| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K131782 |
11/18/2013 |
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 |
AAP IMPLANTATE AG |
CHRISTIAN ZIETSCH |
| K131753 |
11/14/2013 |
MERIDIAN |
AB ARDENT |
DONNA MARIE HARTNETT |
| K131383 |
11/27/2013 |
X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE |
ADVANCED BRAIN MONITORING INC. |
ADRIENNE LENZ |
| K132561 |
11/05/2013 |
NURO NEUROMODULATION SYSTEM |
ADVANCED URO-SOLUTIONS, INC. |
PENNY NORTHCUTT |
| K132821 |
11/20/2013 |
AGAMATRIX HEALTH MANAGER |
AGAMATRIX INC |
WILLIAM H MCGRAIL |
| K131165 |
11/14/2013 |
ANKER DENTAL IMPLANT SYSTEM |
ALLIANCE GLOBAL |
YAYUAN CHANG |
| K132687 |
11/27/2013 |
E-CUBE 7 |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K130845 |
11/01/2013 |
AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW |
AMBU A/S |
SANJAY PARIKH |
| K132655 |
11/20/2013 |
RETROARC RETROPUBIC SLING SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
RENEE MELLUM |
| K131904 |
11/13/2013 |
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA |
AMERIWATER |
BRIAN R BOWMAN |
| K130730 |
11/22/2013 |
V-STICK VASCULAR ACCESS SET |
ARGON MEDICAL |
JENNIFER BONACCI |
| K132217 |
11/25/2013 |
ARTHREX COMPRESSION FT SCREWS |
ARTHREX, INC. |
COURTNEY SMITH |
| K131377 |
11/19/2013 |
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K130514 |
11/21/2013 |
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT |
AUDIFON-USA INC. |
JANE E PERRONE |
| K133091 |
11/27/2013 |
ZIP MIS INTERSPINOUS FUSION SYSTEM |
AURORA SPINE |
JUSTIN EGGLETON |
| K133008 |
11/20/2013 |
BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, |
BEACON ENDOSCOPIC |
ANNETTE M FAGNANT |
| K133140 |
11/15/2013 |
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV |
BECTON DICKINSON & CO. |
Gregory P Payne |
| K133138 |
11/13/2013 |
BD VeritorÖ System Flu A+B Assay |
BECTON DICKINSON & CO. |
Gregory P Payne |
| K132456 |
11/07/2013 |
BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV |
Becton, Dickinson and Company |
GREGORY P PAYNE, RAC |
| K132102 |
11/12/2013 |
BECE CAD ZIRKON HT+ |
BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO |
HEIKE GUSTKE |
| K131423 |
11/07/2013 |
G-ARM MULTISCAN SYSTEM |
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. |
BETTER LI |
| K131519 |
11/06/2013 |
BELMONT HYPERTHERMIA PUMP |
BELMONT INSTRUMENT CORP. |
SABRINA BELLADUE |
| K132507 |
11/15/2013 |
VITEK 2 AST ST MEROPENEM |
BIOMERIEUX, INC. |
NATHAN HARDESTY |
| K132898 |
11/19/2013 |
A.L.P.S. CALCANEAL PLATING SYSTEM |
BIOMET MANUFACTURING CORP. |
JARED COOPER |
| K130322 |
11/15/2013 |
SPM-300 |
BIONET CO., LTD. |
MARC GOODMAN |
| K130777 |
11/25/2013 |
INBODY |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM, P.E. |
| K133208 |
11/14/2013 |
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM |
BOSTON SCIENTIFIC CORP. |
MAUREEN SUNDEEN |
| K131700 |
11/04/2013 |
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES |
BOSTON SCIENTIFIC CORP. |
JANIS F TARANTO |
| K130831 |
11/21/2013 |
MALDI BIOTYPER CA (MBT-CA) SYSTEM |
BRUKER DALTONICS, INC |
FRAN WHITE |
| K130101 |
11/08/2013 |
BYTECH |
BYTECH DONGTAI CO., LTD. |
CHU XIAOAN |
| K131689 |
11/20/2013 |
MRI MARKER |
C4 IMAGING LLC |
STEPHEN J GOLDNER, JD, RAC |
| K133399 |
11/22/2013 |
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
CARDIOVASCULAR SYSTEMS INCORPORATED |
BLAIR BUTH |
| K122400 |
11/05/2013 |
CARDIOX FLOW DETECTION SYSTEM |
CARDIOX CORP. |
KAREN MATIS |
| K122490 |
11/13/2013 |
KULAVAC |
CGBIO CO., LTD |
JUNGEUN IM |
| K133357 |
11/25/2013 |
CHARRUAPACS SYSTEM |
CHARRUASOFT SA |
CARL ALLETTO |
| K121587 |
11/22/2013 |
BREATH SHAKE |
CHEEN HOUNG ENT. CO. LTD. |
PAUL DRYDEN |
| K130853 |
11/13/2013 |
IDYS(TM) C |
CLARIANCE |
JANICE M HOGAN |
| K132799 |
11/07/2013 |
CLARISO PACS |
CLARISO, INC. |
CARL ALLETTO |
| K132085 |
11/12/2013 |
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM |
CO-INNOVATION BIOTECH CO., LTD. |
HONG FENG |
| K131240 |
11/07/2013 |
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT |
COCHLEAR AMERICAS |
SEAN BUNDY |
| K131998 |
11/26/2013 |
ASPIRE RX-LP6 ASPIRATION CATHETER |
CONTROL MEDICAL TECHNOLOGY, LLC |
SHAWN FOJTIK |
| K132307 |
11/05/2013 |
VIDA LED SURGICAL LIGHTING SYSTEM |
CONVIDA HEALTHCARE & SYSTEMS CORPORATION |
RYAN HUNG |
| K132504 |
11/25/2013 |
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM |
CORELINK LLC |
JUSTIN EGGLETON |
| K132567 |
11/05/2013 |
ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN |
COVIDIEN |
DOLLY MISTRY |
| K130357 |
11/06/2013 |
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH |
Covidien LLC |
KRISTEN SWANSON |
| K132795 |
11/26/2013 |
CYBERWAND STERILE PROBE SET |
CYBERSONICS, INC. |
LORI COLVIN |
| K131850 |
11/15/2013 |
TENSYN BAND |
DALLEN MEDICAL, INC. |
AL MEMMOLO |
| K130135 |
11/25/2013 |
DANA REUSABLE BI TEST PACK |
DANA PRODUCTS, INC. |
HARRY BALA |
| K131839 |
11/07/2013 |
DC 7 |
DC INTERNATIONAL, LLC |
DAVID BOEGLER |
| K132241 |
11/05/2013 |
GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
YAYORI FUJIMAKI |
| K132515 |
11/08/2013 |
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS |
DIASORIN, INC. |
CAROL A DEPOUW |
| K131302 |
11/26/2013 |
SOLAX |
DONGGUAN PRESTIGE SPORTING GOODS CO., LTD. |
JUNNATA CHANG |
| K132443 |
11/22/2013 |
PIEZON 150 |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
CYNTHIA NOLTE |
| K131819 |
11/22/2013 |
PC ECG |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K132231 |
11/27/2013 |
MYLABSEVEN, MYLABALPHA |
ESAOTE, S.P.A. |
Allison Scott |
| K131298 |
11/26/2013 |
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM |
EXACTECH, INC. |
SHING JEN TAI, PHD |
| K133102 |
11/18/2013 |
FLOWER ANKLE PLATING SET |
FLOWER ORTHOPEDICS CORPORATION |
JANICE M HOGAN |
| K132509 |
11/25/2013 |
FDR D-EVO FLAT PANEL DETECTOR SYSTEM |
FUJIFILM MEDICAL SYSTEMS USA, INC. |
KATHERINE Y CHOI |
| K133134 |
11/04/2013 |
X-PORTE ULTRASOUND SYSTEM |
FUJIFILM SONOSITE,INC. |
SCOTT PAULSON |
| K130759 |
11/09/2013 |
HUMELOCK II CEMENTLESS SHOULDER SYSTEM |
FX SOLUTIONS |
JEAN-JACQUES MARTIN |
| K132913 |
11/08/2013 |
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 |
GE HEALTHCARE |
BRYAN BEHN |
| K132376 |
11/15/2013 |
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T |
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) |
MICHELLE HUETTNER |
| K132261 |
11/18/2013 |
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) |
GE MEDICAL SYSTEMS, LLC |
JOHN L SCHMIDT |
| K132822 |
11/26/2013 |
BD MAX STAPHSR ASSAY, INSTRUMENT |
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
PATRICIA DIONNE |
| K123090 |
11/22/2013 |
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM |
GENERAL LIFE BIOTECHNOLOGY CO., LTD. |
Feng-Yu Lee |
| K131142 |
11/27/2013 |
GENESIS LED WANDS |
GENESIS BIOSYSTEMS, INC. |
JIM LAFFERTY |
| K130419 |
11/06/2013 |
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K132191 |
11/22/2013 |
SP-FIX SPINOUS PROCESS FIXATION PLATE |
GLOBUS MEDICAL, INC. |
CHRISTINA KICHULA |
| K130997 |
11/15/2013 |
NEOVEIL |
GUNZE LIMITED |
NOBUYA ONISHI |
| K122438 |
11/20/2013 |
HAMILTON-MR1 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K132006 |
11/07/2013 |
STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K132883 |
11/01/2013 |
HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) |
HEMODIA S.A.S. |
REMI TEULIERE |
| K132276 |
11/12/2013 |
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML |
HOSPIRA, INC. |
ABIGAIL FERGUSON |
| K132288 |
11/22/2013 |
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER |
i-SENS, Inc. |
CHAE YUN LIM |
| K131629 |
11/26/2013 |
NEURODYN MULTIWAVE, AUSSIE SPORT |
IBRAMED EQUIPAMENTOS MEDICOS |
LILIAN LLULL |
| K132893 |
11/20/2013 |
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW |
ICON ORTHOPAEDIC CONCEPTS DBA EDGE ORTHOPAEDICS |
JAN TRIANI |
| K124006 |
11/19/2013 |
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY |
ILLUMINA, INC. |
LEANNE M KIVIHARJU |
| K132750 |
11/19/2013 |
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY |
ILLUMINA, INC. |
BRYAN SCHNEIDER |
| DEN130011 |
11/19/2013 |
ILLUMINA MISEQDX PLATFORM |
ILLUMINA, INC. |
LEANNE M KIVIHARJU |
| DEN130042 |
11/19/2013 |
MISEQDX UNIVERSAL KIT 1.0 |
ILLUMINA, INC. |
LEANNE M KIVIHARJU |
| K132971 |
11/20/2013 |
MONACO |
IMPAC MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K133031 |
11/15/2013 |
SHARPSOLOGY 2 |
INDUSTRIAL WATER SOLUTIONS, INC. |
THOMAS P STEWART |
| K131661 |
11/05/2013 |
INFUSION SYRINGE SET |
INNOVATIVE MEDICAL MANUFACTURING CO. |
LUCY HUANG |
| K131686 |
11/29/2013 |
INOMAX DSIR (DELIVERY SYSTEM) |
INO THERAPEUTICS/IKARIA |
ROBERT BOVY |
| K132718 |
11/18/2013 |
INTEGRITY SPINE CORE SYSTEM |
INTEGRITY SPINE |
LISA PETERSON |
| K132347 |
11/20/2013 |
MULTICAM 3000 ECO |
INTER MEDICAL MEDIZINTECHNIK GMBH |
WILLIAM CARROLL |
| K132728 |
11/22/2013 |
V8 TRANSLUMINAL BAV CATHETER |
INTERVALVE, INC |
Sew-Wah Tay |
| K132847 |
11/20/2013 |
I2C |
ION BEAM APPLICATIONS S.A. |
BRUCE D ARMON |
| K130856 |
11/25/2013 |
BIA / VITALITY ANALYZER |
IPGDX, LLC |
Kevin Walls |
| K130829 |
11/14/2013 |
IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTS |
IQ IMPLANTS LTD. |
NATALIA DINERSTHEIN |
| K130707 |
11/20/2013 |
ISIRONA MAGELLAN |
ISIRONA, LLC |
THOMAS KROENKE |
| K131566 |
11/04/2013 |
ARIX HAND SYSTEM |
JEIL MEDICAL CORPORATION |
JI-EUN KIM |
| K131828 |
11/26/2013 |
POWDER FREE VINYL PATIENT EXAMINATION GLVOES, LIGHT YELLOW COLOR |
JIANGSU HANDSAFE GLOVE CO., LTD. |
CHU XIAOAN |
| K131826 |
11/22/2013 |
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING |
JIANGSU TOPTOUCH GLOVE CO., LTD. |
CHU XIAOAN |
| K122061 |
11/08/2013 |
K-Y BRAND LIQUIBEADS |
JOHNSON & JOHNSON HEALTHCARE PRODUCTS |
LORNA-JANE BREMER |
| K131533 |
11/09/2013 |
CAYMAN MI PLATE SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K132757 |
11/20/2013 |
EVEREST SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K132597 |
11/25/2013 |
BLACK COLOURED CONDOM |
KAREX INDUSTRIES SDN BHD |
MARY GOH YIN |
| K131369 |
11/26/2013 |
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
LEIGH SPOTTEN |
| K133276 |
11/19/2013 |
V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESS |
KCI USA, INC. |
MELANIE AVILA |
| K132741 |
11/15/2013 |
V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
KCI USA, INC. |
MELANIE AVILA |
| K131841 |
11/07/2013 |
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE |
KIMBERLY-CLARK CORP. |
CHRISTINE L MACAULEY |
| K132124 |
11/01/2013 |
KLARITY VACUUM BAG, KLARITY MOLD CUSHION |
KLARITY MEDICAL PRODUCTS, LLC |
PETER LARSON |
| K132450 |
11/01/2013 |
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K132022 |
11/06/2013 |
LEMAITRE 8F OCCLUSION CATHETER |
LEMAITRE VASCULAR, INC. |
ANDREW HODGKINSON |
| K132047 |
11/05/2013 |
LEMILLS VALVULOTOME |
LEMAITRE VASCULAR, INC. |
ANDREW HODGKINSON |
| K130195 |
11/01/2013 |
SCANNING LASERLINK |
LUMENIS, INC. |
JACE R MCLANE |
| K130199 |
11/22/2013 |
CLARITY LPC LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
| K133265 |
11/12/2013 |
QUADROX-IR ADULT AND SMALL ADULT |
MAQUET CARDIOPULMONARY AG |
WHITNEY TORNING |
| K131778 |
11/14/2013 |
FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT |
MAQUET CARDIOVASCULAR LLC |
MARYLOU INSINGA |
| K132605 |
11/14/2013 |
DOSIMETRY CHECK VERSION 4 RELEASE 1 |
MATH RESOLUTIONS, LLC. |
WENDEL DEAN RENNER |
| K132848 |
11/29/2013 |
PIEZOSURGERY FLEX |
MECTRON S.P.A. |
ROGER GRAY |
| K131518 |
11/04/2013 |
MECTACER BIOLOX OPTION HEADS |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K132498 |
11/25/2013 |
VALVED TEARAWAY INTRODUCER GENERATION II |
MEDCOMP (MEDICAL COMPONENTS, INC.) |
TIMOTHY HOLWICK |
| K122252 |
11/13/2013 |
SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS |
MEDICAL DEVELOPMENTS INTERNATIONAL |
TRACEY BULLIVANT |
| K132574 |
11/08/2013 |
PASS LP SPINAL SYSTEM |
MEDICREA INTERNATIONAL |
AUDREY VION |
| K131339 |
11/25/2013 |
CAPNOMASK |
MEDIPLUS LTD. |
PAUL DRYDEN |
| K122410 |
11/12/2013 |
I RUNE (I-200L) |
MEDIRUNE CO, LTD |
YANG HO DONG |
| K132545 |
11/08/2013 |
MEDIVALVE ACWIRE |
MEDIVALVE LTD. |
LEO BASTA |
| K132712 |
11/19/2013 |
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER |
MEDTRONIC INC. |
LISA STONE |
| K132639 |
11/25/2013 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
SHWETA SHARMA |
| K131669 |
11/01/2013 |
PERIMETER INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LAUREN KAMER |
| K133216 |
11/22/2013 |
CRESCENT SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
ANKIT K SHAH |
| K132297 |
11/05/2013 |
EM SINUS DILATION SYSTEM |
MEDTRONIC XOMED, INC. |
ROZANNE PACIEJ |
| K131699 |
11/26/2013 |
EMOTION ECG MOBILE |
MEGA ELECTRONICS LTD. |
ANDRE KINDSVATER |
| K131420 |
11/01/2013 |
PETITE BASIC SYSTEM 701 ELT |
MEGO AFEK AC LTD |
MARIA GRIFFIN |
| K132155 |
11/07/2013 |
Merit ASAPLP Aspiration Catheter |
MERIT MEDICAL SYSTEMS, INC. |
SUSAN CHRISTENSEN |
| K131482 |
11/22/2013 |
SOFIA DISTAL ACCESS CATHETER |
MICRO VENTION, INC. |
Naomi Gong |
| K131016 |
11/27/2013 |
ROGS |
MOLECULAR PRODUCTS LTD. |
PAUL DRYDEN |
| K132048 |
11/06/2013 |
BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET |
MOLNLYCKE HEALTH CARE US, LLC |
CURTIS D TRUESDALE |
| K131390 |
11/27/2013 |
JUSHA-M52C MEDICAL DISPLAY |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
MIKE GU |
| K133264 |
11/20/2013 |
NMI PICC III |
NAVILYST MEDICAL, INC. |
BRANDON BRACKETT |
| K130565 |
11/27/2013 |
SPECULAR MICROSCOPE CEM-530 |
NIDEK CO., LTD. |
Aron Shapiro |
| K133061 |
11/27/2013 |
ESPIN SYSTEM |
NLT SPINE LTD |
JOHN J SMITH |
| K130368 |
11/15/2013 |
AUTOLITH TOUCH; URO TOUCH |
NORTHGATE TECHNOLOGIES INC. |
CASEY KUREK |
| K131025 |
11/27/2013 |
ARCHON ANTERIOR CERVICAL PLATE SYSTEM |
NUVASIVE, INC. |
Cynthia Adams |
| K132411 |
11/20/2013 |
AFFIX II SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INCORPORATED |
OLGA LEWIS |
| K131672 |
11/15/2013 |
MICROCYN SCAR MANAGEMENT HYDROGEL |
OCULUS INNOVATIVE SCIENCES |
BRIAN W MARTIN |
| K131211 |
11/05/2013 |
DICOMPACS DX-R WITH FLAT PANEL |
OEHM UND REHBEIN GMBH |
FRANZISKA GUENTHER |
| K131128 |
11/13/2013 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES |
OMEGA LABORATORIES, INC. |
ROBERT J BARD, JD |
| K130387 |
11/08/2013 |
ORTHOALIGN PLUS SYSTEM |
ORTHALIGN, INC |
AMY WALTERS |
| K131767 |
11/08/2013 |
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM |
ORTHOSENSOR, INC. |
MARTHA I GARAY |
| K123148 |
11/19/2013 |
PARACE MD EKOSCOPE IS100 |
PARACE LLC |
VANDETTE CARTER |
| K131591 |
11/27/2013 |
FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) |
PEGA MEDICAL INC. |
ARIEL R DUJOVNE |
| K132614 |
11/14/2013 |
PEREGRINE CURVED ILLUMINATING LASER PROBE |
PEREGRINE SURGICAL, LTD. |
RYAN O'LEARY |
| K132306 |
11/21/2013 |
PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE |
PERSYST DEVELOPMENT CORP. |
DARI DARABBEIGI |
| K131913 |
11/26/2013 |
INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
MARKUS STACHA |
| K132526 |
11/26/2013 |
KNIT-PAK+ |
PREMIER DENTAL PRODUCTS CO. |
VINCENT D'ALLESANDRO |
| K132726 |
11/29/2013 |
ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM |
PRIMERADX |
FAYYAZ MEMNON |
| K122338 |
11/05/2013 |
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM |
PRODIGY DIABETES CARE, LLC |
E.J. Smith |
| K122340 |
11/26/2013 |
PRODIGY CHOICE |
PRODIGY DIABETES CARE, LLC |
E J SMITH |
| K123514 |
11/01/2013 |
CLEARPATH ALIGNER |
QSERVE AMERICA, INC. |
Patsy Trisler |
| K132294 |
11/12/2013 |
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS |
RADIOLOGY SOLUTIONS LLC |
DANIEL KAMM |
| K123977 |
11/21/2013 |
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K132066 |
11/21/2013 |
INFLAMMA DRY |
RAPID PATHOGEN SCREENING, INC. |
Douglas Bueschel |
| K131693 |
11/01/2013 |
RAYSCAN A-EXPERT |
RAY CO., LTD |
ANDREW PAENG |
| K131695 |
11/01/2013 |
RAYSCAN A-EXPERT 3D |
RAY CO., LTD |
ANDREW PAENG |
| K130554 |
11/22/2013 |
REDSENSE ALARM SYSTEM |
REDSENSE MEDICAL AB |
PATRIK BYHMER |
| K131932 |
11/08/2013 |
APNEALINK PRO |
RESMED GERMANY INC. |
SANDRA GRUNWALD |
| K132371 |
11/22/2013 |
EASYCARE ONLINE |
RESMED LTD. |
JIM CASSI |
| K132168 |
11/20/2013 |
BRONCHOSCOPY ELBOW |
RESPIRONICS, INC. |
COLLEEN WITT |
| K133282 |
11/27/2013 |
REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
| K131026 |
11/14/2013 |
BOSCH BLOOD PRESSURE METER (BP5000 BT) |
ROBERT BOSCH HEALTHCARE SYSTEMS, INC. |
LOUISE MUSANTE |
| K133330 |
11/26/2013 |
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN |
Roche Diagnostics |
Susan Hollandbeck |
| K133284 |
11/22/2013 |
ELECSYS CK-MB CALCHECK 5 |
Roche Diagnostics |
KELLI TURNER |
| K132970 |
11/29/2013 |
LESSRAY |
SAFERAY SPINE, LLC |
Calley Herzog |
| K133329 |
11/27/2013 |
UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
PARK KYEONG-MI |
| K131355 |
11/07/2013 |
CONCEIVE PLUS |
SASMAR INC |
JOHN-MICHAEL MANCINI |
| K131997 |
11/26/2013 |
NEWTRON BOOSTER |
SATELEC-ACTEON GROUP |
RICK ROSATI |
| K132859 |
11/18/2013 |
INTEGRA FACET FIXATION SYSTEM |
SEASPINE, INC. |
MICHELLE WILLIS |
| K131655 |
11/04/2013 |
LIGHTHOUSE(TM) URINARY CATHETER |
SEEDINGS LIFE SCIENCE VENTURES, LLC |
KEN SOLOVAY |
| K132918 |
11/22/2013 |
SENSE-4BABY SYSTEM |
SENSE4BABY, INC. |
JACQUES GINESTET |
| K131646 |
11/26/2013 |
DISPOSABLE INFUSION SET |
SHANGHAI JINTA MEDICAL CO., LTD |
WANG CHANGQING |
| K130848 |
11/12/2013 |
SHANGHAI PHOENIX MECHANICAL WHEELCHAIR |
SHANGHAI PHOENIX MEDICAL EQUIPMENT CO., LTD. |
Ke-Min Jen |
| K132170 |
11/26/2013 |
SHASER V-MINI RX |
SHASER, INC. |
ANTHONY BURNS |
| K131921 |
11/15/2013 |
ELECTRONIC PULSE STIMULATOR |
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD |
BILL DAI |
| K131243 |
11/12/2013 |
NON-CONTACT INFRARED THERMOMETER |
SHENZHEN JUMPER MEDICAL EQUIPMENT CO., LTD |
FIELD FU |
| K132779 |
11/19/2013 |
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
|
| K133067 |
11/22/2013 |
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
KIRA GORDON |
| K131275 |
11/08/2013 |
MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS |
SIEMENS HELATHCARE DIAGNOSTICS INC. |
ELISABETH WARINER |
| K133226 |
11/12/2013 |
BIOGRAPH MMR |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K132951 |
11/15/2013 |
MAGNETOM AERA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K132119 |
11/22/2013 |
MAGNETOM PRISMA, MAGNETOM PRISMA FIT |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K132831 |
11/01/2013 |
QUIET/SILENT SCANNING SUITE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K130649 |
11/01/2013 |
SILK ROAD ACCESS CATHETER |
SILK ROAD MEDICAL, INC |
RICHARD M RUEDY |
| K132527 |
11/14/2013 |
DIGITAL COLOR DOPPLER ULTASOUND SYSTEM |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K131262 |
11/14/2013 |
DIGITAL ELECTROCARDIOGRAPHS |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K132189 |
11/22/2013 |
OTOMAG BONE CONDUCATION HEARING SYSTEM |
SOPHONO, INC |
KRISTA B TRAYNOR |
| K130066 |
11/12/2013 |
SPECTRUM SPINE SPINOUS PROCESS DEVICE |
SPECTRUM SPINE IP HOLDINGS, LLC |
RICH JANSEN |
| K132029 |
11/25/2013 |
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE |
SPINAL USA |
MEREDITH MAY |
| K132603 |
11/20/2013 |
APEX SPINE SYSTEM |
SPINECRAFT LLC |
AMI AKALLAL-ASAAD |
| K132740 |
11/26/2013 |
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM |
SPINEFRONTIER, INC. |
PAUL L SPEIDEL |
| K122024 |
11/26/2013 |
SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K132372 |
11/26/2013 |
STERITEC GREEN CARD PACK BOWIE-DICK TEST |
STERITEC PRODUCTS MFG. CO., INC. |
JONATHAN RUTIGLIANO |
| K132542 |
11/15/2013 |
TRANSGATE GUIDE CATHETER |
STRYKER NEUROVASCULAR |
ANJALI ATAL-GUPTA |
| K132624 |
11/26/2013 |
TRIATHLON TRITANIUM METAL-BACKED PATELLA |
STRYKER ORTHOPAEDICS |
SHIKHA KHANDELWAL |
| K132968 |
11/18/2013 |
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) |
STRYKER SPINE |
KRISTEN MEANY, MS, CQA, RAC |
| K130426 |
11/19/2013 |
SUMITOMO PROTON THERAPY SYSTEM |
SUMITOMO HEAVY INDUSTRIES, LTD |
RONALD S WARREN |
| K133420 |
11/29/2013 |
TRANQUILL BARBED DEVICE |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K132658 |
11/27/2013 |
HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS |
TELEFLEX MEDICAL |
ASHLEA RICCI, RAC |
| K130405 |
11/06/2013 |
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET |
TELEFLEX MEDICAL |
LORI PFOHL |
| K130689 |
11/15/2013 |
SYMPHONY RF GENERATOR |
THERMIGEN, INC. |
KEVIN O'BRIEN |
| K131834 |
11/04/2013 |
WOLF LONG BONE PLATE SYSTEM |
TOBY ORTHOPAEDICS |
ERIC NEYHARD |
| K132544 |
11/25/2013 |
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA |
TOMTEC IMAGING SYSTEMS, GMBH |
CHRISTINE KLEIN |
| K132588 |
11/22/2013 |
ADHESIVE ELECTRODES |
TOP-RANK HEALTH CARE EQUIPMENT CO., LTD. |
Diana Hong |
| K132106 |
11/12/2013 |
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K132222 |
11/07/2013 |
AQUILION ONE VISION, V6.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K130569 |
11/15/2013 |
ND NABIL DIB INFUSION CATHETER |
Translational Research Institute |
DeAnn Dana |
| K132699 |
11/26/2013 |
AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) |
TYRX , INC. |
REGINA NOVAK |
| K132101 |
11/25/2013 |
ANAX 5.5 SPINAL SYSTEM |
U & I CORPORATION |
YOUNG-GEUN KIM |
| K132552 |
11/13/2013 |
U&U STERILE HYPODERMIC NEEDLE |
U&U MEDICAL TECHNOLOGY CO., LTD |
XUEBO WANG |
| K131236 |
11/07/2013 |
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K132109 |
11/01/2013 |
ENAMELAST |
ULTRADENT PRODUCTS INC. / ORATECH LLC |
KAREN KAKUNES |
| K113135 |
11/06/2013 |
UNISTRIP 1 |
UNISTRIP TECHNOLOGIES, LLC |
E.J. Smith |
| K131897 |
11/26/2013 |
CV3000 HOLTER ANALYSIS SYSTEM |
VALES & HILLS BIOMEDICAL TECH. LTD. |
Diana Hong |
| K130515 |
11/22/2013 |
VIRTUOSO SYSTEM FOR IHC ER (SPI) |
VENTANA MEDICAL SYSTEMS, INC. |
ERIKA AMMIRATI |
| K133142 |
11/15/2013 |
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION |
VOLCANO CORPORATION |
ELAINE ALAN |
| K131284 |
11/14/2013 |
GSP NEONATAL BIOTINIDASE KIT |
WALLAC OY |
JEANETTE SCHIER-PUGSLEY |
| K132808 |
11/20/2013 |
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K131387 |
11/20/2013 |
WRIGHT GRADIENT 52 - TORSO |
WRIGHT THERAPY PRODUCTS, INC |
CAROL WRIGHT |
| K130212 |
11/20/2013 |
SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
GARFIELD WANG |
| K130230 |
11/20/2013 |
STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
GARFIELD WANG |
| K130978 |
11/06/2013 |
ZTX ULTRASONIC DIATHERMY DEVICE |
ZetrOZ INC |
GEORGE K LEWIS, JR. |
| K132201 |
11/27/2013 |
SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR |
ZIBO INTCO MEDICAL PRODUCTS CO., LTD. |
JOHN ZHAO |
| K132258 |
11/19/2013 |
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
JULIE L CORMAN |
| K132884 |
11/25/2013 |
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM |
ZIMMER SPINE, INC. |
JONATHAN GILBERT |
| K133086 |
11/27/2013 |
TITLE 2 POLYAXIAL SPINAL SYSTEM |
ZIMMER SPINE, INC. |
MICHELLE LENZ |
