| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K113464 |
11/22/2011 |
NC TREK OTW CORONARY DILATATION CATHETER |
Abbott Vascular |
SUZANNE REDMAN |
| K113332 |
11/14/2011 |
ON CALL CHOSEN LANCING DEVICE |
ACON LABORATORIES, INC. |
AARON FRIDAY |
| K113315 |
11/09/2011 |
RUMBLE TUFF |
ACUTE IDEAS CO. LTD. |
MATTHEW KHO |
| K113318 |
11/10/2011 |
ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM |
ACUTE INNOVATIONS LLC |
MARIAH KNIGHT |
| K113365 |
11/15/2011 |
INFANT ARRAY |
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS |
RAVI SPRINIVASAN |
| K113371 |
11/16/2011 |
STAPHYLOCOCCUS QUICKFISH BC |
ADVANDX, INC. |
BENJAMIN S CRYSTAL |
| K113436 |
11/21/2011 |
ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT |
ALFA WASSERMANN |
HYMAN KATZ |
| K113382 |
11/16/2011 |
ACE ALT REAGENT |
ALFA WASSERMANN |
HYMAN KATZ |
| K113435 |
11/21/2011 |
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
ALFA WASSERMANN |
HYMAN KATZ |
| K113374 |
11/16/2011 |
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113253 |
11/02/2011 |
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113262 |
11/04/2011 |
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113389 |
11/16/2011 |
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113438 |
11/21/2011 |
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113437 |
11/21/2011 |
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113511 |
11/28/2011 |
ECHOSTAR SPICA 1.5T MR SYSTEM |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
MICHAELEEN DOM |
| K113501 |
11/25/2011 |
AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) |
AMEDITECH, INC. |
BRETT CASEY |
| K113400 |
11/17/2011 |
FIXATE TISSUE BAND |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K113208 |
11/01/2011 |
GAL-1A BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
| K113268 |
11/04/2011 |
ALEXIS O WOUND PROTECTOR/RETRACTOR |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K113263 |
11/04/2011 |
ARGES IMAGING CONTRAST SPRAY |
ARGES IMAGING, INC |
Rebecca K Pine |
| K113508 |
11/28/2011 |
DACRYOCATH |
ARMADILLO BIOMEDICAL, LLC |
ROBYN SCOPIS |
| K113277 |
11/07/2011 |
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS |
ARROW INTERNATIONAL, INC. |
TRACY MADDOCK |
| K113452 |
11/21/2011 |
ACU-CUT VERTEBRAL AUGMENTATION SYSTEM |
ASCENDX SPINE, INC. |
JANICE M HOGAN |
| K113489 |
11/23/2011 |
ORION |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K113424 |
11/21/2011 |
LOFRIC SINGLE USE URINARY CATHETER |
ASTRA TECH AB |
FLOYD G LARSON |
| K113420 |
11/18/2011 |
RNARETAIN |
ASURAGEN, INC. |
Luc Van Hove |
| K113533 |
11/30/2011 |
NEURO CHECK DEVICE WITH IO-FLEX WIRE |
BAXANO, INC. |
EDWARD SINCLAIR |
| K113227 |
11/01/2011 |
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER |
BAXTER HEALTHCARE CORP. |
NANETTE HEDDEN |
| K113241 |
11/02/2011 |
BD EMERALD SINGLE USE, HYPODERMIC SYRINGE |
BECTON DICKINSON |
KARA MCKEE |
| K113431 |
11/21/2011 |
CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA |
BETTINI S.P.A. |
Claude Berthoin |
| K113311 |
11/09/2011 |
TIO2MESH TM |
BIOCER ENTWICKLUNGS GMBH |
CHERYL FISHER |
| K113305 |
11/09/2011 |
VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K113271 |
11/04/2011 |
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS |
BIOMET MANUFACTURING, INC. |
GARY BAKER |
| K113512 |
11/28/2011 |
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM |
BIOMET MICROFIXATION |
SHERYL MALMBERG |
| K113306 |
11/09/2011 |
CARDIO 7 |
BIONET CO., LTD. |
MARC GOODMAN |
| K113213 |
11/01/2011 |
LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2 |
BIOSENSE WEBSTER, INC. |
JOHN JIMENEZ |
| K113401 |
11/17/2011 |
ORTHO-1(NOT FINALIZED) |
BISCO, INC. |
Michelle Schiltz-Taing |
| K113493 |
11/25/2011 |
TCX-I REMOTE CARE MANAGEMENT SYSTEM |
BL HEALTHCARE, INC. |
MICHEAL MATHUR |
| K113220 |
11/01/2011 |
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) |
Boston Scientific Corporation |
VICKY L HAGENS |
| K113308 |
11/09/2011 |
BRUNO ELAN STAIRWAY ELEVATOR |
BRUNO INDEPENDENT LIVING AIDS, INC. |
TERRENCE O'BRIEN |
| K113310 |
11/08/2011 |
ENDOGATER AVANTAGE CO2 INSUFFLATOR |
BYRNE MEDICAL, INC. |
Brent Geiger |
| K113276 |
11/07/2011 |
CATALYST |
C-RAD POSITIONING AB |
JANINA OSTLING |
| K113229 |
11/02/2011 |
VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING |
C.R. BARD, INC. |
STEPHANIE BAKER |
| K113472 |
11/22/2011 |
PRECISE SHP DIODE LASER |
CAO GROUP, INC. |
ROB K LARSEN |
| K113407 |
11/18/2011 |
SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS |
CAREFUSION 2200, INC. |
KATE FULLER |
| K113480 |
11/23/2011 |
SPECTRA OPTIA APHERESIS SYSTEM |
CARIDIANBCT, INC. |
TINA O'BRIEN |
| K113497 |
11/25/2011 |
HYPERION |
CEFLA S.C. CEFLA DENTAL GROUP |
MARISA TESTA |
| K113336 |
11/14/2011 |
CDC DENV-1-4 REAL TIME RT-PCT ASSAY |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM |
| K113440 |
11/21/2011 |
HIGH FIVE |
CENTRAL MEDICARE SDN BHD |
NICK WANG |
| K113212 |
11/01/2011 |
DENTAL LASER THERAPY SYSTEM |
CHINA DAHENG GROUP, INC. |
Diana Hong |
| K113359 |
11/14/2011 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE |
CHISON MEDICAL IMAGING CO., LTD. |
BOB LEIKER |
| K113387 |
11/16/2011 |
CITIEFFE TITANIUM NAILING SYSTEM |
CITIEFFE |
Claude Berthoin |
| K113388 |
11/16/2011 |
CITIEFFE-TITANIUM CANNULATED SCREW |
CITIEFFE |
Claude Berthoin |
| K113384 |
11/16/2011 |
EXTERNAL FIXATOR ST.A R 90 F4 |
CITIEFFE |
Claude Berthoin |
| K113465 |
11/22/2011 |
ACCULIF TL CAGE |
COALIGN INNOVATIONS, INC. |
JUSTIN EGGLETON |
| K113498 |
11/25/2011 |
DISPOSABLE TORQUE DEVICE |
COEUR, INC. |
DEBRA F MANNING |
| K113496 |
11/25/2011 |
VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT |
COLOPLAST A/S |
JANELL COLLEY |
| K113260 |
11/04/2011 |
MODIFIED CONCENTIRC MICROCATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K113378 |
11/16/2011 |
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM |
CONFORMIS, INC. |
AMITA S SHAH |
| K113510 |
11/28/2011 |
EVOLUTION COLONIC STENT SYSTEM |
COOK IRELAND LTD |
Jacinta Kilmartin |
| K113300 |
11/09/2011 |
ATB ADVANCE PTA DILATATION CATHETER |
COOK, INC. |
ELYSIA POOR |
| K113245 |
11/02/2011 |
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL |
COOPERVISION, INC. |
GWEN SHARP |
| K113267 |
11/04/2011 |
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC |
COOPERVISION, INC. |
GWEN SHARP |
| K113351 |
11/14/2011 |
CORTRAK ENTERAL ACCESS DEVICE |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K113372 |
11/16/2011 |
NUVANT, MOBILC CARDIAC TELEMETRY |
CORVENTIS, INC. |
KATHLEEN LUNDBERG |
| K113468 |
11/22/2011 |
ELM PTA BALLON DILATATION CATHETER |
CREAGH MEDICAL LTD |
MAUREEN O'CONNELL |
| K113361 |
11/14/2011 |
SECURIS SPINAL FIXATION |
CUMTOM SPINE |
DAVID BRUMFIELD |
| K113255 |
11/03/2011 |
PUREGRAFT 850/PURE SYSTEM |
CYTORI THERAPEUTICS, INC. |
KENNETH K KLEINHENZ |
| K113316 |
11/09/2011 |
DCS LACRIMAL STENT |
DCS SURGICAL INC |
HARRY ROSS |
| K113343 |
11/14/2011 |
DIACHECK SMART/SUPERIOR BLOOD GLUCOSE MONITORING SYSTEM |
DELBIO INCORPORATION |
NICKY PAN |
| K113301 |
11/08/2011 |
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES |
DENTALEZ, INC. |
JIM WATKINS |
| K113406 |
11/18/2011 |
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K113534 |
11/30/2011 |
HEALIX KNOTLESS ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
DEEP PAL |
| K113324 |
11/10/2011 |
REXIOUS HOOK FIXATION SYSTEMS |
DIO MEDICAL CO., LTD. |
APRIL LEE |
| K113206 |
11/01/2011 |
NANOBLUTM 500 |
Draeger Medical Systems, Inc. |
BRYAN OVERTON |
| K113250 |
11/03/2011 |
DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE |
DYNATRONICS CORP. |
DOUGLAS SAMPSON |
| K113459 |
11/22/2011 |
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING |
EDWARDS LIFESCIENCES, LLC. |
DANNETTE CROOMS |
| K113411 |
11/18/2011 |
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA |
EDWARDS LIFESCIENCES, LLC. |
DANNETTE CROOMS |
| K113478 |
11/23/2011 |
PLIF CAGE |
EISERTECH, LLC |
LUKAS EISERMANN |
| K113240 |
11/02/2011 |
3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K113226 |
11/01/2011 |
8MP COLOR LCD MONITOR,RADIFORCE RX840 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K113504 |
11/28/2011 |
DEKA SMARTXIDE AND DELIVERY ACCESSORIES |
EL.EN. ELECTRONIC ENGINEERING SPA |
PAOLO PERUZZI |
| K113269 |
11/04/2011 |
ELITTECH CLINICAL SYSTEMS ALP IFCC SL |
ELITECHGROUP |
DEBRA K HUTSON |
| K113219 |
11/01/2011 |
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM |
ELLIPSE TECHNOLOGIES, INC. |
JOHN MCLNTYRE |
| K113475 |
11/22/2011 |
ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
| K113522 |
11/29/2011 |
PATHASSIST LIGHT SEEKER |
Entellus Medical, Inc. |
GARRETT P AHLBORG |
| K113344 |
11/14/2011 |
STEREOS WORKSTATION |
EOS IMAGING |
JOHN J SMITH |
| K113243 |
11/02/2011 |
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K113375 |
11/16/2011 |
ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE |
ESWALLOW USA |
WILLIAM INGRAM |
| K113439 |
11/21/2011 |
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) |
EUROIMMUN US |
KATHRYN KOHL |
| K113309 |
11/08/2011 |
EXACTECH EQUINOXE CAGE GLENOIDS |
EXACTECH, INC. |
PATRICK HUGHES |
| K113320 |
11/10/2011 |
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K113383 |
11/16/2011 |
XTRAFIX EXTERNAL FIXATION SYSTEM |
EXTRAORTHO, INC. |
MARCOS VELEZ-DURAN |
| K113516 |
11/29/2011 |
THERASOM-CAST |
FAMILY DENTAL SERVICES, P.C. |
DEANNA L BAXAM |
| K113536 |
11/30/2011 |
MASTERKA 40 MASTERKA 35 MASTERKA 30 |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
BARBARA FRANT |
| K113433 |
11/21/2011 |
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT |
FOCUS DIAGNOSTICS, INC. |
SHARON YOUNG |
| K113236 |
11/02/2011 |
FORYOU NPWT DEVICE |
FORYOU MEDICAL ELECTRONICS CO, LTD |
SCOTT WRIGHT |
| K113427 |
11/21/2011 |
FRESENIUS 2008T HEMODIALYSIS MACHINE |
FRESENIUS MEDICAL CARE NORTH AMERICA |
DENISE OPPERMANN |
| K113284 |
11/07/2011 |
BIOPSY POSITIONER |
FUJI FILM MEDICAL SYSTEMS |
KIMERLY A SHARP |
| K113244 |
11/02/2011 |
SYNAPSE MPR FUSION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOOK |
| K113313 |
11/09/2011 |
MOLECULAR ADSORBENT RECIRCULATING(MARS) |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K113350 |
11/14/2011 |
BRIVO NM 615 |
GE HEALTHCARE |
ELI WERNER |
| K113456 |
11/21/2011 |
READY VIEW |
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) |
ELIZABETH MATHEW |
| K113286 |
11/07/2011 |
ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS |
GE MEDICAL SYSTEMS LUNAR |
TRISHIA DWYER |
| K113403 |
11/17/2011 |
GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM |
GE MEDICAL SYSTEMS SCS |
MICHEL GENUER |
| K113394 |
11/16/2011 |
MAVRIC SL |
GE MEDICAL SYSTEMS, LLC |
YUAN MA |
| K113490 |
11/23/2011 |
OPTIMA MR450W |
GE MEDICAL SYSTEMS, LLC |
ROBIN MARTIN |
| K113408 |
11/18/2011 |
Q. FREEZE (MOTION VUE2) |
GE MEDICAL SYSTEMS, LLC |
DAVID DUERSTELER |
| K113265 |
11/04/2011 |
GENII GI 4000 ELECTROSUGICAL GENERATOR |
GENII, INC. |
JULIE POWELL |
| K113395 |
11/17/2011 |
REVERE 4.5 STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
SARAH M FITZGERALD |
| K113447 |
11/21/2011 |
RISE SPACER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K113358 |
11/14/2011 |
PORTRAIT ANALYZER |
GREAT BASIN SCIENTIFIC |
LARRY REA |
| K113505 |
11/28/2011 |
VACUETTE QUICKSHIELD WITH SNAPPY TUBE HOLDER |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
| K113377 |
11/16/2011 |
GLIADIN IGA AND GLIADIN LGA |
GRIFOLS USA, LLC |
CATHERINE L WONG |
| K113238 |
11/02/2011 |
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K113239 |
11/02/2011 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K113341 |
11/14/2011 |
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K113307 |
11/08/2011 |
GL GOODLIFE SERIES BLOOD GLUCOSE MONITORING SYSMTEM |
HMD BIOMEDICAL, INC. |
JESSICA TUNG |
| K113314 |
11/09/2011 |
PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM |
HMD BIOMEDICAL, INC. |
Wang YunHan |
| K113356 |
11/14/2011 |
HOLOGIC VISCERAL FAT SOFTWARE |
HOLOGIC, INC. |
EILEEN M BOYLE |
| K113409 |
11/18/2011 |
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL |
HOWMEDICA OSTEONICS CORP. |
JUMA HOSHINO |
| K113360 |
11/14/2011 |
MEDICAL IMAGE PROCESSING UNIT |
HUMANRAY CO,LTD |
DAVE KIM |
| K113449 |
11/21/2011 |
FUSION FLAT PANEL |
ICRCO INC. |
GREG WACHTLER |
| K113506 |
11/28/2011 |
IND ONE STEP OCCULT BLOOD (FOB) TEST |
IND DIAGNOSTICS INC. |
KAI LOU |
| K113272 |
11/04/2011 |
INOMAX DS(DELIVERY SYSTEMS |
INO THERAPEUTICS LLC/DBA IKARIA |
LARRY LEPLEY |
| K113317 |
11/10/2011 |
LIFECHOICE OXYGEN CONCENTRATOR |
INOVA LABS, INC. |
DAVID SHOCKLEY |
| K113399 |
11/17/2011 |
IFS SUBTALAR IMPLANT |
INTERNAL FIXATION SYSTEMS, INC. |
CHRIS ENDARA |
| K113527 |
11/30/2011 |
OPTICAGE INTERBODY FUSION DEVICE |
INTERVENTIONAL SPINE, INC. |
JANE METCALF |
| K113210 |
11/01/2011 |
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT |
ISOAID, L.L.C. |
BENJAMIN ROEDELL |
| K113355 |
11/14/2011 |
POSEY BED |
J. T. POSEY CO. |
BONNIE BISHOP |
| K113357 |
11/14/2011 |
POSEY BED |
J. T. POSEY CO. |
BONNIE BISHOP |
| K113348 |
11/14/2011 |
COUGAR SYSTEM |
JOHNSON & JOHNSON |
KEVIN G STEVENS |
| K113273 |
11/07/2011 |
SPOTLIGHT ACCESS SYSTEM |
JOHNSON & JOHNSON |
LAURA BLEYENDAAL |
| K113329 |
11/14/2011 |
K2M, PYRENEES CERVICAL PLATE SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K113507 |
11/28/2011 |
KENT CAMERA |
KENT IMAGING INC. |
DARRELL BARNHART |
| K113279 |
11/07/2011 |
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT |
KETTENBACH GMBH & CO KG |
SIMONE MATUSCHKA |
| K113247 |
11/02/2011 |
ANESTHESIA INJECTION TOOL SET |
KI WORKS CO., LTD. |
EILEEN YANG |
| K113340 |
11/14/2011 |
KIMBERLY-CLARK CHILD'S FACEMASK |
KIMBERLY-CLARK |
ANN WATERHOUSE |
| K113423 |
11/21/2011 |
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE |
KIMBERLY-CLARK CORP. |
LESTER F PADILLA |
| K113333 |
11/14/2011 |
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS |
KIMBERLY-CLARK CORPORATION |
MARCIA JOHNSON |
| K113248 |
11/03/2011 |
AERODR SYSTEM WITH P-21 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K113509 |
11/28/2011 |
LEXUS ANTERIOR CERVICAL PLATE SYSTEM |
L&K BIOMED CO., LTD |
HEE KYEONG JOO |
| K113434 |
11/21/2011 |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, INC. |
MICHAEL FUNK |
| K113264 |
11/04/2011 |
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) |
LD TECHNOLOGY LLC |
ABBERT MAAREK |
| K113285 |
11/07/2011 |
LDR SPINE USA AVENUE L INTERBODY FUSION |
LDR SPINE USA INC. |
MARITZA ELIAS |
| K113523 |
11/29/2011 |
LIMACORPORATE SMR REVERSE SHOULDER SYSTEM |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K113254 |
11/03/2011 |
SMR MODULAR GLENOID-METAL-BACK SMR MODULAR GLENOID-LINER SMR MODULAR GLENOID-BONE SCREWS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K113502 |
11/25/2011 |
ADVANTAGE LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K113524 |
11/29/2011 |
VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT |
MAINE STANDARDS CO. |
HOLLY A CRESSMAN |
| K113232 |
11/02/2011 |
MAXMIXING BLOCK |
MAXTEC, INC. |
TAMMY LAVERY |
| K113228 |
11/01/2011 |
RENAISSANCE SYSTEM |
MAZOR ROBOTICS LTD |
AHAVA STEIN |
| K113515 |
11/28/2011 |
HORIZON CARDIOLOGY ECG MANAGEMENT |
MCKESSON ISRAEL LTD. |
TOMER LEVY |
| K113304 |
11/08/2011 |
BLADDER SCANNER |
MEDA CO. LTD. |
KAI CHEN |
| K113487 |
11/23/2011 |
HEMO-CATH 10F, HEMO-CATH 12.5F |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K113525 |
11/29/2011 |
ACTIVECARE DVT ACTIVECARE+SFT |
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. |
JONATHAN S KAHAN |
| K113353 |
11/14/2011 |
GEMINI STERILZATION WRAP |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K113526 |
11/30/2011 |
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM |
MEDOS INTERNATIONAL SARL |
JOCELYN RAPOSO |
| K113396 |
11/07/2011 |
DEPUY PULSE THORACOLUMBAR SCREW SYSTEM |
MEDOS INTERNATIONAL SARL |
EUGENE BANG |
| K113363 |
11/15/2011 |
ANGIOJET SOLENT DISTA THROMBECTOMY SET |
MEDRAD, INC. |
MIKE BURNSIDE |
| K113428 |
11/21/2011 |
ANGIOJET ULTRA DVX THROMBECTOMY SET |
MEDRAD, INC. |
MIKE BURNSIDE |
| K113235 |
11/02/2011 |
PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS |
MEDTRONIC INC. |
AMRA RACIC |
| K113380 |
11/16/2011 |
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR |
MEDTRONIC INC. |
THOMAS REICHEL |
| K113529 |
11/30/2011 |
CD HORIZON VOYAGER SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MIKE SCOTT |
| K113252 |
11/03/2011 |
PEEK PREVAIL CERVICAL INTERBODY DEVICE |
MEDTRONIC SOFAMOR DANEK |
KRISTI FRISCH |
| K113528 |
11/30/2011 |
CLYDESDALE(R) SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BECKY RONNER |
| K113303 |
11/09/2011 |
OSLEOBRIDGE IDSF SPACER CONECTOR |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOIS |
| K113390 |
11/16/2011 |
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) |
MERIDIAN AG |
Kevin Walls |
| K113337 |
11/14/2011 |
VISIA DYNAMIC REVIEW |
MEVIS MEDICAL SOLUTIONS AG |
THOMAS E TYNES |
| K113455 |
11/21/2011 |
SOLITAIRE FR REVASCULARIZATION DEVICE |
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
Laura Heaton |
| K113454 |
11/21/2011 |
14 WIRE STANDARD, 14 WIRE LS |
MICRO THERAPEUTICS, INC. |
GREGORY J GEISSINGER |
| K113289 |
11/07/2011 |
ORION MICRO CATHETER |
MICRO THERAPEUTICS, INC. |
ANALIA NIETO |
| K113513 |
11/28/2011 |
PLANCET |
MICROPOINT TECHNOLOGIES PTE LTD |
CHEE Y LIM |
| K113457 |
11/22/2011 |
HYDROCOIL EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K113234 |
11/02/2011 |
MOBCARDIO SYSTEM |
MOBHEALTH INCORPORATION |
PATRICIA LIN |
| K113222 |
11/01/2011 |
ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE |
NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. |
SHINICHI NAKAMURA |
| K113530 |
11/30/2011 |
ULTRASONIC SCALER |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K113450 |
11/21/2011 |
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) |
NANOSPHERE, INC |
MARK DEL VECCHIO |
| K113474 |
11/22/2011 |
1.5T GEM FLEX COIL |
NEOCOIL, LLC |
STEVEN NICHOLS |
| K113376 |
11/16/2011 |
NEOSS PROACTIVE TAPERED IMPLANT |
NEOSS LTD |
CHERITA JAMES |
| K113237 |
11/02/2011 |
CERTUS 140 2.45GHZ ABLATION SYSTEM |
NEUWAVE MEDICAL, INC. |
DAN KOSEDNAR |
| K113398 |
11/17/2011 |
NEXUS TKO-6, LUER-ACTIVATED DEVICE |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
| K113246 |
11/02/2011 |
OCS-B |
NIBEC COMPANY, LIMITED |
DANIEL NAM |
| K113451 |
11/21/2011 |
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX |
NIDEK TECHNOLOGIES SRL |
ENRICO BISSON |
| K113471 |
11/22/2011 |
NIPRO HUBER INFUSION SET, EXCEL HUBER INFUSION SET |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K113469 |
11/22/2011 |
NIPRO HUBER INFUSION, EXCEL HUBER NEEDLE |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K113470 |
11/22/2011 |
NIPRO SAFE TOUCH HUBER INFUSION SET |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K113429 |
11/21/2011 |
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K113494 |
11/25/2011 |
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
MARIA HATEGAN |
| K113215 |
11/01/2011 |
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY |
NONIN MEDICAL, INC. |
BRODIE PEDERSON |
| K113221 |
11/01/2011 |
NAMSA BIOLOGICAL INDICATOR SPORE STRIPS |
NORTH AMERICAN SCIENCE ASSOC., INC. |
JULIE WHEELER |
| K113302 |
11/08/2011 |
NAMSA STEAM SELF-CONTAINED BIOLOGICAL INDICATORS |
NORTH AMERICAN SCIENCE ASSOC., INC. |
JULIE WHEELER |
| K113242 |
11/02/2011 |
APEX ARC HIP STEM |
OMNILIFE SCIENCE INC. |
CHRISTINE NASSIF |
| K113334 |
11/14/2011 |
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS |
OPAL ORTHODONTICS BY ULTRADENT PRODUCTS INC. |
DIANE ROGERS |
| K113479 |
11/23/2011 |
OPTIMEDICA CATALYS PRECISION LASER SYSTEM |
OPTIMEDICA CORPORATION |
ALAN MARQUARDT |
| K113326 |
11/10/2011 |
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD |
ORALABS, INC. |
TERESA PURDUE |
| K113338 |
11/14/2011 |
MEDICAL AIR COMPRESSOR |
ORICARE, INC. |
DAVID JAMISON |
| K113312 |
11/09/2011 |
HY-CHLO(TM)WOUND SCRUB |
PATRIN PHARMA |
JAY S TRIVEDI |
| K113354 |
11/14/2011 |
VETA PERITONEAL DIALYSIS CATHETER |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K113483 |
11/23/2011 |
ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION |
PHILIPS HEALTHCARE (CLEVELAND) |
CHRISTINE ANDERSON |
| K113441 |
11/21/2011 |
PHYSIOLOGICAL MONITOR, PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
JENS-PETER SEHER |
| K113366 |
11/15/2011 |
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM |
PHYGEN, LLC |
HARTMUT LOCH |
| K113218 |
11/01/2011 |
PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCLNTYRE |
| K113488 |
11/23/2011 |
JAZZY ELITE 6 |
PRIDE MOBILITY PRODUCT CORPORRATION |
KIMBERLY BLAKE |
| K113249 |
11/03/2011 |
TRANSPORT CULTURE MEDIUM DEVICE |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K113323 |
11/10/2011 |
ARTUS INFL A/B RG RT-PCR KIT |
QIAGEN, GMBH |
KIM DAVIS |
| K113319 |
11/10/2011 |
ROTOR-GENE Q MDX |
QIAGEN, GMBH |
MELISSA MAHALL |
| K113231 |
11/02/2011 |
WARP10,WARP75 |
QUANTUM DEVICES, INC. |
MORRIS WAXLER |
| K113540 |
11/30/2011 |
RELIANCE LUMBAR IBF SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K113288 |
11/07/2011 |
VPAP ST-A |
RESMED LTD. |
DAVID D'CRUZ |
| K113282 |
11/07/2011 |
CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO |
RIEMSER ARZEIMITTEL AG |
James M Clinton |
| K113539 |
11/30/2011 |
REVOIS PRO IMPLANT STSYEM |
RIEMSER ARZNEIMITTEL AG |
CHRISTOPH WAHL |
| K113521 |
11/29/2011 |
CALCIUM GEN. 2 |
Roche Diagnostics |
LISA K KLINEDINST |
| K113299 |
11/08/2011 |
ROG SUTURE ANCHOR |
ROG SPORTS MEDICINE, INC. |
CURTIS RAYMOND |
| K113381 |
11/16/2011 |
MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM |
SAMSUNG MEDISON CO., LTD |
KYEONG-MI PARK |
| K113430 |
11/21/2011 |
PROULTRA PIEZO ULTRASONIC |
SATELEC-ACTEON GROUP |
RICK ROSATI |
| K113321 |
11/10/2011 |
TENS BACK PAIN RELIEF SYSTEM |
SAVIA LIMITED |
GUENTER GINSBERG |
| K113225 |
11/01/2011 |
NYLUS PICC |
SEMPRUS BIOSCIENCES |
Nandini Murthy |
| K113330 |
11/14/2011 |
CABLECAP |
SENSORMED |
WILLIAM MILAM |
| K113233 |
11/02/2011 |
POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM |
SHEN WEI (USA), INC. |
ALBERT LI |
| K113281 |
11/07/2011 |
MRI SYTEMS |
SHENZHEN ANKE HIGH-TECH CO., LTD. |
Diana Hong |
| K113485 |
11/23/2011 |
ELECTROCARDIOGRAPH |
SHENZHEN CAREWELL ELECTRONICS CO., LTD |
Diana Hong |
| K113442 |
11/21/2011 |
3DI |
SHINA SYSTEMS LTD. |
DAN LAOR |
| K113514 |
11/28/2011 |
SMARTHEART |
SHL TELEMEDICINE INTERNATIONAL LTD. |
YORAM LEVY |
| K113426 |
11/18/2011 |
VERACIA SA |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K113216 |
11/01/2011 |
RAPIDPOINT 500 BLOOD GAS ANALYER |
SIEMENS HEALTHCARE DIAGNOSTICS |
Steven Goldberg |
| K113373 |
11/16/2011 |
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL |
Siemens Healthcare Diagnostics Inc. |
FRANCES A DILLON |
| K113448 |
11/21/2011 |
BIOGRAPH MCT FAMILY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K113287 |
11/07/2011 |
SOMATOM PERSPECTIVE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIM MANGUM |
| K113342 |
11/14/2011 |
SOMATOM DEFINITION FLASH |
SIEMENS MEDICAL SYSTEMS, INC. |
KIM MANGUM |
| K113291 |
11/08/2011 |
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 |
SIMEX MEDIZINTECHNIK GMBH |
HAMID KHOSROWSHAHI |
| K113274 |
11/07/2011 |
FOOTPRINT ULTRA PK SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
MELISSA EGAN |
| K113482 |
11/23/2011 |
JOURNEY II DEEP DISHED ARTICULAR INSERTS |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K113294 |
11/08/2011 |
SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
ELIZABETH LAVELLE |
| K113402 |
11/17/2011 |
SOLOHEALTH STATION |
SOLOHEALTH, INC. |
STEPHEN KENDIG |
| K113362 |
11/15/2011 |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) |
SPINE VIEW, INC. |
SEVRINA CIUCCI |
| K113518 |
11/29/2011 |
ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM |
SPINEFRONTIER, INC. |
CHRISTOPHER CHANG |
| K113520 |
11/29/2011 |
SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K113283 |
11/07/2011 |
NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS |
STRAUMANN USA |
ELAINE ALAN |
| K113410 |
11/18/2011 |
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT |
STRAUMANN USA |
ELAINE ALAN |
| K113327 |
11/10/2011 |
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM |
STRYKER CORP. |
ESTELA CELI |
| K113477 |
11/23/2011 |
IVAS 20MM (10 GAUGE) BALLOON CATHETER |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
CHRISTINA MCKEE |
| K113412 |
11/18/2011 |
TARGET DETACHABLE COIL |
STRYKER NEUROVASCULAR |
RHODA SANTOS |
| K113405 |
11/18/2011 |
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM |
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC |
CURTIS RAYMOND |
| K113463 |
11/22/2011 |
POWER WHEELCHAIR |
SUZHOU KD MEDICAL APPLIANCE CO., LTD. |
JUNNATA CHANG |
| K113404 |
11/18/2011 |
DENTAL 3D PLANNING SOFTWARE |
SYMBYO DENTAL, LLC |
PARUL CHANSORIA |
| K113460 |
11/22/2011 |
SYNERGY TISSUE MATRIX |
SYNOVIS ORTHOPEDIC & WOUNDCARE |
AMY BOUCLY |
| K113364 |
11/15/2011 |
2.7MM LCP ULNA OSTEOTOMY SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
REBECCA BLANK |
| K113251 |
11/03/2011 |
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES |
SYNTHES INC |
ALAN HALEY |
| K113297 |
11/08/2011 |
KNOTILUS ANCHOR SYSTEM |
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. |
GEORGE J HATTUB |
| K113422 |
11/21/2011 |
TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE |
TERUMO (PHILIPPINES) CORPORATION |
SANDI HARTKA |
| K113335 |
11/14/2011 |
HEARTRAIL III GUIDING CATHETER |
TERUMO Corporation |
MARK UNTERREINER |
| K113393 |
11/17/2011 |
POWDER FREE BLACK NITRILE EXAMINATION GLOVES |
TG MEDICAL SDN BHD |
NOOR A SAIDIN |
| K113476 |
11/22/2011 |
ANSPACH DISSECTION TOOLS |
THE ANSPACH EFFORT, INC. |
JEANNETTE G DAILEY |
| K113349 |
11/14/2011 |
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO |
THE BINDING SITE GROUP LTD |
MARIANNE SENDER |
| K113413 |
11/18/2011 |
ASCEND SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K113466 |
11/22/2011 |
AQUILION ONE |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
PAUL BIGGINS |
| K113443 |
11/21/2011 |
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023) |
TOTOKU ELECTRIC CO., LTD. |
TSUKASA TASHIRO |
| K113352 |
11/14/2011 |
TRANSCORP SPINAL ACCESS SYSTEM |
TRANSCORP, INC. |
ANDREW RODENHOUSE |
| K113419 |
11/18/2011 |
CS IMAGING |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K113280 |
11/07/2011 |
CAROTID COIL GE 1.5T |
TURSIOP TECHNOLOGIES LLC |
RAJU VISWANTHAN |
| K113259 |
11/04/2011 |
NOTOUCH BREASTSCAN |
UE LIFESCIENCES, INC. |
MIHIR SHAH |
| K113346 |
11/14/2011 |
NEON SYSTEM |
ULRICH GMBH & CO. KG |
HANS STOVER |
| K113500 |
11/25/2011 |
CANADY VIEIRA HYBRID PLASMA SCALPEL |
US MEDICAL INNOVATIONS LLC |
JEROME CANADY |
| K113266 |
11/04/2011 |
GEL-BLOCK EMBOLIZATION PLEDGETS |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K113446 |
11/21/2011 |
VIGNET TELEHEALTH MANAGER |
VIGNET INC. |
CARLOS GONZALEZ |
| K113563 |
11/21/2011 |
N-HYBRIDE-COMPOSITE LC |
VOCO GMBH |
M.TH. PLAUMANN |
| K113444 |
11/21/2011 |
N-HYBRIDE-COMPOSITE LC FLOW |
VOCO GMBH |
T. GERKENSMEIER |
| K113486 |
11/23/2011 |
VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM |
VOLCANO CORPORATION |
JWALA JAWHARKAR |
| K113275 |
11/04/2011 |
COMPRESSIBLE LIMB THERAPY SYSTEM |
WONJINMULSAN CO., LTD. |
EILEEN YANG |
| K113322 |
11/10/2011 |
CONSERVE THIN SHELL |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MATT PAUL |
| K113325 |
11/10/2011 |
EVOLUTION MP ADAPTIVE CS INSERT |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Danielle Mueller |
| K113339 |
11/14/2011 |
ORTHOLOC 3DSI LOCKING SCREWS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
PEGGY S RIVERS |
| K113421 |
11/18/2011 |
MINICAT |
XORAN TECHNOLOGIES, INC. |
MARTHA RUMFORD |
| K113397 |
11/17/2011 |
ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K113369 |
11/15/2011 |
ZIMMER PERSONA KNEE SYSTEM |
ZIMMER INC. |
KELLI ANDERSON |
| K113270 |
11/04/2011 |
INSTINCT JAVA SYSTEM |
ZIMMER SPINE |
ELSA A LINKE |
| K113296 |
11/08/2011 |
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER |
ZIMMER, INC. |
DANIEL J WILLIMAN |
