| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K123015 |
11/21/2012 |
.DECIMAL PHOTON BLOCK |
.DECIMAL, INC. |
KYM RUPP |
| K122467 |
11/20/2012 |
3M TRUE DEFINITION SCANNER |
3M COMPANY |
GINGER CANTOR |
| K113601 |
11/08/2012 |
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K121494 |
11/19/2012 |
LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K123379 |
11/27/2012 |
ABBOTT ARCHITECT FREE T4 |
ABBOTT LABORATORIES |
JACEK GORZOWSKI |
| K122573 |
11/20/2012 |
HI-TORQUE COMMAND GUIDE WIRE FAMILY |
ABBOTT VASCULAR INC. |
KAY SETZER |
| K120280 |
11/05/2012 |
RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM |
ACCLARENT, INC. |
DAN HARFE |
| K122110 |
11/21/2012 |
ACON ON CALL VIVID PAL BLOOD GLUCOSE MONITORING SYSTEM |
ACON LABORATORIES, INC. |
QIYI XIE |
| K122538 |
11/19/2012 |
ACUMED PELVIC BONE PLATE SYSTEM |
ACUMED LLC |
KARA BUDOR |
| K113315 |
11/20/2012 |
RUMBLE TUFF |
ACUTE IDEAS CO. LTD. |
MATTHEW KHO |
| K120350 |
11/01/2012 |
EXTENDED LIFE BATTERY |
AED BATTERY EXCHANGE, LLC |
KEITH HOCHHALTER |
| K122333 |
11/19/2012 |
MOBILECARE MONITOR |
AFRAME DIGITAL, INC. |
JILL THORPE |
| K121712 |
11/20/2012 |
AIRSTRIP RPM FOR LIFENET CONSULT |
AIRSTRIP TECHNOLOGIES, INC. |
ROBERT A MILLER |
| K122350 |
11/01/2012 |
TAP PAP NASAL PILLOW MASK |
AIRWAY MANAGEMENT, INC. |
PAUL DRYDEN |
| K121662 |
11/21/2012 |
VECTTOR VT-200 |
ALAN NEUROMEDICAL TECHNOLOGIES LLC |
DONALD A RHODES |
| K122356 |
11/19/2012 |
ALIVECOR HEART MONITOR FOR IPHONE |
ALIVECOR, INC. |
MICHAEL RIGHTER |
| K113124 |
11/09/2012 |
ALN OPTIONAL VANA CAVA FILTER |
ALN IMPLANTS CHIRURGICAUX |
CYNTHIA COTTEREAU |
| K123218 |
11/28/2012 |
ILLICO FS FACET FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
TREVOR DENBO |
| K121354 |
11/09/2012 |
MICRO/MINI N-PK(F) BONE ANCHOR |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K121356 |
11/09/2012 |
MICRO/MINI N-PK(H) BONE ANCHOR |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K121501 |
11/29/2012 |
ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) |
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
JULIE LAWSON |
| K123268 |
11/07/2012 |
SMARTSTITCH PERFECTPASSER SYSTEM |
ARTHOCARE CORPORATION |
CHERYL FREDERICK |
| K122334 |
11/28/2012 |
CHECKMATE SMALL BONE FUSION SYSTEM |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K122129 |
11/16/2012 |
SPHYGMOCOR XCEL |
ATCOR MEDICAL |
JOHN ABRAM |
| K121793 |
11/01/2012 |
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON |
AUDIFON-USA INC. |
JANE E PERRONE |
| K122380 |
11/07/2012 |
OCELOT SYSTEM |
AVINGER, INC. |
Albert Boniske |
| K121846 |
11/20/2012 |
CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE |
B. BRAUN MEDICAL, INC. |
NANCY SKOCYPEC |
| K121786 |
11/05/2012 |
DYMAXEON SPINE SYSTEM |
B2B SPINE PTY LTD |
JUSTIN EGGLETON |
| K122278 |
11/07/2012 |
BAYLIS MEDICAL COMPANY RADIOFREQUENCY PERFORATION GENERATOR |
BAYLIS MEDICAL COMPANY INC. |
MEGHAL KHAKHAR |
| K122496 |
11/01/2012 |
AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM |
BIO-LOGIC SYSTEMS CORP. |
TIMOTHY KARLOVSKY |
| K122187 |
11/06/2012 |
VRESELECT CULTURE MEDIUM |
BIO-RAD |
FRAN WHITE |
| K123021 |
11/02/2012 |
BIOPLEX 2200 EBV IGM KIT |
Bio-Rad Laboratories |
Juang Wang |
| K123198 |
11/20/2012 |
LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 1 MODEL 271, LIQUICHEK ETHANOL/AMMONIA CONTROL LEVEL 2 MODEL 272, LIQUICHEK ETHA |
Bio-Rad Laboratories |
SUZANNE PARSONS |
| K121100 |
11/19/2012 |
VITEK 2 AST STREPTOCOCUS VANCOMYCIN |
BIOMERIEUX, INC. |
JOCELYN JENNINGS |
| K121546 |
11/20/2012 |
VITEK 2 GRAM NEGATIVE DOXYCYCLINE |
BIOMERIEUX, INC. |
JENNIFER CHIA-HSUAN LIN |
| K121874 |
11/23/2012 |
G7 ACETABULAR SYSTEM |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K123297 |
11/20/2012 |
COMPRESS SEGMENTAL HUMERAL REPLACEMENT SYSTEM |
BIOMET MANUFACTUTING CORP. |
PATRICIA BERES |
| K122443 |
11/20/2012 |
UFIT TEN-10 |
BIOSIGN TECHNOLOGIES, INC. |
ALLISON SCOTT, RAC |
| K121936 |
11/30/2012 |
NAVIOPFS |
BLUE BELT TECHNOLOGIES, INC. |
RICHARD G CONFER |
| K122052 |
11/28/2012 |
MINIFIX BALL MINIFIX ONE |
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC |
JUAN TEZAK |
| K123214 |
11/13/2012 |
ENCORE 26 ADVANTAGE KIT |
BOSTON SCIENTIFIC CORP. |
RACHEL OWENS |
| K122011 |
11/15/2012 |
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K122795 |
11/08/2012 |
STINGRAY GUIDEWIRES |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K123179 |
11/02/2012 |
AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING |
C.R. BARD, INC. |
MICHELE DAVIS |
| K122367 |
11/02/2012 |
BARD PTV DILATATION CATHETER |
C.R. BARD, INC. |
ERIN FOX |
| K122436 |
11/02/2012 |
COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM |
C.R. BARD, INC. |
KETI SINO |
| K122899 |
11/15/2012 |
POWERPORT CLEARVUE SLIM IMPLANTABLE PORT |
C.R. BARD, INC. |
AMY HONEY |
| K120409 |
11/26/2012 |
PICCOLO COMPOSITE PLATE SYSTEM |
CARBOFIX ORTHOPEDICS LTD. |
YAEL RUBIN |
| K122699 |
11/19/2012 |
SENTRYSUITE PRODUCT LINE |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K123020 |
11/28/2012 |
BLIP MODEL BP-700WF |
CAREMATIX INC. |
SUKHWANT KHANUJA |
| K122938 |
11/02/2012 |
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH |
CARL ZEISS MEDITEC AG |
JUDY BRIMACOMBE |
| K120560 |
11/06/2012 |
TRINITY WRINKLE REMOVER |
Carol Cole Company |
BOB DUFFY |
| K122488 |
11/20/2012 |
AMIGO REMOTE CATHETER SYSTEM & ACCESSORIES |
CATHETER ROBOTICS INC |
JENNIFER ENGLUND |
| K121539 |
11/02/2012 |
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) |
CEPHEID |
KERRY J FLOM |
| K122561 |
11/27/2012 |
ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN |
CEREMED, INC. |
CHELSEA MITCHELL |
| K123080 |
11/29/2012 |
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
| K122115 |
11/01/2012 |
COLLAGEN DENTAL WOUND DRESSINGS |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K121562 |
11/05/2012 |
ALTIS SINGLE INCISION CLING SYSTEM |
COLOPLAST A/S |
JANELL A COLLEY |
| K122440 |
11/19/2012 |
RESTORELLE L |
COLOPLAST CORP. |
TIM CRABTREE |
| K122581 |
11/21/2012 |
MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 |
CONCENTRIC MEDICAL, INC. |
CHRISTINA ROWE |
| K122512 |
11/05/2012 |
CS2 HIP SYSTEM |
CONSENSUS ORTHOPEDICS, INC. |
MATTHEW M HULL |
| K121791 |
11/19/2012 |
ZOU ANTERIOR LUMBAR PLATE SYSTEM |
CORELINK LLC |
JUSTIN EGGLETON |
| K122305 |
11/21/2012 |
CORIN TRINITY-I ACETABULAR SHELL |
CORIN USA |
DIANA L MARTONE |
| K121361 |
11/30/2012 |
CURALINE POLYURETHANE FOAM AWC DRESSING |
CURALINE INC |
HAITHAM MATLOUB |
| K122389 |
11/02/2012 |
TRUSCULPT |
CUTERA, INC. |
Connie Hoy |
| K121346 |
11/27/2012 |
PICOSURE WORKSTATION |
CYNOSURE, INC. |
IRINA KULINETS |
| K122405 |
11/09/2012 |
AIR-BAND RADIAL COMPRESSION DEVICE |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
CARLA S CERQUEIRA |
| K113316 |
11/08/2012 |
DCS LACRIMAL STENT |
DCS SURGICAL INC |
HARRY ROSS |
| K122425 |
11/05/2012 |
VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
YAYOI FUJIMAKI |
| K123259 |
11/15/2012 |
MAMMOTOME REOLVE DUAL VACUUM ASSISTED BIOPSY (VAB) SYSTEM |
DEVICOR MEDICAL PRODUCTS, INC. |
SHAWNA M ROSE |
| K122420 |
11/28/2012 |
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA |
DIAZYME LABORATORIES |
Abhijit Datta |
| K120642 |
11/02/2012 |
RESUSCITAIRE WITH AUTOBREATH |
Draeger Medical Systems, Inc. |
GALE WINARSKY |
| K121093 |
11/27/2012 |
D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 |
DXM CO., LTD. |
JIGAR SHAH |
| K122580 |
11/09/2012 |
AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES |
ENCISION, INC. |
JIM LEWIS |
| K122636 |
11/02/2012 |
REVELATION POROUS COATED HIP STEM, SIZE 8 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K120862 |
11/27/2012 |
WATER BOTTLE CAP IRRIGATON SYSTEM |
ENDOCHOICE, INC. |
THERON GOBER |
| K113344 |
11/16/2012 |
STEREOS WORKSTATION |
EOS IMAGING |
JOHN J SMITH |
| K121220 |
11/20/2012 |
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT |
EXACTECH, INC. |
LINDY KNISELY |
| K121989 |
11/27/2012 |
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, |
EXACTECH, INC. |
GINA CASSIDY |
| K121857 |
11/15/2012 |
FEMMYCYCLE |
FEMCAP INCORPORATED |
ALBERT REGO |
| K122154 |
11/21/2012 |
POWERPLAY MUSCLE MASSAGER |
FIG, LLC |
JOE ADKINS |
| K121599 |
11/09/2012 |
CRIT-LINE CLIP (CLIC) |
FRESENIUS MEDICAL CARE-NORTH AMERICA |
DENISE OPPERMANN |
| K112700 |
11/01/2012 |
FRONTIER SADL INTERBODY FUSION DEVICE |
FRONTIER MEDICAL DEVICES, INC. |
RICH JANSEN |
| K122454 |
11/20/2012 |
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K121499 |
11/20/2012 |
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
KATHERINE Y CHOI |
| K123174 |
11/16/2012 |
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER |
GE HEALTHCARE |
CHERYL BORK |
| K121200 |
11/02/2012 |
FLIGHTPLAN FOR LIVER |
GE HEALTHCARE |
CAROL ALLOIAN |
| K122174 |
11/16/2012 |
PEDIATRIC POSITIONER PAD SET |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
MICHELLE HUETTNER |
| K123068 |
11/13/2012 |
OPTIMA MR 430S |
GE MEDICAL SYSTEMS, LLC |
YUAN MA |
| K122893 |
11/30/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR(NON-COLORED) |
GEENLI PLASTIC CO, LTD |
CHU XIAOAN |
| K121365 |
11/20/2012 |
THERMOFORMED MOUTHGUARDS |
GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP |
ARMIN ZEHTABCHI |
| K112877 |
11/07/2012 |
COMEN MULTI-PARAMETER PATIENT MONITOR |
GOLDWAY (US), INC. |
JIMMY WU |
| K122904 |
11/15/2012 |
WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K121858 |
11/05/2012 |
THE ABLATION SYSTEM |
HALT MEDICAL INC. |
CLARISA TATE |
| K121225 |
11/16/2012 |
HAMILTON-C2 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K122912 |
11/07/2012 |
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
AHNEO YANG |
| K113728 |
11/15/2012 |
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY |
HANS BIOMED CORP. |
PATSY J TRISLER |
| K121757 |
11/20/2012 |
HEALTHMATEFOREVER |
HEALTHMATE INTERNATIONAL, LLC |
MEI DODSON |
| K122920 |
11/30/2012 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
HEBEI LEADER PLASTIC CO., LTD |
CHU XIAOAN |
| K122886 |
11/15/2012 |
NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING |
HEMOSTASIS, LLC |
BERNARD HORWATH |
| K121085 |
11/20/2012 |
HET BIPOLAR LIGATOR SYSTEM |
HET SYSTEMS, LLC |
SHELLEY TRIMM |
| K113314 |
11/09/2012 |
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
HMD BIOMEDICAL, INC. |
Wang YunHan |
| K121315 |
11/01/2012 |
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT |
HOWMEDICA OSTEONICS CORP. |
STEPHANIE FULLARD |
| K120659 |
11/06/2012 |
HU-FRIEDY DENTAL CARTRIDGE SYRINGE |
HU-FRIEDY MFG. CO. LLC |
MARIA VRABIE |
| K122008 |
11/16/2012 |
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE |
INCITE INNOVATION LLC |
JOHN KIRWAN |
| K122689 |
11/07/2012 |
INOBLENDER |
INO THERAPEUTICS |
ROBERT BOVY |
| K112599 |
11/06/2012 |
INSURGICAL SINGLE USE POWER EQUIPMENT |
INSURGICAL LLC |
DAVID C FURR |
| K121847 |
11/29/2012 |
TITAN |
INTERACOUSTICS A/S |
ERIK NIELSEN |
| K121026 |
11/02/2012 |
FLO-GUARD BREATHING FILTER |
INTERSURGICAL, INC. |
MICHAEL ZALEWSKI |
| K123229 |
11/20/2012 |
REMOTE PRESENCE SYSTEM, MODEL RP-VITA |
INTOUCH HEALTH, INC. |
STEVE SIDWELL |
| K122646 |
11/02/2012 |
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T |
INVIVO CORPORATION |
Lisa Simpson |
| K121475 |
11/28/2012 |
TXCELL SCANNING LASER DELIVERY SYSTEM |
IRIDEX CORP. |
PAUL H HARDIMAN |
| K121171 |
11/26/2012 |
CUROS TIP |
IVERA MEDICAL, INC. |
DON CANAL |
| K120711 |
11/19/2012 |
NON-CONTACT THERMOMETER |
K-JUMP HEALTH CO., LTD. |
JM LIN |
| K112396 |
11/02/2012 |
IUI CATHETERS |
KITAZATO MEDICAL CO., LTD. |
RICHARD VINCINS |
| K112462 |
11/26/2012 |
KITAZATO OPU NEEDLE |
KITAZATO MEDICAL CO., LTD. |
RICHARD VINCINS |
| K122860 |
11/14/2012 |
KLS MARTIN RECON TALON |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K123267 |
11/02/2012 |
SURFFLASH(R) PLUS SAFETY I.V. CATHETER |
KOFU FACTORY OF TERUMO CORP. |
SANDI HARTKA |
| K120066 |
11/16/2012 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL |
KOSSAN LATEX INDUSTRIES(M)SDN BHD |
CHO S FONG |
| K121151 |
11/16/2012 |
PRO-LINK CERVICAL SPACER SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K123037 |
11/29/2012 |
LIGHTSCALPEL |
LIGHTSCALPEL LLC |
DAVID WALTERS |
| K112091 |
11/09/2012 |
H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K120617 |
11/19/2012 |
PTFE SUPER SHEATH INTRODUCER |
MARTECH MEDICAL PRODUCTS |
ALEXIS ERAZO |
| K120555 |
11/02/2012 |
LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) |
MEDICAL-LATEX (DUA) SDN. BHD |
UMA DEVI |
| K120909 |
11/02/2012 |
EC 2.7 ENDOSCOPIC CUTTER |
MEDTRONIC ADVANCED ENERGY, LLC |
MARTIN J LEIGHTON |
| K121878 |
11/02/2012 |
CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES |
MEDTRONIC INC. |
KARI CHRISTIANSON |
| K113380 |
11/15/2012 |
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR |
MEDTRONIC INC. |
THOMAS REICHEL |
| K123246 |
11/16/2012 |
CD HORIZON SPIRE Z SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
JULIE BASSETT |
| K120787 |
11/27/2012 |
MERETE LOCKING BONE PLATE SYSTEM III |
MERETE MEDICAL GMBH |
DONNA COLEMAN |
| K123378 |
11/30/2012 |
SOLITAIRE 2 REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
LARRY BOUCHER |
| K122526 |
11/16/2012 |
360 GAS ASSISTED ENDOSCOPIC APPLICATOR |
MICROMEDICS, INC. |
JODI L RAUS |
| K122762 |
11/30/2012 |
ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR |
MICROSULIS MEDICAL LIMITED |
STUART MCINTYRE |
| K123384 |
11/28/2012 |
AZUR CX DETACHABLE 18 |
MICROVENTION, INC. |
CYNTHIA VALENZUELA |
| K122543 |
11/28/2012 |
AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 18 AZUR PURE PERIPHERAL COIL SYSTEM, PUSHABLE 35 |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K122606 |
11/20/2012 |
PHT-6500; PHT-60CFO; PAX-I3D |
MTECH GROUP |
DAVE KIM |
| K122294 |
11/01/2012 |
PRESSURIZED INFUSION PUMP |
MUI SCIENTIFIC |
TAMMY MUI |
| K120479 |
11/08/2012 |
MTF FASCIA |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
RANDY PREBULA |
| K120466 |
11/06/2012 |
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) |
NANOSPHERE, INC |
MARK DEL VECCHIO |
| K112735 |
11/02/2012 |
TAMARIN BLUE PTCA RX DILATATION CATHETER |
NATEC MEDICAL LTD |
E.J. Smith |
| DEN100023 |
11/20/2012 |
AHIP INTERNAL TRIGGER POINT WAND MODEL: 1 |
NATIONAL CENTER FOR PELVIC PAIN RESEARCH DEVICES, |
DAVID WISE |
| K120857 |
11/13/2012 |
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
| K121816 |
11/26/2012 |
SENSUS ELECTRODE |
NEUROMETRIX, INC. |
RAINER MAAS |
| K121792 |
11/16/2012 |
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
CHARLES MACK |
| K121891 |
11/09/2012 |
NEWPORT AURA VENTILATOR |
NEWPORT MEDICAL INSTRUMENTS, INC. |
TOM COLONNA |
| K120888 |
11/09/2012 |
PSG-1100 SLEEP DIAGNOSTIC SYSTEM |
NIHON KOHDEN CORP. |
STEVE GEERDES |
| K112830 |
11/13/2012 |
ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) |
NONINVASIVE MEDICAL TECHNOLOGIES, INC. |
MARC O'GRIOFA |
| K122998 |
11/06/2012 |
BLUE POWDERED NITRILE EXAMINATION GLOVE |
NORTHSTAR HEALTHCARE HOLDINGS |
ANTHONY GIACCIO |
| K123026 |
11/16/2012 |
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO |
NORTHSTAR HEALTHCARE HOLDINGS |
ANTHONY GIACCIO |
| K122429 |
11/28/2012 |
VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL |
OBJECT RESEARCH SYSTEMS (ORS) INC. |
ERIC F OURNIER |
| K113066 |
11/08/2012 |
CORVIS ST |
OCULUS OPTIKGERATE GMBH |
ECKHARD LOH |
| K122180 |
11/13/2012 |
HIGH FLOW INSUFFLANTION UNIT |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
DAPHNEY GERMAIN-KOLAWOLE |
| K121927 |
11/29/2012 |
MICROSTREAM FILTERLINE ICU |
ORIDION MEDICAL 1987 LTD. |
DALIA GIVONY |
| K121953 |
11/21/2012 |
HEMASORB APPLY |
ORTHOCON, INC. |
RICHARD KRONENTHAL, PHD |
| K121649 |
11/29/2012 |
CONSTRUX MINI PEEK TI SPACER SYSTEM |
ORTHOFIX |
NATALIA VOLOSEN |
| K122171 |
11/16/2012 |
MS SA IMPLANT SYSTEM |
OSSTEM IMPLANT CO LTD |
PATRICK LIM |
| K121995 |
11/29/2012 |
TS FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K123207 |
11/29/2012 |
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM |
OSTEOMED LP |
PIEDAD PENA |
| K113113 |
11/16/2012 |
ENDOSSEOUS DENTAL IMPLANT |
OT MEDICAL GMBH |
SABINE SCHMAHL |
| K122857 |
11/07/2012 |
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 |
PEGASUS RESEARCH CORP. |
KENNETH MILLER |
| K122772 |
11/20/2012 |
PENUMBRA DDC CATHETERS |
PENUMBRA, INC. |
SETH SCHULMAN |
| K122495 |
11/28/2012 |
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR |
PERKINELMER, INC. |
KAY A TAYLOR |
| K123035 |
11/28/2012 |
SEAL ONE |
Perouse Medical |
CAROLINE DAURELLE |
| K121725 |
11/07/2012 |
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K121566 |
11/29/2012 |
PLANER BT37 INCUBATOR |
PLANER PLC |
ERIC GRUFF |
| K121963 |
11/21/2012 |
PLANMED NUANCE DIGIGUIDE |
PLANMED OY |
LARS MORING |
| K121977 |
11/20/2012 |
PLASMAJET NEUTRAL PLASMA SURGERY SYSTEM |
PLASMA SURGICAL LIMITED |
PETER GIBSON |
| K121559 |
11/30/2012 |
HYLATOPICPLUS LOTION |
PRECISION DERMATOLOGY INCORPORATED |
RONALD M GURGE |
| K122729 |
11/16/2012 |
ABL90 FLEX |
RADIOMETER MEDICAL APS |
Martin Gabler |
| K120326 |
11/21/2012 |
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE |
RADIOMETER MEDICAL APS |
OLE SCHOU |
| K121603 |
11/20/2012 |
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K122122 |
11/09/2012 |
REGEN SPRAY APPLICATOR, |
REGEN LAB SA |
GUY FORTIER |
| K120904 |
11/26/2012 |
POLARIS DIAL-A-DATE CONTACT LENS CASE |
RELIANCE DESIGN & MANUFACTURE CORP. |
CAROLINE TONTINI |
| K122324 |
11/13/2012 |
VPAP S-A |
RESMED LTD. |
JIM CASSI |
| K122686 |
11/16/2012 |
ACCU-CHEK ULTRAFLEX INFUSION SET |
ROCHE DIABETES CARE AG |
CATHERINE GREEN |
| K122722 |
11/29/2012 |
COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 |
Roche Diagnostics |
LISA K KLINEDINST |
| K121763 |
11/27/2012 |
MULTICROSS SUPPORT CATHETER |
ROXWOOD MEDICAL, INC. |
MEHRDAD FARHANGNIA |
| K123182 |
11/05/2012 |
OSOM INFLUENZA A&B TEST MODEL 190 |
SEKISUI DIAGNOSTICS, LLC |
MARK STAVRO |
| K113225 |
11/06/2012 |
NYLUS PICC |
SEMPRUS BIOSCIENCES |
Nandini Murthy |
| K103542 |
11/30/2012 |
GENSTRIP TEST STRIP MODEL 100-201 |
SHASTA TECHNOLOGIES, LLC |
CAROLINE TONTINI |
| K121811 |
11/21/2012 |
POWDER FREE STERILE LATEX EXAM RADIATION ATTENUATION GLOVES |
SHEN WEI (USA), INC. |
ALBERT LI |
| K120217 |
11/21/2012 |
SONICSTIMU COMBO THERAPEUTIC DEVICE |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
KANG JIAN PING |
| K123185 |
11/02/2012 |
DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K123119 |
11/28/2012 |
CERARESIN BOND |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K123375 |
11/20/2012 |
SYNGO.VIA |
SIEMENS AG |
SABINE SCHROEDEL |
| K121994 |
11/30/2012 |
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR |
Siemens Healthcare Diagnostics Inc. |
A. KATHLEEN B ENNIS |
| K121434 |
11/05/2012 |
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO |
SIEMENS MEDICAL SOLUTIONS, INC. |
MICHELLE L BYRNE |
| K121814 |
11/07/2012 |
ENCORE TONGUE SUSPENSION SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K121321 |
11/30/2012 |
HARD SHELL VENTED NASAL MASK |
SLEEPNET CORPORATION |
PAUL DRYDEN |
| K121692 |
11/05/2012 |
MINIME 2 NASAL MASK |
SLEEPNET CORPORATION |
PAUL DRYDEN |
| K122596 |
11/20/2012 |
ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS |
SMITH & NEPHEW, INC. |
SEAN REYNOLDS |
| K121216 |
11/21/2012 |
STR GRAFT |
SOFT TISSUE REGENERATION, INC. |
ROBERT A POGGIE |
| K122738 |
11/07/2012 |
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET |
SOLANA SURGICAL LLC |
REBECCA WAHL |
| K122931 |
11/20/2012 |
S-LOK PSS SYSTEM |
SPINAL USA |
J.D. WEBB |
| K122161 |
11/28/2012 |
SJM CONFIRM |
ST. JUDE MEDICAL |
Saket Bhatt |
| K122090 |
11/15/2012 |
SJM CONFIRM IMPLANTABLE CARDIAC MONITOR |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
PLESSY PAUL |
| K120651 |
11/27/2012 |
STABILIZ FIXATION SYSTEM |
STABILIZ ORTHOPAEDICS, LLC |
DOUGLAS L CERYNIK, MD |
| K122192 |
11/02/2012 |
NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM |
STRAUMANN USA, LLC |
ELAINE ALAN |
| K123377 |
11/30/2012 |
TARGET DETACHABLE COIL |
STRYKER NEUROVASCULAR |
RHODA SANTOS |
| K122637 |
11/01/2012 |
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 |
STRYKER SPINE |
TINA MORNAK |
| K122401 |
11/02/2012 |
TANGO M2 BLOOD PRESSURE MONITOR |
SUNTECH MEDICAL, INC. |
CHUCK SETZER |
| K123409 |
11/20/2012 |
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
KIRSTEN STOWELL |
| K112853 |
11/09/2012 |
VOLTERA POWERED SUCTION PUMP |
SUZRIC ENTERPRISE CO., LTD. |
MICHAEL LEE |
| K122725 |
11/27/2012 |
TANDA PEARL, ULTRAWYTE, PEARL |
SYNERON BEAUTY |
JANICE M HOGAN |
| K113567 |
11/19/2012 |
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM |
SYNTHES INC |
ALAN T HALEY |
| K121363 |
11/23/2012 |
DIOWAVE LOW LEVEL COLD LASER SYSTEM |
TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA) |
BRUCE COREN |
| K121607 |
11/08/2012 |
TERUMO(R) NEEDLE |
TERUMO (PHILIPPINES) CORPORATION |
SANDI HARTKA |
| K123039 |
11/20/2012 |
CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
Kevin Kong |
| K121509 |
11/05/2012 |
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT |
TGM MEDICAL, INC. |
PRAKASH PAI |
| K121560 |
11/01/2012 |
LEVANT, HOMEGLIDE |
THYSSENKRUPP ACCESSIBILITY B.V. |
ARNOLD HEIDEN |
| K122999 |
11/30/2012 |
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
TOP GLOVE SDN. BHD. |
EDDY ROSAYDIE |
| K123056 |
11/13/2012 |
PASCAL LASER INDIRECT OPHTHALMOSCOPE |
TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) |
PAMELA M BUCKMAN |
| K122229 |
11/20/2012 |
VICEROY SPINAL SYSTEM |
TORREY SPINE |
MEREDITH MAY |
| K122959 |
11/07/2012 |
HAMMER TOE IMPLANT |
TRILLIANT SURGICAL LTD |
J D WEBB |
| K122419 |
11/30/2012 |
UCP HOME DRUG SCREENING TEST CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K122236 |
11/16/2012 |
VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K122662 |
11/13/2012 |
VERTIFLEX DIRECT DECOMPRESSION SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K121213 |
11/02/2012 |
VITREAADVANCED |
VITAL IMAGES, INC. |
Daniel Biank |
| K121775 |
11/28/2012 |
ENFLOW IV FLUID WARMER, ENFLOW DISPOSABLE CARTRIDGE, ENFLOW CONTROLLER |
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY |
STACIE GEFFNER-ATIYA |
| K121234 |
11/20/2012 |
GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING |
W. L. GORE & ASSOCIATES, INC. |
ALICIA L HEMPHILL |
| K120508 |
11/07/2012 |
CLEARLUMEN THROMBECTOMY SYSTEM |
WALK VASCULAR LLC |
DAVID LOOK |
| K122058 |
11/05/2012 |
FLEXIPORT ECOCUFF |
WELCH ALLYN, INC. |
KEVIN CROSSEN |
| K121277 |
11/07/2012 |
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE |
Z-MEDICAL GMBH & CO. KG |
ALEXANDER HENNINGER |
| K122326 |
11/30/2012 |
SMARTTOOLS KNEE SYSTEM |
ZIMMER |
CHRISTOPHER MCLEAN |
| K120873 |
11/08/2012 |
ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K122765 |
11/09/2012 |
PERSONA NATURAL TIBIA BASEPLATES |
ZIMMER INC. |
NICOLE J MEREDITH |
| K121771 |
11/07/2012 |
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM |
ZIMMER, INC. |
KELLI J ANDERSON |
| K122529 |
11/16/2012 |
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE |
ZIMMER, INC. |
MARK D WARNER |
| K121865 |
11/20/2012 |
ZOLL RESCUENET 12-LEAD |
ZOLL MEDICAL CORPORATION |
CHARLES W KOLIFRATH |
