| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K111759 |
06/22/2011 |
.DECIMAL ELECTRON APERTURE |
.DECIMAL, INC. |
DANIEL L BENNETT |
| K111686 |
06/16/2011 |
A & D MEDICAL UA-1000 FAMILY DAGITAL BLOOD PRESSURE MONITORS |
A&D COMPANY, LTD. |
JERRY WANG |
| K111697 |
06/17/2011 |
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM |
ABBOTT MEDICAL OPTICS INC |
OPHELIA BIGGS |
| K111617 |
06/10/2011 |
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 |
ACARE TECHNOLOGY CO., LTD. |
Diana Hong |
| K111608 |
06/09/2011 |
SLIC SCREW REPAIR SYSTEM |
ACUMED LLC |
HOLLACE RHODES |
| K111805 |
06/27/2011 |
ECG SERIES ELECTROCARDIOGRAPH |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
| K111518 |
06/02/2011 |
STERRAD CHEMIAL INDICATOR STRIP MODEL 14100 |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K111519 |
06/02/2011 |
STERRAD SEALSURE CHEMICAL INDICATOR TAPE MODEL 14202 |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K111638 |
06/13/2011 |
IMPAX VOLUME VIEWING |
AGFA HEALTHCARE N.V. |
KOEN COBBAERT |
| K111587 |
06/07/2011 |
ALERKAN SPIROMETRY FILTER |
ALERKAN LTD |
Glen Feye |
| K111634 |
06/13/2011 |
XENON(TM) PEDICLE SCREW SYSTEM |
ALPHATEC SPINE, INC. |
CHERYL ALLEN |
| K111864 |
06/30/2011 |
E-CUBE 9 |
ALPINION MEDICAL SYSTEMS CO., LTD |
YUCHI CHU |
| K111680 |
06/15/2011 |
DR. GREENSBURG'S HYBRID |
ALWAYS MORE MARKETING INC |
JONATHAN GREENBURG |
| K111740 |
06/21/2011 |
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION |
AMERIWATER |
BRIAN R BOWMAN |
| K111830 |
06/28/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MO |
ANDON HEALTH CO., LTD |
LIU YI |
| K111826 |
06/28/2011 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| K111750 |
06/22/2011 |
EXTRA PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE; PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
ANGIOSLIDE, LTD |
CLAY ANSELMO |
| K111531 |
06/02/2011 |
RHA2020 |
ANNIDIS HEALTH SYSTEMS CORP. |
MICHAEL MCDONNELL |
| K111532 |
06/03/2011 |
MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE |
ANTHOGYR SAS |
BRAYETTE SABINE |
| K111549 |
06/03/2011 |
ATTUNE SLEEP APNEA SYSTEM |
APNICURE, INC. |
CHRIS DANIEL |
| K111856 |
06/29/2011 |
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE |
APOTHECARY PRODUCTS, INC. |
JAMES JENKINS |
| K111661 |
06/14/2011 |
ARTHREX SCAPHOLUNATE ANCHOR |
ARTHREX, INC. |
COURTNEY SMITH |
| K111799 |
06/27/2011 |
NUGAIT(TM) SUBTALAR IMPLANT SYSTEM |
ASCENSION ORTHOPEDIC |
BRADLEY W STRASSER |
| K111600 |
06/08/2011 |
REPROCESSED HAND ACTIVATE SEALER/DIVIDER |
ASCENT HEALTHCARE SOLUTIONS |
RAMONA KULIK |
| K111851 |
06/29/2011 |
MEDIOSTAR NEXT |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K111828 |
06/28/2011 |
CLEARSPLINT ES |
ASTRON DENTAL CORPORATION |
DOUGLAS S MULLER |
| K111547 |
06/03/2011 |
BILI-THERAPY PAD TYPE |
ATOM MEDICAL CORPORATION |
PAUL DRYDEN |
| K111704 |
06/17/2011 |
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX |
AVINGER, INC. |
SEVRINA CIUCCI, RAC |
| K111662 |
06/14/2011 |
VENOTRAIN CURAFLOW |
BAUERFEIND AG |
INES EXNER |
| K111523 |
06/01/2011 |
OSTEOCOOL (TM) RF ABLATION SYSTEM |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K111860 |
06/30/2011 |
BD MAX GBS ASSAY, BD MAX INSTRUMENT |
BECTON DICKINSON & CO. |
MARY ANNE WILLIAMS |
| K111831 |
06/28/2011 |
MX-7000 MICROXEL |
BIO-MED U.S.A., INC. |
YOUNG CHI |
| K111809 |
06/27/2011 |
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS |
BIOMATERIALS KOREA INC. |
Kevin Walls |
| K111599 |
06/08/2011 |
VITEK 2 AST-ST LINEZOLID |
BIOMERIEUX, INC. |
NATHAN HARDESTY |
| K111564 |
06/06/2011 |
MAXFIRE MARXMEN MENISCAL REPAIR DEVICE |
BIOMET SPORTS MEDICINE |
ELIZABETH WRAY |
| K111746 |
06/21/2011 |
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) |
BIOMET, INC. |
PATRICIA SANDBORN BERES |
| K111839 |
06/29/2011 |
SELECTRA ACCESSORY KIT |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K111593 |
06/07/2011 |
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM |
BM KOREA CO., LTD. |
RONALD D ARKIN |
| K111820 |
06/28/2011 |
SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE |
BM KOREA CO., LTD. |
Priscilla Chung |
| K111609 |
06/09/2011 |
BOSTON BAND |
BOSTON BRACE INTL., INC. |
JAMES WYNNE |
| K111648 |
06/13/2011 |
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR |
BRACCO DIAGNOSTIC, INC. |
TRACEY ALEXANDER |
| K111850 |
06/29/2011 |
VACCESS PTA DILATATION CATHETER |
C.R. BARD, INC. |
CANDACE WADE |
| K111694 |
06/16/2011 |
ASTRA |
CANDELIS, INC. |
VINCENT CIPOLLA |
| K111612 |
06/09/2011 |
DIGITAL RETINAL CAMERA |
CANON, INC. |
KOJI KUBO |
| K111682 |
06/15/2011 |
DIGITAL RADIOGRAPHY |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
| K111824 |
06/28/2011 |
FLAT PANEL DETECTOR |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
DIANE RUTHERFORD |
| K111710 |
06/20/2011 |
FULL AUTO TONOMETER MODEL TX-20 |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
KOJI KUBO |
| K111745 |
06/21/2011 |
KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
CLAY ANSELMO |
| K111649 |
06/13/2011 |
CS 7600 |
CARESTREAM HEALTH, INC. |
DANIEL HOEFER |
| K111566 |
06/06/2011 |
DRYVIEW CHROMA IMAGING SYSTEM |
CARESTREAM HEALTH,INC. |
CHRISTINE EHAMNN |
| K111507 |
06/01/2011 |
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
CAPT HYE-JOO KIM, PHARM.D. |
| K111690 |
06/16/2011 |
DEVINE SPINAL SYSTEM |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K111841 |
06/29/2011 |
SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE |
CHENGDU XINJIN SHIFENG MED APPRATUS INST CO., LTD |
XINGLONG TIAN |
| K111619 |
06/10/2011 |
MODIFIED CONCENTRIC MICROCATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K111779 |
06/24/2011 |
Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 |
CONMED LINVATEC |
JOHN CUSACK |
| K111695 |
06/16/2011 |
HYBRID GRAFT |
COOK BIOTECH, INC. |
MARY A FADERAN, PHD, RAC |
| K111716 |
06/20/2011 |
KNOTLESS SUTURE FIXATION SYSTEM |
CORE ESSENCE ORTHOPAEDICS |
JEFF MILLER |
| K111578 |
06/07/2011 |
CORELEADER COLLA-ALGI FIBER MODEL CAW |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
| K111733 |
06/21/2011 |
CORELEADER SCAR-DIMMER |
CORELEADER BIOTECH CO., LTD. |
IAN LI |
| K111817 |
06/27/2011 |
PALINDROME RT CHRONIC CATHETER |
COVIDIEN |
WING NG |
| K111825 |
06/28/2011 |
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 |
| K111774 |
06/23/2011 |
PATHWAY MODEL 07XXXX |
CUSTOM SPINE |
SAAD ATTIYAH |
| K111726 |
06/20/2011 |
PATHWAY AVID |
CUSTOM SPINE, INC. |
DAVID DRUMFIELD |
| K111542 |
06/02/2011 |
DELTEX MEDICAL CARDIOQ EDM |
DELTEX MEDICAL LIMITED |
NEIL R ARMSTRONG |
| K111689 |
06/16/2011 |
STLASE |
DENTAL PHOTONICS, INC |
Marcy Moore |
| K111631 |
06/13/2011 |
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR, ROTATOR CUFF ANCHOR / ROTATOR CUFF QUICK AN.. |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
| K111663 |
06/14/2011 |
TRAUMA INTERNAL FIXATION SYSTEMS |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K111589 |
06/07/2011 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP A SKIN PROTECTANT DRUG |
DERMA CARE PLUS PRODUCTS, LLC |
JOSEPH NEUSER |
| K111833 |
06/28/2011 |
VIRTUE |
DIAGNOSOFT, INC. |
JEFFREY ROBERTS |
| K111822 |
06/28/2011 |
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH |
DIAGNOSTICA STAGO, INC. |
CARLO D'ALESSANDRO |
| K111534 |
06/02/2011 |
ABACUS 3CP |
DIATRON US INC |
MICHAEL SWITZER |
| K111664 |
06/14/2011 |
DIAZYME CYSTATIN C POC TEST KIT |
DIAZYME LABORATORIES |
Abhijit Datta |
| K111758 |
06/22/2011 |
CADENS (TM) COLON |
DOG MICROSYSTEMS, INC. |
FLORENT CHANDELIER |
| K111583 |
06/07/2011 |
FLAATZ 560 |
DRTECH CORP. |
CHOUL-WOO SHIN |
| K111655 |
06/13/2011 |
FLAATZ 760 |
DRTECH CORP. |
CHOUL-WOO SHIN |
| K111808 |
06/27/2011 |
SONOLITH I-MOVE |
EDAP TMS FRANCE |
HOLSTEIN HOWARD |
| K111705 |
06/17/2011 |
EKOSONIC ENDOVASCULAR SYSTEM |
EKOS CORPORATION |
JOCELYN KERSTEN |
| K111717 |
06/20/2011 |
ELECTRO-GEL |
ELECTRO-CAP INTL., INC. |
AMY B SWALLOWS |
| K111676 |
06/15/2011 |
APEX |
Elekta Limited |
Patrick Hull |
| K111730 |
06/20/2011 |
SONOTT FLOWLAB(R) |
EM-TEC GMBH |
BERNHARD BRAND |
| K111742 |
06/21/2011 |
MDRIVE |
EMBLA SYSTEMS |
ROBERT G SCHUEPPERT |
| K111735 |
06/21/2011 |
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K111629 |
06/13/2011 |
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K111821 |
06/28/2011 |
BIOPSY VALVE |
ENDOCHOICE, INC. |
THERON GOBER |
| K111747 |
06/22/2011 |
ENDOLOGIX AFX INTRODUCER SYSTEM |
ENDOLOGIX, INC. |
Janet M Fauls |
| K111763 |
06/23/2011 |
PATHASSIST LIGHT FIBER |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K111603 |
06/08/2011 |
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM |
EP DYNAMICS, INC. |
ALBERT REGO |
| K111728 |
06/20/2011 |
EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
YC LEI |
| K111527 |
06/01/2011 |
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT |
ERAGEN BIOSCIENCES, INC. |
DAVID LIM |
| K111803 |
06/27/2011 |
G-SCAN |
ESAOTE, S.P.A. |
Allison Scott |
| K111845 |
06/29/2011 |
THE ESPINER SAC OR E SAC |
ESPINER MEDICAL LIMITED |
EDWIN LINDSAY |
| K111541 |
06/02/2011 |
ENDO-EXPRESS (R) HANDPIECE |
ESSENTIAL DENTAL SYSTEMS, INC. |
JEFFREY WAN |
| K111751 |
06/22/2011 |
VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS |
ETHICON, INC. |
BRIAN A KANERVIKO |
| K111723 |
06/20/2011 |
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K111535 |
06/02/2011 |
EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER |
EXACT MEDICAL MANUFACTURING, INC |
ROBERT O DEAN |
| K111702 |
06/17/2011 |
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE |
FENWAL, INC. |
Kim Forch |
| K111683 |
06/15/2011 |
FLIGHT 60 VENTILATOR |
FLIGHT MEDICAL INNOVATIONS LTD. |
SHOSHANA FRIEDMAN |
| K111720 |
06/20/2011 |
AVIAFIT |
FLOWMEDIC LTD. |
AHAVA STEIN |
| K111639 |
06/13/2011 |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE |
DENISE OPPERMANN |
| K111703 |
06/17/2011 |
INFRARED EAR THEROMETER |
FUDAKANG INDUSTRIAL CO LTD |
DANIEL NAM |
| K111645 |
06/13/2011 |
FD TENS 2050 OR SLIDE TENS MODEL FD2050 |
FUJI DYNAMICS LTD |
CHING KONG (FELIX) LEE |
| K111654 |
06/13/2011 |
FD TENS 2070 |
FUJI DYNAMICS LTD |
CHING KONG (FELIX) LEE |
| K111646 |
06/13/2011 |
ASPIRE CR FOR MAMMOGRAPHY SYSTEM (CRM); FCR ASPIRE CRN (READER). NOTE FOR GENERAL RADIOGRAPHY, READER IS CARBON XL2/FCR |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K111865 |
06/30/2011 |
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K111548 |
06/03/2011 |
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
KATHERINE Y CHOI |
| K111859 |
06/30/2011 |
ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL INC. |
AMY MCKINNEY |
| K111791 |
06/27/2011 |
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM |
GAMMA MEDICA-IDEAS INCORPORATED |
Albert Boniske |
| K111731 |
06/20/2011 |
MOLECULAR BREAST IMAGING SOFTWARE |
GAMMA MEDICA-IDEAS INCORPORATED |
Albert Boniske |
| K111582 |
06/06/2011 |
LOGIQ S8 |
GE HEALTHCARE |
BRYAN BEHN |
| K111614 |
06/08/2011 |
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
JEME WALLACE |
| K111551 |
06/03/2011 |
OEC(R) 9800, OEC(R) 9800 PLUS |
GE OEC MEDICAL SYSTEMS, INC |
GERALD BUSS |
| K111644 |
06/13/2011 |
MOBICATH TRANSSEPTAL NEEDLE |
Greatbatch Medical |
Kristi Fox |
| K111560 |
06/03/2011 |
WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K111636 |
06/13/2011 |
REHAB TNT, REHAB RAM, REHAB MAC, REHAB KIDSTER, BARIATRIC REHAB TNT AND REHAB RAM |
GUNNELL, INC. |
ANDREW EVANCHO |
| K111573 |
06/06/2011 |
MONOBLOC BM SERIES |
HASS CORP. |
Priscilla Chung |
| K111832 |
06/28/2011 |
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID |
HERAEUS KULZER, LLC |
CHERYL ZIMMERMAN |
| K111753 |
06/22/2011 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA B AMMIRATI, RAC, MT (ASCP) |
| K111508 |
06/01/2011 |
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001 |
HOLOGIC, INC. |
DEBORAH THOMAS |
| K111766 |
06/23/2011 |
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS |
IDEV TECHNOLOGIES, INC. |
DARENE GARNER |
| K111627 |
06/10/2011 |
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
IDEV TECHNOLOGIES, INC. |
DARLENE GARNER |
| K111650 |
06/13/2011 |
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K111660 |
06/14/2011 |
XELIS CARDIAC |
INFINITT CO., LTD. |
CARL ALLETTO |
| K111613 |
06/09/2011 |
XELIS FUSION |
INFINITT CO., LTD. |
CARL ALLETTO |
| K111857 |
06/30/2011 |
SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE |
INMED GLOVES FACTORY |
XIAOBING LI |
| K111647 |
06/13/2011 |
C2 NERVEMONITOR SYSTEM WITH ACCESSORIES |
INOMED MEDIZINTECHNIK GMBH |
SASCHKA BUSCH |
| K111529 |
06/02/2011 |
MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- |
INSERT MOLDING SOLUTIONS, INC |
PAUL HENDRIXSON |
| K111669 |
06/15/2011 |
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS |
INSULET CORPORATION |
SUSAN FINNERAN |
| K111741 |
06/21/2011 |
INTEGRA(TM) CUSA NXT(TM) BONE TIPS |
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI |
KEVIN J O'CONNELL |
| K111673 |
06/15/2011 |
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL |
INVIVO CORPORATION |
ELIZABETH WHEELER |
| K111838 |
06/29/2011 |
INQU PASTE MIX |
ISTO TECHNOLOGIES, INC. |
PATSY J TRISLER |
| K111743 |
06/21/2011 |
THE INSYNC CERAMIC SYSTEM |
JENSEN INDUSTRIES, INC. |
GARY PHELPS |
| K111571 |
06/06/2011 |
VIPER SYSTEMS |
JOHNSON & JOHNSON |
DAPHNEY GERMAIN-KOLAWOLE |
| K111748 |
06/22/2011 |
RECOVERY+ MODEL PS 511, DVTHERAPY MODEL PS 511A |
JOY LONG |
JOY LONG |
| K111772 |
06/23/2011 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
CHO SOW FONG |
| K111837 |
06/29/2011 |
RADIAL ARTERY COMPRESSION TOURNIQUET |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
SHAN ZHAO |
| K111714 |
06/20/2011 |
HAIRMAX DUAL 12 |
LEXINGTON INTERNATIONAL, LLC |
CASPER E ULDRICKS ESQ. |
| K111569 |
06/06/2011 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K111729 |
06/20/2011 |
PILOT SPINAL SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K111835 |
06/29/2011 |
PLATEAU SPACER SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K111516 |
06/01/2011 |
NMR LIPOPROFILE (R) TEST AND NMR PROFILER |
LIPOSCIENCE, INC |
SUZETTE M WARNER |
| K111598 |
06/08/2011 |
POWDER-FREE NON-STERILE VINYL EXAMINATION GLOVE |
LPL (HUI ZHOU) GLOVE CO., LTD. |
CAMILLE D THORNTON |
| K111816 |
06/27/2011 |
EQUIMATRIX |
LUITPOLD PHARMACEUTICALS, INC. |
MARSHA SIMON |
| K111524 |
06/02/2011 |
MP 719 |
MARINE POLYMER TECHNOLOGIES, INC. |
SERGIO FINKIELSZTEIN |
| K111621 |
06/10/2011 |
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
ANIL BHALANI |
| K111863 |
06/30/2011 |
SIGNATURE PLANNER,SIGNATURE GUIDES |
MATERIALISE N.V. |
ALAXANDRA RAZZHIVINA |
| K111558 |
06/03/2011 |
SURGICASE GUIDE |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K111641 |
06/13/2011 |
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD |
MATERIALISE N.V. |
OLIVER CLEMENS |
| K111785 |
06/24/2011 |
FREEDOM(R) STEMMED TIBIAL COMPONENTS |
MAXX ORTHOPEDICS, INC. |
NACHE DAVE |
| K111651 |
06/13/2011 |
SPLIT CATH III |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K111601 |
06/08/2011 |
HERO |
MEDICAL PREDICTIVE SCIENCE CORP. |
WILL KING |
| K111734 |
06/21/2011 |
MYSAFETY SYRINGE |
MEDICALCHAIN INTL. CORP. |
ROBIN HWANG |
| K111807 |
06/27/2011 |
MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K111577 |
06/07/2011 |
MEDLINE VIAL DECANTER |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K111658 |
06/14/2011 |
AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE |
MEDTRONIC INC. |
LISA STONE |
| K111525 |
06/01/2011 |
PERIMETER INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK |
MIKE SCOTT |
| K111510 |
06/01/2011 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
KEVIN FORD |
| K111520 |
06/02/2011 |
IPC POWEREASE SYSTEM |
MEDTRONIC XOMED, INC. |
RISHI SINHA |
| K111657 |
06/14/2011 |
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE |
MEDTRONIC, INC. |
LISA STONE |
| K111611 |
06/09/2011 |
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT |
MERIT MEDICAL SYSTEMS, INC. |
JOHN C KNORPP |
| K111536 |
06/02/2011 |
METASURG DIGIFUSE IMPLANT |
METASURG |
JOSHUA SCOTT |
| K111652 |
06/13/2011 |
MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K111802 |
06/27/2011 |
SV BRAIN ARRAY, SIEMENS 3T |
MRI INTERVENTIONS, INC. |
E.F. WADDELL |
| K111588 |
06/07/2011 |
LEGACY-500 |
MT TABLES, LLC |
MILBURN TENNIS |
| K111687 |
06/16/2011 |
EMG SYSTEM |
MYOTRONICS-NOROMED, INC. |
F. ADIB |
| K111618 |
06/10/2011 |
AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION |
NATUS MEDICAL INCORPORATED |
CHARLES L MORIN |
| K111668 |
06/14/2011 |
CAVIOS CAVITY LINER |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
ROBERT SEIPLE |
| K111666 |
06/14/2011 |
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
ROBERT SEIPLE |
| K111761 |
06/23/2011 |
NEO TITANIUM MESH, CTI-MEM |
NEOBIOTECH CO., LTD. |
RON ARKIN |
| K111767 |
06/23/2011 |
NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
MONICA STACHURA,JD |
| K111576 |
06/06/2011 |
NT 2000 LESIONING GENERATOR |
NEUROTHERM, INC. |
F. DAVID ROTHKOPF |
| K111581 |
06/07/2011 |
15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE |
NOBEL BIOCARE AB |
HERBERT CRANE |
| K111811 |
06/27/2011 |
BENDINI(TM) SPINAL ROD BENDING SYSTEM |
NUVASIVE, INC. |
Elias Ketchum |
| K111597 |
06/08/2011 |
DISPOSABLE STIMULATING ELECTRODE |
NUVASIVE, INC. |
Sheila Bruschi |
| K111866 |
06/30/2011 |
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K111788 |
06/24/2011 |
ENDOEYE HD II |
OLYMPUS AMERICA, INC. |
STACY ABBATIELLO KLUESNER |
| K111756 |
06/22/2011 |
V1 SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORP. |
STACY ABBATIELLO KLUESNER |
| K111643 |
06/13/2011 |
OPTO MITRA YELLOW LASER |
OPTO ELECTRONICA SA |
PAULO ANEAS LICHTI |
| K111628 |
06/10/2011 |
P200T |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K111678 |
06/15/2011 |
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
| K111575 |
06/06/2011 |
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX |
ORTHOCON, INC. |
ROSEMARY HARRY |
| K111672 |
06/15/2011 |
MAX ORIENT SUCTION DEVICE FOR ELECTROCAUTERIZER |
PACIFIC HOSPITAL SUPPLY CO., LTD |
IRENE LIN |
| K111840 |
06/29/2011 |
EMERGE FRACTIONAL LASER |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K111517 |
06/02/2011 |
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI |
PHARMAJET, INC. |
MICHAEL J RYAN |
| K111804 |
06/27/2011 |
INTELLISPACE PACS 4.X |
PHILIPS HEALTHCARE INFORMATICS, INC. |
VICTORIA S MACKINNON |
| K111693 |
06/16/2011 |
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR |
PHILIPS MEDICAL SYSTEMS |
TAMARA YOUNT |
| K111513 |
06/01/2011 |
CX50 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
PENNY GRECO |
| K111632 |
06/13/2011 |
INFILL GRAFT DELIVERY SYSTEM |
PINNACLE SPINE GROUP, LLC |
REBECCA K SPINE |
| K111528 |
06/02/2011 |
PIONEER ASPECT ANTERIOR CERVICAL PLATE MODEL 24-SERIES |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K111684 |
06/15/2011 |
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD |
PLAYTEX MANUFACTURING INC. |
PUSHPA RAO |
| K111739 |
06/21/2011 |
KIDS ROCK 3 CHAIR |
PRIDE MOBILITY PRODUCTS CORP. |
KIMBERLY BLAKE |
| K111765 |
06/23/2011 |
FULL CORE BIOPSY SYSTEM |
PROMEX TECHNOLOGIES, LLC |
Allison Scott |
| K111522 |
06/02/2011 |
CHARTIS CATHETER MODEL CHR-CA-12.0 |
PULMONX, INC. |
HANS SCHULZ |
| K111764 |
06/23/2011 |
CHARTIS CONSOLE |
PULMONX, INC. |
HANS SCHULZ |
| K111681 |
06/15/2011 |
HISTOBRUSH |
PURITAN MEDICAL PRODUCTS COMPANY LLC |
WILLIAM M YOUNG |
| K111592 |
06/07/2011 |
YOULASER CO2 LASER SYSTEM |
QUANTA SYSTEM, S.P.A. |
Maurizio Bianchi |
| K111555 |
06/03/2011 |
CIRCUMAURAL ADHESIVE REPLACEMENT |
R & D MEDICAL PRODUCTS, INC. |
JAMES PERRAULT |
| K111637 |
06/13/2011 |
INFRARED EAR THERMOMETER |
RADIANT INNOVATION, INC. |
LYNN CHEN |
| K111814 |
06/27/2011 |
PADLOCK |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAULA WENDLAND |
| K111773 |
06/23/2011 |
RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE |
RENU MEDICAL, INC. |
L BRUCE PIERSON |
| K111610 |
06/09/2011 |
TRILOGY SERIES VENTILATOR WITH OXIMETRY |
RESPIRONICS, INC. |
JOSEPH E OLSAVSKY |
| K111776 |
06/23/2011 |
DELTAVIEW MODEL 2.1 |
RIVERAIN MEDICAL GROUP,LLC |
JENNIFER V BUTSCH |
| K111506 |
06/01/2011 |
ELECSYS PRECICONTROL VARIA 3 |
Roche Diagnostics |
Sarah Baumann |
| K111552 |
06/03/2011 |
ELECSYS T3 CALCHECK 5 |
Roche Diagnostics |
KELLY FRENCH |
| K111590 |
06/07/2011 |
ROG SUTURE ANCHOR, ROG KNOTLESS SUTURE ANCHOR |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
| K111616 |
06/10/2011 |
E-CUBE |
SAESHIN PRECISION CO., LTD. |
Y S LEE |
| K111732 |
06/20/2011 |
AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER |
SALIENT SURGICAL TECHNOLOGIES, INC. |
MARTIN J LEIGHTON |
| K111737 |
06/21/2011 |
DISPOSABLE ELECTRODE |
SANIBEL SUPPLY |
ERIK NIELSEN |
| K111858 |
06/30/2011 |
LIFTKAR PT |
SANO TRANSPORTGERAETE GMBH |
JEANINE A CARROCCIO |
| K111623 |
06/10/2011 |
I-ENDO DUAL |
SATELEC-ACTEON GROUP |
RICK ROSATI |
| K111671 |
06/15/2011 |
SEASPINE MONOPOLAR PROBE SYSYEM |
SEASPINE, INC. |
DAN MILLER |
| K111725 |
06/20/2011 |
MOBILEDIAGNOST WDR |
SEDECAL SA |
JENNIFER CARTLEDGE |
| K111572 |
06/06/2011 |
NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODEL |
SERF |
J.D. WEBB |
| K111557 |
06/03/2011 |
X-FORCE |
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC |
MARK IOELE |
| K111752 |
06/22/2011 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHANDONG JIANHONG NEW MATERIAL COMPANY |
CHU XIAOAN |
| K111559 |
06/06/2011 |
SURGICAL MASKS |
SHANGHAI NEO-MEDICAL IMPORT & EXPORT CO., LTD. |
Diana Hong |
| K111855 |
06/29/2011 |
HY-BOND RESIGLASS |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K111782 |
06/24/2011 |
BEAUTISEALANT |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K111685 |
06/16/2011 |
IP TEMP CEMENT |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K111596 |
06/08/2011 |
TOTAL SHOULDER SYSTEM |
SHOULDER INNOVATIONS, LLC |
ANDREW RODENHOUSE |
| K111677 |
06/15/2011 |
MICROSCAN(R) MICROSTREP PLUS(R) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
JENIFER DAWSON DRISCOLL |
| K111674 |
06/15/2011 |
ACUSON |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K111861 |
06/30/2011 |
SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE |
SIEMENS MEDICAL SYSTEMS USA |
NADIA SOOKDEO |
| K111792 |
06/27/2011 |
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINI |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN, PHD |
| K111620 |
06/10/2011 |
SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE MODEL STANDARD 3 HOLE RIGHT, STANDARD 3 HOLE LEFT, SKELETAL DYNAMICS |
SKELETAL DYNAMICS, LLC |
ANA M ESCAGEDO |
| K111538 |
06/02/2011 |
SKAFFOLD CIS |
SKELETAL KINETICS, LLC |
CHRISTINE KUO |
| K111514 |
06/01/2011 |
SBV2, MULTICHARGER MODEL MC10V2 |
SLEEP PERFORMANCE D.B.A. FATIGUE SCIENCE |
MARC GOODMAN |
| K111760 |
06/22/2011 |
NAVIAID(TM) BGC DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| K111843 |
06/29/2011 |
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
JANICE HASELTON |
| K111711 |
06/20/2011 |
JOURNEY II BCS KNEE SYSTEM |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K111635 |
06/13/2011 |
SMITH & NEPHEW RJ CONSTRAINED LINERS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K111692 |
06/16/2011 |
TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC |
SOMATEX MEDICAL TECHNOLOGIES GMBH |
HARALD JUNG |
| K111550 |
06/03/2011 |
SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM) |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CHARLES L NELSON |
| K111553 |
06/03/2011 |
SPINEFRONTIER LUMBAR IBF SYSTEM |
SPINEFRONTIER, INC. |
HANNAH CROWE |
| K111515 |
06/01/2011 |
SPSMEDICAL SPORVIEW STEAM BI |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K111854 |
06/29/2011 |
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER |
ST. JUDE MEDICAL SYSTEMS AB |
MIKAEL SJOLANDER |
| K111794 |
06/27/2011 |
REPROCESSED HARMONIC SCALPEL |
STERILMED, INC. |
ONYA DENDINGER |
| K111810 |
06/27/2011 |
AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS |
STERIS Corporation |
ROBERT SULLIVAN |
| K111798 |
06/27/2011 |
STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... |
STERNGOLD DENTAL LLC. |
MARIA RAO |
| K111724 |
06/20/2011 |
STRAUMANN TIBRUSH |
STRAUMANN USA |
ELAINE ALAN |
| K111848 |
06/29/2011 |
EXETER X3 RIMFIT ACETABULAR CUP |
STRYKER CORP. |
ESTELA CELI |
| K111786 |
06/24/2011 |
HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM |
STRYKER CORP. |
ESTELA CELI |
| K111719 |
06/20/2011 |
OASYS SPINAL SYSTEM |
STRYKER SPINE |
SORAYA KING |
| K111509 |
06/01/2011 |
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE |
SWEETSPOT DIABETES CARE, INC. |
CHRIS LOGAN |
| K111540 |
06/02/2011 |
SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM |
SYNTHES (USA) |
THOMAS N SHEA |
| K111667 |
06/14/2011 |
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS |
SYNTHES (USA) |
CHRISTOPHER HACK |
| K111595 |
06/07/2011 |
NEUMOVENT GRAPHNET |
TECME S.A. |
Ray Kelly |
| K111797 |
06/24/2011 |
27 G X 1/2 K-PACK SURSHIELD NEEDLE |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K111556 |
06/06/2011 |
GLIDECROSS SUPPORT CATHETER |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K111606 |
06/09/2011 |
PINNACLE PRECISION ACCESS SYSTEM |
TERUMO MEDICAL CORP. |
DANIEL R PLONSKI |
| K111570 |
06/06/2011 |
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR |
THAYER MEDICAL CORPORATION |
ERIKA S STRICKLAND |
| K111675 |
06/15/2011 |
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE LLC |
DALE DAVISON |
| K111512 |
06/01/2011 |
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM |
THOMPSON MIS INC |
FRANK SULLIVAN |
| K111626 |
06/10/2011 |
ENDOSKELETON(R) TAS |
TITAN SPINE, LLC |
RICH JANSEN |
| K111633 |
06/13/2011 |
AQUILION LB MOVEMENT BASE KIT |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K111762 |
06/23/2011 |
ST AIA-PACK DHEA-S CALIBRATOR SET |
Tosoh BioScience, Inc. |
JUDITH K OGDEN |
| K111642 |
06/13/2011 |
ONCO TRAC MODEL 1, 2, 4 |
TRANSLATIONAL SCIENCES CORPORATION |
ALLEN GREEN, MD, PHD, JD |
| K111615 |
06/10/2011 |
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS |
CYNTHIA C KNAPP |
| K111834 |
06/29/2011 |
DISCO SUBTALAR IMPLANT |
TRILLIANT SURGICAL LTD |
J D WEBB |
| K111544 |
06/03/2011 |
GLIDER PTCA BALLOON CATHETER |
TRIREME MEDICAL INC |
SHIVA ARDAKANI |
| K111738 |
06/21/2011 |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) |
TRIREME MEDICAL, INC. |
SHIVA ARDAKAMI |
| K111736 |
06/20/2011 |
TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES |
TUTTNAUER CO. LTD. |
THEODORE SULLIVAN |
| K111775 |
06/23/2011 |
JBAIDS INFLUENZA A&B DETECTION KIT |
U.S. ARMY MEDICAL MATERIAL DEVELOPMENT ACITVITY |
PATRICIA BEVERLY |
| K111778 |
06/23/2011 |
JBAIDS INFLUENZA A SUBTYPING KIT |
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
PATRICIA M BEVERLY |
| K111604 |
06/08/2011 |
LANO-E |
UG GLOBAL RESOURCES SDN BHD |
KENNETH STANTON |
| K111718 |
06/20/2011 |
LANO-E |
UG GLOBAL RESOURCES SDN BHD |
KENNETH STANTON |
| K111696 |
06/17/2011 |
OPAL BAND CEMENT |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K111836 |
06/29/2011 |
PERMASHADE VENEER CEMENT |
ULTRADENT PRODUCTS, INC. |
COREY JASEPH |
| K111818 |
06/28/2011 |
SONIXGPS NEEDLE SENSOR |
UltraSonix Medical Corporation |
CHAS YU |
| K111622 |
06/10/2011 |
UNIMAX ANTI-FOG SOLUTION |
UNIMAX MEDICAL SYSTEMS, INC. |
MICHAEL LEE |
| K111715 |
06/20/2011 |
EMBRYOSCOPE |
UNISENSE FERTILITECH A/S |
METTE MUNCH |
| K111771 |
06/23/2011 |
NON-CONTACT TEAR FILM THERMOGRAGH |
UNITED INTEGRATED SERVICES CO., LTD. |
JEN KE-MIN |
| K111546 |
06/03/2011 |
U2 HIP SYSTEM |
UNITED ORTHOPEDIC CORP. |
FANG-YUAN HO |
| K111709 |
06/20/2011 |
FOUNDATION DENTAL RESIN |
UNIX-JAPAN CO., LTD. |
TOSHIKO BOYD |
| K111640 |
06/13/2011 |
PRECISION FLOW(R) - HELIOX |
VAPOTHERM, INC. |
GREGORY A WHITNEY |
| K111543 |
06/02/2011 |
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) |
VENTANA MEDICAL SYSTEMS, INC. |
INDU LAKSHMAN |
| K111755 |
06/22/2011 |
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) |
VENTANA MEDICAL SYSTEMS, INC. |
TROY QUANDER |
| K111670 |
06/15/2011 |
VENUS FREEZE (MP)2 SYSTEM |
VENUS CONCEPT LTD |
YORAM LEVY |
| K111784 |
06/21/2011 |
VENUS SWAN SYSTEM |
VENUS CONCEPT LTD |
YORAM LEVY |
| K111862 |
06/30/2011 |
VIEWRAY SYSTEM |
VIEWRAY INCORPORATED |
JANICE BROWNLEE |
| K111706 |
06/17/2011 |
VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
JWALA JAWHARKAR |
| K111521 |
06/01/2011 |
WAVES |
WATERS MEDICAL SYSTEMS, LLC |
ROBERT WARREN |
| K111781 |
06/24/2011 |
GYMFORM DUAL FLEX BELT MODEL WB-162 |
WELL BRAIN INTERNATIONAL, LTD. |
VICTOR K WAI |
| K111698 |
06/17/2011 |
PROFEMUR(R) E CEMENTLESS HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K111699 |
06/17/2011 |
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K111584 |
06/07/2011 |
XYLOS MACRO-POROUS SURGICAL MESH |
XYLOS CORPORATION |
GONZALO C SERAFICA |
| K111853 |
06/29/2011 |
ANGLED TAPERED ABUTMENT |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K111852 |
06/29/2011 |
ANODIZED HEALING COLLAR |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K111796 |
06/27/2011 |
INVIZIA ANTERIOR CERVICAL PLATE SYSTEM |
ZIMMER SPINE, INC. |
ELSA LINKE |
| K111594 |
06/07/2011 |
ZOLL E SERIES |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
CHUCK KOLIFRATH |
| K111801 |
06/27/2011 |
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM |
Zyga Technology, Inc. |
Diane Brinza |