FDA 510(k) Applications Received During November, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K093650 11/25/2009 BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM MEDTRONIC INC. JEFFREY KOLL
K093604 11/20/2009 ETEST MOXIFLOXACIN 0.002-32 UG/ML AB BIOMERIEUX ASA KARLSSON
K093318 11/03/2009 ACCELERATOR APS ABBOTT LABORATORIES MARK LITTLEFIELD
K092705 11/17/2009 ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 ABBOTT MOLECULAR, INC. PAULA E MARTIN
K093600 11/20/2009 OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM ACCELERATED CARE PLUS PATRICK PARKER
K093594 11/19/2009 MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER ACCLARENT, INC. COURTNEY KALOF
K093518 11/13/2009 ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K093657 11/25/2009 ADAGIO RETRACTING ECG LEAD WIRES ACIST MEDICAL SYSTEMS, INC. AL SAALABI
K093649 11/25/2009 AESCULAP STERILCONTAINER S AESCULAP KATHY RACOSKY
K093493 11/10/2009 AESCULAP STERILCONTAINER S AESCULAP, INC. KATHY RACOSKY
K093476 11/09/2009 AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120 AGA MEDICAL CORP. AMANDA JOHNSON
K093488 11/10/2009 ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K093495 11/10/2009 OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS AMERICAN DIAGNOSTIC CORP. MICHAEL FALCO
K093588 11/19/2009 EXPLORER 4D TREATMENT PLANNING SYSTEM AMERICAN RADIOSURGERY, INC. DAN OLIVIER
K093571 11/24/2009 ZR DENTAL BLOCK AMS CO., LTD CLAUDE YANG
K093452 11/09/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971 ANDON HEALTH CO.,LTD LIU YI
K093528 11/16/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5963, KD-7963 ANDON HEALTH CO.,LTD LIU YI
K093406 11/02/2009 MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 ANGIODYNAMICS, INC. JODI LYNN FRASIER
K093567 11/18/2009 ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM ANOVA IMPLANT SOLUTIONS, LLC WALTER SPIRES
K093523 11/13/2009 MICRO-TOUCH NITRILE ANSELL HEALTHCARE PRODUCTS LLC CYNTHIA A INGRAM
K093579 11/18/2009 PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC GERARD J PRUD'HOMME
K093483 11/09/2009 ATLANTIS ABUTMENT FOR NOBEL BIOCARE ACTIVE IMPLANT, ATLANTIS GEMINI ABUTMENT, GEMINI + ABUTMENT ASTRA TECH INC. BETSY A BROWN
K093679 11/27/2009 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0 ATRICURE, INC. JAMES LUCKY
K093431 11/04/2009 CLEARWAY OTW MODEL 85912 ATRIUM MEDICAL CORP. RAYMOND KELLY
K093458 11/06/2009 SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 BECKMAN COULTER, INC. MARINE BOYAJIAN
K093678 11/27/2009 PLATELIA ASPERGILLUS EIA MODEL 62793 BIO-RAD CHRISTOPHER BENTSEN
K093577 11/18/2009 LIQUICHEK OPIATE CONTROL BIO-RAD LABORATORIES ELIZABETH PLATT
K093630 11/27/2009 BIODENTA DENTAL IMPLANT SYSTEM BIODENTA SWISS AG DAVID EILER
K093549 11/17/2009 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM BIOMET MANUFACTURING CORP. BECKY EARL
K093629 11/23/2009 SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K093455 11/05/2009 CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES BIOSENSE WEBSTER, INC. BALAKA DAS
K093566 11/18/2009 CARTO XP EP NAVIGATION SYSTEM, VERSION 10 BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K093470 11/06/2009 CORE-FLO D/C BISCO, INC. MICHELLE SCHILTZ-TAING
K093691 11/30/2009 ACCUMAX BOSTON SCIENTIFIC CORP. NICHOLE RIEK
K093636 11/24/2009 STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX BOSTON SCIENTIFIC CORP. SHANNON PETTIT
K093515 11/13/2009 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON BRIVANT, LTD. TOMAS FUREY
K093423 11/03/2009 LUNGPOINT PROCEDURE PLANNING BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K093665 11/25/2009 ENDO SMARTCAP BYRNE MEDICAL INC. DON BYRNE
K093659 11/25/2009 ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 C.R. BARD, INC. JONI CREAL
K093663 11/25/2009 RADIONUCLIDE BRACHYTHERAPY SOURCE C.R. BARD, INC. JULIE BASSETT
K093463 11/06/2009 AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 CAREFUSION SHARON NICHOLS
K093616 11/19/2009 V. MUELLER CAMERA CONTROLLER WITH STORAGE CART CAREFUSION 2200 GINA RAJTEROWSKI
K093521 11/13/2009 GDXPRO CARL ZEISS MEDITEC INC JUDY A BRIMACOMBE
K093696 11/30/2009 SR GLOVE, NU GLOVE, HIGHSTRESS MODEL 801, MODEL 802, MODEL 803 CENTRAL MEDICARE SDN BHD NICK WANG
K093565 11/18/2009 PLEURAFLOW CATHETER SYSTEM CLEAR CATHETER SYSTEMS MONICA DOUGHERTY
K093557 11/16/2009 SMARTWAND-DTX CLEARCOUNT MEDICAL SOLUTIONS JEFF WOLFGONG
K093610 11/20/2009 MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K093513 11/17/2009 IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. AMITA SHAH, RAC
K093556 11/17/2009 VCARE DX CONMED CORPORATION SARAH RIZK
K093619 11/23/2009 EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E COOK IRELAND LTD JACINTA KILMARTIN
K093469 11/06/2009 CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS COOK, INC. SUSANNE GALIN
K093472 11/06/2009 TRINITY ACETABULAR SYSTEM CORIN U.S.A. ASHLEA BOWEN
K093480 11/09/2009 CUATTRO UNOMD CUATTRO, LLC MARK SKEELS
K093474 11/06/2009 DEPUY FRACTURE AND FUSION PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K093646 11/25/2009 DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS DEPUY ORTHOPAEDICS, INC. RHONDA MEYER
K093415 11/02/2009 D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. RONALD H LOLLAR
K093492 11/11/2009 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K093498 11/12/2009 LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913 DIASORIN, INC. CAROL A DEPOUW
K093680 11/27/2009 DIAZYME CYSTATIN C ASSAY DIAZYME LABORATORIES ABHIJIT DATTA
K093587 11/19/2009 DENTAL MERCURY DMG USA, INC. PAMELA PAPINEAU
K093465 11/10/2009 FUSION SYSTEM ECLIPSEMED GLOBAL, INC IGOR GRADOV
K093554 11/21/2009 RETROFLEX DILATOR KIT EDWARDS LIFESCIENCES, LLC. JASON K LYON
K093622 11/23/2009 AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 ENCISION, INC. JUDITH V KING
K093613 11/23/2009 VASCUVIEW TAP ULTRASOUND SYSTEM ESCALON MEDICAL CORP. ROGER EDENS
K093681 11/27/2009 MERIDIAN GUIDEWIRE EV3 NEUROVASCULAR DEBORAH BAKER-JANIS
K093430 11/03/2009 EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. EXACTECH, INC. GRAHAM CUTHBERT
K093427 11/03/2009 FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K093608 11/20/2009 GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K093514 11/13/2009 DISCOVERY MODEL NM/CT 670 GE MEDICAL SYSTEMS F.I. HAIFA ELI WERNER
K093581 11/18/2009 DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS GE MEDICAL SYSTEMS, LLC TRACEY ORTIZ
K093694 11/30/2009 GERATHERM UNIQUERESC GERATHERM MEDICAL AG ANDREA PECSI
K093575 11/18/2009 GLUMA DESENSITIZER POWER GEL HERAEUS KULZER, LLC CHERYL V ZIMMERMAN
K093466 11/06/2009 HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUGH THISTLETHWAITE
K093644 11/25/2009 RESTORATION ADM SYSTEM X3 ACETABULAR HOWMEDICA OSTEONICS CORP. AVITAL MERL MARGULIES
K093433 11/04/2009 VARIAX ELBOW SYSTEM PLATE LINE EXTENSION HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K093639 11/24/2009 SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500 HUVITZ CO., LTD. MATEW J WESS
K093475 11/06/2009 BASESENS BLOOD GLUCOSE MONITORING SYSTEM HYGEIA, INC. ROBERT J BARD
K093545 11/17/2009 PINPOINTE FOOTLASER MODEL 6W, 30W, 100W INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) ANNE WORDEN
K093564 11/18/2009 SVED WOUND TREATMENT SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K093669 11/27/2009 SEC IBF CAGE INNVOTEC SURGICAL, INC. JUSTIN EGGLETON
K093399 11/02/2009 PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 INRAD MELISSA LALOMIA
K093683 11/30/2009 ORTHOPANTOMOGRAPH OP300 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY MATTI TULIKOURA
K093623 11/23/2009 GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K093642 11/24/2009 NEUTRASAL INVADO PHARMACEUTICALS EDWARD D KOBUS
K093576 11/18/2009 RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR JIANGSU CUREGUARD GLOVE CO., LTD. CHU XIAOAN
K093570 11/18/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR JIANGSU JAYSUN GLOVE CO., LTD. CHU XIAOAN
K093637 11/24/2009 JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300 JMS NORTH AMERICA CORP. E J SMITH
K093534 11/16/2009 MODIFICATION TO CASPIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K093471 11/06/2009 KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K093603 11/30/2009 STORM-BASE 2.0 KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K093526 11/16/2009 V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D KCI USA, INC. (KINETIC CONCEPTS, INC.) RANDALL WHEELAND
K093473 11/06/2009 KMD-MARK1 TISSUE MARKER KENT MEDICAL DEVICES, INC. JUSTIN EGGLETON
K093484 11/09/2009 PREMISE FLOWABLE MODIFIED KERR CORPORATION WENDY GARMAN
K093499 11/12/2009 HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC CHERITA JAMES
K093662 11/25/2009 ECHOBRIGHT LIFE-TECH, INC. JEFF KASOFF
K093485 11/10/2009 VESISCAN LIFE-TECH, INC. JEFF KASOFF
K093420 11/18/2009 XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254) LUMINEX MOLECULAR DIAGNOSTICS, INC. GLORIA LEE
K093596 11/25/2009 LUMOS, MODEL R 72B LUMOS, INC DANIEL KAMM
K093537 11/16/2009 HANAROSTENT ESOPHAGUS (CCC) M.I. TECH CO., LTD. BRANDON CHOI
K093425 11/03/2009 MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA MAKO SURGICAL CORP. WILLIAM TAPIA
K093522 11/16/2009 QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K093533 11/19/2009 ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0 MATERIALISE N.V. KARL VOM BERGE
K093548 11/17/2009 AVIE A1C TEST SYSTEM MEC DYNAMICS CORP EMMANUEL MPOCK
K093409 11/04/2009 POWERPUMP ARTHROSCOPY SYSTEM MEDICAL VISION AB CONSTANCE G BUNDY
K093444 11/05/2009 EXAPACS MEDINCOM TECHNOLOGY CORP ANDREW LEE
K093593 11/19/2009 CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO MEDTRADE PRODUCTS LIMITED JONATHAN RANFIELD
K093519 11/13/2009 MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K093535 11/16/2009 AUTOLOG AUTOTRANSFUSION SYSTEM MEDTRONIC INC. CARALEE WALTON
K093434 11/04/2009 VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MELISA L WEISMAN
K093520 11/13/2009 VIVOSIGHT TOPICAL OCT SYSTEM MICHELSON DIAGNOSTICS LTD. MARTIN JOHNS
K093647 11/25/2009 TRAXCESS DOCKING WIRE MICROVENTION, INC. NAOMI GONG
K093544 11/17/2009 TROPAZONE CR MIDLOTHIAN LABORATORIES BRYCE HARVEY
K093449 11/11/2009 MINI LAP RETRACTORS MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K093479 11/18/2009 DISPOSABLE SUCTION AND IRRIGATION SYSTEM MODERN MEDICAL EQUIPMENT MFG., LTD. EUGENE YEUNG
K093689 11/30/2009 1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS MR MEDICAL SOLUTIONS LLC FAHAD ALRADADY
K093584 11/19/2009 EZ-MISTER N.M. BEALE CO. INC. PAMELA PAPINEAU
K093329 11/30/2009 SCOPE INTRODUCER MODEL 7400 N.M. BEALE CO. INC. PAMELA PAPINEAU
K093661 11/25/2009 COLONRING NITI SURGICAL SOLUTIONS LTD JONATHAN KAHAN
K093693 11/30/2009 NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH NORAS MRI PRODUCTS GMBH ZAHED SEDIGHIANI
K093585 11/20/2009 MICROCYN SKIN AND WOUND HYDROGEL OCULUS INNOVATIVE SCIENCES, INC. ANTOINETTE DOUGLAS
K093507 11/13/2009 OLYMPUS CHF TYPE Y0003 OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K093395 11/04/2009 OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K093572 11/18/2009 R650 QDASM COLLIMATOR OMEGA MEDICAL IMAGING, INC. JAMES PRINCEHORN
K093451 11/05/2009 OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K093496 11/10/2009 NON-STERILE, POWDER-FREE, PINK LATEX EXAMINATION GLOVES WITH AND/OR WITHOUT STRAWBERRY SCENT AND WITH PROTEIN CONTENT OON CORP. RESOURCES JANNA P TUCKER
K092837 11/30/2009 OTI-SCAN 3000 OPKO INSTRUMENTATION, INC MARIO ARBESU
K093624 11/23/2009 OPTISCAN MODEL OPTISCAN CEIS OPTISCAN PTY LTD. PETER PAVLICEK
K093595 11/23/2009 CERAROOT IMPLANT SYSTEM ORAL ICEBERG S.L. STUART R GOLDMAN
K093611 11/23/2009 VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; ORTHO-CLINICAL DIAGNOSTICS, INC. MARLENE A HANNA
K093442 11/05/2009 GUIDED GROWTH SYSTEM ORTHOFIX INC. MARY BIGGERS
K093438 11/04/2009 PARADIGM INTERSPINOUS FUSION PLATE PARADIGM SPINE, LLC JUSTIN EGGLETON
K093494 11/10/2009 LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM PATHFINDER THERAPEUTICS, INC. CRAIG HENDERSON
K093456 11/05/2009 JETSTREAM G3 SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. CYNDY ADAMS
K093695 11/30/2009 PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE PEAK SURGICAL, INC. LOIS NAKAYAMA
K093553 11/17/2009 POSTURETEK PERSEUS ALTHETICS,LLC KEITH BARRITT
K093459 11/06/2009 ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5538-01, 14-5539-01 PHADIA US INC. MARTIN ROBERT MANN
K093426 11/03/2009 BACT-TRAP HEPA MIDI PHARMA SYSTEMS AB PAUL DRYDEN
K093563 11/18/2009 IU22 ULTRASOUND SYSTEM AND TRANSDUCERS PHILIPS ULTRASOUND, INC. NANCY BURKE
K093618 11/23/2009 BILI-MIRROR MODEL BLM-1 PHYSICIAN ENGINEERED PRODUCTS, INC. ROB ROSE, MD
K093547 11/17/2009 PINPOINTE FOOTLASER PINPOINTE USA, INC. ANNE WORDEN
K093692 11/30/2009 QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES PIONEER SURGICAL TECHNOLOGY EMILY M DOWNS
K093590 11/19/2009 PLANMECA PROMAX 3D MAX PLANMECA OY LARS MORING
K093620 11/24/2009 PULPDENT FLUORIDE VARNISH PULPDENT CORPORATION KENNETH J BERK
K093697 11/30/2009 VASHE WOUND THERAPY SOLUTION PURICORE INC. DENNIS MAHONRY
K093667 11/27/2009 SHOULDER SPEEDER COIL QUALITY ELECTRODYNAMICS CHRISTIE ZYDYK
K093658 11/25/2009 RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS RENU MEDICAL, INC. L. BRUCE PIERSON
K093684 11/30/2009 EASYCARE ONLINE RESMED LTD. DAVID D'CRUZ
K093416 11/02/2009 TRILOGY 200 VENTILATOR RESPIRONICS, INC. ZITA YURKO
K093460 11/06/2009 COAGUCHEK XS PRO SYSTEM ROCHE DIAGNOSTICS JENNIFER TRIBBETT
K093555 11/19/2009 COBAS U411 TEST SYSTEM ROCHE DIAGNOSTICS JENNIFER TRIBBETT
K093582 11/19/2009 ELECSYS CK-MB CALCHECK 5 ROCHE DIAGNOSTICS JACK ROGERS
K093664 11/27/2009 AMPHETAMINES II ASSAY ROCHE DIAGNOSTICS CORP. MICHELLE L NEFF
K093421 11/09/2009 ELECSYS TESTOSTERONE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP. SARAH BAUMANN
K093489 11/10/2009 IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY RYMED TECHNOLOGIES, INC. JOSEPH AZARY
K093453 11/05/2009 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM SCHICK TECHNOLOGIES, INC. HOWARD FIDEL
K093512 11/13/2009 ENCOR BREAST BIOPSY SYSTEM SENORX, INC. EBEN GORDON
K093672 11/27/2009 AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION SENTINELLE MEDICAL, INC. JOAN MEDLEY
K093560 11/21/2009 UPCERA ZIRCONIA BLANKS SHENYANG UPCERA CO., LTD. STUART R GOLDMAN
K093559 11/18/2009 VINTAGE MP SHOFU DENTAL CORP. DAVID P MORAIS
K093612 11/23/2009 SYNGO.PLAZA SIEMENS AG, MEDICAL SOLUTIONS
K093631 11/24/2009 B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 SIEMENS HEALTHCARE DIAGNOSTICS ANNA MARIE KATHLEEN ENNIS
K093441 11/05/2009 DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 SIEMENS HEALTHCARE DIAGNOSTICS FRANCES A DILLON
K093645 11/25/2009 EXL ANEM CAL, MODEL RC640 SIEMENS HEALTHCARE DIAGNOSTICS ANNA M KATHLEEN ENNIS
K093621 11/23/2009 SYNGO.PET&CT ONCOLOGY SIEMENS MEDICAL SOLUTIONS USA, INC. ALAINE MEDIO
K093531 11/16/2009 ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS, INC. SHELLY PEARCE
K093648 11/25/2009 SIMPLISSE ELECTRIC BREASTFEEDING COMPANION SIMPLISSE INC. GLEN FEYE
K093407 11/09/2009 ZQUIET MOUTHPIECE SLEEPING WELL, LLC YOLANDA SMITH
K093550 11/17/2009 MINI RAIL EXTERNAL FIXATOR SYSTEM SMALL BONE INNOVATIONS, INC. JOHN MINIER
K093428 11/03/2009 SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR SMITH & NEPHEW ENDOSCOPY, INC. KATHY REDDIG
K093414 11/04/2009 PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS SMITHS MEDICAL ASD, INC. RACHELLE PARSONS
K093422 11/03/2009 VITAL SYNC MODEL 5000 SERIES SOMANETICS CORP. RONALD A WIDMAN
K093510 11/12/2009 LUMENVU CATHETER GUIDANCE SYSTEM SONOSITE,INC. JANICE HOGAN
K093601 11/20/2009 AF 840 PH.I.S.I.O. ARTERIAL FILTER SORIN GROUP ITALIA S.R.L. BARRY SALL
K093511 11/13/2009 SORING MBC200/BCC140 SORING GMBH MEDIZINTECHNIK JAN SCHUELLER-IWERSEN
K093477 11/09/2009 SHIELD KYPHOPLASTY SYSTEM SOTEIRA, INC. PAMELA PAPINEAU
K093562 11/18/2009 ENDOSSEOUS DENTAL IMPLANT SOUTHERN IMPLANTS, INC. MICHAEL KEHOE
K093501 11/12/2009 ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION SPACELABS MEDICAL INC. DAVID GERAGHTY
K093551 11/17/2009 PARADIS VASO SHIELD SPINEMEDICA, LLC SALLY THORSEN
K093583 11/19/2009 EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE ST. JUDE MEDICAL TIM KAPPERS
K093677 11/27/2009 STRYKER ARTHROSCOPE STRYKER ENDOSCOPY SHIBIR DESAI
K093419 11/02/2009 IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS STRYKER INSTRUMENTS, INSTRUMENTS DIV. BECKY E DITTY
K093670 11/27/2009 MODIFICATION TO: OASYS SYSTEM STRYKER SPINE PAULINE SHAND
K093516 11/13/2009 NITRITECH OR MULTIPLE PRIVATE LABEL NON STERILE POWDERED NITRILE EXAMINATION GLOVES SUMMIT GLOVE, INC. JAMES MOORE
K093517 11/13/2009 NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE SUMMIT GLOVE, INC. JAMES MOORE
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K093676 11/27/2009 OMNITECH LARGE, TRIMED COMPRESSION SCREW TRIMED, INC. KELLI ANDERSON
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K093524 11/16/2009 PIVIT A/B ST AND PIVIT A/B ST-R TYRX ,INC MARK CITRON
K093462 11/06/2009 SONIX ULTRASOUND SCANNER ULTRASONIX MEDICAL CORPORATION CHAS YU
K093400 11/02/2009 1ML UNITRACT INSULIN SYRINGE 27G X 1/2" AND 29G X 1/2" UNILIFE MEDICAL SOLUTIONS LIMITED MELISSA L DEHASS
K093653 11/25/2009 URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK URESIL, LLC LEV MELINYSHYN
K093527 11/16/2009 ARIA RADIATION ONCOLOGY WITH MIRS VARIAN MEDICAL SYSTEMS, INC. VY TRAN
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K093503 11/12/2009 INTRAX FILM PROCESSOR VELOPEX INTERNATIONAL, INC. ANTHONY URELLA
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K093617 11/23/2009 VENTLAB 6000 SERIES HUMIDIFIER VENTLAB CORP. JAMES A COCHIE
K093675 11/27/2009 INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076 VERTEBRAL TECHNOLOGIES, INC. SURESH GHAI
K093446 11/06/2009 VITA VMK MASTER VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. ELIZABETH WOLFSEN
K093500 11/12/2009 POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE WEAR SAFE (MALAYSIA) SDN. BHD. S.H. TAN
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K093591 11/19/2009 STIMPOD MODEL NMS-400 NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD. BRIAN ROTHMAN
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