| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K043217 |
03/03/2005 |
A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR |
A & D ENGINEERING, INC. |
JERRY WANG |
| K050501 |
03/14/2005 |
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM |
ABBOTT VASCULAR DEVICES |
ANN E LEONARD |
| K050552 |
03/28/2005 |
PACHPEN PACHYMETER, MODEL 24-5100 |
ACCUTOME, INC. |
JEFFREY L WRIGHT |
| K043581 |
03/03/2005 |
DUAL LUMEN CATHETER |
ACMI CORPORATION |
GRAHAM BAILLIE |
| K050050 |
03/11/2005 |
ON CALL MULTI-DRUG HOME TEST |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K043361 |
03/22/2005 |
ACCUHEART ELECTRODE BELT |
ADVANCED BIOELECTRIC CORPORATION |
MARC-ANDRE COTE |
| K050241 |
03/14/2005 |
AOS HUMERAL NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
GARY SOHNGEN |
| K040883 |
03/15/2005 |
EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM |
ADVANCED STERILIZATION PRODUCTS |
NEELU MEDHEKAR |
| K042945 |
03/09/2005 |
AURA CPAP SYSTEM |
AEIOMED INC. |
Gary Syring |
| K042344 |
03/16/2005 |
EXCIA TOTAL HIP SYSTEM |
AESCULAP, INC. |
JOYCE KILROY |
| K050338 |
03/04/2005 |
MODIFICATION TO: INSTAREAD LITHIUM SYSTEM |
Akers Biosciences, Inc. |
ERIKA AMMIRATI |
| K033436 |
03/16/2005 |
REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K043392 |
03/25/2005 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ALLIANCE MEDICAL CORP. |
MOIRA BARTON |
| K043393 |
03/23/2005 |
REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS |
ALLIANCE MEDICAL CORP. |
JENN SELVEY |
| K050390 |
03/14/2005 |
TAMARACK ANTERIOR THORACOLUNBAR |
ALPHATEC/NEXMED |
ELLEN A YARMALL |
| K050186 |
03/04/2005 |
AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III |
AMEDITECH, INC. |
JOHN WU |
| K042972 |
03/18/2005 |
XP TECHNOLOGY ULTRASONIC SCALER |
AMERICAN EAGLE INSTRUMENTS, INC. |
TOM THOMPSON |
| K050413 |
03/04/2005 |
AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 |
AMPLIFE CORPORATION |
SUSAN D GOLDSTEIN-FALK |
| K050551 |
03/22/2005 |
VOYAGER PERSONAL IMAGING DEVICE |
Ardent Sound, Inc. |
PETER G BARTHE |
| K050634 |
03/21/2005 |
MODIFICATION TO: ARTHREX V-TAK |
ARTHREX, INC. |
ANN WATERHOUSE, RAC |
| K050201 |
03/18/2005 |
AEU-14CF EXPENDITION |
ASEPTICO, INC. |
GRANT RAMALEY |
| K050052 |
03/07/2005 |
ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE |
ATLANTIS COMPONENTS, INC. |
BETSY A BROWN |
| K043556 |
03/28/2005 |
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT |
BECKMAN COULTER, INC. |
ANNETTE HELLIE |
| K043458 |
03/15/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K050400 |
03/22/2005 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML |
BECTON, DICKINSON & CO. |
MONICA E GIGUERE |
| K024258 |
03/04/2005 |
NEUROTECH KNEEHAB |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K050536 |
03/24/2005 |
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL |
BIO-RAD |
MARIA ZEBALLOS |
| K050328 |
03/29/2005 |
PREGNANCY-SKREEN |
BIOCHEMICAL DIAGNOSTIC, INC. |
ALLEN PANETZ |
| K050318 |
03/04/2005 |
BARI-KAD PACKING DEVICE |
BIOENVELOP AGRO, INC. |
ROBERT SCHIFF |
| K042981 |
03/10/2005 |
HYPERQ SYSTEM |
BIOLOGICAL SIGNAL PROCESSING LTD. |
ARAVA HACOHEN |
| K042711 |
03/14/2005 |
MODEL BMLS03-7 |
BIOMEDICAL LIFE SYSTEMS, INC. |
GARY BUSSETT |
| K050028 |
03/25/2005 |
MAESTRO CARPAL HEMIARTHROPLASTY |
BIOMET MANUFACTURING, INC. |
PATRICIA SANDBORN BERES |
| K042051 |
03/08/2005 |
ARCOMXL POLYETHYLENE LINERS |
BIOMET, INC. |
TRACY J BICKEL |
| K042091 |
03/25/2005 |
BIOLOX DELTA CERAMIC HEADS |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K043521 |
03/24/2005 |
BIOSYAG 50 MED |
BIOS S.R.L. |
ALESSANDRO FRANCHI ONDE |
| K042999 |
03/21/2005 |
CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 |
BIOSENSE WEBSTER, INC. |
MARK O'DONNELL |
| K050217 |
03/30/2005 |
FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K050037 |
03/22/2005 |
TRIAGE TOX DRUG SCREEN CONTROLS |
BIOSITE INCORPORATED |
JEFFREY R DAHLEN |
| K042373 |
03/02/2005 |
GALEO FOCUS GUIDE WIRE |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K050630 |
03/22/2005 |
PIVOT STEERABLE MICROCATHETER |
BOSTON SCIENTIFIC - PRECISION VASCULAR |
RICK GAYKOWSKI |
| K050577 |
03/30/2005 |
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 |
BOSTON SCIENTIFIC CORP. |
VERONICA M KOCKEN |
| K050361 |
03/14/2005 |
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE |
BOSTON SCIENTIFIC CORP. |
NICHOLAS CONDAKES |
| K050232 |
03/11/2005 |
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR |
BOSTON SCIENTIFIC CORP. |
PAIGE SWEENEY |
| K050403 |
03/04/2005 |
SPYGLASS DIRECT VISULATION PROBE |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
| K042696 |
03/11/2005 |
BODYGUARD INFUSION PUMP SYSTEM |
CAESAREA MEDICAL ELECTRONICS LTD. |
GALI TZURY |
| K043590 |
03/25/2005 |
SE INFUSION SYSTEM WITH MMS |
CARDINAL HEALTH, ALARIS PRODUCTS |
STACY L LEWIS |
| K042672 |
03/23/2005 |
14F DUAL FLOATING DIALYSIS CATHETER/TRAY |
CARDIOMED SUPPLIES, INC. |
CHRISTIAN G DUBE |
| K050172 |
03/31/2005 |
CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 |
CARDIOMEDICS, INC. |
JOHN HUTCHINS |
| K050366 |
03/17/2005 |
IMAGENPRO |
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC |
MELANIE HASEK |
| K050345 |
03/29/2005 |
CIE FOLDAWAY WHEELCHAIR |
CARLSBAD INTERNATIONAL EXPORT, INC. |
LAURA MEYER |
| K050440 |
03/24/2005 |
AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K043133 |
03/02/2005 |
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K043580 |
03/24/2005 |
ALLIGATOR RETRIEVAL DEVICE (ARD) |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
ANNA LONGWELL |
| K050213 |
03/28/2005 |
FRESHLOOK ONE-DAY COLOR CONTACT LENS |
CIBA VISION CORPORATION |
ANGELA L BUNN |
| K042058 |
03/23/2005 |
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN |
CLEMENT CLARKE INTL., LTD. |
PHILIP HALLYBONE |
| K050111 |
03/08/2005 |
SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG |
COBE CARDIOVASCULAR, INC. |
EDWARD E NEWTON |
| K050426 |
03/18/2005 |
TEMPOSIL, MODEL 6720 |
COLTENE/WHALEDENT AG |
HENRY J VOGELSTEIN |
| K043570 |
03/14/2005 |
UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD |
CONFORMIS, INC. |
LYNDALL ERB |
| K050304 |
03/08/2005 |
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE |
CONMED CORP. |
THOMAS HIRTE |
| K050337 |
03/09/2005 |
SIS FISTULA PLUG |
COOK BIOTECH, INC. |
MARK BLEYER |
| K050294 |
03/31/2005 |
COOK IRELAND SONNET POLYPECTOMY SNARE |
COOK IRELAND LTD |
EMMETT DEVEREUX |
| K043418 |
03/31/2005 |
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH |
COOK UROLOGICAL, INC. |
CINDY RUMPLE |
| K050698 |
03/30/2005 |
MODIFICATION TO:ZILVER 518 BILIARY STENT |
COOK, INC. |
STEPHANIE ROBERTS |
| K050084 |
03/17/2005 |
COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; |
COSMAN MEDICAL, INC. |
MICHAEL ARNOLD |
| K050272 |
03/24/2005 |
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS |
CRYOMEDICAL INSTRUMENTS, LTD. |
GARETH COPPING |
| K050509 |
03/25/2005 |
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I |
CTI PET SYSTEMS, INC. |
ALAINE MEDIO |
| K050047 |
03/31/2005 |
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY |
CUTERA, INC. |
KATHY MAYNOR |
| K050679 |
03/31/2005 |
CUTERA SOLERA OPUS AESTHETIC PRODUCT |
CUTERA, INC. |
KATHY MAYNOR |
| K042626 |
03/28/2005 |
NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM |
CYBERKINETICS, INC. |
BURKE T BARRETT |
| K042384 |
03/29/2005 |
NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM |
CYBERKINETICS, INC. (CKI) |
BURKE T BARRETT |
| K050585 |
03/18/2005 |
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE |
DADE BEHRING, INC. |
ROBERT EUSEBIO |
| K050043 |
03/29/2005 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN |
DADE BEHRING, INC. |
CYNTHIA VAN DUKER |
| K050626 |
03/25/2005 |
GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K050597 |
03/25/2005 |
GE DATEX-OHMEDA ENGSTROM CARESTATION |
DATEX-OHMEDA, INC. |
DAN KOSEDNAR |
| K043120 |
03/01/2005 |
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER |
DATEX-OHMEDA, INC. |
JOEL KENT |
| K043223 |
03/04/2005 |
DEPUY CAS KNEE INSTRUMENTATION |
DEPUY ORTHOPAEDICS, INC. |
RANDA FRANKLIN |
| K043058 |
03/14/2005 |
PINNACLE CONSTRAINED ACETABULAR LINERS |
DEPUY, INC. |
Natalie Heck |
| K043344 |
03/23/2005 |
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM |
DIALYSIS SERVICES, INC. |
MIKE STERLING |
| K050447 |
03/08/2005 |
PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR |
DIDECO S.R.L. |
BARRY SALL |
| K043491 |
03/16/2005 |
ENFANTTM |
DIOPSYS INC. |
JOSEPH FONTANETTA |
| K050091 |
03/16/2005 |
TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) |
DIREX SYSTEMS CORP. |
LARISA GERSTEIN |
| K042887 |
03/18/2005 |
ACCU-CHEK SPIRIT |
DISETRONIC MEDICAL SYSTEMS AG |
Scott Thiel |
| K043235 |
03/08/2005 |
DRAGON HEART I.V. SET |
DRAGON HEART MEDICAL DEVICES CO., LTD. |
JINA YU |
| K050710 |
03/30/2005 |
MINIMASTER ULTRASONIC SCALER |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
CYNTHIA J.M. NOLTE |
| K050627 |
03/22/2005 |
LIFESTENT TURBO BILIARY STENT SYSTEMS |
EDWARDS LIFESCIENCES, LLC. |
KEVIN DRISKO |
| K050563 |
03/29/2005 |
EKOS PERIPHERAL INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K050472 |
03/11/2005 |
LYSUS INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K050070 |
03/25/2005 |
K-LASER, MODELS 3,4,4D,6D |
ELTECH, S.R.L. |
RICHARD ALBRIGHT |
| K041066 |
03/24/2005 |
ENCORE REVERSE SHOULDER PROSTHESIS |
ENCORE MEDICAL, L.P. |
DEBBIE DE LOS SANTOS |
| K042556 |
03/11/2005 |
SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, |
ENTER MEDICAL CORPORATION |
TZONG-FUH KUO |
| K043467 |
03/31/2005 |
FLEXIBLE SPINAL NEEDLE |
EPIMED INTERNATIONAL, INC. |
CHRISTOPHER LAKE |
| K050344 |
03/14/2005 |
LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER |
ETHICON ENDO SURGERY, INC. |
KIMBERLY SHOEMAKER |
| K050205 |
03/04/2005 |
BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH |
FLOWMEDICA, INC. |
JEFF ELKINS |
| K042727 |
03/18/2005 |
POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A |
FOREMOUNT ENT. CO., LTD. |
TYSON HSU |
| K050293 |
03/18/2005 |
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS |
FOTONA D.D. |
STOJAN TROST |
| K043363 |
03/31/2005 |
FRESENIUS LIBERTY CYCLER |
FRESENIUS MEDICAL CARE NORTH AMERICA |
ARTHUR EILINSFELD |
| K042797 |
03/09/2005 |
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
GAMBRO RENAL PRODUCTS |
ROD J RYLANDS |
| K042699 |
03/16/2005 |
ABILITY POWER GURNEY |
GATOR CUSTOM MOBILITY, INC. |
GREGORY S SIMS |
| K043493 |
03/04/2005 |
FUSION PUTTY TYPE |
GC AMERICA, INC. |
TERRY JORITZ |
| K050559 |
03/17/2005 |
GE DISCOVERY VCT SYSTEM |
GE MEDICAL SYSTEMS |
D DUERSTELER |
| K050489 |
03/11/2005 |
INNOVA 2100 |
GE MEDICAL SYSTEMS, LLC |
LARRY A KROGER |
| K043144 |
03/14/2005 |
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE |
GEN-PROBE, INC. |
ALAN MADERAZO |
| K050255 |
03/17/2005 |
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 |
GENDEX DENTAL SYSTEMS |
JOHN R MILLER |
| K050195 |
03/17/2005 |
V-BAG WITH GBS COATING |
GISH BIOMEDICAL, INC. |
J. HARVEY KNAUSS |
| K050144 |
03/03/2005 |
PRISMATIK CERAMIC |
GLIDEWELL LABORATORIES |
KEITH D ALLRED |
| K043033 |
03/22/2005 |
GLOBAL TREASURES FLUID FILLED TEETHER |
GLOBAL TREASURE INDUSTRIES LTD. |
FRAN WHITE |
| K043352 |
03/31/2005 |
GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR |
GOCANNING TECHNOLOGY LTD. |
JENNIFER REICH |
| K041999 |
03/02/2005 |
GYRUS PLASMA SKIN RESURFACING SYSTEM |
GYRUS MEDICAL, INC. |
MARK JENSEN |
| K041781 |
03/14/2005 |
VENTILAIR II MEDICAL AIR COMPRESSOR |
HAMILTON MEDICAL AG |
J. DAVID THOMPSON |
| K050214 |
03/16/2005 |
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) |
HARTALEGA SDN BHD |
KUAN EU JIN |
| K050215 |
03/11/2005 |
NITRILE POWDERED EXAMINATION GLOVES (WHITE) |
HARTALEGA SDN BHD |
KUAN EU JIN |
| K043261 |
03/11/2005 |
HARVEST GRAFT DELIVERY SYRINGE |
HARVEST TECHNOLOGIES, CORP. |
JACK BONASERA |
| K050491 |
03/31/2005 |
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K050249 |
03/30/2005 |
HL168JP |
HEALTH & LIFE CO., LTD. |
PAUL HUNG |
| K033646 |
03/01/2005 |
TRIFIT 700 |
HEALTHFIRST CORP. |
JAY SKOLNIK |
| K050295 |
03/25/2005 |
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES |
HELIO MEDICAL SUPPLIES, INC. |
ERIC CHENG |
| K050163 |
03/24/2005 |
HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
LYNETTE HOWARD |
| K050048 |
03/04/2005 |
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
| K050539 |
03/29/2005 |
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP |
KAREN ARIEMMA |
| K050138 |
03/21/2005 |
MODIFICATION TO: RESTORATION MODULAR SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K050512 |
03/21/2005 |
STRYKER LOCKED PLATING SYSTEM |
HOWMEDICA OSTEONICS CORP. |
VIVIAN KELLY |
| K043331 |
03/04/2005 |
DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 |
HUBDIC CO., LTD |
GUENTER GINSBERG |
| K043433 |
03/07/2005 |
AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA |
HYCOR BIOMEDICAL LTD. |
DANIELLE M KNIGHT |
| K043451 |
03/17/2005 |
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR |
HYPHEN BIOMED |
OLA ANDERSON |
| K041881 |
03/25/2005 |
ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 |
HYPOGUARD USA, INC. |
BRUCE A MACFARLANE |
| K041374 |
03/02/2005 |
AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 |
IDEV TECHNOLOGIES, INC. |
LYNNE A DAVIES |
| K050145 |
03/15/2005 |
CELLTRACKA ANALYZER II |
IMMUNICON CORP. |
PETER SCOTT |
| K050275 |
03/07/2005 |
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN |
INION LTD. |
HANNA MARTTILA |
| K041838 |
03/01/2005 |
MPS (OR MPS-T) |
INNERSPACE, INC. |
DONALD E BOBO |
| K050108 |
03/14/2005 |
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS |
INNOVAQUARTZ |
STEVE GRIFFIN |
| K042208 |
03/18/2005 |
ISIS MER SYSTEM/ELEKTA MER SYSTEM |
INOMED MEDIZINTECHNIK GMBH |
ANDERS SKOGLUND |
| K050278 |
03/10/2005 |
HEMOSIL D-DIMER |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K050221 |
03/30/2005 |
HEMOSIL SILICA CLOTTING TIME |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K050492 |
03/14/2005 |
INTEGRA BONE FIXATION SYSTEM |
INTEGRA LIFESCIENCES CORP. |
DONNA WALLACE |
| K050319 |
03/31/2005 |
MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 |
INTEGRA LIFESCIENCES CORP. |
CHARLES E DINKLER II |
| K042893 |
03/11/2005 |
UNDER BUTTOCKS DRAPE |
INTERNATIONAL MEDSURG CONNECTION, INC. |
TEODORO SANTIAGO |
| K043288 |
03/03/2005 |
MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS |
INTUITIVE SURGICAL, INC. |
USHA KREADEN |
| K050276 |
03/07/2005 |
DIVER C.E. CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
PATRICE STROMBERG |
| K050301 |
03/24/2005 |
MRIDIUM 3850 MRI PUMP SYSTEM |
IRADIMED CORPORATION |
FRANCIS X CASEY |
| K050235 |
03/23/2005 |
IQ 200 URINE ANALYZER BODY FLUIDS MODULE |
IRIS INTERNATIONAL, INC. |
HARVEY L KASDAN |
| K040419 |
03/25/2005 |
DYNAGRAFT II |
ISOTIS ORTHOBIOLOGICS, INC |
ELIANE SCHUTTE |
| K043497 |
03/21/2005 |
AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K042102 |
03/08/2005 |
YIXIN SAFETY SYRINGE |
JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP |
LIU KUN SHENG |
| K042040 |
03/23/2005 |
TRIACTIV SYSTEM |
KENSEY NASH CORP. |
ROBIN M FATZINGER |
| K043591 |
03/04/2005 |
FEATHERLIFT EXTENDED APTOS THREAD |
KMI KOLSTER METHODS, INC. |
KEITH DAVIS |
| K042418 |
03/21/2005 |
KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
LIU YI |
| K041565 |
03/03/2005 |
LAZRPULSR 4X |
LED HEALING LIGHT LLC |
MICHAEL B KINDER |
| K043357 |
03/04/2005 |
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 |
LINDE MEDICAL SENSORS AG |
JEAN-PIERRE PALMA |
| K050497 |
03/25/2005 |
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET |
LINVATEC CORP. |
ELIZABETH PAUL |
| K050227 |
03/02/2005 |
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER |
LINVATEC CORP. |
ELIZABETH M PAUL |
| K050639 |
03/31/2005 |
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM |
LUMENIS, INC. |
MARTHA MURARI |
| K050504 |
03/25/2005 |
VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS |
MAINE STANDARDS CO. |
CHIRSTINE BEACH |
| K050066 |
03/01/2005 |
C-CO2 COLORIMETRIC CO2 INDICATOR |
MARQUEST MEDICAL PRODUCTS, INC. |
THOMAS W DIELMANN |
| K050040 |
03/30/2005 |
MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR |
MARS MEDICAL PRODUCTS |
E.J. Smith |
| K050039 |
03/25/2005 |
MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR |
MARS MEDICAL PRODUCTS |
E.J. Smith |
| K050372 |
03/25/2005 |
VISITRAK, VERSION 1, RELEASE 1 |
MATH RESOLUTIONS, LLC. |
WENDEL DEAN RENNER |
| K043292 |
03/16/2005 |
HEMOCATH |
MED-CONDUIT, INC. |
ROBERT W CUNNINGHAM |
| K043454 |
03/24/2005 |
CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 |
MEDICOMP, INC. |
SUSAN D GOLDSTEIN-FALK |
| K032666 |
03/16/2005 |
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES |
MEDLINE INDUSTRIES, INC. |
LARA SIMMONS |
| K043585 |
03/08/2005 |
MEDLINE SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K043017 |
03/08/2005 |
PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS |
MEDLINE INDUSTRIES, INC. |
LARA N SIMMONS |
| K033577 |
03/18/2005 |
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS |
MEDLINK IMAGING |
DANIEL KAMM |
| K050584 |
03/22/2005 |
GS-128 GRADIENT COMPRESSION SYSTEM |
MEDMARK TECHNOLOGIES, LLC |
MARK HIGGINS |
| K043600 |
03/29/2005 |
MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C |
MEDTRONIC MINIMED |
GERDA P RESCH |
| K043488 |
03/21/2005 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD TREHARNE |
| K050439 |
03/24/2005 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
RICHARD TREHARNE |
| K050139 |
03/22/2005 |
MODIFICATION TO: EXPORT CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K050162 |
03/03/2005 |
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE |
MEDTRONIC XOMED, INC. |
DAVID S DODD |
| K050579 |
03/24/2005 |
MEGA POWER ELECTROSURGICAL GENERATOR |
MEGADYNE MEDICAL PRODUCTS, INC. |
RONDA K MAGNESON |
| K050148 |
03/09/2005 |
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT |
MENTOR CORPORATION |
DONNA CRAWFORD |
| K050457 |
03/14/2005 |
MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM |
MERETE MEDICAL GMBH |
JENIK RADON |
| K041626 |
03/16/2005 |
IMMUNOCARD STAT! FLU A & B |
MERIDIAN BIOSCIENCE, INC. |
SUSAN ROLIH |
| K050206 |
03/15/2005 |
CEDIA TACROLIMUS ASSAY |
MICROGENICS CORP. |
LISA CHARTER |
| K043013 |
03/04/2005 |
MILTEX LAPAROSCOPIC INSTRUMENTS |
MILTEX, INC. |
CHARLES WEAVER |
| K040335 |
03/30/2005 |
MOONCUP, STYLE A & B |
MOONCUP LLC |
MORRIS WAXLER |
| K050125 |
03/18/2005 |
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 |
MORE DIAGNOSTICS |
JAMES W SNIPES |
| K043183 |
03/25/2005 |
EPI-K |
MORIA S.A. |
ELANIE RENAUD-SAMIRI |
| K050514 |
03/25/2005 |
MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS |
MRI DEVICES CORPORATION |
THOMAS SCHUBERT |
| K040262 |
03/17/2005 |
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
KATHLEEN M LAFFAN |
| K043398 |
03/01/2005 |
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE |
NEO METRICS, INC. |
GENE CHAMPEAU |
| K043195 |
03/07/2005 |
NEO IMPLANT SYSTEM |
NEOSS LTD |
RUSSELL PAGANO |
| K050737 |
03/31/2005 |
NEOTHERMIA EN-BLOC BIOPSY SYSTEM |
NEOTHERMIA CORPORATION |
DAVID JACOBS |
| K050346 |
03/17/2005 |
STABILIZATION SCREW |
NEWDEAL S.A. |
JUDITH E O'GRADY |
| K050697 |
03/25/2005 |
MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR |
NIHON SEIMITSU SOKKI CO., LTD. |
LYNETTE HOWARD |
| K043526 |
03/10/2005 |
SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC |
NOBLE FIBER TECHNOLOGIES, INC. |
PATRICIA DAVIDSON |
| K042109 |
03/09/2005 |
DIASYS INTEGRA II |
NOVACOR FRANCE |
DOMINIQUE GRENIER |
| K043541 |
03/10/2005 |
ENDOLINK TRUE MOVEMENT SYSTEM |
NOVARE SURGICAL SYSTEMS, INC. |
GREGORY MATHISON |
| K050106 |
03/30/2005 |
NOVOFINE AUTOCOVER 30G X 8MM |
NOVO NORDISK INC. |
JOHN SIGNORIN |
| K041715 |
03/24/2005 |
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 |
NUCLETRON CORP. |
LISA DIMMICK |
| K043436 |
03/17/2005 |
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 |
NXSTAGE MEDICAL, INC. |
NORMA LEMAY |
| K050237 |
03/18/2005 |
STARSHIELD V3 RF TRNT |
ODIN MEDICAL TECHNOLOGIES LTD. |
ADI ICKOWICZ |
| K050416 |
03/29/2005 |
OSSAPLAST ORTHO |
OSSACUR AG |
KRISTI KISTNER |
| K043063 |
03/24/2005 |
OXYBAND WOUND DRESSING |
OXYBAND TECHNOLOGIES, INC. |
MAUREEN O'CONNELL |
| K043317 |
03/15/2005 |
OMNILUX PLUS |
PHOTO THERAPEUTICS LIMITED |
STEVEN G HUTSON |
| K043329 |
03/18/2005 |
OMNILUX REVIVE AND BLUE |
PHOTO THERAPEUTICS LIMITED |
STEVE G HUTSON |
| K042901 |
03/16/2005 |
ENDOMARK STERILE INDIA INK |
PMT CORP. |
JAMES R VEALE |
| K043571 |
03/18/2005 |
CRYOCHECK CLOT S |
PRECISION BIOLOGIC INC. |
STEPHEN L DUFF |
| K050112 |
03/15/2005 |
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117 |
PRIME PACIFIC HEALTH INNOVATIONS CORPORATION |
DELMAR VOGEL |
| K050211 |
03/17/2005 |
PERSONAL WARMING GEL |
QUALIS, INC. |
MIKE PETERSON |
| K050212 |
03/17/2005 |
PERSONAL WARMING JELLY |
QUALIS, INC. |
MIKE PETERSON |
| K043613 |
03/24/2005 |
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II |
QUANTEL MEDICAL |
ROGER W BARNES |
| K050667 |
03/29/2005 |
R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE |
R2 TECHNOLOGY, INC. |
RICHARD BALL |
| K043003 |
03/01/2005 |
TCM40 MONITORING SYSTEM |
RADIOMETER MEDICAL APS |
PIERRE PELLETIER |
| K050591 |
03/23/2005 |
MODIFICATION TO RAVEN BACTERIAL SPORE STRIPS |
RAVEN BIOLOGICAL LABORATORIES, INC. |
WENDY ROYALTY-HANN |
| K050184 |
03/16/2005 |
BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE |
REGENT MEDICAL AMERICAS, LLC |
KATHLEEN HARRIS |
| K042319 |
03/10/2005 |
RELIANT LASER II SYSTEM AND ACCESSORIES |
RELIANT TECHNOLOGIES, INC. |
HEATHER TANNER |
| K050142 |
03/01/2005 |
RESMED MERIDIAN MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K050359 |
03/16/2005 |
ULTRA MIRAGE II MASK |
RESMED LTD. |
DAVID D'CRUZ |
| K042523 |
03/18/2005 |
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
ROBERT L CASARSA |
| K043303 |
03/11/2005 |
ONLINE DAT PROPOXYPHENE PLUS |
ROCHE DIAGNOSTICS CORP. |
KERWIN KAUFMAN |
| K040202 |
03/04/2005 |
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM |
SALTER LABS |
DUANE KAZAL |
| K043204 |
03/30/2005 |
SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP |
SGARLATO LABORATORIES, INC. |
MICHAEL MCDOUGALL |
| K050360 |
03/01/2005 |
TULIP CONDOM |
SHANGHAI LATEX FACTORY |
LOU JI |
| K050467 |
03/30/2005 |
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN |
SHEN WEI (USA), INC. |
CYNTHIA LIU |
| K043478 |
03/09/2005 |
POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. |
EMMY TJOENG |
| K050476 |
03/25/2005 |
CORDLESS COIL |
SIEMENS MEDICAL SOLUTION, INC. USA |
ANA LADINO |
| K050297 |
03/01/2005 |
SOMATOM EMOTION 16 |
SIEMENS MEDICAL SOLUTION, INC. USA |
DEBRA PEACOCK |
| K050422 |
03/18/2005 |
550 TXT TREATMENT TABLE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KEN NEHMER |
| K050354 |
03/21/2005 |
PERIOSCAN ULTRASONIC SCALER |
SIRONA DENTAL SYSTEMS GMBH |
MARY MCNAMARA-CULLINANE |
| K041825 |
03/11/2005 |
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT |
SMITH & NEPHEW, INC. |
KIM KELLY |
| K042515 |
03/14/2005 |
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE |
SMITH & NEPHEW, INC. |
JANET JOHNSON AKIL |
| K043578 |
03/07/2005 |
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K043511 |
03/14/2005 |
SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 |
SOLEUS CHAMP INTERNATIONAL CO., LTD. |
Ke-Min Jen |
| K050331 |
03/24/2005 |
ADHESIVE 1 |
SOUTHERN DENTAL INDUSTRIES, INC. |
SAMANTHA J CHEETHAM |
| K050175 |
03/04/2005 |
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 |
SPACELABS MEDICAL, INC. |
AL VAN HOUDT |
| K043401 |
03/16/2005 |
SPECTRANETICS LLD CS, MODEL 518-039 |
SPECTRANETICS CORP. |
MICHAEL J RYAN |
| K050529 |
03/16/2005 |
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER |
SPI GLOVES SDN. BHD. |
CHOOI FONG CHUN |
| K050530 |
03/16/2005 |
POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET, PINK,GREEN) |
SPI GLOVES SDN. BHD. |
CHOOI FONG CHUN |
| K050527 |
03/18/2005 |
POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL |
SPI GLOVES SDN. BHD. |
CHOOI FONG CHUN |
| K050531 |
03/18/2005 |
POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE) |
SPI GLOVES SDN. BHD. |
CHOOI FONG CHUN |
| K042169 |
03/14/2005 |
STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER |
STANBIO LABORATORY |
KIRK JOHNSON |
| K041541 |
03/16/2005 |
COMPEL MLR SURGICAL GOWNS |
STANDARD TEXTILE CO., INC. |
BRADLEY J BUSHMAN |
| K043453 |
03/01/2005 |
STERILEMED REPROCESSED IVUS IMAGING CATHETER |
STERILMED, INC. |
BRUCE LESTER |
| K043513 |
03/01/2005 |
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER |
STERILMED, INC. |
BRUCE R LESTER |
| K043022 |
03/15/2005 |
STRYKER FLEXIBLE CYSTONEPHROSCOPE |
Stryker Endoscopy |
CHRISTOPHER L COOK |
| K043021 |
03/16/2005 |
STRYKER URETEROSCOPE |
Stryker Endoscopy |
CHRISTOPHER L COOK |
| K050535 |
03/17/2005 |
STRYKER MMF SCREW |
STRYKER INSTRUMENTS |
NATHAN M MIERSMA |
| K043180 |
03/02/2005 |
STRYKER SPINE TRIO PS |
STRYKER SPINE |
SIMONA VOIC |
| K050247 |
03/04/2005 |
CONTOUR NECKLIFT THREADS |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K050292 |
03/09/2005 |
SHARPOINT LUKENS BONE WAX |
SURGICAL SPECIALTIES CORP. |
ELIZABETH LAZARO |
| K050452 |
03/09/2005 |
AURORA SR AND SRA APPLICATOR |
SYNERON MEDICAL LTD. |
AMIR WALDMAN |
| K050110 |
03/04/2005 |
SYNTHES (USA) LCP MODULAR FOOT PLATES |
SYNTHES (USA) |
KATHY ANDERSON |
| K042899 |
03/16/2005 |
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K050378 |
03/15/2005 |
SYNTHES MANDIBLE EXTERNAL FIXATOR |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K050204 |
03/04/2005 |
SYNTHES RAPID RESORBABLE TACK SYSTEM |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K050451 |
03/24/2005 |
SYNTHES VECTRA SYSTEM |
SYNTHES SPINE CO.LP |
SUSAN LEWANDOWSKI |
| K050341 |
03/29/2005 |
IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 |
TACTILE TECHNOLOGIES, LTD. |
ZVIKA SLOVIN |
| K042795 |
03/07/2005 |
CLEVER CHEK TD-3213 |
TaiDoc Technology Corporation |
SHU-MEI WU |
| K041311 |
03/18/2005 |
TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) |
TIGER MEDICAL PRODUCTS LTD |
JAY MANSOUR |
| K050355 |
03/09/2005 |
PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 |
TISSUE SCIENCE LABORATORIES, PLC |
VICTORIA TAYLOR |
| K042715 |
03/23/2005 |
TITAN DENTAL IMPLANT ATTACHMENT |
TITAN IMPLANTS, INC. |
FLOYD G LARSON |
| K050670 |
03/30/2005 |
SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS |
TMS TELEMEDIZINISCHE SYSTEME GMBH |
TILO BORCHARDT |
| K043486 |
03/03/2005 |
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 |
TOPCON MEDICAL LASER SYSTEMS, INC |
JOHN JOSSY |
| K050316 |
03/16/2005 |
AEQUALIS REVERSED SHOULDER PROSTHESIS |
TORNIER |
Mireille Lemery |
| K050458 |
03/10/2005 |
TSX-201A AQUILION LB CT SCANNER |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K042482 |
03/21/2005 |
BASS ANTALGIC-TRAK |
TRACTION MASTERS, L.L.C. |
DAVID B BASS |
| K050412 |
03/14/2005 |
VAPORMAX |
TRIMEDYNE, INC. |
GLENN YEIK |
| K042107 |
03/09/2005 |
TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 |
TUNG FU ELECTRIC CO., LTD. |
JEN KE-MIN |
| K050730 |
03/31/2005 |
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM |
ULTRADENT PRODUCTS, INC. |
TAMMY LAVERY |
| K050364 |
03/09/2005 |
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM |
VALLEY FORGE SCIENTIFIC CORP. |
JERRY L MALIS |
| K043594 |
03/31/2005 |
VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K042074 |
03/09/2005 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K040751 |
03/10/2005 |
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K043315 |
03/22/2005 |
VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K043225 |
03/22/2005 |
VANGUARD REPROCESSED ULTRASONIC SCALPEL |
VANGUARD MEDICAL CONCEPTS, INC. |
HEATHER CRAWFORD |
| K050479 |
03/24/2005 |
4D INTEGRATED TREATMENT CONSOLE |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K050442 |
03/23/2005 |
MILLENNIUM MULTI-LEAF COLLIMATOR |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K042956 |
03/11/2005 |
VISION |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K050021 |
03/18/2005 |
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT |
VASCULAR SOLUTIONS, INC. |
LINDA BUSKLEIN |
| K050245 |
03/15/2005 |
CELLSEARCH CIRCULATING TUMOR CELL KIT |
VERIDEX, LLC |
DEBRA J RASMUSSEN |
| K043515 |
03/31/2005 |
GRAFTSAVER |
VESCARE, INC. |
DAVID WALSH |
| K050309 |
03/25/2005 |
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K043004 |
03/16/2005 |
STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 |
VIASYS MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K050362 |
03/15/2005 |
VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) |
VIDENT |
BARBARA J LEWANDOWSKI |
| K050190 |
03/25/2005 |
APOLLO |
VILLA SISTEMI MEDICALI S.P.A. |
VERONICA MEREDITH |
| K050623 |
03/28/2005 |
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D |
VOLK OPTICAL, INC. |
RICHARD E LIPPMAN |
| K050074 |
03/22/2005 |
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 |
WELCH ALLYN, INC. |
CHRISTOPHER KLACZYKN |
| K050042 |
03/14/2005 |
WU'S 4-WHEELED NEO SCOOTER, WT-XL4 |
WU'S TECH CO., LTD. |
JEN KE-MIN |
| K050137 |
03/18/2005 |
TEMPTOUCH DERMAL THERMOMETER |
XILAS MEDICAL, INC. |
RUBEN G ZAMORANO |
| K050455 |
03/29/2005 |
SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES |
ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD |
KAREN ABELL |
| K042951 |
03/10/2005 |
PRE-POWDERED VINYL EXAM GLOVES |
ZIBO HENGCHANG PLASTIC & RUBBER PRODUCTS CO., LTD. |
MARY ANNE DOUCETTE |
| K042952 |
03/10/2005 |
VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE |
ZIBO HENGCHANG PLASTIC & RUBBER PRODUCTS CO., LTD. |
MARY ANNE DOUCETTE |
| K043565 |
03/11/2005 |
MODIFICATION TO DYNESYS SPINAL SYSTEM |
ZIMMER SPINE, INC |
TIM CRABTREE |
| K043101 |
03/07/2005 |
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS |
ZIMMER, INC. |
BRANDON HIPSHER |
