FDA 510(k) Decisions During October, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K052366 10/13/2005 ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCUS SPP. AND ANAEROBIC BACTERIA AB BIODISK ANNE BOLMSTROM
K051501 10/19/2005 ZIRACE ACUCERA, INC. KYUNG-BIN LEE
K051544 10/07/2005 VITALCAREGIVING SYSTEM ADVANCED MONITORING CAREGIVING INC. GEORGE MYERS
K051589 10/31/2005 SLIMMANAGER, MODEL SM-X, SM-E AIIA COMMUNICATION INC. JOHN MYUNG
K051056 10/20/2005 VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR ALBERT BROWNE LTD. CYNTHIA J M. NOLTE
K050985 10/07/2005 GLUCODR SUPERSENSOR SYSTEM ALL MEDICUS CO., LTD JE YOUNG CHANG
K051912 10/11/2005 COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B ALSIUS CORP. KENNETH A COLLINS
K052443 10/17/2005 ICY CATHETER, MODEL IC-3893A ALSIUS CORP. KENNETH A COLLINS
K051044 10/07/2005 ARCTEC SEMIRIGID PLATING SYSTEM ALTIVA CORP. JOHN KAPTIAN
K052124 10/17/2005 ACTICLOT, MODEL 824 AMERICAN DIAGNOSTICA, INC. LEIGH AYRES
K052336 10/11/2005 SPECTRAQUATTRO PULSED LIGHT SYSTEM AMJET DISTRIBUTION, LLC STEVE TRINTER
K052686 10/05/2005 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K050373 10/11/2005 UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS ARTHROSURFACE, INC. STEVEN EK
K052482 10/17/2005 ARTELON SURGICAL SUTURE ARTIMPLANT AB MARIE MARLOW
K051783 10/04/2005 ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES ARTSANA S.P.A. LARA N SIMMONS
K052085 10/14/2005 STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES ASIA-MED GMBH AND CO KG Kevin Walls
K050425 10/20/2005 AURA-PSG ASTRO-MED, INC. MICHAEL J SULLIVAN
K052070 10/14/2005 ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA ATLANTIS COMPONENTS, INC. BETSY A BROWN
K052893 10/25/2005 ATRICURE TRANSPOLAR SYSTEM ATRICURE, INC. ELSA CHI ABRUZZO
K052491 10/07/2005 AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K052242 10/03/2005 ADVIA CHEMISTRY MICROALBUMIN CONTROLS BAYER HEALTHCARE LLC ANDRES HOLLE
K052163 10/11/2005 ADVIA IMS GLUCOSE ASSAY BAYER HEALTHCARE, LLC ANDRES HOLLE
K052270 10/05/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML BECTON, DICKINSON & CO. Monica Giguere
K052269 10/03/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN BECTON, DICKINSON & CO. Monica Giguere
K052547 10/13/2005 BELMONT BUDDY FLUID WARMER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K043341 10/27/2005 BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC. CHRISTOPHER BENTSEN
K042352 10/17/2005 BIODERM SCIENCES WOUND CREAM BIODERM SCIENCES, INC. EDWARD R GUBISH
K050286 10/03/2005 FIDIS CONNECTIVE 8 BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K052685 10/27/2005 ORTHOPEDIC SALVAGE SYSTEM- OSS BIOMET, INC. ALLISON KOSKEY
K050124 10/04/2005 POROUS COATED ACETABULAR COMPONENTS BIOMET, INC. PATRICIA BERES
K052433 10/18/2005 PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM BIOPTICS, INC. JEFFREY ORACH
K051480 10/12/2005 ENTERAL FEEDING TUBE BIOSEARCH MEDICAL PRODUCTS, INC. GENE BOYD
K052757 10/28/2005 PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER BIOTRONIK AG Jon Brumbaugh
K052190 10/04/2005 FETAL MONITOR, MODELS BT-300 AND BT-200 BISTOS CO., LTD. CHARLIE MACK
K052028 10/28/2005 BONART ART-M3II & M4 ULTRASONIC SCALER UNITS WITH ACCESSORIES (INSERTS) BONART CO. LTD. ERIC L ONG
K052783 10/27/2005 MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX BOSTON SCIENTIFIC CORP. Diane Brinza
K050192 10/20/2005 BRC SOFTWARE PRODUCT BRC OPERATIONS PTY LIMITED CARRI GRAHAM
K052155 10/20/2005 BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED C.R. BARD, INC. LUCINDA L FOX
K051991 10/20/2005 POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE C.R. BARD, INC. LYNN M KIRCHOFF
K052161 10/21/2005 POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) CARDIAC SCIENCE, INC. KENNETH F OLSON
K051641 10/20/2005 ALARIS SYSTEM PC UNIT, MODEL 8001 CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K050939 10/28/2005 CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM CARDIOMEMS INC CAROL VIERLING
DEN050006 10/28/2005 CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM CARDIOMEMS INC CAROL VIERLING
K052240 10/19/2005 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 CARDIONET, INC JACK GAIKWAD
K052528 10/11/2005 AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE CEREMED, INC. TADEUSZ WELLISZ
K050689 10/26/2005 SURGICAL FACE MASK CHINA SURGICAL DRESSINGS CENTER CO.,LTD MICHAEL F. L CHANG
K050265 10/14/2005 CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 CHRONO-LOG CORP. NICHOLAS J VERIABO
K052046 10/19/2005 BLOOD PRESSURE METER, MODEL CH-432 CITIZEN WATCH CO., LTD. JOSEPH EDMONDSON
K051089 10/26/2005 GII SPINAL FIXATION SYSTEM CO-LIGNE AG DAVID W SCHLERF
K052449 10/17/2005 CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 Codman & Shurtleff, Inc. JOAN Q BARTLE
K052041 10/25/2005 COLLAGEN BONE HEALING PROTECTIVE SHEET COLLAGEN MATRIX, INC. PEGGY HANSEN
K052010 10/04/2005 HBA1C LINEARITY SET CONE BIOPRODUCTS WILLIAM CONE
K052104 10/21/2005 ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION CONMED CORPORATION PAMELA VETTER
K052740 10/17/2005 NURSE'S ASSISTANT 1.7 O.R. CONTROL SYSTEM CONMED INTEGRATED SYSTEMS (CMIS) C. JEFF LIPPS
K052279 10/11/2005 COOK IRELAND ECHOBRUSH COOK IRELAND LTD EMMETT DEVEREUX
K052501 10/21/2005 MULTIPLE RESIN TOOTH BONDING AGENT COSMEDENT, INC. JAMES L SANDRIK
K052040 10/18/2005 QUICKSMILE COSMETIC DENTAL MATERIALS INC ROBERT BOWERS
K052558 10/27/2005 VCS, MODEL S4T CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC CHANG W LAN
K052346 10/26/2005 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERT EUSEBIO
K052498 10/17/2005 FRAGMENT SPECIFIC FIXATOR DAVID J. SLUTSKY MD DAVID J SLUTSKY
K052436 10/06/2005 PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 DENVER BIOMEDICAL, INC. JEFF HILL
K052630 10/17/2005 ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DENISE LUCIANO
K052631 10/21/2005 SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DENISE LUCIANO
K052178 10/21/2005 DEPUY CAS HIP INSTRUMENTATION DEPUY ORTHOPAEDICS, INC. RANDA FRANKLIN
K052472 10/06/2005 DEPUY GLOBAL SHOULDER CROSSLINK GLENOID DEPUY ORTHOPAEDICS, INC. Natalie Heck
K052079 10/21/2005 PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. KELI K HANKEE
K052746 10/21/2005 CONCORDE VBR SPINAL SYSTEM DEPUY SPINE, INC. LISA GILMAN
K052552 10/13/2005 HYBRID ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. LIZ LAVELLE
K052717 10/20/2005 D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER DIDECO S.R.L. BARRY SALL
K052430 10/04/2005 CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM DIGIRAD CORP. Joel Tuckey
K052754 10/27/2005 WRIST FUSION PLATE DVO EXTREMITY SOLUTIONS, LLC DINA L WEISSMAN
K051680 10/11/2005 DYNATRON DX2 TRACTION UNIT DYNATRONICS CORP. RON HATCH
K043520 10/21/2005 EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K051806 10/03/2005 CARE FECAL OCCULT BLOOD TEST, MODEL KT313 EPITOPE DIAGNOSTICS, INC. PING GAO
K052549 10/06/2005 LEADCARE II BLOOD LEAD TESTING SYSTEM ESA BIOSCIENCES INC. HAROLD ASP
K052805 10/17/2005 MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 ESAOTE S.P.A. CARRI GRAHAM
K051534 10/05/2005 CARDIOLINE AR 600, AR 1200, AR 2100 ET MEDICAL DEVICES SPA ATTILIO CASTELLI
K051950 10/07/2005 INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321 ETHICON ENDO-SURGERY, INC. KIMBERLY SHOEMAKER
K052358 10/05/2005 ETIAM STAR PACS COMPONENTS ETIAM, S.A. CARL ALLETTO
K052112 10/28/2005 XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 EXCEL TECH. LTD. NICOLE LANDREVILLE
K052103 10/19/2005 EXEL SECURE TOUCH II SAFETY SYRINGE EXELINT INTL. CO. ARMAND HAMID
K052849 10/26/2005 INFRARED THERMOMETER, FDIR-V1 FAMIDOC TECHNOLOGY CO., LTD MR. STEELJIN
K052714 10/26/2005 RAVE COMPOSITE BRACKET FDA AGENTS STEVE KLAMIC
K050997 10/07/2005 EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE FLEXUSPINE, INC. COREY HARBOLD
K051580 10/31/2005 VP SHEATH FLOWCARDIA, INC. RICHARD SPANO
K052000 10/25/2005 ARCHITECT CA 19-9XR ASSAY FUJIREBIO DIAGNOSTICS, INC. DIANA L WOLANIUK
K052462 10/20/2005 G-COAT GC AMERICA, INC. TERRY L JORITZ-LYONS
K052755 10/13/2005 DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT GE HEALTHCARE JOEL KENT
K052582 10/14/2005 DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES GE HEALTHCARE JOEL KENT
K052855 10/28/2005 STARSPEED SERIES CT SCANNER SYSTEMS GE HEALTHCARE LEKSHMI NAIR
K052581 10/20/2005 LUNAR IDXA GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA JAMES P RASKOB
K051508 10/05/2005 MED FLASH II INTENSE PULSED LIGHT SYSTEM. GENERAL PROJECT S.R.L. MAUREEN O'CONNELL
K051727 10/26/2005 AIMSTICK URINE REAGENT STRIPS GERMAINE LABORATORIES, INC. MARTIN O'CONNOR
K051721 10/26/2005 GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. CARL KNOBLOCH
K050460 10/25/2005 GYRUS PLASMACISION AND PLASMABLEND ELECTRODES GYRUS MEDICAL, INC. MARK A JENSON
K052626 10/05/2005 SMARTSUCTION HARMONY DEVICE HAEMONETICS CORP. GABRIEL J MURACA
K052416 10/25/2005 PERIPRO PATCH HANCOCK/JAFFE LABORATORIES SUE MONTOYA
K052294 10/21/2005 SHOULDER NAIL PLATE HAND INNOVATIONS, LLC. ERNESTO HERNANDEZ
K052543 10/25/2005 HERACERAM ZIRKONIA HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K051948 10/21/2005 AVON PATELLO-FEMORAL JOINT PROSTHESIS HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K051977 10/12/2005 SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K052718 10/27/2005 V40 BIOLOX DELTA CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051514 10/04/2005 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 HYPOGUARD USA, INC. BRUCE A MACFARLANE
K052368 10/17/2005 OLECRANONPLATE WITH ANGULAR STABILITY I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K051969 10/03/2005 TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA IBL GMBH Gary Lehnus
K051579 10/21/2005 IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation MICHAEL VINCENT
K051577 10/04/2005 IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS Immunalysis Corporation MICHAEL VINCENT
K051626 10/13/2005 IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS Immunalysis Corporation MICHAEL VINCENT
K051476 10/28/2005 UNI-VENT MODEL 73X IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K052648 10/20/2005 MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS IMPLANT INNOVATIONS, INC. JIM BANIC
K051800 10/21/2005 IN6 SAFETY SYRINGE, MODEL 3ML IN6 INCUVESTOR INC. JENNIFER REICH
K052284 10/17/2005 REFORMAT GATEWAY INFINITT CO., LTD. CARL ALLETTO
K052244 10/13/2005 IISIS, VERSION 1.0 INNOVISION MEDICAL TECHNOLOGIES, LLC PATRICIA L ANDREWS
K051742 10/07/2005 OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH INNTEC, INC. Gary Syring
K052143 10/04/2005 QUANTA LITE GLIADIN IGA II INOVA DIAGNOSTICS, INC. BRYS C MYERS
K052142 10/04/2005 QUANTA LITE GLIADIN IGG II INOVA DIAGNOSTICS, INC. BRYS C MYERS
K052262 10/27/2005 QUANTA LITE M2 EP (MIT3) ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K052121 10/21/2005 GEM PREMIER 3000 INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K052468 10/05/2005 YK9000 SERIES MANUAL WHEELCHAIR INTCO METAL PRODUCTS (ZHENJIANG) CO., LTD. JOHN ZHAO
K052473 10/28/2005 CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000 INTER MEDICAL MEDIZINTECHNIK GMBH HANS GUENTER OSIEK
K050970 10/14/2005 MILO DENTAL IMPLANT SYSTEM INTRA-LOCK INTERNATIONAL JEFFREY SAKOFF
K051943 10/04/2005 SUREFLOW SAFETY INFUSION DEVICE INTRASAFE MEDICAL, LLC SHEPARD G BENTLEY
K052497 10/12/2005 NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A INVIVO CORP. TOM SCHUBERT
K051548 10/24/2005 IRRADIA MID - LASER (S3) IRRADIA AB THEO RUSSO-LARSSON
K052979 10/31/2005 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE ISOLUX LLC NILCOLAOS ANDREOULAKIS
K051705 10/14/2005 IPS E.MAX CAD/IPS E.MAX ZIRCAD IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K052341 10/07/2005 AJEX 9015/135H PORTABLE X-RAY JPI AMERICA, INC. ABE ELGOHARY
K051531 10/17/2005 TECTONIC CERVICAL PLATE SYSTEM K2M, LLC RICH WOODS
K051909 10/21/2005 DIAGNODENT KAVO AMERICA DENIEL KAMM
K051584 10/06/2005 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY KENDALL JAMES WELSH
K052673 10/17/2005 KING I POWERED SCOOTER, MODEL CTL-11 KING I TECH CORPORATION Ke-Min Jen
K052203 10/20/2005 AURA 70 WATT BIPOLAR ELECTROSURGICAL COAGULATORS, MODELS 28-2000 AND 28-2600 KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K043213 10/06/2005 KOWA VX-10 KOWA CO. LTD. RICHARD N PHILLIPS
K051812 10/21/2005 TGO SPRAY LABORATOIRES CARILENE S.A.S. EMALEE MURPHY
K052384 10/07/2005 LANX VBR SYSTEM LANX, LLC DAVID W SCHLERF
K052359 10/03/2005 IBL CORTISOL LIA TEST KIT Lehnus & Associates Consulting Gary Lehnus
K051214 10/24/2005 ALUMA SKIN RENEWAL SYSTEM LUMENIS, INC. Connie Hoy
K043494 10/04/2005 MASTEL LASER CLEAN ROOM, MODEL EBS-100 MASTEL PRECISION SURGICAL INSTRUMENTS, INC. MERLE GOERINGER
K052061 10/21/2005 MODUS IMF SCREWS 2.0 MEDARTIS, INC. FLOYD G LARSON
K052563 10/24/2005 INOGEN SATELLITE CONSERVER, MODEL SC-100 MEDICAL ELECTRONIC DEVICES, INC. THOMAS WENZEL
K052495 10/11/2005 ATRILAZE MALLEABLE ABLATION PROBE MEDICALCV, INC. DENNY STEGER
K052911 10/31/2005 ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. SHIM KYUNG-AM
K052720 10/20/2005 MEDLINE IODOFORM PACKING STRIPS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K050394 10/25/2005 SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS MEDTOX DIAGNOSTICS, INC. ALAN MORRIS
K052609 10/21/2005 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052734 10/21/2005 MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052747 10/28/2005 MODIFICATION TO:CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K052261 10/07/2005 MODIFICATION TO: VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K052440 10/11/2005 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER MENTOR CORPORATION DONNA A CRAWFORD
K052351 10/17/2005 HDR IORT SHIELDED APPLICATOR MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MICK
K052379 10/31/2005 MIM 3.5 (CIRCA) MIMVISTA CORP. PETER SIMMELINK
K052721 10/27/2005 MINXRAY, MODEL HF100H+ MINXRAY, INC. DANIEL KAMM
K051872 10/03/2005 MK-DENT LOW SPEED HANDPIECES AND ACCESSORIES INCLUDING SPARE PARTS, TUBINGS, AND LIGHT POWER SYSTEM, MODELS: LS2011 MK-DENT GMBH MARTINA GUNDEROTH
K051869 10/07/2005 NEOBLUE COZY LED PHOTOTHERAPY SYSTEM NATUS MEDICAL, INC. LUANNE NG
K052633 10/17/2005 DUAL SHOT - CONTRAST DELIVERY SYSTEM NEMOTO KYORINDO CO., LTD. TOSHIO KANETAKA
K052571 10/17/2005 MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0 NEUROGNOSTICS, INC. Hrishikesh Gadagkar
K041704 10/17/2005 NEWGEL AND NEWGEL PLUS E NEWMEDICAL TECHNOLOGY, INC. HAITHAM MATLOUB
K051607 10/07/2005 NOVASPINE CEMENT RESTRICTOR NSCR NOVASPINE LLC HAMID KHOSROWSHAHI
K052361 10/24/2005 SIMULIX-EVOLUTION WITH ONCENTRA CONEBEAM NUCLETRON CORPORATION LISA DIMMICK
K051959 10/12/2005 NV CORMED SOLAS SPINAL SYSTEM NV CORMED CARL KNOBLOCH
K051645 10/13/2005 EVIS EXERA 160A SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K050233 10/28/2005 OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI OMRON HEALTHCARE, INC. JIM LI, PH.D.
K052538 10/07/2005 S-BONE HIP TOOL ORTHOPEDIC SCIENCES, INC JAMES K BRANNON
K052173 10/19/2005 VITAGEL SURGICAL HEMOSTAT SPRAY SET ORTHOVITA, INC. GINA M NAGVAJARA
K051656 10/25/2005 OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER
K052681 10/06/2005 START FAMILY OF MANUAL WHEELCHAIRS (BASIC, PLUS, MULTI AND HEMI) OTTO BOCK HEALTH CARE, LP BOB CLARKE
K052770 10/31/2005 PATHFORMER PATH SCIENTIFIC, LLC PATSY J TRISLER
K052349 10/21/2005 AVANTE LED CURING UNIT, MODEL N44 PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K052106 10/31/2005 SIMILE FLOW PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K052707 10/20/2005 M3046B COMPACT PORTABLE PATIENT MONITORS PHILIPS MEDICAL SYSTEMS MICHAEL J DOYLE
K051632 10/05/2005 PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A PHILIPS MEDICAL SYSTEMS TAMARA YOUNT
K052640 10/07/2005 GEMINI RAPTOR PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MELINDA NOVATNY
K043383 10/27/2005 N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 PHYSION, INC. ERIC J NEMETH, ESQ.
K051646 10/07/2005 ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH POINTE SCIENTIFIC, INC. WILLIAM F WALTERS
K051844 10/07/2005 EQUATOR PLUS ACETABULAR CUP SYSTEM PORTLAND ORTHOPAEDICS PTY. LTD. ELAINE DUNCAN
K052378 10/07/2005 PROASIA, MODEL L3402 PROASIA LIMITED JEFF CHANG
K052486 10/07/2005 PROASIA, MODEL L4501 PROASIA LIMITED JEFF CHANG
K052463 10/14/2005 PROMETAL HN86 PROMETAL TECHNOLOGIES DONNA MARIE HARTNETT
K051987 10/06/2005 FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE PT. MANDIRI INTI BUANA SASITHARAN NAIR
K051928 10/12/2005 AUTOCHECK6+ RADIOMETER MEDICAL APS LENE M MARNAES
K052658 10/12/2005 SELECTFLOW - INTRAVASCULAR ADMINISTRATION SET RENASCENCE MEDICAL, INC. DANIEL DYAR
K052227 10/28/2005 RESPCARE FACE MASK RESPCARE INC. FRANK PELC
K052110 10/20/2005 M-SERIES PRO CPAP SYTEM RESPIRONICS, INC. ZITA A YURKO
K051176 10/05/2005 FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K051276 10/28/2005 HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K052193 10/03/2005 ISE COMPENSATOR Roche Diagnostics CORINA HARPER
K052982 10/28/2005 ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET Roche Diagnostics RANDY JOHNSON
K051543 10/17/2005 ELECSYS PRECICONTROL BONE ROCHE DIAGNOSTICS CORP. CORINA HAPER
K052365 10/17/2005 CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE ROCKET MEDICAL PLC TRACY CHARLTON
K052105 10/31/2005 WATER FILLED TEETHER ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD. ANDREW SIMS
K052506 10/06/2005 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 RUBICOR MEDICAL, INC. ROBERT J CHIN
K051888 10/18/2005 TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 SCANTIBODIES LABORATORY, INC. MICHAEL NORDSTROM
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K051976 10/17/2005 PROVEN REVISION MODULAR TIBIAL TRAY STELKAST COMPANY DONALD A STEVENS
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