FDA 510(k) Applications Received During February, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K113845 12/28/2011 TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE MEDTRONIC INC. KEVIN T LAM
K110457 02/17/2011 3M TEGADERM MATRIX DRESSING 3M COMPANY MARIA RUIZ
K110302 02/02/2011 ADHESIVE EXL-759 3M ESPE AG DESI W SOEGIARTO
K110508 02/22/2011 SUGLUE-10 3M ESPE AG DESI W SOEGIARTO
K110471 02/18/2011 BABI PLUS INFANT NASAL CANNULA SYSTEM A PLUS MEDICAL THOMAS C LOESCHER
K110383 02/10/2011 BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 A PLUS MEDICAL THOMAS C LOESCHER
K113601 12/05/2011 AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K113602 12/05/2011 AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K113648 12/12/2011 LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF AAP IMPLANTATE AG MARC SEEGERS
K113652 12/12/2011 LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T AAP IMPLANTATE AG MARC SEEGERS
K113704 12/16/2011 ARCHITECT HAVAB-G ABBOTT LABORATORIES JUDITH WALLACH
K110381 02/10/2011 CELL-DYN EMERALD 22 SYSTEM ABBOTT LABORATORIES MICHELLE B ROEDING
K113719 12/19/2011 SAFETY SCREW CONNECTOR ABBOTT LABORATORIES ELIZABETH M ZOLA
K110458 02/17/2011 SILVER ANTIMICROBIAL WOUND GEL ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K103573 02/11/2011 ARTS2 SPINAL FIXATION SYSTEM ADVANCED MEDICAL TECHNOLOGIES J. D WEBB
K110432 02/15/2011 VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN AFFINITY BIOLOGICALS INC. DENISE FOULON
K113658 12/12/2011 AMPLATZER VASCULAR PLUG 4 AGA MEDICAL CORP. SHERRY KOLLMANN
K110503 02/22/2011 AIRSTRIP REMOTE PATIENT MONITORING (RPM) AIRSTRIP TECHNOLOGIES, LP ANDY MILLER
K113810 12/23/2011 MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES ALMA LASERS INC. TATIANA EPSTEIN
K113849 12/29/2011 HQS INTRODUCER ALSEAL JEAN-FRANCOIS DELFORGE
K113779 12/22/2011 CONELOG IMPLANT SYSTEM ALTATEC GMBH LINDA SCHULZ
K113555 12/01/2011 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA KAREN THOMISON
K113639 12/09/2011 C2 MEDICAL GLOVES AMERCARE, INC. ANDREW LOWERY
K113131 12/30/2011 LIASYS 450 AMS STEFANO CORRADI
K110328 02/03/2011 ACG-8511 PORTABLE ECG MONITOR ANDON HEALTH CO.,LTD LIU YI
K110330 02/03/2011 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K113785 12/23/2011 ADHERENT VISUAL STIMULATOR GOGGLES ANSCHEL TECHNOLOGY, INC. GLEN PARK
K113805 12/23/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K113547 12/01/2011 GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K113569 12/02/2011 APNEARX APNEA SCIENCE CORPORATION GARY MOCNIK
K110345 02/04/2011 SCANVIEW SYSTEM APPLIED SPECTRAL IMAGING DAN LAOR
K113762 12/21/2011 CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K113716 12/19/2011 ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K110553 02/28/2011 ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE ASAHI INTECC USA, INC. YOSHI TERAI
K110481 02/18/2011 TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE ASI MEDICAL, INC. JOHN MCPEEK
K110356 02/07/2011 ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K113812 12/23/2011 ATAL-8 ATLAIM DANIEL KAMM
K113831 12/27/2011 PRIMUS HEARING INSTRUMENT TEST UNIT AUDITDATA A/S DAN HAUGBOL
K113836 12/28/2011 BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) AVERY DENNISON BELGIE, BVBA JERZY WOJCIK
K113838 12/28/2011 WILDCAT CATHETER AVINGER, INC. SEVRINA CIUCCI
K110296 02/01/2011 AXIS-SHIELD ANTI-CCP AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE I DORA
K113703 12/16/2011 BAUSCH + LOMB NESOFILCON A CONTACT LENS BAUSCH & LOMB INCORPORATED BARBARA KLUBE-FALSO
K113852 12/29/2011 BAUSCH & LOMB IOL INJECTOR BAUSCH & LOMB, INC. JASON SMITH
K110413 02/14/2011 POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS BECKMAN COULTER, INC. MARINE BOYAJIAN
K110443 02/16/2011 BD INSYTE AUTOGUARD BC BECTON DICKINSON & CO. RAND PUGMIRE
K113558 12/01/2011 BD BACTEC PLUS AEROBIC/F (PLASTIC) BECTON, DICKINSON AND COMPANY PAUL SWIFT
K110434 02/15/2011 TRIXEL CO2 LASER BEIJING SYNTECH LASER CO., LTD. DIANA HONG
K113791 12/22/2011 B-GENIN, R-GENIN BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K110350 02/07/2011 KNEEHAB XP BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K113610 12/06/2011 ANA-SCREEN WITH MDSS BIO-RAD LABORATORIES JUANG WANG
K113858 12/30/2011 MEGABEAM ENDO-ENT PROBE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113792 12/23/2011 MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113709 12/19/2011 MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113688 12/15/2011 MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113305 12/02/2011 VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. JOLYN TENLLADO
K110449 02/16/2011 ENDOBON XENOGRAFT GRANULES BIOMET 3I MARTHA I GARAY
K110565 02/28/2011 ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE BIOMET 3I, INC. JOSE E CABRERA
K113645 12/12/2011 REGENEROSS ALLOGRAFT PLUS MINERLIZED BIOMET INTERPORE CROSS KATHLEEN OLIVARES
K110555 02/28/2011 ARCOMXL ACTIVE ARTICULATION BIOMET MANUFACTURING CORP. BEKCY EARL
K110320 02/03/2011 COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM BIOMET MANUFACTURING CORP. PATRICIA S BERES
K110400 02/11/2011 TAPERLOC COMPLETE MICROPLASTY STEM BIOMET MANUFACTURING CORP. BECKY EARL
K110362 02/08/2011 VANGUARD ASYMMETRICAL PATELLAR COMPONENT BIOMET MANUFACTURING CORP. TAMARA WEST
K113550 12/01/2011 VANGUARD COMPLETE KNEE SYSTEM BIOMET MANUFACTURING CORP. GARY BAKER
K113593 12/05/2011 NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY
K113764 12/21/2011 GLUCOSE METER-CHECK SOLUTION FOR INFOPIA BIONOSTICS, INC. RANDY BYRD
K113822 12/27/2011 QUADRASPHERE 30 TO 60 BIOSPHERE MEDICAL, INC. LINDA J VARROSO
K110461 02/17/2011 SELECTRA CS LEAD INTRODUCER SYSTEM BIOTRONIK, INC. JON BRUMBAUGH
K110426 02/14/2011 DYNA-EXTOR II BK MEDITECH CO., LTD. ELAINE DUNCAN
K113832 12/27/2011 SONICEYE ULTRASOUND TRANSDUCER BLACKTOE MEDICAL III, INC. KENDRA RATHKEY
K113681 12/15/2011 GLADIATOR PTA BALLOON DILATION CATHETER BOSTON SCIENTIFIC AMBER JOHNSON
K110479 02/18/2011 ACUITY WHISPER VIEW GUIDE WIRES BOSTON SCIENTIFIC CORP. KIRSTIN JOHNSTON
K110295 02/01/2011 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. SHANNON PETTIT
K113651 12/12/2011 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORPORATION HARLAN JONES
K110204 02/09/2011 BRAINLAB TRAUMA BRAINLAB AG ALEXANDER SCHWIERSCH
K113732 12/19/2011 IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) BRAINLAB AG ALEXANDER SCHWIERSCH
K113866 12/30/2011 PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX BRENNEN MEDICAL, LLC KENNETH B HERLAND
K113589 12/05/2011 BIGBOSS CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K110305 02/02/2011 CRY-ACTRACKERCAM BRYMILL CRYOGENIC CYSTEMS CLAUDIO RUSSO
K113811 12/23/2011 V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION ANASTASIA C RANDALL
K110396 02/11/2011 ASPIRA PERITONEAL DRAINAGE SYSTEM C.R. BARD, INC. HENRY BOLAND
K110409 02/14/2011 ASPIRA PLEURAL DRAINAGE SYSTEM C.R. BARD, INC. HENRY BOLAND
K113808 12/23/2011 THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. BARD, INC. HENRY BOLAND
K110395 02/11/2011 C.T.M. MOBILITY SCOOTER - MODEL HS 118 C.T.M. HOMECARE PRODUCT, INC. SHEILA RAMERMAN
K110567 02/28/2011 C.T.M. MOBILITY SCOOTER HS515(3W) C.T.M. HOMECARE PRODUCT, INC. SHEILA RAMERMAN
K113835 12/27/2011 DATACAPTOR SYSTEM CAPSULE TECH INC. PETER KELLEY
K110493 02/22/2011 TANDEMHEART PUMP CARDIACASSIST INC. ROBERT BOLLINGER
K113707 12/16/2011 STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES TATYANA BOGDAN
K110389 02/10/2011 STEALTH 360 ORBITAL PAD SYSTEM CARDIOVASCULAR SYSTEMS, INC. MEGAN M BRANDT
K113854 12/29/2011 PLEURX PERITONEAL CATHETER SYSTEM CAREFUSION JOY GREIDANUS
K110535 02/25/2011 ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION CAREFUSION 303,INC. GABRIELA MURANEVICI
K113813 12/23/2011 SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K113842 12/28/2011 CATHETER CONNECTIONS' DUALCAP SOLO CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K113628 12/08/2011 AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES CATHETER ROBOTICS INC JENNIFER ENGLUND
K110554 02/28/2011 BIOCERAMIC ORBITAL IMPLANT, ORBTEX CERAMISYS LTD. HILLARD W WELCH
K110332 02/03/2011 CLEARCANVAS RIS / PACS CLEARCANVAS INC. CLINTON CHAU
K113618 12/07/2011 CLEARCORRECT SYSTEM CLEARCORRECT, INC. CHERYL FISHER
K113731 12/19/2011 ESENSOR RESPIRATORY VIRAL PANEL CLINICAL MICRO SENSORS, INC. JOEL CENTENO
K113585 12/05/2011 NASAL/EPISTAXIS PACK COGENT THERAPEUTICS, LLC ANNE WORDEN
K110297 02/01/2011 POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES COMFORT RUBBER GLOVES INDUSTRIES SDN BHD TAN KENG BENG
K110483 02/18/2011 MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K110542 02/24/2011 CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD CONSENSUS ORTHOPEDICS, INC. MATTHEW HULL
K113757 12/21/2011 ASPIRE MAX ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC SHAWN P FOJTIK
K110402 02/11/2011 BIODESIGN NIPPLE RECONSTRUCTION CYLINDER COOK BIOTECH, INC. PERRY W GUINN
K113634 12/09/2011 INJEKT CYSTO FLEXIBLE INJECTION NEEDLE COOK IRELAND LTD LAURA GUINANE
K110347 02/16/2011 DOPPLER MONITOR COOK VASCULAR, INC. JIM FERGUSON
K113759 12/21/2011 AVAIRA (ENFILCON A) CONTACT LENS COOPERVISION, INC. KARIN GASTINEAU
K110321 02/03/2011 TIGER SPINE SYSTEM CORELINK, LLC J.D. WEBB
K110404 02/14/2011 EAUM TOTAL KNEE SYSTEM CORENTEC CO., LTD KEVIN A THOMAS
K113572 12/02/2011 LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H JOHN VAN HOVEN
K113738 12/20/2011 CREODENT SOLIDEX CUSTOM ABUTMENT CREODENT PROSTHETICS LTD. CALVIN SHIM
K110531 02/24/2011 ENDOFLIP ECD CROSPON, LTD. PAUL DRYDEN
K110529 02/24/2011 ENDOFLIP GASTRIC TUBE CROSPON, LTD. PAUL DRYDEN
K113660 12/13/2011 COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL CRYOTHERAPY PRODUCTS INC. JORGE CABALLERO
K113548 12/01/2011 PEDCAT CURVEBEAM, LLC DAVID W COWAN
K113543 12/01/2011 ONDEMAND3D CYBERMED, INC. YONG KI IM
K110511 02/23/2011 E4D COMPASS D4D TECHNOLOGIES ALLISON SCOTT
K113787 12/22/2011 DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC ED HORTON
K113545 12/01/2011 VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN DEPUY MITEK, A JOHNSON & JOHNSON COMPANY SUSAN KAGAN
K110397 02/11/2011 TRUMATCH PERSONALIZED SOLUTIONS DEPUY ORTHOPAEDICS, INC. NANCY S FRIDDLE
K110353 02/07/2011 MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. LUKE BULINO
K110546 02/25/2011 MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY DERMA SCIENCES, INC. RONALD S WARREN
K120014 12/29/2011 STA- COAG CONTROL (N+ABN) PLUS DIAGNOSTICA STAGO, INC. KEVIN WYCKOFF
K110384 02/10/2011 DILON 6800 ACELLA (ACELLA) DILON TECHNOLOGIES, INC. ELAINE DUNCAN
K110439 02/15/2011 DOMAIN SURGICAL SYSTEM DOMAIN SURGICAL, INC. CURTIS JENSEN
K110364 02/07/2011 DORNIER MEDILAS D LITEBEAM+ 1470 DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K113798 12/23/2011 INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET DRAEGER MEDICAL SYSTEMS, INC. BETH A ZIS
K113689 12/15/2011 DUKAL LUBRICATING JELLY DUKAL CORPORATION PATRICK J LAMB
K110521 02/23/2011 EVERON CENTRAL DISPLAY STATION (CDS) EARLYSENSE LTD. DALIA ARGAMAN
K113796 12/23/2011 SOLITAIRE-C CERVICAL SPACER SYSTEM EBI, LLC MARGARET CROWE
K113623 12/05/2011 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K113653 12/12/2011 PATIENT MONITOR EDAN INSTRUMENTS, INC. RANDY JIANG
K113667 12/13/2011 CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC. KAREN JONES
K113565 12/02/2011 MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN EDWARDS LIFESCIENCES, LLC. MARGUEITE THOMLINSON
K113562 12/01/2011 3MP COLOR LCD MONITOR, RADIFORCE RX340 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113784 12/22/2011 3MP MONOCHROME LCD MONITOR, RADIFORCE GX40 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113844 12/28/2011 RADIFORCE RX240 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K110393 02/11/2011 EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOGLOBIN MICROCUVETTES (MODIFIED CURVETTE W EKF-DIAGNOSTIC GMBH STEPHEN GORSKI
K113695 12/16/2011 ELLIPSE PRECICE TRAUMA NAIL SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCLNTYRE
K113756 12/21/2011 HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA ENCORE MEDICAL, L.P. TEFFANY HUTTO
K113726 12/19/2011 EPOC CHLORIDE TEST AND EPOC CREATININE TEST EPOCAL, INC. ROY LAYER
K110373 02/08/2011 TEMPOROMANIBULAR COIL 15 ESAOTE S.P.A. DONATELLA RAGGHIANTI
K113767 12/21/2011 MOUNTED MEDICAL OXYGEN SYSTEM ESSEX INDUSTRIES, INC. KEN SEISE
K110431 02/15/2011 PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS ETHICON ENDO-SURGERY THOMAS BOSTICCO
K110385 02/10/2011 ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER ETHICON ENDO-SURGERY, INC. ASIFA VONHOF
K113576 12/06/2011 DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM ETVIEW LTD. YORAM LEVY
K110319 02/03/2011 EVERCROSS 0.035" OTW PTA DILATATION CATHETER EV3 INC PAULA CORDERO
K113743 12/20/2011 EVOLUTION 3E VENTILATOR EVENT MEDICAL, INC. RICK WATERS
K110509 02/22/2011 EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K113609 12/06/2011 NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 EXACTECH, INC. VLADISLAVA ZAITSEVA
K113564 12/02/2011 EXSALT T7 WOUND DRESSING EXCITON TECHNOLOGIES INC. MELANIE USSYK
K113761 12/21/2011 INFRARED THERMOMETER FAMIDOC TECHNOLOGY CO., LTD LEON CAO
K110288 02/01/2011 FEMVUE SALINE-AIR DEVICE FEMASYS INC. LISA PEACOCK
K110541 02/25/2011 FIGURE 8 STERNOTOMY CLOSURE DEVICE FIGURE 8 SURGICAL, INCORPORATED KIT CARIQUITAN
K110316 02/03/2011 INFOSEND GSM FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K110429 02/15/2011 PROSIM 4, PROSIM 6, PROSIM 8 FLUKE BIOMEDICAL JOHN NELSON
K110333 02/03/2011 NATURALASE CO2 LASER SYSTEM FOCUS MEDICAL, LLC. JOHN LEE
K113702 12/16/2011 FOTONA XP ND: YAG LASER SYSTEM FOTONA D.D. STOJAN TROST
K113591 12/05/2011 COLS PEEK FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K113713 12/19/2011 GEN_2 MECHANICAL WHEELCHAIR FREE WHEELCHAIR MISSION SHARON ROCKWELL
K110436 02/15/2011 FDI GLUCOSE CONTROL SOLUTION FOR AVIVA FUJIREBIO DIAGNOSTICS, INC KENT PRUETT
K113722 12/19/2011 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113750 12/21/2011 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113710 12/19/2011 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113749 12/21/2011 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113797 12/23/2011 DISPOSABLE VINYL EXAM GLOVE, POWDER FREE FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113790 12/23/2011 DISPOSABLE VINYL EXAM GLOVE, POWDERED FULL SYNERGY MEDICAL PRODUCTS INC ELIZABTEH DENG
K110518 02/23/2011 IBAG FUTURE PATH MEDICAL, LLC DANIEL KAMM
K113860 12/30/2011 VISUAL-ICE CRYOABLATION SYSTEM GALIL MEDICAL INC. AMY MCKINNEY
K113816 12/27/2011 GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV GC AMERICA, INC. CARL H JENKINS
K113690 12/15/2011 GE LOGIQ I, LOGIQ E AND VIVID E GE HEALTHCARE BRYAN BEHN
K113758 12/21/2011 VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE BRYAN BEHN
K110266 02/01/2011 MAC 5500 HD, MAC 3500 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC PATRICIA TAIGE
K103765 02/18/2011 MAC 600 RESTING ECG ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC JOE LUCAS
K110558 02/28/2011 CS1000 LIGHT THERAPY DEVICE GENESIS HEALTH LIGHT CORPORATION PAUL ZIEMER
K113607 12/06/2011 BIOPSY DIGIT S BIOPSY SL GIOTTO USA, LLC NICOLAAS BESSELING
K113853 12/29/2011 G+ SYSTEM GLYTEC, LLC WILLIAM MATTHEWS
K110299 02/01/2011 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM10 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K113833 12/27/2011 VITAL SIGNS MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD DIANA HONG
K113624 12/08/2011 WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K110480 02/18/2011 PDE PHOTODYNAMIC EYE HAMAMATSU PHOTONICS, K.K. JEFFREY K SHAPIRO
K110390 02/15/2011 ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR HANDELSHAUS DITTMAN GMBH KANG JIANG PING
K113674 12/14/2011 SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT HANDPIECE HEADQUARTERS INC. - HPR INC. TINA STEFFANIE-OAK
K113728 12/19/2011 SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY HANS BIOMED CORP. PATSY J TRISLER
K113622 12/12/2011 ORION II CT CVC HEALTH LINE INTERNATIONAL CORPORATION (HLIC) NOLA BENSTOG
K113837 12/28/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES HEBEI CHANGSHENG PLASTIC PRODUCTS CO., LTD. RICHARD LU
K113574 12/06/2011 FLEXITIME MONOPHASE PRO SCAN HERAEUS KULZER, LLC CHRIS HOLDEN
K113575 12/02/2011 HILLA DIGITAL TRANSFERS HILLA TECHNOLOGIES, INC. CAROLYN M PRIMUS
K113809 12/23/2011 HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) HITACHI CHEMICAL DIAGNOSTICS, INC. ERICKA B AMMIRATI
K110301 02/02/2011 SILK'N FX HOME SKINOVATIONS LTD. AMIR WALDMAN PH. D.
K113683 12/15/2011 LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL HOSPIRA,INC. KAREN KEENER
K113769 12/22/2011 GPSCATH BALLON DILATATION CATHETER HOTSPUR TECHNOLOGIES ERIC ANKERUD
K110290 02/01/2011 EXETER HIP STEM HOWMEDICA OSTEONICS CORP VALERIE GIAMBANCO
K113760 12/21/2011 VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS VALERIE GIAMBANCO
K110425 02/14/2011 HC-BIOS DENTAL IMPLANT HUNG CHUN BIO-S CO., LTD. MICHAEL LEE
K113449 12/05/2011 FUSION FLAT PANEL ICRCO INC. GREG WACHTLER
K113662 12/07/2011 FENESTRATED NERVE BLOCK NEEDLE IMD INC WALTER ZOHMANN
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