| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K112083 |
05/03/2012 |
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES |
INTL., INC. |
MICHAEL D CECCHI |
| K120704 |
05/03/2012 |
3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM |
3M COMPANY |
JON PLATT |
| K120438 |
05/02/2012 |
FLASH (DIFFERENT MATERIALS) |
3M DEUTSCHLAND GMBH |
DESI W SOEGIARTO |
| K121314 |
05/17/2012 |
ARCHITECT B12 |
ABBOTT LABORATORIES |
DARLA A ABANO |
| K121015 |
05/04/2012 |
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM |
Abbott Vascular |
Ivalee Cohen |
| K112585 |
05/24/2012 |
TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM |
ADIN DENTAL IMPLANTS SYSTEM LTD |
YANA PRUS-GALYNSKY |
| K120631 |
05/25/2012 |
PATIENT MONITOR |
ADVANCED INSTRUMENTS, INC. |
JORGE MILLAN |
| K120559 |
05/24/2012 |
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K112671 |
05/04/2012 |
STERILCONTAINER SYSTEM |
AESCULAP, LTD. |
DENISE ADAMS |
| K110212 |
05/01/2012 |
INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP |
ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE |
MARA CALER |
| K113253 |
05/17/2012 |
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K113511 |
05/02/2012 |
ECHOSTAR SPICA 1.5T MR SYSTEM |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
MICHAELEEN DOM |
| K113639 |
05/08/2012 |
C2 MEDICAL GLOVES |
AMERCARE, INC. |
ANDREW LOWERY |
| K120394 |
05/08/2012 |
LIFESTYLES ZERO LUBRICATED LATEX CONDOM |
ANSELL HEATHCARE PRODUCTS LLC |
CYNTHIA INGRAM |
| K120620 |
05/31/2012 |
CLEAN AND BOOST |
APEX DENTAL MATERIALS, INC. |
CHRIS KULTON |
| K120035 |
05/16/2012 |
APEX MEDICAL ICH CPAP SERIES (9S-007XXX) |
APEX MEDICAL CORP. |
ALAN CHANG |
| K112165 |
05/24/2012 |
RHEA CUP |
APEX MEDICAL TECHNOLOGIES, INC. |
SCOTT HERRICK |
| K120106 |
05/07/2012 |
APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM |
APIXIA INC. |
ERIC HUANG |
| K120587 |
05/25/2012 |
AMT T-FASTENER ANCHOR KIT |
APPLIED MEDICAL TECHNOLOGY, INC. |
ELIZABETH MEYER |
| K120412 |
05/30/2012 |
3M SPOTON TEMPERATURE MONITORING SYSTEM |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K112457 |
05/18/2012 |
LEFORTE SYSTEM BONE PLATE & SCREW |
ARKIN CONSULTING GROUP |
PAUL SUMNER |
| K112896 |
05/10/2012 |
ARRW EVOLUTION |
ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) |
TRACY MADDOCK |
| K121124 |
05/16/2012 |
ARTHREX MIXING AND DELIVERY SYSTEM |
ARTHREX, INC. |
CHRISTINA FLORES |
| K112669 |
05/11/2012 |
TATTOOSTAR EFFECT Y |
ASCLEPION LASER TECHNOLOGIES GMBH |
ANTJE KATZER |
| K113812 |
05/03/2012 |
ATAL-8 |
ATLAIM |
DANIEL KAMM |
| K112790 |
05/07/2012 |
AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON |
AXIS-SHIELD DIAGNOSTICS, LTD. |
KAREN HILL |
| K120150 |
05/24/2012 |
DUAL SPIKE TRANSFER DEVICE |
B. BRAUN MEDICAL, INC. |
BONNIE KINCAID |
| K120882 |
05/30/2012 |
SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE |
BARD ACCESS SYSTEMS, INC. |
HENRY BOLAND |
| K120431 |
05/03/2012 |
HALO90 ULTRA ABLATION CATHETER |
BARRX MEDICAL, INC. |
DAWN CHANG |
| K120443 |
05/22/2012 |
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE |
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
NANETTE HEDDEN |
| K121283 |
05/30/2012 |
BD EMERALD SAF-T SINGLE USE, HYPODERMIC |
Becton, Dickinson and Company |
KIMBERLY LANE |
| K121143 |
05/18/2012 |
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) |
Bio-Rad Laboratories |
SUZSNNE PARSONS |
| K121149 |
05/16/2012 |
VANGUARD SSK 360 REVISION KNEE SYSTEM |
BIOMET MANUFACTURING CORP. |
GARY BAKER, M.S. RAC |
| K113271 |
05/18/2012 |
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS |
BIOMET MANUFACTURING, INC. |
GARY BAKER |
| K112905 |
05/24/2012 |
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM |
BIOMET ORTHOPEDICS LLC. |
GARY BAKER |
| K120335 |
05/03/2012 |
EMBRACE THERMOPLASTIC |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER M.D., PH.D. |
| K120057 |
05/11/2012 |
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) |
BIOPTIGEN, INC. |
DAWN REILLY-O'DELL |
| K120550 |
05/07/2012 |
CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K120425 |
05/24/2012 |
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER |
BIOSENSE WEBSTER, INC. |
WAYNE R HOHMAN |
| K120353 |
05/09/2012 |
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM |
BM KOREA CO., LTD. |
Priscilla Chung |
| K120495 |
05/21/2012 |
IMPULSE AND EXPO ANGIOGRAPHIC CATHETER |
BOSTON SCIENTIFIC CORP. |
YUMI WACKERFUSS |
| K121186 |
05/16/2012 |
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS |
BOSTON SCIENTIFIC CORP. |
CORRIE GOODING |
| K120983 |
05/02/2012 |
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM |
Boston Scientific Corporation |
JANIS F TARANTO |
| K113732 |
05/07/2012 |
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K120533 |
05/22/2012 |
BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES |
BRIDGEPOINT MEDICAL |
JILL MUNSINGER |
| K120183 |
05/11/2012 |
ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM |
BROADMASTER BIOTECH CORPERATION |
ROGER LAI |
| K121167 |
05/02/2012 |
CAIRE COMPANION 5 OXYGEN CONCENTRATOR |
CAIRE INC. |
BEN KADRLIK |
| K120327 |
05/10/2012 |
VERTESSA |
CALDERA MEDICAL, INC. |
VICKI GAIL |
| K120798 |
05/14/2012 |
DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR |
CANOPUS MEDICAL SUPPLY CO., LTD. |
GLORIA CHANG |
| K120543 |
05/30/2012 |
TANDEMHEART FEMORAL ARTERIAL CANNULA SET |
CARDIACASSIST INC. |
KATIE DILLON |
| K120934 |
05/23/2012 |
PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K121009 |
05/17/2012 |
HEARTCHECK ECG PEN WITH GEMS HOME |
CARDIO COMM SOLUTIONS, INC. |
JONATHAN WARD |
| K120518 |
05/04/2012 |
END TIDAL CO2 NASAL CANNULA |
CAREFUSION |
ERIKA FERNANDEZ |
| K113813 |
05/10/2012 |
SENTRYSUITE PRODUCT LINE |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K111382 |
05/31/2012 |
CELVER |
CELLULOSE CONCEPTS LLC |
MARIA F GRIFFIN |
| DEN120012 |
05/24/2012 |
CDC DENV-1-4 REAL TIME RT-PCT ASSAY |
CENTERS FOR DISEASE CONTROL AND PREVENTION |
HYE-JOO KIM |
| K113440 |
05/23/2012 |
HIGH FIVE |
CENTRAL MEDICARE SDN BHD |
NICK WANG |
| K120911 |
05/18/2012 |
XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) |
CEPHEID |
KERRY J FLOM |
| K121339 |
05/17/2012 |
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
| K120059 |
05/17/2012 |
LIQUID BANDAGE |
CHESSON LABORATORY ASSOCIATES, INC. |
SCOTT E NEUVILLE |
| K111941 |
05/25/2012 |
CHOYANG THERMAL MASSAGER |
CHOYANG MEDICAL INSTRUMENT CO., LTD. |
SHIN KUK YOO |
| K120287 |
05/16/2012 |
TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT |
CHURCH & DWIGHT CO., INC. |
JOSEPH CICCONE |
| K120249 |
05/11/2012 |
TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT |
CHURCH & DWIGHT VIRGINIA CO., INC. |
JOSEPH CICCONE |
| K113384 |
05/01/2012 |
EXTERNAL FIXATOR ST.A R 90 F4 |
CITIEFFE |
Claude Berthoin |
| K121237 |
05/18/2012 |
BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE |
CLINIQA CORPORATION |
DAWN GAST |
| K112378 |
05/08/2012 |
COBES SURGICAL DRAPE |
COBES INDUSTRIES CO., LTD. |
LEON LU |
| K120284 |
05/23/2012 |
DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX |
COLOPLAST A/S |
JANELL COLLEY |
| K112322 |
05/17/2012 |
RESTORELLE POLYPROPYLENE Y MESH |
COLOPLAST A/S |
TIM CRABTREE |
| K121263 |
05/22/2012 |
TAPER SET HIP SYSTEM RDP STEM |
CONSENSUS ORTHOPEDICS, INC. |
|
| K111476 |
05/23/2012 |
CONTOUR TECHNOLOGY MUSCLE STIMULATOR |
CONTOUR TECHNOLOGY |
SARA PETRIE |
| K113510 |
05/17/2012 |
EVOLUTION COLONIC STENT SYSTEM |
COOK IRELAND LTD |
Jacinta Kilmartin |
| K121039 |
05/25/2012 |
COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM |
COPAN FLOCK TECHNOLOGIES |
CYNTHIA SINCLAIR |
| K112797 |
05/04/2012 |
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER |
CORDIS CORP. |
DANNA MARSHALL |
| K121037 |
05/03/2012 |
LOSPA TIBIAL BASE PLATE |
CORENTEC CO., LTD |
J.S. DANIEL |
| K120362 |
05/04/2012 |
METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY |
CORIN U.S.A. |
LUCINDA GERBER, BA (HONS) |
| K112549 |
05/04/2012 |
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER |
COVALON TECHNOLOGIES, INC. |
KIM CROOKS |
| K121194 |
05/03/2012 |
ENDO CLIP III 5MM CLIP APPLIER |
COVIDIEN |
ANGELA VAN ARSDALE |
| K120944 |
05/31/2012 |
KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER |
COVIDIEN |
JENNIFER SULLIVAN |
| K121139 |
05/02/2012 |
ACCUMESH DEPLOYMENT SYSTEM |
Covidien LLC |
JAMES MCMAHON |
| K120605 |
05/18/2012 |
PERMACOL SURGICAL IMPLANT |
Covidien LLC |
JAMES MCMAHON |
| K112511 |
05/11/2012 |
DOBBHOFF DUAL PORT FEEDING TUBE |
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
DEBORA STAPLETON |
| K113660 |
05/03/2012 |
COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL |
CRYOTHERAPY PRODUCTS INC. |
JORGE CABALLERO |
| K121127 |
05/13/2012 |
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS |
CYNOSURE, INC. |
IRINA KULINETS |
| K120077 |
05/14/2012 |
COMED K-SERIES MANUAL WHEELCHAIR |
DANYANG COMED HEALTHCARE CO., LTD |
RHONDA ALEXANDER |
| K120449 |
05/11/2012 |
HEALIX ADVANCE PEEK ANCHOR |
Depuy Mitek |
YAYOI FUJIMAKI |
| K121020 |
05/03/2012 |
VIPER SYSTEM |
DEPUY SPINE, INC. |
KIRSTEN LEHMULLER |
| K113689 |
05/04/2012 |
DUKAL LUBRICATING JELLY |
DUKAL CORPORATION |
PATRICK J LAMB |
| K113050 |
05/16/2012 |
CLEARPATH LOWER GI |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K113166 |
05/16/2012 |
CLEARPATH UPPER GI |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K120173 |
05/16/2012 |
PATIENT MONITOR |
EDAN INSTRUMENTS INC |
RANDY JIANG |
| K113565 |
05/18/2012 |
MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN |
EDWARDS LIFESCIENCES, LLC. |
MARGUEITE THOMLINSON |
| K120072 |
05/08/2012 |
VENOUS DRAINAGE CANNULA WITH DURAFLO COATING |
EDWARDS LIFESCIENCES, LLC. |
KAREN JONES |
| K120811 |
05/24/2012 |
LEKSELL GAMMA KNIFE PERFEXION |
ELEKTA INSTRUMENT AB |
VIVEKA WRETMAN |
| K120604 |
05/25/2012 |
K-LASER |
ELTECH S.R.L |
RICHARD ALBRIGHT |
| K120184 |
05/02/2012 |
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED |
ENCOMPASS MEDICAL SUPPLIES INC LIMITED |
CJ ANG |
| K120513 |
05/08/2012 |
GLOW BY ENDYMED |
ENDYMED MEDICAL LTD |
YORAM LEVY |
| K121174 |
05/17/2012 |
XPRESS MULTI-SINUS DILATION TOOL |
Entellus Medical, Inc. |
KAREN E PETERSON |
| K121207 |
05/18/2012 |
EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Cynthia Hung |
| K120257 |
05/14/2012 |
MLS, ZERONA-AD |
ERCHONIA MEDICAL, INC. |
Kevin Walls |
| K121384 |
05/23/2012 |
MYLABSOGNO |
ESAOTE, S.P.A. |
ALLISON SCOTT, RAC |
| K120748 |
05/01/2012 |
SPEEDUP SOFTWARE OPTION |
ESAOTE, S.P.A. |
ALLISON SCOTT, RAC |
| K120729 |
05/17/2012 |
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 |
ETHICON ENDO-SURGERY, LLC |
DONOVAN MAY |
| K113576 |
05/18/2012 |
DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM |
ETVIEW LTD. |
YORAM LEVY |
| K121307 |
05/31/2012 |
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ |
EXACTECH, INC. |
PATRICK HUGHES |
| K110734 |
05/31/2012 |
NCI SPATULA |
FISCHER SURGICAL INC. |
JESSICA DIXON |
| K102577 |
05/03/2012 |
FORCE MEDICAL IM NAIL SYSTEM |
FORCE MEDICAL, INC |
AL LIPPINCOTT |
| K112621 |
05/30/2012 |
WIS1000 |
FORESEESON CUSTOM DISPLAYS, INC. |
DANIEL TOMLINSON |
| K113713 |
05/07/2012 |
GEN_2 MECHANICAL WHEELCHAIR |
FREE WHEELCHAIR MISSION |
SHARON ROCKWELL |
| K120637 |
05/08/2012 |
SYNAPSE 3D BRAIN PERFUSION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K120333 |
05/25/2012 |
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY |
GAMBRO RENAL PRODUCTS |
FEI LAW |
| K120521 |
05/10/2012 |
GC BLUE SILICONE |
GC AMERICA, INC. |
MARK HEISS |
| K120601 |
05/24/2012 |
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O |
GEISTLICH PHARMA AG |
DANIEL A KRACOV |
| K111409 |
05/03/2012 |
APTIMA COMBO 2 ASSAY |
GEN-PROBE, INC. |
JODY J FLEMING |
| K112856 |
05/10/2012 |
LUCINA-MELODI |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN-MING GOH |
| K120216 |
05/16/2012 |
GENOSYL MV-1000 |
GENO LLC |
PAUL DRYDEN |
| K120441 |
05/31/2012 |
GETINGE 700HC-E SERIES STEAM STERILIZER |
GETINGE SOURCING LLC |
BARB SMITH |
| K113853 |
05/08/2012 |
G+ SYSTEM |
GLYTEC, LLC |
WILLIAM MATTHEWS |
| K113833 |
05/01/2012 |
VITAL SIGNS MONITOR |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
Diana Hong |
| K121166 |
05/08/2012 |
WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL |
Guangzhou Wondfo Biotech Co., Ltd. |
Joe Shia |
| K121466 |
05/31/2012 |
GUIDEMIA |
GUIDEMIA TECHNOLOGIES, LLC |
FEI GAO |
| K120586 |
05/22/2012 |
CELL SAVER ELITE |
HAEMONETICS CORP. |
GREG CALDER |
| K120574 |
05/30/2012 |
HAMILTON-C1 |
HAMILTON MEDICAL AG |
RALPH AGUILA |
| K111004 |
05/29/2012 |
HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER |
HANSEN MEDICAL, INC. |
KATE WHITIN |
| K120894 |
05/17/2012 |
HAYMAX |
HAYMAX LIMITED |
MAX WISEBERG |
| K110074 |
05/25/2012 |
HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K120548 |
05/04/2012 |
HLIC NEEDLE-LESS VALVE |
HEALTH LINE INTERNATIONAL CORPORATION |
NOLA BENSTOG |
| K113622 |
05/18/2012 |
ORION II CT CVC |
HEALTH LINE INTERNATIONAL CORPORATION (HLIC) |
NOLA BENSTOG |
| K120369 |
05/10/2012 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
BUNICHIRO NAKAJIMA |
| K113145 |
05/01/2012 |
ECHELON OVAL MRI SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K113341 |
05/03/2012 |
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K112800 |
05/23/2012 |
SUNTOUCH TOPICAL HEMOSTATIC DRESSING |
HUIZHOU FORYOU MEDICAL DEVICES CO, LTD |
CHENGYU SHEN |
| K121132 |
05/10/2012 |
EZSENSOR P DIGITAL INTRAORAL SENSOR |
HUMANRAY CO,LTD |
DAVE KIM |
| K120351 |
05/03/2012 |
CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA |
i-SENS, Inc. |
HYUN JOON OH |
| K120267 |
05/15/2012 |
FILMARRAY RP PANEL |
IDAHO TECHNOLOGY, INC. |
BETH LINGENFELTER |
| K113670 |
05/08/2012 |
ELEMENT BLOOD GLUCOSE MONITORING SYSTEM |
INFOPIA CO., LTD |
Priscilla Chung |
| K113088 |
05/02/2012 |
HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) |
INNERSPACE, INC |
DON BOBO |
| K120493 |
05/17/2012 |
MINI CANNULATED HEADED AND HEADLESS SCREW SET |
INSTRATEK, INC. |
Jeff Seavey |
| K112995 |
05/03/2012 |
GEM PREMIER 4000 |
INSTRUMENTATION LABORATORY CO. |
CARL MARBLE |
| K120633 |
05/24/2012 |
MAYFIELD SKULL CLAMP |
INTEGRA LIFESCIENCES CORPORATION |
LINDSAY MIGNONE |
| K112986 |
05/01/2012 |
LATERAL FUSION DEVICE |
INTEGRA SPINE (INTEGRA LIFESCIENCES) |
DALE DAVISON |
| K120895 |
05/24/2012 |
REMOTE PRESENCE SYSTEM |
INTOUCH HEALTH, INC. |
STEVE SIDWELL |
| K121023 |
05/31/2012 |
SPECTRUM V.0 |
INTRINSIC MEDICAL IMAGING |
STEPHEN J GOLDNER, JD, RAC |
| K111450 |
05/18/2012 |
MIROCAM CAPSULE ENDOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
JEFFREY ROBERTS |
| K120736 |
05/14/2012 |
SR PHONARES II |
IVOCLAR VIVADENT AG |
DONNA M HARTNETT |
| K112665 |
05/04/2012 |
TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K113355 |
05/02/2012 |
POSEY BED |
J. T. POSEY CO. |
BONNIE BISHOP |
| K120099 |
05/18/2012 |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
K2M, INC. |
NANCY GIEZEN |
| K120899 |
05/25/2012 |
RANGE SPINAL SYSTEM, UNIT ROD |
K2M, INC. |
NANCY GIEZEN |
| K121232 |
05/24/2012 |
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR |
KAMIYA BIOMEDICAL COMPANY |
SHAWN KAPLAN |
| K120033 |
05/31/2012 |
ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT |
KCI USA, INC. |
Shannon Scott |
| K120141 |
05/04/2012 |
KENSEY NASH BONE VOID FILLER XC |
KENSEY NASH CORORATION |
Susan Pileggi |
| K113340 |
05/04/2012 |
KIMBERLY-CLARK CHILD'S FACEMASK |
KIMBERLY-CLARK |
ANN WATERHOUSE |
| K113333 |
05/11/2012 |
KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS |
KIMBERLY-CLARK CORPORATION |
MARCIA JOHNSON |
| K121109 |
05/23/2012 |
AERODR X70 |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
SHIGEYUKI KOJIMA |
| K111956 |
05/30/2012 |
KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K120879 |
05/23/2012 |
LEXUS CERVICAL FIXATION SYSTEM |
L & K BIOMED CO., LTD |
KI HYANG KIM |
| K120840 |
05/24/2012 |
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM |
L&K BIOMED CO., LTD |
KI HYANG KIM |
| K121116 |
05/08/2012 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
RANDY LEWIS |
| K112158 |
05/10/2012 |
MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K120761 |
05/08/2012 |
LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K121227 |
05/23/2012 |
MANUKA FILL |
LINKS MEDICAL PRODUCTS, INC. |
James Smith |
| K120976 |
05/23/2012 |
MANUKA IG |
LINKS MEDICAL PRODUCTS, INC. |
James Smith |
| K113739 |
05/30/2012 |
SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM |
MATERIALISE DENTAL NV |
GEERT APPELTANS |
| K121322 |
05/31/2012 |
CLOSER TO NATURE |
MAYBORN GROUP LIMITED |
NEIL HEWITT |
| K120497 |
05/14/2012 |
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL |
MEDICA CORP. |
Photios Makris |
| K120980 |
05/02/2012 |
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K120981 |
05/02/2012 |
2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K120860 |
05/08/2012 |
INFU BOX TYPE 0412A |
MEDICAL RESCUE EQUIPMENT HOLDING AS |
KNUT FANGBERGET |
| K112921 |
05/16/2012 |
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM |
MEDICAL.GORITHMICS S.A. |
MARTIN JASINSKI |
| K120130 |
05/21/2012 |
FALLER TROCAR |
MEDIGROUP, INC. |
IRENE NAVIS |
| K120299 |
05/18/2012 |
SRS ENDOSCOPIC STAPLING SYSTEM |
MEDIGUS, LTD. |
JONATHAN S KAHAN |
| K111049 |
05/25/2012 |
MOBILE VERSA LIGHT |
MEDTEK LIGHTING CORP |
ROBERT WAGNER |
| K121265 |
05/22/2012 |
AMPHIRION PLUS PTA CATHETER |
MEDTRONIC INC. |
NAINESH SUREJA |
| K120537 |
05/10/2012 |
AQUAMANTYS3 9.5 XL BIPOLAR SEALER |
MEDTRONIC INC. |
TARA N TURNEY, RAC |
| K120612 |
05/25/2012 |
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT |
MEDTRONIC INC. |
KELLEY BREHEIM |
| K110472 |
05/29/2012 |
SI-FIX SACROILIAC JOINT FUSION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K120271 |
05/30/2012 |
ARTISAN SPACE MAINTENANCE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LIN WU |
| K120978 |
05/02/2012 |
OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR |
MERETE MEDICAL GMBH |
EMMANUEL ANAPLIOTIS |
| K121044 |
05/01/2012 |
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K112527 |
05/22/2012 |
UNIVERSAL DIGITAL INTERFACE (UDI) 1717 |
MERIDIAN MEDICAL SYSTEMS, LLC |
ARIEL MARCIANO |
| K113577 |
05/08/2012 |
MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K120404 |
05/21/2012 |
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH |
MERZ DENTAL GMBH |
RICHARD G HUNTER |
| K120171 |
05/04/2012 |
ACCUSONIC ADVANTAGE |
METRON MEDICAL AUSTRALIA PTY LTD |
DAVID MITCHELL |
| K111008 |
05/02/2012 |
MICROWARE BONE PLATES AND BONE SCREW |
MICROWARE PRECISION CO., LTD. |
HARRISON DU |
| K120821 |
05/11/2012 |
LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM |
MISDER, LLC |
NANCY SAUER |
| K120515 |
05/23/2012 |
TEMPUS CERVICAL PLATE SYSTEM |
NEUROSTRUCTURES, LLC |
MEREDITH MAY |
| K112881 |
05/22/2012 |
NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) |
NEXSTIM OY |
RAINER HARJUNPAA |
| K113451 |
05/08/2012 |
NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX |
NIDEK TECHNOLOGIES SRL |
ENRICO BISSON |
| K113215 |
05/14/2012 |
MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY |
NONIN MEDICAL, INC. |
BRODIE PEDERSON |
| K120619 |
05/21/2012 |
ORTHODONTIC FLOWABLE BRACKET ADHESIVE |
NOVOCOL, INC. |
STEVE RUDOLPH |
| K111262 |
05/23/2012 |
ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP |
OLSEN MEDICAL |
NUNIE TABERMEJO |
| K120516 |
05/17/2012 |
LONG LIFE PADTM |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K121239 |
05/24/2012 |
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE |
OPTOACOUSTICS LTD |
PAUL DRYDEN |
| K113696 |
05/25/2012 |
OPTOS ADVANCE |
OPTOS PLC |
HOWARD M HOLSTEIN |
| K120360 |
05/29/2012 |
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS |
ORTHO SOLUTIONS LIMITED |
AL LIPPINCOTT |
| K111575 |
05/23/2012 |
HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX |
ORTHOCON, INC. |
ROSEMARY HARRY |
| K113006 |
05/25/2012 |
I-FUSE HAMMER TOE SYSTEMS |
ORTHOPRO LLC |
J D WEBB |
| K112952 |
05/10/2012 |
ILWAIT TIMER OCULOPRESSOR |
ORYX MEDICAL PTY LTD |
ANNE F JONES |
| K120622 |
05/23/2012 |
PALOMAR VECTUS LASER |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K102841 |
05/08/2012 |
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY |
PANTEX, DIV. BIO-ANALYSIS, INC. |
ROMULO GARZA |
| K120491 |
05/09/2012 |
DSS STABILIZATION SYSTEM-RIGID |
PARADIGM SPINE, LLC |
MICHELLE MCDONOUGH |
| K112859 |
05/30/2012 |
ERAPID NEBULIZER SYSTEM |
PARI RESPIRATORY EQUIPMENT, INC. |
JAMES L MCINTIRE |
| K120489 |
05/17/2012 |
TISSUE OF ORIGIN TEST KIT FFPE |
PATHWORK DIAGNOSTICS, INC. |
ANNA LONGWELL |
| K120013 |
05/22/2012 |
TEMPSPAN CLEAR MATRIX |
PENTRON CLINICAL |
Wendy Garman |
| K120261 |
05/02/2012 |
PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER |
Perouse Medical |
Isabelle Jeanty |
| K121223 |
05/15/2012 |
QLAB WITH FHN AND VPQ PLUG-IN |
PHILIPS ULTRASOUND, INC. |
PENNY GRECO |
| K120724 |
05/07/2012 |
PIONEER LATERAL PLATE SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC |
SARAH MCINTYRE |
| K120079 |
05/24/2012 |
PRIMED TRACHEOSTOMY TUBES (MULTIPLE) |
PRIMED HALBERSTADT MEDIZINTECHNIK GMBH |
ALEXANDRA SINGER |
| K110420 |
05/08/2012 |
OPHIRA MINI SLING SYSTEM |
PROMEDON S.A. |
STEPHANIE RAIS |
| K120160 |
05/14/2012 |
ROCAMED ROCAUS PLATINUM |
PROMEPLA SAM |
KRISTA JOHNSON |
| K111929 |
05/01/2012 |
PSYCHEMEDICS CANNABINOIDS EIA |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
| K111925 |
05/01/2012 |
PSYCHEMEDICS COCAINE EIA |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
| K111927 |
05/01/2012 |
PSYCHEMEDICS METHAMPHETAMINE EIA |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
| K111926 |
05/01/2012 |
PSYCHEMEDICS OPIATES EIA |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
| K111928 |
05/01/2012 |
PSYCHEMEDICS PHENCYCLIDINE EIA |
PSYCHEMEDICS CORP. |
VIRGINIA HILL |
| K112801 |
05/01/2012 |
AYERS ROCK CERVICAL CAGE |
QUALGENIX |
RICHARD DESLAURIERS |
| K112684 |
05/01/2012 |
MONT BLANC PEDICLE SCREW SYSTEMS |
QUALGENIX |
RICHARD DESLAURIERS |
| K113177 |
05/10/2012 |
COMPLETE D 25-OH VITAMIN D CONTROL |
QUANTIMETRIX CORP. |
KALYNA SNYLYK |
| K112279 |
05/04/2012 |
QUANTUM DENTAL IMPLANT SYSTEM |
QUANTUM BIOENGINEERING, LTD. |
LINDA SCHULZ |
| K120091 |
05/18/2012 |
R&D INNOVATION PEDICLE SCREW SYSTEM |
R&D INNOVATION, LLC |
MEREDITH MAY |
| K120344 |
05/03/2012 |
RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE |
RADIADYNE, LLC (SPECIFICATION DEVELOPER) |
STUART R GOLDMAN |
| K120026 |
05/08/2012 |
PERFORMER HT/ HANG&GO HT BASIC |
RAND S.R.L. |
SIMONE CERETTI |
| K113751 |
05/08/2012 |
RANDOX COCAINE METABOLITE |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K120179 |
05/23/2012 |
REACH SURGICAL STAPLERS |
REACH SURGICAL, INC |
Diana Hong |
| K112334 |
05/08/2012 |
VEIN-GOGH INSTRUMENT |
REFINE USA, LLC |
BRIAN SMITH |
| K120396 |
05/08/2012 |
RELIANCE CERVICAL IBF SYSTEM |
Reliance Medical Systems, LLC |
Bret M Berry |
| K111940 |
05/15/2012 |
S 100 PEDICLE SCREW SYSTEM |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
J.D. WEBB |
| K113801 |
05/25/2012 |
VPAP ADAPT |
RESMED CORP |
DAVID D D'CRUZ |
| K113714 |
05/25/2012 |
VPAP TX |
RESMED LTD. |
DAVID D'CRUZ |
| K113103 |
05/22/2012 |
SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K120556 |
05/23/2012 |
VILET VILET QUICK |
RIVERPOINT MEDICAL |
DOUG ROWLEY |
| K112924 |
05/02/2012 |
RS SAFE BLACK NITRILE MEDICAL EXAMINATION GLOVES POWDER OR OTHER PROPRIETARY NAME |
RIVERSTONE RESOURCES SDN. BHD. |
CHONG CHU MEE |
| K113521 |
05/08/2012 |
CALCIUM GEN. 2 |
Roche Diagnostics |
LISA K KLINEDINST |
| K111188 |
05/14/2012 |
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B |
Roche Diagnostics |
Sarah Baumann |
| K121279 |
05/10/2012 |
ELECSYS LH CALCHECK 5 |
Roche Diagnostics |
K. Colleen Adams |
| K113072 |
05/14/2012 |
TINA-QUANT ALBUMIN GEN.2 |
ROCHE DIAGNOSTICS OPERATIONS |
PATRICK STIMART |
| K120149 |
05/08/2012 |
SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA |
SAKURA SEIKI CO., LTD. |
MARIA F GRIFFIN |
| K120191 |
05/23/2012 |
PUSH-ON NEEDLE 30GX8MM |
SCANDINAVIAN HEALTH LIMITED |
SHARLIN YEH |
| K112550 |
05/25/2012 |
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM |
SEBIA |
KAREN ANDERSON |
| K112491 |
05/24/2012 |
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 |
SEBIA |
KAREN ANDERSON |
| K112266 |
05/08/2012 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR |
SHANDONG ZHIYUAN MEDICAL PRODUCTS CO., LTD. |
FRANK LIU |
| K120080 |
05/25/2012 |
SHASER HRS2 HAIR REMOVAL SYSTEM |
SHASER, INC. |
GLEN EMELOCK |
| K113281 |
05/17/2012 |
MRI SYTEMS |
SHENZHEN ANKE HIGH-TECH CO., LTD. |
Diana Hong |
| K113216 |
05/03/2012 |
RAPIDPOINT 500 BLOOD GAS ANALYER |
SIEMENS HEALTHCARE DIAGNOSTICS |
Steven Goldberg |
| K120681 |
05/15/2012 |
ADVIA CHEMISTRY GLUH_3 REAGENTS |
Siemens Healthcare Diagnostics Inc. |
KIRA GORDON |
| K121084 |
05/09/2012 |
LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L |
Siemens Healthcare Diagnostics Inc. |
FRANCES A DILLON |
| K121138 |
05/17/2012 |
ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTION |
SHELLY PEARCE |
| K113287 |
05/23/2012 |
SOMATOM PERSPECTIVE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIM MANGUM |
| K120579 |
05/23/2012 |
SOMATOM DEFINITION EDGE |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K121072 |
05/08/2012 |
SOMATOM DEFINITION FLASH |
SIEMENS MEDICAL SYSTEMS, INC. |
KIMBERLY MANGUM |
| K120698 |
05/18/2012 |
GENESIS II PS NON-MODULAR FEMORAL COMPONENT |
SMITH & NEPHEW, INC. |
XIANG ZHANG |
| K112127 |
05/16/2012 |
PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
SMITH & NEPHEW, INC. |
TERRY MCMAHON |
| K113402 |
05/30/2012 |
SOLOHEALTH STATION |
SOLOHEALTH, INC. |
STEPHEN KENDIG |
| K121340 |
05/30/2012 |
SOMNODENT G2 |
SOMNOMED INC. |
KATHRYN JAYNE |
| K120440 |
05/17/2012 |
PRESTO BREAST BIOPSY DEVICE |
SONTINA MEDICAL, LLC |
ROBERT PELIKS |
| K120185 |
05/11/2012 |
INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K120767 |
05/24/2012 |
ES BOND |
SPIDENT CO., LTD. |
I.S. WHANG |
| K120768 |
05/03/2012 |
ES FLOW |
SPIDENT CO., LTD. |
I.S. WHANG |
| K110632 |
05/23/2012 |
LUCENT OR LUCENT MAGNUM |
SPINAL ELEMENTS, INC. |
BENJAMIN A KIMBALL |
| K112915 |
05/25/2012 |
SPIRTIUS CUFF INFLATION SYRINGE |
SPIRITUS TECHNOLOGIES LLC |
BRANDON W CLOSE |
| K121006 |
05/03/2012 |
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER |
ST. JUDE MEDICAL |
NICOLE MARWICK |
| K120296 |
05/11/2012 |
CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K120298 |
05/08/2012 |
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K112403 |
05/08/2012 |
AMSCO CHIMERON MEDIUM STEAM STERLILZER |
STERIS Corporation |
ROBERT F SULLIVAN |
| K112593 |
05/01/2012 |
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM |
STRYKER CORPORATION |
MICHELLE JUMP |
| K120119 |
05/11/2012 |
SUNMED GUIDE WIRE |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
GREG HOLLAND |
| K113194 |
05/14/2012 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR |
SUQIAN RUIJANG MEDICAL SUPPLIES CO., LTD |
CHU XIAOAN |
| K120275 |
05/25/2012 |
SYNTHES ACIS/VERTEBRAL SPACER CR |
SYNTHES (USA) LLC |
HEATHER GUERIN |
| K120928 |
05/18/2012 |
SYNTHES MATRIX SYSTEM |
SYNTHES SPINE |
HEATHER GUERIN |
| K120571 |
05/14/2012 |
SYNTHES USS CONNECTOR |
SYNTHES SPINE |
HEMAL MEHTA |
| K120717 |
05/08/2012 |
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) |
SYNTHES USA |
ANGELA F LASSANDRO |
| K120042 |
05/22/2012 |
TD-4268 BLOOD GLUCOSE MONITORING SYSTEM TD-4268 MULTI BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
MEIRU LI |
| K110644 |
05/24/2012 |
PRAEZIS PLUS |
TATRAMED SPOL. S.R.O. |
CAROLINE TONTINI |
| K121380 |
05/25/2012 |
WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT |
Teleflex Medical, Inc. |
NATALIE SMITH |
| K103658 |
05/16/2012 |
FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER |
TELEFLEX, INC. |
PAUL AMUDALA |
| K121141 |
05/15/2012 |
TL-200 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM |
TENSYS MEDICAL SYSTEMS, INC |
Jamie Sulley |
| K121209 |
05/08/2012 |
TERUMO PALL AL20X ARTERIAL FILTER |
Terumo Cardiovascular Systems Corporation |
SUZANNE GRENIER |
| K120829 |
05/30/2012 |
STAINLESS STEEL SPINAL SYSTEM |
THEKEN SPINE, LLC |
DALE DAVISON |
| K120692 |
05/14/2012 |
LATEX EXAMINATION GLOVES (POWDER FREE) |
TOP CALIBRE SDN BHD |
TRACY NGUI |
| K120693 |
05/08/2012 |
LATEX EXAMINATION GLOVES (POWDERED) |
TOP CALIBRE SDN BHD |
TRACY NGUI |
| K120487 |
05/23/2012 |
VANTAGE TITAN 3T |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K112794 |
05/10/2012 |
EOS SMALL BONE FIXATION SYSTEM |
TRIMED, INC. |
DOUG STEINBERGER |
| K120419 |
05/21/2012 |
DYNA LOCKING ANKLE NAIL |
U&I CORP. |
GYEONG-JE KWON |
| K120364 |
05/04/2012 |
UNIMED DISPOSABLE BLOOD PRESSURE CUFF |
UNIMED MEDICAL SUPPLIES INC. |
XINMEI TAN |
| K121427 |
05/29/2012 |
UNIMED TEMPERATURE PROBE |
UNIMED MEDICAL SUPPLIES INC. |
XINMEI TAN |
| K120507 |
05/04/2012 |
UNITED U2 FEMORAL COMPONENT, PS, #7 |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K112698 |
05/18/2012 |
CONCENTRIC BALLOON GOOGLE |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL L MARTIN |
| K120084 |
05/30/2012 |
ENDOSCOPIC RETRIEVAL DEVICE |
UNITED STATES ENDOSCOPY GROUP, INC. |
ERIC MAYNARD |
| K120395 |
05/30/2012 |
NERIA MULTI SUBCUTANEOUS INFUSION SET |
UNOMEDICAL DEVICES S.A DE C.V |
JOHN M LINDSKOG |
| K120964 |
05/25/2012 |
UPSTREAM GR CATHETER |
UPSTREAM PERIPHERAL TECHNOLOGIES |
JANICE HOGAN |
| K112494 |
05/16/2012 |
VARAYA AR , VARAYA SPORT |
VARAYA PHOTOCEUTICALS, LLC |
MYK LUM |
| K113266 |
05/14/2012 |
GEL-BLOCK EMBOLIZATION PLEDGETS |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K120707 |
05/15/2012 |
SWITCH-IT CATHETER |
VASCULAR SOLUTIONS, INC. |
ELLIE GILLESPIE |
| K121236 |
05/24/2012 |
PAX-DUO3D PLUS, PCT-5000 |
VATECH CO., LTD. |
DAVE KIM |
| K120118 |
05/24/2012 |
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER |
VENTLAB CORP. |
JAMES A COCHIE |
| K120020 |
05/04/2012 |
VIVIX-S |
VIEWORKS CO., LTD. |
Priscilla Chung |
| K111862 |
05/22/2012 |
VIEWRAY SYSTEM |
VIEWRAY INCORPORATED |
JANICE BROWNLEE |
| K120170 |
05/30/2012 |
PROCARE PLUS VITRECTOMY SYSTEM |
VISIONCARE DEVICES, INC. |
KURTIS MONTEGNA |
| K120104 |
05/21/2012 |
VISIONSEARCH 1 |
VISIONSEARCH PTY LTD |
ARTHUR BRANDWOOD |
| K121057 |
05/04/2012 |
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS |
WILLIAM COOK EUROPE APS |
Jennifer Brown |
| K120168 |
05/02/2012 |
LULLABY LED PHOTTHERAPY SYSTEM |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
AGATA ANTHONY |
| K120166 |
05/14/2012 |
COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM |
WON INDUSTRIAL CO. |
DANIEL NAM |
| K120359 |
05/03/2012 |
ORTHOLOC 3DI HALLUX SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K112288 |
05/02/2012 |
JIAJIAN TENS |
WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. |
DORIS DONG |
| K121182 |
05/03/2012 |
VIALOK NON-VENTED |
YUKON MEDICAL, LLC |
CARL DUPPER |
| K120023 |
05/02/2012 |
ZELTIQ COOLSCULPTING |
ZELTIQ AESTHETICS, INC. |
LOUIS-PIERRE MARCOUX |
| K113561 |
05/29/2012 |
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
| K112660 |
05/10/2012 |
POCKETCPR |
ZOLL MEDICAL CORP. |
ROBERT MORSE |
