FDA 510(k) Applications Received During July, 2000

FDA 510(k) Number Submission Date Device Name Applicant Contact
K002115 07/13/2000 A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC. JERRY WANG
K002061 07/06/2000 A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR A & D ENGINEERING, INC. JERRY WANG
K002139 07/17/2000 ETEST LINEZOLID AB BIODISK ANNE BOLMSTORM
K002126 07/14/2000 ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP ABBOTT LABORATORIES JILL SACKETT
K002006 07/03/2000 LIFESHIELD ADDITIVE PIERCING PIN ABBOTT LABORATORIES THOMAS P SAMPOGNA
K002075 07/10/2000 ACE SDS 3.75MM SCREW DENTAL IMPLANT ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K002237 07/24/2000 P3IMRT TM ADAC LABORATORIES JANICE E BROWN
K002013 07/03/2000 OMNIPORT ADVANCED SURGICAL CONCEPTS (ASC) MARY MCNAMARA-CULLINANE
K002144 07/17/2000 MEDLINK DIAGNOSTIC OFFLINE WORKSTATION ADVANCED TECHNOLOGY LABORATORIES, INC. TERRENCE J SWEENEY
K002009 07/03/2000 HP M2376A DEVICE LINK SYSTEM, MODEL M2376A AGILENT TECHNOLOGIES, INC. MIKE HUDON
K002122 07/13/2000 VECTOR AIR TECHNIQUES, INC. JOSEPH CAREY
K002192 07/20/2000 DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 ANSELL PERRY JAMES R CHATTERTON
K002054 07/06/2000 X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 APPRIVA MEDICAL, INC. MICHAEL KOLBER
K002256 07/25/2000 ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP ARROW INTL., INC. WILLIAM PAQUIN
K002032 07/03/2000 C02 LASER MULTIPULSE ASCLEPION-MEDITEC AG WILLIAM KELLEY
K002031 07/03/2000 PHACOFRAGMENTATION SYSTEM MEGATRON ASCLEPION-MEDITEC AG WILLIAM KELLEY
K002093 07/11/2000 ATRIUM LITE MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K002182 07/19/2000 AVITA TSO/TS1 INFRARED EAR THERMOMETER AVITA CORPORATION ALLEN REICH
K002316 07/31/2000 PHOENIX DIGITAL EEG AXON SYSTEMS, INC. HOWARD BAILIN
K002085 07/10/2000 ULTRASOUND SCANNER, TYPE 1101 B & K MEDICAL A/S VILLY BRAENDER
K002211 07/21/2000 COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K002210 07/21/2000 SYNTRA DIALYZER, MODEL SYNTRA 120, 160 BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K002033 07/05/2000 BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV CATHETERS BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K002099 07/11/2000 S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- BESCON CO., LTD. MARTIN DALSING
K002109 07/12/2000 OLEEVA FOAM BIO MED SCIENCES, INC. MARK E DILLON
K002120 07/13/2000 LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 BIO-RAD ELIZABETH PLATT
K002196 07/20/2000 LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 BIO-RAD ELIZABETH PLATT
K002233 07/24/2000 BVI SLING BIO-VASCULAR, INC. DAISY P SIN
K002294 07/27/2000 BIOCHECK TESTOSTERONE EIA, MODEL BC-1115 BIOCHECK, INC. ROBIN J HELLEN
K002070 07/07/2000 BIOLOK SCREW BIOCOMPOSITES LTD. J.STEPHEN BRATT
K002020 07/03/2000 LACTOSORB MENISCAL SCREW BIOMET MANUFACTURING, INC. MARY VERSTYNEN
K002278 07/26/2000 BROOKER FEMORAL NAILS BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K002057 07/06/2000 BROOKER TIBIA NAILS BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K002106 07/12/2000 NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER BIOMET, INC. TRACY J BICKEL
K002084 07/10/2000 MICROVASIVE LITHOTRIPTOR FLEXPROBE II BOSTON SCIENTIFIC CORP. ROBERT J MICHALIK
K002133 07/14/2000 NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. JODI LYNN GREENNIZEN
K002181 07/19/2000 GDC ULTRASOFT COIL BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K002263 07/25/2000 BRANAN MEDICAL CORPORARTION MONITECT THC DRUG SCREEN TEST BRANAN MEDICAL CORP. RAPHAEL WONG
K002272 07/26/2000 BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D BRANAN MEDICAL CORP. RAPHAEL WONG
K002266 07/25/2000 BRANAN MEDICAL CORPORATION MONITECT AMPHETAMINE DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002264 07/25/2000 BRANAN MEDICAL CORPORATION MONITECT COCAINE DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002265 07/25/2000 BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002268 07/25/2000 BRANAN MEDICAL CORPORATION MONITECT MORPHINE 2000 DRUG SCREEN TEST BRANAN MEDICAL CORPORATION RAPHAEL WONG
K002321 07/31/2000 PAIN CARE 2000L BREG, INC. KATHLEEN BARBER
K002073 07/10/2000 PAIN CARE 3000 BREG, INC. KATHLEEN BARBER
K002078 07/10/2000 BETA GLUCAN GEL (MACROPRO GEL) BRENNEN MEDICAL, INC. PHILLIP LAWIN
K002077 07/10/2000 GLUCANPRO CREAM BRENNEN MEDICAL, INC. PHILLIP LAWIN
K002205 07/21/2000 CARONY BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K002063 07/07/2000 BIOTRACE, MODEL 1730 BRYAN CORP. ROSE S LOGSDON
K002094 07/11/2000 BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE C.R. BARD, INC. MARION GORDON
K002019 07/03/2000 RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET CALIFORNIA MEDICAL LABORATORIES, INC. MEHMET BICAKCI
K002230 07/24/2000 CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 CAMBRIDGE HEART, INC. JOHN GREENBAUM
K002197 07/20/2000 CARTOUCH CARDIONICS, INC. JEFF MORGAN
K002174 07/19/2000 DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3 CASCO-NERL DIAGNOSTICS CORPORATION (MAINE) KAREN HICKEY
K002296 07/28/2000 CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 CERAMOPTEC, INC. CAROL J MORELLO
K002215 07/24/2000 AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA COGENT DIAGNOTICS LTD. DANIELLE M KNIGHT
K002065 07/07/2000 PATIENT LATEX POLYMER COATED POWDER-FREE GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GR COMFORT RUBBER GLOVES INDUSTRIES SDN BHD CHEE Y FOO
K002147 07/17/2000 FOCUS COMPUTERIZED MEDICAL SYSTEMS, INC. MICHAEL A PARSONS
K002288 07/27/2000 ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER COOK, INC. APRIL LAVENDER
K002254 07/25/2000 COOK PRESSURE MONITORING CATHETER COOK, INC. APRIL LAVENDER
K002286 07/27/2000 LDOB OCCLUSION BALLOON CATHETER COOK, INC. MARY A GOSSARD
K002066 07/07/2000 FREEZER TEETHER COOL BABY, INC. DEWAYNE MOORE
K002188 07/20/2000 SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, CORE-VENT CORP. WILL FISHER
K002190 07/20/2000 POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE (USP) CP MEDICAL PATRICK FERGUSON
K002248 07/25/2000 DINAMAP PRO 1000 MONITOR, MODEL 1000 CRITIKON COMPANY,LLC THOMAS J ENGLISH
K002039 07/05/2000 ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K002080 07/10/2000 BEHRING COAGULATION SYSTEM, MODEL BCS DADE BEHRING, INC. RADAMES RIESGO
K002158 07/17/2000 S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE DATEX-OHMEDA, INC. JOEL KENT
K002298 07/28/2000 SUPER 1 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002301 07/28/2000 SUPER 12 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002302 07/28/2000 SUPER 14 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002299 07/28/2000 SUPER 3 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002300 07/28/2000 SUPER 6 DENTAL ALLOY PRODUCTS, INC. RODNEY GUYTON
K002128 07/14/2000 ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 DIAGNOSTIC SYSTEMS LABORATORIES, INC. MICHAEL (RUSTY) NICAR
K002262 07/25/2000 DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM DIAMEDIX CORP. LYNNE STIRLING
K002165 07/18/2000 LINEZOLID, 30UG, BBL SENSI-DISC DICKINSON, AND CO. BRADFORD SPRING
K002086 07/10/2000 PRIMAFLOW DMG USA, INC. PAMELA PAPINEAU
K002047 07/06/2000 DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2 DOCTOR'S RESEARCH GROUP, INC. RICHARD DESLAURIERS
K002060 07/06/2000 NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL DONGKUK TECHCO RUBBER INDUSTRIES PETER PARK
K002146 07/17/2000 KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY EASTMAN KODAK COMPANY STEPHEN G SLAVENS
K002229 07/24/2000 WACKERS-LIU CQ SOFTWARE ECLIPSE SYSTEMS, INC. ROSINA ROBINSON
K002285 07/26/2000 ATAC PAK ALP REAGENT KIT ELAN DIAGNOSTICS WYNN STOCKING
K002154 07/17/2000 K.E.A.T. EMD ELECTRONIC MEDICAL DEVICES, CORP. JEAN CLAUDE MARTY
K002142 07/17/2000 SALINE IV FLUSH SYRINGE EMT-RX ROBERT J BARD
K002028 07/03/2000 BRAVO PH MONITORING SYSTEM ENDONETICS, INC. WILLIAM A KNAPE
K002223 07/24/2000 EPIC SPO2 FINGER SENSOR, MODEL E412-20 EPIC MEDICAL EQUIPMENT SERVICES, INC. KRISTA OAKES
K002141 07/17/2000 ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT EXACTECH, INC. LISA SIMPSON
K002129 07/14/2000 FERRIS POLYMEM STERILE WOUND DRESSING WITH COLLAGEN FERRIS MFG. CORP. THEODORE THORSEN
K002198 07/20/2000 FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS FLUORO SCAN IMAGING SYSTEMS, INC. WILLIAM J ENGEL
K002277 07/26/2000 FRESENIUS OPTIFLUX 200NR FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K002040 07/05/2000 FMS SOLO FUTURE MEDICAL SYSTEMS, INC. PATRICK JANIN
K002089 07/11/2000 ROSETTA-LT/ROSETTA-RX GENERAL DEVICES MICHAEL SMITH
K002209 07/21/2000 GE MARQUETTE ECG ANALYSIS PROGRAM GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN KRISTIN PABST
K002102 07/12/2000 GENTLE COLONICS IRRIGATION SYSTEM GENTLE COLONICS, INC. GRACE HOLLAND
K002143 07/17/2000 DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM GUIDANT CORP. SUSAN SILAVIN, PH.D.
K002206 07/21/2000 HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO GUIDANT CORP. MARGARET ANDERSON
K002021 07/03/2000 HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADE GYRUS ENT L.L.C. ALICIA FARAGE
K002074 07/10/2000 AB CARDIETTE DAEDALUS VIEW BASE AND AB CARDIETTTE DAEDALUS VIEW HES H&C MEDICAL DEVICES SPA ATTILIO CASTELLI
K002177 07/19/2000 THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES HAEMOSCOPE CORP. ELI COHEN
K002221 07/24/2000 KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR S MASER
K002235 07/24/2000 HORIZONS ERCP CANNULA HORIZONS INTL. CORP. RAFIC SALEH
K002236 07/24/2000 HORIZONS PAPILLOTOME HORIZONS INTL. CORP. RAFIC SALEH
K002320 07/31/2000 ACCOLADE C FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP. NANCY J RIEDER
K002213 07/21/2000 BULL'S-EYE DISPOSABLE NEEDLE RECAPPING AID HUNTER RESEARCH LABORATORIES, INC. BARBARA PEDIGO
K002186 07/20/2000 VASCULAR ASSIST HUNTLEIGH HEALTHCARE, INC. AUDREY A WITKO
K002125 07/14/2000 PINS AND WIRES IMPLANT RESOURCE, INC. AL LIPPINCOTT
K002135 07/14/2000 SLEEPSTRIP DISPOSABLE APNEA SCREENER INFLUENT LTD. JONATHAN S KAHAN
DEN000007 07/18/2000 QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K002011 07/03/2000 GLUTARTEST 1 REAGENT STRIP INTEGRATED BIOMEDICAL TECHNOLOGY, INC. WEN H WU
K002132 07/14/2000 ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS INTELLIGENT INSTRUMENTS PVT. LTD. S.L. KAPOOR
K002171 07/19/2000 INVACARE LIFT CHAIR INVACARE CORP. EDWARD A KROLL
K002317 07/31/2000 MODEL 9000 BARIATRIC WHEELCHAIR INVACARE CORP. EDWARD A KROLL
K002170 07/19/2000 MODEL 9000 PEDIATRIC WHEELCHAIR INVACARE CORP. EDWARD A KROLL
K002157 07/17/2000 RANGER II M6, MODEL IN-888WNL INVACARE CORP. HOWARD M HOLSTEIN
K002284 07/26/2000 VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX INVACARE CORP. EDWARD A KROLL
K002030 07/03/2000 OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES INVIVO RESEARCH, INC. FRANCIS CASEY
K002222 07/24/2000 RD-2104 J.F. JELENKO & CO., INC. RAPHAEL JUDKINS
K002041 07/05/2000 WILLI GELLER CREATION & AV PORCELAIN JENSEN INDUSTRIES, INC. JOHN SLANSKI
K002167 07/18/2000 KARMAN WHEELCHAIR KARMAN HEALTHCARE, INC. ALEX C HORNG
K002202 07/20/2000 KARMAN WHEELCHAIR KARMAN HEALTHCARE, INC. ALEX C HORNG
K002152 07/17/2000 TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION KLS-MARTIN L.P. ART WARD
K002239 07/24/2000 SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM KONTRON MEDICAL SYSTEMS SAS GEORGE MYERS
K002322 07/31/2000 MODIFICATION TO PANAVIA F KURARAY AMERICA, INC. KOICHI KIKUCHI
K002037 07/05/2000 LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS LIFECORE BIOMEDICAL, INC. CAROLYN ANDERSON
K002088 07/11/2000 SHAVER ABLATOR LINVATEC CORP. LAURA D SENEFF
K002207 07/21/2000 MACROPOREPX PEDIATRIC SYSTEM MACROPORE BIOSURGERY, INC. KENNETH K KLEINHENZ
K002200 07/20/2000 CAPELLA MADSEN ELECTRONICS, INC. JIM BERGERSON
K002138 07/17/2000 PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 MAERSK MEDICAL A/S JENNIFER LYONS
K002044 07/05/2000 MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT MAGNA FORTIS CORPORATION MARK WERBLUD
K002005 07/03/2000 BOLUSPRO ULTRA MARCONI MEDICAL SYSTEMS, INC. ROBERT L TUROCY
K002104 07/12/2000 COMBINED PHYSIOLOGICAL MONITORING SYSTEM MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF MARYROSE CUSIMANO
K002279 07/26/2000 ML EYE SPEAR, MODEL ML 27 ES MED-LOGICS, INC. GARY MOCNIK
K002072 07/07/2000 PROLITE VL PULSED LIGHT SYSTEM MEDICAL BIO CARE SWEDEN AB CONNIE WHITE HOY
K002287 07/27/2000 WIZAIR COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. SHOSHANA FRIEDMAN
K002116 07/13/2000 S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0 MEDICAL DEVICE CONSULTANTS, INC. CYNTHIA J NOLTE
K002280 07/26/2000 PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602 MEDICAL DEVICES, INC. WARREN R WALTERS
K002100 07/11/2000 XIMX SYSTEM MEDICAL MANAGER RESEARCH DEVELOPMENT JEFFREY K SHAPIRO
K002232 07/24/2000 AEDEFIBRILLATOR MEDICAL RESEARCH LABORATORIES, INC. JOEL ORLINSKY
K002079 07/10/2000 MULTI-FUNCTION DEFIBRILLATION ELECTRODE MEDICOTEST A/S EMALEE G MURPHY
K002130 07/14/2000 NIR BILIARY STENT MEDINOL LTD. NASR SALMAN
K002153 07/17/2000 ULTRASONIC NEBULIZER, MODEL NE-520 MEDISANA USA, INC. GUENTER GINSBERG
K002185 07/19/2000 SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON AMERICA, INC. GARY J ALLSEBROOK
K002023 07/03/2000 MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714 MEDMIRA LABORATORIES, INC. TODD BISHOP
K002103 07/12/2000 SIMPLICITY SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K002224 07/24/2000 XPS 3000 SYSTEM MEDTRONIC XOMED MARTIN D SARGENT
K002140 07/17/2000 MENICON PROGENT REMOVER MENICON CO. LTD. BEVERLEY D VENUTI
K002310 07/31/2000 CARDIOBEEPER CB12/12, MODEL CB12/12 MERIDIAN MEDICAL TECHNOLOGIES LTD. GERARD LYNN
K002289 07/27/2000 INQWIRE DIAGNOSTIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. CHESTER MCCOY
K002058 07/06/2000 VECTORSURGE 5, MODEL VS-500 METRON MEDICAL AUSTRALIA PTY LTD ROB HOPKINS
K002212 07/21/2000 MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608 MICRO THERAPEUTICS, INC. MARIBELLE AGUINALDO
K002059 07/06/2000 AMT SPINAL SYSTEM MICRON PRECISION ENGINEERING, INC. FRANK E BAILY
K002056 07/06/2000 MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 MICRUS CORP. TOM HOLDYCH
K002191 07/20/2000 CARRIAZO BARRAQUER II MICROKERATOME MORIA, INC. DAVID CONRAD
K002293 07/27/2000 3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002291 07/27/2000 MOTOR-DRIVE MANIPULATOR MM-89 NARISHIGE CO., LTD. MITSUKO YONEYAMA
K002042 07/05/2000 TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018 NEW ENGLAND MEDICAL CORP. STEVEN FODOR
K002068 07/07/2000 ORG-9200A NIHON KOHDEN AMERICA, INC. BONNIE BISHOP
K002260 07/25/2000 SPINA SYSTEM NORTH AMERICAN MEDICAL CORPORATION (NAM) CARLOS BECERRA
K002242 07/24/2000 POLESTAR N-10 ODIN TECHNOLOGIES LTD. ADI ICKOWICZ
K002231 07/24/2000 LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT OLYMPUS OPTICAL CO., LTD. LAURA STORMS-TYLER
K002313 07/31/2000 COMPLEXED PSA MICROTITER ELISA ONCOGENE SCIENCE, INC. SHERYL BROWN-SHIMER
K002121 07/13/2000 TOTAL PSA MICROTITER ELISA ONCOGENE SCIENCE, INC. SHERYL BROWN-SHIMER
K002010 07/03/2000 STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421 ORASURE TECHNOLOGIES, INC. R. SAM NIEDBALA
K002163 07/18/2000 MICROSTREAM EXTERNAL BATTERY CHARGER ORIDION MEDICAL 1987 LTD. SANFORD BROWN
K002053 07/06/2000 NAVITRAK SYSTEM-OPTICAL OPTION, MODEL 900.004 ORTHOSOFT, INC. NICOLE LANDREVILLE
K002156 07/17/2000 APPRAISE URINE MICROALBUMIN COLLECTION KIT OSBORN GROUP, INC. GILBERT P BOURK III
K002036 07/05/2000 OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD OSI MEDICAL, INC. JAMES R LEVANI
K002150 07/17/2000 SONICAID FM820, SONICAID FM830 OXFORD INSTRUMENTS STEVE VALE
K002204 07/20/2000 PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V PACE MEDICAL ROBERT C MACE
K002024 07/03/2000 PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA PANBIO, INC. DAVID C BISHOP
K002228 07/24/2000 PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-"X" & Z-13175-"X" PARADIGM MEDICAL INDUSTRIES, INC. TRACY S BEST
K002195 07/20/2000 FORAMATRON V, MODEL D680 PARKELL, INC. DANIEL R SCHECHTER
K002314 07/31/2000 LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM; 100 MICROGRAM OR LESS OF TOTAL WATER EXTR PERUSAHAAN GETAH ASAS SDN BHD TAN KONG CHANG
K002114 07/12/2000 RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER PERUSAHAAN PELINDUNG GETAH (M) SDN BHD PETER YEW NIENG CHOON
K002112 07/12/2000 RUBBERCARE POLYMER-CHLORINATED POWDER-FREE GUARDIAN POLYMER-CHLORINATED POWDER-FREE PERUSAHAAN PELINDUNG GETAH (M) SDN BHD PETER YEW NEING CHOON
K002111 07/12/2000 RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI PERUSAHAAN PELINDUNG GETAH (M) SDN BHD PETER YEW NIENG CHOON
K002016 07/03/2000 PHILIPS INTEGRIS ALLURA PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. PETER ALTMAN
K002110 07/12/2000 SPL CRIMP SYSTEM PIONEER SURGICAL TECHNOLOGY AMY H MOMMAERTS
K002199 07/20/2000 MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET POINTE SCIENTIFIC, INC. RON JAMISON
K002214 07/24/2000 SINUSCOPE AND BACCESSORIES POLLUX ENDOSCOPY, INC. PRECIOUS J RESCH
K002025 07/03/2000 RIGID GAS PERMEABLE CONTACT LENS POLYMER TECHNOLOGY DEBRA L.B. KETCHUM
K002240 07/24/2000 RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 PRECISION THERAPY INTL., INC. PAUL SUMNER
K002096 07/11/2000 TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR PROCTER & GAMBLE CO. MARK M ANDERSON
K002043 07/05/2000 PELVEX HOMETRAINER PURDUE TECHNOLOGY PARK CHRISTOPH WEISMAYER
K002319 07/31/2000 PURILENS SALINE SOLUTION PURILENS, INC. ART WARD
K002087 07/10/2000 BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD ZECHUAN SHAO
K002241 07/24/2000 QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM QUANTUM BIOENGINEERING, LTD. FLOYD G LARSON
K002366 07/27/2000 QUEST MPS BACK-UP SYSYEM QUEST MEDICAL, INC. DOUG BRYAN
K002067 07/07/2000 RADIANALYZER, MODEL 12710 RADI MEDICAL SYSTEMS AB MATS GRANLUND
K002290 07/27/2000 ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) RADIOMETER MEDICAL A/S KIRSTEN RONO
K002148 07/17/2000 ELECSYS HCG TEST SYSTEM ROCHE DIAGNOSTICS CORP. PRISCILLA A HAMILL
K002168 07/17/2000 ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE RONVIG INSTRUMENTS, LTD. ANNETTE RAVN NEILSEN
K002159 07/17/2000 SNORE SAT RECORDER, MODEL SS41 SAGATECH ELECTRONICS, INC. HEATHER PLATT-MELAX
K002098 07/11/2000 SALUMEDICA NERVE CUFF SALUMEDICA, L.L.C. DAVID N KU
K002062 07/06/2000 SAMSUNG 10DR IMPLANT SYSTEM SAMSUNG SDS CO., LTD CARL ALLETTO
K002051 07/06/2000 INVIDOS SCANDITRONIX MEDICAL AB EVA LARSTEN
K002169 07/18/2000 GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM SCIMEDX CORP. GARY LEHNUS
K002189 07/19/2000 GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM SCIMEDX CORP. GARY L EHNUS
K002107 07/12/2000 IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA. SCIMEDX CORP. GARY LEHNUS,PH.D
K002049 07/03/2000 INVERNESS MEDICAL EARLY PREGNANCY TEST SELFCARE, INC. CAROL A ADILETTO
K002134 07/14/2000 ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM SELFCARE, INC. CAROL A ADILETTO, M.S.
K002175 07/19/2000 NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR SGMP CO., LTD. JANNA P TUCKER
K002176 07/19/2000 NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE SGMP CO., LTD. JANNA P TUCKER
K002218 07/24/2000 NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K002217 07/24/2000 NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K002220 07/24/2000 NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA P TUCKER
K002216 07/24/2000 NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE SHANGHAI CHAMPION PLASTIC PRODUCTS CO., LTD. JANNA T TUCKER
K002015 07/03/2000 SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT JAMES CHU
K002012 07/03/2000 SYNTHETIC POWDERED (YELLOW) VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT JAMES CHU
K002137 07/14/2000 CATHCOR DESKTOP SIEMENS ELEMA AB DAVE SIMARD
K002179 07/19/2000 MAGNETOM ALLEGRA SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
K002225 07/24/2000 OR TABLE/MAGNETOM OPEN VIVA SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JAMIE YIEH
K002105 07/12/2000 SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K002201 07/20/2000 ELECTROSTATIC HYDROPHOBIC BREATHING FILTER SIMS PORTEX, INC. TIMOTHY J TALCOTT
K002261 07/25/2000 MR-III SMITH & NEPHEW, INC. DEMETRIOS TSAKONAS
K002274 07/26/2000 SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW SMITH & NEPHEW, INC. TEDD GOSIAN
K002095 07/11/2000 SNAP MODEL 6 SNAP LABORATORIES, L.L.C. GIL RAVIV
K002082 07/10/2000 SPEEDLINK TRANSVERSE CONNECTOR SPINAL CONCEPTS, INC. DAVID M HOOPER
K002069 07/07/2000 ASCEND SPINAL FIXATION SYSTEM SPINAL INNOVATIONS, LLC. KEN RUSSELL
K002371 07/27/2000 K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM SPINEOLOGY, INC. PAMELA SNYDER
K002281 07/24/2000 STELKAST PROVEN KNEE SYSTEM STELKAST COMPANY DONALD A STEVENS
K002127 07/14/2000 INJECTRITE-C15 AND INJECTRITE-C30 STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K002180 07/19/2000 SIMPLICITY DISPOSABLE PEN NEEDLE STERLING MEDIVATIONS, INC. JOEL DOUGLAS
K002273 07/26/2000 STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE STOECKERT INSTRUMENTE BARBARA WATSON
K002118 07/13/2000 STOCKERT COMPACT SYSTEM VERSION 2.0 STOECKERT INSTRUMENTE CYNTHIA J. M. NOLTE
K002007 07/03/2000 SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS SULZER CARBOMEDICS, INC. LISA O'CONNER
K002324 07/31/2000 MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA SULZER MEDICA FRANCES E HARRISON
K002018 07/03/2000 NDO SURGICAL SURGICAL OVERTUBE SURGICAL, INC. JEFF CERIER
K002271 07/26/2000 2.4MM CORTEX SCREW, SELF-TAPPING SYNTHES (USA) THOMAS M MAGUIRE
K002257 07/25/2000 TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 TECNO INSTRUMENTS (PVT.) LTD. SUSAN D GOLDSTEIN-FALK
K002238 07/24/2000 CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY A COURTNEY
K002026 07/03/2000 CAPIOX ARTERIAL FILTER TERUMO MEDICAL CORP. GARRY A COURTNEY
K002193 07/20/2000 TETRAD TC-C3-ACP TETRAD CORP. DENNIS R DIETZ
K002071 07/07/2000 SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES TISSUE TECHNOLOGIES, INC. JESSE KRAMER
K002045 07/05/2000 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS TOTAL WATER TREATMENT SYSTEMS, INC. KENNETH J CLARK
K002308 07/28/2000 OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A TRIMEDYNE, INC. SUSAN H GAMBLE
K002258 07/25/2000 ULTRAGUIDE CT-GUIDE 1010 ULTRAGUIDE LTD. GEORGE MYERS
K002318 07/31/2000 UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES UNITED CHAIR MFG., LLC. DOUGLAS A HANBY
K002008 07/03/2000 SURGICAL DYNAMICS SPINAL RETRACTOR UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER E SCHUCK
K002297 07/28/2000 YORAMED, MODEL T-202 UNITED YORAM DISTRIBUTORS, INC. MORRIS MIZRAHI
K002276 07/26/2000 PSI SKULL CLAMP V. MUELLER NEURO/SPINE GARY COOPER
K002312 07/31/2000 PROTON VISION 7.0 VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K002194 07/20/2000 TREATVISION VARIAN MEDICAL SYSTEMS, INC. LINDA S NASH
K002046 07/05/2000 MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 VSM TECHNOLOGY, INC. HOWARD M HOLSTEIN
K002184 07/19/2000 COD COMPRESSION OSTEOTOMY DEVICE WALTER ABENDSCHEIN, M.D. WALTER ABENDSCHEIN
K002131 07/14/2000 LACTOSORB ETHMOID STENT WALTER LORENZ SURGICAL, INC. TREVOR BYRD
K002083 07/10/2000 LORENZ RESORBABLE DISTRACTOR SYSTEM WALTER LORENZ SURGICAL, INC. STEVE HERRINGTON
K002219 07/24/2000 WANDY SELF-ADHESIVE NEUROSTIMULATION ELECTRODE WANDY RUBBER INDUSTRIAL CO., LTD JANIS YANG
K002227 07/24/2000 WANDY SILICONE CONDUCTIVE RUBBER PAD WANDY RUBBER INDUSTRIAL CO., LTD JANIS YANG
K002315 07/31/2000 WISEBANDS SKIN CLOSURE DEVICE WISEBANDS LTD. MARY PAGE
K002255 07/25/2000 LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) WOLFE TORY MEDICAL, INC. TIM WOLFE
K002149 07/17/2000 LINEAGE ACETABULAR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K002064 07/07/2000 COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL WRP ASIA PACIFIC SDN. BHD. YUE WAH CHOW
K002269 07/26/2000 ELECTROSURGICAL PROBES AND DEVICES-GELTX XIMED/PROSURE/INJECTX ASHVIN DESAI
K002172 07/19/2000 POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) XIROS PLC JIM ROWLAND
K002029 07/03/2000 ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION ZOLL MEDICAL CORP. PAUL DIAS
K002004 07/03/2000 ZYBIT ZYMED MEDICAL INSTRUMENTATION GRETEL LUMLEY


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