FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
K061903 |
08/18/2006 |
RELIEVA SINUS BALLOON CATHETER |
ACCLARENT, INC. |
KERI YEN |
K061397 |
08/16/2006 |
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
K061975 |
08/10/2006 |
PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK |
ACMI CORPORATION |
TERRENCE E SULLIVAN |
K061559 |
08/11/2006 |
ACON URINALYSIS REAGENT STRIPS |
ACON LABORATORIES CO. |
MARTIN O'CONNOR |
K060355 |
08/07/2006 |
ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000 |
ACRO BIOTECH LLC. |
GREGORY LEE |
K061522 |
08/01/2006 |
TRIVARION BUFFERED IONTOPHORESIS ELECTRODE SYSTEM |
ACTIVA TEK INC |
DAVID SCOFIELD |
K053509 |
08/16/2006 |
ACUBAND ACUPRESSURE WRIST BAND DEVICE |
ACUBAND INC. |
RICHARD GRIFFITH |
K062084 |
08/18/2006 |
7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
K062145 |
08/23/2006 |
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 |
ACUMEN MEDICAL, INC. |
Marybeth Gamber |
K062298 |
08/23/2006 |
APOLLO GAMMA CAMERA SYSTEM |
ADAC LABORATORIES |
ANNIE WRIGHT |
K061699 |
08/18/2006 |
EXCIA |
AESCULAP, INC. |
LISA M BOYLE |
K061344 |
08/02/2006 |
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET |
AESCULAP, INC. |
KATHY A RACOSKY |
K061738 |
08/25/2006 |
ALBERT BROWNE LTD. VERIFY STEAM AND EO LOAD RECORD CARD |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
K061045 |
08/31/2006 |
REPROCESSED ELECTROPHYSIOLOGY CATHETERS |
ALLIANCE MEDICAL CORP. |
ELIZABETH RENKEN |
K060760 |
08/07/2006 |
RAPIDONE-BUPRENORPHINE TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
K061555 |
08/31/2006 |
ANCHOR LAPARSCOPIC TISSUE RETIEVAL SYSTEM |
ANCHOR PRODUCTS CO. |
ROBERT H THRUN |
K061733 |
08/24/2006 |
ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
K062169 |
08/24/2006 |
APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS |
APPLIED MEDICAL RESOURCES CORP. |
CHERYL BLAKE |
K061289 |
08/24/2006 |
ARROW PRESSURE INJECTABLE PICC |
ARROW INTERNATIONAL, INC. |
ELIZABETH DUNCAN |
K061246 |
08/23/2006 |
ENDOSCOPIC SPINE SYSTEM |
ARTHRO KINETICS INC. |
MARY MCNAMARA-CULLINANE |
K061801 |
08/07/2006 |
2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS |
ARTHROTEK, INC. |
SUSAN ALEXANDER |
K061451 |
08/11/2006 |
ASCENSION, MODELS CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 |
ASCENSION ORTHOPEDICS, INC. |
GLEN NEALLY |
K061071 |
08/29/2006 |
V-808 ATOM TRANSCAPSULE |
ATOM MEDICAL INC |
MARY STANIEWICZ |
K061862 |
08/28/2006 |
AXIOM ORTHOPAEDICS SHOULDER RESURFACING SYSTEM |
AXIOM ORTHOPAEDICS, INC. |
MARY MCNAMARA-CULLINANE |
K061383 |
08/03/2006 |
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
LEYRE Z HERNANDO |
K061926 |
08/18/2006 |
CORONIS 2MP AND MDCG 2121 - CB |
BARCOVIEW |
LIEVEN DE WANDEL |
K062225 |
08/28/2006 |
HALO COAGULATION CATHETER |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
K061867 |
08/10/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML |
BECTON, DICKINSON & CO. |
JANINE MATLAK |
K061869 |
08/18/2006 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML |
BECTON, DICKINSON & CO. |
Monica Giguere |
K061638 |
08/04/2006 |
BEST STRAND AND BEST SPACER |
BEST MEDICAL INTERNATIONAL, INC. |
MICHAEL J PHELAN |
K061857 |
08/01/2006 |
MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR |
BIO COMPRESSION SYSTEMS, INC. |
JAMES JOCHEN ROGERS |
K061799 |
08/28/2006 |
QUADRATENS, MODEL QT-42 |
BIO-RESEARCH ASSOCIATES, INC. |
JOHN C RADKE |
K053505 |
08/14/2006 |
REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS |
BIOMET MANUFACTURING, INC. |
TRACY B JOHNSON |
K061433 |
08/21/2006 |
VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE |
BIOMET MANUFACTURING, INC. |
TRACY BICKEL-JOHNSON |
K061798 |
08/21/2006 |
BIOPRO MEMORY STAPLE |
BIOPRO, INC. |
DAVID MRAK |
K061463 |
08/14/2006 |
ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S |
BIOSENSE WEBSTER, INC. |
NATALIE BENNINGTON |
K061468 |
08/14/2006 |
REFSTAR EXTERNAL REFERENCE PATCH |
BIOSENSE WEBSTER, INC. |
NATALIE BENNINGTON |
K062126 |
08/09/2006 |
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135 |
BIOSPHERE MEDICAL, INC. |
IRINA KULINETS |
K061166 |
08/15/2006 |
DEEPWAVE PERCUTANEOUS NEUROMODULATION PAIN THERAPY SYSTEM |
BIOWAVE CORPORATION |
MARY MCNAMARA-CULLINANE |
K061367 |
08/10/2006 |
BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 |
BLUE SKY MEDICAL GROUP INCORPORATED |
JASPER BENKE |
K061448 |
08/17/2006 |
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES |
BONART CO. LTD. |
ERIC L ONG |
K061332 |
08/11/2006 |
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) |
BOSTON SCIENTIFIC CORP. |
DEBBIE MCINTIRE |
K060727 |
08/21/2006 |
VECTORVISION HIP |
BRAINLAB AG |
RAINER BIRKENBACH |
K060657 |
08/18/2006 |
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. |
BREAS MEDICAL AB |
KARL-JOHAN HOLM |
K061912 |
08/01/2006 |
FUSION |
BURKE, INC. |
DUWAYNE E KRAMER, JR. |
K061179 |
08/09/2006 |
POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER |
C.R. BARD, INC. |
MICHAELA RIVKOWICH |
K061325 |
08/24/2006 |
BODYGAURD PAIN MANAGER INFUSION SYSTEM |
CAESAREA MEDICAL ELECTRONICS LTD. |
SHLOMI DINES |
K061425 |
08/10/2006 |
PUREWRIST SCISSORS, MODEL PW1101-01;PUREWRIST DISSECTOR, MODEL PW1201-01;PUREWRIST HOOK, MODEL PW1301-01 |
CAMBRIDGE ENDOSCOPIC DEVICES |
LYNN BOUGIE |
K062221 |
08/17/2006 |
CXDI-40EC |
CANON, INC. |
SHEILA DRISCOLL |
K060911 |
08/22/2006 |
CG-6108 ARRHYTHMIA ECG EVENT RECORDER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
K061369 |
08/22/2006 |
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 |
CARDIAC ASSIST, INC. |
ROBERT BOLLINGER |
K061762 |
08/01/2006 |
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N |
CARDINAL HEALTH, INC. |
LAVENIA FORD |
K061335 |
08/09/2006 |
ENHANCE DENTAL IMPLANT SYSTEM |
COASTAL BIOCARE |
FLOYD G LARSON |
K052687 |
08/31/2006 |
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM |
CONFORMIS, INC. |
PATRICK HESS |
K060624 |
08/04/2006 |
MARATHON STENT WITH FUSION TECHNOLOGY |
COOK IRELAND LTD |
EMMETT DEVEREUX |
K061371 |
08/17/2006 |
SYDNEY IVF SPERM CRYOPRESERVATION BUFFER |
COOK UROLOGICAL, INC. |
BRENDA DAVIS |
K061855 |
08/10/2006 |
NEUROQUANT |
CORTECHS LABS, INC |
ALLAN GREEN |
K061955 |
08/04/2006 |
RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS |
CREATIVE MEDICAL DESIGNS, INC. |
JANE RAYHACK |
K061722 |
08/02/2006 |
BLOXX RAPID CLOTTING AGENT |
CROSSLINK-D, INC |
LOUIS J MAZZARESE |
K062140 |
08/24/2006 |
SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1 |
CRYOCATH TECHNOLOGIES, INC. |
FRED MILDER |
K060720 |
08/25/2006 |
CURATIVE DENTAL ACRYLIC TEETH |
CURATIVE, LLC |
JAMES R VEALE |
K062152 |
08/16/2006 |
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061838 |
08/21/2006 |
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061703 |
08/02/2006 |
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062236 |
08/21/2006 |
DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K061839 |
08/29/2006 |
DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 |
DADE BEHRING, INC. |
GEORGE M PLUMMER |
K061923 |
08/25/2006 |
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061845 |
08/24/2006 |
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K061793 |
08/07/2006 |
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR |
DADE BEHRING, INC. |
ANDREA M TASKER |
K062055 |
08/07/2006 |
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062122 |
08/25/2006 |
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062121 |
08/25/2006 |
DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K062191 |
08/21/2006 |
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061750 |
08/11/2006 |
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061885 |
08/14/2006 |
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 |
DADE BEHRING, INC. |
VICTOR M CARRIO |
K061719 |
08/25/2006 |
DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212 |
DADE BEHRING, INC. |
GEORGE W PLUMMER |
K062179 |
08/23/2006 |
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) |
DADE BEHRING, INC. |
SHANNON POPSON |
K061872 |
08/23/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062276 |
08/23/2006 |
MICROSCAN MICROSTREP PLUS PANEL |
DADE BEHRING, INC. |
MAUREEN MENDE |
K062293 |
08/24/2006 |
MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) |
DADE BEHRING, INC. |
MAUREEN MENDE |
K060677 |
08/25/2006 |
N LATEX CDT |
DADE BEHRING, INC. |
KATHLEEN DRAY-LYONS |
K062128 |
08/21/2006 |
THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS |
DADE BEHRING, INC. |
LORRAINE H PIESTRAK |
K060423 |
08/15/2006 |
CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES |
DAKOCYTOMATION CALIFORNIA, INC. |
TIFFANY D ALMEROTH |
K061808 |
08/17/2006 |
DARCO LOCKING BONE PLATE SYSTEM |
DARCO INTERNATIONAL, INC. |
MARK S COOPER |
K062170 |
08/22/2006 |
BIOKNOTLESS AND LUPINE PLUS ANCHORS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
K062116 |
08/18/2006 |
DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
K061221 |
08/28/2006 |
DUPUY S-ROM STD HIP STEM PROSTHESIS |
DEPUY ORTHOPAEDICS, INC. |
ANNE SCHULER |
K061531 |
08/30/2006 |
SPACE CPSXL BONE CEMENT |
DFINE, INC. |
ROBERT D POSER |
K062007 |
08/16/2006 |
DMS 300-7 |
DIAGNOSTIC MONITORING SOFTWARE |
WILLIAM PARSONS |
K062088 |
08/25/2006 |
PREMIER 11 HOLTER |
DIAGNOSTIC MONITORING SOFTWARE |
WILLIAM PARSONS |
K050590 |
08/10/2006 |
ENZY-WELL SYPHILIS IGG, MODEL 91106 |
DIESSE DIAGNOSTICA SENESE S.P.A |
GLORIA SCHLANSER |
K061873 |
08/18/2006 |
VERT-X |
DIREX SYSTEMS CORP. |
LARISA GERSHTEIN |
K061455 |
08/01/2006 |
DORNIER MEDILAS H 20 LASER |
DORNIER MEDTECH AMERICA, INC. |
Tim Thomas |
K053399 |
08/04/2006 |
VERSALET 7700 CARE CENTER |
DRAEGER MEDICAL INFANT CARE, INC. |
MONICA FERRANTE |
K061978 |
08/11/2006 |
EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM |
EBI, L.P. |
DEBRA BING |
K062134 |
08/22/2006 |
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
K062053 |
08/07/2006 |
MONOCHROME LCD MONITOR, RADIFORCE, GS320 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
K061941 |
08/21/2006 |
LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
K061721 |
08/17/2006 |
PEDI-SPIDER STRAP |
EMERGENCY PRODUCTS AND RESEARCH |
MARK MOEHLER |
K062175 |
08/28/2006 |
CRYOCARE CN2 SYSTEM |
ENDOCARE, INC. |
ALDEN KAY |
K061755 |
08/07/2006 |
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM |
ESAOTE EUROPE B.V. |
CARRI GRAHAM |
K061566 |
08/31/2006 |
PRIMUS GPS BILIARY STENT SYSTEM |
EV3 INC |
MELISSA SOMMERFELD |
K062201 |
08/11/2006 |
SPIDERX EMBOLIC PROTECTION DEVICE |
EV3 INC |
BRENDA JOHNSON |
K061269 |
08/14/2006 |
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES |
EXCEL TECH. LTD. |
NICOLE LANDREVILLE |
K061361 |
08/15/2006 |
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50 |
FAXITRON X-RAY CORP. |
DOUGLAS C WIEGMAN |
K061404 |
08/07/2006 |
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE |
FCI OPHTHALMICS, INC. |
HILLARD W WELCH |
K061236 |
08/29/2006 |
FLEXIFIT HC432 FULL FACE MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
REENA DAKEN |
K062389 |
08/21/2006 |
Z-BLOCK, MODELS 20/19, 40/19, 55/19 |
FOUNDATION MILLING CENTRE |
IAN P GORDON |
K060367 |
08/09/2006 |
TENOLIG |
FOURNITURES HOSPITALIERES INDUSTRIE |
CHRISTINE QUENDEZ |
K061918 |
08/18/2006 |
FOLEY CATHETERS WITH TEMPERATURE PROBE |
GE HEALTHCARE |
JOEL KENT |
K061994 |
08/11/2006 |
WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE |
GE HEALTHCARE |
JOEL KENT |
K060307 |
08/04/2006 |
12 RL ALGORITHM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
PATRICK ZIELINSKI |
K060833 |
08/01/2006 |
12SL ECG ANALYSIS PROGRAM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LISA M BAUMHARDT |
K061953 |
08/15/2006 |
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS |
GE OEC MEDICAL SYSTEMS |
GREG HANSEN |
K060652 |
08/17/2006 |
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
BRIAN J SHEA |
K061686 |
08/30/2006 |
IDI-VANR ASSAY |
GENEOHM SCIENCES CANADA, INC. |
Judi Smith |
K053041 |
08/02/2006 |
MED SCULPT |
GENERAL PROJECT S.R.L. |
MAUREEN O'CONNELL |
K061853 |
08/18/2006 |
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
JEFF COBB |
K061483 |
08/14/2006 |
VACUETTE VISIO PLUS BLOOD COLLECTION NEEDLES |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
K053555 |
08/21/2006 |
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L |
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD |
CHARLIE MACK |
K061306 |
08/07/2006 |
CO-1000 COLPOSCOPE, MULTIPLE |
GYNEX CORP. |
KAREN CARDIFF |
K062245 |
08/23/2006 |
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 |
HARDY DIAGNOSTICS |
Andre Hsiung |
K061950 |
08/18/2006 |
HHF1 ECHELON MULTI-PURPOSE COIL |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUGLAS THISTLETHWAITE |
K061099 |
08/11/2006 |
BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 |
HOFFMAN LABORATORIES, LLC |
KEITH BOSECKER |
K062107 |
08/18/2006 |
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 |
HOLOGIC, INC. |
GAIL YAEKER-DAUNIS |
K060854 |
08/24/2006 |
ABX PENTRA 400: LIPOPROTEINS |
HORIBA ABX |
TIM LAWTON |
K060325 |
08/16/2006 |
ABX PENTRA BILIRUBIN, DIRECT CP, ABX PENTRA BILIRUBIN, TOTAL CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P |
HORIBA ABX |
TIM LAWTON |
K060318 |
08/08/2006 |
HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER |
HORIBA ABX |
TIM LAWTON |
K061450 |
08/04/2006 |
HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS |
HOSPIRA, INC. |
THOMAS SAMPOGNA |
K062066 |
08/15/2006 |
OMEGA 3 SYSTEM |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
K053348 |
08/04/2006 |
STRYKER ORTHOPAEDICS RFID INSTRUMENTATION |
HOWMEDICA OSTEONICS CORP |
VIVIAN KELLY |
K062037 |
08/03/2006 |
TRIATHLON LOW PROFILE TIBIAL TRAY |
HOWMEDICA OSTEONICS CORP |
FRANCISCO HARO |
K061521 |
08/11/2006 |
TRIATHLON METAL BACKED PATELLA |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
K061434 |
08/22/2006 |
TRIDENT LARGE DIAMETER HIP SYSTEM |
HOWMEDICA OSTEONICS CORP |
TIFFANI ROGERS |
K060557 |
08/15/2006 |
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060 |
IDEV TECHNOLOGIES, INC. |
TIMOTHY R PLACEK |
K061392 |
08/01/2006 |
IKONISCOPE FASTFISH AUTO/AMNIOCYTE TEST SYSTEM |
IKONISYS INC |
S. MICHAEL SHARP |
K061595 |
08/17/2006 |
XAMINER |
IMAGING DYNAMICS COMPANY LTD. |
SHIRANTHA SAMARAPPULI |
K061916 |
08/11/2006 |
NEURO II-SE, MODELS OR-MB-DR AND OR-DR |
IMRIS, INC. |
THOMAS M TSAKERIS |
K060810 |
08/07/2006 |
ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC |
IND DIAGNOSTIC INC. |
JASON PENG |
K062019 |
08/17/2006 |
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
FRANK PELC |
K060151 |
08/08/2006 |
ORBITAL TISSUE EXPANDER (OTE) |
INNOVIA, LLC |
STEWART B DAVIS |
K061176 |
08/11/2006 |
STRAUMANN DENTAL IMPLANTS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
K060372 |
08/16/2006 |
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 |
INTRA LASE CORP. |
CHARLINE GAUTHIER |
K061675 |
08/02/2006 |
VISION VXC CENTRAL STATION, MODEL 4300 |
INVIVO CORPORATION |
MARIA KEELAN |
K062259 |
08/15/2006 |
ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 |
ISCIENCE SURGICAL |
GRACE BARTOO |
K061701 |
08/25/2006 |
HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) |
J. MORITA USA, INC. |
KEITH A BARRITT |
K062218 |
08/16/2006 |
JAN MAO WHEELCHAIR, MODELS JMC612-FL318EPP AND JMC612-FL418EPP |
JAN MAO INDUSTRIES CO., LTD. |
Ke-Min Jen |
K053556 |
08/31/2006 |
BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 |
JAWON MEDICAL CO., LTD. |
HEUNG BONG LIM |
K061760 |
08/14/2006 |
ARM BLOOD PRESSURE MONITOR, MODEL KP-7600 |
K-JUMP HEALTH CO., LTD. |
DANNY WANG |
K060972 |
08/04/2006 |
KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) |
KENDALL |
KEITH MARTIN |
K061999 |
08/15/2006 |
DRY LASER IMAGER, DRYPRO MODEL 832 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
JOJI MATSUSHIMA |
K061541 |
08/21/2006 |
KSEA BIPOLAR ELECTROTOME |
KSEA |
JAMES A LEE |
K061491 |
08/09/2006 |
LAC-MAC INNERBLOC O.R. GOWN |
LAC MAC, LTD. |
JEFFREY O STULL |
K061017 |
08/10/2006 |
EASYSPINE SYSTEM |
LDR SPINE USA |
EDWARD E NEWTON |
K061600 |
08/22/2006 |
ARX SPINAL SYSTEM |
LIFE SPINE |
ERIN MALLOY |
K062195 |
08/16/2006 |
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
CINDY MORROW |
K061279 |
08/18/2006 |
LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
LITTLE DOCTOR (SHANGHAI) ELECTRONIC |
SUSAN D GOLDSTEIN-FALK |
K061832 |
08/11/2006 |
JOSTRA HLM TUBING SETS WITH SAFELINE COATING |
MAQUET CARDIOPULMONARY AG |
JAMES COLLIE |
K061628 |
08/22/2006 |
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 |
MAQUET CARDIOPULMONARY AG |
JAMES COLLIE |
K061666 |
08/24/2006 |
CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX |
MAUNA KEA TECHNOLOGIES |
FOUAD TARABAH |
K061831 |
08/07/2006 |
MEDCHANNEL HTS SYSTEM |
MEDCHANNEL, LLC |
FREDERICK TOBIA |
K061986 |
08/03/2006 |
1.9F X 20 CM VASCU-PICC, MODELS VP1.9S20 AND VP1.9S50 |
MEDCOMP |
SUSAN MOTZER |
K053092 |
08/01/2006 |
MEDCOMP VASCU-SHEATH II |
MEDCOMP |
JEAN CALLOW |
K060297 |
08/02/2006 |
PEPER |
MEDICAL MONITORS LTD |
RICHARD HYMAN |
K061560 |
08/18/2006 |
SONOMARK |
MEDICAL PRODUCTS MANUFACTURING, INC. |
THERON E JOHNSON |
K061551 |
08/24/2006 |
POWDER FREE LATEX EXAMINATION GLOVES, NATURAL OR BLUE COLOUR AND WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS) |
MEDIPURE CORPORATION (M) SDN. BHD. |
TERENCE LIM SIN KOOI |
K062041 |
08/16/2006 |
MODEL 3875 1 X 8 SC TEST STIMULATION LEAD |
MEDTRONIC INC. |
PAULA CORDERO |
K061480 |
08/21/2006 |
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM |
MEDTRONIC IRELAND |
MICHELLE NIVALA |
K061248 |
08/31/2006 |
AXIEM IMAGELESS HIP MODULE FOR THE STEALTHSTATION SYSTEM |
MEDTRONIC NAVIGATION, INC. |
TINA DREILING |
K061579 |
08/11/2006 |
MODIFICATION TO CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
RICHARD W TREHARNE |
K062073 |
08/14/2006 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
K061938 |
08/09/2006 |
VERTE-STACK SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
LEE GRANT |
K062057 |
08/02/2006 |
U-CLIP DEVICE, MODEL NC65 |
MEDTRONIC VASCULAR |
DAVID D COX |
K061963 |
08/04/2006 |
MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
K062036 |
08/25/2006 |
MICRUS MICROCOIL SYSTEM PRESIDIO-18, MODEL PC4 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
K061904 |
08/08/2006 |
COMPUDENT STA |
MILESTONE SCIENTIFIC, INC. |
DANIEL J MANELLI |
K062230 |
08/31/2006 |
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002 |
MINRAD, INC. |
JOHN MCNEIRNEY |
K062231 |
08/31/2006 |
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001 |
MINRAD, INC. |
JOHN MCNEIRNEY |
K050842 |
08/02/2006 |
AGCEL WOUND DRESSING,AGCEL BURN DRESSING |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
BOB STILLMAN |
K053451 |
08/25/2006 |
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); |
MOELLER MEDICAL GMBH & CO. KG |
BILL KELLEY |
K061959 |
08/22/2006 |
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 |
MYTECH TECHNOLOGY CO., LTD. |
Ke-Min Jen |
K060576 |
08/14/2006 |
NELLCOR OXIMAX N-600X PULSE OXIMETER |
NELLCOR PURITAN BENNETT, INC. |
PATRICK GARVEY |
K062168 |
08/18/2006 |
CONTRAST DELIVERY SYSTEM - DUAL SHOT ALPHA |
NEMOTO KYORINDO CO., LTD. |
TOSHIO KANETAKA |
K061917 |
08/28/2006 |
DISTAL RADIUS LOCKING PLATING SYSTEM |
NEWCLIP TECHNICS |
J.D. WEBB |
K060474 |
08/03/2006 |
LISFRANC PLATE |
NEWDEAL S.A. |
JUDITH E O'GRADY |
K061086 |
08/10/2006 |
DM-3000 DIGITAL BLOOD PRESSURE MONITOR |
NIHON SEIMITSU SOKKI CO., LTD. |
LYNETTE HOWARD |
K062008 |
08/09/2006 |
ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) |
NITI MEDICAL TECHNOLOGIES LTD. |
ORLY MAOR |
K061477 |
08/11/2006 |
MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K061478 |
08/21/2006 |
PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K061529 |
08/23/2006 |
PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM |
NOBEL BIOCARE AB |
PHUONG NGUYEN SON |
K062248 |
08/17/2006 |
AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM |
NORTH AMERICAN CLINICAL LASERS, LTD. |
GEOFFREY D SWANK |
K061293 |
08/25/2006 |
TELAHEART DIGITAL RECORDER |
NORTHEAST MONITORING, INC. |
JOSEPH M AZARY |
K061920 |
08/21/2006 |
NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER |
NOVARAD CORP. |
PAUL SHUMWAY |
K061354 |
08/17/2006 |
MICROSELECTRON V3, MODEL 106.990 |
NUCLETRON CORPORATION |
LISA DIMMICK |
K061789 |
08/10/2006 |
LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
K061313 |
08/31/2006 |
EVIS EXERA 180 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
K060072 |
08/24/2006 |
MONOBLOCK PRESS-FIT HIP STEM |
OMNI LIFE SCIENCE, INC. |
EDWARD J CHEAL |
K061822 |
08/02/2006 |
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 |
OMRON HEALTHCARE, INC. |
DONNA DJINOVICH |
K061581 |
08/16/2006 |
EXCEL HIGH SPEED DENTAL HANDPIECE |
ORTHOSOURCE, INC. |
LLOYD TAYLOR |
K061730 |
08/04/2006 |
OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 |
OSMETECH, INC. |
BERNIE HEITZ |
K060397 |
08/31/2006 |
RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANNULA, X-RAY CONTRAST CANNULA, CANNULA, FACET DENERATION NEED |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
K060936 |
08/07/2006 |
PARAGOLFER |
PARABASETEC, GMBH |
WILLIAM JACKSON |
K062158 |
08/28/2006 |
LC SPRINT STAR |
PARI INNOVATIVE MANUFACTURERS, INC. |
MIKE JUDGE |
K061707 |
08/11/2006 |
HEARTSTART MRX, INVASIVE PRESSURE & TEMPERATURE OPTIONS |
PHILIPS MEDICAL SYSTEMS |
SONGHUA ZHANG |
K062137 |
08/24/2006 |
MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
K061610 |
08/14/2006 |
PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH |
HAUKE SCHIK |
K062247 |
08/18/2006 |
HD11 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
STEVE SINGLAR |
K053570 |
08/07/2006 |
TREP-SURE TREPONEMAL ANTIBODY EIA |
PHOENIX BIOTECH CORP. |
Gary Lehnus |
K062108 |
08/08/2006 |
COMCASET SAFETY IV CATHETER |
PITANGO MEDICAL LTD |
BEN LEVIN |
K061013 |
08/15/2006 |
PLAYTEX EMBRACE PETITE BREAST PUMP |
PLAYTEX PRODUCTS, INC. |
KARIN E JORDAN |
K062091 |
08/08/2006 |
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION |
POROUS MEDIA CORP. |
KEITH A ROBERTS |
K062220 |
08/11/2006 |
MODIFICATION TO GUARDDOG OCCLUSION SYSTEM |
POSSIS MEDICAL, INC. |
MARK D STENOIEN |
K062146 |
08/21/2006 |
UNI KNEE SURGETICS NAVIGATION SYSTEM |
PRAXIM S.A |
MADY BATAILH |
K061716 |
08/14/2006 |
PRESTIGE AMERITECH FACE MASK |
Prestige Ameritech |
DAN REESE |
K061486 |
08/01/2006 |
TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES) |
PROCTER & GAMBLE CO. |
PHILIP J PHILLIPS |
K062219 |
08/04/2006 |
PRODRIVE SYSTEMS REPLACEMENT TURBINE |
PRODRIVE SYSTEMS, INC. |
TIM NASON |
K061689 |
08/24/2006 |
AQUATINE EC ENDODONTIC CLEANSER |
PURICORE, INC. |
HOWARD MANN |
K062004 |
08/15/2006 |
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT |
QUANTUM ORTHOPEDICS, INC. |
KERRI DIMARTINO |
K061810 |
08/07/2006 |
COUGAR WHEELCHAIR |
R82 A/S |
KIRK MACKENZIE |
K062224 |
08/17/2006 |
RESPCARE HYBRID AV MASK |
RESPCARE INC. |
FRANK PELC |
K061256 |
08/02/2006 |
SMARTMONITOR 2PS |
RESPIRONICS, INC. |
ZITA A YURKO |
K061870 |
08/31/2006 |
VITALSENSE XHR |
RESPIRONICS, INC. |
ZITA A YURKO |
K060978 |
08/11/2006 |
COAGUCHEK XS SYSTEM |
Roche Diagnostics |
JENNIFER TRIBBETT |
K061970 |
08/31/2006 |
ELECSYS IGE II IMMUNOASSAY |
Roche Diagnostics |
KAY A TAYLOR |
K060620 |
08/11/2006 |
ACCU-CHEK AVIVA TEST STRIPS |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
K053287 |
08/10/2006 |
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K053289 |
08/10/2006 |
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE |
ROCHE DIAGNOSTICS CORP. |
THERESA M AMBROSE |
K060773 |
08/23/2006 |
ONLINE TDM PROCAINAMIDE |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
K060690 |
08/08/2006 |
ONLINE VALPROIC ACID |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
K060738 |
08/16/2006 |
TDM N-ACETYLPROCAINAMIDE |
ROCHE DIAGNOSTICS CORP. |
DIMITRIS DEMIRTZOGLOU |
K061401 |
08/18/2006 |
INTERPLATE VBR SYSTEM |
RSB SPINE LLC. |
KAREN E WARDEN |
K060578 |
08/30/2006 |
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) |
SCANTIBODIES LABORATORY, INC. |
MICHAEL NORDSTROM |
K060010 |
08/04/2006 |
NAUTIFLUX |
SEDAT |
LAETITIA COUSIN |
K061500 |
08/08/2006 |
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS |
SIC INVENT AG |
FRANZ MENEAN |
K061980 |
08/17/2006 |
SIEMENS ACUSON X500 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA INC. |
SHEILA W PICKERING |
K060923 |
08/15/2006 |
NAVIAID BGE DEVICE, MODEL 21-001 |
SMART MEDICAL SYSTEMS, LTD. |
AHAVA STEIN |
K061779 |
08/04/2006 |
COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE |
SMITH & NEPHEW, INC. |
GINO ROUSS |
K061783 |
08/10/2006 |
KNEE FUSION NAIL |
SMITH & NEPHEW, INC. |
JOHN REABE |
K061513 |
08/01/2006 |
LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET |
SMITHS MEDICAL ASD, INC. |
TIMOTHY J TALCOTT |
K061194 |
08/24/2006 |
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558 |
SMITHS MEDICAL ASD, INC. |
BRIAN FARIAS |
K061589 |
08/04/2006 |
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY |
SOLARC SYSTEMS, INC. |
BRUCE ELLIOTT |
K061752 |
08/15/2006 |
SPINAL USA VBR SYSTEM |
SPINAL USA |
JEFFREY JOHNSON |
K060235 |
08/04/2006 |
ENDO-EASE ENDOSCOPIC OVERTUBE |
SPIRUS MEDICAL, INC. |
PAMELA PAPINEAU |
K061843 |
08/01/2006 |
VENTURE WIRE CONTROL CATHETER, MODEL WCC |
ST. JUDE MEDICAL |
SHANNON SPRINGER |
K061015 |
08/03/2006 |
FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER |
ST.JUDE MEDICAL |
GLENN JACQUES |
K042850 |
08/09/2006 |
CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE) |
STEREOTAXIS, INC. |
GARY RAUVOLA |
K060958 |
08/24/2006 |
STRAUMANN NARROW NECK IMPLANTS |
STRAUMANN USA |
ELAINE ALAN |
K061836 |
08/03/2006 |
AVS ASL PEEK SPACER SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K062132 |
08/16/2006 |
AVS PL PEEK SPACER SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K062310 |
08/18/2006 |
REFLEX HYBRID ACP SYSTEM |
STRYKER SPINE |
SIMONA VOIC |
K061165 |
08/03/2006 |
ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 |
SWEDEN DIAGNOSTICS (US), INC. |
MARTIN R MANN |
K061230 |
08/03/2006 |
VECTORS TEMPORARY ANCHORAGE SYSTEM |
SYBRON DENTAL SPECIALTIES |
COLLEEN BOSWELL |
K061753 |
08/04/2006 |
SYNTHES (USA) CLAVICLE HOOK PLATES |
SYNTHES (USA) |
DEBORAH JACKSON |
K062299 |
08/31/2006 |
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT |
SYNTHES (USA) |
SHERI L MUSGNUNG |
K061891 |
08/18/2006 |
SYNEX II |
SYNTHES SPINE CO.LP |
BONNIE J SMITH |
K061674 |
08/23/2006 |
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER |
TALIA TECHNOLOGY LTD. |
JONATHAN S KAHAN |
K061736 |
08/18/2006 |
COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA |
TELEFLEX MEDICAL |
LORI HAYS |
K062381 |
08/24/2006 |
CAPIOX RX OXYGENATOR WITH OR WITHOUT RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
K061936 |
08/09/2006 |
KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311 |
THE KENDALL COMPANY |
PAUL W EVANS |
K061107 |
08/08/2006 |
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 |
THERMO ELECTRON OY |
PAIVI SORMUNEN |
K061866 |
08/22/2006 |
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS |
THERMOTEK, INC. |
TONY QUISENBERRY |
K062190 |
08/31/2006 |
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
K061492 |
08/03/2006 |
MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE |
TYCO HEALTHCARE |
MICHELLE KELLEY |
K061457 |
08/21/2006 |
UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
K061827 |
08/04/2006 |
SONIX ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
LULIA NUCA |
K061565 |
08/02/2006 |
LANGSTON DUAL LUMEN CATHETER |
VASCULAR SOLUTIONS, INC. |
JULIE TAPPER |
K062110 |
08/16/2006 |
VERTEBRON SCP CERVICAL PLATE SYSTEM |
VERTEBRON, INC. |
LUIS NESPRIDO |
K062154 |
08/10/2006 |
VITAL CONNECT 4.0 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
K062328 |
08/21/2006 |
VITREAACCESS, VERSION 1.0 |
VITAL IMAGES, INC. |
TIMOTHY J KAPPERS |
K061373 |
08/01/2006 |
VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 |
VNUS MEDICAL TECHNOLOGIES, INC. |
CARELLE L KARIMIMANESH |
K061215 |
08/10/2006 |
VOLCANO S51 FAMILY OF IMAGING SYSTEMS |
VOLCANO CORPORATION |
Michelle J Badal |
K061727 |
08/07/2006 |
GORE PRECLUDE VESSEL GUARD |
W.L. GORE & ASSOCIATES,INC |
Michael Ivey |
K061223 |
08/18/2006 |
ADVANCE TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
K062173 |
08/23/2006 |
MODIFICATION TO BONE GRAFT SYRINGE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
WESLEY L REED |
K053519 |
08/11/2006 |
SAFETY SYRINGE |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
GARY POND |
K061834 |
08/07/2006 |
XCAT; XCAT FOR NEURO |
XORAN TECHNOLOGIES, INC. |
JIM BERTOLINA |
K061353 |
08/30/2006 |
TRINICA ANTERIOR LUMBAR PLATE SYSTEM |
ZIMMER SPINE, INC. |
TIM CRABTREE |
K061882 |
08/01/2006 |
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES |
ZIMMER, INC. |
MASON W ROBBINS |
K061226 |
08/02/2006 |
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE |
ZIMMER, INC. |
PATRICIA JENKS |
K060559 |
08/17/2006 |
ZOLL R SERIES DEFIBRILLATOR |
ZOLL MEDICAL CORPORATION |
SEAN REYNOLDS |