FDA 510(k) Decisions During August, 2006  

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
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