATHETER {GRIFFITHS} VISITEC CO. DAVID A CLAPP
K953888 10/07/1995 TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE VISTA MEDICAL TECHNOLOGIES, INC. KENT RICHARDS
K950854 10/12/1995 VITALOGRAPH 2110 SOFTWARE INTERFACE VITALOGRAPH LTD. PHIL HEMES
K953791 10/30/1995 VLV SA EF INFUSION PORT VLV ASSOCIATES, INC. VINCENT L VAILLANCOURT
K953287 10/06/1995 DIASTAT VASCULAR ACCESS GRAFT W.L. GORE & ASSOCIATES,INC TIMOTHY J RYNN
K953288 10/06/1995 DIASTAT VASCULAR ACCESS GRAFT W.L. GORE & ASSOCIATES,INC TIMOTHY J RYNN
K951676 10/07/1995 GORE-TEX DUALMESH BIOMATERIAL W.L. GORE & ASSOCIATES,INC JOHN W NICHOLSON
K951675 10/07/1995 GORE-TEX MYCROMESH BIOMATERIAL W.L. GORE & ASSOCIATES,INC JOHN W NICHOLSON
K951700 10/07/1995 GORE-TEX SOFT TISSUE PATCH W.L. GORE & ASSOCIATES,INC JOHN W NICHOLSON
K934866 10/20/1995 HYS-SURGIMAT W.O.M. WORLD OF MEDICINE, GMBH E KEEFER
K942631 10/27/1995 ELECTROCARE WACO CORP. DANIEL DE TOUR
K950172 10/05/1995 WAKO AUTOKIT GLUCOSE WAKO CHEMICALS, USA, INC. T ONYA
K954639 10/25/1995 SUNGLASSES WALMART STORES SUSAN DUFFY
K951921 10/30/1995 SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES) WEMBLEY RUBBER PRODUCTS (M) SDN BHD ONG GHEE CHEE
K952052 10/30/1995 SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD) WEMBLEY RUBBER PRODUCTS (M) SDN BHD ONG G CHEE
K954526 10/18/1995 WIDEX SENSO DIGITAL (PX) WIDEX HEARING AID CO., INC. RON MELTSNER
K953776 10/12/1995 STERIKING STERILIZATION POUCHES & ROLLS WIHURI OY JONATHAN S KAHAN
K954435 10/23/1995 WILOMAT STERILIZABLE CLIP FORCEPS W/INTERCHANGABLE MAGAZINES WILO MEDIZINTECHNIK LOTHAR WILBERG GMBH MARK HELLER
K953264 10/20/1995 QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. KIM TOMPKINS
K944689 10/20/1995 ZIRCONIA CERAMIC FEMORAL HEAD WRIGHT MEDICAL TECHNOLOGY, INC. JUDY ENGLISH
K954178 10/23/1995 OSOM PREGNANCY TEST WYNTEK DIAGNOSTICS, INC. SHU-CHING CHENG
K952765 10/13/1995 DELWA-STAR PACIFIER THERMOMETER ZEWA, INC. DAVID L ROSEN
K935892 10/17/1995 INDURENT GEL ZHERMACK DENTAL PRODUCTION EVAN C DICK, PH.D.
K953490 10/20/1995 TRILOGY ACETABULAR SHELL & LINERS 36MM ZIMMER, INC. THEODORE M WENDT
K952072 10/04/1995 ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE ZOMED INTL. THOM WEHMAN
K951370 10/06/1995 ZYMED TELEMETRY SYSTEM; MODEL T8010 ZYMED MEDICAL INSTRUMENTATION J. D HARRIS


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