FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K004009 |
03/25/2002 |
3M ATTEST 290 AUTO-READER |
3M COMPANY |
STEPHAN NORSTED |
K020256 |
03/25/2002 |
UNICEM |
3M ESPE AG DENTAL PRODUCTS |
ANDREAS PETERMANN |
K012998 |
03/13/2002 |
AMPHETAMINE/METHAMPHETAMINE |
ABBOTT LABORATORIES |
ALICIA SIMPSON |
K012996 |
03/20/2002 |
BARBITURATES |
ABBOTT LABORATORIES |
LINDA MORRIS |
K013143 |
03/13/2002 |
BENZODIAZEPINES |
ABBOTT LABORATORIES |
LINDA MORRIS |
K013247 |
03/13/2002 |
CANNABINOIDS |
ABBOTT LABORATORIES |
LINDA MORRIS |
K013004 |
03/13/2002 |
COCAINE |
ABBOTT LABORATORIES |
ALICIA SIMPSON |
K013001 |
03/20/2002 |
METHADONE |
ABBOTT LABORATORIES |
ALICIA SIMPSON |
K013314 |
03/13/2002 |
OPIATES |
ABBOTT LABORATORIES |
ALICIA SIMPSON |
K013096 |
03/13/2002 |
PHENCYCLIDINE |
ABBOTT LABORATORIES |
LINDA MORRIS |
K013100 |
03/20/2002 |
PROPOXYPHENE |
ABBOTT LABORATORIES |
LINDA MORRIS |
K012983 |
03/13/2002 |
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER |
ACIST MEDICAL SYSTEMS, INC. |
CARL M BEAURLINE |
K013987 |
03/01/2002 |
REPROCESSED DISPOSABLE TROCARS |
ADVEN MEDICAL |
MARK W ALDANA |
K011030 |
03/01/2002 |
AESCULAP -MIETHKE SHUNT SYSTEM |
AESCULAP, INC. |
JOYCE THOMAS |
K014172 |
03/19/2002 |
NELSON ELECTROSURGICAL UNIT, MODEL GN640 |
AESCULAP, INC. |
LISA MILLINGTON |
K014149 |
03/18/2002 |
PAEDISCOPE, MODEL # P010A AND PF011A |
AESCULAP, INC. |
GEORG KELLER |
K014207 |
03/21/2002 |
REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 |
AESCULAP, INC. |
LISA MILLINGTON |
K020324 |
03/13/2002 |
LIFESTYLE OXYGEN CONCENTRATOR |
AIRSEP CORP. |
CHARLOTTE H HAMILTON |
K010131 |
03/26/2002 |
PHD PERSONAL HEMODIALYSIS INSTRUMENT-1M101, PHD WATER PRE-TREATMENT KIT-1W605,PHD HARD PLUMBING KIT-1W604, PHD BLOOD TUB |
AKSYS, LTD. |
JAN L ZORN |
K014081 |
03/05/2002 |
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES |
AKTINA MEDICAL PHYSICS CORP. |
JOAN KACHAROPOULOS |
K020593 |
03/18/2002 |
CONVERTORS SMS POLYOLEFIN GOWN |
ALLEGIANCE HEALTHCARE CORP. |
SHARON ROBBINS |
K020536 |
03/15/2002 |
GAZELLE WHEELCHAIR |
ALUM CREEK WHEELCHAIR CO., INC. |
RICHARD ROY |
K014101 |
03/20/2002 |
RAPIDONE-OXY TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
K013318 |
03/08/2002 |
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 |
AMERICAN DIAGNOSTICA, INC. |
JOHN BERRYMAN |
K013168 |
03/07/2002 |
IMUBIND PLASMA PAI-1 ELISA,MODEL 822 |
AMERICAN DIAGNOSTICA, INC. |
JOHN B BERRYMAN |
K013492 |
03/13/2002 |
IMUBIND TPA ELISA, MODEL 860 |
AMERICAN DIAGNOSTICA, INC. |
JOHN B BERRYMAN |
K020663 |
03/28/2002 |
MODIFICATION TO SPARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
MARK MCINTYRE |
K020446 |
03/13/2002 |
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
ELSA A LINKE |
K012796 |
03/14/2002 |
AMLUCK AUTOMATIC DIGITAL WRIST, BLOOD PRESSURE MONITOR AK-3000/AK-4000 |
AMLUCK, INC. |
YANG TIEN-HSING |
K012189 |
03/05/2002 |
ANGELTOUCH VENTED IV ADMINISTRATION SET |
ANGIPLAST PRIVATE LTD. |
ASHIT B SHAH |
K020359 |
03/06/2002 |
ULTRA TOUCH POWDERED LATEX EXAMINATION GLOVES |
AR ALLIANCE HEALTHCARE SDN. BHD. |
CHUA CHOON CHUAN |
K013433 |
03/05/2002 |
TROJAN PASSION BERRY GEL |
ARMKEL LLC |
STEPHEN C KOLAKOWSKY |
K014155 |
03/18/2002 |
OPENING/CLOSING WEDGE OSTETOMY PLATES |
ARTHREX, INC. |
ANN WATERHOUSE |
K020622 |
03/28/2002 |
ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K020557 |
03/21/2002 |
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
K020621 |
03/28/2002 |
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
K014290 |
03/28/2002 |
ENTEC PLASMA WANDS |
ARTHROCARE CORP. |
BRUCE PROTHRO |
K014305 |
03/29/2002 |
RESORBABLE LACTOSORB-L ACL CROSSPIN |
ARTHROTEK, INC. |
SARA B SHULTZ |
K014057 |
03/08/2002 |
DERMASTAR ER:YAG LASER SYSTEM |
ASCLEPION-MEDITEC AG |
WILLIAM KELLEY |
K020137 |
03/04/2002 |
AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON |
ASEPTICO, INC. |
GRANT RAMALEY |
K020156 |
03/06/2002 |
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T |
AXIS-SHIELD DIAGNOSTICS, LTD. |
EILEEN MCCAFFERTY |
K020485 |
03/12/2002 |
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML |
BAXTER HEALTHCARE CORP. |
MARY KONKOWSKI |
K020806 |
03/27/2002 |
ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY |
BAYER CORP. |
THOMAS F FLYNN |
K020217 |
03/15/2002 |
ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY |
BAYER DIAGNOSTICS CORP. |
KENNETH T EDDS |
K014075 |
03/07/2002 |
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 |
BAYLIS MEDICAL CO., INC. |
KRIS SHAH |
K020523 |
03/20/2002 |
BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 |
BD |
PASQUALE AMOTO |
K020521 |
03/01/2002 |
MODIFICATION TO VIGIL LIPID CONTROL |
BECKMAN COULTER, INC. |
GAIL LEFEBVRE |
K020322 |
03/27/2002 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM |
BECTON, DICKINSON & CO. |
BRADFORD M SPRING |
K020068 |
03/04/2002 |
SONOREAL 3D SYSTEM |
BIO MEDI COM |
COLLEEN DENSMORE |
K012960 |
03/08/2002 |
BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR |
BIOGENEX LABORATORIES |
GURVINDER S NANDA |
K020645 |
03/15/2002 |
MODIFICATION TO THE MAESTRO SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
DONALD E DALTON |
K020870 |
03/25/2002 |
VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
K020871 |
03/29/2002 |
VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN |
BIOMERIEUX, INC. |
Nancy Weaver |
K020580 |
03/22/2002 |
X-SERIES BI-METRIC HIP FEMORAL COMPONENTS |
BIOMET, INC. |
PATRICIA S BERES |
K014000 |
03/11/2002 |
VISTITOME 20-10 MICROKERATOME |
BIOVISION AG |
DAVID S FERNQUIST |
K014195 |
03/19/2002 |
KAYAK HYDROPHILIC GUIDE WIRES |
BOSTON SCIENTIFIC CORP. |
MARK MURPHY |
K014109 |
03/12/2002 |
IN-TIME RETRIEVAL DEVICE |
BOSTON SCIENTIFIC, TARGET |
SETH A SCHULMAN |
K004022 |
03/26/2002 |
M3 (MIRCO-MULTILEAF COLLIMATOR |
BRAINLAB AG |
STEFAN VILSMEIER |
K012448 |
03/14/2002 |
VECTORVISION TRAUMA |
BRAINLAB AG |
RAINER BIRKENBACH |
K014280 |
03/20/2002 |
LATEX EXAMINATION GLOVE (POWDERED) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
K014279 |
03/20/2002 |
LATEX EXAMINATION GLOVES (POWDER FREE) |
BRIGHTWAY GLOVES PVT. LTD. |
N. PARAMASIVAN |
K020470 |
03/08/2002 |
MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE |
BYPASS LTD. |
JONATHAN S KAHAN |
K020702 |
03/29/2002 |
O'REGAN DISPOSABLE ANOSCOPE |
CANADIAN THEATRE PRODUCTS LTD. |
ANN-MARIE O'KEEFE |
K012520 |
03/27/2002 |
GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E |
CARDIAC ASSIST DEVICES, INC. |
RASSOLL RASHIDI |
K013201 |
03/18/2002 |
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR |
CARDIOFOCUS, INC. |
JOHN GREENBAUM |
K020437 |
03/15/2002 |
CLASSIC TENS |
CARE REHAB, INC. |
CHRISTIAN HUNT |
K020233 |
03/14/2002 |
CHASE CARDIOVASCULAR PATCH KIT |
CHASE MEDICAL, INC. |
DAVE HERNON |
K020241 |
03/13/2002 |
QACA IGG/IGM ELISA KIT |
CHESHIRE DIAGNOSTICS LTD. |
NEIL B STRINGER |
K013949 |
03/27/2002 |
UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR |
CHURCHILL MEDICAL SYSTEMS, INC. |
KETIH PALUCH |
K020544 |
03/12/2002 |
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA |
CHURCHILL MEDICAL SYSTEMS, INC. |
KEITH PALUCH |
K014236 |
03/26/2002 |
CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES |
CLINICON CORP. |
SEAN M CURRY |
K014153 |
03/15/2002 |
COAPT SYSTMES ENDOTINE DEVICE |
COAPT SYSTEMS, INC. |
JUDE PAGANELLI |
K013714 |
03/28/2002 |
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP |
CODAN US CORP. |
MARILYN R POURAZAR |
K020667 |
03/28/2002 |
CODMAN HAKIM SHUNT SYSTEMS |
Codman & Shurtleff, Inc. |
ELIZABETH DOLAN |
K020451 |
03/14/2002 |
COMFORT WHEELCHAIRS |
COMFORT ORTHOPEDIC CO. LTD. |
ERIC LEE |
K013551 |
03/28/2002 |
ZEUS MICROWRIST ROBOTIC SURGICAL SYSTEM |
COMPUTER MOTION, INC. |
DAVID U THOMAS |
K020490 |
03/28/2002 |
PBS, PBSW WITH CATIONS AND PHENOL RED |
CONCEPTION TECHNOLOGIES |
GRACE HOLLAND |
K020237 |
03/19/2002 |
IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 |
CONSOLIDATED TECHNOLOGY |
CANDICE BETZ |
K014035 |
03/07/2002 |
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS |
COOLTOUCH CORP. |
DONALD V JOHNSON |
K020316 |
03/20/2002 |
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR; MODELS 466-P306AU & 466-P306BU |
CORDIS CORP. |
KAREN WILK |
K014041 |
03/07/2002 |
TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM |
CORDIS NEUROVASCULAR |
ALINA CARABALLO |
K020680 |
03/27/2002 |
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS |
CORDIS NEUROVASCULAR, INC. |
MARITZA CELAYA |
K012377 |
03/11/2002 |
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES |
CORIN U.S.A. |
JOEL BATTS |
K014262 |
03/26/2002 |
COSMED QUARK C12/QUARK T12 |
COSMED S.R.L. |
ROBERT SCHIFF |
K014156 |
03/18/2002 |
CERASORB ORTHO |
CURASAN AG |
ERIC WIECHERT |
K014216 |
03/21/2002 |
SECCA SYSTEM |
CURON MEDICAL, INC. |
JONATHAN S KAHAN |
K020160 |
03/14/2002 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
K020162 |
03/14/2002 |
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
K020441 |
03/28/2002 |
EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
K020142 |
03/14/2002 |
MICROSCAN SYNERGIES PLUS |
DADE BEHRING, INC. |
MAUREEN MENDE |
K020248 |
03/14/2002 |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K020037 |
03/22/2002 |
DRIED GRAM NEGATIVE MIC/COMBO PANELS |
DADE MICROSCAN, INC. |
CYNTHIA VAN DUKER |
K020511 |
03/06/2002 |
MICROSCAN SYNERGIES PLUS |
DADE MICROSCAN, INC. |
MAUREEN MENDE |
K020479 |
03/26/2002 |
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES |
DATEX-OHMEDA |
JOEL C KENT |
K020310 |
03/20/2002 |
DAVLITE MICROENDOSCOPE & ACCESSORIES |
DAVLITE TECHNOLOGIES |
DAVID A MCNALLY |
K013359 |
03/08/2002 |
LP(A)-LATEX SEIKEN ASSAY KIT |
DENKA SEIKEN'S |
YOUSUKE MEGURO |
K011400 |
03/27/2002 |
MRSA-SCREEN |
DENKA SEIKEN'S |
KEVIN MANGAN |
K014188 |
03/15/2002 |
NEW PROPHY POWDER |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K014053 |
03/08/2002 |
CONDUIT TCP GRANULES |
DEPUY ACROMED |
KAREN F JURCZAK |
K020522 |
03/21/2002 |
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
K013984 |
03/28/2002 |
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
K020128 |
03/01/2002 |
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 |
DIAGNOSTIC SYSTEMS LABORATORIES, INC. |
CARROLL POTTS |
K020596 |
03/23/2002 |
CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS |
DIAMOND DIAGNOSTICS, INC. |
LINDA STUNDTNER |
K014030 |
03/26/2002 |
1,25-DIHYDROXYVITAMIN D125I RIA |
DIASORIN, INC. |
DAVID IKEDA |
K014072 |
03/08/2002 |
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) |
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. |
JONATHAN S KAHAN |
K012535 |
03/01/2002 |
DRG DISPOSABLE VAGINAL SPECULUM |
DOCTOR'S RESEARCH GROUP, INC. |
RICHARD DESLAURIERS |
K012989 |
03/20/2002 |
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 |
DOLPHIN MEDICAL INC. |
BILL CURNAN |
K020526 |
03/19/2002 |
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR |
DON WILSON/WILSON-COOK MEDICAL, INC. |
MARGARET J POSNER |
K012957 |
03/06/2002 |
TOWEL DRAPE, MODELS 4409, 4410 |
DYNAREX CORP. |
JOHN GAGLIARDI |
K020635 |
03/21/2002 |
KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 |
EASTMAN KODAK COMPANY |
SUSAN PATE |
K020403 |
03/08/2002 |
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR |
EBI, L.P. |
PATRICIA FLOOD |
K014276 |
03/01/2002 |
MODIFICATION TO EBI XFIX DFS SYSTEM |
EBI, L.P. |
FREDERIC TESTA |
K014052 |
03/08/2002 |
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
K014054 |
03/08/2002 |
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
K014090 |
03/11/2002 |
ENDIUS SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
GENE DIPOTO |
K013680 |
03/04/2002 |
CARBODISSECTING ENDOSCOPE |
ENDO SURGICAL DEVICES, INC. |
DEBBIE IAMPIETRO |
K013089 |
03/14/2002 |
EMS HEPA FILTER AND HME COMBINATIONS |
ENGINEERED MEDICAL SYSTEMS |
PAUL DRYDEN |
K013123 |
03/14/2002 |
EMS PULMONARY FUNCTION TESTING FILTER |
ENGINEERED MEDICAL SYSTEMS |
PAUL DRYDEN |
K020243 |
03/05/2002 |
LASERPRO 16 |
ERADLINK, INC. |
ALBERT J KOUBA |
K020428 |
03/04/2002 |
ENDOPATH DILATING TIP TROCAR, MODEL #512XD |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
K010761 |
03/05/2002 |
SPL-50 SPIROLYSER |
FIM MEDICAL |
ERIC DEREI |
K014002 |
03/04/2002 |
ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 |
FORTUNE MEDICAL INSTRUMENT CORP. |
ABE WANG |
K013867 |
03/15/2002 |
XIVE DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
K020342 |
03/28/2002 |
UNIFIL FLOW |
GC AMERICA, INC. |
TERRY L JORITZ |
K020796 |
03/26/2002 |
CARD IQ ANALYSIS II |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
K012915 |
03/21/2002 |
DINAMAP PRO 1000 MONITOR, MODEL 1000 |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
THOMAS J ENGLISH |
K014289 |
03/28/2002 |
ORTHOSS RESORBABLE BONE VOID FILLER |
GEISTLICH-PHARMA |
PETER S REICHERTZ |
K020524 |
03/20/2002 |
PATIENTNET MONITORING SYSTEM |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
DIANA M THORSON |
K020590 |
03/20/2002 |
MODEL 733HC GRAVITY/VACUUM STEAM STERILIZER |
GETINGE/CASTLE, INC. |
FREDERICK R CATT |
K012869 |
03/11/2002 |
GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 |
GIMMI GMBH |
DAGMAR MASER |
K020340 |
03/01/2002 |
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING |
GUIDANT CORP. |
JENNIFER PAE RIGGS |
K020594 |
03/08/2002 |
DIEGO POWERED DISSECTOR AND DRILL SYSTEM |
GYRUS ENT L.L.C. |
GREGORY SREDIN |
K013109 |
03/12/2002 |
SONOPSY |
HAKKO MEDICAL CO., LTD. |
SHIRO JITAGAWA |
K012805 |
03/13/2002 |
AUTOMARQER |
HAMILTON THORNE RESEARCH |
DIARMAID DOUGLAS-HAMITON |
K014164 |
03/12/2002 |
GREAT TOE IMPLANT SYSTEM |
HARMOS ORTHOPAEDICS, INC. |
RICHARD W WOODS |
K020467 |
03/29/2002 |
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 |
HELENA LABORATORIES |
PATRICIA FRANKS |
K012045 |
03/12/2002 |
HIGHGATE CURVED ROD SYSTEM |
HIGHGATE ORTHOPAEDICS |
KAREN E WARDEN |
K014240 |
03/22/2002 |
PRONTO |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
ROBERT MCCARTHY |
K013612 |
03/19/2002 |
INCARE PELVIC FLOOR THERAPY SYSTEM |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
K013653 |
03/05/2002 |
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE |
HOLLISTER, INC. |
CINDY ROBERTS |
K013871 |
03/29/2002 |
LIFEGUARD SAFETY INFUSION SET |
HORIZON MEDICAL PRODUCTS, INC. |
PATRICIA D JONES |
K020572 |
03/04/2002 |
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
K020677 |
03/29/2002 |
GAMMA 3 LAG SCREW |
HOWMEDICA OSTEONICS CORP. |
WILLIAM J CYMBALUK |
K020650 |
03/29/2002 |
MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM |
HOWMEDICA OSTEONICS CORP. |
WILLIAM J CYMBALUK |
K020497 |
03/04/2002 |
TRIDENT ELEVATED RIM LINER |
HOWMEDICA OSTEONICS CORP. |
NANCY J RIEDER |
K010744 |
03/26/2002 |
FLOWTRON UNIVERSAL, MODEL AC600 |
HUNTLEIGH HEALTHCARE, INC. |
AUDRY WITKO |
K020660 |
03/20/2002 |
HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, ONE STEP KVO |
I-FLOW CORP. |
SHANE NOEHRE |
K020862 |
03/26/2002 |
I-FLOW ELASTOMERIC PUMP |
I-FLOW CORP. |
SHANE NOEHRE |
K014022 |
03/04/2002 |
MRI LINE MARKER |
I.Z.I. CORP. |
HELEN ZINREICH |
K020223 |
03/04/2002 |
INVIGRA |
INDUS MEDICARE LTD. |
P. K REDDY |
K013005 |
03/08/2002 |
ACT 11 MP VENTRICULAR CATHETER |
INNERSPACE, INC. |
DONALD E BOBO |
K020041 |
03/14/2002 |
IALUSET HYDROCOLLOID |
INSTITUT BIOCHIMIQUE SA (IBSA) |
CLARENCE E JONES |
K020558 |
03/21/2002 |
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE |
INTEGRA NEUROSCIENCES |
NANCY MATHEWSON |
K020798 |
03/28/2002 |
HEMOCHRON JR. SIGNATURE + |
INTERNATIONAL TECHNIDYNE CORP. |
JOHN CLAY |
K012406 |
03/26/2002 |
ACCESS SEQUESTRATION SYSTEM |
INTERPORE CROSS INTL. |
PROISE REY-FESSLER |
K020898 |
03/29/2002 |
D.SIGN 15 (DW286 B) |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
K020183 |
03/13/2002 |
PISCES PLUS (DW286 C) |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
K012849 |
03/27/2002 |
GLASS POST |
J. MORITA USA, INC. |
KEITH A BARRITT |
K020158 |
03/07/2002 |
NON-EUGENOL TEMPORARY CEMENT |
J. MORITA USA, INC. |
KEITH A BARRITT |
K020157 |
03/04/2002 |
TEMPORARY CROWN AND BRIDGE MATERIAL |
J. MORITA USA, INC. |
KEITH A BARRITT |
K014300 |
03/01/2002 |
SAFETOUCH |
JAMES D RUSIN MD, MBA |
JAMES D RUSIN |
K013876 |
03/04/2002 |
INFRARED EAR THERMOMETER, MODEL DX-707 |
JAWON MEDICAL CO., LTD. |
WON-HEE PARK |
K014303 |
03/26/2002 |
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE |
JOSTRA AG |
KATHLEEN JOHNSON |
K014204 |
03/05/2002 |
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 |
K-JUMP HEALTH CO., LTD. |
JONATHAN S KAHAN |
K020091 |
03/21/2002 |
OPTILUX 501 |
KERR CORPORATION (DANBURY) |
COLLEEN BOSWELL |
K020178 |
03/15/2002 |
BELLEGLASS HP MODELING GEL |
KERR DENTAL MATERIALS CENTER |
COLLEEN BOSWELL |
K011590 |
03/20/2002 |
RESORB-X RESORBABLE PLATING SYSTEM |
KLS-MARTIN L.P. |
ARTHUR WARD |
K013054 |
03/01/2002 |
KONICA DIRECT DIGITIZER REGIUS MODEL 350 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
KOJI KUBO |
K014087 |
03/04/2002 |
LATEXX MANUFACTURING NON-CHLORINATED, POLYMER COATED, POWDER-FREE RUBBER LATEX EXAMINATION GLOVE |
LATEXX MANUFACTURING SDN.BHD. |
YOLANDA SMITH |
K020006 |
03/29/2002 |
DYNA INTRA-LIMBAL LENS |
LENS DYNAMICS, INC. |
AL VASKE |
K012825 |
03/19/2002 |
HEARTTRENDS |
LEV-EL, LTD. |
EINAT SHAMMAI |
K020450 |
03/21/2002 |
VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
K011378 |
03/25/2002 |
JOE LUB HELMET CONDOM |
MARKETING SALES CONCEPTS, INC. (MSCI) |
ERIC J ARTHUR |
K011363 |
03/25/2002 |
JOE LUBE CONDOM |
MARKETING SALES CONCEPTS, INC. (MSCI) |
ERIC J ARTHUR |
K020518 |
03/07/2002 |
MEDELA SYMPHONY BREAST PUMP, MODEL 024 |
MEDELA, INC. |
WERNER FREI |
K012994 |
03/27/2002 |
WIZAIR DVT |
MEDICAL COMPRESSION SYSTEMS (DBN) LTD. |
SHOSHANA FRIEDMAN |
K020069 |
03/18/2002 |
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM |
MEDTRONIC MIDAS REX |
GREG CANNEDY |
K012506 |
03/07/2002 |
MASTERGRAFT RESORBABLE CERAMIC GRANULES |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD W TREHARNE |
K020632 |
03/15/2002 |
ENGUARD REMOTE PATIENT MONITOR |
MENNEN MEDICAL LTD. |
EREZ NIMROD |
K012414 |
03/06/2002 |
PRIME ECG SYSTEM |
MERIDIAN MEDICAL TECHNOLOGIES, INC. |
JAMIL F LAHAM |
K013779 |
03/29/2002 |
THERMOMETER MODELS ST8132C, ST8132F, ST8142C, ST8142F, ST8532C, ST8532F, ST8542C, AND ST8542F |
MESURE TECHNOLOGY |
PHIL ZULUETA |
K014060 |
03/05/2002 |
MICROAIRE 1000E SYSTEM |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
CARL ANGLES |
K020725 |
03/12/2002 |
MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
K014272 |
03/27/2002 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
DAVID M HARRIS |
K012294 |
03/04/2002 |
WRISTORE FIXATOR |
MILLENNIUM MEDICAL TECHNOLOGIES, INC. |
DAVID W SCHLERF |
K013572 |
03/14/2002 |
MITEK BIOCRYL INTERFERENCE SCREWS |
MITEK PRODUCTS |
CHRISTINE KUNTZ-NASSIF |
K020737 |
03/21/2002 |
CAT ACTIVE WHEELCHAIR |
MOVINGPEOPLE.NET |
PEGGY SPILIADIS |
K020606 |
03/13/2002 |
NVA-63-8 NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORP. |
TOM SCHUBERT |
K020599 |
03/13/2002 |
MTP CLEARVISION DISPOSABLE TUBING SET |
MTP MEDICAL TECHNICAL PROMOTION GMBH |
JAMES A LEE |
K020060 |
03/05/2002 |
ASTOFLO |
NATS CORP. |
RICHARD C LANZILLOTTO |
K012891 |
03/07/2002 |
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) |
NELLCOR PURITAN BENNETT, INC. |
RONALD J EHMSEN |
K020031 |
03/27/2002 |
EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 |
NEOTHERMIA CORP. |
SHERRIE COVAL-GOLDSMITH |
K012575 |
03/12/2002 |
PREFERNCE IMRT TREATMENT PLANNING MODULE |
NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC. |
LEE MYERS |
K014044 |
03/04/2002 |
MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) |
NOTAL VISION, INC. |
RICHARD E LIPPMAN |
K014251 |
03/26/2002 |
NTERO HOTROD SYSTEM |
NTERO SURGICAL, INC. |
BOMMI BOMMANNAN |
K013353 |
03/04/2002 |
NEUROSPECTQUAD GAMMA CAMERA |
NUCLEAR CARDIOLOGY SYSTEMS, INC. |
CHARLES H ROSE |
K020015 |
03/13/2002 |
IMPLANT GUIDANCE SYSTEM APPLICATOR SET |
NUCLETRON CORP. |
LISA DIMMICK |
K020411 |
03/12/2002 |
NUVASIVE TRIAD FACET SCREW SYSTEM |
NUVASIVE, INC. |
LAETITIA BERNARD |
K011269 |
03/04/2002 |
LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR |
NXSTAGE MEDICAL, INC. |
KAREN ST. ONGE |
K014170 |
03/04/2002 |
STAURENGHI WIDE FIELD SCANNING LASER LENS |
OCULAR INSTRUMENTS, INC. |
RAYMOND GRAHAM |
K014286 |
03/08/2002 |
SALUTE, MODEL 3022 |
ONUX MEDICAL, INC. |
RUTHANN DEPIETRO |
K012852 |
03/26/2002 |
EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS |
OPTONOL, LTD |
RICHARD E LIPPMAN |
K020049 |
03/18/2002 |
FORTAFLEX SURGICAL MESH |
ORGANOGENESIS, INC. |
PATRIC BILBO |
K014189 |
03/21/2002 |
ODI TALON INTRAMEDULLARY HIP NAIL |
ORTHOPEDIC DESIGNS, INC. |
JOHN SODEIKA |
K020669 |
03/28/2002 |
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB |
Oscor Inc. |
MILA DOSKOCIL |
K014253 |
03/26/2002 |
DERMACHILLER 4 |
PARADIGM TREX, LLC |
NIKOLAI TANKOVICH |
K020239 |
03/20/2002 |
TOUCH&BOND-PLUS |
PARKELL, INC. |
NELSON J GENDUSA |
K020331 |
03/20/2002 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K011688 |
03/20/2002 |
PELVICFLEXER EXERCISE DEVICE |
PELVICFLEX, INC. |
SUSAN D GOLDSTEIN-FALK |
K014268 |
03/27/2002 |
NORAPAD PLAIN; NORAPAD TA |
PERLEI MEDICAL, INC. |
ART WARD |
K020055 |
03/15/2002 |
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION |
PHILIPS MEDICAL SYSTEMS |
LYNN HARMER |
K020531 |
03/20/2002 |
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B |
PHILIPS MEDICAL SYSTEMS |
DAVE OSBORN |
K014302 |
03/29/2002 |
UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM |
PISHARODI SURGICALS, INC. |
MADHAVEN PISHARODI |
K020202 |
03/12/2002 |
PLAYTEX DEODORANT TAMPONS, MODEL 34702 |
PLAYTEX PRODUCTS, INC. |
MARK ROSENGARTEN |
K020200 |
03/13/2002 |
PLAYTEX DEODORANT TAMPONS, MODEL 34802 |
PLAYTEX PRODUCTS, INC. |
MARK ROSENGARTEN |
K020201 |
03/12/2002 |
PLAYTEX DEODORANT TAMPONS, MODEL 34902 |
PLAYTEX PRODUCTS, INC. |
MARK ROSENGARTEN |
K012350 |
03/14/2002 |
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL |
POREX SURGICAL, INC. |
HOWARD MERCER |
K020733 |
03/21/2002 |
PVS 1500 SDS |
PRECISION VASCULAR SYSTEMS, INC. |
RICK GAYKOWSKI |
K020269 |
03/27/2002 |
PROCERA ALLCERAM BRIDGE MATERIAL |
PROCERA SANDVIK AB |
AGNETA ODEN |
K020007 |
03/21/2002 |
SAFYRE SLING SYSTEM |
PROMEDON |
DEBBIE IAMPIETRO |
K014133 |
03/14/2002 |
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE |
PULPDENT CORP. |
KENNETH J BERK |
K014138 |
03/14/2002 |
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT |
PULPDENT CORP. |
KENNETH J BERK |
K013662 |
03/08/2002 |
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS |
QUANTIMETRIX CORP. |
GEBHARD NEYER |
K020094 |
03/08/2002 |
EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS |
REGULATORY INSIGHT, INC. |
Kevin Walls |
K020100 |
03/08/2002 |
SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 AND SL 801 MECHANICAL WHEELCHAIRS |
REGULATORY INSIGHT, INC. |
Kevin Walls |
K020777 |
03/20/2002 |
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX |
RESPIRONICS, INC. |
ZITA A YURKO |
K014139 |
03/21/2002 |
DIABETES ASSISTANT SOFTWARE |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
K020369 |
03/06/2002 |
ELECSYS ANTI-TG CALCHECK |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
K020438 |
03/08/2002 |
SAS VALUE HCG |
SA SCIENTIFIC, INC. |
RICARDO R MARTINEZ |
K020605 |
03/08/2002 |
SANARUS VISICA TREATMENT SYSTEM |
SANARUS MEDICAL, INC. |
VINCENT CUTARELLI |
K020881 |
03/27/2002 |
MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT |
SCIENCE INCORPORATED |
LYNN WEIST |
K013931 |
03/27/2002 |
OMNI OXYGEN SYSTEM, MODEL 1000 |
SEQUAL TECHNOLOGIES, INC. |
PAM JACKSON |
K020265 |
03/08/2002 |
SERRALENE, MODEL CATALOG NO 1S |
SERRAL, S.A. DE C.V. |
SCOTT HENDERSON |
K013267 |
03/08/2002 |
POWDER FREE (POLYMER COATED) NON CHLORINATED WHITE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICS |
SIAM SEMPERMED CORP. LTD. |
KATIE LEVINSON |
K020573 |
03/13/2002 |
MODIFICATION TO MAGNETOM RHAPSODY SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMES YIEH |
K013426 |
03/26/2002 |
MOONRAY MOBILE C-ARM |
SIMAD S.R.L. |
JEFFREY S KEES |
K020480 |
03/12/2002 |
RBM |
SMITH & NEPHEW, INC. |
WILLIAM MCCALLUM |
K020159 |
03/26/2002 |
SMITH & NEPHEW TWINFIX TI QUICK T |
SMITH & NEPHEW, INC. |
WILLIAM MCCALLUM |
K012778 |
03/15/2002 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K012787 |
03/15/2002 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K012788 |
03/15/2002 |
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
K013488 |
03/27/2002 |
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 |
SOPHYSA SA |
JACQUELINE E MASSE |
K020270 |
03/14/2002 |
SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERA |
SOPRO |
PIERRE MONTILLOT |
K020611 |
03/27/2002 |
UNIVERSAL BONE PLATE III SYSTEM (UBP III) |
SPINAL CONCEPTS, INC. |
DAVID M HOOPER |
K020659 |
03/29/2002 |
DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT |
SSL AMERICAS, INC. |
JOYCE NING |
K012732 |
03/04/2002 |
INTEGRAPH FLASH, MODEL CI 110 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
K020391 |
03/08/2002 |
STERN MICRO ERA ATTACHMENT SYSTEM |
STERNGOLD |
MARIA RAO |
K020097 |
03/15/2002 |
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM |
Stryker Endoscopy |
ALISA MILLER |
K014263 |
03/08/2002 |
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM |
STRYKER INSTRUMENTS |
ROBIN L ROWE |
K014175 |
03/20/2002 |
SULZER DENTAL CERAMIC SYSTEM-HEXLOCK |
SULZER DENTAL, INC. |
SEAN HARIRI |
K014214 |
03/19/2002 |
SULZER DENTAL CERAMIC SYSTEM-SPLINE |
SULZER DENTAL, INC. |
SEAN HARIRI |
K020136 |
03/20/2002 |
VISUALINE BARBITURATES DIPSTRIP TEST |
SUN BIOMEDICAL LABORATORIES, INC. |
MING SUN |
K014230 |
03/13/2002 |
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) |
SUPERMAX GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
K013774 |
03/05/2002 |
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA |
SUPERMAX SDN BHD |
PRISCILLA WEE |
K011588 |
03/28/2002 |
SURETONE |
SURETONE INTERNATIONAL |
MARYNA BURKE |
K020973 |
03/29/2002 |
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO |
SURGILIGHT, INC. |
TIMOTHY SHEA |
K020126 |
03/15/2002 |
MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) |
SURX, INC. |
ALAN CURTIS |
K020267 |
03/29/2002 |
OPTILUX CURING LIGHTS |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
K014197 |
03/21/2002 |
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
K020472 |
03/08/2002 |
BIOTECH MANUAL WHEELCHAIR B900 SUPER LIGHT WHEELCHAIR |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
Ke-Min Jen |
K020188 |
03/08/2002 |
BIOTECH MANUAL WHEELCHAIR, A1000 SUPER SPORT WHEELCHAIR |
TAIWAN ARMADA ENTERPRISE CO., LTD. |
Ke-Min Jen |
K020175 |
03/21/2002 |
URS-IG (GLUCOSE TEST) |
TECO DIAGNOSTICS |
OLIVIA CHEN |
K013737 |
03/01/2002 |
MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON |
TELEMED SYSTEMS, INC. |
MICHAEL CARROLL |
K012041 |
03/28/2002 |
THE HAMMER MODEL H100 |
TENACORE HOLDINGS, INC. |
Brand Caso |
K014260 |
03/27/2002 |
TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE |
TISSUELINK MEDICAL, INC. |
VICKI ANASTASI |
K001638 |
03/04/2002 |
O-RING PROSTHETIC ATTACHMENT |
TITAN IMPLANTS |
LYNETTE L HOWARD |
K013821 |
03/05/2002 |
SILK TOUCH POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
TOP QUALITY MFG., INC. |
MARC SINKOW |
K010253 |
03/19/2002 |
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 |
TRANSONIC SYSTEMS, INC. |
MARK S ALSBERGE |
K020002 |
03/21/2002 |
MODEL P-33, BATTERY OPERATED, THREE WHEEL, POWER SCOOTER , MODEL P-33 |
TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. |
JUAN C RIVERA |
K020001 |
03/21/2002 |
PF-3, BATTERY OPERATED, FOUR WHEEL, POWER SCOOTER, MODEL PF-3 |
TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. |
JUAN C RIVERA |
K014259 |
03/26/2002 |
SENSITITRE HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K014243 |
03/26/2002 |
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 |
TRIAGE MEDICAL INC |
BRAD CULBERT |
K014304 |
03/27/2002 |
BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S |
TRIAGE MEDICAL INC |
BRAD CULBERT |
K013677 |
03/08/2002 |
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM |
U.S. FILTER/IONPURE, INC. |
DAVID A DENTINO |
K020500 |
03/19/2002 |
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE |
UNIVEC, INC. |
R. COHEN |
K014248 |
03/21/2002 |
DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER |
UROGYN LTD. |
EREZ ADIV |
K014127 |
03/15/2002 |
KARMA DISCOVERY, MODEL KP40 |
VESTIL MANUFACTURING CORP. |
RICH MICHAEL |
K020658 |
03/07/2002 |
VIATRONIX V3D COLON |
VIATRONIX, INC. |
BAMAN PATTANAYAK |
K014154 |
03/18/2002 |
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00 |
VILEX, INC. |
ABRAHIM LAVI |
K014111 |
03/06/2002 |
REBILDA SC |
VOCO GMBH |
EVAN DICK |
K020190 |
03/13/2002 |
PORTADUR P 4 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K020194 |
03/15/2002 |
SIMIDUR KF PLUS |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K020195 |
03/15/2002 |
SIMIDUR S1S |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K020192 |
03/15/2002 |
SIMIDUR S2 |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
K020180 |
03/21/2002 |
RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL |
WOODSIDE BIOMEDICAL, INC. |
CAROL PATTERSON |
K020336 |
03/14/2002 |
ENDOSCOPIC CAMERA MC404/C3 |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
K014158 |
03/14/2002 |
ENDOSCOPIC CAMERA TC804/C4 |
WORLD OF MEDICINE LEMKE GMBH |
SUSANNE RAAB |
K014171 |
03/15/2002 |
ADVANCE UNICONDYLAR KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
K013473 |
03/06/2002 |
XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL |
XTRAK MEDICAL INC. |
DEBBIE IAMPIETRO |
K012755 |
03/15/2002 |
AUTODIMER ASSAY MODEL # 1431 |
XTRANA, INC. |
PATRICK J O'LEARY |
K011388 |
03/25/2002 |
ZOLL PAD |
ZOLL MEDICAL CORP. |
PAUL DIAS |