| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K991663 |
06/30/1999 |
AST/SGOT |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K991666 |
06/30/1999 |
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 |
A.P. TOTAL CARE, INC. |
LUIS P LEON |
| K984116 |
06/24/1999 |
HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C |
ABATEMENT TECHNOLOGIES, INC. |
DAVID WILLYARD |
| K991142 |
06/23/1999 |
CELL-DYN 1200 SYSTEM |
ABBOTT LABORATORIES |
JANICE E BROWN |
| K991372 |
06/01/1999 |
CRP |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K991234 |
06/28/1999 |
THE ACME MEDICAL AESTHETIC ND:YAG LASER |
ACME MEDICAL, INC. |
MIKE LEVERNIER |
| K991630 |
06/11/1999 |
ADVANCED MEDICAL SOLUTIONS-SILICONE GEL SCAR MANAGEMENT SHEET |
ADVANCED MEDICAL SOLUTIONS GROUP PLC |
CHRIS OAKES |
| K991287 |
06/29/1999 |
SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA |
ADVANCED MEDICAL SOLUTIONS GROUP PLC |
CHRISTOPHER OAKES |
| K990469 |
06/03/1999 |
LAMITRODE LEADS |
ADVANCED NEUROMODULATION SYSTEMS |
DREW JOHNSON |
| K991784 |
06/24/1999 |
RENEW LEAD EXTENSION |
ADVANCED NEUROMODULATION SYSTEMS |
KATRYNA WARREN |
| K991675 |
06/15/1999 |
MODIFICATION OF: STERRAD BI TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
KEVIN CORRIGAN |
| K991671 |
06/18/1999 |
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM |
ADVANCED TECHNOLOGY LABORATORIES, INC. |
TERRENCE J SWEENEY |
| K990997 |
06/22/1999 |
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER |
AKTINA MEDICAL PHYSICS CORP. |
JOAN Z ACHAROPOULOS |
| K991418 |
06/10/1999 |
BROWNE MVI ETHYLENE OXIDE INDICATOR |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K991928 |
06/25/1999 |
MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS |
ALLEGIANCE HEALTHCARE CORP. |
PATRICIA SHARPE-GREGG |
| K990198 |
06/29/1999 |
AMIB7 |
ALLIANCE MEDICAL, INC. |
JAMES RIEDL |
| K990321 |
06/01/1999 |
ALPHAMED GEMINI SENSOR, SNORING SENSOR |
ALPHAMED, INC. |
PETER STASE |
| K992033 |
06/30/1999 |
MODIFICATION TO 'RAPID DRUG SCREEN' 9-PANEL |
AMERICAN BIO MEDICA CORP. |
JOHN B DUBECK |
| K991099 |
06/10/1999 |
AMERICAN DENTAL PRODUCTS ETCH-DETECT |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K991314 |
06/29/1999 |
COAGULOOP |
AMERICAN MEDICAL SYSTEMS, INC. |
David Worrell |
| K983987 |
06/08/1999 |
AMIGO MODEL 590000 |
AMIGO MOBILITY INTL., INC. |
DALE CONFER |
| K991680 |
06/03/1999 |
SOFTINJECT |
ANDROSYSTEMS SRL |
ERMANNO GRECO |
| K991793 |
06/25/1999 |
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K991219 |
06/21/1999 |
C-FLEX URETERAL STENTS |
APPLIED MEDICAL RESOURCES |
ANIL BHALANI |
| K991686 |
06/11/1999 |
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS) |
ARISTA LATINDO INDUSTRIAL, LTD. P.T. |
LINGA SUMARTA |
| K991053 |
06/25/1999 |
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO) |
ASTRA TECH, INC. |
NIKLAS LIDSKOG |
| K991813 |
06/01/1999 |
UNI-GRAFT K DV VASCULAR GRAFT |
ATRIUM MEDICAL CORP. |
JOE DE PAOLO |
| K981353 |
06/01/1999 |
AVOGEL |
AVOCET POLYMER TECHNOLOGIES, INC. |
MARY CAPELLI-SCHELLPFEFFER |
| K983373 |
06/22/1999 |
IMPACT BALLOON DILATION CATHETER |
B. BRAUN/MCGAW |
MARK S ALSBERGE |
| K990953 |
06/18/1999 |
RENAL LINK |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
| K991576 |
06/30/1999 |
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM |
BAYER CORP. |
GABRIEL J MURACA |
| K991242 |
06/30/1999 |
GLUCOMETER ELITE TEST STRIPS |
BAYER CORP. |
GEORGE M TANCOS |
| K991410 |
06/09/1999 |
3402 HANDHELD PULSE OXIMETER |
BCI INTL., INC. |
DONALD ALEXANDER |
| K991086 |
06/09/1999 |
CAPNOCHECK II, MODEL 8400 |
BCI INTL., INC. |
DONALD ALEXANDER |
| K991707 |
06/01/1999 |
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 |
BECKMAN |
ANGELA BYLAND |
| K991127 |
06/10/1999 |
VARIANT II B-THALASSEMIA |
BIO-RAD |
JULIET CARRARA |
| K990993 |
06/22/1999 |
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 |
BIOCHECK, INC. |
ROBIN HELLEN |
| K991432 |
06/02/1999 |
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K991311 |
06/02/1999 |
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K991146 |
06/22/1999 |
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 |
BIOCHECK, INC. |
ROBIN J HELLEN |
| K991604 |
06/09/1999 |
EPI-FOAM SILICONE SHEETING |
BIODERMIS CORP. |
JEFF S SCHLEUNING |
| K991199 |
06/22/1999 |
BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150 |
BIOMED PRODUCTS |
TIMOTHY THYGESON |
| K991987 |
06/28/1999 |
COLOR BUFFED ANSWER CEMENTED FEMORAL |
BIOMET, INC. |
DALENE HUFZIGER BINKLEY |
| K991009 |
06/23/1999 |
RC BUTTRESS |
BIOMET, INC. |
TRACY BICKEL |
| K990280 |
06/28/1999 |
BIONIKE AQ BARBITURATE TEST |
BIONIKE, INC. |
CLEVE W LAIRD |
| K990956 |
06/14/1999 |
BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 |
BIOSENSOR CORP. |
STEVE SPRINGROSE |
| K983839 |
06/09/1999 |
BIOTEST ANTI-EBV RECOMBINANT |
BIOTEST DIAGNOSTICS CORP. |
PATRICIA E BONNESS |
| K983842 |
06/09/1999 |
BIOTEST ANTI-EBV RECOMBINANT, EA IGM |
BIOTEST DIAGNOSTICS CORP. |
PATRICIA E BONNESS |
| K983841 |
06/09/1999 |
BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG |
BIOTEST DIAGNOSTICS CORP. |
PATRICIA E BONNESS |
| K990483 |
06/03/1999 |
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K991831 |
06/11/1999 |
BMT ANSCORE HEALTH MANAGEMENT SYSTEM, MODEL 1.1 |
BOSTON MEDICAL TECHNOLOGIES, INC. |
DONALD BROKS |
| K990864 |
06/11/1999 |
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 |
BOSTON SCIENTIFIC CORP. |
ABBY LIPMAN |
| K991056 |
06/22/1999 |
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM |
BOSTON SCIENTIFIC CORP. |
DANIEL J DILLON |
| K990351 |
06/01/1999 |
BONE SCREWS |
BREGMA INTERNATIONAL TRADING COMPANY LTD. |
ASSEM HEDAYAT |
| K990353 |
06/01/1999 |
STAINLESS STEEL FIXATION PINS |
BREGMA INTERNATIONAL TRADING COMPANY LTD. |
ASSEM HEDAYAT |
| K991750 |
06/23/1999 |
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN |
BRIGHTSWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K991752 |
06/23/1999 |
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
BRIGHTSWAY HOLDINGS SDN BHD |
G. BASKARAN |
| K990876 |
06/23/1999 |
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED) |
BRIGHTWAY HOLDINGS SDN. BHD. |
G. BASKARAN |
| K991155 |
06/21/1999 |
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES |
C.V. ANLIS ABADI INTERNATIONAL |
ANWAR FIRMAN |
| K990809 |
06/09/1999 |
CADISCOPE ELECTRONIC STETHOSCOPE |
CADITEC AG |
BETTY LOCK |
| K982448 |
06/11/1999 |
CARDIOLIGHT |
CAPINTEC, INC. |
MARY ANNE DELL |
| K991478 |
06/21/1999 |
TENDER TOUCH SILICONE GEL PADS |
CAPITAL MARKETING TECHNOLOGIES, INC. |
JOHN SNYDER |
| K991307 |
06/14/1999 |
TELEMEDICINE 2000 |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K990795 |
06/08/1999 |
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES |
CARDIAC PATHWAYS CORP. |
ERIN DIGNAN |
| K974683 |
06/22/1999 |
NAVIPORT DEFLECTABLE TIP GUIDING CATHETER |
CARDIMA, INC. |
SHELLEY TRIMM |
| K991891 |
06/24/1999 |
CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 |
CERAMOPTEC, INC. |
CAROL J MORELLO |
| K982950 |
06/22/1999 |
FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550 |
CHALGREN ENTERPRISES, INC. |
RICHARD KAISER |
| K991582 |
06/30/1999 |
CHIRON DIAGNOSTICS ACS: 180 FOLATE |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K991692 |
06/18/1999 |
CHIRON DIAGNOSTICS ACS: 180 FT3 |
CHIRON DIAGNOSTICS CORP. |
William J Pignato |
| K991236 |
06/02/1999 |
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
J. WILLIAM JONES |
| K991578 |
06/03/1999 |
SMARTSPOT 2000 |
CMT MEDICAL TECHNOLOGIES, LTD. |
YESHAYAHU RAZ |
| K991202 |
06/04/1999 |
MODIFICATION TO WOUN'DRES |
COLOPLAST CORP. |
HARVEY M ARBIT |
| K990815 |
06/03/1999 |
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS |
COLORSOFT LABORATORIES CORP. |
MARTIN DALSING |
| K991444 |
06/25/1999 |
HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY). |
COMPUTER MOTION, INC. |
DAVID THOMAS |
| K991734 |
06/09/1999 |
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
| K991855 |
06/15/1999 |
CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX |
CONMED CORP. |
IRA D DUESLER JR |
| K990850 |
06/01/1999 |
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL |
COOPERSURGICAL, INC. |
JONATHAN S KAHAN |
| K990852 |
06/11/1999 |
COOPERSURGICAL INFRARED COAGULATOR |
COOPERSURGICAL, INC. |
JONATHAN S KAHAN |
| K990771 |
06/25/1999 |
6F HYDROLYSER THROMBECTOMY CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K991811 |
06/15/1999 |
CORDIS MAXI DS PTA BALLOON CATHETER |
CORDIS CORP. |
ARIEL MACTAVISH |
| K983344 |
06/22/1999 |
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
| K991181 |
06/01/1999 |
MODIFICATION OF N PROTEIN STANDARD SL |
DADE BEHRING, INC. |
CAROLYN K GEORGE |
| K991704 |
06/25/1999 |
N/T PROTEIN CONTROL LC |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K983922 |
06/17/1999 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
| K991402 |
06/21/1999 |
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1 |
DAKO CORP. |
GRETCHEN M MURRAY |
| K991454 |
06/21/1999 |
MOUSE IGG1 NEGATIVE CONTROLS |
DAKO CORP. |
GRETCHEN M MURRAY |
| K991366 |
06/25/1999 |
DAUM MRI/CONVENTIONAL BIOPSY KIT |
DAUM GMBH |
E.J. Smith |
| K991637 |
06/22/1999 |
BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700 |
DAVOL, INC., SUB. C.R. BARD, INC. |
RINI GEORGEKUTTY |
| K991003 |
06/09/1999 |
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 |
06/22/1999 |
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS |
DAYSPRING MEDICAL, INC. |
NEIL RASMUSSEN |
| K991106 |
06/09/1999 |
P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY |
DEPUY ORTHOPAEDICS, INC. |
JANET G JOHNSON |
| K991061 |
06/28/1999 |
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING |
DERMAPHYLYX, INC. |
ANDREW M REED |
| K991814 |
06/23/1999 |
MULTACHOICE INSTRUMENTS |
DEXIDE, INC. |
JOHN CORZINE |
| K991797 |
06/09/1999 |
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K991796 |
06/09/1999 |
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K991795 |
06/09/1999 |
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K990138 |
06/21/1999 |
DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
JOHN CLASS |
| K991660 |
06/04/1999 |
COPALIS MULTIPLEX EBV ANTIBODY ASSAY |
DIASORIN, INC. |
JUDITH J SMITH |
| K990717 |
06/02/1999 |
FIXION INTRAMEDULLARY NAILING SYSTEM |
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
| K991376 |
06/15/1999 |
DAHEDI INSULIN INFUSION PUMP |
DISETRONIC MEDICAL SYSTEMS |
Lee Leichter |
| K990920 |
06/10/1999 |
DRG TITANIUM BONE PLATE |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
| K991183 |
06/09/1999 |
DORNIER LASERTRODE FIBER |
DORNIER SURGICAL PRODUCTS, INC. |
CAROL WERNECKE |
| K990484 |
06/25/1999 |
INDEPENDENCE 324 |
EAGLE PARTS & PRODUCTS, INC. |
CHARLES B WALKER |
| K990122 |
06/25/1999 |
INDEPENDENCE 624 |
EAGLE PARTS & PRODUCTS, INC. |
CHARLES B WALKER JR. |
| K991872 |
06/16/1999 |
LYNX ULTRASOUND SYSTEM |
ECTON, INC. |
CHRISTOPHER B KNELL |
| K983791 |
06/11/1999 |
PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
JOHN W SMITH |
| K991098 |
06/30/1999 |
DIFOTI SYSTEM |
ELECTRO-OPTICAL SCIENCES, INC. |
PAMELA PAPINEAU |
| K982889 |
06/01/1999 |
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 |
ELECTROMED, INC. |
CHET SIEVERT |
| K991227 |
06/01/1999 |
8MM FORGED CEMENTED STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991226 |
06/01/1999 |
FOUNDATION POROUS HIP STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991603 |
06/29/1999 |
GRIT BLASTED HUMERAL STEM |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991325 |
06/25/1999 |
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP |
ENCORE ORTHOPEDICS, INC. |
DEBBIE DE LOS SANTOS |
| K991008 |
06/18/1999 |
DIMENSION BITE |
ESPE DENTAL AG |
ANDREAS PETERMANN |
| K984240 |
06/22/1999 |
ENDOPATH ENDOSCOPIC INSTRUMENTS |
ETHICON ENDO-SURGERY, INC. |
JACKIE A STRASSER |
| K990778 |
06/03/1999 |
INSIGHT MILLENNIUM |
FASSTECH |
LEE BRODY |
| K991011 |
06/23/1999 |
ORASCOPE |
FIBERDENT CORP. |
MARY MCNAMARA-CULLINANE |
| K990243 |
06/09/1999 |
FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES |
FOTONA D.D. |
MOJCA VALJAVEC |
| K984586 |
06/29/1999 |
FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS |
FRESENIUS HEMOTECHNOLOGY, INC. |
VIRGINIA R SINGER |
| K991257 |
06/25/1999 |
FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JOSEPH AZARY |
| K991288 |
06/08/1999 |
DISTENDER SERIES II BAROSTAT |
G & J ELECTRONICS, INC. |
SAM JUNDLER |
| K973844 |
06/04/1999 |
GASTRIC AND RECTAL CATHETERS |
G & J ELECTRONICS, INC. |
SAM JUNDLER |
| K991780 |
06/29/1999 |
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C |
G.T. LABORATORIES, INC. |
JOHN M SZABOCSIK |
| K991781 |
06/29/1999 |
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS |
G.T. LABORATORIES, INC. |
JOHN M SZABOCSIK |
| K991716 |
06/18/1999 |
HISPEED NX/I CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K991842 |
06/11/1999 |
SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING |
GE VINGMED ULTRASOUND |
PAUL FREDRIKSEN |
| K991611 |
06/09/1999 |
GE LOGIQ 500 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K990996 |
06/18/1999 |
GENYX MEDICAL INJECTION NEEDLE |
GENYX MEDICAL, INC. |
JUDY F GORDON |
| K991191 |
06/22/1999 |
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
MARY E GRAY |
| K991843 |
06/25/1999 |
GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE |
GREINER MEDITECH, INC. |
DOUG HARRIS |
| K991102 |
06/09/1999 |
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331 |
GUIDANT CORP. |
STACEY SIMON |
| K990628 |
06/29/1999 |
GYRUS ENDOUROLOGY SYSTEM |
GYRUS MEDICAL LTD. |
DAVID KAY |
| K991047 |
06/18/1999 |
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) |
HARDCOVER PRODUCTS, INC. |
GERRY PERSON |
| K990925 |
06/17/1999 |
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION) |
HARDCOVER PRODUCTS, INC. |
GERRY GLAZER |
| K991491 |
06/21/1999 |
FLC COMPOSITE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K991488 |
06/21/1999 |
SELF CURE COMPOSITE |
HARRY J. BOSWORTH CO. |
MILDRED M GOLDSTEIN |
| K990998 |
06/28/1999 |
POLYSLIT IFE KIT |
HELENA LABORATORIES |
PAT FRANKS |
| K991587 |
06/25/1999 |
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS |
HELIX MEDICAL, INC. |
CYNTHIA ANDERSON |
| K991229 |
06/29/1999 |
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L |
HENNING KNUDSEN ENGINEERING A/S |
JACOB MOLLENBACH |
| K991425 |
06/15/1999 |
XANTOPREN COMFORT |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K991773 |
06/07/1999 |
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P |
HEWLETT-PACKARD GMBH |
EGON PFEIL |
| K991318 |
06/18/1999 |
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS |
HITACHI MEDICAL CORP. OF AMERICA |
GARY W ENOS |
| K991952 |
06/29/1999 |
OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS |
HOWMEDICA OSTEONICS CORP. |
MARYBETH NAUGHTON |
| K990922 |
06/02/1999 |
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K991513 |
06/21/1999 |
HOMEPUMP C-SERIES AND HOMEPUMP C-SERIES ONE-STEP KVO |
I-FLOW CORP. |
ROBERT J BARD |
| K991518 |
06/18/1999 |
PANATOME |
IMAGING SCIENCES INTL., INC. |
ROBERT E HAY |
| K991526 |
06/17/1999 |
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 |
IMAGYN MEDICAL TECHNOLOGIES, INC. |
CHERYL BLAKE |
| K990183 |
06/11/1999 |
IMPLEX ALUMINA FEMORAL HEAD |
IMPLEX CORP. |
ROBERT POGGIE |
| K984290 |
06/01/1999 |
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM |
IMPLEX CORP. |
JOHN SCHALAGO |
| K982951 |
06/21/1999 |
IMTEC BIOPIN |
IMTEC CORP. |
M.K. PATTERSON |
| K991374 |
06/15/1999 |
INVIGRA |
INDUS MEDICARE LTD. |
P.K. REDDY |
| K984600 |
06/03/1999 |
METRA PS PROCEDURE KIT |
INLET MEDICAL, INC. |
MARK STERRETT |
| K991657 |
06/17/1999 |
QUANTA LITE ANA ELISA |
INOVA DIAGNOSTICS, INC. |
BRYS C MYERS |
| K991081 |
06/25/1999 |
FRAMELESS NEUROMATE |
INTEGRATED SURGICAL SYSTEMS, INC. |
R.D. HIBBERT |
| K990833 |
06/08/1999 |
DOSE CALC, MODEL VS. 1.02 |
INTEGRITY MEDICAL SOFTWARE, INC. |
CRAIG A LAUGHTON |
| K984235 |
06/09/1999 |
INTERSOURCE 125, MODEL 1251L |
INTERNATIONAL BRACHYTHERAPY, INC. |
RUTH FEICHT |
| K990057 |
06/28/1999 |
SYNERGY ADJUSTABLE LENGTH ROD |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K990949 |
06/15/1999 |
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT |
INTERSURGICAL, INC. |
THOMAS R GUNERMAN |
| K990221 |
06/02/1999 |
INTRACOIL PERIPHERAL STENT |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
| K991168 |
06/25/1999 |
ARROW FWD POWER WHEELCHAIR |
INVACARE CORP. |
EDWARD A KROLL |
| K990958 |
06/03/1999 |
ORTHOGONAL EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
ROGER TU |
| K991208 |
06/23/1999 |
ENDOSCOPIC FIBEROPTIC CABLE |
ISOLUX AMERICA |
STUART L MCGHEE |
| K991564 |
06/23/1999 |
JELTEMP |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K991042 |
06/25/1999 |
ASH ADVANTAGE PERITONEAL CATHETER |
JANIN GROUP, INC. |
JOHN A NAVIS |
| K991688 |
06/01/1999 |
WRIST TYPE DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-303S |
JAWON MEDICAL CO., LTD. |
ROBERT D WAXHAM |
| K990581 |
06/18/1999 |
DIRECT HDL-CHOLESTEROL REAGENT |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K991166 |
06/10/1999 |
K-ASSAY MICROALBUMIN CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K991409 |
06/09/1999 |
K-ASSAY RHEUMATOID FACTOR |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K991467 |
06/10/1999 |
K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET |
KAMIYA BIOMEDICAL CO. |
COLIN GETTY |
| K991171 |
06/23/1999 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY |
KEVIN A KENNAN |
| K991228 |
06/23/1999 |
DCI ENDOSCOPE |
KARL STORZ ENDOSCOPY |
KEVIN KENNAN |
| K991051 |
06/01/1999 |
KSEA EPIDUROSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K991069 |
06/03/1999 |
KSEA NEURO-FIBERSCOPE |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
KEVIN KENNAN |
| K990154 |
06/01/1999 |
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM |
KARL STORZ IMAGING, INC. |
TERRY FERNANDEZ |
| K984035 |
06/03/1999 |
XK-95 HIGH SPEED MOTOR DRILL SYSTEM |
KOMET MEDICAL |
COURTNEY S PARADICE |
| K990969 |
06/18/1999 |
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR |
KONICA MEDICAL CORP. |
RUSSELL D MUNVES |
| K990913 |
06/08/1999 |
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 |
| K991749 |
06/23/1999 |
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K991748 |
06/23/1999 |
LAGLOVE BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESSOF WATER EXTRACTABLE PROTEIN PER G |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K983984 |
06/07/1999 |
COOLTOUCH V ND:YAG |
LASER AESTHETICS, INC. |
JONATHAN M BAUMGARDNER |
| K990869 |
06/07/1999 |
LEICA AT550 |
LEICA MICROSYSTEMS, INC. |
FRANK J DREXELIUS |
| K990871 |
06/10/1999 |
PILLOWPOSITIVE CERVICAL PILLOW |
LIFESLEEP SYSTEMS, INC. |
HOWARD M HOLSTEIN |
| K990658 |
06/02/1999 |
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY |
LITTLE NELL LABS, INC. |
JOEL R. L. EHRENKRANZ |
| K990238 |
06/23/1999 |
LONGPORT MODEL LDS -1 |
LONGPORT, INC. |
MICHAEL G FARROW |
| K991305 |
06/21/1999 |
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES |
M.R.G. INDUSTRIES SDN. BHD. |
CHONG ENG LIM |
| K991304 |
06/23/1999 |
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
M.R.G. INDUSTRIES SDN. BHD. |
CHONG ENG LIM |
| K991759 |
06/25/1999 |
MAERSK MEDICAL CONTOUR INFUSION SET |
MAERSK MEDICAL A/S |
DON SELVEY |
| K990966 |
06/07/1999 |
MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS |
MASIMO CORP. |
JAMES J CRONIN |
| K990461 |
06/30/1999 |
MCKINLEY SP DISPOSABLE INFUSION PUMP |
MCKINLEY, INC. |
JOHN MCINROY |
| K990705 |
06/28/1999 |
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET |
MEDAMICUS, INC. |
DENNIS S MADISON |
| K991064 |
06/23/1999 |
METACARPAL FIXATION SYSTEM |
MEDCANICA, INC. |
AL WEISENBORN |
| K991113 |
06/10/1999 |
`INEAR WRIST COIL, MODEL 440GE-09 |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K991115 |
06/08/1999 |
LINEAR SHOULDER COIL, MODEL 414GE-09 |
MEDICAL ADVANCES, INC. |
THOMAS E TYNES |
| K980438 |
06/10/1999 |
11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K983511 |
06/08/1999 |
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH |
MEDICAL COMPONENTS, INC. |
JEANNE M CUSH |
| K991248 |
06/22/1999 |
PRONTO DRY |
MEDICAL INSTRUMENTS CORPORATION MIC AG |
JOHN C MATHERLY |
| K991049 |
06/15/1999 |
CLIMAX |
MEDILATEX SDN. BHD. |
LEE KIM LANG |
| K982961 |
06/07/1999 |
MEDIPOINT |
MEDIPOINT LTD. |
JULES T MITCHEL |
| K991153 |
06/21/1999 |
MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\ |
MEDTEXX INDUSTRIES (THAI) CO. LTD. |
STEPHEN TAN CKENG KIM |
| K991013 |
06/23/1999 |
MINIMED 407C INFUSION PUMP, MODEL 407C |
MEDTRONIC MINIMED |
DON SELVEY |
| K990801 |
06/08/1999 |
MINIMED 508 INSULIN PUMP |
MEDTRONIC MINIMED |
DON SELVEY |
| K991775 |
06/24/1999 |
MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WS |
MENNEN MEDICAL, INC. |
KENNETH RAICHMAN |
| K984343 |
06/25/1999 |
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST |
MERIDIAN DIAGNOSTICS, INC. |
ALAN NICHOL |
| K984346 |
06/25/1999 |
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST |
MERIDIAN DIAGNOSTICS, INC. |
ALAN NICHOL |
| K991619 |
06/09/1999 |
FOUNTAIN Infusion Catheter and Occluding Guide Wire |
MERIT MEDICAL SYSTEMS, INC. |
CHESTER MCCOY |
| K991107 |
06/29/1999 |
SHADOW TRAYS |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K991077 |
06/09/1999 |
MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000) |
MICRORECORDING SYSTEMS CONSULTANTS, LLC. |
ROBERT L ROGERS |
| K991898 |
06/16/1999 |
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE |
MICROVENA CORP. |
ANGELA MALLERY |
| K991033 |
06/23/1999 |
ACTIWATCH-SCORE |
MINI-MITTER CO., INC. |
JACK E MCKENZIE |
| K990202 |
06/04/1999 |
SUGITA TITANIUM ANEURYSM CLIP |
MIZUHO AMERICA, INC. |
T.WHIT ATHEY |
| K991037 |
06/23/1999 |
EUCLID REDUCTION AND GUIDANCE SYSTEM |
MODULAR CUTTING SYSTEMS, INC. |
ALLEN P SCHLEIN |
| K991362 |
06/21/1999 |
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) |
MORAX |
BOREK JANIK |
| K990250 |
06/18/1999 |
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 |
MORAX |
BOREK JANIK |
| K990911 |
06/03/1999 |
MTP ARTHROPUMP DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K990912 |
06/09/1999 |
MTP EXTRACTION BAG |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K990910 |
06/03/1999 |
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K990909 |
06/09/1999 |
MTP UROPUMP DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
KEVIN KENNAN |
| K982646 |
06/02/1999 |
AILEE SUTURES AND AILEE NEEDLES |
MYCO MEDICAL SUPPLIES, INC. |
SANJIV KUMAR |
| K991184 |
06/23/1999 |
HYDROTONE-THERMAL CAPSULE SYSTEM |
NATS CORP. |
RICHARD C LANZILLOTTO |
| K991498 |
06/16/1999 |
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL |
NEOMETRICS, INC. |
DAVID SCHWARTZ |
| K991482 |
06/03/1999 |
UNI-CLIP STAPLE |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K990063 |
06/09/1999 |
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES |
NIHON KOHDEN AMERICA, INC. |
GARY REASONER |
| K990846 |
06/10/1999 |
AMORPHOUS DIAMOND COATED DRILL |
NOBEL BIOCARE UAS INC |
KIM RENDON |
| K984162 |
06/28/1999 |
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE |
NOBELPHARMA USA, INC. |
BETSY A BROWN |
| K991548 |
06/23/1999 |
HAL SCOPE HOLDER SYSTEM |
NOVED MEDICAL |
MIKE GRIFFIN |
| K990954 |
06/09/1999 |
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET |
NSK NAKANISHI, INC. |
HIROSHI SEKIGUCHI |
| K991021 |
06/23/1999 |
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL |
NSK NAKANISHI, INC. |
HIROJI SEKIGUCHI |
| K991243 |
06/18/1999 |
NORMA 10 |
ODIN TECHNOLOGIES LTD. |
ADI ICKOWICZ |
| K990877 |
06/14/1999 |
HISTOFREEZER DEVICE |
ORASURE TECHNOLOGIES, INC. |
R. SAM NIEDBALA |
| K991190 |
06/23/1999 |
DEFLECTABLE ELECTROSURGICAL PROBES |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
| K990859 |
06/14/1999 |
DEFLECTABLE TAC ELECTROTHERMAL PROBE |
ORATEC INTERVENTIONS, INC. |
SHEILA RAMERMAN |
| K991101 |
06/01/1999 |
COAG-A-MATE MAX |
ORGANON TEKNIKA CORP. |
REBECCA A RIVAS |
| K991593 |
06/29/1999 |
ORIBRUSH - STANDARD - B002 |
ORIFICE MEDICAL AB |
PATRIK NILSSON |
| K991595 |
06/29/1999 |
ORIBRUSH - WITH PROTECTIVE TIP - B001 |
ORIFICE MEDICAL AB |
PATRIC NILSSON |
| K990943 |
06/01/1999 |
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK |
Ortho-Clinical Diagnostics, Inc. |
ANNE ZAVERTNIK |
| K991313 |
06/23/1999 |
ACCUTRED SHOE |
ORTHOPEDIC TECHNOLOGY RESEARCH, INC. |
CHERYL G DYER |
| K990944 |
06/16/1999 |
OSTEOMED INTRAORAL DISTRACTION SYSTEM |
OSTEOMED CORP. |
RICK A BUSS |
| K991643 |
06/08/1999 |
IDS4 V3.2 IMAGE DISPLAY SYSTEM |
OTECH, INC. |
HERMAN OOSTERWIJK |
| K991321 |
06/21/1999 |
PACIFIC HEMOSTASIS THROMBOSCREEN 200 |
PACIFIC HEMOSTASIS |
LARRY KOPYTA |
| K981860 |
06/03/1999 |
A P HARNESS |
PARAWORKS ENTERPRISE, LTD. |
MICHAEL C CAMPBELL |
| K983308 |
06/04/1999 |
RC CORNET, MODEL #44F50 |
PARI HOLDING CO. |
MIGUEL A ARRIZON |
| K990905 |
06/11/1999 |
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT |
PASSY-MUIR, INC. |
PATRICIA E PASSY |
| K991118 |
06/29/1999 |
O.B. APPLICATOR TAMPONS, O.B. TAMPONS |
PERSONAL PRODUCTS CO. |
RALPH PETRONE |
| K991511 |
06/03/1999 |
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED) |
PERUSAHAAN GETAH ASAS SDN BHD |
TAN KONG CHANG |
| K991641 |
06/01/1999 |
AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 |
PHAMATECH |
CARL A MONGIOVI |
| K991824 |
06/11/1999 |
AT HOME DRUG TEST, MODEL 9171 |
PHAMATECH |
CARL A MONGIOVI |
| K990688 |
06/24/1999 |
MTM BIOSCANNER C TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K990814 |
06/07/1999 |
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 |
PRECISION BIOLOGIC |
SANDY MORRISON |
| K991751 |
06/18/1999 |
STATUS CUP ACCUSIGN CUP |
PRINCETON BIOMEDITECH CORP. |
JEMO KANG |
| K983713 |
06/08/1999 |
PRODIMED MICROINJECTION PIPETTES |
PRODIMED |
RANDOLPH L COOKE |
| K990644 |
06/21/1999 |
QUANTASE TOTAL GALACTOSE SCREENING ASSAY |
QUANTASE LTD. |
R. STEWART CAMPBELL |
| K990654 |
06/21/1999 |
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT |
QUANTASE LTD. |
R. STEWART CAMPBELL |
| K991876 |
06/17/1999 |
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE |
R & D SYSTEMS, INC. |
SUE GALLO |
| K982096 |
06/18/1999 |
DERMASTIM PLUS, PIGTAILS, FLEXSTIM SUPERFLEX, FLEXSTIM PLUS, CARBONSTIM VERTASTIM, ENDURO |
RAPID MFG. CO. |
CHARITY MARTIN |
| K983497 |
06/27/1999 |
OVERLANDER PEV 2000 |
RAYE'S, INC. |
WILLARD L FRICKEY |
| K991178 |
06/11/1999 |
FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RPBERT L CASARSA |
| K991440 |
06/22/1999 |
ROCHE COBAS INTEGRA SERUM BARBITURATES |
ROCHE DIAGNOSTICS CORP. |
LISA M GERARD |
| K991443 |
06/22/1999 |
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) |
ROCHE DIAGNOSTICS CORP. |
LISA M GERARD |
| K990697 |
06/18/1999 |
RS-4V MUSCLE STIMULATOR |
RS MEDICAL |
MIKE MCGRAW |
| K991653 |
06/24/1999 |
INVISION-PLUS INJECTION PORT CONNECTOR SYSTEM |
RYMED TECHNOLOGIES, INC. |
AL WEISENBORN |
| K991442 |
06/03/1999 |
LC MICROFILL |
S & C POLYMER GMBH |
JURGEN ENGELBRECHT |
| K984374 |
06/04/1999 |
SURGISORB |
SAMYANG CORP. |
DAVID W SCHLERF |
| K990930 |
06/17/1999 |
3D ANATOMICAL MESH |
SANTERRA MEDICAL TECHNOLOGY, INC. |
DAVID P LANG |
| K981141 |
06/23/1999 |
SARGON IMMEDIATE LOAD IMPLANT, MODEL D |
SARGON ENT., INC. |
DANIEL J MANELLI |
| K991282 |
06/30/1999 |
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES |
SEIKO INSTRUMENTS USA, INC. |
HERMAN OOSTERWJICK |
| K990186 |
06/21/1999 |
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES |
SHANGHAI INTCO. PLASTIC & RUBBER PRODUCTS CO., LTD |
FRANK LIU |
| K991743 |
06/23/1999 |
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K991745 |
06/23/1999 |
ROYAL SHIELD NON-STERILE POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K991746 |
06/23/1999 |
ROYAL SHIELD POWDER-FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K991744 |
06/23/1999 |
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT |
SHIELD GLOVES MANUFACTURER (M) SDN BHD |
E. J. SMITH |
| K983856 |
06/21/1999 |
POWDER FREE VINYL EXAMINATION GLOVES |
SHIJIAZHUANG BRETHERN PLASTIC CO.,LTD. |
XIN-LAI ZHOU |
| K983893 |
06/21/1999 |
POWDERED VINYL EXAMINATION GLOVE |
SHIJIAZHUANG BRETHERN PLASTIC CO.,LTD. |
XIN-LAI ZHOU |
| K991553 |
06/08/1999 |
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION |
SHIMADZU CORP. |
MICHAEL FISHBACK |
| K991600 |
06/09/1999 |
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION |
SIEMENS CORP. |
ALICIA BUSTOS-JUERGENSEN |
| K991012 |
06/24/1999 |
SIEMENS INFINITY EEG POD |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K991599 |
06/15/1999 |
CADD ADMINISTRATION SET |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K991301 |
06/09/1999 |
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K991255 |
06/09/1999 |
CADD-TPN ADMINISTRATION SET, MODEL 21-7071 |
SIMS DELTEC, INC. |
EDWARD W NUMAINVILLE |
| K991302 |
06/01/1999 |
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS |
SMARTLIGHT, INC. |
A. ROBERT SOHOVAL |
| K991538 |
06/03/1999 |
OPERA CUPFLANGED ACETABULAR COMPONENTS |
SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. |
JANET JOHNSON GREEN |
| K984562 |
06/08/1999 |
VIVOSONIC |
SONOTECH, INC. |
MARGARET J LARSON |
| K983996 |
06/03/1999 |
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM |
SPACELABS MEDICAL, INC. |
NANCY J GERTLAR |
| K991447 |
06/11/1999 |
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS |
SPECTRAL DIAGNOSTICS, INC. |
JOSEPH P LAURINO |
| K990728 |
06/03/1999 |
THERMAL CAUTERY DEVICE, FORCEPS |
STARION INSTRUMENTS |
GEORGE D HERMANN |
| K991167 |
06/03/1999 |
STERIS SMOKE EVACUATION SYSTEM |
STERIS Corporation |
ROBERT H MCCALL |
| K990246 |
06/10/1999 |
STERI-PAK LF BOWIE-DICK TEST PACK |
STERITEC PRODUCTS MFG. CO., INC. |
LON BRUSO |
| K983220 |
06/04/1999 |
STRYKER INFRAVISION ESOPHAGEAL KIT |
Stryker Endoscopy |
SEAN CAHILL |
| K984536 |
06/16/1999 |
REMOVABLE CUFF ABUTMENT |
SULZER CALCITEK, INC. |
FOSTER BOOP |
| K991143 |
06/11/1999 |
MAGNA-ROM 21 KNEE SYSTEEM |
SULZER ORTHOPEDICS, INC. |
SHAVAWN PARDUHN |
| K991035 |
06/24/1999 |
QUANTEC-E IRRIGATION SYSTEM |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K990743 |
06/04/1999 |
SOLO ORTHO |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K991215 |
06/11/1999 |
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S |
SYMTEX HEALTHCARE CORP. |
RICHARD S WANG |
| K991407 |
06/11/1999 |
SYNTHES LOCKING CALCANEAL PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K991552 |
06/02/1999 |
SYNTHES PEDIATRIC ROD SYSTEM |
SYNTHES (USA) |
JONATHAN GILBERT |
| K991004 |
06/23/1999 |
SYNTHES QUICK LOCK IMF SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K990325 |
06/24/1999 |
QUIKSTRIP DIPSCAN X MULTIDRUG SCREENING DEVICE |
SYNTRON BIORESEARCH, INC. |
CLEVE W LAIRD |
| K990889 |
06/03/1999 |
AUTODOSE INFUSION SYSTEM |
TANDEM MEDICAL, INC. |
ALBERT MISAJON |
| K990020 |
06/24/1999 |
TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC |
TE ME NA S.A.R.L. |
DONALD F RYAN |
| K984576 |
06/14/1999 |
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K |
TERUMO EUROPE N.V. |
M J AERTS |
| K982467 |
06/23/1999 |
CAPIOX CARDIOPLEGIA |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
| K991406 |
06/16/1999 |
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER |
TERUMO MEDICAL CORP. |
KRISTINE WAGNER |
| K990668 |
06/03/1999 |
POWDER FREE BLUE NITRILE GLOVE |
TG MEDICAL SDN BHD |
LIM WEE CHAI |
| K991758 |
06/14/1999 |
MONOJECT INSULIN SYRINGE |
THE KENDAL CO. |
FRANK J FUCILE |
| K991710 |
06/03/1999 |
SSA-370A/POWERVISION 6000 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K991858 |
06/16/1999 |
SSA-390A/POWER VISION 8000 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K990431 |
06/03/1999 |
AIA-PACK CA 125 |
TOSOH MEDICS, INC. |
JUDITH E LOEBEL |
| K991912 |
06/22/1999 |
MODIFICATION TO DIGIPAN |
TROPHY RADIOLOGIE |
MARIR-PIERRE LABAT-CAMY |
| K991455 |
06/25/1999 |
ORTHOSLICE OS1000 SERIES; PANORAMIC ORTHOSLICE OS 1000: OS1000, OS1000E PANORAMIC AND CEPHALOMETRIC ORTHOSLICE OS1000C, |
TROPHY RADIOLOGIE |
MARIE-PIERRE LABAT-CAMY |
| K991405 |
06/29/1999 |
OMNI-FIX, HUMERAL NAIL |
TURNKEY INTERGRATION USA, INC. |
DOUGLAS W STUART |
| K983296 |
06/04/1999 |
AUTO SUTURE ABBI SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHRISTOPHER A GRAHAM |
| K991859 |
06/23/1999 |
DEXIDE BIPOLAR FORCEPS II ** DEVICE |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
CHRISTOPHER A GRAHAM |
| K991689 |
06/24/1999 |
LATEX EXAMINATION GLOVES (POWDER FREE) |
USG HEALTHGUARD SDN BHD |
TOH CHEE YEONG |
| K991690 |
06/24/1999 |
LATEX EXAMINATION GLOVES (PRE POWDERED) |
USG HEALTHGUARD SDN BHD |
TOH CHEE YEONG |
| K991002 |
06/11/1999 |
PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP |
V. MUELLER NEURO/SPINE |
TERRY JOHNSTON |
| K983629 |
06/08/1999 |
RPM RESPIRATORY GATING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
LINDA S NASH |
| K991310 |
06/18/1999 |
EXPLOR-X 70 |
VILLA SISTEMI MEDICALI S.P.A. |
AL SOSA |
| K991163 |
06/08/1999 |
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR |
VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. |
MARTINE D MARTINO |
| K984468 |
06/01/1999 |
VITAL PEP |
VITAL SIGNS, INC. |
ANTHONY P MARTINO |
| K984508 |
06/25/1999 |
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD |
W & H DENTALWERK BUERMOOS GMBH |
HERBERT TRASCHWANDTNER |
| K991000 |
06/28/1999 |
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES |
WESLEY JESSEN CORP. |
JOSEPH FOOS |
| K992010 |
06/29/1999 |
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) |
WESTCON CONTACT LENS CO., INC. |
CAROL NOBLE |
| K983867 |
06/09/1999 |
FUJI CATHETER, MODEL CTH001 |
WINDY HILL TECHNOLOGY, INC. |
ANGELA B SOITO |
| K990974 |
06/09/1999 |
VITOP DRESSING |
WONDER & BIOENERGY HI-TECH AMERICA, INC. |
ARTHUR KING K MA |
| K991123 |
06/01/1999 |
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LYNNE WITKOWSKI |
| K991742 |
06/21/1999 |
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O |
YTY INDUSTRY (MANJUNG) SDN. BHD. |
E. J. SMITH |
| K984298 |
06/23/1999 |
Z KAT FLUROTACTIC GUIDANCE SYSTEM MKI |
Z-KAT, INC. |
RONY ABOVITZ |
| K991610 |
06/25/1999 |
ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
| K991179 |
06/17/1999 |
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
MARK J KOPNITSKY |
