FDA 510(k) Decisions During December, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132967 12/06/2013 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP 3B MEDICAL, INC ALEX LUCIO
K131901 12/23/2013 IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 3B MEDICAL, INC ALEX LUCIO
K132787 12/24/2013 LOQTEQ DISTAL DORSOLATERAL HUMERUS PLATE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K132511 12/24/2013 FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM ABBOTT DIABETES CARE INC. VRUSAHLI TEMBE
K132086 12/19/2013 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K130284 12/20/2013 ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K130329 12/03/2013 SURGISEAL TOPICAL SKIN ADHESIVE ADHEZION BIOMEDICAL, LLC CARIDAD SMITH
K132243 12/20/2013 BARLE TISSUE ADHESIVE 2 ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD KAY MCGRATH
K133081 12/31/2013 TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N ADVANCED ORTHOPAEDIC SOLUTIONS, INC. KAZUNORI MIYAHARA
K132082 12/05/2013 AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK AESKU.DIAGNOSTICS SASCHA PFEIFFER
K122162 12/20/2013 AGGREGUIDE AGGREDYNE, INC. J. HARBEY KNAUSS
K123861 12/12/2013 AIDI DENTAL IMPLANT SYSTEM AIDI BIOMEDICAL LLC CHEN TIAN
K133079 12/17/2013 IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) ALDEN OPTICAL LABS., INC. KEVIN RANDALL
K133411 12/05/2013 ALERE BINAXNOW INFLUENZA A & B CARD ALERE SCARBOROUGH, INC D/B/A BINAX, INC. ANGELA DRYSDALE
K133637 12/18/2013 ALERE INFLUENZA A & B TEST ALERE SCARBOROUGH, INC D/B/A BINAX, INC. ANGELA DRYSDALE
K131229 12/05/2013 SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS AMERICAN MEDICAL SYSTEMS TODD HILDEBRANDT
K133561 12/19/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH ANGIODYNAMICS, INC. LORRAINE M HANLEY
K133043 12/06/2013 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD CLAY ANSELMO
K131766 12/12/2013 PLATINUM DRF IMAGING SYSTEM APELEM-DMS GROUP SHARYN ORTON
K132342 12/20/2013 XVWEB APTERYX, INC. KEVIN CRUCS
K133342 12/17/2013 ARTHREX IBALANCE TKA SYSTEM ARTHREX, INC. MARIELA CABARCAS
K132896 12/02/2013 CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE ASIA-MED GMBH AND CO KG KEVIN WALLS
K121177 12/05/2013 BOND APATITE AUGMA BIOMATERIALS, LTD. KEVIN A THOMAS
K123474 12/03/2013 AVANT LASER AVANT WELLNESS SYSTEMS, LLC ANDY HEWITSON
K123248 12/10/2013 CPR RSQ ASSIST AVANTECH, INC. STEVEN B DATLOF
K121873 12/11/2013 AVINENT DENTAL IMPLANT SYSTEM AVINENT IMPLANT SYSTEM, S.L. ANNA CORTINA
K132310 12/23/2013 ASCOT BACKROADS CONSULTING, INC. KAREN E WARDEN, PHD
K133569 12/20/2013 TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM BARD PERIPHERAL VASCULAR, INC. TIFFINI DIAGE
K132481 12/27/2013 EASY-LOAD LENS DELIVERY SYSTEM BAUSCH & LOMB JASON SMITH
K132715 12/20/2013 BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS BAUSCH & LOMB INCORPORATED JENNIFER KNICLEY
K132674 12/27/2013 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML) BECTON, DICKINSON AND COMPANY MONICA E GIGUERE
K132120 12/12/2013 WTF SECURA SYRINGE AND NEEDLE BEIJING WANTEFU MEDICAL APPARATUS CO., LTD. RAYMOND SUN
K132688 12/16/2013 SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ BIOCHEMICAL DIAGNOSTICS, INC. ALLEN PANETZ
K132400 12/19/2013 LP(A) CALIBRATORS, AND LP(A) CONTROLS BIOKIT S.A. JOAN GUIXER
K132873 12/11/2013 VANGUARD XP KNEE SYSTEM BIOMET, INC. JULIE GANTENBERG, M.S.
K131510 12/20/2013 POLYDIMETHYLSILOXANE IMPRESSION MATERIAL BLACKWELL DEVICE CONSULTING ANGELA BLACKWELL
K132253 12/16/2013 REMOVABLE PATIENT LEADS ECG CABLE BOSTON SCIENTIFIC MELISSA KLAMERUS
K133566 12/20/2013 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS BOSTON SCIENTIFIC CORP. MAYLIN TRUESDELL
K130004 12/06/2013 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORPORATION JANIS TARANTO
K132441 12/13/2013 BARD VENTRALEX HERNIA PATCH C.R. BARD, INC. MARIYA BUHARIN
K132134 12/02/2013 OPTIFIX ABSORBABLE FIXATION SYSTEM C.R. BARD, INC. RADHIKA PONDICHERRY
K133283 12/26/2013 CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS CANDELA CORP. SAM WADE
K132708 12/20/2013 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K132060 12/13/2013 DURABLUE STERILIZATION WRAP CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES LAVENIA FORD
K130208 12/20/2013 BERNOULLI ENTERPRISE SOFTWARE CARDIOPULMONARY CORP. UREY KANG
K132867 12/30/2013 SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 2.2MM CAYENNE MEDICAL, INC. SHIMA HASHEMIAN
K132963 12/16/2013 FUSIONSYNC, CHIMAERA FUSIONSYNC CHIMAERA GMBH MARCUS PRUEMMER
K130439 12/12/2013 EXTERNAL COUNTERPULSATION DEVICE WITH SP02 MORNITORING CHONGQING PSK SCI-TECH DEVELOPMENT CO., LTD FIELD FU
K132463 12/03/2013 CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM CIANNA MEDICAL, INC. GARY MOCNIK
K133029 12/06/2013 ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE COMPRESSION WORKS, LLC MICHAEL FORSTADT
K132640 12/05/2013 IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA SHAH
K131765 12/20/2013 ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM CONMED CORPORATION LISA ANDERSON
K130652 12/17/2013 VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT CONSENSUS ORTHOPEDICS, INC. MATTHEW HULL
K133634 12/23/2013 SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET COOK, INC. SEAN SPENCE
K133627 12/23/2013 AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS COOPERVISION, INC. ANNETTE NELSON
K132994 12/05/2013 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM CORELINK LLC J.D. WEBB
K131952 12/16/2013 CORIN METAFIX HIP STEM CORIN USA LUCINDA GERBER
K131986 12/16/2013 CORIN MINIHIP STEM CORIN USA LUCINDA GERBER
K132604 12/04/2013 VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM COVIDIEN KELSEY LEE
K133338 12/20/2013 LIGASURE 5 MM MARYLAND JAW SEALER/DIVIDER ONE-STEP SEALING (LF 17XX) COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE DONALD HENTON
K132242 12/06/2013 INNO SLA SUBMERGED IMPLANT SYSTEM COWELLMEDI CO., LTD SUSAN PARK
K133372 12/06/2013 CROSSTREES PVA POD CROSSTREES MEDICAL, INC. JANICE HOGAN
K131702 12/06/2013 K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. AMY MCKINNEY
K132500 12/23/2013 CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED CURE MEDICAL LLC. JOHN BEASLEY
K133367 12/20/2013 ORTHOVIS PREOPERATIVE PLAN CUSTOM ORTHOPAEDIC SOLUTIONS JUSTIN BAKER
K132185 12/06/2013 FAMILY OF COOLGLIDE AESTHETIC LASERS CUTERA, INC. SANDRA HANSEN
K130861 12/09/2013 MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK) DAKO NORTH AMERICA, INC. JENNIFER M CHAMBERS
K132875 12/30/2013 COMPRESSYN STAPLE DALLEN MEDICAL, INC. AL MEMMOLO
K133074 12/12/2013 MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES DATASCOPE CORP. LINDA SLUTZKY
K132530 12/20/2013 GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2) DATEX-OHMEDA, INC. JAMES P RASKOB
K123209 12/19/2013 SOFTVUE DELPHINUS MEDICAL TECHNOLOGIES, INC ANDREA N WALLEN
K132308 12/30/2013 CLIQ DV-300 ASPIRATOR DING HWA CO., LTD. ROBERT O DEAN
K131823 12/09/2013 PROPRIETARY / DONGTAI/ OTHER CLIENTS PRIVATE LABELING DONG TAI CITY HUAYI GLOVES CO., LTD. CHU XIAOAN
K123030 12/19/2013 COMPRESSOR NEBULIZER MODEL MCN-S600XX DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT CO., LTD. LEON LU
K132445 12/06/2013 PIEZON 250 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA NOLTE
K131379 12/18/2013 EARLYSENSE EARLYSENSE LTD. DALIA ARGAMAN
K131095 12/05/2013 DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K132794 12/19/2013 SMARTVEST AIRWAY CLEARANCE SYSTEM ELECTROMED, INC. CHET SIEVERT
K133289 12/09/2013 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCINTYRE
K132776 12/20/2013 SEAL BIOPSY VALVE - REUSABLE ENDOCHOICE, INC. DANIEL HOEFER
K132754 12/12/2013 NEOGEN PSR SYSTEM ENERGIST, LTD. DARREN THOMAS
DEN130022 12/13/2013 NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR ENEURA THERAPEUTICS LARRY GETLIN
K130556 12/13/2013 NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR ENEURA THERAPEUTICS LARRY GETLIN
K133425 12/05/2013 SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT ENGINEERED MEDICAL SOLUTIONS CO. LLC. RYAN SAVAGE
K133563 12/20/2013 PATHASSIST LIGHT SEEKER ENTELLUS MEDICAL, INC. GARRETT P AHLBORG
K132202 12/06/2013 DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET ENTHERMICS MEDICAL SYSTEMS, INC. ADAM VAN ESSEN
K133180 12/11/2013 ERBE ESU MODEL VIO DV WITH ACCESSORIES ERBE USA, INC. JOHN TARTAL
K132340 12/17/2013 ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP HYBRID CO2 TUBING/CAP SET FOR OLYMPUS 160/1 ERBE USA, INC. JOHN TARTAL
K133490 12/30/2013 G-SCAN BRIO ESAOTE S.P.A. ALLISON S COTT
K132466 12/04/2013 MYLABSEVEN 6400, MYLABALPHA 7400 ESAOTE S.P.A. ALLISON SCOTT
K131996 12/13/2013 S-SCAN ESAOTE, S.P.A. ALLISON SCOTT, RAC
K124064 12/19/2013 YOUNG AGAIN ESPANSIONE MARKETING SPA GUIDO BONAPACE
K132522 12/16/2013 HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE ETHICON ENDO-SURGERY, LLC DAVID LOCKE
K133314 12/03/2013 HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY ETHICON ENDO-SURGERY, LLC BRIAN GODWIN
K133356 12/06/2013 PROLENE POLYPROPYLENE NONABSORBABLE SUTURE ETHICON, INC. ELLIOTT JANG
K130975 12/24/2013 SWABCAP AND SWABFLUSH EXCELSIOR MEDICAL CORP. MICHAEL HEYL
K130375 12/04/2013 SELF-RETAINING BICANALICULUS INTUBATON SET II FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) BARBARA S FANT
K131957 12/04/2013 MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT FISHER & PAYKEL HEALTHCARE, LTD. ELIZABETH GOLDSTEIN
K123728 12/11/2013 RETRIEVAL BAG FLEXBAR MACHINE CORP. STEPHEN T MLCOCH
K122932 12/23/2013 SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT FOGLESS INTERNATIONAL AB JASON WALTON
K133454 12/16/2013 SONOSITE EDGE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. PATRICIA LIAU
K130788 12/05/2013 CAPELLA FUTURE MOBILITY HEALTHCARE INC. ABDULSAMAD PANCHBHAYA
K133431 12/24/2013 VENUE 50 GE HEALTHCARE BRYAN BEHN
K132533 12/04/2013 CARESCAPE MONITOR B450 GE HEALTHCARE FINLAND OY JOEL KENT
K132437 12/04/2013 MARS HOLTER ANALYSIS WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. KRISTIN PABST
K133605 12/20/2013 BD MAX MRSA XT, BD MAX INSTRUMENT GENEOHM SCIENCES CANADA, INC. PATRICIA DIONNE
K130317 12/11/2013 GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM GENESYS SPINE WILLIAM W SOWERS
K130913 12/13/2013 GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM GENESYS SPINE WILLIAM W SOWERS
K130082 12/20/2013 GENPRIME DRUGS OF ABUSE READER SYSTEM GENPRIME, INC MAUREEN GARNER
K132559 12/30/2013 MONUMENT SPACERS GLOBUS MEDICAL INC. CHRISTINA KICHULA
K130977 12/24/2013 SIGNIFY BIOACTIVE GLOBUS MEDICAL INC. SARAH MARIE FITZGERALD
K132240 12/16/2013 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K130691 12/20/2013 ELECTROTHERAPY DEVICE (COMBO UNIT) GUANGZHOU FINECURE MEDICAL EQUIPMENT CO.,LTD FIELD FU
K131933 12/20/2013 ELECTRONIC PULSE MASSAGER GURIN PRODUCTS, LLC SANJAY GUPTA
K133213 12/05/2013 STARCERAM H.C. STARCK CERAMICS GMBH MAUREEN O'CONNELL
K131550 12/06/2013 HEART SYNC HEART SYNC INC. DANIEL KAMM
K131961 12/04/2013 HEINE BETA 200(R) OPHTHALMOSCOPE HEINE OPTOTECHNIK GMBH & CO. KG. MANFRED BARTSCH-TITTMANN
K130512 12/02/2013 NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS HEINZ KURZ GMBH MEDIZINTECHNIK KRISTINA BITZER
K130736 12/17/2013 BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS HELIX MEDICAL, LLC THOMAS M VASSALLO
K132520 12/31/2013 NASAL EASE ALLERGY BLOCKER HI-TECH PHARMACAL, INC. GARY APRIL
K132067 12/20/2013 MULTI ANGLED ABUTMENT SYSTEM HIOSSEN INC. PATRICK LIM
K130895 12/27/2013 REUNION RSA SHOULDER SYSTEM HOWMEDICA OSTEONICS CORP ESTELA CELI
K133346 12/19/2013 SMARTLOG DIABETES MANAGEMENT SOFTWARE I-SENS, INC. HYE YOUNG KANG
K123678 12/16/2013 HYALMIX CREAM IGI LABORATORIES, INC. FREDERICK WEISS
K123763 12/24/2013 IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K130572 12/24/2013 INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM IMPLANT DIRECT SYBRON MANUFACTURING LLC INES ARAVENA
K132966 12/05/2013 GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K132862 12/12/2013 HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K132996 12/17/2013 CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS ISORAY, INC FREDRIC SWINDLER
K132876 12/18/2013 ARIX HAND LOCKING SYSTEM JEIL MEDICAL CORPORATION HYEROUNG LEE
K132428 12/20/2013 IDEAL JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LTD. GONG BO
K133181 12/03/2013 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K133185 12/03/2013 21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K133511 12/19/2013 21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025) JVC KENWOOD CORPORATION TSUKASA TASHIRO
K133126 12/09/2013 K7 LUMBAR SPACERS K7 LLC KAREN E WARDEN, PHD
K131953 12/20/2013 IMAGE1 SPIES KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K131787 12/23/2013 CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES KEELER LTD. EUGENE R VANARSDALE
K133169 12/20/2013 MESO TENDON MATRIX KENSEY NASH CORPORATION DBA DSM BIOMEDICAL BRIANNA JORDAN
K131879 12/20/2013 KC 300 SURGICAL MASK KIMBERLY-CLARK CORP. MONICA KING
K133111 12/26/2013 KINGTECH DIGITAL THERMOMETER KINGTECH ENTERPRISE, LTD. KE-MIN JEN
K133113 12/26/2013 KINGTECH FOREHEAD THERMOMETER KINGTECH ENTERPRISE, LTD. KE MIN JEN
K132514 12/02/2013 KINSA SMART THERMOMETER KINSA, INC. LAEL J PICKETT
K130758 12/11/2013 KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER KRONNER PROTOTYPES, INC. RICHARD F KRONNER, M.D.
K133078 12/20/2013 K-ETCHANT SYRINGE; NEEDLE TIP (E) KURARAY NORITAKE DENTAL INC. MICHIO TAKIGAWA
K133133 12/23/2013 LAURIMED POLYPVAC MICRODEBRIDER LAURIMED LLC NANCY LINCE, RAC
K131006 12/06/2013 ANESTHESIA CONDUCTION NEEDLES LCCS PRODUCTS LIMITED MIKE GU
K133026 12/31/2013 UNBALLOON NON-OCCLUSION MODELING CATHETER LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K132618 12/16/2013 ONETOUCH REVEAL LIFESCAN, INC. GABRIELLE LOGAN
K132837 12/19/2013 LINA POWERBLADE PLUS LINA MEDICAL APS CHRISTINE E NICHOLS
K130797 12/18/2013 LUCO HYBRID OSA APPLIANCE LUCO HYBRID OSA APPLIANCE INC. KEN LUCO
K133039 12/10/2013 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM MAKO SURGICAL CORPORATION JONATHAN REEVES
K132743 12/03/2013 HARVESTING CANNULA MAQUET CARDIOVASCULAR, LLC MARK DINGER
DEN110009 12/18/2013 RESTLESS LEG DEVICE MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEEPER'S MARY M SORG
K102707 12/18/2013 RESTLESS LEG DEVICE MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEEPER'S MARY M SORG
K131497 12/05/2013 MCKESSON CARDIOLOGY HEMO MCKESSON ISRAEL LTD. PAUL SUMNER
K133630 12/20/2013 GMK SHORT STEM MEDACTA INTERNATIONAL ADAM GROSS
K132878 12/18/2013 M.U.S.T. EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K132803 12/12/2013 MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK MEDAPPS INC., DBA ALERE CONNECT KENT DICKS
K133460 12/18/2013 APTUS CANNULATED COMPRESSION SCREWS MEDARTIS AG ALLISON KOMIYAMA
K132177 12/12/2013 MEDCOMP GEN III POWER INJECTABLE PORT MEDCOMP (MEDICAL COMPONENTS) SARAH SHAFFER
K132395 12/06/2013 LIGAPASS MEDICREA INTERNATIONAL AUDREY VION
K131682 12/05/2013 UD IMPLANT SYSTEM MEDIMECCA CO., LTD. PRISCILLA CHUNG
K132783 12/09/2013 EXOSHAPE DUO SOFT TISSUE FASTENER MEDSHAPE, INC STEPHEN LAFFOON
K130467 12/05/2013 POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE MEDSHAPE, INC KENNETH M DUPONT, PH.D.
K132623 12/19/2013 MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE MEDTRONIC MONICA HERNANDEZ-SOTO
K132974 12/03/2013 AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR MEDTRONIC ADVANCED ENERGY, LLC GABRIELA ANCHONDO
K133650 12/20/2013 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. GREGORY MASCHEK
K132328 12/06/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BECKY RONNER
K132584 12/04/2013 PERIMETER C SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. MICHAEL SCOTT
K132897 12/11/2013 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. BRAD SHEALS
K131789 12/27/2013 CEREBRALOGIK- AEEG MENNEN MEDICAL LTD. IFAT SHWARTS
K131169 12/24/2013 MOZEC - RX PTCA BALLOON DILATATION CATHETER MERIL LIFE SCIENCES PRIVATE LIMITED H. SEMIH OKTAY
K133230 12/12/2013 INQWIRE DIAGNOSTIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. SIOBHAN KING
K133626 12/20/2013 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 MICROVENTION, INC. LARAINE PANGELINA
K132952 12/19/2013 MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K122393 12/10/2013 TG-BODY MI&BODY S-TRAINER MIGA MEDICAL CO., LTD. YANG HO DONG
K130073 12/16/2013 MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS MIKRON MAKINA SANAYI VE TICARET LTD STI OMAR DIKER
K132026 12/20/2013 V SERIES MONITORING SYSTEM, 12.1" DCU/V12 AND 21.0" DCU/V21 MINDRAY DS USA, INC. RUSSELL OLSEN
K132232 12/04/2013 MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM MINILAP TECHNOLOGIES ALLAN ALWARD
K121248 12/13/2013 LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC MOLLER MEDICAL GMBH GRANT GECKELER
K133806 12/31/2013 M1 CAPNOGRAPHY MASK MONITOR MASK, INC. STUART R GOLDMAN
K131929 12/03/2013 SURVEYOR CENTRAL STATION MORTARA INSTRUMENT, INC. AMY YANG
K132264 12/17/2013 PRIMADO2 TOTAL SURGICAL SYSTEM NAKANISHI, INC. DIANE RUTHERFORD
K130738 12/13/2013 ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS NANJING MAIDIXIN MEDICAL DEVICE CO., LTD. DIANA HONG
K133422 12/26/2013 1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE NEOCOIL, LLC KATIE GONZALEZ
K133281 12/20/2013 NEOTRACT UROLIFT SYSTEM NEOTRACT, INC. NANCY E ISAAC
K130570 12/26/2013 NEUROVISION MEDICAL MOTION SENSOR NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K133475 12/19/2013 STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS NEXXT SPINE LLC ERIC LINTULA
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K132329 12/20/2013 NIVATOPIC PLUS NIVAGEN PHARMACEUTICALS INC. LARA NOAH
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K132186 12/18/2013 OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 OPTOMED OY JYRI LESKELA, QUALITY MANAGER
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K133437 12/02/2013 1ST MTP PLATE OSTEOMED BLESSON ABRAHAM
K131851 12/06/2013 OSTEOMED NEURO RONGEUR OSTEOMED PIEDAD PENA, M.S.
K132775 12/09/2013 PONTO PLUS AND PONTO PLUS POWER OTICON MEDICAL AB SATU HJARTSTAM
K131586 12/10/2013 CANCARY BREATHING SYSTEM PALO ALTO HEALTH SCIENCES, INC. LORI ADELS, PHD
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K131821 12/23/2013 ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY PHADIA US INC. MARTIN R MANN
K130704 12/13/2013 MICRODOSE SI PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB GUSTAV LINS
K130519 12/24/2013 PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS PHILIPS LIGHTING COMPANY JAMES R CYRE
K132147 12/16/2013 2D PERFUSION PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LISELOTTE KORNMANN
K130579 12/19/2013 PHYSOFT AMS PHYSICIANS SOFTWARE SYSTEMS, LLC LEWIS A MITCHELL
K131724 12/24/2013 PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE PIONEER SURGICAL TECHNOLOGY, INC EMILY M DOWNS
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K133474 12/10/2013 BIOSIGN FLU A + B, STATUS FLU A & B PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM
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K132148 12/04/2013 S HEALTH SAMSUNG ELECTRONICS CO., LTD. PRISCILLA CHUNG
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K132785 12/16/2013 STRYKER 1488 HD VIDEO CAMERA WITH INFRARED COMPATIBILITY STRYKER ENDOSCOPY LIFEI LIU
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K132646 12/20/2013 SUNETICS CLINICAL BIO-STIMULATION LASER SUNETICS INTERNATIONAL MARKETING GROUP, LLC JOHN CARULLO
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K132558 12/12/2013 SYNC-RX SYSTEM VOLCANO CORPORATION ELAINE ALAN
K132742 12/03/2013 M-VU BREAST DENSITY VUCOMP, INC. RICHARD MORRONEY
K132998 12/20/2013 WANDY SELF-ADHESIVE ELECTRODES WANDY RUBBER INDUSTRIAL CO., LTD JACK YI
K131664 12/18/2013 COPRA TEMP PMMA-DISK WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG JOHN WATERS
K131596 12/11/2013 WOUND MEASURING & MONITORING DEVICE WOUNDVISION, LLC GRETCHEN MILLER BOWKER
K132484 12/13/2013 DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE WRP ASIA PACIFIC SDN. BHD. KIRK PENNER
K133094 12/11/2013 CERTEX OCT SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN, M.D.
K130611 12/19/2013 ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE XERIDIEM MEDICAL DEVICES MICHELLE LOTT
DEN130007 12/18/2013 AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC JANE BEGGS
K123250 12/18/2013 AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC JANE BEGGS
K132854 12/23/2013 EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR YUNG SHENG OPTICAL CO., LTD. WEN-HAN CHEN
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