FDA 510(k) Decisions During November, 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
K123015 11/21/2012 .DECIMAL PHOTON BLOCK .DECIMAL, INC. KYM RUPP
K122467 11/20/2012 3M TRUE DEFINITION SCANNER 3M COMPANY GINGER CANTOR
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
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
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
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
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
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
K121846 11/20/2012 CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE B. BRAUN MEDICAL, INC. NANCY SKOCYPEC
K121786 11/05/2012 DYMAXEON SPINE SYSTEM B2B SPINE PTY LTD JUSTIN EGGLETON
K122278 11/07/2012 BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR BAYLIS MEDICAL COMPANY INC. MEGHAL KHAKHAR
K122496 11/01/2012 AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM BIO-LOGIC SYSTEMS CORP. TIMOTHY KARLOVSKY
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
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
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
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
K122052 11/28/2012 MINIFIX BALL MINIFIX ONE BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC JUAN TEZAK
K123214 11/13/2012 ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. RACHEL OWENS
K122011 11/15/2012 NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP BRAINLAB AG ALEXANDER SCHWIERSCH
K122795 11/08/2012 STINGRAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
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
K120409 11/26/2012 PICCOLO COMPOSITE PLATE SYSTEM CARBOFIX ORTHOPEDICS LTD. YAEL RUBIN
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
K122938 11/02/2012 FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH CARL ZEISS MEDITEC AG JUDY BRIMACOMBE
K120560 11/06/2012 TRINITY WRINKLE REMOVER CAROL COLE COMPANY BOB DUFFY
K122488 11/20/2012 AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES CATHETER ROBOTICS INC JENNIFER ENGLUND
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
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
K121361 11/30/2012 CURALINE POLYURETHANE FOAM AWC DRESSING CURALINE INC HAITHAM MATLOUB
K122389 11/02/2012 TRUSCULPT CUTERA, INC. CONNIE HOY
K121346 11/27/2012 PICOSURE WORKSTATION CYNOSURE, INC. IRINA KULINETS
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
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
K123259 11/15/2012 MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM DEVICOR MEDICAL PRODUCTS, INC. SHAWNA M ROSE
K122420 11/28/2012 DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA DIAZYME LABORATORIES ABHIJIT DATTA
K120642 11/02/2012 RESUSCITAIRE WITH AUTOBREATH DRAEGER MEDICAL SYSTEMS, INC. GALE WINARSKY
K121093 11/27/2012 D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 DXM CO., LTD. JIGAR SHAH
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
K120862 11/27/2012 WATER BOTTLE CAP IRRIGATON SYSTEM ENDOCHOICE, INC. THERON GOBER
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
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
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
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
K122893 11/30/2012 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) GEENLI PLASTIC CO, LTD CHU XIAOAN
K121365 11/20/2012 THERMOFORMED MOUTHGUARDS GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP ARMIN ZEHTABCHI
K112877 11/07/2012 COMEN MULTI-PARAMETER PATIENT MONITOR GOLDWAY (US), INC. JIMMY WU
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
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
K121315 11/01/2012 STRYKER CMF MEDPOR CUSTOMIZED IMPLANT HOWMEDICA OSTEONICS CORP. STEPHANIE FULLARD
K120659 11/06/2012 HU-FRIEDY DENTAL CARTRIDGE SYRINGE HU-FRIEDY MFG. CO. LLC MARIA VRABIE
K122008 11/16/2012 INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE INCITE INNOVATION LLC JOHN KIRWAN
K122689 11/07/2012 INOBLENDER INO THERAPEUTICS ROBERT BOVY
K112599 11/06/2012 INSURGICAL SINGLE USE POWER EQUIPMENT INSURGICAL LLC DAVID C FURR
K121847 11/29/2012 TITAN INTERACOUSTICS A/S ERIK NIELSEN
K121026 11/02/2012 FLO-GUARD BREATHING FILTER INTERSURGICAL, INC. MICHAEL ZALEWSKI
K123229 11/20/2012 REMOTE PRESENCE SYSTEM, MODEL RP-VITA INTOUCH HEALTH, INC. STEVE SIDWELL
K122646 11/02/2012 DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T INVIVO CORPORATION LISA SIMPSON
K121475 11/28/2012 TXCELL SCANNING LASER DELIVERY SYSTEM IRIDEX CORP. PAUL H HARDIMAN
K121171 11/26/2012 CUROS TIP IVERA MEDICAL, INC. DON CANAL
K120711 11/19/2012 NON-CONTACT THERMOMETER K-JUMP HEALTH CO., LTD. JM LIN
K112396 11/02/2012 IUI CATHETERS KITAZATO MEDICAL CO., LTD. RICHARD VINCINS
K112462 11/26/2012 KITAZATO OPU NEEDLE KITAZATO MEDICAL CO., LTD. RICHARD VINCINS
K122860 11/14/2012 KLS MARTIN RECON TALON KLS MARTIN L.P. JENNIFER DAMATO
K123267 11/02/2012 SURFFLASH(R) PLUS SAFETY I.V. CATHETER KOFU FACTORY OF TERUMO CORP. SANDI HARTKA
K120066 11/16/2012 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL KOSSAN LATEX INDUSTRIES(M)SDN BHD CHO S FONG
K121151 11/16/2012 PRO-LINK CERVICAL SPACER SYSTEM LIFE SPINE, INC RANDY LEWIS
K123037 11/29/2012 LIGHTSCALPEL LIGHTSCALPEL LLC DAVID WALTERS
K112091 11/09/2012 H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K120617 11/19/2012 PTFE SUPER SHEATH INTRODUCER MARTECH MEDICAL PRODUCTS ALEXIS ERAZO
K120555 11/02/2012 LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) MEDICAL-LATEX (DUA) SDN. BHD UMA DEVI
K120909 11/02/2012 EC 2.7 ENDOSCOPIC CUTTER MEDTRONIC ADVANCED ENERGY, LLC MARTIN J LEIGHTON
K123246 11/16/2012 CD HORIZON SPIRE Z SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK JULIE BASSETT
K120787 11/27/2012 MERETE LOCKING BONE PLATE SYSTEM III MERETE MEDICAL GMBH DONNA COLEMAN
K123378 11/30/2012 SOLITAIRE 2 REVASCULARIZATION DEVICE MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR LARRY BOUCHER
K122526 11/16/2012 360 GAS ASSISTED ENDOSCOPIC APPLICATOR MICROMEDICS, INC. JODI L RAUS
K122762 11/30/2012 ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR MICROSULIS MEDICAL LIMITED STUART MCINTYRE
K123384 11/28/2012 AZUR CX DETACHABLE 18 MICROVENTION, INC. CYNTHIA VALENZUELA
K122543 11/28/2012 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MICROVENTION, INC. LARAINE PANGELINA
K122606 11/20/2012 PHT-6500; PHT-60CFO; PAX-I3D MTECH GROUP DAVE KIM
K122294 11/01/2012 PRESSURIZED INFUSION PUMP MUI SCIENTIFIC TAMMY MUI
K120479 11/08/2012 MTF FASCIA MUSCULOSKELETAL TRANSPLANT FOUNDATION RANDY PREBULA
K120466 11/06/2012 VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) NANOSPHERE, INC MARK DEL VECCHIO
K112735 11/02/2012 TAMARIN BLUE PTCA RX DILATATION CATHETER NATEC MEDICAL LTD E.J. SMITH
DEN100023 11/20/2012 AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES, DAVID WISE
K100934 11/20/2012 AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES, DAVID WISE
K120857 11/13/2012 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX NCONTACT SURGICAL, INC. JANE RICUPERO
K121816 11/26/2012 SENSUS ELECTRODE NEUROMETRIX, INC. RAINER MAAS
K121792 11/16/2012 NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. CHARLES MACK
K121891 11/09/2012 NEWPORT AURA VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. TOM COLONNA
K120888 11/09/2012 PSG-1100 SLEEP DIAGNOSTIC SYSTEM NIHON KOHDEN CORP. STEVE GEERDES
K112830 11/13/2012 ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) NONINVASIVE MEDICAL TECHNOLOGIES, INC. MARC O'GRIOFA
K122998 11/06/2012 BLUE POWDERED NITRILE EXAMINATION GLOVE NORTHSTAR HEALTHCARE HOLDINGS ANTHONY GIACCIO
K123026 11/16/2012 TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO NORTHSTAR HEALTHCARE HOLDINGS ANTHONY GIACCIO
K122429 11/28/2012 VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL OBJECT RESEARCH SYSTEMS (ORS) INC. ERIC F OURNIER
K113066 11/08/2012 CORVIS ST OCULUS OPTIKGERATE GMBH ECKHARD LOH
K122180 11/13/2012 HIGH FLOW INSUFFLANTION UNIT OLYMPUS MEDICAL SYSTEMS CORPORATION DAPHNEY GERMAIN-KOLAWOLE
K121927 11/29/2012 MICROSTREAM FILTERLINE ICU ORIDION MEDICAL 1987 LTD. DALIA GIVONY
K121953 11/21/2012 HEMASORB APPLY ORTHOCON, INC. RICHARD KRONENTHAL, PHD
K121649 11/29/2012 CONSTRUX MINI PEEK TI SPACER SYSTEM ORTHOFIX NATALIA VOLOSEN
K122171 11/16/2012 MS SA IMPLANT SYSTEM OSSTEM IMPLANT CO LTD PATRICK LIM
K121995 11/29/2012 TS FIXTURE SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K123207 11/29/2012 PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM OSTEOMED LP PIEDAD PENA
K113113 11/16/2012 ENDOSSEOUS DENTAL IMPLANT OT MEDICAL GMBH SABINE SCHMAHL
K122857 11/07/2012 HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 PEGASUS RESEARCH CORP. KENNETH MILLER
K122772 11/20/2012 PENUMBRA DDC CATHETERS PENUMBRA, INC. SETH SCHULMAN
K122495 11/28/2012 PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR PERKINELMER, INC. KAY A TAYLOR
K123035 11/28/2012 SEAL ONE PEROUSE MEDICAL CAROLINE DAURELLE
K121725 11/07/2012 PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K121566 11/29/2012 PLANER BT37 INCUBATOR PLANER PLC ERIC GRUFF
K121963 11/21/2012 PLANMED NUANCE DIGIGUIDE PLANMED OY LARS MORING
K121977 11/20/2012 PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM PLASMA SURGICAL LIMITED PETER GIBSON
K121559 11/30/2012 HYLATOPICPLUS LOTION PRECISION DERMATOLOGY INCORPORATED RONALD M GURGE
K122729 11/16/2012 ABL90 FLEX RADIOMETER MEDICAL APS MARTIN GABLER
K120326 11/21/2012 AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE RADIOMETER MEDICAL APS OLE SCHOU
K121603 11/20/2012 RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K122122 11/09/2012 REGEN SPRAY APPLICATOR, REGEN LAB SA GUY FORTIER
K120904 11/26/2012 POLARIS DIAL-A-DATE CONTACT LENS CASE RELIANCE DESIGN & MANUFACTURE CORP. CAROLINE TONTINI
K122324 11/13/2012 VPAP S-A RESMED LTD. JIM CASSI
K122686 11/16/2012 ACCU-CHEK ULTRAFLEX INFUSION SET ROCHE DIABETES CARE AG CATHERINE GREEN
K122722 11/29/2012 COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 ROCHE DIAGNOSTICS LISA K KLINEDINST
K121763 11/27/2012 MULTICROSS SUPPORT CATHETER ROXWOOD MEDICAL, INC. MEHRDAD FARHANGNIA
K123182 11/05/2012 OSOM INFLUENZA A&B TEST MODEL 190 SEKISUI DIAGNOSTICS, LLC MARK STAVRO
K113225 11/06/2012 NYLUS PICC SEMPRUS BIOSCIENCES NANDINI MURTHY
K103542 11/30/2012 GENSTRIP TEST STRIP MODEL 100-201 SHASTA TECHNOLOGIES, LLC CAROLINE TONTINI
K121811 11/21/2012 POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES SHEN WEI (USA), INC. ALBERT LI
K120217 11/21/2012 SONICSTIMU COMBO THERAPEUTIC DEVICE SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. KANG JIAN PING
K123185 11/02/2012 DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD ZHAI PEI
K123119 11/28/2012 CERARESIN BOND SHOFU DENTAL CORPORATION DAVID P MORAIS
K123375 11/20/2012 SYNGO.VIA SIEMENS AG SABINE SCHROEDEL
K121994 11/30/2012 DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR SIEMENS HEALTHCARE DIAGNOSTICS INC. A. KATHLEEN B ENNIS
K121434 11/05/2012 SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO SIEMENS MEDICAL SOLUTIONS, INC. MICHELLE L BYRNE
K121814 11/07/2012 ENCORE TONGUE SUSPENSION SYSTEM SIESTA MEDICAL, INC. MICHAEL KOLBER
K121321 11/30/2012 HARD SHELL VENTED NASAL MASK SLEEPNET CORPORATION PAUL DRYDEN
K121692 11/05/2012 MINIME 2 NASAL MASK SLEEPNET CORPORATION PAUL DRYDEN
K122596 11/20/2012 ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS SMITH & NEPHEW, INC. SEAN REYNOLDS
K121216 11/21/2012 STR GRAFT SOFT TISSUE REGENERATION, INC. ROBERT A POGGIE
K122738 11/07/2012 GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET SOLANA SURGICAL LLC REBECCA WAHL
K122931 11/20/2012 S-LOK PSS SYSTEM SPINAL USA J.D. WEBB
K122161 11/28/2012 SJM CONFIRM ST. JUDE MEDICAL SAKET BHATT
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