FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K001486 |
09/15/2000 |
GENX CODA AIR PURIFICATION SYSTEM |
INTL., INC. |
MICHAEL D CECCHI |
K002452 |
09/28/2000 |
3M RELY X VENEER CEMENT TRY-IN PASTER |
3M COMPANY |
SHANNON PETTIT |
K002599 |
09/21/2000 |
MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 |
ACRYMED, INC. |
BRUCE GIBBONS |
K002013 |
09/29/2000 |
OMNIPORT |
ADVANCED SURGICAL CONCEPTS (ASC) |
MARY MCNAMARA-CULLINANE |
K002144 |
09/28/2000 |
MEDLINK DIAGNOSTIC OFFLINE WORKSTATION |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
TERRENCE J SWEENEY |
K001725 |
09/08/2000 |
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A |
AGILENT TECHNOLOGIES, INC. |
RICHARD J PETERSEN |
K002470 |
09/08/2000 |
M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER |
AGILENT TECHNOLOGIES, INC. |
ANN F MICHAELS |
K002508 |
09/01/2000 |
EQUIPMENT DRAPES |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
K002701 |
09/13/2000 |
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS) |
ALLIANCE RUBBER PRODUCTS SDN. BHD. |
CHUA HOOI KOON |
K002784 |
09/20/2000 |
ALOKA UST-5280-5 |
ALOKA CO., LTD. |
CHRIS BOHL |
K993933 |
09/14/2000 |
14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO |
ARROW INTL., INC. |
THOMAS D NICKEL |
K002032 |
09/11/2000 |
C02 LASER MULTIPULSE |
ASCLEPION-MEDITEC AG |
WILLIAM KELLEY |
K001980 |
09/27/2000 |
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE M VOZELLA |
K002734 |
09/14/2000 |
ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE M VOZELLA |
K002837 |
09/19/2000 |
BIS ENGINE |
ASPECT MEDICAL SYSTEMS, INC. |
CHRISTINE M VOZELLA |
K994137 |
09/13/2000 |
ATRISORB-D FREEFLOW BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER WITH 4% DOXYCYCLINE |
ATRIX LABORATORIES, INC. |
AMY TAYLOR |
K001149 |
09/06/2000 |
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK |
AUGUSTINE MEDICAL, INC. |
SCOTT D AUGUSTINE |
K002679 |
09/18/2000 |
6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 |
BAXTER HEALTHCARE CORP. |
JENNIFER M PAINE |
K002739 |
09/11/2000 |
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K |
BAXTER HEALTHCARE CORP. |
VICKI DREWS |
K002380 |
09/05/2000 |
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM |
BAXTER HEALTHCARE CORP. |
VICKI L DREWS |
K000664 |
09/20/2000 |
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS |
BAXTER HEALTHCARE CORP. |
PAULA A TORRIANNI |
K992228 |
09/29/2000 |
BAYER IMMUNO 1 HER-2/NEU ASSAY |
BAYER CORP. |
GABRIEL J MURACA |
K002570 |
09/14/2000 |
BIO-LOGIC CEEGRAPH NETLINK |
BIO-LOGIC SYSTEMS CORP. |
NORMAN E BRUNNER |
K002866 |
09/25/2000 |
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 |
BIO-RAD |
ELIZABETH PLATT |
K002865 |
09/25/2000 |
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 |
BIO-RAD |
ELIZABETH PLATT |
K001022 |
09/26/2000 |
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061 |
BIOCHECK, INC. |
ROBIN J HELLEN |
K002678 |
09/19/2000 |
ASCENT KNEE SYSTEM |
BIOMET, INC. |
DALENE T BINKLEY |
K002735 |
09/19/2000 |
ASCENT XXL OPEN BOX FEMORAL COMPONENT |
BIOMET, INC. |
MICHELLE L MCKINLEY |
K001461 |
09/11/2000 |
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET |
BIOMETRIX LTD. |
MIRIAM ABUTBUL |
K002540 |
09/18/2000 |
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS |
BIONOSTICS, INC. |
KATHLEEN STORRO |
K994008 |
09/29/2000 |
BIOSYS FETAL MONITOR, MODEL IFM-500 |
BIOSYS CO. LTD. |
GARY J ALLSEBROOK |
K000277 |
09/26/2000 |
CONSTELLATION CATHETERS |
BOSTON SCIENTIFIC CORP. |
ANDREA BOUMIS |
K000743 |
09/06/2000 |
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 |
BOSTON SCIENTIFIC SCIMED, INC. |
DEBORAH A FRANK |
K002073 |
09/19/2000 |
PAIN CARE 3000 |
BREG, INC. |
KATHLEEN BARBER |
K001901 |
09/19/2000 |
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 |
C.R. BARD, INC. |
MICHAELA RIVKOWICH |
K000830 |
09/07/2000 |
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE |
CALIFORNIA MEDICAL LABORATORIES, INC. |
MEHMET BICAKCI |
K001093 |
09/19/2000 |
CANDELA SPTL-1B PULSED DYE LASER |
CANDELA CORP. |
JOAN M CLIFFORD |
K000512 |
09/26/2000 |
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
K001244 |
09/26/2000 |
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D |
CITIZEN WATCH CO., LTD. |
JOSEPH D EDMONDSON |
K002591 |
09/13/2000 |
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
K001872 |
09/07/2000 |
I.V. SET-LUER LOCK WITH LATEX FREE INJECTION SITE, MODEL B411 |
CODAN US CORP. |
RICHARD A BASLER |
K002215 |
09/28/2000 |
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
K002385 |
09/18/2000 |
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, |
COOK OB/GYN |
BRENDA DAVIS |
K002383 |
09/13/2000 |
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT |
COOK OB/GYN |
BRENDA DAVIS |
K002066 |
09/26/2000 |
FREEZER TEETHER |
COOL BABY, INC. |
DEWAYNE MOORE |
K002625 |
09/13/2000 |
METHAFILCON A |
COOPERVISION, INC. |
BONNIE TSYMBAL |
K001784 |
09/11/2000 |
VIRIDIS LASER |
COSMOS MEDICAL TECHNOLOGY |
JOHN CLARK |
K002248 |
09/21/2000 |
DINAMAP PRO 1000 MONITOR, MODEL 1000 |
CRITIKON COMPANY,LLC |
THOMAS J ENGLISH |
K002039 |
09/27/2000 |
ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART |
CTI PET SYSTEMS, INC. |
WILLIAM SKREMSKY |
K001647 |
09/26/2000 |
BN PROSPEC SYSTEM |
DADE BEHRING, INC. |
REBECCA S AYASH |
K002541 |
09/26/2000 |
PROTEIN C REAGENT |
DADE BEHRING, INC. |
REBECCA S AYASH |
K002878 |
09/21/2000 |
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER |
DATEX-OHMEDA, INC. |
DANIEL KOSEDNAR |
K002158 |
09/06/2000 |
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE |
DATEX-OHMEDA, INC. |
JOEL KENT |
K002301 |
09/08/2000 |
SUPER 12 |
DENTAL ALLOY PRODUCTS, INC. |
RODNEY GUYTON |
K002302 |
09/26/2000 |
SUPER 14 |
DENTAL ALLOY PRODUCTS, INC. |
RODNEY GUYTON |
K002299 |
09/08/2000 |
SUPER 3 |
DENTAL ALLOY PRODUCTS, INC. |
RODNEY GUYTON |
K002300 |
09/26/2000 |
SUPER 6 |
DENTAL ALLOY PRODUCTS, INC. |
RODNEY GUYTON |
K002387 |
09/28/2000 |
COMFORT CONTROL SYRINGE SYSTEM |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K002607 |
09/12/2000 |
MOSS MIAMI 6.35MM ROD SYSTEM MONOAXIAL SCREWS, POLYAXIAL REDUCTION SCREWS AND SACRAL EXTENDERS |
DEPUY ACROMED |
LISA GILMAN |
K002441 |
09/01/2000 |
FENNING HIP STEM |
DEPUY ORTHOPAEDICS, INC. |
ARLENE C SAULL |
K002329 |
09/18/2000 |
PELVX GELLHORN VAGINAL PESSARY 603-608 |
DESCHUTES MEDICAL PRODUCTS, INC. |
DENISE BESTWICK |
K002354 |
09/26/2000 |
CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
K002694 |
09/15/2000 |
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
K002165 |
09/05/2000 |
LINEZOLID, 30UG, BBL SENSI-DISC |
DICKINSON, AND CO. |
BRADFORD SPRING |
K002060 |
09/07/2000 |
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL |
DONGKUK TECHCO RUBBER INDUSTRIES |
PETER PARK |
K002146 |
09/27/2000 |
KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY |
EASTMAN KODAK COMPANY |
STEPHEN G SLAVENS |
K002285 |
09/26/2000 |
ATAC PAK ALP REAGENT KIT |
ELAN DIAGNOSTICS |
WYNN STOCKING |
K001986 |
09/27/2000 |
SURGITRON IEC II |
ELLMAN INTL., INC. |
FRANK LIN |
K002028 |
09/29/2000 |
BRAVO PH MONITORING SYSTEM |
ENDONETICS, INC. |
WILLIAM A KNAPE |
K002793 |
09/26/2000 |
KETAC CEM U |
ESPE DENTAL AG |
ANDREAS PETERMANN |
K002414 |
09/25/2000 |
PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE |
FISHER & PAYKEL HEALTHCARE, LTD. |
BRETT WHISTON |
K002040 |
09/11/2000 |
FMS SOLO |
FUTURE MEDICAL SYSTEMS, INC. |
PATRICK JANIN |
K002177 |
09/14/2000 |
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES |
HAEMOSCOPE CORP. |
ELI COHEN |
K994340 |
09/20/2000 |
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ |
HAI LABORATORIES, INC. |
RICHARD C LANZILLOTTO |
K002770 |
09/26/2000 |
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 |
K002750 |
09/18/2000 |
HL168T |
HEALTH & LIFE CO., LTD. |
PAUL YANG |
K001900 |
09/11/2000 |
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST |
HELIX DIAGNOSTICS, INC. |
VIRGINIA CAPPEL |
K002711 |
09/28/2000 |
HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER |
HOLOGIC, INC. |
DENISE DUCHENE |
K002320 |
09/14/2000 |
ACCOLADE C FEMORAL COMPONENT |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
K002654 |
09/22/2000 |
HOWMEDICA OSTEONICS SHOULDER SCREW |
HOWMEDICA OSTEONICS CORP. |
JENNIFER A DAUDELIN |
K993773 |
09/13/2000 |
HUMID-HEAT |
HUDSON RCJ AB |
CONSTANCE G BUNDY |
K001882 |
09/19/2000 |
BABY DOPPLEX 4002-TWINS, MODEL BD4002 |
HUNTLEIGH HEALTHCARE, INC. |
AUDREY A WITKO |
K993282 |
09/18/2000 |
IPI HUMIDIFIER CHAMBER |
I.P.I. MEDICAL PRODUCTS |
MAZH SAID, PH.D |
K000145 |
09/13/2000 |
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE |
INDUSTRIAL CLOTHINGS, LTD. |
SYED UMAIR AHMED |
K000139 |
09/13/2000 |
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED |
INDUSTRIAL CLOTHINGS, LTD. |
SYED UMAIR AHMED |
K000142 |
09/13/2000 |
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE |
INDUSTRIAL CLOTHINGS, LTD. |
SYED UMAIR AHMED |
K000141 |
09/13/2000 |
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED |
INDUSTRIAL CLOTHINGS, LTD. |
SYED UMAIR AHMED |
K000143 |
09/13/2000 |
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED |
INDUSTRIAL CLOTHINGS, LTD. |
SYED UMAIR AHMED |
K000138 |
09/13/2000 |
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE |
INDUSTRIAL CLOTHINGS, LTD. |
SYED UMAIR AHMED |
K000515 |
09/15/2000 |
PRO OSTEON 200R RESORBABLE BONE GRAFT SUBSTITUTE, MODELS 2RG051, 2RG101, 2RG151, 2RG201, 2RG301, 2RG050, 2RG100, 2RG150, |
INTERPORE CROSS INTL. |
PROSIE REY-FESSLER |
K001992 |
09/25/2000 |
ILT 0.014 CATHETER, MODEL C114NL2 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K002030 |
09/26/2000 |
OMNI-TRAK 3150/3155A SERIES MONITOR WITH ANESTHETIC AGENT, MODEL 3155A SERIES |
INVIVO RESEARCH, INC. |
FRANCIS CASEY |
K002722 |
09/11/2000 |
DIGITAL BLOOD PRESSURE MONITOR, MODELS HD-503 AND HD-505 |
JAWON MEDICAL CO., LTD. |
WON-HEE PARK |
K001023 |
09/22/2000 |
FREEDOM, MODEL 4660 |
JOHNSON & JOHNSON CONSUMER COMPANIES, INC. |
JOSEPH KICEINA |
K001918 |
09/19/2000 |
KSEA PERCUTANEOUS FORAMINOSCOPY SET |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
K001958 |
09/25/2000 |
KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH |
KEYSTONE MEDICAL |
ALAN P SCHWARTZ |
K002322 |
09/18/2000 |
MODIFICATION TO PANAVIA F |
KURARAY AMERICA, INC. |
KOICHI KIKUCHI |
K002413 |
09/19/2000 |
ULTRASORB SUTURE ANCHOR |
LI MEDICAL TECHNOLOGIES, INC. |
RHODEMANN LI |
K000997 |
09/07/2000 |
ZORTRAN DETECTOR |
LUCENT MEDICAL SYSTEMS |
CINDY PESTKA |
K002044 |
09/12/2000 |
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT |
MAGNA FORTIS CORPORATION |
MARK WERBLUD |
K002005 |
09/22/2000 |
BOLUSPRO ULTRA |
MARCONI MEDICAL SYSTEMS, INC. |
ROBERT L TUROCY |
K002647 |
09/13/2000 |
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS |
MARIETTA CONTACT LENS SERVICE |
MARTIN DALSING |
K002477 |
09/08/2000 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
K002574 |
09/06/2000 |
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT |
MASIMO CORP. |
JAMES J CRONIN |
K002682 |
09/13/2000 |
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES |
MASIMO CORP. |
JAMES J CRONIN |
K000825 |
09/21/2000 |
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER |
MEDI-DYNE, INC. |
NORMAN HALL |
K002072 |
09/11/2000 |
PROLITE VL PULSED LIGHT SYSTEM |
MEDICAL BIO CARE SWEDEN AB |
CONNIE WHITE HOY |
K002416 |
09/11/2000 |
GOLDEN-RULE SCALING CATHETER |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
K002451 |
09/29/2000 |
MODIFICATION TO: PRONTO DRY |
MEDICAL INSTRUMENTS CORPORATION, AG |
JOHN C MATHERLY |
K001869 |
09/18/2000 |
DIAGNOSTIC ELECTROMYOGRAPHY NEEDLE ELECTRODE, DISPOSABLE HYPODERMIC NEEDLE |
MEDICOTEST A/S |
EMALEE G MURPHY |
K002685 |
09/15/2000 |
CORDLESS COMPACT MOBILE X-RAY SYSTEM |
MEDISON RADIOLOGY SYSTEMS, INC. |
JOHN W LEE |
K002655 |
09/06/2000 |
DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550 |
MEDITEC CO., LTD. |
D H CHANG |
K001937 |
09/22/2000 |
MEDLINE ELECTRONIC POSITIONING CHAIR |
MEDLINE INDUSTRIES, INC. |
LARA SIMMONS |
K002776 |
09/28/2000 |
MODIFICATION TO PROFILE -II |
MEDTOX DIAGNOSTICS, INC. |
MICHAEL TURANCHIK |
K002346 |
09/27/2000 |
WIRE, GUIDE, CATHETER, MODEL QSW1000 |
MEDTRONIC AVE, INC. |
LINDA (LINN) LAAK |
K991502 |
09/12/2000 |
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 |
MEDTRONIC PS MEDICAL |
JEFFREY HENDERSON |
K002399 |
09/27/2000 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
K000885 |
09/26/2000 |
DRX HBA1C - FOR PRESCRIPTION HOME USE |
METRIKA, INC. |
JOEL M BLATT |
K001717 |
09/20/2000 |
MICOR CONDUCTION CATHETER |
MICOR, INC. |
JEREMIAH COSTELLO |
K002723 |
09/28/2000 |
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS; REBAR MICRO CATHETER: REBAR-10 (1.7F), 170 CM, DUAL MA |
MICRO THERAPEUTICS, INC. |
MARIBELLE AGUINALDO |
K001806 |
09/12/2000 |
REFRACTIVE SURGERY BLADES |
MILLENNIUM BIOMEDICAL, INC. |
JERRY KAENI |
K002602 |
09/05/2000 |
OBC-63 MEBREAST ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
K002293 |
09/13/2000 |
3D MOTOR-DRIVEN COARSE MANIPULATOR MM-188NE |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K002653 |
09/22/2000 |
MMN-1 COARSE MANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K002658 |
09/22/2000 |
MMO-202N THREE-AXIS JOYSTICK OIL HYDRAULIC MICROMANIPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K002659 |
09/22/2000 |
MMO-202ND THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANPULATOR |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K002291 |
09/13/2000 |
MOTOR-DRIVE MANIPULATOR MM-89 |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
K980937 |
09/15/2000 |
NICORE MODEL ESP -1 |
NICORE EQUIPMENT & LEASING, INC. |
MICHAEL G FARROW |
K000643 |
09/07/2000 |
INPLANT ORTHODONTIC ANCHOR SYSTEM |
NOBEL BIOCARE UAS INC |
JEFF HAUSHEER |
K000975 |
09/25/2000 |
LIPIDURE REWETTING DROPS |
NOF CORP. |
ANN KUROWSKI |
K993675 |
09/05/2000 |
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM |
NOMOS CORP. |
FRANCIS X DOBSCHA |
K001833 |
09/28/2000 |
PREFERENCE TREATMENT SYSTEM |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
LEE MYERS |
K991977 |
09/27/2000 |
TYSHAK, MODEL 102 AND Z-MED, MODEL 302 |
NUMED, INC. |
NICHELLE LAFLESH |
K001176 |
09/21/2000 |
DISPOSABLE MICROKERATOME BLADES-PE |
OASIS MEDICAL, INC. |
YVONNE FERNANDEZ |
K002242 |
09/20/2000 |
POLESTAR N-10 |
ODIN TECHNOLOGIES LTD. |
ADI ICKOWICZ |
K001056 |
09/29/2000 |
OLYMPIC WARM-UP |
OLYMPIC MEDICAL CORP. |
JOSEPH P STEFANILE |
K994103 |
09/05/2000 |
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
K001766 |
09/08/2000 |
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TAYLOR |
K994112 |
09/29/2000 |
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) |
ONCOGENE SCIENCE, INC. |
WALTER P CARNEY |
K002448 |
09/11/2000 |
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM). |
OON CORP. RESOURCES |
CLEMENT K K OON |
K000847 |
09/27/2000 |
ORALUBE |
ORASYSTEMS |
BERNARD SESSMAN |
K000678 |
09/18/2000 |
RAEBBITT/EVOLUTION POWERED WHEELCHAIR |
OTTO BOCK ORTHOPEDIC INDUSTRY, INC. |
WILLIAM JACKSON |
K002544 |
09/13/2000 |
MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM |
OXFORD INSTRUMENTS |
BARRY BRIGHT |
K002360 |
09/26/2000 |
CLOUD CUFF |
PARTS PORT, LTD. |
CATHY SEBASTIAN |
K002111 |
09/08/2000 |
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
PETER YEW NIENG CHOON |
K001987 |
09/06/2000 |
EXPLORER GRADIENT |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
K001796 |
09/06/2000 |
GYROSCAN INTERA (R7.5) |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
K002016 |
09/06/2000 |
PHILIPS INTEGRIS ALLURA |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
PETER ALTMAN |
K992476 |
09/13/2000 |
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS |
PILLING WECK SURGICAL |
RICHARD G JONES |
K001175 |
09/18/2000 |
SERAGARD VASCULAR ACCESS PATCH |
PLATINUM SERVICES, INC. |
NANCY Y STREET |
K001342 |
09/07/2000 |
P.O.P. PAIN KIT |
POST OPERATIVE PAIN MANAGEMENT |
CHARLES ROWLAND II |
K001970 |
09/26/2000 |
JET 1 POWERED WHEELCHAIR |
PRIDE MOBILITY PRODUCTS CORP. |
GENE KULON |
K001951 |
09/08/2000 |
PRIMED PLEATED TIE-BACK, PROCEDURE MASK PM4-305, PRIMED PLEATED EAR-LOOP, PROCEDURE MASK PM4-306 |
PRIMELINE MEDICAL PRODUCTS, INC. |
KATHERINE CO |
K002096 |
09/08/2000 |
TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR |
PROCTER & GAMBLE CO. |
MARK M ANDERSON |
K001366 |
09/19/2000 |
PROSTEC 125I BRANCHYTHERAPY SNAPSEED |
PROSTEC LLC. |
AL WEISENBORN |
K002001 |
09/06/2000 |
BREEZE SLEEPGEAR WITH DREAMSEAL |
PURITAN BENNETT CORP. |
DARIN BUSCH |
K994420 |
09/18/2000 |
POWDER FREE LATEX EXAMINATION PATIENT GLOVES |
PURNABINA SDN BHD |
LIEW YOON FONG |
K002087 |
09/13/2000 |
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS) |
QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD |
ZECHUAN SHAO |
K001995 |
09/08/2000 |
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER |
QRS DIAGNOSTIC, LLC. |
JILL R KRALL |
K002366 |
09/18/2000 |
QUEST MPS BACK-UP SYSYEM |
QUEST MEDICAL, INC. |
DOUG BRYAN |
K001599 |
09/18/2000 |
ACTI-FLEX IV ADMINISTRATION SET |
R-GROUP INTL. |
KERRY ANNE KAHN |
K002290 |
09/13/2000 |
ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) |
RADIOMETER MEDICAL A/S |
KIRSTEN RONO |
K000705 |
09/08/2000 |
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 |
RESPIRONICS, INC. |
DAVID J VANELLA |
K002465 |
09/08/2000 |
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 |
RESPIRONICS, INC. |
DAVID J VANELLA |
K001800 |
09/12/2000 |
ACCUWARM EMG HEAT LAMP |
RJL ASSOCIATES, LLC. |
RONALD LUICH |
K001907 |
09/05/2000 |
CAMIT DIABETES MANAGEMENT SOFTWARE |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
K994349 |
09/06/2000 |
COAGUCHEK S SYSTEM, MODEL 2138280 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
K002609 |
09/05/2000 |
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
K002051 |
09/05/2000 |
INVIDOS |
SCANDITRONIX MEDICAL AB |
EVA LARSTEN |
K002767 |
09/27/2000 |
COMPRESSAR FEMORAL ACCESS COMPRESSION DEVICE |
SEMLER TECHNOLOGIES, INC. |
HERBERT J SEMLER |
K002461 |
09/26/2000 |
HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT |
SHOFU DENTAL CORP. |
CINDY RHOADES |
K002553 |
09/15/2000 |
DS DS I-SERIES |
SMV AMERICA |
LONNIE MIXON |
K001842 |
09/15/2000 |
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 |
SOMANETICS CORP. |
RONALD A WIDMAN |
K992465 |
09/21/2000 |
SOPHY SU8 PRESSURE ADJUSTABLE VALVE |
SOPHYSA SA |
JACQUELINE MASSE |
K002371 |
09/15/2000 |
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM |
SPINEOLOGY, INC. |
PAMELA SNYDER |
K002833 |
09/28/2000 |
MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
K002796 |
09/28/2000 |
MODIFICATION TO PROVIDENT HIP SYSTEM |
STELKAST COMPANY |
DONALD A STEVENS |
K001984 |
09/27/2000 |
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT |
STELKAST COMPANY |
DONALD A STEVENS |
K001642 |
09/12/2000 |
INSIGHT IMAGE GUIDED SURGICAL SYSTEM |
SURGICAL INSIGHTS, INC. |
JON T LEA |
K001765 |
09/07/2000 |
LOOK COLLAGEN SPACERS, MODEL 1514B |
SURGICAL SPECIALTIES CORP. |
LINDA F TEXTER |
K002710 |
09/29/2000 |
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) |
SYNTHES (USA) |
BONNIE J SMITH |
K001945 |
09/22/2000 |
SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K001941 |
09/22/2000 |
SYNTHES MODULAR FOOT SYSTEM |
SYNTHES (USA) |
ANGELA J SILVESTRI |
K002517 |
09/12/2000 |
USS VAS |
SYNTHES (USA) |
JONATHAN GILBERT |
K002026 |
09/06/2000 |
CAPIOX ARTERIAL FILTER |
TERUMO MEDICAL CORP. |
GARRY A COURTNEY |
K000095 |
09/26/2000 |
OLYMPUS SONOSURG TROCAR XT3900 SYSTEM |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
K002559 |
09/12/2000 |
EL-ANA PROFILES-2K1 |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
K001926 |
09/22/2000 |
VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES |
THORATEC LABORATORIES CORP. |
DONALD A MIDDLEBROOK |
K002511 |
09/11/2000 |
FETALTROL |
TRILLIUM DIAGNOSTICS, LLC. |
BRUCE H DAVIS |
K001768 |
09/19/2000 |
OCCU-FLO PUNCTUM PLUGS |
U.S. IOL, INC. |
TERESA BURTON |
K001874 |
09/25/2000 |
PERIPHERALLY INSERTED CENTRAL CATHETER |
UTAH MEDICAL PRODUCTS, INC. |
KEVIN L CORNWELL |
K002432 |
09/01/2000 |
STRATO X |
VILLA SISTEMI MEDICALI S.P.A. |
JEFF MOELLER |
K000599 |
09/08/2000 |
VITALOGRAPH BASE STATION |
VITALOGRAPH, INC. |
PHIL HEMES |
K002255 |
09/18/2000 |
LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) |
WOLFE TORY MEDICAL, INC. |
TIM WOLFE |
K002579 |
09/08/2000 |
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
MOHD HAIZAN HUSSEIN |
K000727 |
09/19/2000 |
BUFFLIGHT CLT SURGICAL LASER SYSTEM |
Y-BEAM TECHNOLOGIES, INC. |
JUDY F GORDON |
K002029 |
09/21/2000 |
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION |
ZOLL MEDICAL CORP. |
PAUL DIAS |
K002004 |
09/21/2000 |
ZYBIT |
ZYMED MEDICAL INSTRUMENTATION |
GRETEL LUMLEY |