FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K041687 |
08/18/2004 |
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR |
ABBOTT LABORATORIES |
KENT SMITH |
K041685 |
08/30/2004 |
ACON MULTI-CLIN DRUG SCREEN TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG, PH.D. |
K041946 |
08/16/2004 |
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG, PH.D. |
K041604 |
08/16/2004 |
MACRO-MICRO DEPTH ELECTRODE |
AD-TECH MEDICAL INSTRUMENT CORP. |
Gary Syring |
K042246 |
08/31/2004 |
MULTI-DRIP INFUSION CATHETER |
ADVANCED INFUSION, INC. |
JAMES CHRISTENSEN |
K041316 |
08/05/2004 |
ANTIMICROBIAL ALGINATE DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
JOHN E GREENHAM |
K032742 |
08/16/2004 |
SILVER FOAM WOUND DRESSING |
ADVANCED MEDICAL SOLUTIONS LTD. |
JOHN GREEN |
K040191 |
08/25/2004 |
BICONTACT HIP STEM AND FEMORAL HEAD |
AESCULAP |
JOYCE KILROY |
K041120 |
08/30/2004 |
EV APAN DIGITAL, MODEL K1VSM2000 |
AFP IMAGING CORP. |
JAMES JOHNSON |
K042266 |
08/31/2004 |
ACCLAIM |
AIR TECHNIQUES, INC. |
JOSEPH CAREY |
K041585 |
08/26/2004 |
AUTOFUSER AMBULATORY INFUSION PUMP |
ALGOS, LC |
ROBERT J BARD |
K040819 |
08/16/2004 |
TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 |
AMERICAN I.V. PRODUCTS, INC. |
GREGORY FALK |
K041948 |
08/11/2004 |
SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS |
AMERICAN MEDICAL SYSTEMS, INC. |
KRISTYN BENSON |
K041057 |
08/12/2004 |
FLO-RITE |
AMERIFLO CORP. |
MATTHEW THIE |
K041434 |
08/06/2004 |
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS |
ANALOGIC CORP. |
DONALD J SHERRATT |
K040082 |
08/04/2004 |
PORE-SI BONE GRAFT SUBSTITUTE |
APATECH LTD. |
BARRY SALL |
K041711 |
08/26/2004 |
ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K041263 |
08/03/2004 |
NEUROGUIDE ANALYSIS SYSTEM |
APPLIED NEUROSCIENCE INC. |
ROBERT W THATCHER |
K041782 |
08/16/2004 |
SEEMOR 5.0 IMAGE DISPLAY PROGRAM |
AREEDA ASSOC., LTD. |
JOSEPH AREEDA |
K042126 |
08/27/2004 |
PICC |
ARROW INTL., INC. |
SUZANNE SCHORLE |
K041589 |
08/05/2004 |
ARTHREX FIBERWIRE WITH SILK |
ARTHREX, INC. |
ANN WATERHOUSE |
K041531 |
08/03/2004 |
ASAHI PTCA GUIDE WIRE CONFIANZA PRO |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
K041451 |
08/25/2004 |
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 |
ASCENSION ORTHOPEDICS, INC. |
PETER STRZEPA |
K041492 |
08/09/2004 |
ASTRA TECH IMPLANTS - DENTAL SYSTEM |
ASTRA TECH, INC. |
BRUCE R MANNING |
K041748 |
08/09/2004 |
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM) |
AZOG, INC. |
AZUBUIKE OGALA |
K041683 |
08/27/2004 |
B. BRAUN BICARBONATE DIALYSATE |
B. BRAUN MEDICAL, INC. |
JENNIFER A PUNG |
K041415 |
08/04/2004 |
EVA TPN CONTAINER |
B. BRAUN MEDICAL, INC. |
AMY SMITH |
K041508 |
08/27/2004 |
BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM |
BARCO NV BARCOVIEW |
FRANK FERGUSON |
K041998 |
08/16/2004 |
PHACO CHOP NEEDLES |
BAUSCH & LOMB, INC. |
DENNIS POZZO |
K041428 |
08/27/2004 |
ACCUSOL DIALYSIS SOLUTION |
BAXTER HEALTHCARE CORP. |
DAVID E CURTIN |
K041643 |
08/18/2004 |
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT |
BECKMAN COULTER, INC. |
MARY BETH TANG |
K042061 |
08/26/2004 |
0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE |
BECTON DICKINSON |
PETER ZURLO |
K041384 |
08/03/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE |
BECTON, DICKINSON & CO. |
MICHELLE B BANDY |
K041572 |
08/12/2004 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/ML |
BECTON, DICKINSON AND CO. |
MONICA E GIGUERE |
K041889 |
08/19/2004 |
TRI-OSTETIC |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
K041049 |
08/10/2004 |
BINAXNOW INFLUENZA A & B TEST |
BINAX, INC. |
PAM ANGELL |
K041089 |
08/31/2004 |
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM |
BIOMET MANUFACTURING, INC. |
PATRICIA SANDBORN BERES |
K041970 |
08/03/2004 |
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML |
BIOTOP TECHNOLOGY CO., LTD. |
Ke-Min Jen |
K041939 |
08/17/2004 |
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM LORDOTIC LATERAL SPACERS |
BLACKSTONE MEDICAL, INC. |
DEAN E CIPORKIN |
K041359 |
08/20/2004 |
BODY CLOCK STIMPLUS AND STIMPLUS PRO |
BODY CLOCK HEALTH CARE LTD |
RASHELLE PRESTON |
K041827 |
08/06/2004 |
DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
K032884 |
08/06/2004 |
FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH |
BOSTON SCIENTIFIC EPI |
DEBBIE MCINTIRE |
K041993 |
08/16/2004 |
2 CM PERIPHERAL CUTTING BALOON |
BOSTON SCIENTIFIC IVT |
RENUKA KRISHNAN |
K040368 |
08/23/2004 |
VECTORVISION HIP 3.0 |
BRAINLAB AG |
RAINER BIRKENBACH |
K042036 |
08/23/2004 |
AIRGUARD VALVED INTRODUCER |
C.R. BARD, INC. |
GLENN NORTON |
K041169 |
08/24/2004 |
PIESOMETER, MODEL MK-1 |
CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. |
DANIEL KAMM |
K040637 |
08/06/2004 |
POWERHEART AED G3 PRO |
CARDIAC SCIENCE, INC. |
KENNETH OLSON |
K040947 |
08/27/2004 |
DURASUL BIPOLAR |
CENTERPULSE ORTHOPEDICS, INC. |
AUDREY SWEARINGEN |
K041898 |
08/16/2004 |
CLINIQA LIQUID QC TDM CONTROLS LEVELS 1,2 & 3/CLINIQA LINICAL TDM CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEM |
CLINIQA CORPORATION |
CAROL RUGGIERO |
K042078 |
08/27/2004 |
ENDOTINE FOREHEAD TRIPLE DEVICE |
COAPT SYSTEMS, INC. |
LORI DONDIEGO |
K033736 |
08/11/2004 |
MERCI RETRIEVER, MODELS 90065, 90066 |
CONCENTRIC MEDICAL, INC. |
KEVIN F MACDONALD |
K040745 |
08/11/2004 |
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038 |
CONCENTRIC MEDICAL, INC. |
KEVIN F MACDONALD |
K041953 |
08/09/2004 |
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART |
CONMED CORP. |
IRA DUESLER |
K032831 |
08/31/2004 |
PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 |
CONMED CORPORATION |
IRA DUESLER |
K033843 |
08/12/2004 |
SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING |
COOK, INC. |
JENNIFER BOSLEY, MBA |
K041796 |
08/03/2004 |
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
CORDIS CORPORATION |
ELENA S JUGO |
K041689 |
08/06/2004 |
POLYURETHANE BLOOD PRESSURE CUFFS |
D. E. HOKANSON, INC. |
D. EUGENE HOKANSON |
K041503 |
08/12/2004 |
HOVERJACK AIR PATIENT LIFT DEVICE |
D.T. DAVIS ENTERPRISES LTD. |
DAVID T DAVIS |
K040580 |
08/26/2004 |
AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR |
D.Y. INSTRUMENT, INC. |
ANNA D LEE |
K041438 |
08/11/2004 |
ADVANCED D-DIMER ASSAY |
DADE BEHRING, INC. |
KATHLEEN DRAYLYONS |
K041878 |
08/16/2004 |
N LATEX CYSTATIN |
DADE BEHRING, INC. |
KATHLEEN A DRAY-LYONS |
K032954 |
08/09/2004 |
ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80 |
DANMETER A/S |
HANNE NIELSEN |
K042154 |
08/31/2004 |
GE DATEX-OHMEDA AISYS CARESTATION |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR, RAC |
K042022 |
08/12/2004 |
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER |
DATRIX, INC. DBA OF JON BARRON, INC. |
LAURA M LUHMANN |
K041458 |
08/24/2004 |
MARE DENTAL OPERATIVE UNIT |
DENIMED ELECTRONICA S.H. |
GEORGE ECHEVERRI |
K042178 |
08/30/2004 |
ORTHODONTIC CERAMIC BRACKETS |
DENTSPLY INTL. |
P. JEFFERY LEHN |
K041806 |
08/03/2004 |
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE; AND PASSING NEEDLE WITH ETHIBOND LOOP |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FORSTADT |
K041205 |
08/17/2004 |
EXPEDIUM ANTERIOR SPINE SYSTEM |
DEPUY SPINE, INC. |
JENNIFER MOONEY |
K041666 |
08/17/2004 |
DC-ACETA/SAL CONTROLS |
DIAGNOSTIC CHEMICALS LTD. |
NANCY OLSCAMP |
K040703 |
08/26/2004 |
URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS |
DIRUI INDUSTRIAL CO., LTD. |
JOSEPH F LUDFORD |
K041960 |
08/30/2004 |
COMPOSITE/COMPOMER REPAIR KIT |
DMG USA, INC. |
PAMELA PAPINEAU |
K040380 |
08/31/2004 |
DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 |
DOLPHIN MEDICAL INC. |
JON WERNER |
K041935 |
08/16/2004 |
DR SYSTEMS PACS, RELEASE 6.1 |
DR. SYSTEMS, INC. |
KIMBERLY J MEADE |
K042086 |
08/31/2004 |
FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM |
DRAEGER MEDICAL, INC. |
MICHAEL A KELHART |
K041956 |
08/09/2004 |
EMG - ESSENTIAL GAS MODULE, MODEL M1013A |
DRAEGET MEDICAL AG & CO. KGAA |
JAMES J BRENNAN |
K041915 |
08/04/2004 |
HEMO-DOP |
DWL ELEKTRONISCHE SYSTEME GMBH |
GEROLD WIDENHORN |
K033918 |
08/16/2004 |
EBI LACTOSORB GRAFT CONTAINMENT SYSTEM |
EBI, L.P. |
JON CAPAROTTA |
K041629 |
08/06/2004 |
LYSUS INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
K033399 |
08/04/2004 |
GEODESIC EEG SYSTEM SERIES 100 |
ELECTRICAL GEODESICS, INCORPORATED |
ROBERT S MCQUATE |
K041264 |
08/10/2004 |
ELEKTA OY |
ELEKTA NEUROMAG OY |
BIRGITTA FAGERSTROM |
K040314 |
08/12/2004 |
HEALICOLL |
ENCOLL CORP. |
SUBRAMANIAN GUNASEKARAN |
K042017 |
08/26/2004 |
BAHA DIVINO |
ENTIFIC MEDICAL SYSTEMS, INC. |
CONSTANCE G BUNDY |
K041034 |
08/31/2004 |
SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) |
ENTRACARE, LLC |
GRACE HOLLAND |
K041843 |
08/24/2004 |
PENCIL POINT NEEDLE |
EPIMED INTERNATIONAL, INC. |
CHRIS LAKE |
K040108 |
08/17/2004 |
OPUE-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN |
EST INTERNATIONAL CORPORATION |
ELIZABETH DENG |
K042204 |
08/23/2004 |
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT |
EV3 INC |
GLEN D SMYTHE |
K040358 |
08/06/2004 |
XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 |
EXCEL TECH. LTD. |
CAMERON MAHON |
K042150 |
08/27/2004 |
XLTEK TREX MODEL#10309 |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
K041900 |
08/31/2004 |
HC604 CPAP HUMIDIFIER |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
K041192 |
08/12/2004 |
ARCHITECT STAT TROPONIN-I IMMUNOASSAY |
FISHER DIAGNOSTICS |
JOSEFINA INFANTAS |
K041400 |
08/24/2004 |
FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 |
FORTIFIER INTERNATIONAL CO., LTD. |
Ke-Min Jen |
K041456 |
08/25/2004 |
SNAP-OFF SCREWS |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
K041509 |
08/26/2004 |
ANKYLOS DENTAL IMPLANT SYSTEM |
FRIADENT GMBH |
CAROL PATTERSON |
K042023 |
08/25/2004 |
FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
FRANK GIANELLI |
K041990 |
08/06/2004 |
FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
FRANK GIANELLI |
K042177 |
08/27/2004 |
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
K042053 |
08/26/2004 |
INNOVA 4100, INNOVA 3100 |
GE MEDICAL SYSTEMS, INC. |
LARRY A KROGER |
K041932 |
08/18/2004 |
OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM |
GE OEC MEDICAL SYSTEMS, INC. |
JEFF WAGNER |
K041931 |
08/26/2004 |
OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION |
GE OEC MEDICAL SYSTEMS, INC. |
JEFF WAGNER |
K041563 |
08/27/2004 |
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS |
GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. |
ANTHONY G AMITRANO |
K041945 |
08/20/2004 |
POWDER-FREE BLUE VINYL EXAM GLOVES |
GLORMED INTL., INC. |
JANNA P TUCKER |
K042218 |
08/31/2004 |
ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM |
GUIDANT CORP. |
LARAINE PANGELINA |
K041762 |
08/06/2004 |
FINISHING WIRE SUPPORTRAK |
GUIDANT CORPORATION |
JENNIFER TANG |
K041981 |
08/20/2004 |
GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 |
GUIDANT CORPORATION |
M. LAURIE WONG |
K040996 |
08/20/2004 |
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM |
GYRUS ENT L.L.C. |
ALICIA E FARAGE |
K041504 |
08/06/2004 |
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 |
HAEMACURE CORP. |
ELAINE WHITMORE |
K040307 |
08/12/2004 |
HANSON SCAR ADE |
HANSON MEDICAL, INC. |
ERIK HANSON |
K042265 |
08/31/2004 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR MODEL# HL888 |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
K042273 |
08/31/2004 |
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY |
HEALTH HERO NETWORK, INC. |
GEOFFREY J CLAPP |
K040741 |
08/19/2004 |
ULTRASOUND LOCALIZATION SYSTEM ULS 0142 |
HMT HIGH MEDICAL TECHNOLOGIES AG |
TRISH LANDRY |
K041266 |
08/11/2004 |
PEDIATRIC REFERENCE DATABASE |
HOLOGIC, INC. |
ANA RANDALL |
K041555 |
08/09/2004 |
SECURVIEW DX SOFTCOPY WORKSTATION |
HOLOGIC, INC. |
RICHARD FOLLETT |
K042080 |
08/19/2004 |
TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM |
HOME DIAGNOSTICS, INC. |
KAREN DEVINCENT |
K040799 |
08/18/2004 |
HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONS |
HOMMED LLC. |
TOMMIE J MORGAN |
K040651 |
08/10/2004 |
HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEM |
HOMMED LLC. |
TOMMIE J MORGAN |
K042081 |
08/24/2004 |
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE |
HOSPIRA, INC. |
TOM KOZMA |
K040734 |
08/25/2004 |
MODIFICATION TO RESTORATION MODULAR SYSTEM |
HOWMEDICA OSTEONICS CORP. |
GINNY STAMBERGER |
K041710 |
08/03/2004 |
VERSAWAVE DENTAL ER:YAG LASER SYSTEM |
HOYA CONBIO |
JIM GREEN |
K041721 |
08/05/2004 |
LVI AESTHETIC LASER |
HOYA PHOTONICS, INC. |
JIM GREEN |
K040798 |
08/04/2004 |
HES ULTRASONIC THERAPY APPLIANCE |
HWANG SUN ENTERPRISE CO., LTD. |
RICHARD C LANZILLOTTO |
K040710 |
08/11/2004 |
TEGO NEEDLE FREE ACCESS ACCESS DEVICE |
ICU MEDICAL, INC. |
DALE FAIRCHILD |
K041517 |
08/05/2004 |
INFUSIONCATH |
ID LLC |
MARIO ARBESU |
K041728 |
08/11/2004 |
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE |
IMMUNOSTICS, INC. |
JEFFREY FLEISHMAN |
K031714 |
08/16/2004 |
INION TRINION BIODEGRADABLE MENISCUS SCREW |
INION LTD. |
HANNA MARTTILA |
K041947 |
08/16/2004 |
I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND |
INNOVATIVE IMAGING, INC. |
CYNTHIA KENDALL |
K041650 |
08/16/2004 |
MICRO PRIME |
INNOVX MEDICAL, INC. |
ELAINE DUNCAN |
K041409 |
08/20/2004 |
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799 |
INOMED GMBH |
ANDERS SKOGLUND |
K040928 |
08/27/2004 |
EXPANDABLE PEEK VBR IMPLANT |
INTERPORE CROSS INTL. |
WENDY SPIELBERGER |
K041973 |
08/16/2004 |
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
PAMELA MISAJON |
K041562 |
08/09/2004 |
CRYOTIP |
IRVINE SCIENTIFIC SALES CO., INC. |
WENDELL LEE |
K031813 |
08/20/2004 |
OSSATURA DENTAL |
ISOTIS NV |
MARY MCNAMARA-CULLINANE |
K041433 |
08/19/2004 |
BRIGHT GOLD XH |
IVOCLAR VIVADENT, INC. |
ANDERJEET GULATI |
K032975 |
08/16/2004 |
JMS BLOOD TUBING SETS |
JMS NORTH AMERICA CORP. |
SWEE CHEAU |
K040476 |
08/26/2004 |
STORZ MODULITH, MODEL SLX-F2 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
RENATE A MACLAREN |
K041677 |
08/05/2004 |
KARMA SCOOTER, MODEL KS-747.2 |
KARMA MEDICAL PRODUCTS CO., LTD. |
JEN KE-MIN |
K041123 |
08/26/2004 |
RINSPIRATION SYSTEM,RINSPIRATION SYSTEM SHORT TIP, MODELS FG01477/FG01703 |
KERBEROS PROXIMAL SOLUTIONS, INC. |
TOM MASON |
K041334 |
08/11/2004 |
ALCOMATE, MODEL CA2000 |
KHN SOLUTIONS, LLC |
DANIEL KAMM |
K041461 |
08/16/2004 |
KMI DISTAL VOLAR RADIUS PLATE SYSTEM |
KINETIKOS MEDICAL, INC. |
JOHN G SPAMPINATO |
K042066 |
08/25/2004 |
KLSA MARTIN HAND DISTRACTOR |
KLS-MARTIN L.P. |
JENNIFER DAMATO |
K041378 |
08/02/2004 |
BIO 60 |
KODENT, INC. |
DAE KYU CHANG |
K041262 |
08/13/2004 |
DURALITE-GL |
LASER SCIENTIFIC |
JOHN CROWNOVER |
K040562 |
08/31/2004 |
LIFECLINIC, MODEL 2400 |
LIFECLINIC INTERNATIONAL, INC. |
GEORGE MYERS |
K032291 |
08/24/2004 |
TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM |
LINDE MEDICAL SENSORS AG |
JEAN-PIERRE PALMA |
K041485 |
08/02/2004 |
MARPAC MESSENGER MODEL #501 |
MARPAC, INC. |
EVELYN TRUJILLO |
K041778 |
08/31/2004 |
REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T |
MAXI-AIDS, INC. |
ELLIOT ZARETSKY |
K040315 |
08/27/2004 |
MYOHEALTH CLENCHING INHIBITOR |
MCI-MYOHEALTH SYSTEMS |
DAVID BALDING |
K041974 |
08/24/2004 |
MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER |
MED2000 S.R.L. |
SUSAN D GOLDSTEIN-FALK |
K041194 |
08/16/2004 |
ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H |
MEDICAL ANALYSIS SYSTEMS, INC. |
MARY THORSNESS |
K041419 |
08/26/2004 |
LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM |
MEDICAL ENERGY, INC. |
DAVID P LEWING |
K041780 |
08/11/2004 |
NEW BRID |
MEDICAL IMAGING SOLUTIONS, INC. |
NANCY BUTCHER |
K033685 |
08/03/2004 |
NORTHRUP UNIVERSAL ANNULOPLASTY SYSTEM, MODEL 1000 |
MEDICALCV, INC. |
DENNY STEGER |
K041527 |
08/19/2004 |
AARHUS ANCHORAGE SYSTEM |
MEDICON, E.G. |
COLLEEN BOSWELL |
K041980 |
08/06/2004 |
MSI S-500L RF GENERATOR |
MEDSPHERE INTERNATIONAL, INC |
ERIC KAO |
K041197 |
08/09/2004 |
MODIFICATION TO VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
K042025 |
08/25/2004 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
K041244 |
08/12/2004 |
POLYGRAM NET BIOFEEDBACK APPLICATION |
MEDTRONIC VASCULAR |
JULIE GOODE |
K041985 |
08/12/2004 |
XPS CURVED BUR |
MEDTRONIC XOMED, INC. |
MARTIN D SARGENT |
K041840 |
08/20/2004 |
MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM |
MEDX, INC. |
FLOYD R ROWAN |
K041445 |
08/13/2004 |
IMMUNOCARD STAT! RSV MODEL #750630 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
K041003 |
08/20/2004 |
IMMUNOCARD TOXINS A & B, MODEL 712050 |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
K041846 |
08/26/2004 |
SABRESOURCE DRAPE |
MINRAD, INC. |
JOHN MCNEIRNEY |
K042103 |
08/16/2004 |
NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORPORATION |
TOM SCHUBERT |
K041573 |
08/25/2004 |
NANMA VACUUM PUMP PROXZEK MODEL 2M9498S |
NANMA MFG CO., LTD. |
YOLANDA SMITH |
K041320 |
08/12/2004 |
MODIFICATION TO NC-STAT |
NEUROMETRIX, INC. |
JOSEPH F BURKE |
K033580 |
08/05/2004 |
NEXFLEX TOTAL HIP SYSTEM |
NEXMED, INC. |
ELLEN A YARNALL |
K041845 |
08/24/2004 |
NEXUS PAV LUER LOCK DEVICE, MODEL NIS-4 |
NEXUS MEDICAL, LLC |
AL BOEDEKER |
K041661 |
08/26/2004 |
NOBEL BIOCARE ENDOSSEOUS IMPLANTS |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
K041876 |
08/20/2004 |
NOBELDIRECT OD IMPLANT |
NOBEL BIOCARE UAS INC |
ELIZABETH J MASON |
K033587 |
08/05/2004 |
SILVERSEAL |
NOBLE FIBER TECHNOLOGIES |
PATRICIA DAVIDSON |
K041901 |
08/31/2004 |
SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER |
NORTHEAST MONITORING, INC. |
JOSEPH AZARY |
K041613 |
08/25/2004 |
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE |
NovaBone Products, LLC |
DAVID M GAISSER |
K041371 |
08/23/2004 |
BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMIN |
NOVAMIN TECHNOLOGY, INC. |
DAVID C GREENSPAN |
K040343 |
08/03/2004 |
TEMP F |
NOVOCOL, INC. |
STEVE RUDOLPH |
K041933 |
08/18/2004 |
MICROSELECTRON PDR |
NUCLETRON CORP. |
LISA DIMMICK |
K040717 |
08/12/2004 |
NUNC IVF MULTIDISH 4 WELLS NUNCLON |
NUNC A/S |
HENRIK KVISTGAARD |
K041447 |
08/16/2004 |
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA BERNARD |
K042045 |
08/27/2004 |
NXSTAGE PUREFLOW-B SOLUTION |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
K041668 |
08/19/2004 |
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT |
OLYMPUS AMERICA INC. |
BEV HARDING |
K042140 |
08/18/2004 |
OLYMPUS BF TYPE UC160-OL8 |
OLYMPUS CORPORATION |
TINA STEFFANIE-OAK |
K033222 |
08/02/2004 |
OLYMPUS STERILIZATION TRAYS |
OLYMPUS WINTER & IBE GMBH |
TINA STEFFANIE-OAK |
K041720 |
08/25/2004 |
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
K041799 |
08/25/2004 |
VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 17, VITROS CHEMISTRY PRODUCTS FS |
Ortho-Clinical Diagnostics, Inc. |
CAREY MAYO |
K041616 |
08/25/2004 |
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID |
ORTHOS (UK) LIMITED |
ALAN RORKE |
K041809 |
08/06/2004 |
PERMANENT PACING LEAD, MODEL PY2 |
Oscor Inc. |
MILA DOSKOCIL |
K033707 |
08/16/2004 |
POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX |
OSTEOBIOLOGICS, INC. |
GABRIELE G NIEDERAUER, PH.D. |
K041231 |
08/10/2004 |
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M |
PANBIO LIMITED |
CRAIG BREADMORE |
K041776 |
08/03/2004 |
PASCO MIC AND MIC/ID PANELS |
PASCO LABORATORIES, INC. |
LINDA K DILLON |
K041393 |
08/17/2004 |
FASSIER-DUVAL TELSCOPIC IM SYSTEM |
PEGA MEDICAL INC. |
ARIEL R DUJOVNE |
K041076 |
08/09/2004 |
DELTA T |
PENLON LTD. |
ALAN GREEN |
K033648 |
08/09/2004 |
PERFORMANCE WATER TREATMENT SYSTEM |
PERFORMANCE WATER SYSTEMS, LLC |
ROBERT DOWNEY |
DEN040002 |
08/24/2004 |
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 |
PERKINELMER LIFE SCIENCES, INC. |
CINDY LLOYD |
K041219 |
08/04/2004 |
ELECTRO |
PERMOBIL A.B. |
JAN' ASTROM |
K030819 |
08/05/2004 |
PLASMAJET SYSTEM |
PLASMA SURGICAL, LTD. |
PETER F GIBSON |
K041996 |
08/03/2004 |
NIGHTFORM |
PLASTIC SURGERY SOLUTIONS, LLC |
PHIL CARTER |
K033730 |
08/03/2004 |
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES |
PMT CORP. |
ERIC CAILLE |
K041297 |
08/12/2004 |
POLYMEDCO OC LIGHT FOBT TEST |
POLYMEDCO, INC. |
HELEN LANDICHO |
K033122 |
08/25/2004 |
5000Z SYSTEM (OTC) |
PRIZM MEDICAL, INC. |
CATHRYN N CAMBRIA |
K041831 |
08/09/2004 |
PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR |
PROGENY, INC. |
E.M. DOLAN |
K031152 |
08/17/2004 |
PROPPER VAPOR LINE PCD (STEAM STERILIZATION PROCESS CHALLENGE TEST) |
PROPPER MFG. CO., INC. |
JOHN D DYCKMAN |
K041635 |
08/16/2004 |
G5 I HBA1C TEST, G5 II HBA1C TEST |
PROVALIS DIAGNOSTICS LTD. |
THOMAS M TSAKERIS |
K041929 |
08/26/2004 |
MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY |
PROXIMA THERAPEUTICS, INC. |
MARTINE D SCHNEIDER |
K041848 |
08/20/2004 |
POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR |
PT. SMART GLOVE INDONESIA |
FOO KHON PU |
K040792 |
08/12/2004 |
POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) |
PT. SMART GLOVE INDONESIA |
FOO KHON PU |
K041997 |
08/27/2004 |
RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
K041386 |
08/09/2004 |
RAVEN PROTEST - STEAM |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
K032949 |
08/23/2004 |
SPOT CHECK PULSE OXIMETER,512/513 |
RESPIRONICS NOVAMETRIX, INC. |
MICHAEL J MALIS |
K032971 |
08/26/2004 |
TIDAL WAVE SP MODEL 710/715 AND 715 |
RESPIRONICS NOVAMETRIX, INC. |
MICHAEL J MALIS |
K041610 |
08/19/2004 |
MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
K040529 |
08/19/2004 |
COCOON HYGIENIST |
SATELEC |
JEAN-LUC BOULNOIS |
K033738 |
08/24/2004 |
MONITORING SYSTEM, MODEL ARGUS PB-2200 |
SCHILLER AG |
MARKUS BUETLER |
K032910 |
08/30/2004 |
CARRIAZO PENDULAR |
SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG |
WILLIAM T KELLEY |
K041886 |
08/04/2004 |
PROVISO |
SCIENTIFIC PHARMACEUTICALS, INC. |
JAN A ORLOWSKI |
K042101 |
08/27/2004 |
CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES |
SEAL POLYMER INDUSTRIES BHD. |
CHUN CHOOI FONG |
K042014 |
08/06/2004 |
DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 |
SEIN ELECTRONICS CO., LTD. |
JAY MANSOUR |
K042138 |
08/24/2004 |
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 |
SEIN ELECTRONICS CO., LTD. |
JAY MANSOUR |
K042098 |
08/19/2004 |
SENORX INTRODUCER |
SENORX, INC. |
AMY BOUCLY |
K041548 |
08/09/2004 |
SENTEC DIGITAL MONITOR MODEL #SDM |
SENTEC INC. |
STEPHEN GORSKI |
K041276 |
08/20/2004 |
POWDER-FREE NITRILE EXAMINATION GLOVES |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
WUNAN HUANG |
K041379 |
08/31/2004 |
PRE-POWDERED VINYL EXAM GLOVES |
SHIJIAZHUANG WALLY PLASTICS CO., LTD |
IRIS YANG |
K033027 |
08/12/2004 |
SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 |
SHINING WORLD HEALTH CARE CO., LTD. |
JEN KE-MIN |
K042044 |
08/13/2004 |
ACUSON CV70 CARDIOVASCULAR SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK LYNCH |
K042055 |
08/16/2004 |
CYPRESS ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICK LYNCH |
K042121 |
08/26/2004 |
SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY |
SIGMA INTL. |
CHARLES L MARTINA |
K041888 |
08/10/2004 |
CURVED PEEK TETRIS SPINAL IMPLANT |
SIGNUS MEDIZINTECHNIK GMBH |
TRACY L GRAY |
K041976 |
08/23/2004 |
SMITH & NEPHEW GRAFT DELIVERY SYSTEM |
SMITH & NEPHEW, INC. |
KIM P KELLY |
K040542 |
08/19/2004 |
SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW |
SMITH & NEPHEW, INC. |
MARION W GORDON |
K033178 |
08/04/2004 |
ULTRABIO |
SONOTECH, INC. |
MARGARET J LARSON |
K040525 |
08/17/2004 |
SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000 |
SONTRA MEDICAL INC. |
ALBERT FARINHA |
K030774 |
08/09/2004 |
STIMULEN COLLAGEN |
SOUTHWEST TECHNOLOGIES, INC. |
EDWARD I STOUT |
K041421 |
08/26/2004 |
NAME BONE VOID FILLER |
STRYKER BIOTECH |
SHARON MCDERMOTT |
K033135 |
08/09/2004 |
STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM |
Stryker Endoscopy |
MIKE HILLDOERFER |
K040731 |
08/05/2004 |
STRYKER SPINE VERTEBRAL SPACER |
STRYKER SPINE |
SIMONA VOIC |
K032596 |
08/05/2004 |
STURDY MANUAL RESUSCITATOR |
STURDY INDUSTRIAL CO., LTD |
ERIC LUO |
K041601 |
08/27/2004 |
SURFIX KNEE OSTEOTOMY SYSTEM |
SURFIX TECHNOLOGIES |
NORMAN F ESTRIN |
K041173 |
08/02/2004 |
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MICHAEL LINSS |
K041357 |
08/02/2004 |
VARELISA GLIADIN IGG ANTIBODIES |
SWEDEN DIAGNOSTICS (GERMANY) GMBH |
MICHAEL LINSS |
K041887 |
08/19/2004 |
SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS |
SYNTHES (USA) |
LISA M BOYLE |
K041333 |
08/27/2004 |
SYNTHES (USA) TITANIUM WIRE |
SYNTHES (USA) |
LISA M BOYLE |
K042005 |
08/27/2004 |
ACHTUNG TD-4207, CLEVER CHEK TD-4209, CLEVER CHEK TD-4222 |
TaiDoc Technology Corporation |
SHU-MEI WU |
K041752 |
08/05/2004 |
TEH LIN POWERED WHEELCHAIR, MDG-601 |
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. |
JEN KE-MIN |
K041493 |
08/19/2004 |
CEMENTEK |
TEKNIMED SA |
J.D. WEBB |
K041436 |
08/20/2004 |
SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2 |
TERANG NUSA SDN BHD |
CHIN-GUAN LOW |
K041697 |
08/11/2004 |
TERUMO CIRCUIT CONNECTORS |
Terumo Cardiovascular Systems Corporation |
GARRY A COURTNEY |
K041657 |
08/30/2004 |
THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT |
THERMO ELECTRON CORPORATION |
BOLA NICHOLSON |
K041873 |
08/25/2004 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
Mireille Lemery |
K041871 |
08/16/2004 |
INTERLAB MICROCAL SERUM CONTROLS |
TROUBLE SHOOTER CONSULING, INC. |
Gary Lehnus |
K032192 |
08/12/2004 |
PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V |
TUTTNAUER USA CO. LTD. |
MARK M YACURA |
K041995 |
08/19/2004 |
MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY |
URESIL, LLC |
MATTHEW MAHON |
K042207 |
08/26/2004 |
11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL |
USA INSTRUMENTS, INC. |
JAMES WRENN |
K042186 |
08/26/2004 |
3.0T 8-CHANNEL CTL SPINE ARRAY |
USA INSTRUMENTS, INC. |
JAMES WRENN |
K042009 |
08/11/2004 |
MARK III PHASED ARRAY SHOULDER COIL |
USA INSTRUMENTS, INC. |
JAMES WRENN |
K031502 |
08/27/2004 |
USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM |
USFILTER |
EDWARD L ARMSTRONG |
K042245 |
08/30/2004 |
VAPOTHERM MODEL#2000I, 200H |
VAPOTHERM, INC. |
PAUL E DRYDEN |
K041519 |
08/04/2004 |
MODIFICATION TO: ON-BOARD IMAGER DEVICE |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
K040922 |
08/18/2004 |
VENTURE WIRE CONTROL CATHETER |
VELOCIMED INC. |
Sew-Wah Tay |
K042124 |
08/13/2004 |
DENFIL |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
K041289 |
08/05/2004 |
TALUS OF VILEX (TOV) |
VILEX, INC. |
ABRAHAM LAVI |
K041287 |
08/05/2004 |
VILEX BONE PLATE SYSTEM |
VILEX, INC. |
ABRAHAM LAVI |
K040848 |
08/11/2004 |
EZ SMART |
VIP INTERNATIONAL WHOLESALERS, CORP. |
DAVID L ROSEN |
K041202 |
08/12/2004 |
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST |
W.H.P.M., INC. |
FRAN WHITE |
K040490 |
08/18/2004 |
WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE |
WELCH ALLYN, INC. |
|
K041691 |
08/05/2004 |
CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT |
WEST PHARMACEUTICAL SERVICES, INC. |
DAVID WEISER |
K041168 |
08/02/2004 |
ALLOMATRIX PUTTY |
WRIGHT MEDICAL TECHNOLOGY, INC. |
ROGER D BROWN |
K042028 |
08/09/2004 |
VINYL EXAMINATION GLOVE, POWDER-FREE, NON-STERILE |
ZIBO BORUI PLASTIC & RUBBER PRODUCTS CO., LTD. |
MARY ANN DOUCETTE |