FDA 510(k) Decisions During October, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K072824 10/23/2007 FOX SV PTA CATHETER ABBOTT LABORATORIES GEORGE J PRENDERGAST
K070296 10/03/2007 VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM ACE VISION GROUP IAN GORDON
K063295 10/12/2007 ACON UTI URINARY TRACT INFECTION TEST STRIPS ACON LABORATORIES, INC. JINN-NAN LIN
K072519 10/23/2007 ACTIVATOR V SPINAL ADJUSTING INSTRUMENT ACTIVATOR METHODS INTERNATIONAL, LTD. DEBBIE KOENEMAN
K071230 10/03/2007 APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 ADVANCED BRAIN MONITORING, INC. DANIEL J LEVENDOWSKI
K072462 10/11/2007 WIDE SPACED QUATTRODE LEADS ADVANCED NEUROMODULATION SYSTEMS MIA M WARE
K072680 10/25/2007 DRYSTAR AXYS, MODEL EYZ4E AGFA HEALTHCARE CORPORATION PATRICK J LYNCH
K062932 10/19/2007 AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER AHLSTROM MOUNT HOLLY SPRINGS LLC HEATHER MOWERS
K072035 10/16/2007 RESOLVE UVB PHOTOTHERAPY SYSTEM ALLUX MEDICAL LLOYD H GRIESE
K072699 10/05/2007 ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL ALMA LASERS LTD. A WORDEN
K072081 10/24/2007 ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K071990 10/29/2007 VALEO CERVICAL PLATE SYSTEM AMEDICA CORP. Glenn Stiegman
K070411 10/01/2007 AMSURE NEBULIZER AMSINO INTERNATIONAL, INC. CHING C SEAH
K072225 10/12/2007 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. MELINDA SWANSON
K071128 10/10/2007 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES PERRY JOHNSTON
K070865 10/23/2007 EXPANDING VASCULAR SHEATH APPLIED MEDICAL CHERYL BLAKE
K072674 10/05/2007 KII TROCAR SYSTEM APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K071398 10/04/2007 SCANVIEW, MODEL SC-300 APPLIED SPECTRAL IMAGING, LTD. SILVIA STOLARSKI
K071491 10/10/2007 ARROW INTERNATIONAL, INC., SURGICAL DRAPES ARROW INTL., INC. KARL J NITTINGER
K072865 10/23/2007 MODIFICATON TO: ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K072705 10/23/2007 ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J ASAHI INTECC CO., LTD. YOSHI TERAI
K063788 10/15/2007 REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K070059 10/02/2007 REPROCESSED TROCARS ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON
K072624 10/01/2007 ASTRA TECH IMPLANT SYSTEM, NEW COMPONENT ASTRA TECH AB LINDA SCHULZ
K071946 10/05/2007 ATLANTIS, GEMINI AND GEMINI+ ABUTMENTS IN ZIRCONIA FOR ASTRA IMPLANTS ATLANTIS COMPONENTS, INC. BETSY A BROWN
K072426 10/19/2007 ATLAS SPINE PEDICLE SCREW SYSTEM ATLAS SPINE LLC JEANETTE G DAILEY
K070773 10/11/2007 AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K071909 10/18/2007 PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R BARKEY GMBH & CO. KG THOMAS BARKEY
K072612 10/26/2007 ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 BECKMAN COULTER, INC. RACHELLE PARSONS
K071681 10/04/2007 CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 BECKMAN COULTER, INC. LOURDES COBA
K071561 10/12/2007 HI-SPEED TURBINE HANDPIECES, MODEL GSO1-B,GSO2-B,GSO3-B,GSO1-D,GSO2-D BEIJING NORTH POLE DENTAL HANDPIECE CO., LTD Diana Hong
K072087 10/05/2007 BELIMED STEAM STERILIZER MODEL TOP 5000 SERIES 24 BELIMED SAUTER AG HANS STADLER
K072294 10/25/2007 SYSTEM-MINI, MODELS: 390, E30 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K072358 10/31/2007 BIOPLEX VASCULITIS KIT Bio-Rad Laboratories PRIYA BONDRE
K071638 10/10/2007 BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. LINDA K SCHULZ
K070520 10/23/2007 PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) BIOLIFE, LLC Karen O'Toole
K071146 10/11/2007 VIDAS B.R.A.H.M.S. PCT ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K072668 10/15/2007 VITEK 2 GRAM POSITIVE VANCOMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K071934 10/11/2007 MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT BIOMET MANUFACTURING CORP. MARY L VERSTYNEN
K071271 10/23/2007 BIOMET CABLE SYSTEM BIOMET MANUFACTURING, INC. BECKY EARL
K070955 10/12/2007 ACID ETCHED LAG SCREWS BIOMET ORTHOPEDICS, INC. BECKEY EARL
K072298 10/29/2007 BIOPRO MEMORY STAPLE, MODELS 18062-18073 BIOPRO, INC. DAVID MRAK
K071981 10/26/2007 BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS) BONART CO. LTD. ERIC L ONG
K072008 10/03/2007 BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER BRAEMAR, INC. DARREN DERSHEM
K072046 10/17/2007 EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM BRAINLAB AG RAINER BIRKENBACH
K072506 10/26/2007 EXACTRAC 5.5 BRAINLAB AG RAINER BIRKENBACH
K072716 10/12/2007 VECTOR VISION HIP BRAINLAB AG BENJAMIN WAGNER
K072573 10/11/2007 VECTORVISION HIP AND HIP SR BRAINLAB AG BENJAMIN WAGNER
K070195 10/15/2007 BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B BROADSOUND CORPORATION JIANN HWA JENG, PHD
K072230 10/05/2007 POWERPICC SOLO C.R. BARD, INC. LYNN M KIRCHOFF
K072800 10/25/2007 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. JOHN CARLINE
K071904 10/25/2007 DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) CARLETON LIFE SUPPORT SYSTEMS INC. GARY BYRD
K071796 10/19/2007 CAPSEW PLICATION SYSTEM CAYENNE MEDICAL, INC. DAVID J COLLETTE
K071313 10/26/2007 TROJAN-ENZ BRAND CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K072402 10/19/2007 FLEX-STAR V CMP INDUSTRIES LLC. DEVON O HOWE
K071931 10/22/2007 CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 Codman & Shurtleff, Inc. EMILY E VALERIO
K070798 10/04/2007 ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS COEUR, INC. DEBRA F MANNING
K072397 10/18/2007 SYNOSS SYNTHETIC BONE GRAFT MATERIAL COLLAGEN MATRIX, INC. PEGGY HANSEN
K071632 10/18/2007 PERFECT TISSUE CONTOURING SYSTEM II COLTENE/WHALEDENT INC. GLENN PERSELLO
K072712 10/31/2007 COMFORT ELECTRIC SCOOTER, LY-EW408 COMFORT ORTHOPEDIC CO. LTD. Ke-Min Jen
K072711 10/31/2007 COMFORT POWERED WHEELCHAIR, LY-EB 206 COMFORT ORTHOPEDIC CO. LTD. Ke-Min Jen
K071100 10/15/2007 AMNISCREEN HOME DETECTION LINER KIT COMMON SENSE, LTD. NATASHA LESKOVSEK
K071938 10/01/2007 MONACO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K071907 10/05/2007 VCARE RETRACTOR/ELEVATOR CONMED CORPORATION BRIAN KILLORAN
K072706 10/24/2007 MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL CONMED LINVATEC SUE F DAUTERMAN
K070405 10/17/2007 MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT COOK BIOTECH, INC. DANIEL J DILLON
K072148 10/03/2007 CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER COOK, INC. SUSANNE GALIN
K072620 10/31/2007 GAME READY CLASSIC SYSTEM, MODEL 550550 COOLSYSTEMS, INC. MARIANNE BALDWIN
K070749 10/24/2007 ESTECH PERCUTANEOUS INSERTION DILATOR KIT COOMBS MEDICAL DEVICE CONSULTING CRAIG COOMBS
K072011 10/18/2007 COPD LIQUID OXYGEN PORTABLE, MODEL 300P COPD PARTNERS, INC. PAUL DRYDEN
K072229 10/05/2007 MONOSWIFT CP MEDICAL BETSY CORTELLONI
K072422 10/24/2007 CYBERWAND STERILE PADS, MODEL: CW-RBPBX CYBERSONICS, INC. WILLIAM A STOLL
K072086 10/26/2007 INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM D B ORTHODONTICS LTD ANNA M DYSON
K072435 10/17/2007 DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H DADE BEHRING, INC. KATHLEEN ENNIS
K072512 10/03/2007 MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY) DATEX-OHMEDA, INC. AGATA SMIEJA
K072713 10/12/2007 ION DENTAL RESIN SYSTEM DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072342 10/03/2007 SULTAN TOOTH ROOT DESENSITIZER DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K072083 10/25/2007 SMALL FRAGMENT LOCKING PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K072546 10/05/2007 SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE,INC FRANK S JURCZAK
K072496 10/05/2007 MODIFICATION TO SPACE CPSXL BONE CEMENT DFINE, INC. ROBERT POSER
K070265 10/24/2007 DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000 DIAGNOSTIC HYBRIDS, INC. GAIL GOODRUM
K071480 10/01/2007 LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 DIASORIN, INC. CHARLES D KAFADER II
K072529 10/26/2007 TRACKPORT DIREX SYSTEMS CORP. LARISA GERSHTEIN
K071787 10/26/2007 BEMITT, MODEL 0001 DJA DISTRIBUTORS, LLC BETH BROMBERG
K071737 10/25/2007 GENERAL SEMEN ANALYSIS KIT DYN-BIOSHAF (2006) LTD. THOMAS M TSAKERIS
K072507 10/04/2007 ENDOWAVE INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K072126 10/02/2007 HABIB VESEAL EMCISION, LTD. NAGY HABIB
K072789 10/19/2007 DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES ENCISION, INC. JUDITH V KING
K072404 10/31/2007 ERBE ERBEJET 2 SYSTEM ERBE USA, INC. JOHN TARTAL
K071445 10/29/2007 TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS ESCADA INTERNATIONAL, INC. Kevin Walls
K072636 10/23/2007 A-BSM BONE SUBSTITUTE MATERIAL ETEX CORP. PAMELA W ADAMS
K072557 10/30/2007 FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20 FAXITRON X-RAY CORP. DOUGLAS WIEGMAN
K071511 10/05/2007 PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G FOCUS DIAGNOSTICS, INC. SID MATHUR
K071330 10/31/2007 GALTSTICK INTRODUCER SYSTEM GALT MEDICAL CORP. DAVID CATLIN
K070414 10/12/2007 GAMBRO CARTRIDGE BLOOD SETS GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K071097 10/10/2007 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K072797 10/17/2007 GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K072655 10/23/2007 ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SR Genesee BioMedical, Inc. JOHN T WRIGHT, PH.D.
K072465 10/04/2007 NIKO CORPECTOMY SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K071484 10/10/2007 PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 GLUSTITCH, INC. DON BLACKLOCK
K072191 10/25/2007 CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM GVI TECHNOLOGY PARTNERS KEVIN M MURROCK
K071194 10/18/2007 RAPHAEL COLOR ASV VENTILATOR HAMILTON MEDICAL AG JOERG SCHNEIDER
K071851 10/18/2007 HDC STERILE SPIDER SCREW HDC S.R.L. GUIDO BONAPACE
K071652 10/25/2007 HEMOCUE WBC SYSTEM HEMOCUE AB ALLAN WHITE
K072727 10/26/2007 INRATIO 2 PT MONITORING SYSTEM HEMOSENSE, INC. DOUG RUNDLE
K072900 10/26/2007 EXCELARREST FOAM HEMOSTASIS, LLC KEITH ROBERTS
K070146 10/12/2007 ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP HORIBA ABX PASCAL MACZIOLA
K072020 10/18/2007 RESTORATION ADM SYSTEM HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K071881 10/09/2007 TRIATHLON PKR SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K072221 10/15/2007 MODIFICATION TO TRIATHLON TS KNEE SYSTEM HOWMEDICA OSTEONICS CORP. TIFFANI ROGERS
K070856 10/05/2007 ICU MEDICAL SINGLE-USE SYRINGE ICU MEDICAL, INC TRACY S BEST
K070998 10/11/2007 INION BIORESTORE INION OY KATI MARTTINEN
K072120 10/11/2007 PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE INNOVATIVE SPINAL TECHNOLOGIES INC GINA YEH
K071516 10/03/2007 INOMAX DS INO THERAPEUTICS LLC RICHARD K BOURNE
K072679 10/12/2007 P.004 ABUTMENTS INSTITUT STRAUMANN AG ELAINE ALAN
K072113 10/10/2007 INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301 INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K072454 10/16/2007 INTEGRA RADIONICS INTERFIX PATIENT ADAPTERS INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K070354 10/05/2007 IMD'S ANESTHESIA NEEDLES (TUOHY, QUINCKE AND PENCIL POINT) INTERNATIONAL MEDICAL DEVELOPMENT, INC WALTER ZOHMANN
K070601 10/12/2007 MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM INTRA-LOCK INTERNATIONAL JEFFREY SAKOFF
K072130 10/31/2007 PTFE PEEL AWAY MICROINTRODUCER INTROMED PHIL TRIOLO
K071405 10/09/2007 PROBE HOLDER SYSTEM INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K070751 10/15/2007 ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY ISOTIS ORTHOBIOLOGICS, INC KARON MORELL
K071799 10/02/2007 MODIFICATION TO BIOSTAR OIA SHIGATOX IVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS ROBIN C HART
K072262 10/26/2007 GENTLERAY 980 DIODE LASER SYSTEM KAVO AMERICA JOHN MILLER
K071070 10/23/2007 OLYMPUS DENTAL IMPLANT SYSTEM KEYSTONE DENTAL, INC. FLOYD G LARSON
K072063 10/26/2007 KFX TISSUE FIXATION SYSTEM AND ACCESSORIES KFX MEDICAL M D HEAVEN
K072630 10/03/2007 FORU, MODEL EQ30 KWANG YANG MOTOR CO., LTD. JUANNATA CHANG
K063631 10/05/2007 POLYPERF / POLYPERF SAFE LABORATOIRES PEROUSE MARIE NOELLE EROUT
K072233 10/05/2007 SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORS LEONHARD LANG GMBH ELAINE DUNCAN
K072050 10/18/2007 PROLONG-EX, MODELS: PLEX-50CS, PLEX-100CS, PLEX-150CS LIFE-TECH, INC. JEFF KASOFF
K071986 10/19/2007 LTM-RC SURGICAL MESH LIFECELL CORP. LORRAINE T MONTEMURRO
K072572 10/05/2007 PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS LIFECORE BIOMEDICAL, INC. KAREN CLEMENT
K072768 10/23/2007 RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS LIFECORE BIOMEDICAL, INC. KAREN CLEMENT
K072543 10/05/2007 ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. Alison Wilson
K070315 10/30/2007 LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 LINA MEDICAL APS WALT BRITTLE
K071713 10/12/2007 CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR MEDICAL DECISIONS NETWORK JONATHAN KAHAN
K072898 10/25/2007 HEXAPOD EVO RT COUCH TOP MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K072097 10/30/2007 BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 MEDICAL SELECT, INC. AMY JONES
K072525 10/05/2007 ZIPKNOT, MODEL 1017-3000 MEDICINELODGE, INC. MARY SINNOTT
K070530 10/18/2007 MODIFICATION TO PASSMED SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
K071740 10/04/2007 CHLORINATED POWDER FREE NITRILE LATEX EXAMINATION GLOVES MEDTEXX MANUFACTURING SDN. BHD. OOI LOON SENG
K072990 10/31/2007 GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID MEDTRONIC INC. KAREN A BROZOWSKI
K072155 10/05/2007 PIONEER CATHETER MEDTRONIC INC. CATHERINE PRIESTLEY
K070438 10/17/2007 MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 MEDTRONIC MINIMED, INC. JODIE ROGERS
K062447 10/15/2007 TRAVERSE OCT SPINAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. ED CHIN
K072559 10/05/2007 SUCTION COAGULATOR MEGADYNE MEDICAL PRODUCTS, INC. RONDA MAGNESON
K071899 10/22/2007 BIS MODULE FOR ENVOY PATIENT MONITOR MENNEN MEDICAL LTD. IFAT OREN
K071101 10/18/2007 TRU RSV MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K072569 10/31/2007 METOXIT CAM-BLANKS Metoxit AG IAN GORDON
K071085 10/03/2007 E3-80 PORTABLE ECG RECORDER & ANALYZER MICRO-STAR INTERNATIONAL CO., LTD. ALBUM D TSAI
K072200 10/26/2007 STIMLAB MICROPACE PTY. LTD. MICHAEL CEJNAR
K072526 10/05/2007 MICRUS COURIER ENZO MICROCATHETER 0.0190 MICRUS ENDOVASCULAR CORPORATION MICHAEL CROMPTON
K072173 10/05/2007 MICRUS MICROCOIL SYSTEM CASHMERE-CERECYTE, MODEL CRC; CASHMERE-SR, MODEL SRC MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K072516 10/18/2007 MIDMARK DIAGNOSTICS IQMARK VITAL SIGNS MONITOR MIDMARK DIAGNOSTICS GROUP TONY CAPPARELLI
K071814 10/16/2007 LIGHT SABRE SPINAL ACCESS DEVICE MINRAD, INC. JOHN MCNEIRNEY
K072255 10/18/2007 MINRAD INC. NASAL SCAVENGING CIRCUIT MINRAD, INC. JOHN MCNEIMEY
K072438 10/05/2007 MEDICAL MAGGOTS, CREATURE COMFORTS MONARCH LABS, LLC. RONALD S SHERMAN
K072931 10/30/2007 MC 3003G-32R HEAD COIL MR INSTRUMENTS, INC. MARK WATSON
K072685 10/19/2007 NGARDE SYSTEM N SPINE, INC. JUDE V PAGANELLI
K070597 10/11/2007 VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST NANOSPHERE, INC SUE KENT
K072125 10/18/2007 ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT NDO SURGICAL, INC. JOHN J VOZELLA
K071838 10/19/2007 NEOSS VARIOUS TITANIUM ABUTMENTS NEOSS LTD FREDRIK ENGMAN
K072841 10/16/2007 NEUVIZ SPIRAL CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN TANFANG
K072029 10/15/2007 PHENIX VERTEBRAL BODY REPLACEMENT NEW BUSINESS DEVELOPMENT, LLC TIM B LUSBY
K072424 10/03/2007 COOLTOUCH, MODEL LC215,COOLLIPO NEW STAR LASERS, INC. NATALIE VOLLRATH
K071384 10/09/2007 MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K072024 10/04/2007 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693 NIPRO MEDICAL CORP. JESSICA OSWALD
K072362 10/23/2007 NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG NOVALUNG GMBH ROSINA ROBINSON
K072715 10/16/2007 REALHAND HIGH DEXTERITY INSTRUMENTS NOVARE SURGICAL SYSTEMS, INC. DAVID W SCHLERF
K072499 10/30/2007 NOVOFLO CATHETER LT NOVOSCI, INC. DAVID MAKANANI
K072343 10/29/2007 NEUROVISION JJB SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K072339 10/19/2007 NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K071764 10/24/2007 REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360 OBTECH MEDICAL SARL ELIZABETH MILLER
K071617 10/19/2007 ORAL NEUTRALIZER ORAL BIOTECH ROBERT BOWERS
K072665 10/03/2007 SUNIRAY 5.2 ORANGEDENTAL GMBH & CO. KG MARC FIEBER
K072295 10/11/2007 CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE ORIDION CAPNOGRAPHY, INC. RACHEL WEISSBROD
K072076 10/31/2007 CYTOPLAST PTFE SUTURE OSTEOGENICS BIOMEDICAL, INC. DUSTYN WEBB
K070212 10/12/2007 CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM) OVALUM LTD. KEN RAICHMAN
K072591 10/10/2007 CARDIOP-B SYSTEM, VERSION 2.1 PAIEON, INC. RAVIT BARKAMA
K071912 10/29/2007 APACERAM BONE GRAFT SUBSTITUTE PENTAX CORP. PATSY J TRISLER
K072545 10/26/2007 ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 PENTRON CLINICAL TECHNOLOGIES GREG MOREAU
K071993 10/17/2007 T-PORT HP INFUSION PORT PFM MEDICAL, INC SALVADORE PALOMARES
K072299 10/04/2007 POWRSYRINGE ASPIRATOR PINYONS MEDICAL TECHNOLOGY, INC. SHAWN P FOJTIK
K072187 10/12/2007 PIONEER LOWTOP SPINAL ROD SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K071593 10/15/2007 PTS PANELS CHOL+HDL PANEL TEST STRIPS POLYMER TECHNOLOGY SYSTEMS, INC. MARGO ENRIGHT
K071421 10/04/2007 PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET PROMEPLA PATSY J TRISLER
K072735 10/18/2007 PULSION PICCO-2, MODEL 8500 PULSION MEDICAL SYSTEMS AG Jamie Sulley
K072935 10/31/2007 SPEEDER 1.5T WRIST ARRAY COIL QUALITY ELECTRODYNAMICS CHRISTIE ZYDYK
K070484 10/22/2007 QUANTRX FEMALE FERTILITY TEST QUANTRX BIOMEDICAL CORPORATION LORRAINE C COGAN
K070502 10/04/2007 RADIUS SNARE RADIUS MEDICAL TECHNOLOGIES, INC. RICHARD DEMELLO
K071013 10/18/2007 REDSENSE REDSENSE MEDICAL AB CONSTANCE G BUNDY
K072327 10/24/2007 CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON REGENERATION TECHNOLOGIES, INC. Lisa Simpson
K071621 10/09/2007 RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. DAN MARINSIK
K070443 10/05/2007 INTRACEPT BI-POLAR RF PROBE, MODEL 04814 RELIEVANT MEDSYSTEMS, INC. Mark Smutka
K071808 10/10/2007 MIRAGE MICRO RESMED LTD. DAVID D'CRUZ
K072026 10/26/2007 RNK ELECTRONIC STETHOSCOPE RNK PRODUCTS, INC. CHARLES R ABBRUSCATO
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