| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K123546 |
11/19/2012 |
3M ATTEST(TM) AUTO-READER |
3M COMPANY |
SUZANNE LEUNG |
| K123679 |
11/30/2012 |
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING |
3M COMPANY |
JOANN HUEHN |
| K123379 |
11/01/2012 |
ABBOTT ARCHITECT FREE T4 |
ABBOTT LABORATORIES |
JACEK GORZOWSKI |
| K123372 |
11/01/2012 |
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR |
ABBOTT LABORATORIES |
LINDA MORRIS |
| K123659 |
11/28/2012 |
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) |
ACTUATED MEDICAL, INC. |
DEBORA DEMERS, PHD |
| K123569 |
11/20/2012 |
ANTEGRADE FEMORAL NAIL |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
JULIE GLENDRANGE |
| K123418 |
11/06/2012 |
GRAM-NEGATIVE QUICKFISH BC |
ADVANDX, INC. |
BENJAMIN S CRYSTAL |
| K123683 |
11/30/2012 |
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR |
AEROCRINE AB |
KATHLEEN RICKARD, MD |
| K123419 |
11/06/2012 |
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM |
AFP IMAGING CORP. |
DANIEL KAMM, P.E. |
| K123645 |
11/23/2012 |
AGE AUTOMATIC WRIST BLOOD PRESSURE MONITOR |
AGELESS HEALTH INDUSTRIAL |
VICTOR WAN |
| K123623 |
11/23/2012 |
ILLICO MIS POSTERIOR FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
NADINE SMITH |
| K123610 |
11/21/2012 |
E-CUBE 15 |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K123611 |
11/21/2012 |
E-CUBE 7 |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K123519 |
11/15/2012 |
INVIVO DENTAL |
ANATOMAGE, INC |
MIKE MENDEZ |
| K123613 |
11/23/2012 |
SYNSPAR ADVANCED |
ARDENT INC |
DONNA M HARTNETT |
| K123618 |
11/23/2012 |
AXERA 2 ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K123474 |
11/13/2012 |
AVANT LASER |
AVANT WELLNESS SYSTEMS, LLC |
ANDY HEWITSON |
| K123462 |
11/09/2012 |
OCELOT CATHETER |
AVINGER, INC. |
Albert Boniske |
| K123532 |
11/16/2012 |
OCELOT PIXL CATHETER |
AVINGER, INC. |
BABU PERIASAMY |
| K123404 |
11/05/2012 |
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) |
BECTON, DICKINSON & CO. |
MONICA E GIGURERE |
| K123435 |
11/07/2012 |
IPL THERAPY SYSTEM |
BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD |
MIKE GU |
| K123483 |
11/13/2012 |
DIODE LASER |
BEIJING SYNTECH LASER CO., LTD. |
Diana Hong |
| K123663 |
11/28/2012 |
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K123491 |
11/13/2012 |
BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT |
BIODENTA SWISS AG |
DAVID EILER |
| K123512 |
11/13/2012 |
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM |
BIODENTA SWISS AG |
DAVID EILER |
| K123415 |
11/05/2012 |
BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED |
BIODENTA SWISS AG |
DAVID EILER |
| K123620 |
11/23/2012 |
FILMARRAY RESPIRATORY PANEL (RP) |
BIOFIRE DIAGNOSTICS, INC. |
BETH LINGENFELTER |
| K123549 |
11/19/2012 |
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY, MS, RAC |
| K123451 |
11/09/2012 |
POLARIS SPINAL SYSTEM - BALLISTA II RODS |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY MS, RAC |
| K123485 |
11/13/2012 |
JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF |
BIOMET SPORTS MEDICINE |
ELIZABETH WRAY |
| K123501 |
11/13/2012 |
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS |
BIOMET, INC. |
GARY BAKER |
| K123449 |
11/09/2012 |
BIOMONDE LARVAE |
BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED) |
ROSINA ROBINSON RN, MED, RAC |
| K123636 |
11/23/2012 |
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE |
BIONESS, INC. |
KIM TOMPKINS |
| K123411 |
11/05/2012 |
LITTLE ANGELS SWADDLING BLANKET |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K123559 |
11/19/2012 |
SOLUSMOBILE BLOOD GLUCOSE MANAGMENT SYSTEM |
Biotest Medical Corp. |
FRED LEE |
| K123653 |
11/27/2012 |
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) |
BISCO, INC. |
Michelle Schiltz-Taing |
| K123422 |
11/07/2012 |
X-RAY ATTENUATING CREAM |
BLOXR CORPORATION |
RAI CHOWDHARY |
| DEN120022 |
11/07/2012 |
X-RAY ATTENUATING CREAM |
BLOXR CORPORATION |
RAI CHOWDHARY |
| K123380 |
11/01/2012 |
STRIDE UNICONDYLAR KNEE |
BLUE BELT TECHNOLOGIES, INC. |
RICK CONFER |
| K123535 |
11/16/2012 |
ILAB ULTRASOUND IMAGING SYSTEM |
BOSTON SCIENTIFIC CORP. |
LORI R SMITH |
| K123424 |
11/07/2012 |
MDU5 PLUS STERILE BAG |
BOSTON SCIENTIFIC CORP. |
LORI R SMITH |
| K123621 |
11/23/2012 |
OPTICROSS 40 MHZ CORONARY IMAGING CATHETER |
BOSTON SCIENTIFIC CORP. |
ERIC ELLIOTT |
| K123561 |
11/19/2012 |
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS |
BSN MEDICAL, INC. |
CARROLL D HOYLE |
| K123589 |
11/21/2012 |
CADWELL DISPOSABLE PROBE HANDLE |
CADWELL |
CHRIS BOLKAN |
| K123443 |
11/08/2012 |
PRECISE SHP DIODE LASER |
CAO GROUP, INC. |
ROBERT K LARSEN |
| K123571 |
11/20/2012 |
CARDIO VISION MICS AORTIC CLAMPS |
CARDIOMEDICAL GMBH |
ANGELIKA SCHERP |
| K123527 |
11/16/2012 |
AIRLIFE |
CAREFUSION |
ERIKA FERNANDEZ |
| K123464 |
11/09/2012 |
CALLISTO EYE |
CARL ZEISS MEDITEC AG |
JUDY BRIMACOMBE |
| K123433 |
11/07/2012 |
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE |
CEDARS-SINAI MEDICAL CENTER |
GEOFF POLLARD, PROGRAM MANAGER |
| K123381 |
11/01/2012 |
HYPERION X9 |
CEFLA S.C. |
BERTHOIN CLAUDE |
| K123638 |
11/26/2012 |
PEKKTON IVORY |
CENDRES & METAUX SA |
T. BONGNI |
| K123436 |
11/07/2012 |
FIRST RESPONSE EARLY RESULT PREGNANCY TEST |
CHURCH & DWIGHT CO., INC. |
JOSEPH CICCONE |
| K123567 |
11/20/2012 |
FIRST RESPONSE GOLD DIGITAL PREGNANCY TEST |
CHURCH & DWIGHT CO., INC. |
LISA BURNS |
| K123427 |
11/07/2012 |
NIRVANA D PERSONAL LUBRICANT (TBD) |
CHURCH & DWIGHT CO., INC. |
EMILY PEREZ |
| K123386 |
11/02/2012 |
PERIOTYPE X-PERT |
CLINICAL HOUSE EUROPE GMBH |
JUDI WEISSINGER |
| K123560 |
11/19/2012 |
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM |
Codman & Shurtleff, Inc. |
RICHARD KIMURA |
| K123675 |
11/30/2012 |
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR |
COLOPLAST A/S |
BRIAN SCHMIDT |
| K123650 |
11/27/2012 |
ARIX RAD ACQUISITION CONSOLE |
COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V. |
CARL ALLETTO |
| K123481 |
11/13/2012 |
AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE |
CONVATEC INC |
KATRINA FIEDLER |
| K123494 |
11/13/2012 |
SOLEA |
CONVERGENT DENTAL, INC |
Carrie Hetrick |
| K123394 |
11/02/2012 |
CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING |
CORELEADER BIOTECH CO., LTD. |
VINCENT HUANG |
| K123555 |
11/19/2012 |
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY |
COVIDIEN |
JIM WELSH |
| K123581 |
11/20/2012 |
NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
MIA M WARE |
| K123444 |
11/08/2012 |
LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER |
COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
DAWN TINDALL |
| K123407 |
11/05/2012 |
CELLULAZE LASER |
CYNOSURE, INC. |
IRINA KULINETS |
| K123615 |
11/23/2012 |
IRIS - HIGH STRENGTH GLASS CERAMIC |
DENTSPLY INTL. |
HELEN LEWIS |
| K123668 |
11/29/2012 |
ORTHOCORD |
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
TATYANA KORSUNSKY |
| K123362 |
11/01/2012 |
MILAGRO ADVANCE INTERFERENCE SCREW |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
YAYOI FUJIMAKI |
| K123647 |
11/27/2012 |
CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE |
DEVON MEDICAL INC. |
RUTH WU |
| K123364 |
11/01/2012 |
25OH VITAMIN D TOTAL ELISA TEST |
DIASOURCE IMMUNOASSAYS, S.A. |
NAPOLEON MONCE |
| K123408 |
11/05/2012 |
ERGO IMAGING SYSTEM |
DIGIRAD CORP. |
MATTHEW OLOW |
| K123385 |
11/02/2012 |
MEDILAS H LASER FIBERS |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K123431 |
11/07/2012 |
DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D |
DREAMCON CO., LTD |
ALBERT REGO |
| K123370 |
11/01/2012 |
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA |
EDWARDS LIFESCIENCES, LLC. |
KAREN JONES |
| K123538 |
11/16/2012 |
EPIEN ROOT CANAL CLEANSER |
EPIEN MEDICAL, INC. |
JEFFREY K SHAPIRO |
| K123660 |
11/28/2012 |
25-OH VITAMIN D ELISA |
EUROIMMUN US |
KATHRYN KOHL |
| K123544 |
11/19/2012 |
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER |
EV3 INC |
LAURA J LIND |
| K123607 |
11/21/2012 |
OCTANE ELEVATE SPINAL IMPLANT SYSTEM |
EXACTECH, INC. |
PATRICK HUGHES |
| K123497 |
11/13/2012 |
FACET SCREW SYSTEM |
FACET-LINK, INC. |
JANICE M HOGAN |
| K123562 |
11/19/2012 |
FLOWER SMALL AND MEDIUM BONE IMPLANTS |
FLOWER ORTHOPEDICS CORPORATION |
JANICE M HOGAN |
| K123630 |
11/23/2012 |
FRESENIUS LIBERTY CYCLER |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
DENISE OPPERMANN |
| K123566 |
11/20/2012 |
SYNAPSE 3D COLON ANALYSIS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
JYH-SHYAN LIN |
| K123612 |
11/23/2012 |
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA |
FUJIREBIO DIAGNOSTICS, INC. |
KENT PRUETT |
| K123430 |
11/07/2012 |
MICROSLIDER TEARAWAY INTRODUCER SET |
GALT MEDICAL CORP. |
DAVID DERRICK |
| K123631 |
11/23/2012 |
MFP-051 |
GC AMERICA, INC. |
MARK HEISS |
| K123417 |
11/06/2012 |
BRIVO MR355, OPTIMA MR360 |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
RUOQIAN LIU |
| K123596 |
11/21/2012 |
OPTIMA CT520 |
GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
HELEN PENG |
| K123564 |
11/20/2012 |
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM |
GE HEALTHCARE |
BRYAN BEHN |
| K123522 |
11/15/2012 |
OPTIMA MR450W |
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) |
MICHELLE HUETTNER |
| K123603 |
11/21/2012 |
OEC BRIVO 865 ADVANCE, OEC BRIVO 785 ESSENTIAL, AND OEC BRIVO 715 PRIME |
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
GERALD BUSS |
| K123666 |
11/29/2012 |
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM |
GIVEN IMAGING LTD. |
TIM THOMAS |
| DEN120023 |
11/29/2012 |
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM |
GIVEN IMAGING LTD. |
Tim Thomas |
| K123487 |
11/13/2012 |
GSO GS1 CANNULATED SCREW SYSTEM |
GOLD STANDARD ORTHOPAEDICS, LLC |
DAVID BAUGHMAN |
| K123429 |
11/07/2012 |
OLYMPUS ENERGY POWER SYSTEM (EPS) |
GYRUS ACMI, INC. |
DOLAN MILLS |
| K123637 |
11/26/2012 |
HAMILTON-C3 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K123368 |
11/01/2012 |
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K123410 |
11/05/2012 |
HEALTHY SLEEP APPLIANCE |
HEALTHY SLEEP DENTAL LABORATORY |
PAUL DRYDEN |
| K123587 |
11/21/2012 |
HEINE MINI 3000 LED OPHTHALMOSCOPE |
HEINE OPTOTECHNIK GMBH & CO. KG. |
JOERG ROENNAU |
| K123641 |
11/26/2012 |
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL CULTURE DISH, CENTRE WELL DISH, ICSI DISH |
HERTART |
HENRIK DORGE |
| K123627 |
11/23/2012 |
ET SMARTFIT ABUTMENT |
HIOSSEN INC. |
PATRICK LIM |
| K123471 |
11/13/2012 |
ETII SA FIXTURE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K123509 |
11/13/2012 |
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K123530 |
11/16/2012 |
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) |
HOLOGIC, INC. |
GAIL YAEKER-DAUNIS |
| K123604 |
11/21/2012 |
ABG III MONOLITHIC HIP STEM |
HOWMEDICA OSTEONICS CORP |
COLLEEN BURDEL |
| K123442 |
11/08/2012 |
XOFT AXXENT CERVICAL APPLICATORS |
ICAD, INC. |
JOHN A DELUCIA |
| K123678 |
11/30/2012 |
HYALMIX CREAM |
IGI LABORATORIES, INC. |
FREDERICK WEISS |
| K123575 |
11/20/2012 |
MAMMOWORKSTATION |
IMAGE DIAGNOST INTERNATIONAL GMBH |
MOUNIR ZAOUALI |
| K123672 |
11/29/2012 |
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW) |
INION OY |
KATI MARTTINEN |
| K123682 |
11/30/2012 |
INMODE HAIR REMOVAL (HR) DEVICE |
INMODE MD LTD. |
AHAVA STEIN |
| K123551 |
11/19/2012 |
ITCLAMP 50 |
INNOVATIVE TRAUMA CARE INC |
RICHARD WAITE |
| K123593 |
11/21/2012 |
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, |
INOVA DIAGNOSTICS, INC. |
GABRIELLA LAKOS |
| K123428 |
11/07/2012 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
STEVE KWON |
| K123463 |
11/09/2012 |
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS |
INTUITIVE SURGICAL, INC. |
CRYSTAL ONG |
| K123397 |
11/05/2012 |
MULTILINK AUTOMIX |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K123662 |
11/28/2012 |
THE JUSTRIGHT SURGICAL VESSEL SEALING SYSTEM |
JUSTRIGHT SURGICAL, LLC |
MICHELE LUCEY |
| K123412 |
11/06/2012 |
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS |
K2M, INC. |
NANCY GIEZEN |
| K123388 |
11/02/2012 |
K7C SPACER |
K7 LLC |
KARREN E WARDEN, PHD |
| K123402 |
11/05/2012 |
DIAGNOCAM |
KALTENBACH & VOIGT GMBH |
STEFAN TRAMPLER |
| K123507 |
11/13/2012 |
KCI NPWT GAUZE DRESSING |
KCI USA, INC. |
ANONA GOEBEL |
| K123468 |
11/09/2012 |
DEMI ULTRA |
KERR CORPORATION |
Wendy Garman |
| K123595 |
11/21/2012 |
NEXUS RMGI |
KERR CORPORATION |
COLLEEN BOSWELL |
| K123499 |
11/13/2012 |
AEROPILOT |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K123665 |
11/28/2012 |
LIFELINES IEEG |
KVIKNA EHF |
YOLANDA SMITH |
| K123531 |
11/16/2012 |
UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
LEMAITRE VASCULAR, INC. |
BRYAN COWELL, RAC |
| K123473 |
11/13/2012 |
HOPER PTCA BALLOON CATHETER |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
ARTHUR GODDARD |
| K123475 |
11/13/2012 |
SHOOCIN INTRODUCER KIT |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD |
ARTHUR GODDARD |
| K123373 |
11/01/2012 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K123369 |
11/01/2012 |
ILUMIEN OPTIS |
LIGHTLAB IMAGING, INC. |
JEFFREY ROBERTS |
| K123600 |
11/21/2012 |
DIGITAL BLOOD PRESSURE MONITOR |
LITTLE DOCTOR ELECTRONIC (NANTONG) CO., LTD. |
SELINA QIAN |
| K123476 |
11/13/2012 |
MEGA 5.5 SPINE SYSTEM |
LSK BIOPARTNERS, INC. |
SHIN KUK YOO |
| K123629 |
11/23/2012 |
FINESSIS POLYISOPRENE POWDERFREE SURGICAL GLOVES |
LUCENXIA PRESCIENCE AG |
ROBERT HILL |
| K123628 |
11/23/2012 |
STERILE LATEX SURGICAL GLOVE |
LUCENXIA PRESCIENCE AG |
ROBERT HILL |
| K123466 |
11/09/2012 |
HEALTHVIEW ECG MANAGER |
LUMEDX |
CHRIS PEARCE |
| K123414 |
11/06/2012 |
SPECBOARD JR. |
MACBRUD CORP., MEDICAL DIVISION |
TODD LARY |
| K123563 |
11/19/2012 |
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM |
MAGELLAN DIAGNOSTICS |
STUART NAYLOR |
| K123676 |
11/30/2012 |
CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES |
MAUNA KEA TECHNOLOGIES |
MICHAEL DANIEL |
| K123586 |
11/21/2012 |
EASYRA CREATININE REAGENT |
MEDICA CORPORATION |
Photios Makris |
| K123617 |
11/23/2012 |
3F PRO-PICC |
MEDICAL COMPONENTS INC |
JESSICA LEO |
| K123591 |
11/21/2012 |
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) |
MEDTRONIC CRYOCATH LP |
VANESSA WARE |
| K123448 |
11/08/2012 |
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE |
MEDTRONIC INC. |
JULIA A NELSON |
| K123524 |
11/15/2012 |
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM |
MEDTRONIC NEUROSURGERY |
DONOVAN MAY |
| K123568 |
11/20/2012 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MIKE SCOTT |
| K123656 |
11/28/2012 |
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CLAIRE EVANS |
| K123619 |
11/23/2012 |
INTRABLOCK BIOBALL HIP SYSTEM (IBS) |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K123423 |
11/06/2012 |
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K123609 |
11/21/2012 |
MERIT HYDROPHILIC GUIDE WIRE |
MERIT MEDICAL SYSTEMS, INC. |
STEPHANIE ERSKINE |
| K123363 |
11/01/2012 |
SUPER STAPLE(TM) CLASSIC |
METRIC MEDICAL DEVICES, INC. |
W CASEY FOX PHD PE |
| K123378 |
11/01/2012 |
SOLITAIRE 2 REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
LARRY BOUCHER |
| K123518 |
11/14/2012 |
ABBOTT CARBAMAZEPINE ASSAY |
Microgenics Corporation |
KAREN LEE |
| K123384 |
11/02/2012 |
AZUR CX DETACHABLE 18 |
MICROVENTION, INC. |
CYNTHIA VALENZUELA |
| K123624 |
11/23/2012 |
OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM |
MIMOSA ACOUSTICS, INC. |
PATRICIA S JENG |
| K123556 |
11/19/2012 |
MORTARA SURVEYOR PATIENT MONITOR |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K123605 |
11/21/2012 |
SMARTFLOW CATHETER |
MRI INTERVENTIONS, INC. |
EDWARD F WADDELL |
| K123516 |
11/14/2012 |
CRYO-TOUCH IV |
MYOSCIENCE INC |
TRACEY HENRY |
| K123445 |
11/08/2012 |
NMI COAXIAL MICROINTRODUCER SET |
NAVILYST MEDICAL, INC. |
WANDA CARPINELLA |
| K123439 |
11/08/2012 |
NEO ERCP GUIDEWIRE |
NEOMETRICS, INC. |
GENE CHAMPEAU |
| K123554 |
11/19/2012 |
SHUNTCHECK |
NEURODX DEVELOPMENT LLC |
FREDERICK J FRITZ |
| K123642 |
11/26/2012 |
MUSCLE STIMULATION SYSTEM |
NIVEUS MEDICAL, INC. |
CINDY DOMECUS, R.A.C. (US & EU) |
| K123395 |
11/05/2012 |
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K123421 |
11/06/2012 |
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORP. |
DAPHNEY GERMAIN-KOLAWOLE |
| K123601 |
11/21/2012 |
SINGLE USE REPOSITIONABLE CLIP |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI L MUSGNUNG |
| K123498 |
11/13/2012 |
BP652N (HEM-6300-Z) |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K123416 |
11/06/2012 |
INSIGNIA WITH ITERO |
ORMCO CORP. |
Wendy Garman |
| K123426 |
11/07/2012 |
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS |
ORPHEUS MEDICAL, LTD. |
CLAY ANSELMO |
| K123457 |
11/08/2012 |
BALANCED KNEE SYSTEM HIGH FLEX PS |
ORTHO DEVELOPMENT CORP. |
TOM HAUETER |
| K123470 |
11/13/2012 |
PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE |
PAS SYSTEMS INTERNATIONAL, INC. |
JAREL R KELSEY |
| K123576 |
11/20/2012 |
IMR SOFTWARE APPLICATION |
PHILIPS HEALTHCARE (CLEVELAND) |
CHRISTINE ANDERSON |
| K123599 |
11/21/2012 |
INGENUITY DIGITAL PET/CT |
PHILIPS HEALTHCARE (CLEVELAND) |
MICHAEL S PRETO |
| K123492 |
11/13/2012 |
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) |
PHILIPS MEDICAL SYSTEMS |
Lisa Simpson |
| K123450 |
11/09/2012 |
PHONAK TINNITUS BALANCE |
PHONAK LLC |
LAURA ELLMAN |
| K123597 |
11/21/2012 |
TRUECPR COACHING DEVICE |
PHYSIO-CONTROL, INC. |
TERESA DAVIDSON |
| K123565 |
11/20/2012 |
PRESTO 1000 SYSTEM |
PHYSIOSONICS, INC |
DAVID CRONISER |
| K123651 |
11/27/2012 |
CINCHLOCK KNOTLESS SUTURE ANCHOR |
PIVOT MEDICAL |
Jon Cook |
| K123399 |
11/05/2012 |
MYOVISION 3.0 WIREFREE SYSTEM |
PRECISION BIOMETRICS, INC. |
ERIC CHEN |
| K123488 |
11/13/2012 |
LINSHI NITRILE DISPOSABLE EXAM GLOVES, POWDER-FREE |
PUYANG LINSHI HEALTH CO., LTD |
LAURA WENG |
| K123514 |
11/14/2012 |
CLEARPATH ALIGNER |
QSERVE AMERICA, INC. |
Patsy Trisler |
| K123573 |
11/20/2012 |
YOULASER CO2 LASER |
QUANTA SYSTEM, S.P.A. |
Maurizio Bianchi |
| K123537 |
11/16/2012 |
POWDER FREE LATEX EXAMINATION GLOVES |
QUBE MEDICAL PRODUCT SDN BHD |
TERENCE LIM |
| K123521 |
11/15/2012 |
RELIANCE SPINAL SCREW SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K123398 |
11/05/2012 |
DR. SCHOLL'S COMPRESSION SOCKS |
RENFRO CORPORATION |
Rebecca K Pine |
| K123557 |
11/19/2012 |
EASYCARE ONLINE |
RESMED LTD. |
JIM CASSI |
| K123511 |
11/13/2012 |
S9 VPAP TX |
RESMED LTD. |
JIM CASSI |
| K123548 |
11/19/2012 |
THE ARTAS SYSTEM |
RESTORATION ROBOTICS, INC |
JIM TALBOT |
| K123526 |
11/15/2012 |
CLEARREAD +CONFIRM |
RIVERAIN TECHNOLOGIES |
JENNIFER BUTSCH |
| K123582 |
11/20/2012 |
ENDO A CLASS |
SAEYANG MICROTECH CO., LTD |
JIGAR SHAH |
| K123608 |
11/21/2012 |
ENDO E CLASS |
SAEYANG MICROTECH CO., LTD |
JIGAR SHAH |
| K123671 |
11/29/2012 |
WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM |
SANITAS, INC. |
ALAN DONALD |
| K123606 |
11/21/2012 |
CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISPOSABLE |
SCION MEDICAL TECHNOLOGIES LLC |
JOSEPH OSTENDORF |
| K123517 |
11/14/2012 |
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM |
SD BIOSENSOR |
JIGAR SHAH |
| K123477 |
11/13/2012 |
VIA MICROCATHETER, VIA PLUS MICROCATHETER |
SEQUENT MEDICAL, INC |
MELANIE PARRAVI |
| K123503 |
11/13/2012 |
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
BAI YANHONG |
| K123508 |
11/13/2012 |
TRINIAS |
Shimadzu Corporation |
Toshio Kadowaki |
| K123375 |
11/01/2012 |
SYNGO.VIA |
SIEMENS AG |
SABINE SCHROEDEL |
| K123677 |
11/30/2012 |
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K123622 |
11/23/2012 |
ACUSON |
SIEMENS MEDICAL SOLUTIONS USA INC. |
PATRICK LYNCH |
| K123529 |
11/16/2012 |
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K123510 |
11/13/2012 |
MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K123520 |
11/15/2012 |
MAMMOMAT INSPIRATION PRIME |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K123528 |
11/16/2012 |
SCENIUM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
| K123420 |
11/06/2012 |
SYNGO, BREAST CARE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K123584 |
11/21/2012 |
SYNGO, CT BONE READING |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K123585 |
11/21/2012 |
SYNGO, CT CARDIAC FUNCTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K123577 |
11/20/2012 |
SYNGO.VIA MI WORKFLOWS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO, RAC |
| K123540 |
11/19/2012 |
SYNGO CT PULMO 3D |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K123541 |
11/19/2012 |
SYNGO.CT NEURO PERFUSION |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K123545 |
11/19/2012 |
INCORIS TZI |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K123664 |
11/28/2012 |
INCORIS ZI |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K123579 |
11/19/2012 |
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL |
SMITH & NEPHEW, INC. |
CATHERINE KILSHAW |
| K123393 |
11/02/2012 |
HEALICOIL SUTURE ANCHOR WITH REGENESORB |
SMITH & NEPHEW, INC. |
SUE DAHLQUIST |
| K123598 |
11/21/2012 |
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION |
SMITH & NEPHEW, INC. |
Bradley Heil |
| K123425 |
11/07/2012 |
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL |
SMITH & NEPHEW, INC. |
CATHERINE KILSHAW |
| K123479 |
11/13/2012 |
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K123684 |
11/30/2012 |
SOL-CARE SAFETY NEEDLE |
SOL-MILLENNIUM MEDICAL |
JIM BARLEY |
| K123616 |
11/23/2012 |
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K123632 |
11/23/2012 |
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 |
SPECTRANETICS CORP. |
CHRISTINE GODLESKI |
| K123461 |
11/09/2012 |
STAXX(R) IB SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K123390 |
11/02/2012 |
PEDIGUARD NERVE DETECTOR SYSTEM |
SPINEGUARD, S.A. |
JOHN J SMITH, M.D. J.D. |
| K123652 |
11/27/2012 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K123484 |
11/13/2012 |
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS |
ST. SHINE OPTICAL CO., LTD. |
ELLA LEE |
| K123539 |
11/16/2012 |
STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK |
STAYHEALTHY, INC. |
COLIN HILL PHD. |
| K123478 |
11/13/2012 |
STINGRAY BIPOLAR FORCEPS |
STINGRAY SURGICAL PRODUCTS |
MARK MCBRINN |
| K123452 |
11/08/2012 |
TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM |
Stryker |
JEAN CHEN |
| K123486 |
11/13/2012 |
TRIATHLON TRITANIUM TIBIAL BASEPLATE |
Stryker |
AUDREY WITKO |
| K123441 |
11/08/2012 |
STRYKER CROSSFLOW ARTHROSCOPY PUMP |
Stryker Endoscopy |
KEVIN POTGIETER |
| K123377 |
11/01/2012 |
TARGET DETACHABLE COIL |
STRYKER NEUROVASCULAR |
RHODA SANTOS |
| K123403 |
11/05/2012 |
AXSOS PROXIMAL LATERAL TIBIA LONG PLATES |
Stryker Trauma AG |
ESTELA CELI |
| K123401 |
11/05/2012 |
GAMMA3 AND T2 RECON TARGETING DEVICES |
Stryker Trauma AG |
ESTELA CELI |
| K123409 |
11/05/2012 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K123646 |
11/27/2012 |
EMORY CARDIAC TOOLBOX 4.0 |
SYNTERMED, INC. |
KENNETH VAN TRAIN |
| K123640 |
11/26/2012 |
TX1 TISSUE REMOVAL SYSTEM |
TENEX HEALTH |
DAVID SALZBERG |
| K123472 |
11/13/2012 |
CIMVA UNIVERSAL |
THERAPEUTIC MONITORING SYSTEMS (TMS), INC. |
CRAIG J COOMBS |
| K123396 |
11/05/2012 |
I.FLEX BY TCS |
THERMOPLASTIC COMFORT SYSTEMS, INC. |
MARLIN POSCA |
| K123633 |
11/23/2012 |
TRS CRANIAL BONE VOID FILLER(TRS C-BVF) |
TISSUE REGENERATION SYSTEMS, INC. |
JIM FITZSIMMONS |
| K123542 |
11/19/2012 |
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER |
TOPCON MEDICAL LASER SYSTEMS, INC |
PAMELA M BUCKMAN |
| K123460 |
11/09/2012 |
TRC-NW300 NON-MYDRIATIC RETINAL CAMERA |
TOPCON MEDICAL SYSTEMS, INC. |
MICHAEL GUSEL |
| K123500 |
11/13/2012 |
AQUILION LB TRITON V4.91 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K123525 |
11/15/2012 |
GRIDLOCK PLATING SYSTEM |
TRILLIANT SURGICAL LTD |
J.D. WEBB |
| K123400 |
11/05/2012 |
AEROBIKA POSITIVE EXPIRATORY PRESSURE DEVICE |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
| K123614 |
11/23/2012 |
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) |
TRUDELL MEDICAL INTL. |
DARRYL FISCHER |
| K123550 |
11/19/2012 |
UTF STEM, REDUCED |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K123446 |
11/08/2012 |
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM |
United States GTM Medical Devices, Inc. |
Kenneth K Kleinhenz |
| K123493 |
11/09/2012 |
VEX-S 100W INTRAORAL X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K123371 |
11/01/2012 |
ALIGNRT PLUS |
VISION RT LIMITED |
NORMAN SMITH |
| K123467 |
11/09/2012 |
VS3 |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K123644 |
11/26/2012 |
VIZION + DR |
VIZTEK LLC |
DANIEL KAMM, P.E. |
| K123482 |
11/13/2012 |
REFLOW ASPIRATION CATHETER |
VOLCANO CORPORATION |
BRIAN PARK |
| K123469 |
11/13/2012 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE AND WHITE COLORED, NON-STERILE |
WEAR SAFE (MALAYSIA) SDN BHD - FACILITY II |
ALEX YOONG |
| K123578 |
11/20/2012 |
ANTERIOR CERVICAL PLATE SYSTEM |
WEIGAO ORTHOPAEDIC DEVICE CO., LTD |
Diana Hong |
| K123590 |
11/21/2012 |
VINYL EXAMINATION POWDER FREE GLOVES, CLEAR |
WEILIN PLASTIC AND RUBBER PRODUCTS CO., LTD. |
LING ZHU |
| K123588 |
11/21/2012 |
INTRADERMAL ADAPTER |
WEST PHARMACEUTICAL SERVICES, INC. |
DEBBIE M THOMAS |
| K123680 |
11/30/2012 |
COPRANCOLOR |
WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG |
OLIVER PUCKERT |
| K123681 |
11/30/2012 |
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
SHASHIDHAR C S |
| K123434 |
11/07/2012 |
PROFEMUR Z CLASSIC STEMS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
DAVID FITCH |
| K123438 |
11/08/2012 |
XENX STONE MANAGEMENT DEVICE |
XENOLITH MEDICAL |
OFER ZIGMAN |
| K123387 |
11/02/2012 |
QUIKCLOT HEMOSTATIC DRESSING |
Z-MEDICA, LLC |
SHEILA WALLIN |
| K123658 |
11/28/2012 |
BIOMODULE 3-M1 |
ZEPHYR TECHNOLOGY CORPORATION |
RICHARD KEEN |
| K123669 |
11/29/2012 |
TRANSTEK WRIST BLOOD PRESSURE MONITOR |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K123392 |
11/02/2012 |
AVENIR MULLER STEM |
ZIMMER GMBH |
KAREN O'LEARY |
| K123553 |
11/19/2012 |
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM |
ZIMMER INC. |
ALLISON SCOTT, RAC |
| K123459 |
11/09/2012 |
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM |
ZIMMER INC. |
CAROL VIERLING, RAC |
| K123552 |
11/19/2012 |
INSTINCT JAVA SYSTEM |
ZIMMER SPINE |
ELSA A LINKE |
| K123602 |
11/21/2012 |
TM ARDIS INTERBODY SYSTEM INSERTER |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
