FDA 510(k) Decisions During September, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132030 09/27/2013 MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING MEDTRONIC INC. CHECHAMMA VARUGHESE
K131442 09/06/2013 FIRECR DENTALIMAGING SYSTEM 3DISC AMERICAS DANIEL KAMM
K131508 09/13/2013 VYSIS D7S486/CEP 7 FISH PROBE KIT ABBOTT MOLECULAR, INC. NANCY W BENGTSON
K132366 09/03/2013 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS ACCEL SPINE AEKTA PATEL
K131148 09/04/2013 THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH ACCESS SCIENTIFIC, LLC ALBERT MISAJON
K131845 09/30/2013 ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC ACUMED LLC KARA BUDOR
K131764 09/05/2013 ACUMED WRIST SPANNING PLATE ACUMED LLC NATHAN WOLF
K132005 09/10/2013 RETROGRADE FEMORAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ALLYSON PARKS
K130409 09/06/2013 ALIVECOR HEART MONITOR ALIVECOR, INC. MICHAEL RIGHTER
K131622 09/20/2013 MROZ REVERSE OSMOSIS SYSTEM AMERIWATER BRIAN R BOWMAN
K131111 09/11/2013 IHEALTH FINGERTIP PULSE OXIMETER ANDON HEALTH CO.,LTD LIU YU
K130150 09/26/2013 TCM MASSAGER ANHUI JINJIANQIAO MED-TECH CO,. LTD. FIELD FU
K131043 09/10/2013 APEX UNIVERSAL ADHESIVE APEX DENTAL MATERIALS, INC. CHRIS KULTON
K132133 09/26/2013 CG+ ARROW JACC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K130510 09/25/2013 ARTHREX COMPRESSION PLATES ARTHREX, INC. IVETTE GALMEZ
K131633 09/27/2013 ARTHREX UNIVERS APEX ARTHREX, INC. COURTNEY SMITH
K132590 09/17/2013 5.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, INSERTION GUIDE WITH OBTURATOR, TA ARTHROCARE CORPORATION MITCHELL DHORITY
K132513 09/19/2013 Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER ARTHROCARE CORPORATION MITCHELL DHORITY
K130417 09/12/2013 AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S AUDIFON-USA INC. JANE E PERRONE
K132593 09/17/2013 CRYSTALSERT DELIVERY SYSTEM BAUSCH & LOMB YI GAO
K132216 09/09/2013 BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION BAUSCH & LOMB INCORPORATED SAMANTHA DUFFY
K131208 09/11/2013 BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, BAUSCH & LOMB, INC. BARBARA KLUBE-FALSO
K122370 09/26/2013 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR BAYER HEALTHCARE ROGER SONNENBURG
K121790 09/25/2013 ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM BECKMAN COULTER, INC. KERRIE OETTER
K130373 09/18/2013 NAVIOS FLOW CYTOMETER SYSTEM BECKMAN COULTER, INC. NANCY NADLER
K132692 09/23/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K130760 09/16/2013 ELECTROSURGICAL GENERATOR BEIJING JINHENGWEI TECHNOLOGY DEVELOPMENT CO., LTD. LIGANG MAO
K130172 09/23/2013 BELIMED STEAM STERILIZER MST-V BELIMED, INC. JAY UPCHURCH
K123896 09/10/2013 CCS-200 SPIROMETER BENSON MEDICAL INSTRUMENTS CO. DAVID MAYOU
K132097 09/30/2013 BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY BEST MEDICAL INTERNATIONAL, INC. DHARMENDRA THAKUR
K130641 09/13/2013 LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE BINDER BIOMEDICAL, INC LAWRENCE BINDER
K130053 09/19/2013 BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI BIO-RAD LABORATORIES, INC. JUANG WANG
K132573 09/13/2013 VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN BIOMERIEUX, INC. NATHAN HARDESTY
K132239 09/06/2013 COMPREHENSIVE REVERSE SHOULDER SCREWS BIOMET MANUFACTURING CORP. PATRICIA S BERES
K123907 09/03/2013 PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, BIOMET MANUFACTURING CORP. ELIZABETH WRAY
K131615 09/04/2013 POLARIS SPINAL SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY
K131064 09/04/2013 BIOSPACE BIOSPACE CORPORATION LIMITED DANIEL KAMM
K132578 09/13/2013 INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. TODD KORNMANN
K132069 09/23/2013 DESARA MESH, DESARA BLUE CALDERA MEDICAL, INC. VICKI GAIL
K131059 09/13/2013 PIONEER ELITE DIODE LASER CAO GROUP, INC. ROBERT K LARSEN
K131526 09/23/2013 SFI-BAR CENDRES & METAUX SA TANJA BONGNI
K132508 09/23/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM, PHARM.D.
K132198 09/12/2013 ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI CEREMED, INC. CHELSEA MITCHELL
K123567 09/10/2013 FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST CHURCH & DWIGHT CO., INC. LISA BURNS
K131161 09/17/2013 EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, CIVCO MEDICAL INSTRUMENTS CO., INC. AMANDA STAHLE
K132505 09/12/2013 ACCULIF TL AND PL CAGE COALIGN INNOVATIONS, INC.
K112796 09/12/2013 SURGICAL GOWN (EO STERILIZED) COBES INDUSTRIES CO., LTD. LEON LU
K132278 09/26/2013 COCHLEAR BAHA 4 SOUND PROCESSOR COCHLEAR AMERICAS SEAN BUNDY
K131206 09/27/2013 COOK CERVICAL RIPENING BALLOON COOK, INC. CHIRS KILANDER
K131250 09/10/2013 TIGER SPINE SYSTEM CORELINK LLC MEREDITH MAY
K132644 09/19/2013 LOSPA IS PEDICLE SCREW (MONOAXIAL & POLYAXIAL), LOSPA IS ROD- STRAIGHT (STANDARD), LOSPA IS ROD- PRE BENT (STANDARD & BU CORENTEC CO., LTD J.S. DANIEL
K131647 09/27/2013 TRINITY ACETABULAR SYSTEM CORIN USA DIANA L MARTONE
K113738 09/17/2013 CREODENT SOLIDEX CUSTOM ABUTMENT CREODENT PROSTHETICS LTD. CALVIN SHIM
K130663 09/27/2013 BESTFIT2 NASAL MASK CURATIVE MEDICAL INC. AMY MCKINNEY
K130349 09/06/2013 FREEMIE BREAST COLLECTION SYSTEM DAO HEALTH DAN GARBEZ
K131385 09/27/2013 EASY-GRAFT DEGRADABLE SOLUTIONS AG DEBORAH LAVOIE GRAYESKI
K130654 09/24/2013 CRYSTAL ULTRA DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS) SCOTT ATKIN
K124025 09/18/2013 ALPHA-PRO WHITE VARNISH DENTAL TECHNOLOGIES, INC. PAULA ERICKSON
K130455 09/25/2013 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES DENTALEZ GROUP, STARDENTAL DIVISION JIM WATKINS
K123991 09/16/2013 DEPUY CORAIL AMT HIP PROSTHESIS DEPUY FRANCE S.A.S. ALMA RELJA, RAC
K131802 09/12/2013 EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON COMPANY KIRSTEN LEHMULLER
K132252 09/27/2013 EXTRICARE 100CC/ 250CC/ 400CC CANISTERS DEVON MEDICAL RUTH WU
K131044 09/04/2013 SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION DIACOUSTIC MEDICAL DEVICES (PTY) LTD. YOLANDA SMITH
K132492 09/05/2013 LIAISON 25 TOTAL-D DIASORIN, INC. MARI MEYER
K131037 09/06/2013 LIAISON XL HCG DIASORIN, INC. MARI MEYER
K132672 09/23/2013 EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER DORNIER MEDTECH AMERICA JOHN HOFFER
K131903 09/19/2013 EQUINOX CO2 LASER ECLIPSE AESTHETICS, LLC TOM O'BRIEN
K131830 09/17/2013 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. CHERRY SUN
K132175 09/13/2013 EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. LUKE MEIDELL
K131396 09/30/2013 WIRED MOUTH PROTECTOR (WMP) ELBA LABORATORIES, INC. RICHARD A HAMER
K131965 09/25/2013 XVI R5.0 ELEKTA LIMITED ANDREW HEDGES
K132665 09/25/2013 PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC ELLMAN INTERNATIONAL, INC. ALISON SATHE
K130365 09/23/2013 X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER ENCORE MEDICAL, L.P. TEFFANY HUTTO
K130996 09/16/2013 ERCHONIA EMERGE ERCHONIA MEDICAL, INC. KEVIN WALLS
K131656 09/27/2013 MORCELLEX SIGMA GENERATOR ETHICON, INC. SARAH MCMANUS
K132777 09/26/2013 NANOCROSS ELITE .14" OVER-THE-WIRE PTA, BALLOON DILATION CATHETER EV3 INC
K123630 09/09/2013 FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE DENISE OPPERMANN
K124024 09/19/2013 APD LUER-LOCK ADAPTER FRESENSIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K131977 09/17/2013 CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT GE HEALTHCARE NICOLE LANDREVILLE
K131937 09/24/2013 VOLUSON I/E GE HEALTHCARE BRYAN BEHN
K132696 09/27/2013 TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR GE HEALTHCARE FINLAND OY JOEL KENT
K132045 09/04/2013 ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS GE HUNGARY KFT STEPHEN SLAVENS
K131885 09/26/2013 SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI) GE MEDICAL SYSTEMS SCS MOUNIR ZAOUALI
K131685 09/24/2013 GE ECHOPAC GE VINGMED ULTRASOUND AS BRYAN BEHN
K130983 09/26/2013 GENII ARC SMART ARGON PROBE GENII, INC. TRACY EBERLY
K131394 09/18/2013 TRANSTEK GLASS BODY FAT ANALYZER GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD LEO WANG
K132630 09/27/2013 WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K132369 09/27/2013 MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR HANSEN MEDICAL, INC. HASSAN LABAY
K131494 09/16/2013 HEART SYNC HEART SYNC INC. DANIEL KAMM
K131440 09/25/2013 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD CHARLES SHEN
K131177 09/20/2013 SINUFLUSH LAVAGE SYSTEM HEDGEPATH, LLC FRANK E O'DONNELL, JR MD.
K131745 09/17/2013 BLOM-SINGER SEPTAL PERFORATION PROSTHESIS HELIX MEDICAL, LLC PAUL DRYDEN
K123822 09/27/2013 KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET HK SURGICAL, INC. CLARE BENNETT
K132287 09/25/2013 JAZZ SYSTEM HOGAN LOVELLS US LLP JANICE M HOGAN
K130925 09/12/2013 AUTOMATIC BLOOD PRESSURE MONITOR HONSUN (NANTONG) CO., LTD. SELINA QIAN
K131681 09/06/2013 EYESEECAM VHIT INTERACOUSTICS A/S ERIK NIELSEN
K132479 09/19/2013 OPTICAGE INTERBODY FUSION DEVICE, MODEL 9080-00 INTERVENTIONAL SPINE, INC. JANE METCALF
K124031 09/13/2013 DA VINCI FLUORESCENCE IMAGING VISION SYSTEM INTUITIVE SURGICAL, INC. CINDY DOMECUS
K121817 09/17/2013 VCARE A IVT MEDICAL LTD ELI ORBACH
K131311 09/05/2013 ARIX FOOT SYSTEM JEIL MEDICAL CORPORATION JI-EUN KIM
K131411 09/26/2013 COSEAL JILIN CORONADO MEDICAL LTD. ERIC CHIEN
K130232 09/17/2013 ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM JINXINBAO ELECTRONIC CO.,LTD HELEN NAN
K124037 09/12/2013 JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE JUNG RIM MEDICAL INDUSTRIAL CO., LTD KYU LEE
K123402 09/24/2013 DIAGNOCAM KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K130560 09/27/2013 MASTERTORQUE LUX 8900 L KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K131491 09/11/2013 KITAZATO IUI CATHETER KITAZATO MEDICAL CO., LTD. RICHARD VINCINS, CBA, CQA, RAC
K123944 09/05/2013 KOSTEC MEDICAL GRADE LDC MONITORS KOSTEC CO., LTD RHONDA ALEXANDER, MS, MPA
K130341 09/06/2013 STRAWBERRY, STRAWBERRY & CREAM LASER LIPO LIMITED IAN COBLEY
K132136 09/06/2013 SINGLE USE GROUNDING PAD LCCS PRODUCTS LIMITED
K132203 09/20/2013 PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA LEXION MEDICAL, LLC. BERNARD HORWATH
K124043 09/26/2013 LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM LIGHTMED CORP. JOCELYN LIU
K131751 09/25/2013 FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES LUCENXIA PRESCIENCE AG ROBERT HILL
K130028 09/03/2013 RESURFX 1565NM LASER MODULE LUMENIS, LTD. YORAM LEVY
K131565 09/11/2013 XTAG CYP2C19 KIT V3 LUMINEX MOLECULAR DIAGNOSTICS, INC. RONALD DUNN
K131559 09/27/2013 MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K132084 09/26/2013 PROTURA COUCH SOFTWARE MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS AMANDA STAHLE
K123866 09/13/2013 TANYX MEDECELL US, INC RHONDA ALEXANDER, M.S., M.P.A.
K132314 09/18/2013 MEDLINE ANTI-REFLUX VALVE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K132324 09/06/2013 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST MEDOS INTERNATIONAL SARL KIRSTEN LEHMULLER
K130177 09/23/2013 ANATOMIC PEEK CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LEE GRANT
K132700 09/26/2013 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK, INC. ANKIT K SHAH
K131888 09/23/2013 T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE MEDTRONIC SOFAMOR DANEK, INC. BECKY RONNER
K131289 09/25/2013 I-GEN MEGAGEN IMPLANT CO., LTD APRIL LEE
K132164 09/17/2013 HEARTSPAN STEERABLE INTRODUCER KIT MERIT MEDICAL SYSTEMS, INC. ALINA STUBBS
K131873 09/25/2013 NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) METHODSENSE, INC. RITA KING
K132137 09/12/2013 MULTISTIM METRON MEDICAL AUSTRALIA PTY LTD DAVID MITCHELL
K132317 09/20/2013 MICROPLEX COIL SYSTEM (MCS), VFC MICROVENTION, INC. LARAINE PANGELINA
K131431 09/26/2013 AIRO CT SYSTEM MOBIUS IMAGING, LLC NORMA LEMAY
K131375 09/19/2013 AUTOLAP SYSTEM MST - MEDICAL SURGERY TECHNOLOGIES LTD. JOHN J SMITH, M.D., J.D.
K131578 09/12/2013 IPROPHY MOBILE NAKANISHI, INC. DIANE RUTHERFORD
K131389 09/06/2013 JUSHA-C31 MEDICAL DISPLAY NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MIKE GU
K130010 09/06/2013 PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY NANOSTRING TECHNOLOGIES SYLVA KRIZAN, PHD
K132713 09/27/2013 NMI COAXIAL MICROINTRODUCER SET NAVILYST MEDICAL, INC. MICHAEL P HANLEY
K132044 09/30/2013 CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM NEOS SURGERY S.L. CHERITA JAMES
DEN130023 09/13/2013 UROLIFT SYSTEM NEOTRACT, INC. Nancy E Isaac
K130651 09/13/2013 UROLIFT SYSTEM NEOTRACT, INC. NANCY E ISAAC
K131021 09/11/2013 PULSE OXIMETER NONIN MEDICAL, INC. BRODIE PEDERSEN
K131398 09/16/2013 NOVOKNEE TOTAL KNEE SYSTEM NOVOSOURCE INC JAMES PINKSTON
K132092 09/26/2013 ESTEYA NUCLETRON B.V. LU ANNE JOHNSON
K122711 09/17/2013 FACIAL SPA NUSKIN PAUL RUBIN
K131723 09/20/2013 COROENT SINGLE TAB SYSTEM NUVASIVE, INC. JEREMY MARKOVICH
K123902 09/13/2013 PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) OKTX LLC MARY ROSE C REASTON
K131854 09/13/2013 CEROX OR-NIM MEDICAL LTD. MICHA OESTEREICH
K131795 09/26/2013 NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS ORFIT INDUSTRIES NV EDDY MARIVOET
K123811 09/05/2013 STITCHKIT ORIGAMI SURGICAL LLC JOHN GILLESPIE
K132591 09/17/2013 MAXLOCK EXTREME SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K131409 09/13/2013 CAS PSI KNEE SYSTEM ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K130840 09/18/2013 SMARTBUILDER SYSTEM (SB1) OSSTEM IMPLANT CO.,LTD PATRICK LIM
K131773 09/24/2013 BRILLIANCE ICT PHILIPS HEALTHCARE (CLEVELAND) CATHERINE M CONNELL
K132068 09/26/2013 PHILIPS DXL 12/16-LEAD ECG ALGORITHM PHILIPS MEDICAL SYSTEMS THERESA POOLE
K130021 09/19/2013 PHILIPS HERCEPTEST DIGITAL SCORE PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. DIRK VOSSEN
K130893 09/06/2013 XPERCT REL. 3 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LISELOTTE KORNMANN
K131529 09/24/2013 SHENGGUANG MANUAL WHEELCHAIR PINGDINGSHAN SHENXING HEALTHCARE TECHNOLOGY CO., LTD. WANG QING
K132626 09/19/2013 PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) PIPELINE BIOTECHNOLOGY TERRY POWELL
K132046 09/23/2013 PIPELINE KNEE SYSTEM PIPELINE ORTHOPEDICS TERRY POWELL
K130952 09/26/2013 PRECISION ONE LIFECARE; DETECTO; DETECTO PRECISION ONE LIFECARE, LTD. STEVEN CHERNOFF
K132465 09/09/2013 BIOSIGN FLU A + B, STATUS FLU A & B PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM, PH.D.
K130604 09/12/2013 UNIVERSAL PASTE STAINS AND GLAZE PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K131813 09/06/2013 QUIDEL MOLECULAR RSV + HMPV ASSAY QUIDEL CORP. RONALD H LOLLAR
K131988 09/17/2013 ABL90 FLEX ANALYZER RADIOMETER MEDICAL APS GITTE JUEL FRIIS
K131114 09/17/2013 DIGITAL FLAT PANEL X-RAY DETECTOR RAYENCE CO., LTD DAVE KIM
K132420 09/19/2013 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL REBECCA K PINE
K131429 09/23/2013 RELIANCE CERVICAL IBF SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K131354 09/19/2013 RENOVIS BIPOLAR HIP SYSTEM RENOVIS SURGICAL TECHNOLOGIES LLC SHARYN ORTON
K131122 09/18/2013 S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC SHARYN ORTON, PH.D.
K131138 09/09/2013 RESPIRE PINK SERIES - HERBST RESPIRE MEDICAL DANIELA LEVY
K131084 09/13/2013 SASMAR ORIGINAL, SASMAR CLASSIC SASMAR INC JOHN-MICHAEL MANCINI
K124026 09/13/2013 LOBSTER AUTO-INJECTOR SCANDINAVIAN HEALTH LIMITED JAMES HAYNES
K121924 09/04/2013 INTEGRA INTERSPINOUS PROCESS SYSTEM SEASPINE, INC. NICK M CORDARO
K132266 09/30/2013 SHASER HRS2 RX HAIR REMOVAL SYSTEM SHASER, INC. ANTHONY BURNS
K132610 09/04/2013 5MP GRAYSCALE LCD DISPLAY SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD WU QIN
K130802 09/16/2013 OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060) SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. JIANPING KANG
K122311 09/18/2013 GC-3000E DIGITAL COLPOSCOPE SHENZHEN GOLDCARE MEDITECH CO., LTD. JIMMY WU
K130841 09/11/2013 SHOFU BLOCK HC SHOFU DENTAL CORPORATION DAVID P MORAIS
K132249 09/13/2013 ADVIA CENTAUR FT4, ADVIA CENTAUR T4 SIEMENS HEALTHCARE DIAGNOSTICS INC. MATTEW GEE
K132391 09/20/2013 IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL SIEMENS HELATHCARE DIAGNOSTICS INC. GARO MIMARYAN
K132654 09/26/2013 ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GROUP PATRICK LYNCH
K123957 09/16/2013 PNEUPAC PARAPAC PLUS SMITHS MEDICAL INTERNATIONAL LTD. LORI BERENDS
K132431 09/06/2013 THERMAGE CPT SYSTEM SOLTA MEDICAL, INC. RAYMOND LEE
K131388 09/26/2013 TRANSCEND HEATED HUMIDIFIER SOMNETICS INTERNATIONAL, INC. MELINDA SWANSON
K132053 09/16/2013 RAMPART-O, RAMPART-T SPINEOLOGY, INC. BRYAN BECKER
K132073 09/09/2013 EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE ST. JUDE MEDICAL KRIS MILLER
K131452 09/05/2013 PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 ST. JUDE MEDICAL SYSTEMS AB ERDULFO DE PERALTA
K130874 09/27/2013 STRYKER NAV3I PLATFORM STRYKER CORPORATE LILIAN ECKERT
K132171 09/24/2013 AIXPLORER SUPERSONIC IMAGINE AURELIE GRUENER
K132274 09/24/2013 AIXPLORER SUPERSONIC IMAGINE JACQUES SONQUET
K123723 09/05/2013 SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM SYNTHES ALAN T HALEY
K123130 09/17/2013 ANSWATCH WRIST MONITOR MODEL TS-0411 TAIWAN SCIENTIFIC CORPORATION DEHCHUAN SUN
K132091 09/20/2013 MULTICHEM IA AND IA PLUS TECHNO-PATH MANUFACTURING LTD. STEPHANIE G GARTH
K131992 09/25/2013 MULTICHEM P TECHNO-PATH MANUFACTURING LTD. STEPHANIE G GARTH
K132174 09/20/2013 MULTICHEM WBT TECHNO-PATH MANUFACTURING LTD. STEPHANIE G GARTH
K122235 09/06/2013 RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET TELEFLEX MEDICAL, INC. LORI PFOHL
K132348 09/05/2013 TEPHAFLEX BRAIDED SUTURE TEPHA, INC. MARY P LEGRAW
K131618 09/27/2013 LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6") ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST TERUMO CARDIOVASCULAR SYSTEMS CORPORATION JOHN CHESNEY
K132233 09/06/2013 K-PACK II NEEDLE - 27G X 3/4" THIN WALL TERUMO EUROPE N.V. M.J. AERTS
K132701 09/26/2013 PRIMI SUPPORT CATHETER THERMOPEUTIX INC. JASON FORD
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