FDA 510(k) Applications Received During September, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K002986 09/25/2000 A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 A.R.C. LASER AG DANIEL HOEFER
K002909 09/18/2000 ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 ACRYMED, INC. BRUCE GIBBINS
K002807 09/08/2000 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING ACUSON CORP. CHALON GREEN
K003022 09/28/2000 AERONEB PORTABLE NEBULIZER AEROGEN, INC. TRACI V.A. EDWARDS
K002824 09/11/2000 MACS MODULAR ANTERIOR CONSTRUCT SYSTEM AESCULAP, INC. DAVID W SCHLERF
K002871 09/14/2000 MODIFICATION TO YASARGIL ANEURYSM CLIPS AESCULAP, INC. JOYCE THOMAS
K002758 09/05/2000 AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A AGILENT TECHNOLOGIES DEUTSCHLAND GMBH EGON PFEIL
K003038 09/29/2000 AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A AGILENT TECHNOLOGIES DEUTSCHLAND GMBH EGON PFEIL
K002967 09/22/2000 M2376A DEVICELINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K002741 09/01/2000 BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK ALBERT BROWNE LTD. CYNTHIA J.M.NOLTE
K002937 09/21/2000 TST CONTROL INTEGRATOR FOR STEAM STERILIZERS ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K002894 09/18/2000 MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K002784 09/06/2000 ALOKA UST-5280-5 ALOKA CO., LTD. CHRIS BOHL
K003031 09/28/2000 LENSOCLEAN MULTI-PURPOSE SOLUTION, MODEL 355ML ALPHA VISTA, INC. HELMUT WEBER
K002910 09/18/2000 HOLY DRAGON ACUPUNCTURE NEEDLES ANC IMPORT & EXPORT CO. LTD. WILLIAM ZHANG
K002915 09/18/2000 FLEXIBLE OCCLUSION SYSTEM APPLIED MEDICAL ANIL BHALANI
K002745 09/05/2000 VINYL EXAMINATION GLOVES, POWDER FREE, BLUE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K002746 09/05/2000 VINYL EXAMINATION GLOVES, POWDER FREE, VANILLA COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K003006 09/26/2000 TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION ARROW INTL., INC. THOMAS D NICKEL
K002734 09/01/2000 ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K002837 09/12/2000 BIS ENGINE ASPECT MEDICAL SYSTEMS, INC. CHRISTINE M VOZELLA
K003033 09/28/2000 SCAPHIX, STAPLE, FIXATION, BONE AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K003041 09/29/2000 ULTRASOUND SCANNER TYPE 2101 B-K MEDICAL A/S VILLY BRAENDER
K003029 09/28/2000 INFUSOMAT P B. BRAUN MEDICAL, INC. GARY A GULTAS
K002823 09/11/2000 RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION BAUSCH & LOMB, INC. PAUL G STAPLETON
K002739 09/01/2000 INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K BAXTER HEALTHCARE CORP. VICKI DREWS
K002738 09/01/2000 BAYER RAPIDPOINT 400 SYSTEM BAYER CORP. William J Pignato
K002938 09/21/2000 B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC PETER ZURLO
K002905 09/18/2000 ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER BECKMAN COULTER, INC. MARA CALER
K002799 09/08/2000 PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 BECKMAN COULTER, INC. ANNETTE HELLIE
K002866 09/13/2000 LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 BIO-RAD ELIZABETH PLATT
K002865 09/13/2000 LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 BIO-RAD ELIZABETH PLATT
K003030 09/28/2000 LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET BIO-RAD ELIZABETH PLATT
K002855 09/13/2000 BIOLYTE 2000 NA+,K+,CL-/LI+ELECTROLYTE ANALYZER BIOCARE CORP. PAUL W MCDONALD
K002838 09/12/2000 GASTRIC SUCTION AND DRAINAGE CATHETER BIOENTERICS CORP. DAVID MUNJAL
K002772 09/06/2000 ASCENT XXL CLOSED BOX FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K002735 09/01/2000 ASCENT XXL OPEN BOX FEMORAL COMPONENT BIOMET, INC. MICHELLE L MCKINLEY
K002998 09/26/2000 BIOMET BI-POLAR SHOULDER SYSTEM BIOMET, INC. TRACY J BICKE;
K003044 09/29/2000 COPELAND RESURFACING HEADS BIOMET, INC. SARA A BAILEY
K002757 09/05/2000 ONCOLOGY SALVAGE SYSTEM BIOMET, INC. TINA LAKIN
K002879 09/15/2000 MODIFICATION TO BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. ERIC V HOHENSTEIN
K002835 09/12/2000 BODYSTAT BODYSTAT LTD. I.J. MEEUWSEN
K002802 09/08/2000 RAPID EXCHANGE TAPERTOME BOSTON SCIENTIFIC CORP. CAROL J HOLLOWAY
K002868 09/13/2000 BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER C.R. BARD, INC. ANGELA L BUNN
K002792 09/07/2000 CARESIDE CHOLINESTERASE CARESIDE, INC. KENNETH B ASARCH
K003020 09/27/2000 CARDIAC FUNCTION LABORATORY; PRESSURE INTERFACE; PRESSURE / VOLUME CATHETER CD LEYCOM BV TIM LENIHAN
K003035 09/28/2000 CLARREN HELMET CHILDREN'S HOSPITAL & MEDICAL CENTER DAVID J BLOCH
K002798 09/07/2000 CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS Codman & Shurtleff, Inc. JAMES M FLAHERTY
K002830 09/11/2000 PELVIC MUSCLE THERAPY COLONIAL MEDICAL SUPPLY PATRICIA LEIGH, R.N.
K003034 09/28/2000 COLTENE AURA COMPOMER RESTORATIVE SYSTEM COLTENE/WHALEDENT INC. H. J VOGELSTEIN
K002958 09/22/2000 SHAPEABLE DOPPLER FLOW PROBE COOK VASCULAR, INC. THOMAS J KARDOS
K002898 09/18/2000 CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST CURON MEDICAL, INC. THOMAS C WEHMAN
K002984 09/25/2000 EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION CYBERCARE TECHNOLOGIES, INC. J. TERRY DRURY
K002885 09/15/2000 DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP DADE BEHRING, INC. RADAMES RIESGO
K002731 09/01/2000 N LATEX B2-MICROGLOBULIN DADE BEHRING, INC. RADAMES RIESGO
K002804 09/08/2000 N PROTEIN STANDARD SL DADE BEHRING, INC. REBECCA S AYASH
K002852 09/13/2000 N/T PROTEIN CONTROL SL DADE BEHRING, INC. REBECCA S AYASH
K002949 09/21/2000 MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC; MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 40CC DATASCOPE CORP. JOANNE WOLF
K002878 09/15/2000 DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER DATEX-OHMEDA, INC. DANIEL KOSEDNAR
K002925 09/19/2000 COOLBLU CURING LIGHT DENTAL SYSTEMS.COM, INC. SHINOBU DOI
K002733 09/01/2000 SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM DEPUY ACROMED FRANK MASS
K003043 09/29/2000 SURGICAL TITANIUM MESH SYSTEM DEPUY ACROMED KAREN F JURCZAK
K003026 09/28/2000 PFC SIGMA LUGGED TIBIAL TRAY DEPUY ORTHOPAEDICS, INC. JANET G JOHNSON
K002883 09/15/2000 PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. CHERYL K HASTINGS
K002768 09/06/2000 ACAPELLA DHD HEALTHCARE CORP. LAWRENCE WEINSTEIN
K002756 09/05/2000 EASE-A-CULT DIAGNOSTICA, INC. YOLANDA SMITH
K002783 09/06/2000 FIXION INTERLOCKING NAIL (FIXION IL NAIL) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K002829 09/11/2000 DJ ORTHOPEDICS FEMORAL ANCHOR DJ ORTHOPEDICS, LLC JAMAL D RUSHDY
K002929 09/20/2000 DORNIER COMPACT ALPHA LITHOTRIPTER DORNIER MEDTECH AMERICA, INC. CAROL WERNECKE
K002877 09/15/2000 MICTEC ENDOSCOPES AND ACCESSORIES DUFNER INSTRUMENTE GMBH DAGMAR MASER
K002980 09/25/2000 MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM EBI, L.P. PATRICIA FLOOD
K002817 09/11/2000 SYNETEC ELA MEDICAL, INC. SUSAN OLIVE
K002973 09/22/2000 EMBOL-X INTRODUCER, MODEL CF00200 EMBOL-X, INC. ED LEE
K002941 09/21/2000 ACETABULAR PLATES ENCORE ORTHOPEDICS, INC. J.D. WEBB
K002959 09/22/2000 MODIFICATION TO ISOBAR SPINAL SYSTEM ENCORE ORTHOPEDICS, INC. JOANNA DROEGE
K002778 09/06/2000 ENTERIC INJECTION CATHETER WITH IRRIGATION ENTERIC MEDICAL TECHNOLOGIES, INC. JILL M VISOR
K002913 09/18/2000 HEADBAND FOR BAHA ENTIFIC MEDICAL SYSTEMS, INC. CONSTANCE G BUNDY
K002848 09/13/2000 SPO2 WRAP SENSOR EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K002920 09/19/2000 MEGAVISION CPX, MEGAVISION FA, MODEL I AND II ESCALON MEDICAL CORP. RONALD HUENEKE
K002793 09/07/2000 KETAC CEM U ESPE DENTAL AG ANDREAS PETERMANN
K002981 09/25/2000 ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODEL LCSC5,LCSC1,CS23C,CS231,CS14C,CS141,LCSB5,LCSK5,LCS15,LCS16,CS150 ETHICON ENDO-SURGERY, INC. RUTH A WOOD
K002906 09/18/2000 ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 ETHICON ENDO-SURGERY, INC. RUTH ANN WOOD
K002839 09/12/2000 END EXPIRATORY FILTER, MODEL RT020 FISHER & PAYKEL HEALTHCARE, LTD. CHRIS MANDER
K002884 09/15/2000 PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES FOTONA D.D. MOJCA VALJAVEC
K002761 09/05/2000 FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K002892 09/15/2000 FRSENIUS PD IQCARD CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFEILD
K002997 09/26/2000 FIESTA IMAGING OPTION GE MEDICAL SYSTEMS LARRY A KROGER
K002978 09/25/2000 LIGTHSPEED 3.0 CT SCANNER SYSTEM GE MEDICAL SYSTEMS LARRY A KROGER
K002957 09/22/2000 SOLAR SPO2 MODULE WITH MASIMO SET GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN DAVID WAHLIG
K002803 09/08/2000 THE O'NEIL STERILE FIELD URINARY CATHETER KIT GO MEDICAL INDUSTRIES PTY. LTD. GEORGE O'NEIL
K003000 09/26/2000 GRAMS NYLON NONABSORBABLE SUTURE GRAMSMED LLC ANTHONY J DIMERCURIO
K002999 09/26/2000 GRAMS POLYPROPYLENE NONABSORBABLE SUTURE GRAMSMED LLC ANTHONY J DIMERCURIO
K003001 09/26/2000 GRAMS SILK NONABSORBABLE SUTURE GRAMSMED LLC ANTHONY J DIMERCURIO
K003017 09/27/2000 GRAMSORB SYNTHETIC ABSORBABLE SUTURE GRAMSMED LLC A. J DIMERCURIO
K002777 09/06/2000 VACUETTE WITH PPACK GREINER VACUETTE NORTH AMERICA, INC. Judi Smith
K002737 09/01/2000 SMITH & NEPHEW PORPS & TORPS GYRUS ENT L.L.C. ALICIA FARAGE
K002947 09/21/2000 BIOMOL ASPIRATION BIOPSY NEEDLE H.S. HOSPITAL SERVICE S.R.L. LUCIO IMPROTA
K002944 09/21/2000 PRECISA BIOPSY NEEDLE H.S. HOSPITAL SERVICE S.R.L. LUCIO IMPROTA
K002946 09/21/2000 SILENT BIOPSY NEEDLE H.S. HOSPITAL SERVICE S.R.L. LUCIO IMPROTA
K002827 09/11/2000 MAC ACUPUNCTURE NEEDLE HAENGLIM SEOWON CORP. YUN CHOL CHO
K002775 09/06/2000 DISTAL VOLAR RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. AL WEISENBORN
K003045 09/29/2000 HA-TI (HAND TITANIUM SCREW) IMPLANT HATI DENTAL AG. HEINZ E WICK
K002770 09/06/2000 IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10 HDC CORP. EARL SMART
K002846 09/12/2000 HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR HEADSTAR MEDICAL PRODUCTS CO., LTD
K002882 09/15/2000 HL168B HEALTH & LIFE CO., LTD. PAUL YANG
K002750 09/05/2000 HL168T HEALTH & LIFE CO., LTD. PAUL YANG
K003012 09/26/2000 RAICHEM PHOSPORUS REAGENT HEMAGEN DIAGNOSTICS, INC. JOSE A MONTANEZ
K003023 09/28/2000 COBE HC 700 MIDI HEMOCONCENTRATOR HOSPAL INDUSTRIE BARBARA A WATSON
K002921 09/19/2000 SUREONE INSULIN SYRINGE HOSUK CO., LTD. Y. H KIM
K002923 09/19/2000 DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K003018 09/27/2000 TITAN TIBIAL NAIL HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K002858 09/13/2000 XIA SPINE SYSTEM HOWMEDICA OSTEONICS CORP. MARY-CATHERINE DILLON
K002764 09/05/2000 HYDROCISION ARTHROJET SYSTEM WITH CAUTERY AND BURR HYDROCISION, INC. DEBBIE IAMPIETRO
K002794 09/07/2000 MODEL 5000 MULTIPLACE HYPERBARIC THERAPY HYPERTEC, INC. DANIEL KAMM
K002795 09/07/2000 MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS HYPERTEC, INC. DANIEL KAMM
K002985 09/25/2000 ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS ICS MEDICAL CORP. DELMAR F BLOEM
K002886 09/15/2000 IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) IMPLANTECH ASSOCIATES, INC. EDWARD LEICHT
K002964 09/22/2000 NEURO II INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC. JOEL S FADEN
K002765 09/05/2000 LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE INTEGRA NEUROSCIENCES NANCY MATHEWSON
K002890 09/15/2000 INTRALASE 600C LASER KERATOME INTRALASE CORP. CHARLINE GAUTHIER
K003040 09/29/2000 INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY INTRATHERAPEUTICS, INC. MARIA E BRITTLE
K002872 09/14/2000 R&D PROJECT DW271#11A IVOCLAR NORTH AMERICA, INC. ANDY GULATI
K002993 09/25/2000 HERACERAM J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K002815 09/11/2000 GOLD CORE HF PRE SOLDER JENERIC/PENTRON, INC. ANNMARIE TENERO
K003039 09/29/2000 GOLD CORE II JENERIC/PENTRON, INC. ANNMARIE TENERO
K002854 09/11/2000 GOLD CORE POST SOLDER JENERIC/PENTRON, INC. ANNMARIE TENERO
K003037 09/29/2000 JEWEL CAST III JENERIC/PENTRON, INC. ANNMARIE TENERO
K003011 09/26/2000 SELF ETCH BONDING PRIMER JENERIC/PENTRON, INC. ANUMARIE TENERO
K002826 09/11/2000 EQUITY JENSEN INDUSTRIES, INC. JOHN SLANSKI
K002904 09/18/2000 WILLI GELLER CREATION AND LF PORCELAIN JENSEN INDUSTRIES, INC. JOHN SLANSKI
K002908 09/18/2000 JET THERAPY JET THERAPY OWEN B LAMB
K003042 09/29/2000 V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT JOE B. GOLDBERG, O.D. JOE B GOLDBERG
K002857 09/13/2000 ELS CANNULA (KIT), MODEL M1210-88,M1510-88 JOSTRA AG KATHLEEN JOHNSON
K002948 09/21/2000 K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT KAMIYA BIOMEDICAL CO. COLIN GETTY
K002924 09/19/2000 3D ENDOSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNEN
K002788 09/07/2000 KSEA NEURO-FIBERSCOPE KARL STORZ ENDOSCOPY-AMERICA, INC. KEVIN KENNAN
K002806 09/08/2000 K-DEFIB/PACE, MODEL KDP-60A KATECHO, INC. WARREN R WALTERS
K002805 09/08/2000 KENDRO HERACELL CO2 INCUBATOR KENDRO LABORATORY PRODUCTS, L.P. SUSAN D GOLDSTEIN-FALK
K002859 09/13/2000 SSW-STERILE SOLUTION WARMER KMI KOLSTER METHODS, INC. ALWIN H KOLSTER
K002943 09/21/2000 WHEELCHAIR, MECHANICAL SERIES MODEL 3100 MADA MEDICAL PRODUCTS, INC. JEFFERY W ADAM
K002751 09/05/2000 MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K002939 09/21/2000 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER MASIMO CORP. JAMES J CRONIN
K002847 09/13/2000 INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX MAXXIM MEDICAL GAIL DOHERTY
K002933 09/20/2000 STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES MAXXIM MEDICAL PALLIE STODDARD
K002789 09/07/2000 MEDEVIEW SYSTEM MEDEVIEW.COM JEFFREY O BOILY
K002781 09/06/2000 MEDICAL CABLES PATIENT MONITORING CABLES FOR ECG, EEG, SPO2, AND BLOOD PRESSURE MONITORS MEDICAL CABLES, INC. CHRISTOPHER FONTANA
K002970 09/22/2000 SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 MEDICAL DESIGNS L.L.C. PAUL JOHN AXT
K002763 09/05/2000 REMREST MEDICAL INDUSTRIES AMERICA, INC. ANNE B CARLSON
K002801 09/08/2000 MPS M ELECTRODE MEDICAL PHYSICS AND SERVICES, INC. HOWARD C THOMAS
K002822 09/11/2000 VERTEX SYSTEM MEDICAL POSITIONING, INC. CAROL PATTERSON
K002968 09/22/2000 MEDLINE STERILIZATION WRAP MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K002930 09/20/2000 INSTACCULT MEDTEK DIAGNOSTICS, LLC. LIANE F GOSSET
K002776 09/06/2000 MODIFICATION TO PROFILE -II MEDTOX DIAGNOSTICS, INC. MICHAEL TURANCHIK
K002992 09/25/2000 DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TOVE KJAER
K002931 09/20/2000 METRX SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K002869 09/13/2000 LOCALISA CARDIAC NAVIGATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES THOMAS PARKER
K002972 09/22/2000 MEROGEL CONTROL GEL ENT SURGICAL DRESSING MEDTRONIC XOMED DIANA PRESTON
K002812 09/08/2000 IRIS RETRACTING PHACOEMULSIFICATION SLEEVE MICHAEL REYNARD, M.D. MICHAEL REYNARD
K002864 09/13/2000 MODEL 6600GE-64: TRAMA NECK ARRAY MIDWEST R.F. LLC. RALPH S HASHOIAN
K002860 09/13/2000 MODEL 6900GE-64: C-SPINE ARRAY MIDWEST R.F. LLC. RALPH S HASHOIAN
K002774 09/06/2000 HRH-63 HEAD ARRAY COIL MRI DEVICES CORP. THOMAS SCHUBERT
K002850 09/13/2000 MWO-202 3D HYDRAULIC COARSE/FINE MICROMANIPULATOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002889 09/15/2000 PNS MAGNETIC STIMULATOR SYSTEM NEOTONUS, INC. SHEILA HEMEON-HEYER
K002888 09/15/2000 NICHOLS ADVANTAGE THYROGLOB NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K002766 09/05/2000 NICOLET VASOGUARD NICOLET BIOMEDICAL DAVID W WAGNER
K002813 09/08/2000 NIPRO SAFETOUCH SAFETY FISTULA NEEDLE NIPRO MEDICAL CORP. RICHARD D BLISS
K002808 09/08/2000 ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY NORDISKA DENTAL AB RICHARD KIRSCHNER
K002810 09/08/2000 ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY NORDISKA DENTAL AB RICHARD KIRSCHNER
K002811 09/08/2000 ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY NORDISKA DENTAL AB RICHARD KIRSCHNER
K002782 09/06/2000 HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION NUCLEAR DIAGNOSTICS AB JIM HOWARD
K002951 09/21/2000 MAGELLAN VENTILATOR OCEANIC MEDICAL PRODUCTS, INC. WILLIAM M GATES
K002966 09/22/2000 OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR OCU-EASE OPTICAL PRODUCTS, INC. CHARLES R VERNETTE
K002927 09/20/2000 SNARE,FLEXIBLE ODON LIFETECHNOLOGY J M DURAND
K002982 09/25/2000 OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K002918 09/19/2000 OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K002922 09/19/2000 OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS) OMNIGRACE (THAILAND) LTD. WILLIAM E PATTON
K002899 09/18/2000 OPUS 20, MODEL 1ST OPUSDENT LTD. SHOSHANA FRIEDMAN
K002989 09/25/2000 PROCLUDE ORTEK THERAPEUTICS, INC. JULES T MITCHEL
K003028 09/28/2000 CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC OSTEOGENICS BIOMEDICAL, INC. CHAD BARTEE
K002787 09/07/2000 MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 PALCO LABS, INC. RICHELLA GOO
K002845 09/12/2000 PAFLUFOCON C AND E DAILY CONTACT LENS PARAGON VISION SCIENCES WILLIAM E MEYERS
K002862 09/13/2000 PRONEB ULTRA MODEL NUMBER 85B0100 PARI HOLDING CO. DEBRA A PEKAR
K002942 09/21/2000 PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K002880 09/15/2000 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC PIE MEDICAL COLLEEN J HITTLE
K002907 09/18/2000 PVS 1300 NEURO GUIDE WIRE PRECISION VASCULAR SYSTEMS, INC. JOHN R RAGAZZO
K002881 09/15/2000 VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 PULMONETIC SYSTEMS, INC. ROBERT HANKINS
K002742 09/01/2000 SPHYGMOCOR MX MODEL SCOR-MX PWV MEDICAL PTY, LT. KIRSTEN H PAULSON
K002752 09/05/2000 BAYONET FORCEPS BIPOLAR IRRIGATING Q2 MEDICAL ERIC MILLS
K002962 09/22/2000 PRESSURE WIRE SENSOR, MODEL 12003/12303 RADI MEDICAL SYSTEMS AB MATS GRANLUND
K002911 09/18/2000 XSCAN32 TELERADIOLOGY SOFTWARE RADIOGRAPHIC DIGITAL IMAGING, INC. STEPHEN NEUSHUL
K002773 09/06/2000 NEUROMAP WITH NEURO 100 RADIONICS, INC. NANCY C MACDONALD
K003036 09/29/2000 TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 RETINALABS.COM FRANK TIGHE
K002760 09/05/2000 ELECSYS DHEA-S CALSET ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K003048 09/29/2000 ALL TERRAIN WHEELCHAIR (ATW) ROLL-ABILITY (PTY) LTD. VICTOR F MYBURGH
K003047 09/29/2000 AMBULATORY ENTERAL NUTRITION PUMP ROSS PRODUCT DIV. ABBOTT LABORATORIES YUKA HENDERSHOT
K002955 09/22/2000 EMPIRE N BLOOD PRESSURE MANOMETERS RUDOLF RIESTER GMBH & CO. KG PATRICIA RIESTER-FREUDENMANN
K002954 09/22/2000 RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS RUDOLF RIESTER GMBH & CO. KG PATRICIA RIESTER-FREUDENMANN
K002836 09/12/2000 MEDIA FOR GAMETE PREPARATION AND EMBRYO CULTURE SAGE BIOPHARMA GREG HOLLAND
K003046 09/29/2000 IMAGE VASCULAR LASER SCITON, INC. PETER ALLEN
K002853 09/13/2000 SCITON IMAGE HAIR REMOVAL LASER SCITON, INC. PETER ALLEN
K002936 09/21/2000 MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM SECTRA-IMTEC AB HERMAN OOSTERWIJK
K002841 09/12/2000 COOL-TEC ELECTRODES SEEDLING ENTERPRISES. LLC. PAMELA PAPINEAU
K002867 09/13/2000 INVERNESS MEDICAL OVULATION PREDICTOR TEST SELFCARE, INC. CAROL A ADILETTO
K002767 09/06/2000 COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE SEMLER TECHNOLOGIES, INC. HERBERT J SEMLER
K002814 09/11/2000 DISPOSBABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI PM PLASTICS ENTERISE CO., LTD. CHANG T SUN
K002870 09/13/2000 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR SHANGHAI PT PLASTICS ENTERPRISE COMPANY, LTD. PETER WANG
K003014 09/27/2000 SOMATOM EMOTION MS SIEMENS MEDICAL SOLUTIONS USA, INC. KATHLEEN RUTHERFORD
K002832 09/11/2000 CONDUCTIVE GEL FOR ULTRASOUND SKYLARK DEVICE & SYSTEMS CO., LTD GEORGE K.C. CHEN
K002747 09/05/2000 REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS SMITH & NEPHEW, INC. DAVID HENLEY
K002996 09/25/2000 SYNERGY HA COATED POROUS FEMORAL STEMS SMITH & NEPHEW, INC. DAVID HENLEY
K002740 09/01/2000 TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS SMITH & NEPHEW, INC. KIM P KELLY
K002991 09/25/2000 ZAP DUAL CURING LIGHT SOFT-CORE TEXAS, INC. ROY MARTIN
K002856 09/13/2000 AT3C70 TRANSDUCER SONORA MEDICAL SYSTEMS COLLEEN HITTLE
K002753 09/05/2000 SPARTAN A-10 SPARTAN ULTRASONICS, INC. ALDO E EAGLE
K003087 09/27/2000 MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION SPORICIDIN INTL. HAROLD E PLANK
K002834 09/12/2000 SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR SRS MEDICAL SYSTEMS, INC. LEE BRODY
K002976 09/25/2000 RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX ST. JUDE MEDICAL DEAN BRUHN-DING
K002833 09/12/2000 MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER STANDARD IMAGING, INC. RAYMOND RIDDLE
K002796 09/07/2000 MODIFICATION TO PROVIDENT HIP SYSTEM STELKAST COMPANY DONALD A STEVENS
K002912 09/18/2000 VAGINAL PORT, NON-STERILE / 600065, VAGINAL PORT, STERILE / 600073 STERINC TODD ABRAHAM
K002861 09/13/2000 EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124 STERITEC PRODUCTS, INC. LINDA NELSON
K003002 09/26/2000 STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 STERITEC PRODUCTS, INC. LINDA NELSON
K003007 09/26/2000 GALAXY STERNGOLD SUSAN L SPEAR
K002732 09/01/2000 STRYKER NAVIGATION SYSTEM - ENT MODULE STRYKER CORP. NICOLE PETTY
K002876 09/14/2000 JOBSITE ENHANCED MOBILITY CHAIR, MODEL JEM SUITER MEDICAL L.L.C. JAMES P SUITER
K002843 09/12/2000 SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 SULTAN CHEMISTS, INC. CLARK SMITH
K002786 09/07/2000 BIOSENSORS CENTRAL VENOUS CATHETER KITS SUNSCOPE INTL., INC. JORGE HAIDER
K003004 09/25/2000 OSCAR 2, MODEL 222 SUNTECH MEDICAL INSTRUMENTS, INC. GEORGE MYERS
K002916 09/19/2000 SURGI-VISION PROSTATE COIL SURGI-VISION, INC. NANCY E TAYLOR
K002849 09/13/2000 PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES SURGICAL SPECIALTIES CORP. VIKKI M HOFFMAN
K003015 09/27/2000 SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD SURGICAL SPECIALTIES CORP. VIKKI M HOFFMAN
K002932 09/20/2000 PHACOGARD SYNTEC, INC. JIM EASLEY
K002935 09/21/2000 SYNTHES 1.5MM TI BROW LIFT SCREW SYNTHES (USA) THOMAS M MAGUIRE
K002729 09/01/2000 SYNTHES PROXIMAL HUMERAL NAIL SYNTHES (USA) THOMAS M MAGUIRE
K002755 09/05/2000 NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE T. KOROS SURGICAL INSTRUMENTS CORP. TIBOR KOROS
K002903 09/18/2000 ANSPACH ANGLED MICRONOSE ATTACHMENT THE ANSPACH EFFORT, INC. WILLIAM E ANSPACH III
K002901 09/18/2000 KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER THE KENDALL COMPANY PAUL EVANS
K002902 09/18/2000 TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS THE KENDALL COMPANY FRANK J FUCILE
K002749 09/05/2000 ENDOSCOPE CONTOUR DETECTION DEVICE, MODEL 3DX45 AND COLONOSCOPE, MODEL XCF-Q140L/13D THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K002840 09/12/2000 MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM THE PHANTOM LABORATORY, INC. JOSHUA R LEVY
K002896 09/18/2000 ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING THE WESTAIM CORP. STEVEN CHARTIER
K003005 09/26/2000 TISSUELINK BIPOLAR FORCEPS TISSUELINK MEDICAL, INC. ROBERTA L THOMPSON
K002863 09/13/2000 PALFIQUE ESTELITE LV TOKUYAMA AMERICA, INC. DANIEL J MANELLI
K002816 09/11/2000 TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV TRANSONIC SYSTEMS, INC. MARK S ALSBERGE
K003010 09/26/2000 SPIRIT ACUPUNCTURE NEEDLE UNITED PACIFIC CO., LTD. DANIEL YE HUA
K002791 09/07/2000 NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM UNIX ELECTRONIC CO. LTD. GUENTER GINSBERG
K002990 09/25/2000 VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 VASCULAR TECHNOLOGY INCORPORATED DAVID L REGAN
K002831 09/11/2000 VEGA ULTRASONIC NEBULIZER VEGA TECHNOLOGIES, INC. JOSEPH LU
K002780 09/06/2000 VIATRONIX VISUALIZATION SYSTEM (VVS) VIATRONIX, INC. SUSAN D GOLDSTEIN-FALK
K002790 09/07/2000 ADD-ON CONDYLE WALTER LORENZ SURGICAL, INC. TREVOR BYRD
K002983 09/25/2000 C.T.M. POWER CHAIR, MODEL HS-5600 WAREPALMY ENTERPRISE LLC (USA) ROBERT S MCQUATE
K002874 09/14/2000 WELL-TENS WELL-LIFE CONSULTANT KEVIN CHIU
K003016 09/27/2000 PRO-FEMUR R WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K003019 09/27/2000 PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K002975 09/22/2000 DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL WRP SPECIALTY PRODUCTS SDN. BHD. MOHD HAIZAN HUSSEIN
K002969 09/22/2000 XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8 XLTEK DEBBIE DAVY
K002987 09/25/2000 REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE XOMED, INC. MARTIN D SARGENT
K002897 09/18/2000 TITANIUM MIDDLE EAR PROSTHESES XOMED, INC. DAVID TIMLIN
K002828 09/11/2000 XPS NITRO SYSTEM XOMED, INC. MARTIN D SARGENT
K002893 09/18/2000 FLUOROLAB PLUS Z-KAT, INC. WILLIAM F TAPIA
K002961 09/22/2000 MINITUB MULTI-PURPOSE CASSETTES ZANDER MEDICAL SUPPLIES, INC. FRIEDEL MW ZANDER
K002971 09/22/2000 MTG - MINITUB HEATED STAGE SYSTEMS ZANDER MEDICAL SUPPLIES, INC. FRIEDEL MW ZANDER
K002960 09/22/2000 TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 ZIMMER, INC. KAREN CAIN


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