| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K001245 |
08/15/2001 |
3T L. V. CONTROL VALVE |
3T MEDICAL SYSTEMS, LLC. |
TIMOTHY J SIMMONS |
| K011801 |
08/16/2001 |
FUTURA TOPCAP NON GAMMA-2 |
AB ARDENT |
CLYDE E INGERSOLL |
| K012281 |
08/01/2001 |
TRS-2000 POWER TILT/POWER RECLINE SYSTEM |
ACCELERATED REHAB DESIGNS, INC. |
RANDALL POTTER |
| K011024 |
08/10/2001 |
CYBERKNIFE SYSTEM |
ACCURAY, INC. |
E. BRUCE FLOYD |
| K011730 |
08/09/2001 |
ACON PCP ONE-STEP PHENCYCLIDINE TEST STRIP, ACON PCP ONE-STEP PHENCYCLIDINE TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K012215 |
08/07/2001 |
QUIK-CHECK HOME PREGNANCY TEST |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K012252 |
08/24/2001 |
QUIK-CHECK OVULATION PREDICTOR |
ACON LABORATORIES, INC. |
FRAN WHITE |
| K011962 |
08/09/2001 |
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST |
ADVANTAGE DIAGNOSTICS CORP. |
JANIS FREESTONE |
| K011372 |
08/01/2001 |
AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE |
AESCULAP, INC. |
STEVE REITZLER |
| K011102 |
08/03/2001 |
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM |
AESCULAP, INC. |
LISA M MILLINGTON |
| K011721 |
08/14/2001 |
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES |
ALLEGIANCE HEALTHCARE CORP. |
ERICA SETHI |
| K012253 |
08/30/2001 |
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
KELVIN BURROUGHS |
| K012080 |
08/29/2001 |
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
KELVIN BURROUGHS |
| K011706 |
08/06/2001 |
FLEXICAST PRIME |
AMERICAN DENT-ALL, INC. |
VACHAKAN H KHOIE |
| K011705 |
08/03/2001 |
SUPREMCAST |
AMERICAN DENT-ALL, INC. |
VACHAKAN H KHOIE |
| K012213 |
08/13/2001 |
GULLIVER AND CLASSE A |
AMERICAN DENTAL TECHNOLOGIES, INC. |
JOHN VICKERS |
| K011251 |
08/01/2001 |
SPARC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
GINGER S GLASER |
| K012754 |
08/27/2001 |
EZ SET INFUSION SET |
ANIMAS CORP. |
MICHAEL J ANDREWS |
| K010544 |
08/10/2001 |
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE |
APEX DENTAL MATERIALS, INC. |
SCOTT LAMERAND |
| K010547 |
08/16/2001 |
VERTEX SEALAND L/C ORTHODONTIC SEALANT |
APEX DENTAL MATERIALS, INC. |
SCOTT LAMERAND |
| K002339 |
08/24/2001 |
AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600 |
APEX MEDICAL CORP. |
DANIEL LEE |
| K012476 |
08/31/2001 |
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010 |
APPLIED MEDICAL TECHNOLOGY, INC. |
CHRIS ZANTOPULOS |
| K012489 |
08/30/2001 |
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10 |
APPRIVA MEDICAL, INC. |
MICHAEL KOLBER |
| K011495 |
08/01/2001 |
ARTHREX BIO-POST AND WASHER |
ARTHREX, INC. |
ANN WATERHOUSE |
| K012374 |
08/23/2001 |
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER |
ASTRA TECH, INC. |
BRUCE R MANNING |
| K011722 |
08/30/2001 |
ATRICURE BIPOLAR COAGULATION SYSTEM |
ATRICURE, INC. |
MARK L FRIEDMAN |
| K012369 |
08/10/2001 |
BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 |
ATYS MEDICAL |
CHRISTINE TURLAT |
| K011912 |
08/31/2001 |
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 |
AXYA MEDICAL, INC. |
HOWARD L SCHRAYER |
| K012299 |
08/01/2001 |
MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
| K011504 |
08/14/2001 |
BAUMER LOCKING NAIL |
BAUMER S.A. |
BRENO CORREA FARAGO JR. |
| K010755 |
08/20/2001 |
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY |
BAYER CORP. |
William J Pignato |
| K011984 |
08/29/2001 |
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET |
BECTON DICKINSON & CO. |
M. WENDY BOSSHARDT |
| K012104 |
08/21/2001 |
SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES |
BEIJING REAGENT LATEX PRODUCTS CO., LTD. |
WANG YANNAN |
| K012166 |
08/01/2001 |
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN) |
BEST MANUFACTURING COMPANY |
DAVID C YOUNG |
| K012513 |
08/29/2001 |
LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 |
BIO-RAD |
MARIA ZEBALLOS |
| K010635 |
08/20/2001 |
INTERLOK / HA COPELAND RESURFACING HEADS |
BIOMET, INC. |
MARY L VERSTYNEN |
| K003281 |
08/07/2001 |
LACTOSORB RAPIDFLAP |
BIOMET, INC. |
CAROL LAUSTER |
| K012348 |
08/15/2001 |
MAXIM RPG PS FEMORAL COMPONENT |
BIOMET, INC. |
MICHELLE MCKINLEY |
| K012431 |
08/28/2001 |
COMBITROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3, AUTOTROL TS MULTI ANALYTE CONTROL, LEVELS 1,2,3 |
BIONOSTICS, INC. |
KATHY STORRO |
| K012430 |
08/27/2001 |
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3 |
BIONOSTICS, INC. |
KATHY STORRO |
| K011459 |
08/07/2001 |
WUJIN #3 FEMORAL BONE PLATE |
BIOPRO, INC. |
PATRICK PRINGLE |
| K011460 |
08/07/2001 |
WUJIN #3 TIBIAL BONE PLATE |
BIOPRO, INC. |
PATRICK PRINGLE |
| K010735 |
08/17/2001 |
SPEEDYBELL |
BIOPSYBELL S.A.S. |
LUCIO IMPROTA |
| K012728 |
08/29/2001 |
E-SCAN MRI SYSTEM |
BIOSOUND ESAOTE, INC. |
COLLEEN HITTLE |
| K011906 |
08/13/2001 |
BACK-UP MEIER GUIDEWIRE |
BOSTON SCIENTIFIC CORP. |
JODI LYNN GREENIZEN |
| K003839 |
08/01/2001 |
CENTRAL VENOUS CATHETER |
BOSTON SCIENTIFIC CORP. |
THERESA A MCGOVERN |
| K012365 |
08/24/2001 |
VAXCEL DIALYSIS CATHETER |
BOSTON SCIENTIFIC CORP. |
NICHOLAS CONDAKES |
| K012216 |
08/17/2001 |
NIROYAL BILIARY PREMOUNTED STENT SYSTEM |
BOSTON SCIENTIFIC SCIMED, INC. |
CANDICE BURNS |
| K010968 |
08/30/2001 |
VECTORVISION CT/FLUORO |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K012187 |
08/14/2001 |
CG-3250 MINIRECEIVER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K011840 |
08/10/2001 |
CERVILENZ UTERINE MEASURING SOUND |
CERVILENZ INC |
JUDY F GORDON |
| K012248 |
08/10/2001 |
CHASE CARDIOVASCULAR PATCH |
CHASE MEDICAL, INC. |
DAVE JERNON |
| K011550 |
08/14/2001 |
HCG STAT PAK ULTRA-FAST |
Chembio Diagnostic Systems, Inc. |
FRAN WHITE |
| K011551 |
08/14/2001 |
SURE CHECK PREGNANCY TEST |
Chembio Diagnostic Systems, Inc. |
FRAN WHITE |
| K010039 |
08/10/2001 |
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD GLUCOSE STRIPS, QUICKTEK CONTROL SOLUTION |
CHRONIMED, INC. |
BRUCE A MACFARLANE |
| K012203 |
08/27/2001 |
CLAY-PARK LABS, INC. - LUBRICATING JELLY |
CLAY-PARK LABS, INC. |
GARY L YINGLING |
| K012855 |
08/30/2001 |
LIQUISPX LIQUID LIPID CONTROL |
CLINICAL CONTROLS DIVISION |
JAMES F GODFREY |
| K012317 |
08/31/2001 |
COALESCENT SURGICAL U-CLIP |
COALESCENT SURGICAL |
MICHAEL A DANIEL |
| K011695 |
08/07/2001 |
COLLAGEN DENTAL MEMBRANE |
COLLAGEN MATRIX, INC. |
SHU-TUNG LI |
| K010242 |
08/13/2001 |
COOK ZILVER BILIARY STENT |
COOK, INC. |
LISA HOPKINS |
| K012087 |
08/01/2001 |
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT |
CORDIS CORP. |
CHUCK RYAN |
| K010411 |
08/27/2001 |
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM |
CORDIS CORP. |
CHARLES J RYAN |
| K012056 |
08/01/2001 |
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM |
CORDIS EUROPA N.V. |
CHUCK RYAN |
| K012090 |
08/01/2001 |
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT |
CORDIS, A JOHNSON & JOHNSON CO. |
CHARLES J RYAN |
| K012567 |
08/23/2001 |
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT |
CORGENIX, INC. |
NANCI DEXTER |
| K012059 |
08/01/2001 |
8100/8500 VITAL SIGNS MONITOR |
CRITICARE SYSTEMS, INC. |
ALEX KAPLAN |
| K011073 |
08/22/2001 |
CRYOPLAN SYSTEM |
CRYOMEDICAL SCIENCES, INC. |
E.J. Smith |
| K012282 |
08/06/2001 |
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE |
CYPRESS MEDICAL PRODUCTS, LTD. |
ANTONIO L GIACCIO |
| K011665 |
08/09/2001 |
BCT SYSTEM |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K010418 |
08/22/2001 |
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
| K011069 |
08/16/2001 |
AQUASENS FLUID MONITORING SYSTEM |
DAVOL, INC., SUB. C.R. BARD, INC. |
LUCINDA L FOX |
| K011333 |
08/20/2001 |
CERCON CERAM |
DEGUSSA - NEY DENTAL, INC. |
THOMAS C CAMERON |
| K011762 |
08/23/2001 |
HI-WAVE; POUR-PLUS |
DENPLUS, INC. |
SHUOJIA DONG |
| K012311 |
08/20/2001 |
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K012312 |
08/20/2001 |
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K012053 |
08/20/2001 |
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM |
DIAMEDIX CORP. |
LYNNE STIRLING |
| K010399 |
08/14/2001 |
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) |
DIATEK, INC. |
TODD CASSIDY |
| K012307 |
08/23/2001 |
LUXACORE/LUXACORE DUAL |
DMG USA, INC. |
PAMELA PAPINEAU |
| K012316 |
08/23/2001 |
PERMACEM / PERMACEM DUAL |
DMG USA, INC. |
PAMELA PAPINEAU |
| K011729 |
08/30/2001 |
SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000 |
DNI NEVADA, INC. |
KRISTINE BOGGS |
| K011873 |
08/31/2001 |
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) |
DORNIER |
SUZANNEW COURTNEY |
| K991822 |
08/15/2001 |
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH |
DR. IHDE DENTAL AG SWITZERLAND |
MOURAD BARAKET |
| K012155 |
08/10/2001 |
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS |
EASTMAN KODAK COMPANY |
ANNE ZAVERTNIK |
| K011386 |
08/03/2001 |
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE |
EBI, L.P. |
JON CAPAROTTA |
| K012445 |
08/24/2001 |
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) |
ELECTRO MEDICAL SYSTEMS SA |
SHEILA HEMEON-HEYER |
| K012289 |
08/14/2001 |
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) |
ELEKTA ONCOLOGY SYSTEMS, LTD. |
PETER STEGAGNO |
| K011679 |
08/15/2001 |
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY |
EMBRYOTECH LABORATORIES, INC. |
ANN D MCGONIGLE |
| K011856 |
08/22/2001 |
RADIOGRAPHIC MARKERS |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K012488 |
08/30/2001 |
MODIFICATION TO:ENDIUS BIPOLAR SHEATH |
ENDIUS, INC. |
SUSAN FINNERAN |
| K011538 |
08/09/2001 |
ENDOPATH NON-BLADED SOLID OBTURATOR TROCAR SYSTEM |
ETHICON ENDO-SURGERY, INC. |
ELIZABETH MILLER |
| K012128 |
08/01/2001 |
PROTECTIV ACUVANCE IV CATHETER SYSTEM |
ETHICON ENDO-SURGERY, INC. |
KATIE FORDYCE |
| K012493 |
08/29/2001 |
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 |
EXACTECH, INC. |
ROBERT PAXSON |
| K010404 |
08/30/2001 |
EXEL I.V. ADMINISTRATION SET |
EXELINT INTL. CO. |
ARMAND HAMID |
| K011983 |
08/30/2001 |
INSIGHT GENESIS |
FASSTECH |
LEE BRODY |
| K012373 |
08/09/2001 |
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE |
FERRANIA S.P.A. |
MANNELA PAOLO |
| K011992 |
08/14/2001 |
FHC MICROTARGETING DRIVE SYSTEM |
FHC, INC. |
FREDERICK HAER |
| K011775 |
08/30/2001 |
MICRO TARGETING DRIVE SYSTEM |
FHC, INC. |
FREDERICK HAER |
| K011521 |
08/01/2001 |
ORTHO VLC; ORTHO VLC CAPSULE |
FIRST SCIENTIFIC LIMITED |
ADE AKINMADE |
| K012161 |
08/24/2001 |
FLEX-NAILS |
FIXANO SA |
FRANK FERGUSON |
| K012242 |
08/16/2001 |
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K011368 |
08/02/2001 |
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K011661 |
08/27/2001 |
CONCORD 88 |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K011659 |
08/27/2001 |
GPW-SF |
GATEWAY ALLOYS, INC. |
JOHN C CONSTANTINE |
| K012134 |
08/07/2001 |
GC E-LIGHT |
GC AMERICA, INC. |
TERRY L JORITZ |
| K011917 |
08/03/2001 |
ADVANCED HIP ASSESSMENT SOFTWARE |
GE LUNAR CORP. |
JAMES P RASKOB |
| K012200 |
08/03/2001 |
1.5T INFINITY TWINSPEED MR SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K012313 |
08/07/2001 |
CT COLONOGRAPHY/NAVIGATOR2 |
GE MEDICAL SYSTEMS, INC. |
LARRY KROGER |
| K012385 |
08/10/2001 |
HISPEED X/I SMART GANTRY OPTION |
GE MEDICAL SYSTEMS, INC. |
JOHN W JAECKLE |
| K011604 |
08/22/2001 |
PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
| K012389 |
08/10/2001 |
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM |
GE MEDICAL SYSTEMS, INC. |
JODI PARKER |
| K981693 |
08/06/2001 |
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 |
GEBAUER CO. |
DENISE E SPELLMAN |
| K011072 |
08/24/2001 |
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS |
GELFLEX |
PETER G BRYANT |
| K012560 |
08/23/2001 |
GE LOGIQ A100 MP, MODEL 2272413 |
GENERAL ELECTRIC CO. |
ALLEN SCHUH |
| K011843 |
08/10/2001 |
GENZYME DIRECT-AMYLASE TEST REAGENT |
GENZYME CORP. |
BARBARA PIZZA |
| K012198 |
08/09/2001 |
GIBBONS STERILE TROCAR KITS |
GIBBONS SURGICAL CORP. |
LISA CRISSON |
| DEN010002 |
08/01/2001 |
GIVEN DIAGNOSTIC IMAGING SYSTEM |
GIVEN IMAGING LTD. |
SHOSHANA FRIEDMAN |
| K012553 |
08/17/2001 |
GSIBP BLOOD PRESSURE CUFF |
GLOBALSHOP, INC. |
GARY C BAUMAN |
| K011565 |
08/16/2001 |
INFANT OXYGEN TREATMENT HOOD |
GULF COAST HYPERBARICS, INC. |
JAMES W MCCARTHY |
| K012310 |
08/22/2001 |
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR |
HEALTH & LIFE CO., LTD. |
SUSAN CHEN |
| K010807 |
08/09/2001 |
MUSCLE STIMULATOR SA-100 |
HEALTH@FITNESS TECHNOLOGIES, INC. |
IVAN VRDOLJAK |
| K011666 |
08/06/2001 |
CHILLIT |
HEATSHIELD, INC. |
WILLIAM A PLOUMIS |
| K012243 |
08/20/2001 |
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL |
HEMATRONIX, INC. |
JAMES S AFRANKO |
| K012341 |
08/30/2001 |
TRANSLUX ENERGY |
HERAEUS KULZER, INC. |
CHERYL V ZIMMERMAN |
| K012239 |
08/10/2001 |
MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM |
HITACHI MEDICAL CORP. |
WALTER WEYBURNE |
| K011320 |
08/09/2001 |
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
ROBERT H MCCARTHY |
| K011519 |
08/15/2001 |
AMEDA HYGIENIKIT |
HOLLISTER, INC. |
JOSEPH S TOKARZ |
| K011667 |
08/16/2001 |
HORIZONS INTERNATIONAL POLYPECTOMY SNARES |
HORIZONS INTL. CORP. |
RAFIC SALEH |
| K012158 |
08/01/2001 |
MODIFICATION TO: LONG LENGTH GAMMA NAIL |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K012162 |
08/31/2001 |
STRYKER PLATING SYSTEM BASIC FRAGMENT SET |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K012478 |
08/20/2001 |
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER |
I-STAT CORP. |
PAUL VANDERWERF |
| K011971 |
08/03/2001 |
NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000 |
IMAGE-GUIDED NEUROLOGICS, INC. |
DAVID M LEE |
| K010772 |
08/23/2001 |
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM |
IMAGING SERVICES, INC. |
DEAN JAMES |
| K011575 |
08/17/2001 |
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022 |
IMAGYN SURGICAL |
JULIE POWELL |
| K011694 |
08/29/2001 |
VIEWSTATION |
IMPAC MEDICAL SYSTEMS, INC. |
THOMAS H FARIS |
| K012507 |
08/30/2001 |
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY (ZIMMER), 02-212-05XX1 ( IMPLEX) |
IMPLEX CORP. |
ROBERT A POGGIE |
| K011423 |
08/07/2001 |
INPULSE DENTAL LASER |
INCISIVE, LLC. |
MICHAEL YESSIK |
| K011698 |
08/23/2001 |
STRAUMANN GBR SYSTEM |
INSTITUT STRAUMANN AG |
LINDA JALBERT |
| K003552 |
08/17/2001 |
ITI DENTAL IMPLANT SYSTEM |
INSTITUT STRAUMANN SA |
LINDA JALBERT |
| K003714 |
08/09/2001 |
OSSTELL RESONANCE FREQUENCY ANALYZER |
INTEGRATION DIAGNOSTICS LTD |
CONSTANCE BUNDY |
| K010530 |
08/03/2001 |
GEO STRUCTURE |
INTERPORE CROSS INTL. |
LYNN M RODARTI |
| K011972 |
08/27/2001 |
DIRECT BILIRUBIN REAGENT |
INTERSECT SYSTEMS, INC. |
MARK E LEGAZ |
| K002890 |
08/09/2001 |
INTRALASE 600C LASER KERATOME |
INTRALASE CORP. |
CHARLINE GAUTHIER |
| K012169 |
08/30/2001 |
ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
| K011184 |
08/13/2001 |
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS |
INTRATHERAPEUTICS, INC. |
AMY PETERSON |
| K012167 |
08/01/2001 |
MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR |
INVACARE CORP. |
RAE ANN FARROW |
| K012370 |
08/03/2001 |
SOLARA JR. MANUAL WHEELCHAIR |
INVACARE CORP. |
RAE ANN FARROW |
| K010852 |
08/13/2001 |
OSMED TISSUE EXPANDER |
IOP, INC. |
JASON MALECKA |
| K012174 |
08/27/2001 |
ERIS LAYERING MATERIALS |
IVOCLAR NORTH AMERICA, INC. |
DONNA M HARTNETT |
| K011491 |
08/16/2001 |
HELIOSEAL CLEAR CHROMA |
IVOCLAR NORTH AMERICA, INC. |
ANDERJEET GULATI |
| K012303 |
08/22/2001 |
JEL-20 |
J.F. JELENKO & CO., INC. |
RAPHAEL JUDKINS |
| K012038 |
08/21/2001 |
JAS URIC ACID LIQUID REAGENT |
JAS Diagnostics, Inc. |
David Johnston |
| K012231 |
08/23/2001 |
AVANTE MICRO CRYSTAL SYSTEM |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K011748 |
08/03/2001 |
FIRST FILL R.C.S. |
JENERIC/PENTRON, INC. |
ANNMARIE TENERO |
| K002908 |
08/30/2001 |
JET THERAPY |
JET THERAPY |
OWEN B LAMB |
| K012422 |
08/21/2001 |
K-ASSAY D-DIMER CONTROLS |
KAMIYA BIOMEDICAL CO. |
DON TRAN |
| K010785 |
08/21/2001 |
KSEA DION-GRACIA SET |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K010345 |
08/03/2001 |
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K011514 |
08/13/2001 |
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE |
KENCAP LTD. |
MARTY DELIN |
| K011725 |
08/31/2001 |
OLYMPUS SUCTION PUMP, MODEL KV-5 |
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
ROGER GRAY |
| K984380 |
08/06/2001 |
DISPO ETCH |
KIS PRODUCTS |
REUBEN HERTZ |
| K993124 |
08/06/2001 |
DISPODRILL |
KIS PRODUCTS |
REUBEN HERTZ |
| K993182 |
08/06/2001 |
DISPOPROPHY |
KIS PRODUCTS |
REUBEN HERTZ |
| K010702 |
08/09/2001 |
XUB EXTERNAL ULTRASOUND |
KMI KOLSTER METHODS, INC. |
ALWIN H KOLSTER |
| K010413 |
08/02/2001 |
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI |
KONICA MINOLTA SENSING, INC. |
NANCI DEXTER |
| K010500 |
08/01/2001 |
AUTOMATED WORKCELL CONTROL SOFTWARE |
LAB-INTERLINK, INC. |
DEBORAH S KIPP |
| K011792 |
08/01/2001 |
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES |
LATEXX PARTNERS BHD. |
CHRISTINA SMITH |
| K011791 |
08/01/2001 |
POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR |
LATEXX PARTNERS BHD. |
CHRISTINA SMITH |
| K010372 |
08/22/2001 |
LIGHTLAS 532 PHOTOCOAGULATOR |
LIGHTMED CORP. |
GARY LEE |
| K011176 |
08/10/2001 |
REUSABLE GLASS SYRINGES |
LOCKETT MEDICAL CORP. |
WILLIAM LOCKETT III |
| K011703 |
08/29/2001 |
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES |
LUMENIS |
LISA MCGRATH |
| K011715 |
08/27/2001 |
MACROPORE IB RESORBABLE PLUG |
MACROPORE BIOSURGERY, INC. |
KENNETH K KLEINHENZ |
| K011746 |
08/24/2001 |
MB 11 |
MAICO DIAGNOSTIC GMBH |
DANIEL E EGGAN |
| K012117 |
08/20/2001 |
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K012118 |
08/20/2001 |
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K012119 |
08/20/2001 |
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K012120 |
08/20/2001 |
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004 |
MAINE STANDARDS CO. |
CHRISTINE V BEACH |
| K012122 |
08/20/2001 |
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 |
MAINE STANDARDS CO. |
CHRISTINE V BEACH |
| K011621 |
08/10/2001 |
KOALA CLAMP, KOALA CLAMP AND CUTTER |
MATERNUS, INC. |
RONALD B HICKS |
| K003924 |
08/24/2001 |
MAVIDON MEDICAL ELECTRODE JELLY |
MAVIDON MEDICAL PRODUCTS |
TIM CARROLL |
| K011905 |
08/28/2001 |
SNIPER ELITE MODEL-OR-E3872XX SERIES |
MAXXIM MEDICAL |
GAIL DOHERTY |
| K011608 |
08/14/2001 |
MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL |
MEDICAL ADVANCES, INC. |
MICHAEL J LEIGH |
| K012276 |
08/20/2001 |
TEMP 3 |
MEDICAL SOLUTIONS, INC. |
BRUCE HEYMANN |
| K010908 |
08/01/2001 |
MEDICON TITANIUM YASARGIL ANEURYSM CLIPS |
MEDICON, E.G. |
JOACHIM SCHMID |
| K010910 |
08/01/2001 |
MEDICON YASARGIL CLIP APPLYING FORCEPS |
MEDICON, E.G. |
JOACHIM SCHMID |
| K012217 |
08/01/2001 |
M5T INSTANT FEVER THERMOMETER |
MEDISIM LTD. |
SHOSHANA FRIEDMAN |
| K011991 |
08/21/2001 |
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR |
MEDRAD, INC. |
LORRAINE R FREDES |
| K001853 |
08/22/2001 |
SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1 |
MEDTECH SYSTEMS, INC. |
GARY MILLER |
| K011817 |
08/22/2001 |
BRIDGE FX |
MEDTRONIC AVE, INC. |
JOHN RIOLO |
| K002992 |
08/15/2001 |
DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431 |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
| K011472 |
08/10/2001 |
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID |
MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S |
TOVE KJAER |
| K010918 |
08/23/2001 |
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM |
MEDTRONIC PHYSIO-CONTROL CORP. |
SHERRI L POCOCK |
| K011443 |
08/03/2001 |
THREADED CEMENT RESTRICTOR (CR) TITANIUM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
RICHARD TREHARNE |
| K012255 |
08/01/2001 |
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD W TREHARNE |
| K012225 |
08/28/2001 |
ATTAIN 6215 VENOGRAM BALLOON CATHETER |
MEDTRONIC VASCULAR |
KAREN REIDT |
| K012083 |
08/28/2001 |
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 |
MEDTRONIC VASCULAR |
KAREN REIDT |
| K012130 |
08/28/2001 |
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM |
MEDTRONIC VASCULAR |
KAREN REIDT |
| K010300 |
08/01/2001 |
MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION |
MEDTRONIC VASCULAR |
PAM SCHAUB |
| K012454 |
08/14/2001 |
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD |
MEDTRONIC VASCULAR |
TINA BENOIT |
| K012458 |
08/14/2001 |
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD |
MEDTRONIC VASCULAR |
TINA BENOIT |
| K012459 |
08/14/2001 |
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE |
MEDTRONIC VASCULAR |
TINA BENOIT |
| K012460 |
08/14/2001 |
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD |
MEDTRONIC VASCULAR |
TINA BENOIT |
| K012452 |
08/14/2001 |
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD |
MEDTRONIC VASCULAR |
TINA BENOIT |
| K012538 |
08/23/2001 |
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE |
MEDTRONIC VASCULAR |
MARIE HOLM |
| K011784 |
08/16/2001 |
MODIFICATION TO ENVOY PATIENT MONITOR |
MENNEN MEDICAL LTD. |
EREZ NIMROD |
| K011811 |
08/22/2001 |
MONARCH INFLATION SYRINGE; UNIVERSAL FLUID DISPENSING SYRINGE |
MERIT MEDICAL SYSTEMS, INC. |
DAN REIGLE |
| K011844 |
08/28/2001 |
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS |
MERITS HEALTH PRODUCTS., INC. |
Lee Leichter |
| K011687 |
08/03/2001 |
MP-3C POWER BASE CHAIR, MODEL MP3C |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K011513 |
08/10/2001 |
MP3U, POWER WHEELCHAIR |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K011751 |
08/06/2001 |
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3 |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K011753 |
08/03/2001 |
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4 |
MERITS HEALTH PRODUCTS., INC. |
WINSTON ANDERSON |
| K011707 |
08/03/2001 |
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2 |
MERITS MEDICAL INDUSTRIES CO., LTD. |
WINSTON ANDERSON |
| K011657 |
08/27/2001 |
HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
FELIX MICK |
| K011535 |
08/02/2001 |
CADENCE PRECISION INJECTOR, MODEL 103-0304 |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
| K011937 |
08/28/2001 |
TRULINE INFUSION CATHETERS |
MICRO THERAPEUTICS, INC. |
EBEN GORDON |
| K012110 |
08/27/2001 |
DRI ECSTASY ENZYME IMMUNOASSAY |
MICROGENICS CORP. |
SHERRIE RINNE |
| K012109 |
08/27/2001 |
DRI ECSTASY URINE CALIBRATORS |
MICROGENICS CORP. |
SHERRIE RINNE |
| K010295 |
08/03/2001 |
MICROSTIM 100I TENS DEVICE |
MICROSTIM, INC. |
JOEL ROSSEN |
| K011416 |
08/06/2001 |
MUSCLE IMAGING SYSTEM (MIS) |
MILLENNIUM MAGNETIC IMAGING, INC. |
DONALD H MARKS |
| K011427 |
08/31/2001 |
MBI PD-103 SL; MBI PD-103 SH |
MILLS BIOPHARMACEUTICALS, INC. |
STANLEY MILLS |
| K012353 |
08/14/2001 |
HNC-127 NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K011646 |
08/27/2001 |
NEUROEDGE INFUSION CATHETER |
NEURO VASX, INC. |
JACK SLOVICK |
| K012069 |
08/01/2001 |
MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT |
NEUROTRON MEDICAL, INC. |
WHITT ATHEY |
| K012530 |
08/31/2001 |
AA-1 SYSTEM |
NEUROVISION, INC. |
RICHARD E LIPPMAN |
| K011946 |
08/24/2001 |
THE SPIN SNAP-OFF SCREW |
NEW DEAL, S.A. |
NORMAN F ESTRIN |
| K011716 |
08/30/2001 |
THE UNI-CLIP STAPLE |
NEWDEAL S.A. |
NORMAN F ESTRIN |
| K003631 |
08/10/2001 |
SMARTWAVE IF 2000 |
NEWWAVE MEDICAL LLC. |
ROBERT ARMSTRONG |
| K012123 |
08/03/2001 |
NIDOIL |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K011607 |
08/10/2001 |
SPERMCATCH |
NIDACON INTERNATIONAL AB |
DANIEL KAMM |
| K003804 |
08/30/2001 |
SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 |
NIKO MEDICAL PRODUCTS |
RICHARD A HAMER |
| K011949 |
08/29/2001 |
ELK LASER IMAGER, MODEL EL-DRY 4000 |
NISHIMOTO SANGYO CO., LTD. |
GARY J ALLSEBROOK |
| K012020 |
08/21/2001 |
RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC |
NON-INVASIVE MONITORING SYSTEMS, INC. |
ALLAN F BRACK |
| K011928 |
08/10/2001 |
HYDROTOWER ARTHROSCOPIC ADMINISTRATION TUBING SET, MODEL 7-460-05 |
NORTHGATE TECHNOLOGIES, INC. |
CASEY KUREK |
| K012058 |
08/20/2001 |
STAT PROFILE PHOX PLUS L ANALYZER |
NOVA BIOMEDICAL CORP. |
PAUL W MACDONALD |
| K012096 |
08/24/2001 |
DISPOSABLE VITRECTOMY LENS |
OCULAR INSTRUMENTS, INC. |
RAYMOND GRAHAM |
| K011886 |
08/27/2001 |
OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, |
OLYMPUS AMERICA, INC. |
LAURA STORMS-TYLER |
| K011484 |
08/10/2001 |
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 |
OLYMPUS OPTICAL CO., LTD. |
LAURA STORMS-TYLER |
| K011769 |
08/30/2001 |
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND |
OPUSDENT LTD. |
SHOSHANA FRIEDMAN |
| K003198 |
08/29/2001 |
VULCAN TAC PROBES, MODEL 911XXX |
ORATEC INTERVENTIONS, INC. |
LARAINE PANGELINA |
| K011025 |
08/24/2001 |
FORTAFLEX SURGICAL MESH |
ORGANOGENESIS, INC. |
PATRICK R BILBO |
| K012395 |
08/15/2001 |
MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
| K012391 |
08/15/2001 |
MAC-LINE CO2 NASAL CANNULA SAMPLE LINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
| K012394 |
08/15/2001 |
ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
| K012129 |
08/22/2001 |
ORTHO DEVELOPMENT ORION-I EMF SYSTEM |
ORTHO DEVELOPMENT CORP. |
CAROL FREASIER |
| K012561 |
08/29/2001 |
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS |
ORTHO-CLINICAL DIAGNOSTICS |
SUSAN WERNER WERNER |
| K012593 |
08/30/2001 |
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A SHULMAN |
| K010738 |
08/01/2001 |
CANNULATED PLUS SCREW SYSTEM |
ORTHOMATRIX, INC. |
BEN SHAPPLEY |
| K011827 |
08/28/2001 |
ORTELIUS 800 |
ORTHOSCAN LTD. |
SHOSHANA FRIEDMAN |
| K011807 |
08/07/2001 |
SCS CLARIS SPINAL SCREWS, TYPES V,G,E |
ORTHOTEC,LLC |
KAREN E WARDEN |
| K012533 |
08/22/2001 |
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES |
OSI MEDICAL, INC. |
JON WERNER |
| K010118 |
08/14/2001 |
NORMED MANDIBULAR FIXATION SYSTEM |
OSTEOMEDICS, INC. |
ALBERT ENAYATI |
| K011951 |
08/02/2001 |
EZ SYRINGE |
OWEN MUMFORD, LTD. |
ROBERT SHAW |
| K012407 |
08/14/2001 |
PACEART TX3 CARDIAC EVENT RECORDER |
PACEART, INC. |
GEORGE MYERS |
| K011747 |
08/30/2001 |
PALOMAR LC 100 DIODE LASER |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Marcy Moore |
| K011397 |
08/03/2001 |
PERSYST REVEAL |
PERSYST DEVELOPMENT CORP. |
SCOTT B WILSON |
| K011382 |
08/02/2001 |
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 |
PHOTO MEDEX, INC. |
BOB ROSE |
| K012163 |
08/20/2001 |
POLYTITER SYSTEM |
POLYMEDCO, INC. |
HELLEN LANDICHO |
| K011527 |
08/07/2001 |
PRAXSYS RELIA TSH TEST |
PRAXSYS BIOSYSTEMS, INC. |
RICHARD M THAYER |
| K010454 |
08/01/2001 |
THE ALBERTA LENS SM2, SULFOCON B |
PROGRESSIVE OPTICAL RESEARCH LTD. |
NICK NOVICKY |
| K012444 |
08/16/2001 |
ABN ANEROID SPHYGMOMANOMETER |
PT. SUGIH INSTRUMENDO ABADI |
RICHARD GRAVER |
| K011759 |
08/23/2001 |
RADIUS NEXT GENERATION GUIDEWIRE |
RADIUS MEDICAL TECHNOLOGIES, INC. |
MAUREEN FINLAYSON |
| K012319 |
08/24/2001 |
RANDOX HUMAN ASSSAYED DRUG CONTROL |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K012224 |
08/22/2001 |
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW |
RANFAC CORP. |
GEORGE J HATTUB |
| K012044 |
08/28/2001 |
BI-PHASIC INFILTRATOR |
RELIANCE MEDICAL CORP. |
ROBERT W NICKS |
| K011496 |
08/10/2001 |
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K002328 |
08/27/2001 |
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K011822 |
08/07/2001 |
PIT AND FISSURE CHEMICAL CURING SEALANT |
RITE-DENT MANUFACTURING CORP. |
CESAR E VELIZ |
| K012210 |
08/09/2001 |
MODIFICATION TO ACCU-CHEK INFORM METER |
ROCHE DIAGNOSTICS CORP. |
MIKE FLIS |
| K012399 |
08/24/2001 |
MODIFICATION TO ELECSYS FSH II CALSET |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K012287 |
08/07/2001 |
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K012286 |
08/08/2001 |
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION |
ROCHE DIAGNOSTICS CORP. |
SHERRI L COENEN |
| K011467 |
08/10/2001 |
ROSS EMBRACE PUMP SET |
ROSS PRODUCTS |
DANIEL HAMILTON |
| K011210 |
08/15/2001 |
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY |
RUSCH INTL. |
JULIE A BEAUMONT |
| K010203 |
08/28/2001 |
ACCU-PULSE TENS UNIT |
SADLER ELECTRONICS |
C A SADLER |
| K011935 |
08/08/2001 |
REJUVENIQUE MODEL #RJV10 |
SALTON, INC. |
GEORGIA C RAVITZ |
| K012663 |
08/31/2001 |
EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) |
SEDECAL USA, INC. |
DANIEL KAMM |
| K011544 |
08/15/2001 |
HADGEL, 4 GRAM/SYRINGE |
SEIKAGAKU CORP. |
JOHN J SHEA |
| K012054 |
08/08/2001 |
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 |
SEIN ELECTRONICS CO., LTD. |
WON. KY KIM |
| K011749 |
08/22/2001 |
LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS |
SEMPERMED USA, INC. |
KATIE LEVINSON |
| K012085 |
08/02/2001 |
SOMNO STAR & SERIES SLEEP SYSTEM |
SENSORMEDICS CORP. |
LINDA MURDOCK |
| K011447 |
08/03/2001 |
IN SPACE 3D |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PRAVEEN NADKARNI |
| K012461 |
08/17/2001 |
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PENELOPE H GRECO |
| K012068 |
08/03/2001 |
WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S |
SIMS PORTEX LTD. |
CLAIRE MULLINS |
| K002832 |
08/06/2001 |
CONDUCTIVE GEL FOR ULTRASOUND |
SKYLARK DEVICE & SYSTEMS CO., LTD |
GEORGE K.C. CHEN |
| K012170 |
08/10/2001 |
DIGORA PCT |
SOREDEX PALODEX GROUP OY |
KAI LANER |
| K011339 |
08/20/2001 |
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 |
SPACELABS BURDICK, INC. |
JOHN E GREENBAUM |
| K003555 |
08/29/2001 |
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC |
SPECTRUM BIOTECH, INC. |
IAN MCDOUGALL |
| K012362 |
08/23/2001 |
MODIFICATION TO VASCULAR CLOSURE DEVICE |
STD MFG., INC. |
STEPHEN M PALUMBO |
| K010534 |
08/06/2001 |
CROSS-CHECKS DUAL, MODEL CI 125 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K012330 |
08/10/2001 |
SIMPLICITY EURO QD INFUSION SET |
STERLING MEDIVATIONS, INC. |
JOEL S DOUGLAS |
| K012757 |
08/22/2001 |
ITI DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
LINDA JALBERT |
| K010204 |
08/31/2001 |
STRYKER NAVIGATION SYSTEM-KNEE MODULE |
STRYKER CORP. |
NICOLE PETTY |
| K012347 |
08/23/2001 |
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARCIA R ELLIS |
| K012066 |
08/01/2001 |
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY |
SULZER INTRATHERAPEUTICS, INC. |
MARIA E BRITTLE |
| K012305 |
08/22/2001 |
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM |
SULZER SPINE-TECH |
JANELL A COLLEY |
| K011765 |
08/16/2001 |
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE |
SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
SUSAN D GOLDSTEIN-FALK |
| K011717 |
08/14/2001 |
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES |
SUNMAX ENTERPRISE SHANGHAI CO. LTD. |
SUSAN D GOLDSTEIN-FALK |
| K011781 |
08/31/2001 |
INTERCEPT-URETHRAL MICROCOIL |
SURGI-VISION, INC. |
NANCY E TAYLOR |
| K011798 |
08/14/2001 |
CORERESTORE 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K012322 |
08/30/2001 |
OPTIBOND 2 |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K012321 |
08/27/2001 |
POINT 4 FLOWABLE |
SYBRON DENTAL SPECIALTIES, INC. |
COLLEEN BOSWELL |
| K011978 |
08/09/2001 |
SYNTHES LCP PROXIMAL TIBIA PLATE |
SYNTHES (USA) |
MATTHEW M HULL |
| K011458 |
08/02/2001 |
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM |
SYNTHES (USA) |
MATTHEW M HULL |
| K011878 |
08/13/2001 |
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL |
SYVA CO. |
SUSAN L COLLINS |
| K012257 |
08/03/2001 |
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 |
SYVA CO. |
SUSAN L COLLINS |
| K011543 |
08/31/2001 |
TENS CARE, MODEL XL-Y3 |
TENS CARE LTD. |
BERNARD JOHN TREMAINE |
| K012209 |
08/15/2001 |
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K012646 |
08/27/2001 |
TERUMO 30 GAUGE HYPODERMIC NEEDLE |
TERUMO MEDICAL CORP. |
BARBARA SMITH |
| K012355 |
08/09/2001 |
IMAGE-X SYSTEM |
TG GROUP, INC. |
WAYNE LEBEAU |
| K011444 |
08/08/2001 |
ANSPACH EMAX DRILL SYSTEM |
THE ANSPACH EFFORT, INC. |
WILLIAM E ANSPACH |
| K012296 |
08/31/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K012291 |
08/20/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA |
THE BINDING SITE, LTD. |
JAY GELLER |
| K012292 |
08/31/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K012295 |
08/20/2001 |
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K011941 |
08/22/2001 |
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 |
THE KENDALL COMPANY |
MICHAEL SPEARS |
| K012073 |
08/10/2001 |
OLYMPUS SPRAY CATHETER PW-6C-1 |
THE OLYMPUS OPTICAL CO. |
LAURA STORMS-TYLER |
| K011571 |
08/09/2001 |
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE |
THE RX FILES CORP. |
YOLANDA SMITH |
| K011768 |
08/03/2001 |
THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 |
THERMO-ELECTRIC CO. |
LAWRENCE E MADSON |
| K012212 |
08/15/2001 |
MODIFICATION TO AEQUALIS SHOULDER SYSTEM |
TORNIER |
IRENE GOSSET |
| K010796 |
08/16/2001 |
AIA-PACK BRCA, ST AIA PACK BRCA |
TOSOH MEDICS, INC. |
LOIS NAKAYAMA |
| K011745 |
08/30/2001 |
HP-3, BATTETRY OPERATED, FONT WHEEL DRIVE, POWER WHEELCHAIR |
TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. |
JUAN C RIVERA |
| K011744 |
08/24/2001 |
HP-5, BATTERY OPERATED, REAR WHEEL DRIVE, POWER WHEELCHAIR |
TRANSWORLD MOBILITY DISTRIBUTION, L.L.C. |
JUAN C RIVERA |
| K012151 |
08/29/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K011803 |
08/15/2001 |
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K012379 |
08/16/2001 |
PDX-2000 PORTABLE DIGITAL X-RAY SYSTEM |
TREX ENTERPRISES CORP. |
PETER J MARTIN |
| K012280 |
08/17/2001 |
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 |
TRIAGE MEDICAL INC |
GREG HOLLAND |
| K012220 |
08/27/2001 |
TAO EMBRYO TRANSFER CATHETER SYSTEM |
TTJ BIOMEDICAL, LLC. |
RICHARD JORTBERG |
| K012196 |
08/24/2001 |
ULTRACELL ABSORBENT STICK |
ULTRACELL MEDICAL TECHNOLOGIES, INC. |
COLLEEN MARTIN |
| K012273 |
08/15/2001 |
SPIRAL RADIUS 90-D SST SYSTEM |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
JENNIFER SCHUCK |
| K010754 |
08/15/2001 |
NURSE'S ASSISTANT O.R. CONTROL SYSTEM |
VAL MED CORP. |
HOWARD M HOLSTEIN, ESQ. |
| K011031 |
08/03/2001 |
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT |
VYSIS |
RUSSEL K ENNS |
| K012284 |
08/28/2001 |
WH ACCU TEST PREGNANCY TEST |
W.H.P.M., INC. |
FRAN WHITE |
| K010332 |
08/01/2001 |
WAKO IMMUNOASSAY CALIBRATOR SET |
WAKO CHEMICALS, USA, INC. |
TONYA MALLORY |
| K011603 |
08/15/2001 |
VHS PEDIATRIC HIP SCREW SYSTEM |
WALTER ABENDSCHEIN, M.D. |
WALTER ABENDSCHEIN |
| K002790 |
08/06/2001 |
ADD-ON CONDYLE |
WALTER LORENZ SURGICAL, INC. |
TREVOR BYRD |
| K011660 |
08/21/2001 |
WECK CARDIAC PACING WIRES |
WECK CLOSURE SYSTEMS |
BRIAN YOUNG |
| K012451 |
08/20/2001 |
PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246 |
WELCH ALLYN PROTOCOL, INC. |
DONALD M ABBEY |
| K012455 |
08/17/2001 |
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM |
WELCH ALLYN, INC. |
DAVID A YOUNG |
| K012156 |
08/16/2001 |
IMAGINE H.E. |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012135 |
08/01/2001 |
POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K012048 |
08/16/2001 |
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE |
WRP ASIA PACIFIC SDN. BHD. |
YUE WAH CHOW |
| K002172 |
08/28/2001 |
POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) |
XIROS PLC |
JIM ROWLAND |
