| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K112271 |
02/16/2012 |
3B WILLOW |
3B PRODUCTS, LLC |
ALEX LUCIO |
| K123085 |
12/20/2012 |
FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE |
3M COMPANY |
LISA NELSON |
| K113197 |
02/02/2012 |
APC FLASH-FREE ADHESIVE |
3M UNITEK CORPORATION |
ROBERT WANG |
| K121495 |
12/07/2012 |
LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K121003 |
12/21/2012 |
ABBOTT PLEX-ID FLU ASSAY |
ABBOTT LABORATORIES |
DARREN CLARKE |
| K111874 |
02/16/2012 |
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS |
ABBOTT LABORATORIES |
ARUL STERLIN |
| K123010 |
12/14/2012 |
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
Xie Qiyi |
| K121803 |
12/19/2012 |
INTRAVASCULAR ADMINISTRATION SET |
ACTA MEDICAL LLC |
JOHN BREWER |
| K123659 |
12/20/2012 |
TUBE-CLEAR, CONTROL BOX (COMPONENT OF TUBECLEAR), CLEARING STEM (COMPONENT OF TUBECLEAR) |
ACTUATED MEDICAL, INC. |
DEBORA DEMERS, PHD |
| K120163 |
02/17/2012 |
ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEM |
ACUTE INNOVATIONS LLC |
MARIAH KNIGHT |
| K123017 |
12/26/2012 |
STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR MODEL 14324 |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K123683 |
12/27/2012 |
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR |
AEROCRINE AB |
KATHLEEN RICKARD, MD |
| K123352 |
12/12/2012 |
S4 SPINAL SYSTEM |
AESCULAP IMPLANT SYSTEMS, INC. |
LISA M BOYLE |
| K120955 |
12/17/2012 |
COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
KATHY A RACOSKY |
| K111959 |
02/06/2012 |
AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE |
AESCULAP, INC. |
KATHY A RACOSKY |
| K122734 |
12/18/2012 |
AESCULAP NOVOSYN ABSORBABLE SUTURE |
AESCULAP, INC. |
KATHY A RACOSKY |
| K123419 |
12/27/2012 |
EVA SELECT DIGITAL DENTAL IMAGING SYSTEM |
AFP IMAGING CORP. |
DANIEL KAMM, P.E. |
| K121555 |
12/21/2012 |
CENTURION VISION SYSTEM |
ALCON LABORATORIES, INC. |
CHARLES OGBONNA |
| K123120 |
12/12/2012 |
LENSX LASER SYSTEM |
ALCON LENSX, INC. |
JUDY GORDON, DVM |
| K123611 |
12/21/2012 |
E-CUBE 7 |
ALPINION MEDICAL SYSTEMS CO., LTD |
DONGHWAN KIM |
| K113779 |
12/14/2012 |
CONELOG IMPLANT SYSTEM |
ALTATEC GMBH |
LINDA SCHULZ |
| K122753 |
12/14/2012 |
EMPOWER CLEAR |
AMERICAN ORTHODONTICS |
TRANG ADAMS |
| K120813 |
12/07/2012 |
BLOOD GLUCOSE MONITORING SYSTEM |
ANDON MEDICAL CO., LTD |
YI LIU |
| K121218 |
12/13/2012 |
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, |
ANDREW TECHNOLOGIES, LLC |
HERBERT CRANE |
| DEN090007 |
12/19/2012 |
BIO-SEAL LUNG BIOPSY TRACT SYSTEM |
ANGIOTECH |
TRUDY ESTRIDGE |
| K113744 |
02/01/2012 |
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) |
ANGIOTECH |
KIRSTEN STOWELL |
| K113805 |
02/23/2012 |
FIXATE TISSUE BAND |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K100404 |
12/14/2012 |
ASCENDX VCF REDUCTION SYSTEM |
AOI MEDICAL, INC. |
JANICE M HOGAN |
| K112079 |
12/06/2012 |
APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 |
APEX MEDICAL CORP. |
ALAN CHANG |
| K122248 |
12/05/2012 |
IGROW II HAIR GROWTH SYSTEM |
APIRA SCIENCE, INC. |
RAYMOND R BLANCHE |
| K120143 |
02/16/2012 |
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL |
APOLLO SPINE |
MICHELE LUCEY |
| K122330 |
12/07/2012 |
FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE |
ARJOHUNTLEIGH POLSKA SP Z.O.O. |
DAVID MOYNHAM |
| K122690 |
12/21/2012 |
ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE |
ARROW INTERNATIONAL, INC. |
PAUL AMUDALA |
| K120791 |
12/11/2012 |
AMBIENT TURBOFLASH 90 IFS |
ARTHOCARE CORPORATION |
CHERYL FREDERICK |
| K120155 |
02/17/2012 |
ARTHREX KNOTLESS SUTURETAK ANCHOR |
ARTHREX, INC. |
CHRISTINA FLORES |
| K123341 |
12/21/2012 |
ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON |
ARTHREX, INC. |
CHRISTINA FLORES |
| K113762 |
02/06/2012 |
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K113716 |
02/06/2012 |
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K113452 |
02/17/2012 |
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM |
ASCENDX SPINE, INC. |
JANICE M HOGAN |
| K121661 |
12/27/2012 |
EZ-ASSIST-FILL |
ASSIST FILL, LLC |
GRIFFIN |
| K113165 |
02/02/2012 |
MINI-MEDIC |
ATHENA GTX |
SEAN MAHONEY |
| K111018 |
02/14/2012 |
POLYFUSE - NEUROBONE |
ATPAC MEDICAL LLC |
GARY MALINOWSKI |
| K122892 |
12/11/2012 |
MTA2 ROOT AND PULP MATERIALS |
AVALON BIOMED INC. |
CAROLYN PRIMUS |
| K123462 |
12/07/2012 |
OCELOT CATHETER |
AVINGER, INC. |
Albert Boniske |
| K123532 |
12/14/2012 |
OCELOT PIXL CATHETER |
AVINGER, INC. |
BABU PERIASAMY |
| K121842 |
12/12/2012 |
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C |
AXIS-SHIELD DIAGNOSTICS, LTD. |
CLAIRE I DORA |
| K120147 |
02/17/2012 |
ACE STAPLER AND CARTRIDGE |
BAROSENSE, INC |
SHEILA STEVENS, PHD |
| K122575 |
12/20/2012 |
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI |
BAUSCH & LOMB, INC. |
NANCY A FEHRMAN |
| K111860 |
02/16/2012 |
BD MAX GBS ASSAY, BD MAX INSTRUMENT |
BECTON DICKINSON & CO. |
MARY ANNE WILLIAMS |
| K113018 |
12/14/2012 |
APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM |
BEIJING SYNTECH LASER CO., LTD. |
Diana Hong |
| K113065 |
02/22/2012 |
RL, UL, SL, EL, AND EPL VERTICAL PLATFORM LIFTS |
BELLA ELEVATOR, LLC |
RICK CRANE |
| K120392 |
02/16/2012 |
CHROMOPHARE F 628 AND F 528 |
BERCHTOLD GMBH & CO. KG |
VOLKER HORNSCHEIDT |
| K120189 |
02/22/2012 |
BONETRAP |
BERNI FARNS INCORPORATED |
NICOLA BERNI |
| K103044 |
02/10/2012 |
AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION |
BESTGEN BIOTECH CORP. |
STEVEN SHEN |
| K121268 |
12/20/2012 |
WANDY DISPERSVIE ELECTRODE |
BIO-MED USA INC. |
YOUNG CHI |
| K123663 |
12/27/2012 |
LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K111976 |
02/17/2012 |
VITEK 2 STREPTOCOCCUS ERYTHROMYCIN |
BIOMERIEUX, INC. |
JENNIFER CHIA-HSUAN LIN |
| K113305 |
02/10/2012 |
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K111893 |
02/28/2012 |
VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K113550 |
02/29/2012 |
VANGUARD COMPLETE KNEE SYSTEM |
BIOMET MANUFACTURING CORP. |
GARY BAKER |
| K123451 |
12/03/2012 |
POLARIS SPINAL SYSTEM - BALLISTA II RODS |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY MS, RAC |
| K120121 |
02/16/2012 |
COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE |
BIOMET, INC. |
PATRICIA BERES |
| K122784 |
12/27/2012 |
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT |
BIONESS, INC. |
KIM TOMPKINS |
| K113007 |
02/27/2012 |
BIONIME DIABETES MANAGEMENT SYSTEM VI.0 |
BIONIME CORPORATION |
Feng-Yu Lee |
| K113401 |
02/07/2012 |
ORTHO-1(NOT FINALIZED) |
BISCO, INC. |
Michelle Schiltz-Taing |
| K110375 |
02/23/2012 |
BLUESHINE'S GOLD SERIES |
BLUESHINE SRL |
CHIARA RICCI |
| K122649 |
12/12/2012 |
NAVIGATOR HD URETERAL ACCESS SHEATH SET |
BOSTON SCIENTIFIC CORP. |
HUDA YUSUF |
| K122794 |
12/18/2012 |
UPSYLON Y MESH |
BOSTON SCIENTIFIC CORP. |
LAUREN ANDERSON |
| K112994 |
02/10/2012 |
CRE DITATATION BALLON |
Boston Scientific Corporation |
JANIS TARANTO |
| K122459 |
12/13/2012 |
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM |
Boston Scientific Corporation |
MICHELLE BERRY |
| K122660 |
12/03/2012 |
RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 |
Boston Scientific Corporation |
THOMAS HIRTE |
| K120129 |
02/03/2012 |
MANTARAY CATHETER |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K120137 |
02/14/2012 |
VICTORY GUIDEWIRE (32 MODELS) |
BRIVANT, LTD. |
KENNETH WALSH |
| K113308 |
02/01/2012 |
BRUNO ELAN STAIRWAY ELEVATOR |
BRUNO INDEPENDENT LIVING AIDS, INC. |
TERRENCE O'BRIEN |
| K123561 |
12/18/2012 |
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS |
BSN MEDICAL, INC. |
CARROLL D HOYLE |
| K113276 |
02/27/2012 |
CATALYST |
C-RAD POSITIONING AB |
JANINA OSTLING |
| K112841 |
02/16/2012 |
SURFACE BEACON TRANSPONDERS |
CALYPSO MEDICAL TECHNOLOGIES INC |
MARCIA PAGE |
| K122852 |
12/06/2012 |
PHYSIOSTAR NFC |
CANDULOR USA, INC. |
DONNA MARIE HARTNETT |
| K112831 |
02/16/2012 |
PLEURX PLEURAL CATHETER SYSTEMS |
CAREFUSION |
JOY GREIDANUS |
| K121653 |
12/27/2012 |
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS |
CARL ZEISS MEDITEC, INC. |
SARAH HARRINGTON |
| K123065 |
12/14/2012 |
CATHETER CONNECTIONS DUALCAP SOLO |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
| K121710 |
12/27/2012 |
XPERT CT/NG |
CEPHEID |
RUSSEL K ENNS |
| K123191 |
12/21/2012 |
XPERT FLU |
CEPHEID |
RUSSEL K ENNS |
| K122000 |
12/12/2012 |
HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER |
CHANGZHOU HOLYMED PRODUCTS CO LTD |
ALAN YU |
| K121998 |
12/20/2012 |
HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED |
CHANGZHOU HOLYMED PRODUCTS CO LTD |
ALAN YU |
| K113359 |
02/03/2012 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE |
CHISON MEDICAL IMAGING CO., LTD. |
BOB LEIKER |
| K122208 |
12/20/2012 |
EXTERNAL FIXATOR SYSTEM |
CHRISTOPHER D. ENDARA |
CHRISTOPHER ENDARA |
| K122813 |
12/18/2012 |
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM |
CINCINNATI SUB-ZERO PRODUCTS, INC. |
STEVEN J BERKE |
| K120081 |
02/17/2012 |
NORM-O-TEMP HYPERTHERMIA SYSTEM INCLIDING BLANKETS/PADS |
CINCINNATI SUB-ZERO PRODUCTS, INC. |
STEVEN J BERKE |
| K111937 |
02/08/2012 |
CLEARFLASH AC2100 COSMETIC SYSTEM |
CLEARFLASH TECHNOLOGIES, INC. |
JOSEPH NEEV |
| K120229 |
02/24/2012 |
ENVOY DISTAL ACCESS GUIDING CATHETER |
Codman & Shurtleff, Inc. |
CATHERINE KILSHAW |
| K113496 |
02/14/2012 |
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT |
COLOPLAST A/S |
JANELL COLLEY |
| K122968 |
12/18/2012 |
NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 |
COLOPLAST CORP. |
MARGARET BATCHELDER |
| K120068 |
02/03/2012 |
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS) |
CONFORMIS, INC. |
AMITA SHAH |
| K113378 |
02/15/2012 |
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K122991 |
12/20/2012 |
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
| K123260 |
12/21/2012 |
DETACHATIP III |
CONMED CORPORATION |
LISA ANDERSON |
| K112650 |
02/01/2012 |
CONNEXALL SUITE OF SOFTWARE PRODUCTS |
CONNEXALL USA, INC. |
THOMAS KROENKE |
| K112099 |
02/03/2012 |
CONTOUR HEALER |
CONTOUR HEALER, LLC |
ALLEN HARDIN WHITE |
| K113757 |
02/22/2012 |
ASPIRE MAX ASPIRATION CATHETER |
CONTROL MEDICAL TECHNOLOGY, LLC |
SHAWN P FOJTIK |
| K113634 |
02/14/2012 |
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE |
COOK IRELAND LTD |
LAURA GUINANE |
| K122937 |
12/14/2012 |
SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) |
COOK, INC. |
AMBER BROWN |
| K121514 |
12/14/2012 |
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM |
CORELINK LLC |
JUSTIN EGGLETON |
| K110404 |
02/16/2012 |
EAUM TOTAL KNEE SYSTEM |
CORENTEC CO., LTD |
KEVIN A THOMAS |
| K111481 |
02/06/2012 |
CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS |
CORIN U.S.A. |
LUCINDA GERBER |
| K120146 |
12/11/2012 |
QUARK SERIES |
COSMED S.R.L. |
ROBERT SCHIFF |
| K120258 |
02/29/2012 |
DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
JENNIFER BRENNAN |
| K123318 |
12/18/2012 |
IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
SARAH RIZK |
| K112791 |
02/24/2012 |
SITESCRUB IPA DEVICE |
CR BARD |
LYNN M KIRCHOFF |
| K113021 |
02/07/2012 |
TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT |
CSA MEDICAL, INC. |
COLLEEN KISTLER |
| K111105 |
12/20/2012 |
CURASAN OSSEOLIVE DENTAL |
CURASAN AG |
ROGER GRAY |
| K111726 |
02/06/2012 |
PATHWAY AVID |
CUSTOM SPINE, INC. |
DAVID DRUMFIELD |
| K111411 |
02/01/2012 |
FREEMIE (R) |
DAO HEALTH |
DAN GARBEZ |
| K121853 |
12/13/2012 |
DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES |
DEFIBTECH, LLC |
Ed Horton |
| K122927 |
12/20/2012 |
OXICARE FINGERTIP PULSE OXIMETER |
DELBIO INCORPORATED |
NICKY PAN |
| K120866 |
12/11/2012 |
DA01 BLOOD GLUCOSE MONITORING SYSTEM |
DELBIO INCORPORATION |
NICKY PAN |
| K113343 |
02/08/2012 |
DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM |
DELBIO INCORPORATION |
NICKY PAN |
| K121007 |
12/28/2012 |
NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 |
DELTA MED SRL |
HARRY BONTRAGER |
| K111689 |
02/16/2012 |
STLASE |
DENTAL PHOTONICS, INC |
Marcy Moore |
| K122582 |
12/07/2012 |
DENTAL X-RAY Z70 (W); DENTAL X-RAY Z70 (M); DENTAL X-RAY Z70 (C) |
DENTERPRISE INTERNATIONAL, INC. |
Claude Berthoin |
| K111364 |
02/01/2012 |
HAPTITE COATING IMPLANT SYSTEM |
DENTIS CO., LTD. |
APRIL LEE |
| K122268 |
12/11/2012 |
ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS |
DENTSPLY INTERNATIONAL |
HELEN LEWIS |
| K113406 |
02/13/2012 |
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K120078 |
02/29/2012 |
HEALIX ADVANCE BR ANCHOR |
DEPUY MITEK INC., JOHNSON AND JOHNSON COMPANY |
YAYOI FUJIMAKI |
| K122869 |
12/13/2012 |
MILAGRO INTERFERENCE SCREWS |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K113545 |
02/27/2012 |
VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
SUSAN KAGAN |
| K110078 |
02/10/2012 |
EXTRICARE |
DEVON MEDICAL PRODUCTS, INC. |
RUTH WU |
| K121027 |
12/20/2012 |
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
| K121620 |
12/11/2012 |
ULTRASONIC SURGERY |
DMETEC CO., LTD. |
DANIEL NAM |
| K111758 |
02/14/2012 |
CADENS (TM) COLON |
DOG MICROSYSTEMS, INC. |
FLORENT CHANDELIER |
| K110821 |
02/27/2012 |
BARF BAND |
DOODLEBUG PRODUCTS, LLC |
BARRY E SANDS |
| K123385 |
12/14/2012 |
MEDILAS H LASER FIBERS |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K112723 |
02/08/2012 |
EPIGRAY |
DOSISOFT SA |
ROBERT J MORTON |
| K113206 |
02/17/2012 |
NANOBLUTM 500 |
Draeger Medical Systems, Inc. |
BRYAN OVERTON |
| K113250 |
02/09/2012 |
DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE |
DYNATRONICS CORP. |
DOUGLAS SAMPSON |
| K120144 |
02/14/2012 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS INC |
RANDY JIANG |
| K113653 |
02/06/2012 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
| K113623 |
02/01/2012 |
PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
| K113844 |
02/27/2012 |
RADIFORCE RX240 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K111467 |
02/09/2012 |
FLEXI-Q DV AND DVR AUTO-INJECTORS |
ELCAM MEDICAL A.C.A.L. |
SHAY SHAHAM |
| K112353 |
02/17/2012 |
GEODESIC EEG MOBILE 100 (GEM 100) |
ELECTRICAL GEODESICS, INC. |
LINDA J BOVARD |
| K121663 |
12/05/2012 |
CLARITY |
ELEKTA LTD. |
GEORGE PAPAGIANNIS |
| K123729 |
12/21/2012 |
VERSARATE FLOW RATE CONTROLER |
EMED TECHNOLOGIES CORPORATION |
PETER KOLLINGS |
| K122489 |
12/10/2012 |
EMERGE MEDICAL SOLID BONE SCREWS |
EMERGE MEDICAL |
VICTORIA TRAFKA |
| K123257 |
12/14/2012 |
EMVERA DIOLUX |
EMVERA TECHNOLOGIES, INC. |
|
| K120241 |
02/24/2012 |
LINEAR HIP STEM, SIZE 5 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K120212 |
02/09/2012 |
AFX INTRODUCER SYSTEM |
ENDOLOGIX, INC. |
Janet M Fauls |
| K120995 |
12/03/2012 |
ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT |
ERAD, INC. |
JILLIAN M REED |
| K113743 |
12/18/2012 |
EVOLUTION 3E VENTILATOR |
EVENT MEDICAL, INC. |
RICK WATERS |
| K122814 |
12/03/2012 |
GALLEON PEDICLE SCREW SYSTEM |
EVEREST SPINE, LLC |
CHRISTINA VACCA |
| K112074 |
02/01/2012 |
EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
JAY MANSOUR |
| K121067 |
12/06/2012 |
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE |
EXACTECH, INC. |
LINDY KNISELY |
| K113010 |
12/21/2012 |
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR |
FAMIDOC TECHNOLOGY CO., LTD |
CAO LIANG |
| K122658 |
12/20/2012 |
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 |
FEMASYS INC. |
LISA PEACOCK |
| K120027 |
02/23/2012 |
PILAIRO NASAL PILLOWS MASK |
FISHER & PAYKEL HEALTHCARE LIMITED |
TINA MASON |
| K122432 |
12/06/2012 |
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS |
FISHER & PAYKEL HEALTHCARE, LTD. |
ROBERT PETRY |
| K113202 |
02/28/2012 |
TISSUE MARKER |
FOCAL THERAPEUTICS |
GEORGE HERMANN |
| K121508 |
12/12/2012 |
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N |
FOTONA D.D. |
STOJAN TOST |
| K122954 |
12/19/2012 |
CINCHER-2.6 SUTURE ANCHOR MODEL FG-001 |
FOUNDRY NEWCO XI, INC. |
MICHAEL KOLBER |
| K120017 |
02/02/2012 |
FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM |
FRESENIUS MEDICAL CARE, NORTH AMERICA |
DENISE OPPERMANN |
| K121341 |
12/06/2012 |
FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM |
FRESENIUS MEDICAL CARE, NORTH AMERICA |
DENISE OPPERMANN |
| K122535 |
12/13/2012 |
FUJINON/FUJIFILM EB-530 SERIES BRONCHOSCOPES (EB-530S, EB-530T AND EB-530H |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
|
| K113722 |
02/14/2012 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, BLUE COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
| K113710 |
02/14/2012 |
DISPOSABLE POWDER FREE VINYL EXAM GLOVE, YELLOW COLOR |
FULL SYNERGY MEDICAL PRODUCTS INC |
ELIZABETH DENG |
| K123255 |
12/20/2012 |
g.HIamp |
G.TEC MEDICAL ENGINEERING GMBH |
CHRISTOPH GUGER |
| K113313 |
12/14/2012 |
MOLECULAR ADSORBENT RECIRCULATING(MARS) |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K123564 |
12/18/2012 |
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM |
GE HEALTHCARE |
BRYAN BEHN |
| K120770 |
12/06/2012 |
QT GUARD PLUS ANALYSIS SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
KRISTIN PABST |
| K113403 |
02/14/2012 |
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM |
GE MEDICAL SYSTEMS SCS |
MICHEL GENUER |
| K113394 |
12/11/2012 |
MAVRIC SL |
GE MEDICAL SYSTEMS, LLC |
YUAN MA |
| K113408 |
02/24/2012 |
Q. FREEZE (MOTION VUE2) |
GE MEDICAL SYSTEMS, LLC |
DAVID DUERSTELER |
| K122948 |
12/21/2012 |
GEM-STIM COMBO STIMULATOR |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K122944 |
12/21/2012 |
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR |
GEMORE TECHNOLOGY CO., LTD. |
BODEN S.P. LAI |
| K122097 |
12/06/2012 |
PATRIOT SPACERS |
GLOBUS MEDICAL, INC. |
MERIAM YOUSSEF |
| K122142 |
12/21/2012 |
GLOOKO LOGBOOK CHARTS |
GLOOKO, INC. |
SHILPA MYDUR |
| K123113 |
12/11/2012 |
L.A.M. IMP WOUND GEL |
GLYCOBIOSCIENCES, INC |
JAMES JOHNSON |
| K110899 |
02/01/2012 |
GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT |
GOLD STANDARD DIAGNOSTICS |
NAPOLEON MONCE |
| K122832 |
12/19/2012 |
MOBICATH TRANSSEPTAL NEEDLE |
Greatbatch Medical |
DENISE THOMPSON |
| K110051 |
02/02/2012 |
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT |
Greatbatch Medical |
SARA BAKKER |
| K112541 |
02/07/2012 |
Z FLEX-270TM STEERABLE SHEATH |
Greatbatch Medical |
SARA BAKKER |
| K113505 |
02/17/2012 |
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
| K113377 |
12/14/2012 |
GLIADIN IGA AND GLIADIN LGA |
GRIFOLS USA, LLC |
CATHERINE L WONG |
| K122961 |
12/21/2012 |
WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K121398 |
12/13/2012 |
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) |
GUIDEPATH MEDICAL, INC. |
JOHN MITCHELL TATUM |
| K122605 |
12/05/2012 |
PKS BILL |
GYRUS ACMI, INC. |
NEIL KELLY |
| K123637 |
12/21/2012 |
HAMILTON-C3 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K112006 |
02/09/2012 |
HAMILTON-TC1 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K111405 |
02/13/2012 |
BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER, |
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. |
ALLYSON ZHOU |
| K112976 |
02/02/2012 |
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) WITH COLLOIDAL OATM |
HARTALEGA SND. BHD. |
NURUL A KONG |
| K120006 |
02/02/2012 |
HERO GRAFT |
HEMOSPHERE INC |
LAURIE LYNCH |
| K123278 |
12/07/2012 |
IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF |
HERAEUS KULZER, LLC |
JAMIE MEARNA |
| K121278 |
12/18/2012 |
HERMES MEDICAL IMAGING SUITE V5.2 |
HERMES MEDICAL SOLUTIONS, AB |
JOAKIM ARWIDSON |
| K113054 |
02/17/2012 |
EQUIVITAL |
HIDALGO LIMITED |
EKTA SOOD |
| K120886 |
12/17/2012 |
LACRIFAST |
HIROYASU HIGUCHI |
FUMIAKI KANAI, PH.D. |
| K112910 |
12/20/2012 |
AP 72OS SEMI-AUTOMATED INSTRUMENT |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
DONALD POSTEL |
| K123530 |
12/20/2012 |
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE) |
HOLOGIC, INC. |
GAIL YAEKER-DAUNIS |
| K113409 |
02/15/2012 |
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL |
HOWMEDICA OSTEONICS CORP. |
JUMA HOSHINO |
| K113360 |
02/07/2012 |
MEDICAL IMAGE PROCESSING UNIT |
HUMANRAY CO,LTD |
DAVE KIM |
| K121369 |
12/19/2012 |
NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR |
IBRAMED EQUIPAMENTOS MEDICOS |
LILIAN LLULL |
| K122546 |
12/07/2012 |
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
IDEV TECHNOLOGIES, INC. |
DARLENE GARNER |
| K121077 |
12/21/2012 |
NHANCER |
IMDS OPERATIONS B.V. |
E SCHULTING |
| K120946 |
12/17/2012 |
ALPHA CRYPTOCOCCAL ANTIGEN EIA |
IMMUNO-MYCOLOGICS, INC. |
SEAN K BAUMAN |
| K111938 |
02/14/2012 |
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K103325 |
02/03/2012 |
IDS-ISYS INTACT PTH |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K120067 |
02/28/2012 |
MOSAIQ ONCOLOGY INFORMATION SYSTEM |
IMPAC MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K123230 |
12/12/2012 |
MOSAIQ ONCOLOGY INFORMATION SYSTEM |
IMPAC MEDICAL SYSTEMS, INC. |
KATHRYN STINSON |
| K111473 |
02/16/2012 |
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR |
IMPACT INSTRUMENTATION, INC. |
SUSAN MCNEVIN |
| K123091 |
12/27/2012 |
VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T |
IMRIS, INC. |
Sanjay Shah |
| K110179 |
02/22/2012 |
INCONTROL |
INCONTROL MEDICAL, LLC |
MICHAEL LEIGH |
| K113506 |
12/19/2012 |
IND ONE STEP OCCULT BLOOD (FOB) TEST |
IND DIAGNOSTICS INC. |
KAI LOU |
| K113272 |
02/29/2012 |
INOMAX DS(DELIVERY SYSTEMS |
INO THERAPEUTICS LLC/DBA IKARIA |
LARRY LEPLEY |
| K120822 |
12/21/2012 |
STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST |
INSTITUT STRAUMANN AG |
ANDREAS PETERMANN |
| K122953 |
12/07/2012 |
OMNIPOD INSULIN MANAGMENT SYSTEM |
INSULET CORPORATION |
MICHAEL J DOYLE |
| K113570 |
02/22/2012 |
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP |
INTEGRA BURLINGTON MA, INC. |
LINDSAY MIGNONE |
| K123000 |
12/21/2012 |
INTEGRA TOTAL FOOT SYSTEMS |
INTEGRA LIFESCIENCES CORPORATION |
STEPHEN H BEIER |
| K113104 |
02/09/2012 |
INTEGRA WOUND MATRIX (THIN) |
INTEGRA LIFESCIENCES CORPORATION |
STEPHEN H BEIER |
| K103726 |
02/08/2012 |
JARIT TAKE-APART ENDOSCOPIC INSTRUMENTS |
INTEGRA LIFESCIENCES CORPORATION |
STEPHANIE SHEESLEY |
| K122075 |
12/20/2012 |
DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER |
INTERSURGICAL, INC. |
MICHAEL ZALEEWSKI |
| K123463 |
12/03/2012 |
INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS |
INTUITIVE SURGICAL, INC. |
CRYSTAL ONG |
| K100624 |
02/23/2012 |
INVENDO C20 COLONOSCOPY SYSTEM |
INVENDO MEDICAL GBMH |
OLIVER V RUEPPRECHT |
| K121582 |
12/20/2012 |
INVENDO C25 COLONOSCOPY SYSTEM |
INVENDO MEDICAL GBMH |
OLIVER V RUEPPRECHT |
| K122897 |
12/21/2012 |
SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645 |
INVIVO CORPORATION |
LANCE AULABAUGH |
| K120122 |
02/10/2012 |
SENSE MSK S 8CH 1.5T |
INVIVO CORPORATION |
Lisa Simpson |
| K113697 |
02/10/2012 |
EIGR SURGICAL ILLUMINATION SYSTEM |
INVUITY, INC. |
THERESA BRANDNER-ALLEN |
| K113862 |
02/06/2012 |
ZIO PATCH |
IRHYTHM TECHNOLOGIES, INC. |
MICHAEL RIGHTER |
| K112812 |
02/22/2012 |
LEFORTE NEURO SYSTEM BONE PLATE |
JEIL MEDICAL CORPORATION |
PAUL SUMNER |
| K122740 |
12/10/2012 |
JETPREP FLUSHING DEVICE OL-103037, JETPREP FLUSHING DEVICE OL-133037, JETPREP FLUSHING DEVICE OL-168037, JETPREP FLUSHIN |
JETPREP, LTD. |
JOHN SMITH, MD, JD |
| K121152 |
12/12/2012 |
SURGICAL GOWN, SMS |
JIANGSU GUANGDA MEDICAL MATERIAL, CO., LTD |
DARREN REEVES |
| K112758 |
02/23/2012 |
KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10 |
KAT IMPLANTS, LLC |
VITALI BONDAR |
| K123172 |
12/21/2012 |
KOGENT BIPOLAR FORCEPS |
KATALYST SURGICAL, LLC |
MONA DEAN |
| K112888 |
02/10/2012 |
MESO WOUND MATRIX |
KENSEY NASH CORPORATION |
LORI A BURNS |
| K120272 |
02/17/2012 |
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET |
KENTEC MEDICAL, INC. |
KEITH ROOKS |
| K122039 |
12/27/2012 |
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B |
KETTENBACH GMBH & CO KG |
JUERGEN BERGER |
| K120985 |
12/19/2012 |
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K112695 |
12/12/2012 |
CRYOTOP |
KITAZATO BIOPHARMA CO;LTD |
RICHARD VINCINS CQA,RAC(US,EU) |
| K123499 |
12/20/2012 |
AEROPILOT |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K120131 |
02/10/2012 |
REGIUS SIGMA2 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K112330 |
02/16/2012 |
KOWA VX-20 |
KOWA CO. LTD. |
HIROYUKI KOIDE |
| K121046 |
12/20/2012 |
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K122421 |
12/11/2012 |
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K120140 |
02/15/2012 |
FOCUS SPINAL SYSTEM |
L&K BIOMED CO., LTD |
HEE KYEONG JOO |
| K122474 |
12/28/2012 |
LANSINOH POWERED ELECTRIC BREAST PUMP |
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SAN |
Calley Herzog |
| K123531 |
12/14/2012 |
UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
LEMAITRE VASCULAR, INC. |
BRYAN COWELL, RAC |
| K122829 |
12/03/2012 |
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS |
LENSAR, INC. |
SHIRLEY K MCGARVEY |
| K122414 |
12/21/2012 |
AB COMMAND DUAL CHANNEL FITNESS BELT |
LETO ENTERPRISES INCORPORATION |
SABRINA WEI |
| K112898 |
12/21/2012 |
DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K113254 |
02/24/2012 |
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K123031 |
12/03/2012 |
BWF-5 MEDICAL LASER SERIES |
LITECURE, LLC |
LIANG LU |
| K120454 |
12/07/2012 |
SAFEAIR SMOKE PENCIL, |
LNA MEDICAL APS |
RICK GILLIS, PH.D |
| K112644 |
12/19/2012 |
SEAFORIA SPERM SEPARATION ASSISTANCE SYSTEM |
LOTUS BIO LTD |
LORI KAHLER |
| K123466 |
12/20/2012 |
HEALTHVIEW ECG MANAGER |
LUMEDX |
CHRIS PEARCE |
| K112781 |
02/17/2012 |
TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I) |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
LUBNA SYED |
| K113588 |
02/22/2012 |
SPECTRA LASER SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
| K113596 |
02/24/2012 |
MASIMO SET REUSABLE OXIMETRY SENSORS |
MASIMO CORPORATION |
DAVID COLLETTE |
| K112679 |
02/22/2012 |
SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM |
MATERIALISE DENTAL NV |
CARL VAN LIERDE |
| K121640 |
12/05/2012 |
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM |
MATERIALISE N.V. |
Alexandra Razzhivina |
| K113100 |
02/06/2012 |
POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
MAXTER GLOVE MANUFACTURING SDN BHD |
YAP P GEEH |
| K113664 |
02/17/2012 |
CLOSER TO NATURE ELECTRIC BREAST PUMP |
MAYBORN GROUP LIMITED |
NEIL HEWITT |
| K122322 |
12/06/2012 |
PIEZOSURGERY TOUCH |
MECTRON S.P.A. |
ROGER GRAY |
| K120024 |
02/28/2012 |
MECTALIF TRANSFORAMINAL |
MEDACTA INTERNATIONAL, SA |
ADAM GROSS |
| K121703 |
12/07/2012 |
LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE |
MEDI-KHAN USA, INC |
KACHI ENYINNA |
| K122764 |
12/28/2012 |
RAPID STRAND RX |
MEDI-PHYSICS, INC. |
DAVID RISLEY |
| K122423 |
12/12/2012 |
VASU-PICC |
MEDICAL COMPONENTS INC |
JESSICA LEO |
| K120956 |
12/12/2012 |
VSP SYSTEM |
MEDICAL MODELING INC |
JONATHAN S KAHAN |
| K113074 |
02/02/2012 |
CMAP PRO |
MEDICAL TECHNOLOGIES, INC. |
ANGELA MORRIS |
| K111341 |
02/29/2012 |
CLEANE / CLEANE POP |
MEDICON CO., LTD. |
Priscilla Chung |
| K112736 |
02/01/2012 |
PASS LP SPINAL |
MEDICREA INTERNATIONAL |
J D WEBB |
| K112807 |
02/27/2012 |
X-RAY VVA |
MEDIS MEDICAL IMAGING SYSTEMS, B.V. |
D.J.W. BIERHUIZEN |
| K120156 |
02/08/2012 |
PUREIMAGE ULTRASOUND TRANSMISSION GEL |
MEDLINE |
MATT CLAUSEN |
| K120844 |
12/13/2012 |
MEDLINX SURGICAL MESH |
MEDLINX ACALA PTE LTD |
STEPHEN P RHODES |
| K113526 |
02/16/2012 |
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM |
MEDOS INTERNATIONAL SARL |
JOCELYN RAPOSO |
| K123167 |
12/28/2012 |
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM |
MEDOS INTERNATIONAL SARL |
EUGENE BANG |
| K113396 |
02/08/2012 |
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM |
MEDOS INTERNATIONAL SARL |
EUGENE BANG |
| K113828 |
02/29/2012 |
DYNANAIL ANKLE ARTHRODESIS NAIL |
MEDSHAPE, INC |
JEREMY BLAIR |
| K123771 |
12/21/2012 |
KYPHON EXPRESS II INFLATABLE BONE TAMPS |
Medtronic |
HETAL JAWAHAR THAKKER |
| K123591 |
12/27/2012 |
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) |
MEDTRONIC CRYOCATH LP |
VANESSA WARE |
| K122760 |
12/07/2012 |
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE |
MEDTRONIC INC. |
JULIA A NELSON |
| K123448 |
12/13/2012 |
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE |
MEDTRONIC INC. |
JULIA A NELSON |
| K122827 |
12/14/2012 |
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 |
MEDTRONIC INC. |
MARY E DONLIN |
| K113529 |
02/09/2012 |
CD HORIZON VOYAGER SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MIKE SCOTT |
| K113642 |
02/06/2012 |
PERIMETER INTERBODY FUSION DEVICE |
MEDTRONIC SOFAMOR DANEK USA |
LAUREN KAMER |
| K123568 |
12/18/2012 |
VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MIKE SCOTT |
| K110623 |
02/10/2012 |
PILLAR PALATAL IMPLANT SYSTEM |
MEDTRONIC XOMED, INC. |
ROZANNE PACIEJ |
| K113390 |
02/14/2012 |
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) |
MERIDIAN AG |
Kevin Walls |
| K113190 |
02/24/2012 |
TRU LEGIONELLA |
MERIDIAN BIOSCIENCE, INC. |
SUSAN BOGAR |
| K122321 |
12/19/2012 |
BASIXCONPAK ANALOG INFLATION SYRINGE |
MERIT MEDICAL IRELAND, LTD. |
STEPHANIE ERSKINE |
| K122088 |
12/05/2012 |
MERIT ONE SNARE SYSTEM |
MERIT MEDICAL SYSTEMS, INC. |
MARK MULLANEY |
| K113701 |
02/16/2012 |
VISIA NEURO |
MEVIS MEDICAL SOLUTIONS AG |
THOMAS E TYNES |
| K122840 |
12/14/2012 |
CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 |
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
CHUCK SMITH |
| K113454 |
02/24/2012 |
14 WIRE STANDARD, 14 WIRE LS |
MICRO THERAPEUTICS, INC. |
GREGORY J GEISSINGER |
| K120936 |
12/13/2012 |
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS |
Microgenics Corporation |
KAREN LEE |
| K120628 |
12/19/2012 |
HELIO |
MOTION COMPOSITES |
VINCENT LECUYER |
| K113222 |
02/23/2012 |
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE |
NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. |
SHINICHI NAKAMURA |
| K110278 |
02/15/2012 |
CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K112673 |
02/07/2012 |
PROPHY-MATE NEO |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K123197 |
12/05/2012 |
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) |
NANOSPHERE, INC |
MARK DEL VECCHIO |
| K121117 |
12/14/2012 |
NDX ABUTMENTS |
NATIONAL DENTEX CORP |
LINDA K SCHULZ |
| K120356 |
12/11/2012 |
NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD |
NCS LAB SRL |
MATTEO MANTOVANI |
| K112540 |
02/03/2012 |
S-MINI IMPLANT SYSTEM |
NEOBIOTECH CO., LTD. |
APRIL LEE |
| K113771 |
12/13/2012 |
SIGNAL GEAR URETHRAL CATHETER ELECTRODE |
NEUROVISION MEDICAL PRODUCTS, INC. |
CHRISTINE VERGELY |
| K122217 |
12/19/2012 |
CERTUS 140 2.45GHZ ABLATION SYSTEM |
NEUWAVE MEDICAL, INC |
DAN KOSEDNAR |
| K112690 |
02/24/2012 |
BLOOD PRESSURE MONITOR |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KUBO |
| K112691 |
02/24/2012 |
BLOOD PRESSURE MONITOR |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KUBO |
| K120490 |
12/27/2012 |
QUICK SAMPLER HOLDER |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K122874 |
12/10/2012 |
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE |
NITRILIST GLOVES MANUFACTURING SDN BHD |
LAU SIONG HUT |
| K122435 |
12/20/2012 |
NOVA ONE BLOOD GLUCOSE MONITOR |
NOVA BIOMEDICAL CORPORATION |
PAUL W MACDONALD |
| K120237 |
12/11/2012 |
BPA-FREE MICROHYBID COMPOSITE |
NOVOCOL, INC. |
CORA BRACHO-TROCONIS |
| K111935 |
02/17/2012 |
TI-BASE ABUTMENT, 1 CONNECT ABUTMENT |
NT-TRADING GMBH AND CO KG |
WILLIAM GREENROSE |
| K122742 |
12/07/2012 |
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K112709 |
02/09/2012 |
STIMULATION/DISSECTION INSTRUMENTS |
NUVASIVE, INCORPORATED |
Elias Ketchum |
| K113023 |
12/21/2012 |
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K123359 |
12/19/2012 |
OVS1 VIDEO SYSTEM |
OLIVE MEDICAL CORP. |
BRIAN DEAN |
| K120357 |
12/20/2012 |
ENDOSCOPE REPROCESSOR OER-MINI |
OLYMPUS MEDICAL SYSTEMS CORP. |
LAURA STORMS-TYLER |
| K122831 |
12/14/2012 |
VIDEO SYSTEM CENTER |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI L MUSGNUNG |
| K123317 |
12/11/2012 |
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
SHERI L MUSGNUNG |
| K112680 |
02/16/2012 |
EVIS EXERA III VIDEO SYSTEM |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K123319 |
12/14/2012 |
GYRUS ACMI BICOAG HEMOSTASIS PROBE |
OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
NEIL KELLY |
| K110748 |
02/15/2012 |
OLYMPUS INSTRUMENT TRAY |
OLYMPUS WINTER & IBE GMBH |
STACY KLUESNER |
| K122759 |
12/05/2012 |
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) |
OMEGA LABORATORIES, INC. |
ROBERT J BARD |
| K112891 |
02/29/2012 |
APEX REVISION KNEE SYSTEMS |
OMNI LIFE SCIENCE, INC. |
CHRISTINE NASSIF |
| K123357 |
12/28/2012 |
ONQ RTS |
ONCOLOGY SYSTEMS, INC. |
CARL WALKER |
| K110691 |
02/01/2012 |
ONE PERSONAL LUBRICANT (WATER BASED) |
ONE |
SHARON PIETILA |
| K122603 |
12/19/2012 |
ONTEX AND OTHER PROPRIETARY NAMES |
ONTEX BVBA |
ROBERT J STAAB |
| K113334 |
02/03/2012 |
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS |
OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. |
DIANE ROGERS |
| K122875 |
12/18/2012 |
ORICARE L2700 |
ORICARE, INC. |
DAVID T JAMISON |
| K111678 |
02/07/2012 |
ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
| K113627 |
02/17/2012 |
HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY |
ORTHOCON |
ROSEMARY HARRY |
| K122901 |
12/03/2012 |
FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM |
ORTHOFIX |
JACKI GEREN |
| K111448 |
02/16/2012 |
ICON (TM) MODULAR PEDICLE SCREW SYSTEM |
ORTHOFIX, INC. |
DARLA CHEW |
| K123203 |
12/14/2012 |
MAXLOCK EXTREME SYSTEM MODEL MXL |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K111249 |
02/08/2012 |
ORTHOSLENDERIZER |
ORTHOMATICS, INC. |
PAUL ROCKE |
| K122958 |
12/13/2012 |
DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY |
Oscor Inc. |
MILA DOSKOCIL |
| K122960 |
12/13/2012 |
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO |
Oscor Inc. |
MILA DOSKOCIL |
| K121843 |
12/11/2012 |
NP-CAST ABUTMENT SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K122861 |
12/07/2012 |
XTOOL |
OUROBOROS MEDICAL |
SHELLEY TRIMM |
| K122152 |
12/14/2012 |
OXTI INFLATION DEVICE |
OXTI CORPORATION |
JOSEPH J CHANG |
| K120282 |
12/10/2012 |
CARDNAV |
PAIEON, INC. |
SHIMON VAKNIN |
| K113724 |
02/15/2012 |
ELECTROPULSE-COSMETIC |
PAIN RELIEF TECHNOLOGIES |
KENDALL GORHAM |
| K113207 |
02/29/2012 |
SONO TAP, TUOHY SONO |
PAJUNK GMBH |
CHRISTIAN QUASS |
| K113196 |
02/06/2012 |
VASCULAR SONO |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G QUASS |
| K122018 |
12/10/2012 |
OP300 |
PALODEX GROUP OY |
MATTI TULIKOURA |
| K113612 |
02/10/2012 |
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A |
PANASONIC HEALTHCARE CO., LTD. |
RAM BEDI |
| K112595 |
02/13/2012 |
COFLEX-F |
PARADIGM SPINE, LLC |
MARC VISCOGLIOSI |
| K122034 |
12/06/2012 |
MRJ 3300 |
PARAMED SRL |
LUISELLA DEBENEDETTI |
| K120242 |
02/24/2012 |
JETSTREAM NAVITUS L SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIT BAIRD |
| K122975 |
12/20/2012 |
GKS PRIME FLEX CR TOTAL KNEE SYSTEM |
PERMEDICA |
NATALIE J KENNEL |
| DEN120001 |
02/15/2012 |
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR STRIP, CURVE CONTROL STRIP, ANTI-TRYPTASE |
PHADIA US INC. |
MARTIN MANN |
| K103295 |
02/01/2012 |
QUICKSCREEN COCAINE 150 SCREENING TEST |
PHAMATECH INC. |
CARL MONGIOVI |
| K120321 |
02/17/2012 |
CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS HEALTHCARE |
ROB BUTLER |
| K121498 |
12/14/2012 |
PERCUNAV |
PHILIPS HEALTHCARE |
TARA MACKINNON |
| K123492 |
12/13/2012 |
DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L) |
PHILIPS MEDICAL SYSTEMS |
Lisa Simpson |
| K110825 |
02/16/2012 |
PHILIPS HEARTSTART XL+, PHILIPS HEARTSTART EXTERNAL PADDLES, PHILIPS MULTIFUNCTION ELECTRODES |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K120132 |
02/14/2012 |
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K123754 |
12/21/2012 |
CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILIPS ULTRASOUND, INC. |
|
| K110550 |
02/03/2012 |
BRIGHT EMBRACE MODEL SBL60 |
PHYSICIAN ENGINEERED PRODUCTS, INC. |
ROBERT ROSE |
| K123565 |
12/13/2012 |
PRESTO 1000 SYSTEM |
PHYSIOSONICS, INC |
DAVID CRONISER |
| K122158 |
12/11/2012 |
PBP TOTAL HIP SYSTEM |
PIPELINE BIOMEDICAL PRODUCTS, LLC |
TERRY POWELL |
| K111684 |
02/03/2012 |
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD |
PLAYTEX MANUFACTURING INC. |
PUSHPA RAO |
| K122376 |
12/19/2012 |
PMT TRUSCAN SURFACE ELECTRODE |
PMT CORP. |
AL IVERSEN |
| K122749 |
12/27/2012 |
PRESTIGE-MOBIE |
PRESTIGE SPORTING GOODS CO. LTD. |
JUNNATA CHANG |
| K112815 |
02/29/2012 |
QUANTUM BARIATRIC 451 |
PRIDE MOBILITY PRODUCT CORPORRATION |
KIMBERLY BLAKE |
| K120858 |
12/06/2012 |
IMPLANT BAR |
PRISMATIK DENTALCRAFT, INC. |
KATHLEEN DRAGOVICH |
| K121391 |
12/10/2012 |
INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K122616 |
12/21/2012 |
PANTHER OIS/R & V MODEL VERSION 2.0 |
PROWESS, INC. |
RACHEL SCARANO |
| K113772 |
02/09/2012 |
HPR EMOLLIENT FOAM |
PRUGEN IP HOLDINGS, INC |
SEAN LONERGAN |
| K113774 |
02/09/2012 |
HPR PLUS EMOLLIENT FOAM |
PRUGEN IP HOLDINGS, INC |
SEAN LONERGAN |
| K112654 |
02/17/2012 |
POWDERFREE POLYISOPRENE SURGICAL GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K123265 |
12/07/2012 |
RMGI LOW VISCOSITY |
PULPDENT CORPORATION |
KENNETH J BERK |
| K121266 |
12/11/2012 |
CARDIOSCOPE |
PULSECOR LIMITED |
E.J. Smith |
| K113323 |
02/06/2012 |
ARTUS INFL A/B RG RT-PCR KIT |
QIAGEN, GMBH |
KIM DAVIS |
| K113319 |
02/06/2012 |
ROTOR-GENE Q MDX |
QIAGEN, GMBH |
MELISSA MAHALL |
| K120290 |
02/28/2012 |
TOSHIBA 1.5T CARDIAC COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
| K123168 |
12/20/2012 |
Q-PLUS T+ IPL LASER SYSTEM |
Quanta System SpA |
Maurizio Bianchi |
| K113231 |
02/27/2012 |
WARP10,WARP75 |
QUANTUM DEVICES, INC. |
MORRIS WAXLER |
| K123355 |
12/13/2012 |
AMPLIVUE C. DIFFICILE ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K120381 |
02/24/2012 |
Q50 PLUS STENT GRAFT BALLOON CATHETER |
QXMEDICAL, LLC |
|
| K120103 |
02/03/2012 |
REST ASSURED GENERATION III DENTAL PROTECTOR |
RANIR LLC |
GERARD J PRUD'HOMME |
| K122645 |
12/05/2012 |
MOBILE CAREGUIDE 2100 OXIMETER |
REFLECTANCE MEDICAL INC |
Nandini Murthy |
| K120178 |
02/08/2012 |
WINGMAN EXTENDABLE TIP SUPPORT CATHETER |
REFLOW MEDICAL |
Rebecca K Pine |
| K123398 |
12/18/2012 |
DR. SCHOLL'S COMPRESSION SOCKS |
RENFRO CORPORATION |
Rebecca K Pine |
| K113053 |
02/01/2012 |
BIPAP A 30 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
ELAINE LARKIN |
| K121623 |
12/14/2012 |
BIPAP A 40 VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
ELAINE LARKIN |
| K121955 |
12/14/2012 |
COUGHASSIST T70 DEVICE |
RESPIRONICS, INC. |
COLLEEN WITT |
| K122111 |
12/31/2012 |
RESPIRONICS SIMPLYCLEAR DEVICE |
RESPIRONICS, INC. |
COLLEEN WITT |
| K122684 |
12/07/2012 |
REVERSE MEDICAL MICROCATHETER |
REVERSE MEDICAL CORPORATION |
JEFFREY VALKO |
| K123526 |
12/27/2012 |
CLEARREAD +CONFIRM |
RIVERAIN TECHNOLOGIES |
JENNIFER BUTSCH |
| K122242 |
12/05/2012 |
ELECSYS CA 15-3 II CALCHECK 5 |
Roche Diagnostics |
EDIE EADS |
| K123695 |
12/18/2012 |
TRAUS SIP10 |
SAESHIN PRECISION CO., LTD. |
Y.S. LEE |
| K112591 |
02/07/2012 |
SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS |
SAFE SECURE PACKAGING CO., LTD |
GARFIELD WANG |
| K123226 |
12/05/2012 |
LESSRAY |
SAFERAY SPINE, LLC |
Calley Herzog |
| K120268 |
02/10/2012 |
AMID STAPLER |
SAFESTICH MEDICAL, LLC |
ALINA CARABALLO |
| K113542 |
02/10/2012 |
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) |
SALTER LABS, ARVIN FACILITY |
MICHAEL SHOUP |
| K121693 |
12/27/2012 |
A-WEDGE ANTERIOR INTERBODY SYSTEM (A-WEDGE AIS) |
SAPPHIRE MEDICAL GROUP, INC |
ROBERT POGGIE |
| K112188 |
02/03/2012 |
PIEZOTOME SOLO |
SATELEC - ACTEON, INC. |
RICK ROSATI |
| K113430 |
02/23/2012 |
PROULTRA PIEZO ULTRASONIC |
SATELEC-ACTEON GROUP |
RICK ROSATI |
| K113755 |
02/01/2012 |
SAVANNAH TECHNOLOGIES SPINAL SYSTEM |
SAVANNAH TECHNOLOGIES LLC |
J.D. WEBB |
| K122571 |
12/12/2012 |
MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM |
SEASPINE, INC. |
ETHEL BERNAL |
| K122101 |
12/06/2012 |
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C |
SEBIA |
KAREN ANDERSON |
| K121397 |
12/28/2012 |
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT |
SEKISUI DIAGNOSTICS, LLC |
MARK STAVRO |
| K113693 |
12/11/2012 |
NIXALL TM WOUND AND SKIN CARE |
SERIOUSLY CLEAN LTD |
KIP GLASS |
| K122828 |
12/10/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
SHANDONG HONGXIN CHEMICALS CO., LTD |
CHU XIAOAN |
| K113183 |
02/09/2012 |
PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 |
SHANGHAI 3F ELECTRONICS CO LTD |
CHARILIE MACK |
| K120475 |
12/21/2012 |
ANESTHESIA CONDUCTION NEEDLES |
SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD |
MIKE GU |
| K113587 |
02/24/2012 |
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) |
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD. |
CHARLIE MACK |
| K120502 |
12/07/2012 |
PC-60NW FINGERTIP OXIMETER |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
CHARLES MACK |
| K112042 |
02/10/2012 |
KINGYIELD WRIST BLOOD PRESSURE MONITOR |
SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. |
DACHENG GONG |
| K123503 |
12/13/2012 |
DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
BAI YANHONG |
| K113442 |
02/16/2012 |
3DI |
SHINA SYSTEMS LTD. |
DAN LAOR |
| K113514 |
02/22/2012 |
SMARTHEART |
SHL TELEMEDICINE INTERNATIONAL LTD. |
YORAM LEVY |
| K113426 |
02/08/2012 |
VERACIA SA |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K121549 |
12/27/2012 |
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K123046 |
12/20/2012 |
ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR |
Siemens Healthcare Diagnostics Inc. |
NEIL PARKER |
| K123622 |
12/05/2012 |
ACUSON |
SIEMENS MEDICAL SOLUTIONS USA INC. |
PATRICK LYNCH |
| K123528 |
12/20/2012 |
SCENIUM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
| K123585 |
12/20/2012 |
SYNGO, CT CARDIAC FUNCTION |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K122909 |
12/27/2012 |
SYNGO SINGLE SOURCE DUAL ENGERY |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K121440 |
12/06/2012 |
ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K121297 |
12/28/2012 |
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR |
SIGNATURE ORTHOPAEDICS, PTY, LTD |
DECLAN BRAZIL |
| K122787 |
12/06/2012 |
COMFORT EZ |
SIMPLE DIAGNOSTICS, INC. |
DANIEL KAMM, P.E. |
| K112861 |
02/24/2012 |
SINTEA PLUSTEK ANTERIOR CERVICAL PLATE SYSTEM |
SINTEA PLUSTEK, LLC |
DANIELLE WERNIKOWSKI |
| K111421 |
02/17/2012 |
SIRONA DENTAL CAD/CAM SYSTEM |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K112383 |
02/07/2012 |
CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER |
SKELETAL KINETICS, LLC |
CHRISTINE KUO |
| K122475 |
12/07/2012 |
ZQUIET PRO-PLUS |
SLEEPING WELL, LLC |
DANIEL WEBSTER |
| K112106 |
02/06/2012 |
NAVIAID ICVI-F,S,B,R DEVICE |
SMART MEDICAL SYSTEMS, LTD. |
ADVA YOSELZON |
| K123184 |
12/19/2012 |
FINN CHAMBERS AQUA |
SMART PRACTICE |
KIM SULLIVAN |
| K113482 |
02/27/2012 |
JOURNEY II DEEP DISHED ARTICULAR INSERTS |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K112407 |
02/09/2012 |
SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS |
SMITHS MEDICAL MD, INC. |
TOM BLISS |
| K122213 |
12/12/2012 |
ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
SOFLEX LIMITED |
Kevin Walls |
| K123479 |
12/11/2012 |
PROGRIP LAPAROSCOPIC SELF-FIXATING MESH |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K112777 |
02/24/2012 |
SOL-M EXCHANGEABLE NEEDLES |
SOL-MILENNIUM MEDICAL, INC. |
JIM BARLEY |
| K120029 |
02/06/2012 |
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
LOUISE FOCHT |
| K113752 |
02/06/2012 |
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
LOUISE FOCHT |
| K122105 |
12/07/2012 |
SMI CARDIOVASCULAR PATCH |
SOLINAS MEDICAL INC |
JAMES HONG |
| K123616 |
12/21/2012 |
PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM |
SONOSCAPE COMPANY LIMITED |
Diana Hong |
| K113203 |
02/24/2012 |
SONY LMD-2451MT LCD MONITOR |
SONY ELECTRONICS, INC. |
CYNTHIA SINCLAIR |
| K123093 |
12/20/2012 |
STABILINK MIS SPINAL FIXATION SYSTEM |
SOUTHERN SPINE, LLC |
JULIE STEPHENS |
| K122630 |
12/05/2012 |
IN:C2 SPINAL FIXATION SYSTEM |
SPINE SMITH PARTNERS L.P. |
CLIFTON (CHRIS) NAIVAR |
| K122134 |
12/27/2012 |
FLEXLITE CAMERA |
SPINE VIEW, INC. |
MBITHI MUTHINI |
| K113362 |
02/10/2012 |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) |
SPINE VIEW, INC. |
SEVRINA CIUCCI |
| K113518 |
02/16/2012 |
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
SPINEFRONTIER, INC. |
CHRISTOPHER CHANG |
| K120293 |
02/29/2012 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DRIVE |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K111515 |
02/01/2012 |
SPSMEDICAL SPORVIEW STEAM BI |
SPS MEDICAL SUPPLY CORP. |
GARY J SOCOLA |
| K120301 |
02/24/2012 |
MEDIGUIDE TECHNOLOGY |
ST. JUDE MEDICAL, MEDIGUIDE NAVIGATION SYSTEMS |
JONATHAN S KAHAN |
| K113520 |
02/21/2012 |
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K122555 |
12/12/2012 |
STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPE |
STERITEC PRODUCTS MFG. CO., INC. |
JONATHAN RUTIGLIANO |
| K122855 |
12/12/2012 |
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS |
STRAUMANN USA |
ELAINE ALAN |
| K122845 |
12/07/2012 |
ES2 SPINAL SYSTEM MODEL 48280XXXX |
STRYKER SPINE |
SORAYA KING |
| K121913 |
12/20/2012 |
REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER |
STRYKER SUSTAINABILITY SOLUTIONS, INC. |
MOIRA BARTON-VARTY |
| K113737 |
02/23/2012 |
SUREFIRE GUIDE SHEATH |
SUREFIRE MEDICAL, INC |
MARIO ARBESU |
| K123836 |
12/21/2012 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K123005 |
12/07/2012 |
DDRVERSA MOTION |
SWISSRAY MEDICAL AG |
DANIEL KAMM |
| K113600 |
02/08/2012 |
IM BAND |
SYNEXMED (SHENZHEN) COMPANY LIMITED |
ERIC CHIEN |
| K113148 |
02/28/2012 |
E-PASS |
SYNEXMED(SHENZHEN)COMPANY LIMITED |
TONY ZHANG |
| K111189 |
12/20/2012 |
SYNTEC DENTAL IMPLANT |
SYNTEC SCIENTIFIC CORP. |
CHIA-CHING LEE |
| K113364 |
02/29/2012 |
2.7MM LCP ULNA OSTEOTOMY SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
REBECCA BLANK |
| K122211 |
12/17/2012 |
SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS |
SYNTHES SPINE |
HEMAL MEHTA |
| K113149 |
02/01/2012 |
SYNTHES USS CONNECTORS |
SYNTHES SPINE |
HEATHER GUERIN |
| K120083 |
02/08/2012 |
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) |
SYNTHES USA |
THOMAS N SHEA |
| K113551 |
02/14/2012 |
ESOPHAGEAL TTS STENT |
TAEWOONG MEDICAL CO., LTD |
STEPHEN RHODES |
| K111890 |
02/06/2012 |
FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
MEIRU LI |
| K122481 |
12/31/2012 |
LIPIVIEW OCULAR SURFACE INTERFEROMETER |
TEARSCIENCE, INC. |
CHRISTY STEVENS |
| K123273 |
12/07/2012 |
HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) |
TEMREX CORP. |
HABIB LAFIR |
| K113721 |
02/15/2012 |
TEPHAFLEX LIGHT MESH |
TEPHA, INC. |
MARY P LEGRAW |
| K113723 |
02/15/2012 |
TEPHAFLEX MESH |
TEPHA, INC. |
MARY P LEGRAW |
| K112953 |
02/03/2012 |
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS |
TERATECH CORP. |
|
| K113214 |
02/07/2012 |
TLINK DATA MANAGEMENT SYSTEM (DMS) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
REBECCA ANDERSEN |
| K122980 |
12/11/2012 |
GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ |
Terumo Medical Corporation |
DANIEL R PLONSKI |
| K103824 |
02/27/2012 |
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS |
THE BINDING SITE |
SUZANNE HORNE |
| K120932 |
12/07/2012 |
OPELASER PRO II AND THE OPELASER LITE II |
THE YOSHIDA DENTAL MFG. CO., LTD. |
DANIEL KAMM |
| K120948 |
12/21/2012 |
PREXION 3D |
THE YOSHIDA DENTAL MFG. CO., LTD. |
HIDENORI WATANABE |
| K120047 |
02/03/2012 |
CORAL SPINAL SYSTEM |
THEKEN SPINE, LLC |
DALE DAVISON |
| K111456 |
02/28/2012 |
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM |
TIANJIN EMPECS MEDICAL DEVICE CO., LTD. |
HL JUNG |
| K122717 |
12/21/2012 |
FACE MASK, SURGICAL MASK, PROCEDURE MASK, SURGICAL FACE MASK |
TIGER MEDICAL PRODUCTS LTD |
DAVID WANG |
| K120953 |
12/10/2012 |
PLEUR-EVAC SAHARA PLUS CONTINOUS REINFUSION AUTOTRANSFUSION SYSTEM |
TLELFLEX MEDICAL, INC. |
LORRAINE DELONG |
| K123092 |
12/21/2012 |
CERAMIN BRACKETS Z |
TOMY, INC. |
CAROLYN PRIMUS |
| K123094 |
12/13/2012 |
ORTHODONTIC CERAMIC BRACKETS |
TOMY, INC. |
CAROLYN PRIMUS |
| K111970 |
02/23/2012 |
KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT |
TORNIER |
STEPHANIE BERNARD |
| K122613 |
12/13/2012 |
VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
CHARLEMAGNE CHUA |
| K112906 |
02/01/2012 |
KLASSIC KNEE SYSTEM |
TOTAL JOINT ORTHOPEDICS, INC. |
HEATHER LAKE |
| K113419 |
02/16/2012 |
CS IMAGING |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K113259 |
02/10/2012 |
NOTOUCH BREASTSCAN |
UE LIFESCIENCES, INC. |
MIHIR SHAH |
| K113346 |
02/28/2012 |
NEON SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K123446 |
12/07/2012 |
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM |
United States GTM Medical Devices, Inc. |
Kenneth K Kleinhenz |
| K120337 |
02/16/2012 |
I-PORT ADVANCE INJECTION PORT |
UNOMEDICAL A/S |
SOREN MELSTED |
| K112886 |
02/23/2012 |
UPSTREAM SUPPORT CATHETER |
UPSTREAM PERIPHERAL TECHNOLOGIES |
JANICE M HOGAN |
| K111463 |
02/17/2012 |
VALEO VT-601 SERIES IR THERMOMETER |
VALEO CORP. |
JENNIFER REICH |
| K123137 |
12/05/2012 |
CALYPSO SYSTEM |
VARIAN MEDICAL SYSTEMS |
MARCIA PAGE |
| K123291 |
12/20/2012 |
TRUEBEAM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K123152 |
12/07/2012 |
VITESSE 3.0 |
VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS |
VY TRAN |
| K123493 |
12/13/2012 |
VEX-S 100W INTRAORAL X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K122609 |
12/21/2012 |
VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F |
VENOUS HEALTH SYSTEMS, INC. |
RICH LAGUNA |
| K110215 |
12/17/2012 |
CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY |
VENTANA MEDICAL SYSTEMS, INC. |
ROXANE BONNER |
| K111755 |
02/22/2012 |
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) |
VENTANA MEDICAL SYSTEMS, INC. |
TROY QUANDER |
| K122106 |
12/21/2012 |
SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLE |
VERAN MEDICAL TECHNOLOGIES, INC. |
SCOTT WRIGHTSTONE |
| K122821 |
12/13/2012 |
CELLTRACKS AUTOPREP SYSTEM |
VERIDEX, LLC |
KIMBERLY PRESCOTT |
| K122509 |
12/17/2012 |
VERTIFLEX SPINOUS PROCESS FIXATION PLATE |
VERTIFLEX, INC. |
STEVE REITZLER |
| K122269 |
12/13/2012 |
ENAMIC |
VITA ZAHNFABRIK H. RAUTER GMBH & CO. |
ELIZABETH WOLFSEN |
| K123773 |
12/21/2012 |
X-TRA BASE |
VOCO GMBH |
T. GERKENSMEIER |
| K121105 |
12/18/2012 |
NUTRISAFE 2 FEEDING TUBE |
VYGON CORP. |
JILLIAN MIKOVICH |
| K123156 |
12/13/2012 |
GORE FLOW REVERSAL SYSTEM MODEL GFRS073 |
W. L. GORE & ASSOCIATES, INC. |
SHARON ALEXANDER |
| K112642 |
02/06/2012 |
AQUILEX FLUID CONTROL SYSTEM H112 |
W.O.M. WORLD OF MEDICINE AG |
SUSANNE RAAB |
| K120391 |
12/21/2012 |
MR4500 WHEELCHAIR |
WARDRAY PREMISE LTD |
JAMES WASON PH.D. |
| K111521 |
02/16/2012 |
WAVES |
WATERS MEDICAL SYSTEMS, LLC |
ROBERT WARREN |
| K120343 |
02/24/2012 |
CONNEX WORKSTATION |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K121405 |
12/20/2012 |
PANOPTIC |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K120314 |
02/24/2012 |
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM |
WELLDOC, INC |
LAUREN BRONICH-HALL |
| K111141 |
02/21/2012 |
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR |
WENZHOU BOKANG INSTRUMENTS CO., LTD. |
JOHNNY CAO |
| K121382 |
12/06/2012 |
WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] |
Westmed, Inc. |
R. JOHN MCKINNON |
| K113275 |
02/27/2012 |
COMPRESSIBLE LIMB THERAPY SYSTEM |
WONJINMULSAN CO., LTD. |
EILEEN YANG |
| K120019 |
02/23/2012 |
COLLAGEN RIBBON |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K113322 |
02/03/2012 |
CONSERVE THIN SHELL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K112016 |
02/10/2012 |
L-SER KO LAMP |
YA-MAN LTD |
NELSON MARQUINA |
| K112542 |
02/08/2012 |
YOMURA SAFETY I.V. CATHETER |
YOMURA TECHNOLOGIES INC. |
SHERRY LIN |
| K122835 |
12/10/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
YUANHANG PLASTIC CO., LTD |
CHU XIAOAN |
| K120793 |
12/21/2012 |
Z-LOOK3 EVO SLM |
Z-Systems AG |
LINDA SCHULZ |
| K123669 |
12/21/2012 |
TRANSTEK WRIST BLOOD PRESSURE MONITOR |
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. |
LEO WANG |
| K113556 |
02/17/2012 |
WAGNER CONE PROSTHESIS SYSTEM |
ZIMMER GMBH |
DANIEL J WILLIAM |
| K122733 |
12/07/2012 |
V2F ANTERIOR FIXATION SYSTEM |
ZIMMER SPINE, INC |
JENNIFER TRIBBETT |
| K122745 |
12/05/2012 |
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM |
ZIMMER, INC. |
PAULINE A SHAND |
| K122692 |
12/03/2012 |
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
| K122839 |
12/13/2012 |
ZOLL SUREPOWER SINGLE BAY CHARGER |
ZOLL MEDICAL CORPORATION |
TANMAY B SHUKLA |
