| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K113652 |
08/30/2012 |
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T |
AAP IMPLANTATE AG |
MARC SEEGERS |
| K121352 |
08/15/2012 |
ARMADA 14XXT PTA CATHETER |
Abbott Vascular |
Ivalee Cohen |
| K120714 |
08/09/2012 |
PICASSO MIS SPINAL FIXATION SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K121136 |
08/09/2012 |
RENOIR POSTERIOR CERVIAL FIXATION SYSTEM |
ACCEL SPINE |
DANIEL CHON |
| K121934 |
08/29/2012 |
TOMOTHERAPY TREATMENT SYSTEM |
ACCURAY INCORPORATED |
GREG BANGE |
| K121324 |
08/23/2012 |
AVT NATURASOFT |
ADVANCED VISION TECHNOLOGIES |
MARTIN DALSING |
| K122353 |
08/30/2012 |
CRAINFIX 2 TITANIUM CLAMP SYSTEM |
AESCULAP, INC. |
DENISE ADAMS |
| K121611 |
08/23/2012 |
AMPLATZER TORQVUE FX |
AGA MEDICAL CORPORATION |
SHERRY KOLLMANN |
| K121095 |
08/16/2012 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
DAVID LEDWIG |
| K121429 |
08/10/2012 |
AIMAGO EASYLDI MICROCIRCULATION CAMERA |
AIMAGO SA |
MARC ANDRE |
| K113389 |
08/10/2012 |
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113437 |
08/06/2012 |
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K122302 |
08/27/2012 |
ACE MAGNESIUM REGENT |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
HYMAN KATZ |
| K121181 |
08/22/2012 |
SWANNSHIDI BONE MARROW ASPIRATION NEEDLE |
ALLIANCE PARTNERS, LLC |
JENNIFER PALINCHIK |
| K112548 |
08/15/2012 |
ALTOMEC ARTHROSCOPE |
ALTOMEC ENDOSCOPY INC |
DARREN REEVES |
| K121892 |
08/24/2012 |
PHANTOM PLUS CERAMIC CAGE SYSTEM |
AMEDICA CORP. |
ROBERT M WOLFARTH |
| K121168 |
08/08/2012 |
APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH |
APTUS ENDOSYSTEMS, INC. |
BURT GOODSON |
| K110954 |
08/24/2012 |
ARJORAD STERILE WRAP |
ARJO WIGGINS MEDICAL, INC. |
JON WARD |
| K113508 |
08/31/2012 |
DACRYOCATH |
ARMADILLO BIOMEDICAL, LLC |
ROBYN SCOPIS |
| K111246 |
08/10/2012 |
SPIRALE DRUG DELIVERY SYSTEM |
ARMSTRONG MEDICAL LTD. |
IAN STEWART |
| K122027 |
08/28/2012 |
ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER |
ARROW INTERNATIONAL, INC. |
PAUL AMUDALA |
| K122276 |
08/29/2012 |
ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP |
ATRICURE, INC. |
JAMES LUCKY |
| K122138 |
08/17/2012 |
ATRIUM FLIXENE IFG VASCULAR GRAFT |
ATRIUM MEDICAL CORP. |
MEGAN MCCAGH |
| K122297 |
08/28/2012 |
ENLUXTRA HUMIFIBER WOUND DRESSING |
BASF VENTURE CAPITAL AMERICA INC. |
NADI ERGENC, PH.D. |
| K120994 |
08/07/2012 |
BD BACTEC PLUS PRIME AEROBIC/F |
Becton, Dickinson and Company |
Paul Swift |
| K121854 |
08/22/2012 |
SYSTEM, X-RAY, STATIONARY |
BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO. |
Diana Hong |
| K122281 |
08/29/2012 |
PADNET 2.0 |
BIOMEDIX, INC. |
GREG HOCKING |
| K113783 |
08/07/2012 |
VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE |
BIOMERIEUX, INC. |
ELIZABETH LANDON |
| K121863 |
08/16/2012 |
VITEK 2 AST-ST CEFOTAXIME |
BIOMERIEUX, INC. |
ELIZABETH LANDON |
| K122359 |
08/28/2012 |
VITEK 2 STRPTOCOCCUS CEFTRIAXONE |
BIOMERIEUX, INC. |
THI MY LAN DANG |
| K120030 |
08/17/2012 |
TAPERLOC COMPLETE SIZE 4MM AND XR 123 |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K120423 |
08/03/2012 |
BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 |
BIONIME CORPORATION |
Feng-Yu Lee |
| K121267 |
08/02/2012 |
BT-200V VASCULAR DOPPLER |
BISTOS CO., LTD. |
YOUNG CHI |
| K121196 |
08/31/2012 |
EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) |
BOSTON SCIENTIFIC CORP. |
VICKY L HAGENS |
| K121667 |
08/13/2012 |
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) |
BOSTON SCIENTIFIC CORP. |
LAURA J LIND |
| K122394 |
08/30/2012 |
RUBICON 18 SUPPORT CATHETER |
BOSTON SCIENTIFIC CORP. |
DIANE NELSON |
| K122203 |
08/17/2012 |
TRUETOME |
BOSTON SCIENTIFIC CORP. |
LAURIE PANNELLA |
| K121048 |
08/03/2012 |
ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED |
BOSTON SCIENTIFIC CORP. |
JANIS F TARANTO |
| K120789 |
08/14/2012 |
EXACTRAC X-RAY X-RAY |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K113472 |
08/30/2012 |
PRECISE SHP DIODE LASER |
CAO GROUP, INC. |
ROB K LARSEN |
| K121176 |
08/17/2012 |
STGC |
CARDINAL SPINE, LLC |
KEVIN A THOMAS |
| K122285 |
08/14/2012 |
TABLET COMMANDER |
CARDIOCOM LLC |
DANIEL L COSENTINO |
| K120246 |
08/28/2012 |
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) |
CARESTREAM HEALTH,INC. |
KATHERINE HONSINGER |
| K122246 |
08/13/2012 |
MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 |
CELLERATION, INC. |
KATHY SIMPSON |
| K120819 |
08/31/2012 |
STALIF C |
CENTINEL SPINE, INC. |
JOHN PARRY |
| K120004 |
08/23/2012 |
(MULTIPLE) DIGITAL THERMOMETER |
CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. |
ANN D MCGONIGLE |
| K121867 |
08/02/2012 |
SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS |
CHISON MEDICAL IMAGING CO., LTD. |
|
| K112864 |
08/02/2012 |
SOFTSEAL-C |
CHITOGEN, INC. |
JAMES F DRAKE |
| K120469 |
08/13/2012 |
ERISMA-LP |
CLARIANCE |
WILLIAM JACKSON |
| K121311 |
08/30/2012 |
THIXO-GEL ULTRASOUND SPRAY |
CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH |
CHRISTINA BERNSTEIN |
| K121776 |
08/14/2012 |
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE |
Codman & Shurtleff, Inc. |
JOAN BARTLE |
| K122118 |
08/03/2012 |
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM |
Codman & Shurtleff, Inc. |
KATHY STRANGE |
| K122179 |
08/20/2012 |
VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) |
COMPRESSION THERAPY CONCEPTS |
LEONARD NASS |
| K120961 |
08/03/2012 |
TREVO RETRIEVER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K121819 |
08/13/2012 |
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER |
COVALON TECHNOLOGIES, INC. |
CHRISTOPHER FREDRIC |
| K120997 |
08/27/2012 |
BAROSTAT SOFTWARE OPTION |
CROSPON, LTD. |
PAUL DRYDEN |
| K121718 |
08/17/2012 |
A-V FOOT PUMP |
DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. |
DORIS DONG |
| K121698 |
08/06/2012 |
NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
| K121140 |
08/22/2012 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC |
KATHY CRUZ |
| K121040 |
08/30/2012 |
SMARTLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K111534 |
08/02/2012 |
ABACUS 3CP |
DIATRON US INC |
MICHAEL SWITZER |
| K121938 |
08/01/2012 |
MEDILAS H RFID LASER FIBER |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K121396 |
08/14/2012 |
DYNAFLEX |
DYNA FLEX |
MATTHEW MALABEY |
| K120835 |
08/20/2012 |
DYNATRON THERMOSTIM PROBE-DONE |
DYNATRONICS CORPORATION |
DOUGLAS SAMPSON |
| K121996 |
08/03/2012 |
BE PLUS LTM AMPLIFIER GWI AMPLIFIER |
EB NEURO, S.P.A. |
Allison Scott |
| K121185 |
08/22/2012 |
EDWARDS PERCUTANEOUS SHEATH INTRODUCER |
EDWARDS LIFESCIENCES, LLC. |
SPENCER WALKER |
| K122444 |
08/30/2012 |
CERVICAL CAGE |
EISERTECH, LLC |
LUKAS EISERMANN |
| K120451 |
08/03/2012 |
8MP COLOR LCD MONITOR, REDIFORCE RX840 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K122083 |
08/22/2012 |
ELITECH CLINICAL SYSTEMS CK NAC SL |
ELITECHGROUP |
DEBRA K HUTSON |
| K121727 |
08/15/2012 |
MOVATION KNEE SYSTEM |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K113062 |
08/21/2012 |
ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES |
ENDOSERVICE OPTICAL INSTRUMENTS GMBH |
ANDREA PECSI |
| K121943 |
08/22/2012 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K121351 |
08/29/2012 |
SINUS DILATION SYSTEM |
ENTRIGUE SURGICAL, INC. |
GABRIELE G NIEDERAUER, PH.D. |
| K111603 |
08/23/2012 |
LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM |
EP DYNAMICS, INC. |
ALBERT REGO |
| K121695 |
08/23/2012 |
ERCHONIA ZERONA |
ERCHONIA CORPORATION |
Kevin Walls |
| K121690 |
08/23/2012 |
ETCHONIA ZERONA ARMS |
ERCHONIA CORPORATION |
Kevin Walls |
| K122006 |
08/06/2012 |
G-SCAN BRIO |
ESAOTE, S.P.A. |
ALLISON SCOTT, RAC |
| K121550 |
08/22/2012 |
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY |
ETHICON ENDO-SURGERY, LLC |
MARCIA ARETZ |
| K122205 |
08/15/2012 |
EXINI |
EXINI DIAGNOSTICS AB |
Allison Scott |
| K121142 |
08/09/2012 |
CRAWFORD BIOCANALICULUS INTUBATION |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
BARBARA FANT |
| K113536 |
08/03/2012 |
MASTERKA 40 MASTERKA 35 MASTERKA 30 |
FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) |
BARBARA FRANT |
| K120986 |
08/16/2012 |
STRATIFY JCV DXSELECT |
FOCUS DIAGNOSTICS, INC. |
TARA VIVIANI |
| K121154 |
08/20/2012 |
ULTRASONIC NEBULIZER |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
GUENTER GINSBERG |
| K120781 |
08/09/2012 |
CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH |
FUJI SYSTEMS CORP. |
PAUL MASON |
| K120629 |
08/28/2012 |
FDR GO FLEX |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
PETER ALTMAN |
| K120446 |
08/13/2012 |
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 |
FUJINON, INC. |
MARK JOB |
| K121251 |
08/28/2012 |
ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK |
GALIL MEDICAL LTD. |
LYNNE DAVIES |
| K122234 |
08/16/2012 |
OEC 9900 ELITE |
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC |
GERALD BUSS |
| K121062 |
08/17/2012 |
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEM ISRAEL LTD. |
BRYAN BEHN |
| K121063 |
08/21/2012 |
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEM ISRAEL LTD. |
BRYAN BEHN |
| K113607 |
08/10/2012 |
BIOPSY DIGIT S BIOPSY SL |
GIOTTO USA, LLC |
NICOLAAS BESSELING |
| K120169 |
08/24/2012 |
INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT |
GRIFOLS USA, LLC |
Gary Lehnus |
| K121987 |
08/01/2012 |
WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K121678 |
08/30/2012 |
DTAD |
GYRUS ACMI, INC. |
DOLAN MILLS |
| K122275 |
08/29/2012 |
ARTISAN EXTEND CONTROL CATHETER |
Hansen Medical |
HASSAN LABAY |
| K120536 |
08/06/2012 |
HEART SYNC PEDIATRIC PHYSIO AED PAD |
HEART SYNC INC. |
DANIEL KAMM |
| K121485 |
08/21/2012 |
GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING |
HEMCON MEDICAL TECHNOLOGIES EUROPE LTD |
BARBARA MCGRATH |
| K112532 |
08/06/2012 |
ET II BIO-SA FIXTURE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K113809 |
08/17/2012 |
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERICKA B AMMIRATI |
| K120500 |
08/20/2012 |
THE PAIN PILOT (A.K.A PAIN PILOT) |
HOLLYWOG, LLC |
MICHAEL W TREAS |
| K120398 |
08/16/2012 |
WITOUCH PRO |
HOLLYWOG, LLC |
MICHAEL W TREAS |
| K112692 |
08/03/2012 |
IDENTIFY |
HUMEDIQ GMBH |
MORITZ HOYER |
| K111627 |
08/21/2012 |
SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM |
IDEV TECHNOLOGIES, INC. |
DARLENE GARNER |
| K122141 |
08/07/2012 |
IDS-ISYS IGF-I CALIBRATION VERIFIERS |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
| K121997 |
08/10/2012 |
IMRIS ONCOLOGY PACKAGE |
IMRIS, INC. |
Sanjay Shah |
| K112373 |
08/17/2012 |
CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION |
INNOVA VISION INC. |
JENNIFER REICH |
| K121012 |
08/31/2012 |
FLEXLAB 3.6, ACCELERATOR A3600 |
INPECO S.P.A. |
ROBERTO TAMBORRA |
| K113552 |
08/23/2012 |
FREEDOM INGUINAL HERNIA IMPLANT |
Insightra Medical |
Wayne Noda |
| K113210 |
08/10/2012 |
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT |
ISOAID, L.L.C. |
BENJAMIN ROEDELL |
| K121230 |
08/29/2012 |
IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K122329 |
08/16/2012 |
BIOJET |
JET SOFT SRL |
PETER-M KLEWS |
| K113507 |
08/08/2012 |
KENT CAMERA |
KENT IMAGING INC. |
DARRELL BARNHART |
| K113685 |
08/10/2012 |
POWDER FREE LATEX EXAMINATION GLOVES |
KHAI HOAN JOINT STOCK COMPANY |
TERENCE LIM |
| K112787 |
08/08/2012 |
KERATOR |
KJ MEDITECH CO., LTD |
PRICILLA CHUNG |
| K121940 |
08/02/2012 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
PATRICK HUNT |
| K122145 |
08/17/2012 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
MICHAEL FUNK |
| K121824 |
08/23/2012 |
ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 |
LASCOD SPA |
BLIX WINSTON |
| K121103 |
08/24/2012 |
LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S |
LDR SPINE USA INC. |
BRADLEY W STRASSER |
| K121839 |
08/08/2012 |
UNBALLOON NON-OCCLUSIVE MODELING CATHETER |
LEMAITRE VASCULAR INC. |
ANDREW HODGKINSON |
| K111953 |
08/07/2012 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K112534 |
08/10/2012 |
LIFECELL TISSUE EXPANDER |
LIFECELL CORP. |
KRISTEN MEANY |
| K121289 |
08/03/2012 |
LTM-LABAROSCOPIC SURGICAL MESH |
LIFECELL CORP. |
MARK R JAKUBOWSKI |
| K121890 |
08/22/2012 |
GENESYS PRESSFT SUTURE ANCHOR |
LINVATEC CORPORATION D/B/A CONMED LINVATEC |
LORNA K LINVILLE |
| K113830 |
08/30/2012 |
VANTERA CLINICAL ANALYZER |
LIPOSCIENCE |
SUZETTE WARNER |
| K121368 |
08/10/2012 |
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) |
MATANG MFG. SDN. BHD. |
LESLIE LEONG |
| K122201 |
08/30/2012 |
PROTURA COUCH SOFTWARE |
MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS |
AMANDA STAHLE |
| K121148 |
08/20/2012 |
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D |
MEDICAL DESIGN LLC. |
KRISTI VONDRA |
| K121014 |
08/01/2012 |
SOLAR GI |
MEDICAL MEASUREMENT SYSTEMS,B.V. |
K. OGINK SOMHORST |
| K113673 |
08/03/2012 |
MYSAFETY SYRINGE |
MEDICALCHAIN INTERNARTIONAL CORPORATION |
ROBIN HWANG |
| K120008 |
08/17/2012 |
MEDLINE HIGH PRESSURE INJECTION TUBING |
MEDLINE, INDUSTRIES, INC. |
MATT CLAUSEN |
| K113560 |
08/01/2012 |
CELOX GAUZE PRO |
MEDTRADE PRODUCTS LTD. |
CLAIRE RYAN |
| K121760 |
08/29/2012 |
CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
BRAD SHEALS |
| K121764 |
08/21/2012 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
BRAD SHEALS |
| K121264 |
08/27/2012 |
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE |
MEDTRONIC SURGICAL TECHNOLOGIES |
RISHI SINHA |
| K121320 |
08/10/2012 |
C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE |
MEDYSSEY CO., LTD. |
MICHAEL KVITNITSKY |
| K122240 |
08/21/2012 |
BONE PLUS BCP EAGLE EYE |
MEGAGEN IMPLANT CO., LTD |
APRIL LEE |
| K122190 |
08/17/2012 |
PRELUDE 7F SHORT SHEATH INTRODUCER |
MERIT MEDICAL SYSTEMS, INC. |
DAN CLARK |
| K113289 |
08/01/2012 |
ORION MICRO CATHETER |
MICRO THERAPEUTICS, INC. |
ANALIA NIETO |
| K121785 |
08/10/2012 |
SCEPTER C OCCLUSION BALLOON CATHETER |
MICRO VENTION, INC. |
Naomi Gong |
| K113128 |
08/17/2012 |
MICROAIRE SURGICAL INSTRUMENTS LLC |
MICROAIRE SURGICAL INSTRUMENTS, LLC |
DARREN REEVES |
| K122291 |
08/31/2012 |
THERMO SCIENTIFIC MAS OMNI-CARDIO |
Microgenics Corporation |
KAREN LEE |
| K120430 |
08/02/2012 |
MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN GOLDSTEIN-FALK |
| K122086 |
08/23/2012 |
THERMAL LIGATING SHEARS |
MICROLINE SURGICAL, INC |
WILLIAM MCCALLUM |
| K120734 |
08/02/2012 |
MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE |
MICROSOFT CORP. |
ADRIENNE LENZ |
| K122316 |
08/29/2012 |
AZUR DETACHABLE 35 |
MICROVENTION, INC. |
CYNTHIA VALENZUELA |
| K120917 |
08/02/2012 |
HEADWAY DUO MICROCATHETER |
MICROVENTION, INC. |
Naomi Gong |
| K120239 |
08/24/2012 |
ELEVANCE |
MIDMARK |
ROBYN SCOPIS |
| K112162 |
08/08/2012 |
CONICAL CONNECTION IMPLANTS |
MIS IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K122073 |
08/02/2012 |
ELI 280 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K121089 |
08/23/2012 |
NMI PICC III |
NAVILYST MEDICAL, INC. |
Lorraine M Hanley |
| K121990 |
08/03/2012 |
PICC CONVENIENCE KIT |
NAVILYST MEDICAL, INC. |
MARION W GORDON |
| K121184 |
08/02/2012 |
SENSUS |
NEUROMETRIX, INC. |
RAINER MAAS |
| K121276 |
08/29/2012 |
NEURO VENTION LAMINPLASTY PLATING SYSTEM |
NEUROVENTION LLC |
MEREDITH MAY |
| K112620 |
08/02/2012 |
DISITAL BLOOD PRESSURE MONITOR |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KUBO |
| K120553 |
08/09/2012 |
ESPIN |
NLT SPINE LTD |
JOHN J SMITH |
| K113795 |
08/07/2012 |
SUCTION LIPOLASTY ACCESSORIES |
NORMAN M. BLACK III |
NORMAN BLACK |
| K120151 |
08/17/2012 |
NEBULAE I |
NORTHGATE TECHNOLOGIES INC. |
CASEY KUREK |
| K113820 |
08/08/2012 |
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER |
NOVABAY PHARMACEUTICALS |
SHEILA W PICKERING |
| K121859 |
08/31/2012 |
TYSHAK NUCLEUS |
NUMED, INC. |
NICHELLE LAFLESH |
| K121390 |
08/10/2012 |
LUBE JELLY SURINGE |
NURSE ASSIST, INC. |
BILL KANEWSKE |
| K121619 |
08/24/2012 |
NUVASIVE POLYAXIAL SPINAL SCREWS |
NUVASIVE, INC. |
Elias Ketchum |
| K111914 |
08/21/2012 |
VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM |
OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP |
SHERI L MUSGNUNG |
| K120278 |
08/10/2012 |
WIRELESS IMAGE TRANSMITTER UNIT |
OLYMPUS MEDICAL SYSTEMS CORP. |
SHERI MUSGNUNG |
| K121932 |
08/29/2012 |
HEM-7200-Z (BP742) |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K121173 |
08/16/2012 |
CHORD-X EPTFE SUTURE |
ON-XLIFETECHNOLOGIES |
JOHN ELY |
| K121091 |
08/28/2012 |
CATALYS PRECISION LASER SYSTEM |
OPTIMEDICA CORPORATION |
ALAN MARQUARDT |
| K111460 |
08/20/2012 |
OPTO HYALUS GREEN LASER |
OPTO ELETRONICA S/A |
PAULO ANEAS LICHTI |
| K113338 |
08/10/2012 |
MEDICAL AIR COMPRESSOR |
ORICARE, INC. |
DAVID JAMISON |
| K121524 |
08/09/2012 |
INSIGNIA |
ORMCO CORP. |
Wendy Garman |
| K122084 |
08/29/2012 |
INTRODUCER SET, MODEL ADELANTE-S SERIES |
Oscor Inc. |
MILA DOSKOCIL |
| K120847 |
08/10/2012 |
ET/SS IMPLANT SYSTEM |
OSSTEM IMPLANT CO.,LTD |
PATRICK LIM |
| K121304 |
08/22/2012 |
OSTEOMED CRANIAL DISTRACTION SYSTEM |
OSTEOMED |
PIEDAD PENA |
| K121102 |
08/08/2012 |
OSTEOSYMBIONICS PEEK CRANIAL IMPLANT |
OSTEOSYMBIONICS, LLC |
ELAINE DUNCAN |
| K113312 |
08/21/2012 |
HY-CHLO(TM)WOUND SCRUB |
PATRIN PHARMA |
JAY S TRIVEDI |
| K113568 |
08/21/2012 |
MTA-FILLAPEX |
PAXMED INTERNATIONAL |
ALLISON KOMIYAMA |
| K120585 |
08/08/2012 |
CONVEY GUIDING CATHETER |
PENDRACARE INTERNATIONAL, B.V. |
TOM NOLAN |
| K122439 |
08/29/2012 |
INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HERBERT VAN DYK |
| K121542 |
08/27/2012 |
PICIS WEIGHT BASED DOSE CONVERTER |
PICIS INC. |
JANICE HOGAN |
| K121476 |
08/29/2012 |
INFILL GRAFT DELIVERY SYSTEM |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K113705 |
08/31/2012 |
PINTLER PATIENT WARMING SYSTEM |
PINTLER MEDICAL |
MARIBETH MACINTYRE-ELLIS |
| K112967 |
08/28/2012 |
PMMA CAD/CAM DISC |
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY |
JANJA LIPUSCEK |
| K121197 |
08/10/2012 |
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT |
PREVENTICE, INC. |
DREW PALIN |
| K122121 |
08/02/2012 |
PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE |
PULSION MEDICAL SYSTEMS SE |
Jamie Sulley |
| K122126 |
08/14/2012 |
DIRECT LDL/HDL CHOLESTEROL CALIBRATOR |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K113747 |
08/24/2012 |
RANDOX OPIATES ASSAY |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K122182 |
08/16/2012 |
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC |
RAYENCE CO., LTD |
DAVE KIM |
| K121497 |
08/17/2012 |
VENOFER PUMP |
RENAL SOLUTIONS INC. |
DAVID VANELLA |
| K120898 |
08/03/2012 |
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
RON HASELHORST |
| K120152 |
08/13/2012 |
CERASORB PLUS |
RIEMSER ARZNEIMITTEL AG |
James M Clinton |
| K121895 |
08/24/2012 |
ELECSYS HSV-2 IGG IMMUNOASSAY |
Roche Diagnostics |
K. Colleen Adams |
| K121410 |
08/02/2012 |
DRAGON LW |
SEDECAL SA |
DANIEL KAMM |
| K120554 |
08/10/2012 |
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K121526 |
08/03/2012 |
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES |
SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD. |
CECILY SHENG |
| K120890 |
08/17/2012 |
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE |
SHEN WEI (USA), INC. |
ALBERT LI |
| K121157 |
08/02/2012 |
POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SHIJAZHUANG JIUYUAN PLASTIC CO., LTD |
CHU XIAOAN |
| K122323 |
08/28/2012 |
DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI |
SIEMENS HEALTHCARE DIAGNOSTICS |
ROSE T MARINELLI |
| K121513 |
08/10/2012 |
MULTIX FUSION |
SIEMENS MEDICAL SOLUTION |
PATRICIA D JONES |
| K122317 |
08/29/2012 |
TETRIS II |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
| K112362 |
08/14/2012 |
C100 WRINKLE REDUCTION DEVICE |
SILVER BAY, LLC |
ROBERT WAGNER |
| K113291 |
08/30/2012 |
SIMEX NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMPS SERIES: SIM-EX200 AND SIM-EX300 |
SIMEX MEDIZINTECHNIK GMBH |
HAMID KHOSROWSHAHI |
| K120921 |
08/21/2012 |
CLEVER CHOICE |
SIMPLE DIAGNOSTICS, INC. |
DANIEL KAMM |
| K121632 |
08/10/2012 |
COMFORT EZ |
SIMPLE DIAGNOSTICS, INC. |
DANIEL KAMM |
| K121443 |
08/13/2012 |
JOURNEY II CR KNEE SYSTEM |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K122244 |
08/23/2012 |
POLARCUP DUAL MOBILITY SYSTEM |
SMITH & NEPHEW, INC. |
JOHN CONNOR |
| K122296 |
08/28/2012 |
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING |
SMITH & NEPHEW, INC. |
JOHN CONNOR |
| K121393 |
08/07/2012 |
SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K121525 |
08/02/2012 |
PERIFUSE CATHETER |
SMITHS MEDICAL ASD, INC. |
CHRISTINE LLOYD |
| K121615 |
08/15/2012 |
4CIS VANE SPINE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K122254 |
08/24/2012 |
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K121536 |
08/22/2012 |
INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR |
SORIN GROUP ITALIA S.R.L. |
SCOTT LIGHT |
| K122036 |
08/15/2012 |
VISI MOBILE MONITORING SYSTEM |
SOTERA WIRELESS, INC |
EBEN GORDON |
| K121172 |
08/08/2012 |
REFORM PEDICLE SCREW SYSTEM |
SPINAL USA |
J.D. WEBB |
| K121548 |
08/16/2012 |
SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) |
SPINE VIEW, INC. |
Diana DeGregorio |
| K121889 |
08/29/2012 |
STAXX XD SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K121158 |
08/06/2012 |
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
STERILMED, INC. |
JASON SKRAMSTED |
| K120486 |
08/20/2012 |
AVS AS PEEK SPACER |
STRYKER SPINE |
SORAYA KING |
| K113666 |
08/28/2012 |
XIA 3 SPINAL SYSTEM |
STRYKER SPINE |
G. STIEGMAN |
| K121855 |
08/16/2012 |
RESPROCESSED SERFAS ENERGY PROBE |
STRYKER SUSTAINABILITY SOLUTIONS |
ERIC VARTY |
| K121329 |
08/24/2012 |
AIXPLORER |
SUPERSONIC IMAGINE |
JACQUES SOUQUET |
| K112255 |
08/28/2012 |
AIXPLORER |
SUPERSONIC IMAGINE |
JACQUES SOUQUET |
| K113776 |
08/08/2012 |
FLASHPAK |
SYMMETRY MEDICAL |
ROBERT JOHNSON |
| K121502 |
08/23/2012 |
SYNTHES CURVILINEAR DISTRACTION SYSTEM |
SYNTHES INC |
ALAN T HALEY |
| K113077 |
08/03/2012 |
BIOLAND G-423 GLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
LINDA KO |
| K121257 |
08/28/2012 |
LARYNGEAL ELECTRODE |
TECHNOMED EUROPE |
PIERRE VREULS |
| K121192 |
08/03/2012 |
NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) |
TEKMEDIC (M) SDN BHD |
PATRICK LEONG |
| K122249 |
08/28/2012 |
TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE |
TERUMO (PHILIPPINES) CORPORATION |
PHILLIP LESTER |
| K122066 |
08/30/2012 |
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS |
THE BINDING SITE GROUP LTD |
JILL CONSTANTINE |
| K120902 |
08/15/2012 |
GID 700 |
THE GID GROUP, INC. |
LEWIS WARD |
| K121482 |
08/28/2012 |
INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY |
THEKEN SPINE LLC |
DALE DAVISON |
| K120158 |
08/14/2012 |
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K121334 |
08/14/2012 |
VARIOECO |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K121422 |
08/16/2012 |
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
CHARLEMAGNE CHUA |
| K113715 |
08/17/2012 |
LUNG VOLUME ANALYSIS |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K121910 |
08/17/2012 |
OCTAVE SPEEDER HEAD |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K121911 |
08/17/2012 |
OCTAVE SPEEDER SPINE |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K120991 |
08/23/2012 |
TRANS1 INTERBODY FUSION SYSTEM |
TRANS1 INCORPORATED |
CHERYL L WAGONER |
| K121452 |
08/20/2012 |
GRIDLOCK PLATING SYSTEM |
TRILLIANT SURGICAL LTD |
J.D. WEBB |
| K122070 |
08/15/2012 |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G |
TRIREME MEDICAL INC |
SHIVA ARDAKANI |
| K112916 |
08/21/2012 |
TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BLOOD GLUCISE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K122528 |
08/28/2012 |
ULTHERA SYSTEM |
ULTHERA, INC. |
SUZON LOMMEL |
| K121337 |
08/03/2012 |
UROPLASTY RIGID ENDOSCPIC NEEDLES |
UROPLASTY, INC. |
EMILY METCALFE |
| K121400 |
08/28/2012 |
PAX-UNI3D, PHT-7500 |
VATECH CO., LTD. |
DAVE KIM |
| K120626 |
08/22/2012 |
EON CALCIUM REGENT |
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
MELITA LAMBIRIS |
| K120320 |
08/14/2012 |
CONNECTED CARE CLINICAL APPLICATION |
WATERMARK MEDICAL INC |
MICHAEL J LEIGH |
| K121720 |
08/20/2012 |
WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM |
WELKINS, LLC |
CHRISTOPHER BLODGETT |
| K121505 |
08/31/2012 |
DISPOSABLE HEMOSTASIS CHIP |
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY |
SCOTTIE FARIOLE |
| K121221 |
08/09/2012 |
PROFEMUR Z REVISION HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
YUAN LI |
| K121789 |
08/03/2012 |
SHANGRING |
WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C |
CYNTHIA NOLTE |
| K113692 |
08/09/2012 |
XENX |
XENOLITH MEDICAL |
OFER ZIGMAN |
| K121025 |
08/17/2012 |
YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION |
YA HORNG ELECTRONIC CO., LTD. |
JEN KE-MIN |
| K122265 |
08/14/2012 |
VIALOK SINGLE VIAL ACCESS DEVICE VENTED |
YUKON MEDICAL, LLC |
|
| K113045 |
08/14/2012 |
BIOHARNESS |
ZEPHYR TECHNOLOGY CORPORATION |
RICHARD KEEN |
| K113753 |
08/30/2012 |
ZIMMER DENTAL TAPERED SCREW-VENT X |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K120715 |
08/10/2012 |
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT |
ZIMMER GMBH |
STEPHEN H MCKELVEY |
| K121059 |
08/07/2012 |
SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM |
ZIMMER MEDIZINSYSTEMS GMBH |
ARMIN PETRASCHKA |
| K120906 |
08/24/2012 |
ZIMMER TRABECULAR METAL TOTAL ANKLE |
ZIMMER, INC. |
REBECCA DILL |
| K121820 |
08/24/2012 |
INWAVE |
ZYNEX MEDICAL, INC. |
JIM ARNOLD |
