| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K991020 |
03/29/1999 |
DOUBLE LUMEN NEEDLE |
INTL., INC. |
MICHAEL D CECCHI |
| K991022 |
03/29/1999 |
SPERM WASHING MEDIA |
INTL., INC. |
MICHAEL D CECCHI |
| K990978 |
03/23/1999 |
ALBUMIN BCG, MODEL AL 103-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K990980 |
03/23/1999 |
BUN, MODEL BU 104-01 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K990981 |
03/23/1999 |
GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K990776 |
03/09/1999 |
AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM |
AAP IMPLANTATE AG |
ELLEN HENKE-KNUPP |
| K990722 |
03/05/1999 |
ETEST FOR CEFUROXIME |
AB BIODISK |
ANNE BOLMSTROM |
| K990685 |
03/03/1999 |
TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19) |
AB BIODISK |
ANNE BOLMSTROM |
| K991010 |
03/26/1999 |
ACP |
ABBOTT DIAGNOSTICS MFG., INC. |
LINDA MORRIS |
| K990774 |
03/09/1999 |
ABBOTT ARCHITECT CEA |
ABBOTT LABORATORIES |
KAREN L GATES |
| K991175 |
03/29/1999 |
MODIFICATION TO ALCYON DIRECT BILIRUBIN |
ABBOTT LABORATORIES |
MARK LITTLEFIELD |
| K990729 |
03/05/1999 |
FAMOUS PHYSICIANS BRAND DISPOSABLE ACUPUNCTURE NEEDLES |
ACC INTL. |
ARTHUR K.K. MA |
| K990693 |
03/03/1999 |
FLEXNEEDLE PLUS |
ACT MEDICAL, INC. |
WENDY V SHOTTS |
| K990788 |
03/10/1999 |
AD-TECH'S FORAMEN OVALE ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORP. |
DAVID PUTZ |
| K990867 |
03/16/1999 |
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. |
SANDRA SUNDELL |
| K990845 |
03/15/1999 |
MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15 |
ADVANCED SPINE FIXATION SYSTEMS, INC. |
GREG HOLLAND |
| K990779 |
03/09/1999 |
HEMASEAL & CIDE |
ADVANTAGE DENTAL PRODUCTS, INC. |
INGRID K PELERIN |
| K990997 |
03/25/1999 |
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER |
AKTINA MEDICAL PHYSICS CORP. |
JOAN Z ACHAROPOULOS |
| K991034 |
03/29/1999 |
CONVERTORS SURGICAL GOWNS |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
| K990822 |
03/11/1999 |
RAPIDONE - COCAINE TEST |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K990818 |
03/11/1999 |
RAPIDONE - MARIJUANA TEST |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K990820 |
03/11/1999 |
RAPIDONE - OPIATES TEST |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K990665 |
03/02/1999 |
BQ/BM INTEGRATED LASER DELIVERY SYSTEM |
AMERICAN LASER CORP. |
DANIEL HOEFER |
| K990725 |
03/05/1999 |
NUVOLASE 532 LASER SYSTEM |
AMERICAN LASER CORP. |
DANIEL HOFFER |
| K990780 |
03/09/1999 |
NUVOLASE 532 CUTANEOUS LASER SYSTEM |
AMERICAN LASER MEDICAL |
DANIEL HOEFER |
| K990873 |
03/16/1999 |
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE |
AMERITEK, INC. |
K.C. YEE |
| K990681 |
03/02/1999 |
DBSET MULTIDRUG SCREEN TEST KIT |
AMERITEK, INC. |
K. C. YEE |
| K991075 |
03/31/1999 |
ATLAST GLUCOSE CONTROL SOLUTION |
AMIRA MEDICAL, INC. |
NINA PELED |
| K990677 |
03/02/1999 |
ABSOGEL CHEMOTHERAPHY GLOVES |
AMPRI RUBBERWARE INDUSTRIES SDN BHD |
LI KIM PHNG |
| K990812 |
03/11/1999 |
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTA |
AMPRI RUBBERWARE INDUSTRIES SDN BHD |
PACK LOON TANG |
| K990901 |
03/18/1999 |
POWDER FREE LATEX EXAMINATION GLOVES |
APL PRODUCTS SDN. BHD. |
SON HONG LEE |
| K990879 |
03/16/1999 |
PRE POWDERED LATEX EXAMINATION GLOVES |
APL PRODUCTS SDN. BHD. |
SON HONG LEE |
| K990775 |
03/09/1999 |
URETERAL ACCESS SHEATH SET |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K990829 |
03/12/1999 |
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 |
ARROW INTL., INC. |
THOMAS D NICKEL |
| K990987 |
03/24/1999 |
BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B |
ARTHREX, INC. |
VERNON BROWN |
| K990957 |
03/22/1999 |
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K |
ASTORIA-PACIFIC,INC. |
RAYMOND L PAVITT |
| K991053 |
03/30/1999 |
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) |
ASTRA TECH, INC. |
NIKLAS LIDSKOG |
| K990683 |
03/03/1999 |
AXON MP-1 MICROPOSITIONER |
AXON INSTRUMENTS, INC. |
ANDREW L BLATZ |
| K990710 |
03/04/1999 |
BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES |
BARRIERMED GLOVE CO. |
CARLO PONCIPE |
| K990953 |
03/22/1999 |
RENAL LINK |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K990649 |
03/01/1999 |
GLUCOMETER ELITE XL BLOOD GLUCOSE METER, GLUCOMETER ELITE BLOOD GLUCOSE TEST SYSTEMS |
BAYER CORP. |
GEORGE M TANCOS |
| K991086 |
03/31/1999 |
CAPNOCHECK II, MODEL 8400 |
BCI INTL., INC. |
DONALD ALEXANDER |
| K990704 |
03/04/1999 |
ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K990777 |
03/09/1999 |
MED-RX EXTENSION SETS |
BENLAN, INC. |
BILL C.K. LIM |
| K990656 |
03/01/1999 |
CHROMOPHARE D 530 LDR SURGICAL LIGHT |
BERCHTOLD HOLDING GMBH |
WOLFRAM K HILL |
| K990928 |
03/19/1999 |
LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 |
BIO-RAD |
ELIZABETH PLATT |
| K990858 |
03/15/1999 |
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 |
BIO-RAD |
ELIZABETH PLATT |
| K990827 |
03/12/1999 |
MICROPLATE NEONATAL GALT ASSAY |
BIO-RAD |
JULIET CARRARA |
| K990888 |
03/10/1999 |
MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 |
BIO-RAD |
ELIZABETH PLATT |
| K990993 |
03/24/1999 |
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 |
BIOCHECK, INC. |
ROBIN HELLEN |
| K990955 |
03/22/1999 |
MODIFICATION OF:BIODERM FOAM WOUND DRESSING |
BIODERM, INC. |
GEORGE WORTHLEY |
| K990830 |
03/12/1999 |
MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K991009 |
03/26/1999 |
RC BUTTRESS |
BIOMET, INC. |
TRACY BICKEL |
| K990821 |
03/11/1999 |
PROVIDENCE CUP SYSTEM |
BIOPRO, INC. |
CHERYL WARSINSKE |
| K990956 |
03/22/1999 |
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 |
BIOSENSOR CORP. |
STEVE SPRINGROSE |
| K990968 |
03/23/1999 |
E-SCAN |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K990856 |
03/15/1999 |
HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 |
BIRD PRODUCTS CORP. |
TOM GUTIERREZ |
| K990864 |
03/16/1999 |
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 |
BOSTON SCIENTIFIC CORP. |
ABBY LIPMAN |
| K991056 |
03/30/1999 |
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
DANIEL J DILLON |
| K990659 |
03/01/1999 |
NASAL AIRE |
BREATHING TECHNOLOGIES CORP. |
TERRY C MCMAHAON |
| K990878 |
03/16/1999 |
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDER FREE) |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K990876 |
03/16/1999 |
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K991038 |
03/29/1999 |
VASO PRESS DVT SYSTEM, MODELS VP500, VP501 |
BRITT CORP., INC. |
J. JAMES BRITTON |
| K990670 |
03/02/1999 |
HELIOFORM GOLD-BASED ALLOY |
C. HAFNER GMBH & CO. |
JOHN F LEMKER |
| K990809 |
03/11/1999 |
CADISCOPE ELECTRONIC STETHOSCOPE |
CADITEC AG |
BETTY LOCK |
| K990757 |
03/08/1999 |
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA |
CANTOR & SILVER LTD. |
MARTIN DALSING |
| K990795 |
03/10/1999 |
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES |
CARDIAC PATHWAYS CORP. |
ERIN DIGNAN |
| K991073 |
03/31/1999 |
ACIER SUTURES |
CARDIO THORACIC SYSTEMS |
MICHAEL J BILLIG |
| K991065 |
03/31/1999 |
CARESIDE PT |
CARESIDE, INC. |
NENNETH B ASARCH |
| K991023 |
03/29/1999 |
STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL |
CASE MEDICAL, INC. |
LARRY R PILOT |
| K990711 |
03/04/1999 |
CODAN CHEMOSPIKE |
CODAN US CORP. |
FERGIE FERGUSON |
| K990798 |
03/10/1999 |
AUTOSTAT II ANTI-JO-1 ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K990796 |
03/10/1999 |
AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K990797 |
03/10/1999 |
AUTOSTAT II ANTI-SCL-70 ELISA |
COGENT DIAGNOTICS LTD. |
DANIELLE M KNIGHT |
| K991202 |
03/22/1999 |
MODIFICATION TO WOUN'DRES |
COLOPLAST CORP. |
HARVEY M ARBIT |
| K990815 |
03/11/1999 |
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS |
COLORSOFT LABORATORIES CORP. |
MARTIN DALSING |
| K990691 |
03/03/1999 |
HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
| K990895 |
03/17/1999 |
OXYCON LENS |
CONCISE CONTACT LENS CO. |
DANIEL J MANELLI |
| K990964 |
03/23/1999 |
SIGNADRESS DUODERM DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
NANCY L WOLLEY |
| K990724 |
03/05/1999 |
CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES |
CONWAY STUART MEDICAL, INC. |
THOMAS WEHMAN |
| K990726 |
03/05/1999 |
ENVY GUIDING CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K990753 |
03/08/1999 |
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K990850 |
03/15/1999 |
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL |
COOPERSURGICAL, INC. |
JONATHAN S KAHAN |
| K990852 |
03/15/1999 |
COOPERSURGICAL INFRARED COAGULATOR |
COOPERSURGICAL, INC. |
JONATHAN S KAHAN |
| K990855 |
03/15/1999 |
COOPERSURGICAL INFRARED COAGULATOR FOR ENT |
COOPERSURGICAL, INC. |
JONATHAN S KAHAN |
| K990771 |
03/09/1999 |
6F HYDROLYSER THROMBECTOMY CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K991028 |
03/29/1999 |
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES |
CORDIS CORP. |
CHARLES J RYAN |
| K990805 |
03/11/1999 |
MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K990657 |
03/01/1999 |
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY |
CORIN U.S.A. |
CRAIG CORRANCE |
| K991070 |
03/31/1999 |
COULTER Z2 ANALYZER |
COULTER CORP. |
THOMAS J ENGLISH |
| K990825 |
03/12/1999 |
REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE PIESTRAK |
| K990824 |
03/12/1999 |
REVISED C-REACTIVE PROTEIN CALIBRATOR |
DADE BEHRING, INC. |
LORRAINE PIESTRAK |
| K990782 |
03/09/1999 |
DAUM NEUROGATE TROCAR |
DAUM GMBH |
E.J. Smith |
| K991003 |
03/25/1999 |
PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI |
DAYSPRING MEDICAL, INC. |
NEIL RASMUSSEN |
| K991005 |
03/25/1999 |
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS |
DAYSPRING MEDICAL, INC. |
NEIL RASMUSSEN |
| K990844 |
03/15/1999 |
STARDENTAL AXCS STERILE WATER SYSTEM |
DENTALEZ GROUP |
FRANK OELLIG |
| K990680 |
03/02/1999 |
DENTEC LD 15 DIODE LASER |
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H. |
DI WOLFGANG NINAUS |
| K991061 |
03/30/1999 |
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING |
DERMAPHYLYX, INC. |
ANDREW M REED |
| K990875 |
03/16/1999 |
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING |
DERMAPHYLYX, INC. |
ANDREW M REED |
| K990891 |
03/17/1999 |
DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING |
DERMAPHYLYX, INC. |
ANDREW M REED |
| K990754 |
03/08/1999 |
CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 |
DIAGNOSTIC CHEMICALS LTD. |
KAREN CALLBECK |
| K990886 |
03/17/1999 |
IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K990717 |
03/04/1999 |
FIXION INTRAMEDULLARY NAILING SYSTEM |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K990920 |
03/18/1999 |
DRG TITANIUM BONE PLATE |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K990669 |
03/02/1999 |
MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) |
DONGKUK TECHCO RUBBER INDUSTRIES SDN. BHD. |
PETER PARK |
| K990731 |
03/05/1999 |
EASTGATE PERSONAL MONITOR |
EASTGATE TRADING CORP. |
MORRIS CORN |
| K990748 |
03/08/1999 |
EDGE SYSTEMS STERILE TUBING |
EDGE SYSTEMS CORP. |
GARY MOCNIK |
| K990727 |
03/05/1999 |
SYNEFLASH & SYNEVIEW |
ELA MEDICAL, INC. |
CATHERINE G GOBLE |
| K990999 |
03/25/1999 |
MODIFICATION OF: EBI SPINELINK SYSTEM |
ELECTRO-BIOLOGY, INC. |
JONAS WILF |
| K990813 |
03/11/1999 |
REHCOR |
ELECTROMED CORP. |
DANIEL KAMM |
| K990759 |
03/08/1999 |
VIEW COM |
ELECTROMED INTL., LTD. |
PASCAL M KAUFMANN |
| K990908 |
03/18/1999 |
MILLENNIUM |
ENDO TECHNIC CORP. |
ANDREW I KIMMEL |
| K991001 |
03/25/1999 |
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER |
EP MEDSYSTEMS |
JOSEPH C GRIFFIN, III |
| K990982 |
03/24/1999 |
CAVIT LC |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K991008 |
03/26/1999 |
DIMENSION BITE |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K990763 |
03/08/1999 |
VITRON M |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K991030 |
03/29/1999 |
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES |
ETHICON ENDO-SURGERY, INC. |
EDWIN O BILLIPS |
| K990778 |
03/09/1999 |
INSIGHT MILLENNIUM |
FASSTECH |
LEE BRODY |
| K990906 |
03/18/1999 |
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER |
FERRIS MFG. CORP. |
THEODORE R THORSON |
| K991011 |
03/26/1999 |
ORASCOPE |
FIBERDENT CORP. |
MARY MCNAMARA-CULLINANE |
| K990765 |
03/08/1999 |
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER GUIDE WIRE (REGULAR SHAFT/STIFF SHAFT) NO |
FLEXMEDICS |
WILLIAM C CORRIGAN, JR. |
| K990716 |
03/04/1999 |
GALLINI BYCUT NEEDLE |
GALLINI U.S., LLC. |
PAUL L HAWTHORNE |
| K990736 |
03/05/1999 |
GC RELINE SOFT/EXTRA SOFT |
GC AMERICA, INC. |
TERRY L JORITZ |
| K991014 |
03/26/1999 |
CASE 8000 EXERCISE TESTING SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
LAURA L MCCOMIS |
| K990996 |
03/25/1999 |
GENYX MEDICAL INJECTION NEEDLE |
GENYX MEDICAL, INC. |
JUDY F GORDON |
| K991411 |
03/26/1999 |
GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR |
GEREONICS, INC. |
GERALD A ROST |
| K991043 |
03/29/1999 |
LATEX EXAMINATION GLOVES POWDERED, LOW PROTEIN |
GLOVCO (M) SDN. BHD. |
TAN PENG HOCK |
| K991032 |
03/29/1999 |
GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 |
GUIDANT CORP. |
KOBBY DANKWAH |
| K991047 |
03/30/1999 |
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) |
HARDCOVER PRODUCTS, INC. |
GERRY PERSON |
| K990925 |
03/19/1999 |
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) |
HARDCOVER PRODUCTS, INC. |
GERRY GLAZER |
| K990699 |
03/03/1999 |
ORTHO-GLOW GLITTER |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K990807 |
03/11/1999 |
HL148 & HL168 |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K990772 |
03/09/1999 |
DIRECTFLOW ARTERIAL CANNULA |
HEARTPORT, INC. |
MARIANNE C DRENNAN |
| K990923 |
03/19/1999 |
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 |
HEINZ KURZ |
DAGMAR S MAESER |
| K990998 |
03/25/1999 |
POLYSLIT IFE KIT |
HELENA LABORATORIES |
PAT FRANKS |
| K990756 |
03/08/1999 |
FLOW LINE |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K990972 |
03/23/1999 |
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K990861 |
03/16/1999 |
WOUND DRESSING/ABD PAD, MODEL #10810 |
HOSPITAL SPECIALTY CO. |
JOHN QUIGLEY |
| K990849 |
03/15/1999 |
DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K990712 |
03/04/1999 |
OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K990922 |
03/19/1999 |
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K991055 |
03/30/1999 |
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K990847 |
03/15/1999 |
INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
CINDY SHOWALTER |
| K990941 |
03/22/1999 |
NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L |
HUMAGEN FERTILITY DIAGNOSTICS, INC. |
CINDY SHOWALTER |
| K990671 |
03/02/1999 |
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE |
HURRICANE MEDICAL |
DAVID A CLAPP |
| K990672 |
03/02/1999 |
LACRIMAL INTUBATION SET, DACRYOCYSTORHINOSTOMY (DCR) SET |
HURRICANE MEDICAL |
DAVID A CLAPP |
| K990652 |
03/01/1999 |
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER |
IDEM (INT'L DIST. OF ELECTRONICS FOR MEDICINE) |
DONNA WARD |
| K991087 |
03/31/1999 |
HANNAH WIRELESS VITAL SIGNS MONITOR |
ILIFE SYSTEMS, INC. |
JOSHUA A ADLER |
| K990907 |
03/18/1999 |
REMOTE INTRODUCER, MODEL PI-1000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
MICHAEL J RENNER |
| K990848 |
03/15/1999 |
TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION |
IMMEDICA, INC. |
ROY BOGERT |
| K991063 |
03/31/1999 |
QUALICODE B. BURGDORFERI IGG WESTERN BLOT KIT, MODEL DK-C052-024 |
IMMUNETICS, INC. |
ANDREW E LEVIN |
| K991062 |
03/31/1999 |
QUALICODE B. BURGDORFERI IGM WESTERN BLOT KIT, MODEL DK-C062-024 |
IMMUNETICS, INC. |
ANDREW E LEVIN |
| K991027 |
03/29/1999 |
BI-DIRECTIONAL TUNNELER |
IMPRA, INC. |
KRISTI M KISTNER |
| K990983 |
03/24/1999 |
MODIFICATION TO IMTEC SENDAX MDI |
IMTEC CORP. |
M.K. PATTERSON |
| K990851 |
03/15/1999 |
INDIGO LASEROPTIC TREATMENT SYSTEM |
INDIGO MEDICAL, INC. |
JACQUELYN A HUGHES |
| K990854 |
03/15/1999 |
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE |
INNERDYNE, INC. |
RICK GAYKOWSKI |
| K991081 |
03/31/1999 |
FRAMELESS NEUROMATE |
INTEGRATED SURGICAL SYSTEMS, INC. |
R.D. HIBBERT |
| K990833 |
03/12/1999 |
DOSE CALC, MODEL VS. 1.02 |
INTEGRITY MEDICAL SOFTWARE, INC. |
CRAIG A LAUGHTON |
| K990949 |
03/22/1999 |
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT |
INTERSURGICAL, INC. |
THOMAS R GUNERMAN |
| K990800 |
03/10/1999 |
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS |
INTERVASCULAR, INC. |
JAMES S MILLER |
| K991074 |
03/31/1999 |
BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST |
INTRACEL CORP. |
SHERYL RUPPEL |
| K990664 |
03/01/1999 |
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW |
INTRACEL CORP. |
CECILIA MATOS-ROSA |
| K991025 |
03/29/1999 |
LUMA-CATH FIXED CURVE EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
ROGER TU |
| K990958 |
03/22/1999 |
ORTHOGONAL EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
ROGER TU |
| K990787 |
03/10/1999 |
TRIO 300 |
ITO CO., LTD. |
T. WHIT ATHEY |
| K990817 |
03/11/1999 |
IPS D.SIGN PORCELAIN |
IVOCLAR NORTH AMERICA, INC. |
PETER P MANCUSO |
| K990785 |
03/09/1999 |
TROCAR & TROCAR SLEEVES, LAPAROSCOPES, LAPAROSCOPIC FORCEPS, & LAPAROSCOPIC INSTRUMENTS |
JAKOUBEK MEDIZINTECHNIK GMBH |
DOUGLAS HULFISH |
| K991042 |
03/29/1999 |
ASH ADVANTAGE PERITONEAL CATHETER |
JANIN GROUP, INC. |
JOHN A NAVIS |
| K991051 |
03/30/1999 |
KSEA EPIDUROSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K991069 |
03/31/1999 |
KSEA NEURO-FIBERSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K991007 |
03/26/1999 |
K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 |
KATECHO, INC. |
LORNE SCHARNBERG |
| K990648 |
03/01/1999 |
KELLER VITAL SIGNS MONITOR, KMS 890+ |
KELLER MEDICAL SPECIALTIES PRODUCTS, INC. |
JEAN WAGNER |
| K990667 |
03/02/1999 |
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT |
KLS-MARTIN L.P. |
ARTHUR J WARD |
| K990969 |
03/23/1999 |
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR |
KONICA MEDICAL CORP. |
RUSSELL D MUNVES |
| K990913 |
03/18/1999 |
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG, HOC SET WITHOUT VALVE - SOFT PLUG, OPS WITHOU |
LABORATOIRES PRODIMED |
RANDOLPH L COOKE |
| K990883 |
03/16/1999 |
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K990882 |
03/16/1999 |
LAGLOVE BRAND COLORED NITRILE EXAMINATION GLOVES (POWDER FREE) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K991015 |
03/26/1999 |
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) |
LAMDA POLYTECH LTD. |
MARTIN DALSING |
| K990903 |
03/18/1999 |
LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL HARDIMAN |
| K990718 |
03/04/1999 |
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION) |
LASERSCOPE |
PAUL H HARDIMAN |
| K990869 |
03/16/1999 |
LEICA AT550 |
LEICA MICROSYSTEMS, INC. |
FRANK J DREXELIUS |
| K990871 |
03/16/1999 |
PILLOWPOSITIVE CERVICAL PILLOW |
LIFESLEEP SYSTEMS, INC. |
HOWARD M HOLSTEIN |
| K990770 |
03/09/1999 |
BIORC ANCHOR |
LINVATEC CORP. |
LAURA SENEFF |
| K991024 |
03/29/1999 |
BONE BULLET SUTURE ANCHOR |
LINVATEC CORP. |
LAURA SENEFF |
| K990658 |
03/01/1999 |
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY |
LITTLE NELL LABS, INC. |
JOEL R. L. EHRENKRANZ |
| K990946 |
03/22/1999 |
BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES |
LONG FIRST (XIAMEN) CO.,LTD. |
STONE CHEN |
| K991085 |
03/30/1999 |
BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES |
LONG FIRST (XIAMEN) CO.,LTD. |
STONE CHEN |
| K990947 |
03/22/1999 |
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY |
LUMENIS, INC. |
MICHELLE DEETON |
| K990942 |
03/22/1999 |
DUET II GLUCOSE CONTROL MONITORING SYSTEM |
LXN CORP. |
NEDA RASHTI |
| K990738 |
03/05/1999 |
DR. JAHANGER'S CUTTER |
M.S. JAHANGER, MD |
MOHAMMED JAHANGER |
| K990810 |
03/11/1999 |
ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING |
MAERSK MEDICAL, LTD. |
EVAN DICK |
| K990966 |
03/23/1999 |
MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS |
MASIMO CORP. |
JAMES J CRONIN |
| K990705 |
03/04/1999 |
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET |
MEDAMICUS, INC. |
DENNIS S MADISON |
| K991064 |
03/31/1999 |
METACARPAL FIXATION SYSTEM |
MEDCANICA, INC. |
AL WEISENBORN |
| K990971 |
03/23/1999 |
EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 |
MEDICA CORP. |
Photios Makris |
| K990808 |
03/11/1999 |
PBN DILATORS |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K990839 |
03/15/1999 |
TRU-CORE I REUSABLE BIOPSY INSTRUMENT |
MEDICAL DEVICE TECHNOLOGIES, INC. |
KARL SWARTZ |
| K990902 |
03/18/1999 |
MODIFICATION OF MLT R694 RUBY LASER SYSTEM |
MEDICAL LASER TECHNOLOGIES LTD. |
DAVID HAMILTON |
| K991049 |
03/30/1999 |
CLIMAX |
MEDILATEX SDN. BHD. |
LEE KIM LANG |
| K990970 |
03/23/1999 |
SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS |
MEDISON AMERICA, INC. |
BOB LEIKER |
| K990803 |
03/10/1999 |
MEDISYSTEMS BUTTONHOLE NEEDLE SETS |
MEDISYSTEMS CORP. |
LARRY R PILOT |
| K990663 |
03/01/1999 |
INTROMIT HAND ACCESS PORT FOR HAND ASSISTED LAPAROSCOPIC SURGERY, MODEL FP880-150 |
MEDTECH LTD. |
JONATHAN S KAHAN |
| K991013 |
03/26/1999 |
MINIMED 407C INFUSION PUMP, MODEL 407C |
MEDTRONIC MINIMED |
DON SELVEY |
| K990801 |
03/10/1999 |
MINIMED 508 INSULIN PUMP |
MEDTRONIC MINIMED |
DON SELVEY |
| K991066 |
03/31/1999 |
MADTRONIC DLP ARTERIAL CANNULAE |
MEDTRONIC VASCULAR |
JAMES BALUN |
| K990793 |
03/10/1999 |
ACCUGUIDE MUSCLE INJECTION MONITOR |
MEDTRONIC XOMED |
DAVID TIMLIN |
| K990707 |
03/04/1999 |
MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS |
MEDTRONICS INTERVENTIONAL VASCULAR |
MARK CHARTIER |
| K990975 |
03/23/1999 |
IN-LINE HEMOSTASIS VALVE |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K990931 |
03/19/1999 |
EZ-HBT HELICOBACTER BLOOD TEST |
METABOLIC SOLUTIONS, INC. |
DAVID A WAGNER |
| K991077 |
03/31/1999 |
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) |
MICRORECORDING SYSTEMS CONSULTANTS, LLC. |
ROBERT L ROGERS |
| K991033 |
03/29/1999 |
ACTIWATCH-SCORE |
MINI-MITTER CO., INC. |
JACK E MCKENZIE |
| K991045 |
03/29/1999 |
MINI-LOGGER SERIES 2000 |
MINI-MITTER CO., INC. |
JACK E MCKENZIE |
| K990816 |
03/11/1999 |
AVCORE SYSTEM |
MODULAR CUTTING SYSTEMS, INC. |
ALLEN P SCHLEIN |
| K991037 |
03/29/1999 |
EUCLID REDUCTION AND GUIDANCE SYSTEM |
MODULAR CUTTING SYSTEMS, INC. |
ALLEN P SCHLEIN |
| K990911 |
03/18/1999 |
MTP ARTHROPUMP DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K990912 |
03/18/1999 |
MTP EXTRACTION BAG |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K990910 |
03/18/1999 |
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K990909 |
03/18/1999 |
MTP UROPUMP DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K991072 |
03/31/1999 |
AHMED GLAUCOMA VALVE IMPLANT |
NEW WORLD MEDICAL, INC. |
A.M. AHMED |
| K991054 |
03/30/1999 |
BRAVO MULTI-MODALITY SYSTEM |
NICOLET BIOMEDICAL, INC. |
DOUGLAS E PFRANG |
| K990900 |
03/18/1999 |
MICROKERATOME, MODEL MK-2000 |
NIDEK, INC. |
JERRY TSUTSUMI |
| K990660 |
03/01/1999 |
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX |
NMT NEUROSCIENCES IMPLANTS S.A. |
BARBARA RAMSEYER |
| K990846 |
03/15/1999 |
AMORPHOUS DIAMOND COATED DRILL |
NOBEL BIOCARE UAS INC |
KIM RENDON |
| K990954 |
03/22/1999 |
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET |
NSK NAKANISHI, INC. |
HIROSHI SEKIGUCHI |
| K990646 |
03/01/1999 |
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K990682 |
03/03/1999 |
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K991021 |
03/29/1999 |
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K990990 |
03/24/1999 |
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066 |
NUCLETRON CORP. |
RALPH E SHUPING |
| K990687 |
03/01/1999 |
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS |
OLYMPUS OPTICAL, CO. |
LAURA STORMS TYLER |
| K990701 |
03/03/1999 |
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE, PURPLE |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
| K990696 |
03/03/1999 |
OMNI FLEX NITRILE EXAMINATION GLOVE, POWDER-FREE,WHITE |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
| K990702 |
03/03/1999 |
OMNI GRACE LATEX EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED WITH PROTEIN CLAIM |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
| K990698 |
03/03/1999 |
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED PURPLE |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
| K990695 |
03/03/1999 |
OMNI TOUCH NITRILE EXAMINATION GLOVE, POWDERED WHITE |
OMNIGRACE (THAILAND) LTD. |
K.C. CHOONG |
| K990872 |
03/16/1999 |
SCLERAL PLUGS, 19 AND 20 GAUGE |
OPHTHALMIC CONSULTANTS, INC. |
JOHN E LINCOLN |
| K990877 |
03/16/1999 |
HISTOFREEZER DEVICE |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K990859 |
03/16/1999 |
DEFLECTABLE TAC ELECTROTHERMAL PROBE |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
| K990986 |
03/24/1999 |
CONTOUR SPINAL SYSTEM |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
| K990783 |
03/09/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K990943 |
03/22/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K990984 |
03/24/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K990899 |
03/18/1999 |
HEMOCHEK-A1C SAMPLE COLLECTION KIT |
OSBORN GROUP, INC. |
GILBERT P BOURK III |
| K990944 |
03/22/1999 |
OSTEOMED INTRAORAL DISTRACTION SYSTEM |
OSTEOMED CORP. |
RICK A BUSS |
| K990843 |
03/15/1999 |
SERUM CROSSLAPS ONE STEP ELISA |
OSTEOMETER BIOTECH A/S |
PER QVIST |
| K991083 |
03/31/1999 |
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY |
OTSUKA PHARMACEUTICAL CO., LTD. |
JAMES W HARRIS |
| K990766 |
03/08/1999 |
CERSR ELECTROMYOGRAPHY SYSTEM |
PARASPINAL DIAGNOSTIC CORP. |
JOEL S FADEN |
| K990905 |
03/18/1999 |
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT |
PASSY-MUIR, INC. |
PATRICIA E PASSY |
| K990960 |
03/22/1999 |
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) |
PERIMED, INC. |
JAMES HOWARD |
| K990927 |
03/19/1999 |
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER |
PERRY BAROMEDICAL CORP. |
JAMES P DODSON |
| K991048 |
03/30/1999 |
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2 |
PHARMACIA & UPJOHN CO. |
KAREN E MATIS |
| K990860 |
03/16/1999 |
VIEWPOINT MICROSCOPE OPTION |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K990868 |
03/16/1999 |
VIEWPOINT PASSIVE TOOL OPTION |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
ELAINE K KEELER |
| K990935 |
03/19/1999 |
JACKSON ESOPHAGEAL DILATOR |
PILLING WECK SURGICAL |
ELIZABETH LAZARO |
| K990804 |
03/10/1999 |
STAYFUSE |
PIONEER SURGICAL TECHNOLOGY |
BURNS SEVERSON |
| K990814 |
03/11/1999 |
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 |
PRECISION BIOLOGIC |
SANDY MORRISON |
| K990737 |
03/05/1999 |
'ECURLINE UMBILICAL CORD CLAMP #3500 |
PRECISION DYNAMICS CORP. |
KALYNA SNYLYK |
| K990823 |
03/12/1999 |
PVS 1400 GUIDEWIRE |
PRECISION VASCULAR SYSTEMS, INC. |
JOHN RAGAZZO |
| K991018 |
03/26/1999 |
ACCUSIGN BAR, BIOSIGN BAR, STATUS BAR |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991079 |
03/26/1999 |
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K990786 |
03/10/1999 |
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991082 |
03/26/1999 |
ACCUSIGN DOA2, DOA, BAR/BZO, BIOSIGN DOA2, BAR/BZO, STATUS DS BAR/BZO, SYVA RAPIDTEST D.A.U. 2 BAR/BZO |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991084 |
03/26/1999 |
ACCUSIGN DOA3, DOA, BAR/BZO/MTD, BIOSIGN DOA3, BIOSIGN BAR/BZO/MTD |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991076 |
03/26/1999 |
ACCUSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP, BIOSIGN DOA3, DOA3(BZO/BAR/PCP), BZO/BAR/PCP |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991078 |
03/26/1999 |
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K991080 |
03/26/1999 |
ACCUSIGN MTD, BIOSIGN MTD |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K990897 |
03/18/1999 |
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER |
PURITAN-BENNETT IRELAND, LTD. |
ROBBIE WALSH |
| K990654 |
03/01/1999 |
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT |
QUANTASE LTD. |
R. STEWART CAMPBELL |
| K990977 |
03/23/1999 |
SERAQUEST EB VAC IGM |
QUEST INTL., INC. |
ROBERT A CORT |
| K990866 |
03/16/1999 |
QUINTON MEDTRACK CR PLUS TREADMILL |
QUINTON, INC. |
MATTHEW J HEDLUND |
| K990703 |
03/04/1999 |
SPOROX II STERILIZING & DISINFECTING SOLUTION |
RECKITT BENCKISER, INC. |
SEAN MCNEAR |
| K990870 |
03/16/1999 |
REDI-TEST THC |
REDWOOD BIOTECH, INC. |
JANIS FREESTONE |
| K991052 |
03/30/1999 |
FS 1000 KNEE SYSTEM |
RENAISSANCE INSTRUMENTS, LLC. |
KENT M SAMUELSON |
| K990963 |
03/23/1999 |
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE) |
RIVERSTONE RESOURCES SDN. BHD. |
CHU MEE CHONG |
| K990992 |
03/24/1999 |
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC |
ROCHE DIAGNOSTICS CORP. |
PRISCILLA A HAMILL |
| K990863 |
03/16/1999 |
MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE |
ROSS PRODUCT DIV. ABBOTT LABORATORIES |
DANIEL HAMILTON |
| K990697 |
03/03/1999 |
RS-4V MUSCLE STIMULATOR |
RS MEDICAL |
MIKE MCGRAW |
| K990684 |
03/03/1999 |
MODIFICATION OF SAS SERUM/URINE HCG |
SA SCIENTIFIC, INC. |
JOSH WESSLING |
| K990720 |
03/05/1999 |
SAS HCG SERUM CONTROLS |
SA SCIENTIFIC, INC. |
HARBI A SHADFAN |
| K990755 |
03/08/1999 |
SAS HCG URINE CONTROLS |
SA SCIENTIFIC, INC. |
HARBI A SHADFAN |
| K990741 |
03/08/1999 |
SAS ONE-STEP PREGNANCY |
SA SCIENTIFIC, INC. |
HARBI A SHADFAN |
| K990842 |
03/15/1999 |
SAS ROTA TEST |
SA SCIENTIFIC, INC. |
J. WESSLING |
| K991039 |
03/29/1999 |
EASYSAFE RETRACTING NEEDLE SYRINGE |
SAF-T-MED, INC. |
JAMES ERBS |
| K990678 |
03/02/1999 |
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) |
SALTER LABS |
DUANE KAZAL |
| K990930 |
03/19/1999 |
3D ANATOMICAL MESH |
SANTERRA MEDICAL TECHNOLOGY, INC. |
DAVID P LANG |
| K990734 |
03/05/1999 |
DPD-12PCC |
SCANDITRONIX MEDICAL AB |
EVA LARSTEN |
| K990721 |
03/05/1999 |
ISOLOCK SPINAL SYSTEM |
SCIEN'TX USA INC. |
DEBBIE DE LOS SANTOS |
| K990962 |
03/22/1999 |
FLOSENSE, MODEL 29-8010 |
SDI DIAGNOSTICS, INC. |
MICHAEL J BOYLE |
| K990939 |
03/22/1999 |
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM |
SELFCARE, INC. |
Carol Adiletto |
| K990790 |
03/10/1999 |
VISION PORCELAIN |
SERVO DENTAL USA, INC. |
ANGELIKA RINEHART |
| K990715 |
03/04/1999 |
SHIMADZU CEILING TUBE SUPPORT CH-30GH |
SHIMADZU CORP. |
MICHAEL FISHBACK |
| K990719 |
03/05/1999 |
EARLOOP FACE MASK |
SHUENN BAO SHING CORP. |
CHARLIE CHEN |
| K990826 |
03/12/1999 |
INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMIE YIEH |
| K991012 |
03/26/1999 |
SIEMENS INFINITY EEG POD |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K991067 |
03/30/1999 |
MODIFICATION OF: DAVIDSTRIP HCG |
SIMEX MEDICAL, INC. |
MICHELLE J HALL |
| K990723 |
03/05/1999 |
DYONICS VARICOSE VEIN ABLATION BLADE |
SMITH & NEPHEW, INC. |
DEBORAH CONNORS |
| K990666 |
03/02/1999 |
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL |
SMITH & NEPHEW, INC. |
JANET JOHNSON GREEN |
| K991026 |
03/29/1999 |
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC. |
EHAB M ESMAIL |
| K991031 |
03/29/1999 |
COLORADO II SPINAL SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD W TREHARNE |
| K991036 |
03/29/1999 |
DANEK PLATE AND SCREW SYSTEM |
SOFAMOR DANEK USA,INC. |
RICHARD TREHARNE |
| K990806 |
03/11/1999 |
C1 ULTRASOUND SYSTEM |
SONOSITE,INC. |
HOWARD HOLMAN |
| K990948 |
03/22/1999 |
S575 INTRAORAL DOCKING DENTAL CAMERA |
SOPRO |
PIERRE MONTILLOT |
| K990650 |
03/01/1999 |
CONSEAL F |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K990751 |
03/08/1999 |
SOUTHLAND POWDERFREE (POLYMER-COATED) LATEX EXAMINATION GLOVES |
SOUTHLAND PRODUCTS CO., LTD. |
NG PENG LEONG |
| K990746 |
03/08/1999 |
SOUTHLAND POWDERFREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM |
SOUTHLAND PRODUCTS CO., LTD. |
NG PENG LEONG |
| K991059 |
03/30/1999 |
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 |
SPECTRANETICS CORP. |
MICHAEL J QUINN |
| K990713 |
03/04/1999 |
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER |
SPECTRANETICS CORP. |
MICHAEL J QUINN |
| K990959 |
03/22/1999 |
K-CENTRUM ANTERIOR SPINAL FIXATION SYSTEM |
SPINEOLOGY, INC. |
PAMELA SNYDER |
| K990728 |
03/05/1999 |
THERMAL CAUTERY DEVICE, FORCEPS |
STARION INSTRUMENTS |
GEORGE D HERMANN |
| K990979 |
03/23/1999 |
STECO-TITANMAGNETICS |
STECO-SYSTEM-TECHNIK GMBH & COKG |
JORN PROBST |
| K990916 |
03/18/1999 |
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY |
STELLAR BIO SYSTEMS, INC. |
JOHN BREWER |
| K990915 |
03/18/1999 |
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY |
STELLAR BIO SYSTEMS, INC. |
JOHN BREWER |
| K990936 |
03/19/1999 |
THE VAULT |
STIK STOPPERS, INC. |
DARRYL CRAWFORD |
| K990898 |
03/18/1999 |
PRODIGY 4 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K990739 |
03/05/1999 |
QUANTEC-E ENDO SYSTEM |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K991035 |
03/29/1999 |
QUANTEC-E IRRIGATION SYSTEM |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K990743 |
03/08/1999 |
SOLO ORTHO |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K990965 |
03/22/1999 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K991004 |
03/25/1999 |
SYNTHES QUICK LOCK IMF SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K990745 |
03/08/1999 |
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM |
SYNTHES SPINE |
J0NATHAN GILBERT |
| K991089 |
03/31/1999 |
SYNTHES CERVIFIX SYSTEM |
SYNTHES SPINE |
JONATHAN GILBERT |
| K990889 |
03/17/1999 |
AUTODOSE INFUSION SYSTEM |
TANDEM MEDICAL, INC. |
ALBERT MISAJON |
| K990841 |
03/15/1999 |
NUGARD NITRIL NITRILE EXAMINATION GLOVE |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K990840 |
03/15/1999 |
NUGARD NITRIL POWDERFREE NITRILE EXAMINATION GLOVE |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
| K990668 |
03/02/1999 |
POWDER FREE BLUE NITRILE GLOVE |
TG MEDICAL SDN BHD |
LIM WEE CHAI |
| K990894 |
03/18/1999 |
ETB TROCAR SYSTEM |
THE ALTOMEC CORP. |
JIM CHITTY |
| K990690 |
03/03/1999 |
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES |
TOP GLOVE SDN. BHD. |
LIM WEE CHAI |
| K991057 |
03/30/1999 |
EXTRA LARGE BODY COIL FOR OPART (MRT-600) |
TOSHIBA AMERICA MRI, INC. |
KEN NEHMER |
| K990686 |
03/03/1999 |
POWDER FREE LATEX EXAMINATION GLOVES |
TOWER RUBBER INDUSTRIES SDN. BHD. |
S. VICKNESWARAN |
| K990761 |
03/08/1999 |
TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE |
TUTTNAUER USA CO. LTD. |
MARK M YACURA |
| K990831 |
03/12/1999 |
SUPERGUARD SAFETY SYRINGE |
U.S. SAFETY SYRINGES CO., INC. |
JAMES GINESI |
| K990651 |
03/01/1999 |
SKIN 2 FORTE SILICONE SHEETING |
UNITED HOSPITAL TECHNOLOGIES, INC. |
SAMUEL SWETLAND |
| K990951 |
03/22/1999 |
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR M CLAVELLI |
| K990952 |
03/22/1999 |
NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
VICTOR M CLAVELLI |
| K991002 |
03/25/1999 |
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP |
V. MUELLER NEURO/SPINE |
TERRY JOHNSTON |
| K990919 |
03/18/1999 |
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG |
VISUALIZATION TECHNOLOGY, INC. |
PETER OHANIAN |
| K990732 |
03/05/1999 |
LAP-WAVE 3000 (P07) |
W.O.M. WORLD OF MEDICINE, GMBH |
MICHAEL MCGRAIL |
| K991029 |
03/29/1999 |
RAPIDFLAP CRANIAL CLAMP |
WALTER LORENZ SURGICAL, INC. |
DIANA PRESTON |
| K991000 |
03/24/1999 |
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES |
WESLEY JESSEN CORP. |
JOSEPH FOOS |
| K990662 |
03/01/1999 |
DISPOSABLE HEATING TUBING SET #7642HSES |
WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH |
S. GRUNWALD |
| K990974 |
03/23/1999 |
VITOP DRESSING |
WONDER & BIOENERGY HI-TECH AMERICA, INC. |
ARTHUR KING K MA |
| K990708 |
03/04/1999 |
TITANIUM VERSALOK |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DAN REGAN |
| K990750 |
03/08/1999 |
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
CHENG HEAN KHOO |
| K991044 |
03/30/1999 |
DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVE, NON STERILE (PROTEIN CONTENT LABELING) |
WRP SPECIALTY PRODUCTS SDN. BHD. |
CHENG HEAN KHOO |
| K990752 |
03/08/1999 |
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE |
WRP SPECIALTY PRODUCTS SDN. BHD. |
CHENG HEAN KHOO |
| K990749 |
03/08/1999 |
SOF-SUCTION FLUID EVACUATION SYSTEM |
X-TECH MEDICAL, LLC. |
EDGAR A RAININ |
| K990914 |
03/18/1999 |
POLARIS DIODE LASER SYSTEM AND ACCESSORIES |
XINTEC CORPORATION |
MARILYN M CHOU |
| K990689 |
03/03/1999 |
ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9 |
ZCV ,INC. |
PRISCILLA WHITEHEAD COX |
| K991060 |
03/30/1999 |
ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000 |
ZCV ,INC. |
PRISCILLA WHITEHEAD COX |
| K990762 |
03/08/1999 |
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) |
ZOLL MEDICAL CORP. |
PAUL DIAS |
