| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K103434 |
10/13/2011 |
3B FLEX-LITE |
3B PRODUCTS, LLC |
ALBERT ALEXANDER LUCIO |
| K110471 |
10/07/2011 |
BABI PLUS INFANT NASAL CANNULA SYSTEM |
A PLUS MEDICAL |
THOMAS C LOESCHER |
| K111883 |
10/18/2011 |
SMARTLOC SPINAL FIXATION SYSTEM |
A-SPINE ASIA, CO., LTD |
FRANK HSU |
| K110579 |
10/06/2011 |
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS |
ABBOTT LABORATORIES |
DARLA ABANO |
| K103627 |
10/14/2011 |
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS |
ABBOTT LABORATORIES |
JUDITH R WALLACH |
| K111899 |
10/03/2011 |
ARMADA 35/35LL PTA CATHETER |
Abbott Vascular |
LAARNI RICAFORT |
| K111875 |
10/11/2011 |
RELIEVA SPIN SINUS DILATION SYSTEM |
ACCLARENT, INC. |
KERI YEN |
| K110687 |
10/07/2011 |
RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) |
ACCLARENT, INC. |
DEAN KNIGHT |
| K111371 |
10/06/2011 |
ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
QIYI XIE |
| K112529 |
10/27/2011 |
TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
| K110979 |
10/20/2011 |
DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS |
ADVANCED MEDICAL PRODUCTS SDN BHD |
ZAHARI DARUS |
| K103513 |
10/24/2011 |
LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
| K110206 |
10/27/2011 |
AESCULAP- MEITHKE SHUNT SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K110432 |
10/20/2011 |
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
| K112670 |
10/27/2011 |
DX-D 600 |
AGFA HEALTHCARE N.V. |
PHIL CUSCUNA |
| K112222 |
10/27/2011 |
ALCATRON AND / OR MULTIPLE BRAND |
ALCATRON GLOVES FACTORY |
SHUQIN GAO |
| K101774 |
10/13/2011 |
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) |
ALCON MANUFACTURING, LTD. |
Catherine Goble |
| K110951 |
10/17/2011 |
27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA |
ALCON RESEARCH, LTD. |
MARTIN A KAUFMAN |
| K111587 |
10/20/2011 |
ALERKAN SPIROMETRY FILTER |
ALERKAN LTD |
Glen Feye |
| K110998 |
10/25/2011 |
AFFIRM (TM) VCF SYSTEM |
ALGEA THERAPIES |
KELLY J BAKER |
| K102063 |
10/11/2011 |
HEALTH-E-CONNECT SYSTEM |
ALR TECHNOLOGIES |
PAUL DRYDEN |
| K112842 |
10/25/2011 |
AMS ELEVATE PC |
AMERICAN MEDICAL SYSTEMS, INC. |
MATTHEW D STEPANEK |
| K111740 |
10/05/2011 |
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION |
AMERIWATER |
BRIAN R BOWMAN |
| K112116 |
10/04/2011 |
DIGITAL CLINICAL THERMOMETER MODEL V901US |
AMPEROR-ELECTRONIC(SZ) CO., LTD |
RAJ KASBEKAR |
| K102329 |
10/24/2011 |
NANOKNIFE SYSTEM |
ANGIODYNAMICS, INC. |
KIT CARIQUITAN |
| K111532 |
10/07/2011 |
MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE |
ANTHOGYR SAS |
BRAYETTE SABINE |
| K112849 |
10/27/2011 |
FIXATE TISSUE BAND |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K112254 |
10/11/2011 |
APEX KIRSCHNER WIRES AND STEINMANN PINS |
APEX TOOLS & ORTHOPEDICS CO. |
SCOTT LIANG |
| K103155 |
10/28/2011 |
SUMO ACCESS AND TISSUE RESECTION SYSTEM |
APOLLO ENDOSURGERY, INC. |
GREG MATHISON |
| K110804 |
10/19/2011 |
AMT G-J TUBE |
APPLIED MEDICAL TECHNOLOGY, INC. |
JOSHUA D MEINKE |
| K110345 |
10/19/2011 |
SCANVIEW SYSTEM |
APPLIED SPECTRAL IMAGING |
DAN LAOR |
| K111904 |
10/18/2011 |
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN |
ARK DIAGNOSTICS,INC |
KENNETH C KASPER |
| K103643 |
10/06/2011 |
ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) |
ASCOT TECHNOLOGIES, INC. |
MARY E RANDALL |
| K103251 |
10/28/2011 |
DUOCENTRIC REVERSED |
ASTON MEDICAL |
CATHERINE GLOSTER |
| K111828 |
10/26/2011 |
CLEARSPLINT ES |
ASTRON DENTAL CORPORATION |
DOUGLAS S MULLER |
| K112759 |
10/18/2011 |
APCLO PEDICLE SCREW SYSTEMS |
ATLAS SPINE INC. |
THOMAS G SMITH |
| K112579 |
10/06/2011 |
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER |
AVINGER, INC. |
SEVRINA CIUCCI |
| K111990 |
10/17/2011 |
CORONIS 5MP |
BARCO NV |
LIEVEN DE WANDEL |
| K111662 |
10/04/2011 |
VENOTRAIN CURAFLOW |
BAUERFEIND AG |
INES EXNER |
| K112192 |
10/25/2011 |
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS |
BAUSCH & LOMB, INC. |
TRICIA GARRETT |
| K112893 |
10/18/2011 |
CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS |
BAXTER HEALTHCARE CORPORATION |
NANETTE HEDDEN |
| K102416 |
10/20/2011 |
BD GENEOHM VANR ASSAY |
BD DIAGNOSTICS SCIENCE |
RAYMOND BOULE |
| K110646 |
10/12/2011 |
BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER |
BEAM-MED LTD |
RITA KOREMBLUM |
| K112586 |
10/18/2011 |
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) |
BECTON DICKINSON AND COMPANY (BD) |
KATIE COYLE |
| K112277 |
10/28/2011 |
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B |
Becton, Dickinson and Company |
Gregory P Payne |
| K112911 |
10/27/2011 |
FETAL DOPPLER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Diana Hong |
| K103684 |
10/21/2011 |
VRESELECT CULTURE MEDIUM |
BIO-RAD |
FRAN WHITE |
| K112810 |
10/26/2011 |
MULTI-ANALYTE DETECTION SYSTEMS |
Bio-Rad Laboratories |
Juang Wang |
| K111979 |
10/18/2011 |
RADIOACTIVE SEED LOCALIZATION NEEDLE |
BIOCOMPATIBLES INC. |
WAYNE RICHARDSON |
| K111909 |
10/18/2011 |
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE |
BIOMERIEUX, INC. |
NATHAN HARDESTY |
| K112228 |
10/03/2011 |
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN |
BIOMERIEUX, INC. |
JENNIFER CHIA-HSUAN LIN |
| K112000 |
10/26/2011 |
VITEK 2 STREPTOCOCCUS PENICILLIN |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K103752 |
10/14/2011 |
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K112014 |
10/17/2011 |
ZYSTON STRAIGHT SPACER SYSTEM |
BIOMET SPINE |
JULIE A RYAN |
| K112007 |
10/05/2011 |
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K112701 |
10/25/2011 |
CHARGER BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC |
GLENN JACQUES |
| K112745 |
10/18/2011 |
V-14 CONTROL WIRE GUIDEWIRE |
Boston Scientific Corporation |
SHANNON PETTIT |
| K110021 |
10/18/2011 |
DASH HIP |
BRAINLAB, AG |
ALEXANDER SCHWIERSCH |
| K111436 |
10/14/2011 |
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX |
BRENNEN MEDICAL, LLC |
KENNETH B HERLAND |
| K102316 |
10/07/2011 |
GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM |
BROADMASTER BIOTECH CORPORATION |
ROGER LAI |
| K112051 |
10/12/2011 |
LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE |
BRONCUS TECHNOLOGIES, INC. |
MAHTAB FATEMI |
| K112497 |
10/24/2011 |
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT |
C.R. BARD, INC. |
Joni Creal |
| K112744 |
10/20/2011 |
SAPIENS TIP CONFIRMATION SYSTEM |
C.R. BARD, INC. |
HENRY BOLAND |
| K112715 |
10/05/2011 |
CANDELA GENTLEMAX FAMILY OF LASERS |
CANDELA CORP. |
SAM WADE |
| K112211 |
10/20/2011 |
DURA BLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K112283 |
10/20/2011 |
DURA BLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K103651 |
10/04/2011 |
CARDIOMED |
CARDIO MEDICAL PRODUCTS, INC. |
NICK MENDISE |
| K111320 |
10/07/2011 |
GLOBALCARDIO |
CARDIOCOMM SOLUTIONS, INC. |
JON WARD |
| K111408 |
10/17/2011 |
MICROGARD II |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K110919 |
10/20/2011 |
CARESTREAM PACS |
CARESTREAM HEALTH, INC. |
LINDA STEWART |
| K111566 |
10/06/2011 |
DRYVIEW CHROMA IMAGING SYSTEM |
CARESTREAM HEALTH,INC. |
CHRISTINE EHAMNN |
| K101592 |
10/06/2011 |
ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM |
CHENG MEDICAL, CORPORATION |
MARY P GALLUP |
| K103675 |
10/03/2011 |
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE |
CHIENMAX VIETNAM CO. LTD |
JIGAR SHAH |
| K112335 |
10/12/2011 |
BANTAM CATHETER (280MM BALLOON LENGTHS) |
CLEAR STREAM TECHNOLOGIES, LTD. |
FIONA NI MHULLAIN |
| K112828 |
10/25/2011 |
REVIVE INTERMEDIATE CATHETER (REVIVE IC) |
Codman & Shurtleff, Inc. |
CATHERINE KILSHAW |
| K103791 |
10/21/2011 |
PHYSIOGLOVE ES WITH ECG ANALYSIS |
COMMWELL LTD. |
IRVING LEVY |
| K112384 |
10/18/2011 |
ABDOMINAL TOURNIQUET SYSTEM |
COMPRESSION WORKS LLC |
Ruth Forstadt |
| K112019 |
10/12/2011 |
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP |
CORENTEC CO., LTD |
J.S. DANIEL |
| K111825 |
10/25/2011 |
ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
FRANK GIANELLI |
| K110531 |
10/06/2011 |
ENDOFLIP ECD |
CROSPON, LTD. |
PAUL DRYDEN |
| K111343 |
10/06/2011 |
CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS |
CROSSTEX INTERNATIONAL, INC. |
RICHARD M ORMSBEE |
| K111120 |
10/14/2011 |
CSM SUBMERGED-R IMPLANT SYSTEM |
CSMIMPLANT |
APRIL LEE |
| K112974 |
10/20/2011 |
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
CURVE DENTAL, INC. |
GEORGE STANTCHEV |
| K110912 |
10/20/2011 |
SMART TOUCH UVTHERAPY MULTIPLE MACHINE |
DAAVLIN DISTRIBUTING CO. |
MICHELE THIEL |
| K111542 |
10/20/2011 |
DELTEX MEDICAL CARDIOQ EDM |
DELTEX MEDICAL LIMITED |
NEIL R ARMSTRONG |
| K112249 |
10/25/2011 |
HEALIX KNOTLESS(TM) ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
| K111822 |
10/26/2011 |
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH |
DIAGNOSTICA STAGO, INC. |
CARLO D'ALESSANDRO |
| K112746 |
10/21/2011 |
DIOSLIMON IMPLANT SYSTEM |
DIO CORPORATION |
TIMOTHY LEE |
| K112874 |
10/17/2011 |
EZ VEIN INFLATABLE TOURNIQUET |
DOMINION MEDICAL DEVICES, LLC |
ELAINE DUNCAN |
| K103625 |
10/06/2011 |
OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE |
Draeger Medical Systems, Inc. |
JOYCE KILROY |
| K111583 |
10/04/2011 |
FLAATZ 560 |
DRTECH CORP. |
CHOUL-WOO SHIN |
| K112694 |
10/14/2011 |
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER |
EDWARDS LIFESCIENCES, LLC. |
SPENCER WALKER |
| K112466 |
10/27/2011 |
4MP COLOR LCD MONITOR, RADIFORCERX430 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K110780 |
10/07/2011 |
ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II |
ELITECH GROUP |
DEBRA K HUTSON |
| K111735 |
10/03/2011 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K111010 |
10/27/2011 |
SPIDERFX EMBOLIC PROTECTION DEVICE |
EV3 INC |
BRENDA JOHNSON |
| K111723 |
10/27/2011 |
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K110716 |
10/18/2011 |
EVERYWAY LOW BACK PAIN RELIEF SYSTEM |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
ROBERT TU |
| K112415 |
10/21/2011 |
LIFECARE ARM & LEG PAIN RELIEF SYSTEM |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
ROBERT TU |
| K111155 |
10/20/2011 |
XTRAFIX EXTERNAL FIXATION SYSTEM |
EXTRAORTHO INC |
MARCOS VELEZ-DURAN |
| K110993 |
10/12/2011 |
FEMCHEC PRESSURE MANAGEMET DEVICE |
FEMASYS INC. |
LISA PEACOCK |
| K111683 |
10/31/2011 |
FLIGHT 60 VENTILATOR |
FLIGHT MEDICAL INNOVATIONS LTD. |
SHOSHANA FRIEDMAN |
| K111639 |
10/21/2011 |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE |
DENISE OPPERMANN |
| K112439 |
10/17/2011 |
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K111859 |
10/07/2011 |
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL INC. |
AMY MCKINNEY |
| K111200 |
10/12/2011 |
MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM |
GE HEALTHCARE |
CAROL ALLOIAN |
| K111551 |
10/04/2011 |
OEC(R) 9800, OEC(R) 9800 PLUS |
GE OEC MEDICAL SYSTEMS, INC |
GERALD BUSS |
| K103485 |
10/06/2011 |
SENOGRAPH DS, SENOGRAPH ESSENSTIAL |
GENERAL ELECTRIC COMPANY |
STEVEN KACHELMEYER |
| K111434 |
10/27/2011 |
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L |
GIOTTO USA, LLC |
PATRICK MOONEY |
| K112756 |
10/07/2011 |
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K102278 |
10/20/2011 |
QUADRA BLOC TENS PLUS |
GRADIENT TECHNOLOGIES, LLC |
JOHN TOWNSEND |
| K111644 |
10/03/2011 |
MOBICATH TRANSSEPTAL NEEDLE |
Greatbatch Medical |
Kristi Fox |
| K103757 |
10/13/2011 |
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT |
GRIFOLS |
Gary Lehnus |
| K111354 |
10/17/2011 |
GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) |
GS MEDICAL CO., LTD. |
DONALD W GUTHNER |
| K112803 |
10/24/2011 |
PATIENT MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Diana Hong |
| K112844 |
10/27/2011 |
REHASTIM 2, REHAMOVE 2 |
HASOMED GMBH |
MATTHIAS WEBER |
| K111988 |
10/28/2011 |
EASYSCAN MODEL 1.2 |
I-OPTICS BV |
WILLIAM GREENROSE |
| K103278 |
10/28/2011 |
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION |
i-SENS, Inc. |
HYUN JOON OH |
| K111766 |
10/19/2011 |
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS |
IDEV TECHNOLOGIES, INC. |
DARENE GARNER |
| K111647 |
10/06/2011 |
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES |
INOMED MEDIZINTECHNIK GMBH |
SASCHKA BUSCH |
| K111414 |
10/20/2011 |
QUANTA FLASH (TM) DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
RUFUS BURLINGAME |
| K110569 |
10/24/2011 |
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) |
INOVISE MEDICAL, INC. |
EARL ANDERSON |
| K112250 |
10/28/2011 |
CHX=CHX PLUS |
INTER-MED, INC. |
JOHN BAETEN |
| K111030 |
10/21/2011 |
E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
JINYOUNG LEE |
| K112263 |
10/07/2011 |
MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY |
INTUITIVE SURGICAL, INC. |
BRANDON HANSEN |
| K112520 |
10/26/2011 |
US-101L, US-103S |
ITO CO., LTD. |
HARUHISA OKADA |
| K111958 |
10/14/2011 |
TETRIC EVOCERAM BULK FILL |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K110819 |
10/05/2011 |
SINGHMED ROOLIP MANIPULATOR |
J.SINGH INSTRUMENTS |
CAROLINE TONTINI |
| K113091 |
10/28/2011 |
SYRINGES AND NEEDLES |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
Diana Hong |
| K112178 |
10/27/2011 |
JMS APHERESIS NEEDLE SET WINGEATER(R) V2 |
JMS NORTH AMERICA CORPORATION |
E.J. Smith |
| K111948 |
10/24/2011 |
WINGEATER V2 |
JMS NORTH AMERICA CORPORATION |
E J SMITH |
| K110694 |
10/11/2011 |
CONCORDE BULLET SPINAL SYSTEM |
JOHNSON & JOHNSON |
DAPHNEY GERMAIN-KOLAWOLE |
| K110551 |
10/26/2011 |
EXPEDIUM SPINE SYSTEM |
JOHNSON & JOHNSON |
FRANK JURCZAK |
| K112037 |
10/06/2011 |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
K2M, INC. |
NANCY GIEZEN |
| K111402 |
10/20/2011 |
KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL |
KIMBERLY-CLARK |
ANN WATERHOUSE, RAC |
| K112635 |
10/07/2011 |
U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS |
KIMBERLY-CLARK CORP. |
Swarna Mukund |
| K110153 |
10/12/2011 |
SFC VERTEBRAL BODY REPLACEMENT |
KONIGSEE IMPLANTATE GMBH |
JUSTIN EGGLETON |
| K111772 |
10/20/2011 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
CHO SOW FONG |
| K103348 |
10/20/2011 |
DIGIVIEW 250 |
KUB TECHNOLOGIES, INC |
VIKRAM BUTANI |
| K111980 |
10/14/2011 |
CLEARFIL TRI-S BOND PLUS |
KURARAY AMERICA, INC. |
KIYOYUKI ARIKAWA |
| K111975 |
10/14/2011 |
CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK |
KURARAY MEDICAL INC. |
MICHIO TAKIGAWA |
| K111169 |
10/03/2011 |
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF |
KWANG MYUNG DAICOM INC |
Priscilla Chung |
| K110783 |
10/24/2011 |
VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE |
L & K BIOMED CO., LTD |
HEE KYEONG JOO |
| K112460 |
10/07/2011 |
MULTIPLE |
LARSON MEDICAL PRODUCTS, INC. |
PETER LARSON |
| K112098 |
10/19/2011 |
TBD |
LENSAR, INC. |
SHIRLEY MCGARVEY |
| K101286 |
10/20/2011 |
SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 |
LINDE HEALTHCARE AB |
ANDERS PALM |
| K110655 |
10/27/2011 |
MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM |
MAHE MEDICAL GMBH |
ANDREA PECSI |
| K111621 |
10/26/2011 |
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
ANIL BHALANI |
| K111492 |
10/13/2011 |
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K112703 |
10/04/2011 |
SHAKER DIGITAL THERMOMETER |
MEASURE TECHNOLOGY CO. LTD. |
RACK YU |
| K112115 |
10/07/2011 |
MECTACER BIOLOX(R) DELTA FEMORAL HEADS |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K112788 |
10/20/2011 |
EASTLYTE NA/K/CA/PH |
MEDICA CORP. |
Photios Makris |
| K112626 |
10/20/2011 |
LIPSONIX(R) SYSTEM MODEL 2 |
MEDICIS TECHNOLOGIES CORPORATION |
MICHAEL A HOFFMAN |
| K102387 |
10/24/2011 |
MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES |
MEDISCOPE MANUFACTURING, INC. |
DIANE SUDDUTH MS, DVM, MPH |
| K112156 |
10/17/2011 |
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM |
MEDOS INTERNATIONAL SARL |
JOCELYN RAPOSO |
| K112345 |
10/31/2011 |
DISTAL VOLAR RADIUS PLATING SYSTEMS |
MEDOS INTERNATIONAL SARL |
SUZANA OTANO |
| K112086 |
10/14/2011 |
MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE |
MEDRAD, INC. |
MIKE BURNSIDE |
| K111264 |
10/12/2011 |
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA |
REGINA HOLMES |
| K112473 |
10/21/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
CHRIS MCKEE |
| K110063 |
10/04/2011 |
SOVEREIGN SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
MIKE SCOTT |
| K111520 |
10/26/2011 |
IPC POWEREASE SYSTEM |
MEDTRONIC XOMED, INC. |
RISHI SINHA |
| K112917 |
10/27/2011 |
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID |
MEDTRONIC, INC. |
DEBORAH KIDDER |
| K112323 |
10/18/2011 |
CARDIA-CATH |
MILLAR INSTRUMENTS, INC. |
FATMA M ALI |
| K110057 |
10/28/2011 |
MINI MASSEUSE |
MJ SPECIALTY RETAIL |
CHARLES MACK |
| K110003 |
10/13/2011 |
MTF NEW BONE VOID FILLER |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY JOY |
| K112107 |
10/28/2011 |
BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS |
NEUROVIRTUAL USA, INC. |
EDUARDO FARIA |
| K110315 |
10/20/2011 |
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE |
NEXGEN MEDICAL SYSTEMS, INC. |
CRAIG PAGAN |
| K110594 |
10/28/2011 |
GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K112259 |
10/28/2011 |
NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K112713 |
10/27/2011 |
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS |
NORFOLK MEDICAL PRODUCTS, INC. |
MICHAEL DALTON |
| K112773 |
10/14/2011 |
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
| K111597 |
10/13/2011 |
DISPOSABLE STIMULATING ELECTRODE |
NUVASIVE, INC. |
Sheila Bruschi |
| K111311 |
10/17/2011 |
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING |
OMISA INC. (SEGASIST TECHNOLOGIES) |
ALLISON MANNERS |
| K112629 |
10/11/2011 |
ONSET ACCESS CATHETER SYSTEM |
ONSET MEDICAL CORPORATION |
JOSEPH BISHOP |
| K111965 |
10/25/2011 |
VUSION(R) OS |
ORTHO DEVELOPMENT |
TOM HAUETER |
| K110326 |
10/27/2011 |
OSRAM ITOS |
OSRAM SYLVANIA, INC. |
MARIE A SCHROEDER |
| K110308 |
10/03/2011 |
PROSTHETIC SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K112269 |
10/20/2011 |
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE |
OSTAR MEDITECH CORP. |
STEVEN CHANG |
| K111419 |
10/07/2011 |
OSTEOMED HAND FUSION SYSTEM |
OSTEOMED L.P. |
SUZANNE CHEANG |
| K111693 |
10/28/2011 |
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K112652 |
10/11/2011 |
SURESIGNS VS2+ -SURESIGNS VSI |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K111905 |
10/04/2011 |
INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
MARKUS STACHA |
| K111378 |
10/04/2011 |
OXIMETRY INTERFACE KIT |
PHILIPS RESPIRONICS, INC |
ELAINE LARKIN |
| K102871 |
10/03/2011 |
SILVER CARE ANITBACTERIAL TOOTHBRUSH |
PIAVE SPAZZOLIFICIO S.P.A. |
KEILA LACOURT |
| K112267 |
10/20/2011 |
NEUROLAC(R) NERVE GUIDE |
Polyganics BV |
BETTY IJMKER |
| K103115 |
10/12/2011 |
PRODIGY DIABETES MANAGEMENT SOFTWARE |
PRODIGY DIABETES CARE, LLC. |
E.J. Smith |
| K111978 |
10/13/2011 |
SULCUS BLUE |
PRODUITS DENTAIRES PIERRE ROLLAND |
RICK ROSATI |
| K111993 |
10/24/2011 |
FRAMEWALKER |
QUANTUM MEDICAL CONCEPTS, LLC. |
ALICIA BACH |
| K112177 |
10/24/2011 |
SOFIA ANALYZER AND INFLUENZA A+B FIA |
QUIDEL CORP. |
JOHN D TAMERIUS |
| K102346 |
10/14/2011 |
RANDOX DIGOXIN ASSAY |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K112017 |
10/11/2011 |
RAUMEDIC ICP MONITORING SYSTEM |
RAUMEDIC AG |
REINER THIEM |
| K112468 |
10/20/2011 |
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE |
REGULATORY SPECIALISTS, INC. |
GRACE HOLLAND |
| K102454 |
10/25/2011 |
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM |
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. |
PAUL DRYDEN |
| K111610 |
10/14/2011 |
TRILOGY SERIES VENTILATOR WITH OXIMETRY |
RESPIRONICS, INC. |
JOSEPH E OLSAVSKY |
| K112512 |
10/20/2011 |
VANISHPOINT BLOOD COLLECTION SET |
RETRACTABLE TECHNOLOGIES, INC. |
RHONDA WELLS |
| K112528 |
10/18/2011 |
ELECSYS T4 CALCHECK 5 |
ROCHE DIAGNOSTICS CORPORATION |
Michael Leuther |
| K112646 |
10/12/2011 |
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
| K111737 |
10/14/2011 |
DISPOSABLE ELECTRODE |
SANIBEL SUPPLY |
ERIK NIELSEN |
| K112961 |
10/31/2011 |
CLO-SURPLUS P.A.D. |
SCION CARDIO-VASCULAR, INC. |
CRAIG PAGAN |
| K110586 |
10/14/2011 |
ADVIA CENTAUR VITAMIN D TOTAL ASSAY |
Siemens Healthcare Diagnostics Inc. |
NEIL PARKER |
| K102772 |
10/07/2011 |
DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) |
SIEMENS HEATLHCARE DIAGNOSTICS INC |
HELEN M LEE |
| K111538 |
10/25/2011 |
SKAFFOLD CIS |
SKELETAL KINETICS, LLC |
CHRISTINE KUO |
| K110135 |
10/14/2011 |
POLARCUP DUAL MOBILITY SYSTEM |
SMITH & NEPHEW, INC. |
THERESA LEISTER |
| K111994 |
10/11/2011 |
SMITH & NEPHEW CANNULATED SCREWS AND WASHERS |
SMITH & NEPHEW, INC. |
MAUREEN WHITSON |
| K112771 |
10/14/2011 |
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K112173 |
10/05/2011 |
SPEACELABS MULTIGAS MODULE |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K112032 |
10/17/2011 |
8FR TURBO - TANDEM SYSTEM |
SPECTRANETICS CORP. |
SHELLEY WILCOX |
| K110992 |
10/21/2011 |
ENSPIRE DEBRIDER SYSTEM |
SPINE VIEW, INC. |
MBITHI MUTHINI |
| K111854 |
10/21/2011 |
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER |
ST. JUDE MEDICAL SYSTEMS AB |
MIKAEL SJOLANDER |
| K110407 |
10/13/2011 |
INVISIPORT |
STEALTH THERAPEUTICS, INCORPORATED |
Gary J Syring |
| K111357 |
10/03/2011 |
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
ELAINE ALAN |
| K111848 |
10/05/2011 |
EXETER X3 RIMFIT ACETABULAR CUP |
STRYKER CORP. |
ESTELA CELI |
| K112292 |
10/21/2011 |
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER |
STRYKER SUSTAINABILITY SOLUTIONS |
RAMONA KULIK |
| K110672 |
10/03/2011 |
ETWO SKIN TREATMENT SYSTEM |
SYNERON, LTD. |
YORAM LEVY |
| K112786 |
10/25/2011 |
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF |
SYNOVIS ORTHOPEDIC AND WOUNDCARE, INC. |
AMY BOUCLY |
| K112689 |
10/26/2011 |
SYNTHES STERNAL FIXATION SYSTEM |
SYNTHES INC |
ELIZABETH KIERZEK |
| K103320 |
10/20/2011 |
SYNTHES XRL |
SYNTHES SPINE CO.LP |
HEATHER GUERIN |
| K103487 |
10/04/2011 |
FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST |
TaiDoc Technology Corporation |
TELING HSU |
| K111206 |
10/04/2011 |
TECO DIAGNOSTICS SALIVA ALCOHOL TEST |
TECO DIAGNOSTICS |
JAMES LI |
| K112456 |
10/04/2011 |
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT |
Teleflex Medical, Inc. |
NATALIE SMITH |
| K111606 |
10/03/2011 |
PINNACLE PRECISION ACCESS SYSTEM |
TERUMO MEDICAL CORP. |
DANIEL R PLONSKI |
| K111512 |
10/26/2011 |
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM |
THOMPSON MIS INC |
FRANK SULLIVAN |
| K110318 |
10/03/2011 |
EXCELLAGEN |
TISSUE REPAIR COMPANY |
LOIS CHANDLER |
| K112445 |
10/28/2011 |
SOFRELINER TOUGH S |
TOKUYAMA DENTAL CORPORATION |
KEITH A BARRITT |
| K112446 |
10/07/2011 |
TOMOTHERAPY TREATMENT SYSTEM |
TOMOTHERAPY INCORPORATED |
GREG BANGE |
| K112615 |
10/11/2011 |
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K110870 |
10/04/2011 |
APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K110250 |
10/14/2011 |
MPXX POWDER FREE NATURAL RUBBER EXAMINATION GLOVES |
TOTAL GLOVES SDN BHD |
OOI LOON SENG |
| K112604 |
10/27/2011 |
21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356) |
TOTOKU ELECTRIC CO., LTD |
TSUKASA TASHIRO |
| K112737 |
10/20/2011 |
TIGER HEADLESS CANNULATED SCREWS |
TRILLIANT SURGICAL LTD |
J D WEBB |
| K111266 |
10/06/2011 |
EASYLOCK OSTEOSYSTEM |
TRIMED, INC. |
DOUG STEINBERGER |
| K112358 |
10/17/2011 |
UNIMAX TROCAR SYSTEM |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
| K111640 |
10/07/2011 |
PRECISION FLOW(R) - HELIOX |
VAPOTHERM, INC. |
GREGORY A WHITNEY |
| K112631 |
10/27/2011 |
VSI GUIDEWIRE |
VASCULAR SOLUTIONS, INC. |
MELINDA SWANSON |
| K112571 |
10/06/2011 |
XL EXTRACTION CATHETER |
VASCULAR SOLUTIONS, INC. |
MATT NIENSTEDT |
| K111543 |
10/12/2011 |
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) |
VENTANA MEDICAL SYSTEMS, INC. |
INDU LAKSHMAN |
| K111784 |
10/07/2011 |
VENUS SWAN SYSTEM |
VENUS CONCEPT LTD |
YORAM LEVY |
| K112929 |
10/18/2011 |
THERMOFLASH(TM) INFRARED THERMOMETER |
VISIOMED GROUP SA |
ERIC SEBBAN |
| K112661 |
10/20/2011 |
VIZION DR |
VIZTEK LLC |
DANIEL KAMM |
| K112374 |
10/20/2011 |
X-TRA BASE |
VOCO GMBH |
T. GERKENSMEIER |
| K100163 |
10/13/2011 |
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX |
VYGON CORP. |
CINDY VARUGHESE |
| K112166 |
10/21/2011 |
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE |
W AND R INVESTMENTS DBA LASER ENGINEERING |
ROBERT I RUDKO |
| K112370 |
10/14/2011 |
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM |
WELLDOC, INC |
LAUREN BRONICH-HALL |
| K112710 |
10/17/2011 |
ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K111910 |
10/14/2011 |
GLADIATOR HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K112772 |
10/07/2011 |
ORTHOLOC(TM) BONE SCREWS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K103598 |
10/17/2011 |
PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K111404 |
10/07/2011 |
HUIBAO BODY FAT SCALE |
ZHONGSHAN HUIBAO WEIGHING APPARATUS CO., LTD |
KEVIN DENG |
| K110836 |
10/07/2011 |
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY |
ZIMMER GMBH |
DANIEL J WILLIMAN |
| K111447 |
10/05/2011 |
ZIMMER PERIARTICULAR SCREWS |
ZIMMER INC. |
STEPHEN H MCKELVEY |
| K111796 |
10/27/2011 |
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM |
ZIMMER SPINE, INC. |
ELSA LINKE |
| K112174 |
10/26/2011 |
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM |
ZIMMER, INC. |
STEPHEN H MCKELVEY |
| K111296 |
10/27/2011 |
ZOLL RESCUENETLINK |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
CHARLES W KOLIFRATH |
