| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| 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 Yi |
| 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 |
| K132030 |
09/27/2013 |
MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING |
MEDTRONIC INC. |
CHECHAMMA VARUGHESE |
| 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 |
| 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., L |
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 GRO |
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 |
| K122219 |
09/27/2013 |
THEYFIT MALE CONDOM |
THEYFIT |
PENNY NORTHCUTT |
| K130275 |
09/26/2013 |
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST |
Tianjin New Bay Bioresearch Co., Ltd. |
Roger De Bock |
| K132632 |
09/19/2013 |
TORNIER INSITE FT SUTURE ANCHOR WITH NEEDLES |
TORNIER, INC. |
JANELL A COLLEY |
| K130573 |
09/30/2013 |
TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF |
TYBER MEDICAL LLC |
JEFF TYBER |
| K131357 |
09/06/2013 |
PEAK Z |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K132455 |
09/03/2013 |
U-MOTION II PS+ CUP |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K131860 |
09/27/2013 |
VASCULAB VL4000 PHOTOPLETHYSMOGRAPH WITH PULSE VOLUME RECORDING |
US VASCULAR, LLC |
E.J. Smith |
| K131891 |
09/25/2013 |
ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K121516 |
09/26/2013 |
VIRTUOSO SYSTEM FOR IHC HER2 (4B5) |
VENTANA MEDICAL SYSTEMS, INC. |
ERIKA AMMIRATI |
| K121033 |
09/06/2013 |
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) |
VENTANA MEDICAL SYSTEMS, INC. |
ERIKA AMMIRATI |
| K122143 |
09/19/2013 |
VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER |
VENTANA MEDICAL SYSTEMS, INC. |
Erika B Ammirati |
| K131540 |
09/03/2013 |
INTERFUSE L INTERVERTEBRAL BODY FUSION DEVICE |
VERTEBRAL TECHNOLOGIES, INC. |
SURESH GHAI |
| K132302 |
09/12/2013 |
QXLINK |
VIEWORKS CO., LTD. |
Priscilla Chung |
| K130873 |
09/13/2013 |
VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M |
VITAL ACCESS |
CHRISTOPHER PHILLIPS |
| K130703 |
09/12/2013 |
VIVORTE BVF |
VIVORTE, INC |
STEPHEN J PEOPLES |
| K132659 |
09/27/2013 |
VOLCANO PREVIEW FORWARD-LOOKING IVUS SYSTEM |
VOLCANO CORPORATION |
MARCUS GARCIA |
| K131658 |
09/06/2013 |
GORE SEAMGUARD REINFORCEMENT |
W. L. GORE & ASSOCIATES, INC. |
BARBARA L SMITH |
| K122102 |
09/09/2013 |
POWER FREE VINYL EXAMINATION GLOVES |
WANG TONG XINGHUA CO., LTD |
GUO YANG |
| K131296 |
09/03/2013 |
VARILIFT-L INTERBODY FUSION DEVICE |
WENZEL SPINE, INC. |
SANDIE ROTH |
| K121844 |
09/06/2013 |
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES |
WORLDMED MANUFACTURING SDN. BHD. |
CHANDRASEGARAN |
| K131701 |
09/05/2013 |
Z5MLB, Z5MLC |
Z-Systems AG |
LINDA K SCHULZ |
| K131242 |
09/03/2013 |
ARDIS INTERBODY SYSTEM |
ZIMMER SPINE, INC |
JON GILBERT |
| K131980 |
09/04/2013 |
SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM |
ZIMMER SPINE, INC. |
JONATHAN GILBERT |
| K130810 |
09/19/2013 |
ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM |
ZIMMER, INC. |
SCOTT M DURLACHER |
| K130595 |
09/17/2013 |
ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
