FDA 510(k) Applications Received During February, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K123733 12/05/2012 CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM MEDTRONIC INC. KARI CHRISTIANSON
K123762 12/07/2012 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF MEDTRONIC INC. CHELSEA PIOSKE
K120612 02/29/2012 MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT MEDTRONIC INC. KELLEY BREHEIM
K120438 02/13/2012 FLASH (DIFFERENT MATERIALS) 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K120453 02/14/2012 FILTEK BULK FILL FLOWABLE RESTORATIVE 3M ESPE DENTAL PRODUCTS SCOTT ERICKSON
K123875 12/17/2012 AAP RADIUS SET 2.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K123888 12/18/2012 Z CARTRIDGE IOL DELIVERY SYSTEM AAREN SCIENTIFIC, INC ROBERT K SHEEHAN
K120568 02/29/2012 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. ARUL STERLIN
K123372 12/04/2012 ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR ABBOTT LABORATORIES LINDA MORRIS
K123951 12/21/2012 VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) ABBOTT MOLECULAR, INC. NANCY W BENGTSON
K123890 12/18/2012 ACUMED CANNULATED SCREW SYSTEM ACUMED LLC KARA BUDOR
K123936 12/27/2012 SURGISEAL TOPICAL SKIN ADHESIVE ADHEZION BIOMEDICAL, LLC CARIDAD SMITH
K120450 02/14/2012 SLEEP PROFILER ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K120447 02/14/2012 X4 ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K120350 02/06/2012 EXTENDED LIFE BATTERY AED BATTERY EXCHANGE, LLC KEITH HOCHHALTER
K123909 12/19/2012 AESCULAP CESPACE XP AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K123939 12/20/2012 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K120559 02/24/2012 AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM AESCULAP, INC. KATHY A RACOSKY
K123882 12/17/2012 AGE AUTOMATIC UPPER ARM BLOOD PRESSURE MONITOR AGELESS HEALTH INDUSTRIAL VICTOR WAN
K120615 02/29/2012 ALERE CHOLESTECH LDX ANALYZER, ALERE CHOLESTECH LDX LIPID PROFILE - GLU CASSETTE ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN EDWARD BREHM, PH.D.
K123986 12/26/2012 ACTIM PROM ALERE SCARBOROUGH, INC ANGELA DRYSDALE
K123953 12/21/2012 ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ PH.D.
K120401 02/08/2012 ALAMO T ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K123796 12/10/2012 NEURO OMEGA SYSTEM ALPHA OMEGA ENGINEERING LTD. ILAN SHARON
K120527 02/22/2012 ALPHA ORTHOPAEDICS AT2 SYSTEM ALPHA ORTHOPAEDICS, INC GINA TO
K123993 12/26/2012 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K120371 02/06/2012 DR GREENBURGS HYBRID ACRYLIC ALWAYS MORE MARKETING INC JONATHAN GREENBURG
K120372 02/06/2012 DR GREENBURGS HYBRID VACUUM ALWAYS MORE MARKETING INC JONATHAN GREENBURG
K123943 12/20/2012 AMECATH DUAL LUMEN HEMODIALYSIS CATHETER AMECO MEDICAL INDUSTRIES RAY KELLY
K123746 12/14/2012 AMES THERAPY DEVICE AMES TECHNOLOGY, INC. SHEILA RAMERMAN, RAC
K123935 12/20/2012 IHEALTH BG5/BG5L WIRELESS SMART GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. YI LIU
K123699 12/03/2012 FAHL TRACHEOSTOMY TUBES (MULTIPLE) ANDREAS FAHL MEDIZINTECHNIK-VERTRIEB GMBH CLAUDIA WINTERSCHLADEN
K123823 12/12/2012 INTERLIG ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LILIAN LLULL
K120394 02/08/2012 LIFESTYLES ZERO LUBRICATED LATEX CONDOM ANSELL HEATHCARE PRODUCTS LLC CYNTHIA INGRAM
K120448 02/14/2012 MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL APEX BIOTECHNOLOGY CORP. LISA LIU
K124027 12/28/2012 MONSTER SCREW SYSTEM APOGEE ORTHOSOLUTIONS KAREN E WARDEN, PHD
K120340 02/06/2012 VENUS FACET SCREW SYSTEM APOLLO SPINE, INC. CHRISTINE SANTAGATE
K123716 12/04/2012 AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT APPLIED MEDICAL TECHNOLOGY, INC. GRANT W PHILLIPS
K120587 02/29/2012 AMT T-FASTENER ANCHOR KIT APPLIED MEDICAL TECHNOLOGY, INC. ELIZABETH MEYER
K120412 02/10/2012 3M SPOTON TEMPERATURE MONITORING SYSTEM ARIZANT HEALTHCARE INC. DAVID WESTLIN
K123759 12/07/2012 CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ELIZABETH DUNCAN
K120540 02/23/2012 BIOBOLT ARTHREX, INC. COURTNEY SMITH
K123760 12/07/2012 MULTIPLE NAME ASSURGUARD SDN. BHD. LIM HUI GUAN
K123757 12/07/2012 POWDER FREE LATEX PATIENT EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM, NATURAL COLOR ASSURGUARD SDN. BHD. LIM H GUAN
K120414 02/10/2012 OSSEOSPEED PLUS ASTRA TECH AB LINDA K SCHULZ
K120338 02/03/2012 ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIA ASTRA TECH INC. B A BROWN
K123937 12/20/2012 ATOM TRANSCAPSULE V-707 ATOM MEDICAL CORPORATION PAUL DRYDEN
K120427 02/13/2012 EEVA 2.0 AUXOGYN, INC. CINDY DOMECUS
K120431 02/13/2012 HALO90 ULTRA ABLATION CATHETER BARRX MEDICAL, INC. DAWN CHANG
K123921 12/20/2012 BODYTRONIC 200 BAUERFEIND AG INES EXNER
K123736 12/10/2012 CRYSTALSERT DELIVERY SYSTEM BAUSCH & LOMB JASON SMITH
K123874 12/17/2012 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K123868 12/17/2012 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET BAXTER HEALTHCARE CORP. GARY CHUMBIMUNE
K120443 02/14/2012 NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE BAXTER HEALTHCARE CORPORATION - RENAL DIVISION NANETTE HEDDEN
K120384 02/07/2012 PROTECTOR, INJECTOR, CONNECTOR BD MEDICAL-MEDICAL SURGICAL SYSTEMS JOHN ROBERTS
K123903 12/19/2012 BD BACTEC LYTIC/10 ANAEROBIC/F (PLASTIC) BECTON DICKINSON & CO. PAUL SWIFT
K123734 12/05/2012 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. KIMBERLY GEISLER
K124038 12/28/2012 BEDSIDE PAEDIATRIC EARLY WARNING SYSTEM (BEDSIDEPEWS) BEDSIDE CLINICAL SYSTEMS INC DIANE SUDDUTH
K123929 12/20/2012 BEGOPAL+ BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO HEIKE GUSTKE
K123871 12/17/2012 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K120375 02/06/2012 MED-RX PATIENT DELIVERY SET BENLAN INC CHERYL BROWN
K123896 12/18/2012 CCS-200 SPIROMETER BENSON MEDICAL INSTRUMENTS CO. DAVID MAYOU
K120392 02/08/2012 CHROMOPHARE F 628 AND F 528 BERCHTOLD GMBH & CO. KG VOLKER HORNSCHEIDT
K123710 12/18/2012 UNITOX BOTOX SYRINGE BIO-MED USA INC YOUNG CHI
K123775 12/10/2012 LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K123798 12/10/2012 LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K120439 02/13/2012 BIOPLEX 2200 EBV IGG AND SYPHILIS IGG BIO-RAD LABORATORIES, INC. JUANG WANG
K120572 02/27/2012 BIOPLEX 2200 TORC IGG BIO-RAD LABORATORIES, INC. JUANG WANG
K120504 02/21/2012 LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K120552 02/23/2012 "AIR LIFT/XEROSTOM" ARTIFICIAL SALIVA BIOCOSMETICS LABORATORIES RAY KELLY
K123947 12/21/2012 ARCHITECT IVANCOMYCIN BIOKIT S.A. GUILLEM ANGLERILL
K120437 02/13/2012 TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM BIOLITEC SIA (LATVIA) HARRY HAYES
K123745 12/06/2012 SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTOPEDICOS LT TARA CONRAD
K124022 12/28/2012 SPEED SHIFT BIOMEDICAL ENTERPRISES, INC JOE SOWARD
K123907 12/19/2012 PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K120557 02/24/2012 SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 BIOMET SPINE & BONE HEALING TECHNOLOGIES MARGARET F CROWE
K120423 02/13/2012 BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 BIONIME CORPORATION FENG-YU LEE
K120335 02/08/2012 EMBRACE THERMOPLASTIC BIONIX DEVELOPMENT CORP. JAMES HUTTNER M.D., PH.D.
K123966 12/26/2012 GLUCOSE METER-CHECK SOLUTION FOR BAYER BIONOSTICS, INC. RANDY BYRD
K123851 12/17/2012 GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK BIONOSTICS, INC. RANDY BYRD
K123961 12/26/2012 SENTREX BIOSPONGE MPD BIONOVA MEDICAL, INC ALEX GREENE
K120550 02/23/2012 CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K120425 02/13/2012 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K120464 02/15/2012 INNESIS PEEK CAGE BK MEDITECH CO., LTD. SHIN KUK YOO
K123821 12/12/2012 AIO HD OTOSCOPE BLUE FOCUS KI CHEOL HAN
K120353 02/06/2012 SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM BM KOREA CO., LTD. PRISCILLA CHUNG
K123820 12/12/2012 BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS BOSSONG HOSIERY MILLS, INC ROGER RAND
K123765 12/07/2012 GUIDEZILLA GUIDE EXTENSION CATHETER BOSTON SCIENTIFIC HOLLY RAMIREZ
K120495 02/17/2012 IMPULSE AND EXPO ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. YUMI WACKERFUSS
K120520 02/21/2012 EXACTRAC ROBOTICS NOVALIS ROBOTICS BRAINLAB AG ALEXANDER SCHWIERSCH
K120533 02/22/2012 BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K123718 12/04/2012 PERMASORB DISPOSABLE FIXATION DEVICE C.R. BARD INC RADHIKA PONDICHERRY
K123911 12/19/2012 SENOMARK ULTRA BREAST TISSUE MARKER C.R. BARD, INC. SARAH MCCARTNEY
K120327 02/02/2012 VERTESSA CALDERA MEDICAL, INC. VICKI GAIL
K123810 12/11/2012 PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K120409 02/09/2012 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K112975 02/16/2012 CARBONAID C02 DIFFUSER CARDIA INNOVATION AB JEFFREY R SHIDEMAN
K120543 02/23/2012 TANDEMHEART FEMORAL ARTERIAL CANNULA SET CARDIACASSIST INC. KATIE DILLON
K123857 12/14/2012 DURABLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K120542 02/23/2012 CARDINAL HEALTH DURABLUE STERILIZATION WRAP CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES LAVENIA FORD
K120518 02/21/2012 END TIDAL CO2 NASAL CANNULA CAREFUSION ERIKA FERNANDEZ
K120560 02/24/2012 TRINITY WRINKLE REMOVER CAROL COLE COMPANY BOB DUFFY
K124053 12/31/2012 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL, INC. TANYA EBERLE
K123700 12/03/2012 FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K123967 12/26/2012 CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K123905 12/19/2012 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM, PHARM. D
K123844 12/13/2012 CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST CHEMTRON BIOTECH, INC. JANE ZHANG
K120570 02/27/2012 CHOICE SPINE VERTEBRAL BODY REPLACEMENT (VBR) DEVICE SYSTEM CHOICE SPINE, LP MARK BEKKALA
K123994 12/26/2012 DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL CIBA VISION CORPORATION MARTINA HEIM, PH.D., RAC
K123946 12/21/2012 WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS CINCINNATI SUB-ZERO PRODUCTS, INC STEVEN J BERKE
K120469 02/16/2012 ERISMA-LP CLARIANCE WILLIAM JACKSON
K123752 12/06/2012 ACCULIF TL AND PL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K120274 02/02/2012 DELTAMAXX 18 MICROCOIL SYSTEM CODMAN AND SHURTLEFF, INC. KIM FONDA
K123675 12/04/2012 RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR COLOPLAST A/S BRIAN SCHMIDT
K123914 12/19/2012 RESTORELLE Y CONTOUR COLOPLAST A/S TIM CRABTREE
K120316 02/01/2012 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K120322 02/02/2012 CONMED SUREFIT DUAL DISPERSIVE ELECTRODE CONMED CORPORATION SHAWN RIEDEL
K120476 02/16/2012 MACROLYTE DISPERSIVE ELECTRODE CONMED CORPORATION SHAWN RIEDEL
K120595 02/28/2012 UNISYN PLUS HIP STEM CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K120501 02/21/2012 CHAMP CHAMP TRANSIT CONVAID PRODUCTS, INC. MERVYN WATKINS
K124030 12/28/2012 COOK HOLMIUM LASER FIBER COOK INCORPORATED CONNIE RICE
K120468 02/16/2012 NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR COOK INCORPORATED SUSANNE GALIN
K123712 12/04/2012 RETRACTA DETACHABLE EMBOLIZATION COIL COOK INCORPORATED JENNIFER RICHARDSON
K123707 12/03/2012 ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE COOK, INC. DAVID LEHR
K120362 02/06/2012 METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY CORIN U.S.A. LUCINDA GERBER, BA (HONS)
K123705 12/03/2012 TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS CORIN USA DIANA L MARTONE
K123756 12/07/2012 COVAGEN COVALON TECHNOLOGIES LTD. CHRISTOPHER FREDRIC
K120605 02/28/2012 PERMACOL SURGICAL IMPLANT COVIDIEN LLC JAMES MCMAHON
K123581 12/10/2012 NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. MIA M WARE
K120402 02/09/2012 CRUX VENA CAVA FILTER SYSTEM CRUX BIOMEDICAL ELISA HEBB
K123893 12/18/2012 CURA COLLIMATOR CURA MEDICAL TECHNOLOGIES, LLC THOMAS H FARIS
K123897 12/18/2012 K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. AMY MCKINNEY
K123818 12/12/2012 URSA ANGIOGRAPHIC CATHETER CURATIVE MEDICAL TECHNOLOGY, INC. AMY MCKINNEY
K120597 02/28/2012 KOMPREDA CUSTOM SPINE, INC. DAVID BRUMFIELD
K120303 02/13/2012 CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM CYBERSONICS, INC. LORI COLVIN
K123971 12/26/2012 CYNOSURE 1064NM DIODE LASER CYNOSURE, INC. IRINA KULINETS
K123830 12/12/2012 INTERMITTENT PNEUMATIC COMPRESSION DEVICE DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. DORIS DONG
K120592 02/28/2012 DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS DANA PRODUCTS, INC. HARRY BALA
K123869 12/17/2012 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES DEHAI (SHANDONG) MEDICAL GLOVES, CO., LTD RAY ZHOU
K124018 12/27/2012 AMIA AUTOMATED PD SYSTEM DEKA RESEARCH & DEVELOPMENT CORP. ROGER A LEROUX
K123940 12/20/2012 DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE DEMETECH CORP. JOHN O'BRIEN
K124025 12/28/2012 ALPHA-PRO WHITE VARNISH DENTAL TECHNOLOGIES, INC. PAULA ERICKSON
K123849 12/14/2012 NEW COMFORT-FIT DENTAL GUARD DENTEK ORAL CARE, INC. LINDA GILES
K120530 02/22/2012 DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION S DENTIN IMPLANTS TECHNOLOGIES LTD. DANIELA LEVY
K123925 12/20/2012 MTM CLEAR ALIGNER IN-OFFICE DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K123991 12/26/2012 DEPUY CORAIL AMT HIP PROSTHESIS DEPUY FRANCE S.A.S. ALMA RELJA, RAC
K120449 02/14/2012 HEALIX ADVANCE PEEK ANCHOR DEPUY MITEK YAYOI FUJIMAKI
K120589 02/28/2012 MILAGRO INTERFERENCE SCREWS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K123924 12/20/2012 DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS DEPUY ORTHOPAEDICS CORRENE RAMY
K120599 02/28/2012 DEPUY M-SPEC 36MM FEMORAL HEADS DEPUY ORTHOPAEDICS CORRENE RAMY
K123959 12/21/2012 CIRCUFLOW 5150 DEVON MEDICAL INC. RUTH WU
K123824 12/12/2012 VITRO FIL LC DFL INDUSTRIA E COMERCIO S.A. TARA CONRAD
K123826 12/12/2012 VITRO MOLAR DFL INDUSTRIA E COMERCIO S.A. TARA CONRAD
K120591 02/28/2012 DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K124009 12/27/2012 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS LEVEL 2, MISSION C DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K123969 12/26/2012 XIPHOS DIFUSION TECHNOLOGIES KAREN E WARDEN, PHD
K124016 12/27/2012 EMPI PHOENIX DJO, LLC KEN FISHER
K123776 12/10/2012 POLARIS 100/200 DRAGER MEDICAL GMBH BETH ZIS
K120465 02/15/2012 EARLYSENSE (EVERON) SYSTEM EARLYSENSE LTD. DALIA ARGAMAN
K123806 12/10/2012 FIBROSCAN ECHOSENS ZVI LADIN, PH.D.
K123263 12/05/2012 HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS ECKERT & ZIEGLER BEBIG GMBH HUB VAN DE BERGH
K123714 12/04/2012 EDWARDS EMBOL-X INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. LUKE MEIDELL
K120407 02/09/2012 2MP MONOCHROME LCD MONITOR, RADIFORCE GX240 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K120451 02/14/2012 8MP COLOR LCD MONITOR, REDIFORCE RX840 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K123808 12/11/2012 AGILITY ELEKTA LTD. PATRICK HULL
K120604 02/28/2012 K-LASER ELTECH S.R.L RICHARD ALBRIGHT
K123729 12/05/2012 VERSARATE FLOW RATE CONTROLER EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K123982 12/26/2012 TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ ENCORE MEDICAL, L.P. MICHAELA NORRIS
K123696 12/03/2012 MEDUSA VASCULAR PLUG ENDOSHAPE, INC. MICHAEL PARMENTER
K124055 12/31/2012 T1040 AKA AURAWAVE ENDURANCE THERAPEUTICS BRAD BREZDEN
K120513 02/21/2012 GLOW BY ENDYMED ENDYMED MEDICAL LTD YORAM LEVY
K123740 12/05/2012 EOS EOS IMAGING JOHN J SMITH
K124064 12/31/2012 YOUNG AGAIN ESPANSIONE MARKETING SPA GUIDO BONAPACE
K120334 02/03/2012 VIVA EB ETVIEW LTD. YORAM LEVY
K123853 12/31/2012 VIVASIGHT-DL SYSTEM ETVIEW LTD. YORAM LEVY
K123687 12/03/2012 OPTETRAK LOGIC POROUS FEMORAL COMPONENT EXACTECH, INC. PATRICK HUGHES
K120452 02/14/2012 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN III
K120413 02/10/2012 SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K120304 02/01/2012 FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER FOOTPRINT MEDICAL INC. CLYDE BAKER
K123831 12/12/2012 OPHTACATH KIT FRANCE CHIRURGAE INSTRUMENTATION BARBARA S FANT
K124035 12/28/2012 2008K@HOME HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K120505 02/21/2012 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE DENISE OPPERMANN
K124024 12/28/2012 APD LUER-LOCK ADAPTER FRESENSIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K123701 12/03/2012 HEARLAB ACA FRYE ELECTRONICS, INC. KRISTINA FRYE
K120361 02/06/2012 SYNAPSE 3D BASE TOOLS FUJIFILM MEDICAL SYSTEMS USA, INC. DEBBIE PEACOCK
K120446 02/14/2012 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 FUJINON, INC. MARK JOB
K123612 12/20/2012 FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA FUJIREBIO DIAGNOSTICS, INC. KENT PRUETT
K123814 12/14/2012 HUMELOCK II CEMENTED SHOULDER SYSTEM FX SOLUTIONS JEAN-JACQUES MARTIN
K123865 12/17/2012 VISUAL-ICE CRYOABLATION SYSTEM GALIL MEDICAL INC. AMY MCKINNEY
K120333 02/03/2012 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY GAMBRO RENAL PRODUCTS FEI LAW
K120473 02/16/2012 PIXEL APP GAUSS SURGICAL, INC. PEGGY MCLAUGHLIN
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