FDA 510(k) Decisions During January, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K121878 11/02/2012 CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES MEDTRONIC INC. KARI CHRISTIANSON
K113380 11/15/2012 PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR MEDTRONIC INC. THOMAS REICHEL
K113845 01/25/2012 TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE MEDTRONIC INC. KEVIN T LAM
K123015 11/21/2012 .DECIMAL PHOTON BLOCK .DECIMAL, INC. KYM RUPP
K122467 11/20/2012 3M TRUE DEFINITION SCANNER 3M COMPANY GINGER CANTOR
K120011 01/13/2012 HEISENBERG EFFECT SHADES 3M ESPE AG DESI W SOEGIARTO
K112852 01/13/2012 BABI PLUS NEONATAL RESUSCITATION BAG A PLUS MEDICAL THOMAS C LOESCHER
K112143 01/31/2012 AUDIT MICROCV T-UPTAKE LINEARITY AALTO SCIENTIFIC LTD. DESSI LYAKOV
K112705 01/24/2012 AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL AALTO SCIENTIFIC LTD. DESSI LYAKOV
K113601 11/08/2012 AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM AAP IMPLANTATE AG MARC SEEGERS
K121494 11/19/2012 LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING AAP IMPLANTATE AG MARC SEEGERS
K123379 11/27/2012 ABBOTT ARCHITECT FREE T4 ABBOTT LABORATORIES JACEK GORZOWSKI
K122573 11/20/2012 HI-TORQUE COMMAND GUIDE WIRE FAMILY ABBOTT VASCULAR INC. KAY SETZER
K111381 01/13/2012 MEDI-SIS SYRINGE INFUSION SYSTEM ACACIA, INC. FERGIE FERGUSON
K120280 11/05/2012 RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM ACCLARENT, INC. DAN HARFE
K122110 11/21/2012 ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K111221 01/18/2012 MISSION U500 URINE ANALYZER ACON LABORATORIES, INC. QIYI XIE
K122538 11/19/2012 ACUMED PELVIC BONE PLATE SYSTEM ACUMED LLC KARA BUDOR
K113315 11/20/2012 RUMBLE TUFF ACUTE IDEAS CO. LTD. MATTHEW KHO
K113318 01/12/2012 ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM ACUTE INNOVATIONS LLC MARIAH KNIGHT
K112514 01/09/2012 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K120075 01/26/2012 AM-6000 ANESTHESIA MACHINE ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K111407 01/18/2012 TRIPORT, TRIPORT+, TRIPORT15, QUADPORT ADVANCED SURGICAL CONCEPTS JONATHAN S KAHAN
K120350 11/01/2012 EXTENDED LIFE BATTERY AED BATTERY EXCHANGE, LLC KEITH HOCHHALTER
K122333 11/19/2012 MOBILECARE MONITOR AFRAME DIGITAL, INC. JILL THORPE
K121712 11/20/2012 AIRSTRIP RPM FOR LIFENET CONSULT AIRSTRIP TECHNOLOGIES, INC. ROBERT A MILLER
K122350 11/01/2012 TAP PAP NASAL PILLOW MASK AIRWAY MANAGEMENT, INC. PAUL DRYDEN
K121662 11/21/2012 VECTTOR VT-200 ALAN NEUROMEDICAL TECHNOLOGIES LLC DONALD A RHODES
K122356 11/19/2012 ALIVECOR HEART MONITOR FOR IPHONE ALIVECOR, INC. MICHAEL RIGHTER
K113124 11/09/2012 ALN OPTIONAL VANA CAVA FILTER ALN IMPLANTS CHIRURGICAUX CYNTHIA COTTEREAU
K123218 11/28/2012 ILLICO FS FACET FIXATION SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K111634 01/25/2012 XENON(TM) PEDICLE SCREW SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K112811 01/11/2012 SANICLAVE 200 ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT ISAAC ERICKSON
K113555 01/30/2012 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE AM USA KAREN THOMISON
K112044 01/26/2012 ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A ANAXDENT GMBH JOHN BALISTRERI
K110017 01/18/2012 AG-608N BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. YI LIU
K112046 01/06/2012 MTA ANGELUS ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LINDA K SCHULZ
K112600 01/30/2012 ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K113800 01/20/2012 QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE ANGIOTECH KIRSTEN STOWELL
K121354 11/09/2012 MICRO/MINI N-PK(F) BONE ANCHOR ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K121356 11/09/2012 MICRO/MINI N-PK(H) BONE ANCHOR ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K113098 01/17/2012 AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K113208 01/26/2012 GAL-1A BLOOD GLUCOSE MONITORING SYSTEM APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K121501 11/29/2012 ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K123268 11/07/2012 SMARTSTITCH PERFECTPASSER SYSTEM ARTHOCARE CORPORATION CHERYL FREDERICK
K122334 11/28/2012 CHECKMATE SMALL BONE FUSION SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K122129 11/16/2012 SPHYGMOCOR XCEL ATCOR MEDICAL JOHN ABRAM
K121793 11/01/2012 AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON AUDIFON-USA INC. JANE E PERRONE
K122380 11/07/2012 OCELOT SYSTEM AVINGER, INC. ALBERT BONISKE
K112825 01/18/2012 AVITA ARM TYPE BLOOD PRESSURE MONITOR AVITA CORPORATION JENNIFER REICH
K110559 01/06/2012 AVITA INFRARED THEROMETER WITH BLUETOOTH AVITA CORPORATION JENNIFER REICH
K121846 11/20/2012 CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE B. BRAUN MEDICAL, INC. NANCY SKOCYPEC
K113059 01/24/2012 CONTIPLEX FX B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K121786 11/05/2012 DYMAXEON SPINE SYSTEM B2B SPINE PTY LTD JUSTIN EGGLETON
K112454 01/05/2012 HALO60 ABLATION CATHETER BARRX MEDICAL, INC. DAWN CHANG
K111877 01/24/2012 EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION BAUSCH & LOMB, INC. HEATHER MICHAELS
K122278 11/07/2012 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K112333 01/30/2012 LRT ATTACHMENT BCF CERTIFICATION INC. LOUIS-PAUL MARIN
K111494 01/18/2012 HANDHELD PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. SUNNY WANG
K100437 01/12/2012 AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION BESTGEN BIOTECH CORP. STEVEN SHEN
K122496 11/01/2012 AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM BIO-LOGIC SYSTEMS CORP. TIMOTHY KARLOVSKY
K112258 01/09/2012 NEUROTECH PLUS BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K112934 01/20/2012 NEUROTECH RECOVERY BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K122187 11/06/2012 VRESELECT CULTURE MEDIUM BIO-RAD FRAN WHITE
K123021 11/02/2012 BIOPLEX 2200 EBV IGM KIT BIO-RAD LABORATORIES JUANG WANG
K123198 11/20/2012 LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA BIO-RAD LABORATORIES SUZANNE PARSONS
K113858 01/24/2012 MEGABEAM ENDO-ENT PROBE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113792 01/19/2012 MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K113709 01/20/2012 MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K112013 01/13/2012 EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER BIOLITEC, INC. HARRY HAYES
K121100 11/19/2012 VITEK 2 AST STREPTOCOCUS VANCOMYCIN BIOMERIEUX, INC. JOCELYN JENNINGS
K121546 11/20/2012 VITEK 2 GRAM NEGATIVE DOXYCYCLINE BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K112730 01/13/2012 ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION BIOMET 3I MAYANK CHOUDHARY
K113645 01/20/2012 REGENEROSS ALLOGRAFT PLUS MINERLIZED BIOMET INTERPORE CROSS KATHLEEN OLIVARES
K113069 01/11/2012 COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY BIOMET MANUFACTURING CORP. PATRICIA S BERES
K121874 11/23/2012 G7 ACETABULAR SYSTEM BIOMET MANUFACTURING CORP. BECKY EARL
K123297 11/20/2012 COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM BIOMET MANUFACTUTING CORP. PATRICIA BERES
K113764 01/30/2012 GLUCOSE METER-CHECK SOLUTION FOR INFOPIA BIONOSTICS, INC. RANDY BYRD
K122443 11/20/2012 UFIT TEN-10 BIOSIGN TECHNOLOGIES, INC. ALLISON SCOTT, RAC
K121936 11/30/2012 NAVIOPFS BLUE BELT TECHNOLOGIES, INC. RICHARD G CONFER
K112875 01/27/2012 BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS BLUE SKY BIO, LLC MICHELE VOVOLKA
K122052 11/28/2012 MINIFIX BALL MINIFIX ONE BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC JUAN TEZAK
K113681 01/11/2012 GLADIATOR PTA BALLOON DILATION CATHETER BOSTON SCIENTIFIC AMBER JOHNSON
K123214 11/13/2012 ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. RACHEL OWENS
K113101 01/17/2012 EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL BOSTON SCIENTIFIC CORPORATION SUSAN EICHLER-HUSTON
K113651 01/11/2012 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORPORATION HARLAN JONES
K112233 01/27/2012 BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE BOVIE MEDICAL CORPORATION RICHARD A KOZLOFF
K122011 11/15/2012 NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP BRAINLAB AG ALEXANDER SCHWIERSCH
K113589 01/04/2012 BIGBOSS CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K122795 11/08/2012 STINGRAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K110305 01/13/2012 CRY-ACTRACKERCAM BRYMILL CRYOGENIC CYSTEMS CLAUDIO RUSSO
K123179 11/02/2012 AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING C.R. BARD, INC. MICHELE DAVIS
K122367 11/02/2012 BARD PTV DILATATION CATHETER C.R. BARD, INC. ERIN FOX
K122436 11/02/2012 COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM C.R. BARD, INC. KETI SINO
K122899 11/15/2012 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT C.R. BARD, INC. AMY HONEY
K102383 01/27/2012 MICRODOT & MICRODOT XTRA CAMBRIDGE SENSORS LIMITED BERNADETTE YON-HIN
K120409 11/26/2012 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
K112918 01/20/2012 DURABLUE STERILIZATION (AMSCO V-PRO) WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K122699 11/19/2012 SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K123020 11/28/2012 BLIP MODEL BP-700WF CAREMATIX INC. SUKHWANT KHANUJA
K113480 01/20/2012 SPECTRA OPTIA APHERESIS SYSTEM CARIDIANBCT, INC. TINA O'BRIEN
K122938 11/02/2012 FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH CARL ZEISS MEDITEC AG JUDY BRIMACOMBE
K111157 01/19/2012 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, OPTIC DISC, MACULAR, GANGLION CELL AND ASIAN NORMATIVE DATABASES CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K120560 11/06/2012 TRINITY WRINKLE REMOVER CAROL COLE COMPANY BOB DUFFY
K112820 01/26/2012 FORE-SIGHT ABSOLUTE TISSUE OXIMETER CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K112904 01/24/2012 STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K113842 01/27/2012 CATHETER CONNECTIONS' DUALCAP SOLO CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K122488 11/20/2012 AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES CATHETER ROBOTICS INC JENNIFER ENGLUND
K112814 01/17/2012 CUFFINK CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K112960 01/09/2012 LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K113497 01/17/2012 HYPERION CEFLA S.C. CEFLA DENTAL GROUP MARISA TESTA
K121539 11/02/2012 XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) CEPHEID KERRY J FLOM
K122561 11/27/2012 ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN CEREMED, INC. CHELSEA MITCHELL
K123080 11/29/2012 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS CHEMTRON BIOTECH, INC. JANE ZHANG
K103695 01/10/2012 PREPEX SYSTEM CIRC MEDTECH SHOSHANA FRIEDMAN
K113132 01/20/2012 DISPOSABLE HEMOSTATIC Y-CONNECTORS COEUR, INC. DEBRA F MANNING
K122115 11/01/2012 COLLAGEN DENTAL WOUND DRESSINGS COLLAGEN MATRIX, INC. PEGGY HANSEN
K121562 11/05/2012 ALTIS SINGLE INCISION CLING SYSTEM COLOPLAST A/S JANELL A COLLEY
K122440 11/19/2012 RESTORELLE L COLOPLAST CORP. TIM CRABTREE
K122581 11/21/2012 MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 CONCENTRIC MEDICAL, INC. CHRISTINA ROWE
K122512 11/05/2012 CS2 HIP SYSTEM CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K121791 11/19/2012 ZOU ANTERIOR LUMBAR PLATE SYSTEM CORELINK LLC JUSTIN EGGLETON
K122305 11/21/2012 CORIN TRINITY-I ACETABULAR SHELL CORIN USA DIANA L MARTONE
K113351 01/10/2012 CORTRAK ENTERAL ACCESS DEVICE CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K113187 01/04/2012 AVIVO MOBILE PATIENT MANAGEMENT CORVENTIS, INC. KATHLEEN LUNDBERG
K110581 01/10/2012 PROPATCH SOFT TISSUE REPAIR MATRIX CRYOLIFE, INC. BRYAN BROSSEAU
K121361 11/30/2012 CURALINE POLYURETHANE FOAM AWC DRESSING CURALINE INC HAITHAM MATLOUB
K122389 11/02/2012 TRUSCULPT CUTERA, INC. CONNIE HOY
K102541 01/26/2012 CYNOSURE CELLULAZE LASER CYNOSURE, INC. GEORGE CHO
K121346 11/27/2012 PICOSURE WORKSTATION CYNOSURE, INC. IRINA KULINETS
K113106 01/04/2012 DNE EXTERNAL FIXATION SYSTEM D.N.E., LLC J.D. WEBB
K112441 01/17/2012 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM DAESUNG MAREF CO., LTD. DANIEL NAM
K112677 01/13/2012 THE VENOUS ASSIST SYSTEM DAESUNG MAREF CO., LTD. DANIEL NAM
K122405 11/09/2012 AIR-BAND RADIAL COMPRESSION DEVICE DATASCOPE CORP., CARDIAC ASSIST DIVISION CARLA S CERQUEIRA
K113316 11/08/2012 DCS LACRIMAL STENT DCS SURGICAL INC HARRY ROSS
K113301 01/23/2012 CONCENPIECE,HIGH-SPEED HANDPIECE SERIES DENTALEZ, INC. JIM WATKINS
K112045 01/26/2012 SIMPLELINE II ABUTMENT SYSTEM DENTIUM CO., LTD. JONGHYUN CHOI
K111162 01/13/2012 SLIM ONEBODY SYSTEM DENTIUM CO., LTD. EUNKYUNG SON
K122425 11/05/2012 VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYOI FUJIMAKI
K112417 01/13/2012 VARIOUS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K123259 11/15/2012 MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM DEVICOR MEDICAL PRODUCTS, INC. SHAWNA M ROSE
K112725 01/20/2012 LIAISON 25 OH VITAMIN D TOTAL ASSAY DIASORIN, INC. JUDI SMITH
K122420 11/28/2012 DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA DIAZYME LABORATORIES ABHIJIT DATTA
K112189 01/13/2012 THERMO PAL INFRARED EAR THERMOMETER DIGIO2 INTERNATIONAL CO., LTD. JENNIFER REICH
K110888 01/12/2012 ABSOLUTE WHITE LIGHT DR. FRESH, INC. M. JOYCE HEINRICH
K120642 11/02/2012 RESUSCITAIRE WITH AUTOBREATH DRAEGER MEDICAL SYSTEMS, INC. GALE WINARSKY
K112868 01/19/2012 DREAMGARD REM-SOFT, DREAMGARD REM-LITE, DREAMGARD REM-ULTRA, DREAMGARD REM-MAX DREAMGARD, INC. SUZAN ONEL
K121093 11/27/2012 D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 DXM CO., LTD. JIGAR SHAH
K112429 01/26/2012 GIZA(R) VERTEBRAL BODY REPLACEMENT EDEN SPINE, LLC RICH JANSEN
K113667 01/12/2012 CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC. KAREN JONES
K112319 01/27/2012 ELECTRO-CAP SYSTEM ELECTRO-CAP INTL., INC. AMY B SWALLOWS
K111717 01/05/2012 ELECTRO-GEL ELECTRO-CAP INTL., INC. AMY B SWALLOWS
K111332 01/30/2012 CLARITY OBP SYSTEM ELEKTA LTD. GEORGE PAPAGIANNIS
K111730 01/06/2012 SONOTT FLOWLAB(R) EM-TEC GMBH BERNHARD BRAND
K122580 11/09/2012 AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES ENCISION, INC. JIM LEWIS
K122636 11/02/2012 REVELATION POROUS COATED HIP STEM, SIZE 8 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K112576 01/25/2012 ENDOCHOICE WATER BOTTLE CAP SYSTEM ENDOCHOICE, INC. THERON GOBER
K120862 11/27/2012 WATER BOTTLE CAP IRRIGATON SYSTEM ENDOCHOICE, INC. THERON GOBER
K113522 01/27/2012 PATHASSIST LIGHT SEEKER ENTELLUS MEDICAL, INC. GARRETT P AHLBORG
K113344 11/16/2012 STEREOS WORKSTATION EOS IMAGING JOHN J SMITH
K121220 11/20/2012 EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT EXACTECH, INC. LINDY KNISELY
K113609 01/04/2012 NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 EXACTECH, INC. VLADISLAVA ZAITSEVA
K121989 11/27/2012 OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, EXACTECH, INC. GINA CASSIDY
K121857 11/15/2012 FEMMYCYCLE FEMCAP INCORPORATED ALBERT REGO
K122154 11/21/2012 POWERPLAY MUSCLE MASSAGER FIG, LLC JOE ADKINS
DEN120008 01/20/2012 STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K112394 01/20/2012 STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K121599 11/09/2012 CRIT-LINE CLIP (CLIC) FRESENIUS MEDICAL CARE-NORTH AMERICA DENISE OPPERMANN
K112700 11/01/2012 FRONTIER SADL INTERBODY FUSION DEVICE FRONTIER MEDICAL DEVICES, INC. RICH JANSEN
K122454 11/20/2012 FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K121499 11/20/2012 FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC. KATHERINE Y CHOI
K123174 11/16/2012 CENTRICITY PACS-IW WITH UNIVERSAL VIEWER GE HEALTHCARE CHERYL BORK
K121200 11/02/2012 FLIGHTPLAN FOR LIVER GE HEALTHCARE CAROL ALLOIAN
K113758 01/10/2012 VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE BRYAN BEHN
K122174 11/16/2012 PEDIATRIC POSITIONER PAD SET GE HEALTHCARE COILS (USA INSTRUMENTS INC.) MICHELLE HUETTNER
K123068 11/13/2012 OPTIMA MR 430S GE MEDICAL SYSTEMS, LLC YUAN MA
K113490 01/13/2012 OPTIMA MR450W GE MEDICAL SYSTEMS, LLC ROBIN MARTIN
K122893 11/30/2012 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) GEENLI PLASTIC CO, LTD CHU XIAOAN
K112716 01/17/2012 OSTEON II GENOSS CO., LTD. SUNGWON LEE
K121365 11/20/2012 THERMOFORMED MOUTHGUARDS GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP ARMIN ZEHTABCHI
K113447 01/26/2012 RISE SPACER GLOBUS MEDICAL, INC. KELLY J BAKER
K112060 01/06/2012 RADIANCE GMV AEROSPACE AND DEFENCE S.A. WILLIAM GREENROSE
K112877 11/07/2012 COMEN MULTI-PARAMETER PATIENT MONITOR GOLDWAY (US), INC. JIMMY WU
K112804 01/27/2012 FINGERTIP PULSE OXIMETER GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K122904 11/15/2012 WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K121858 11/05/2012 THE ABLATION SYSTEM HALT MEDICAL INC. CLARISA TATE
K110480 01/13/2012 PDE PHOTODYNAMIC EYE HAMAMATSU PHOTONICS, K.K. JEFFREY K SHAPIRO
K121225 11/16/2012 HAMILTON-C2 HAMILTON MEDICAL AG RALPH AGUILA
K122912 11/07/2012 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., AHNEO YANG
K113728 11/15/2012 SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY HANS BIOMED CORP. PATSY J TRISLER
K121757 11/20/2012 HEALTHMATEFOREVER HEALTHMATE INTERNATIONAL, LLC MEI DODSON
K122920 11/30/2012 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) HEBEI LEADER PLASTIC CO., LTD CHU XIAOAN
K122886 11/15/2012 NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING HEMOSTASIS, LLC BERNARD HORWATH
K121085 11/20/2012 HET BIPOLAR LIGATOR SYSTEM HET SYSTEMS, LLC SHELLEY TRIMM
K113314 11/09/2012 PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM HMD BIOMEDICAL, INC. WANG YUNHAN
K112858 01/24/2012 GENESIS TOUCH SYSTEM HONEYWELL HOMMED, LLC CLAUDIA JACKSON
K113683 01/12/2012 LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL HOSPIRA,INC. KAREN KEENER
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