| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K112742 |
06/15/2012 |
AUDIT MICROLQ SPINAL FLUID CONTROL |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
| K113704 |
06/28/2012 |
ARCHITECT HAVAB-G |
ABBOTT LABORATORIES |
JUDITH WALLACH |
| K121222 |
06/22/2012 |
TREK OTW CORONARY DILATATION CATHETER MINI TREK OTW CORONARY DILATATION CATHETER |
Abbott Vascular |
SUZANNE REDMAN |
| K121571 |
06/13/2012 |
TUBECLEAR |
ACTUATED MEDICAL, INC |
DEBORA DEMERS |
| K120447 |
06/20/2012 |
X4 |
ADVANCED BRAIN MONITORING, INC. |
ADRIENNE LENZ |
| K121288 |
06/29/2012 |
FUSE CAGE |
ADVANCED MEDICAL TECHNOLOGIES AG |
J.D. WEBB |
| K121332 |
06/29/2012 |
LOOP CAGE |
ADVANCED MEDICAL TECHNOLOGIES AG |
J.D. WEBB |
| K121333 |
06/29/2012 |
WAVE D CAGE |
ADVANCED MEDICAL TECHNOLOGIES AG |
J.D. WEBB |
| K121330 |
06/29/2012 |
WAVE O CAGE |
ADVANCED MEDICAL TECHNOLOGIES AG |
J.D. WEBB |
| K113658 |
06/12/2012 |
AMPLATZER VASCULAR PLUG 4 |
AGA MEDICAL CORP. |
SHERRY KOLLMANN |
| K120912 |
06/15/2012 |
INFINITI(R) VISION SYSTEM |
ALCON MANUFACTURING, LTD. |
MARTIN A KAUFMAN |
| K121031 |
06/21/2012 |
WAVELIGHT FS200 PATIENT INTERFACE 1505 |
ALCON RESEARCH, LTD. |
MICHAEL BUENGER |
| K113438 |
06/01/2012 |
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
HYMAN KATZ |
| K120098 |
06/12/2012 |
STERILE DISPOSABLES FOR MER |
ALPHA OMEGA ENGINEERING, LTD. |
ILAN SHARON |
| K120527 |
06/18/2012 |
ALPHA ORTHOPAEDICS AT2 SYSTEM |
ALPHA ORTHOPAEDICS, INC |
GINA TO |
| K120371 |
06/27/2012 |
DR GREENBURGS HYBRID ACRYLIC |
ALWAYS MORE MARKETING INC |
JONATHAN GREENBURG |
| K120372 |
06/27/2012 |
DR GREENBURGS HYBRID VACUUM |
ALWAYS MORE MARKETING INC |
JONATHAN GREENBURG |
| K120870 |
06/15/2012 |
GREENLIGHT MOXY FIBER OPTIC |
AMERICAN MEDICAL SYSTEMS |
DOREEN NAKAMURA |
| K121470 |
06/14/2012 |
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR |
ANDON HEALTH CO., LTD |
LIU YI |
| K120672 |
06/01/2012 |
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
THOMAS BECZE |
| K120164 |
06/08/2012 |
PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE |
ANGIOSLIDE, LTD |
CLAY ANSELMO |
| K113785 |
06/06/2012 |
ADHERENT VISUAL STIMULATOR GOGGLES |
ANSCHEL TECHNOLOGY, INC. |
GLEN PARK |
| K113277 |
06/21/2012 |
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS |
ARROW INTERNATIONAL, INC. |
TRACY MADDOCK |
| K121521 |
06/21/2012 |
AXERA ACCESS SYSTEM |
ARSTASIS, INC. |
DEBRA COGAN |
| K120025 |
06/26/2012 |
SURGIMESH XB - SKIRTED |
ASPIDE MEDICAL |
JOHN J SMITH |
| K121507 |
06/06/2012 |
ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) |
ATRICURE, INC. |
JAMES LUCKY |
| K112090 |
06/07/2012 |
BAHADIR STERILIZATION TRAYS |
BAHADIR USA CORP. |
ISMAIL KILIC |
| K113703 |
06/05/2012 |
BAUSCH + LOMB NESOFILCON A CONTACT LENS |
BAUSCH & LOMB INCORPORATED |
Barbara Klube-Falso |
| K121092 |
06/29/2012 |
FLOWEASE [SUBCUTANEOUS] INFUSION SET |
BAXTER HEALTHCARE CORP. |
NIEDRE M HECKMAN |
| K121634 |
06/29/2012 |
INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR |
BAXTER HEALTHCARE CORPORATION |
NANETTE HEDDEN |
| K121087 |
06/28/2012 |
CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM |
BAYER HEALTHCARE |
ROGER SONNENBURG |
| K121165 |
06/21/2012 |
BEAM BRUSH/BEAM APP |
BEAM TECHNOLOGIES, LLC |
ALEX CURRY |
| K120375 |
06/28/2012 |
MED-RX PATIENT DELIVERY SET |
BENLAN INC |
CHERYL BROWN |
| K120959 |
06/22/2012 |
BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT |
Bio-Rad Laboratories |
Juang Wang |
| K112817 |
06/19/2012 |
MICROEEG SYSTEM |
BIO-SIGNAL GROUP CORPORATION |
ANDERSON MICU |
| K120552 |
06/06/2012 |
AIR LIFT/XEROSTOM ARTIFICIAL SALIVA |
BIOCOSMETICS LABORATORIES |
Ray Kelly |
| K113200 |
06/29/2012 |
VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM |
BIOMERIEUX, INC. |
SANDRA PERREAND |
| K113512 |
06/29/2012 |
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM |
BIOMET MICROFIXATION |
SHERYL MALMBERG |
| K121130 |
06/15/2012 |
POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS |
BIOMET SPINE |
VIVIAN KELLY |
| K112191 |
06/05/2012 |
HEALEX BIOSPONGE WOUND DRESSING |
BIONOVA MEDICAL, INC |
DEBORAH LAVOIE GRAYESKI |
| K120520 |
06/29/2012 |
EXACTRAC ROBOTICS NOVALIS ROBOTICS |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K120002 |
06/26/2012 |
I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K113310 |
06/20/2012 |
ENDOGATER AVANTAGE CO2 INSUFFLATOR |
BYRNE MEDICAL, INC. |
Brent Geiger |
| K121073 |
06/01/2012 |
POWERGLIDE MIDLINE CATHETER |
C.R. BARD, INC. |
JESSICA AGNELLO |
| K121444 |
06/07/2012 |
FLAT PANEL DETECTOR |
CANON, INC. - MEDICAL EQUPMENT GROUP |
DIANE RUTHERFORD |
| K113835 |
06/27/2012 |
DATACAPTOR SYSTEM |
CAPSULE TECH INC. |
PETER KELLEY |
| K112975 |
06/22/2012 |
CARBONAID C02 DIFFUSER |
CARDIA INNOVATION AB |
JEFFREY R SHIDEMAN |
| K120658 |
06/13/2012 |
DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH 200, LLC |
LAVENIA FORD |
| K120542 |
06/01/2012 |
CARDINAL HEALTH DURABLUE STERILIZATION WRAP |
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES |
LAVENIA FORD |
| K112184 |
06/18/2012 |
CIRRUS PHOTO |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
| K113628 |
06/12/2012 |
AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES |
CATHETER ROBOTICS INC |
JENNIFER ENGLUND |
| K121413 |
06/04/2012 |
CROSSFIX II MEMISCAL REPAIR DEVICE |
CAYENNE MEDICAL, INC. |
KERESHMEH SHAHRIARI |
| K120220 |
06/06/2012 |
ADAPTAIN SOLUBLE IMPLANT MATERIAL |
CEREMED, INC. |
CHELSEA MITCHELL |
| K120801 |
06/14/2012 |
CHISON DIAGNOSTIC ULTRASOUND SYSTEM |
CHISON MEDICAL IMAGING CO., LTD. |
BOB LEIKER |
| K120286 |
06/19/2012 |
TROJAN HER PLEASURE (RIBBED) ECSTASY LATEX CONDOM WITH LUBRICANT |
CHURCH & DWIGHT CO., INC. |
JOSEPH CICCONE |
| K113388 |
06/05/2012 |
CITIEFFE-TITANIUM CANNULATED SCREW |
CITIEFFE |
Claude Berthoin |
| K121208 |
06/14/2012 |
OBIX PERINATAL DATA SYSTEM 7.0 |
CLINICAL COMPUTER SYSTEMS, INC. |
CYNTHIA BELL |
| K112860 |
06/08/2012 |
PERISTEEN ANAL IRRIGATION SYSTEM, PERISTEEN ANAL IRRIGATION ACCESSORY UNIT, PERISTEEN ANAL IRRIGATION RECTAL CATHETER |
COLOPLAST A/S |
BRIAN SCHMIDT |
| K121534 |
06/20/2012 |
CONE-TROL HEMOGLOBIN A1C CONTROL SET |
CONE BIOPRODUCTS |
GAIL SCHIEVELBEIN |
| K120322 |
06/12/2012 |
CONMED SUREFIT DUAL DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K120476 |
06/12/2012 |
MACROLYTE DISPERSIVE ELECTRODE |
CONMED CORPORATION |
SHAWN RIEDEL |
| K121442 |
06/14/2012 |
POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER |
CORDIS CORPORATION |
DONNA MARSHALL |
| K120303 |
06/05/2012 |
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM |
CYBERSONICS, INC. |
LORI COLVIN |
| K112580 |
06/01/2012 |
COLLAGEN WOUND DRESSING |
DALIM TISSEN CO., LTD. |
APRIL LEE |
| K120695 |
06/12/2012 |
DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT |
DENTIST IN A BOX PTY. LTD |
JOHN BANKY |
| K120174 |
06/11/2012 |
DEPUT DELTA XTEND REVERSE SHOULDER |
DEPUY FRANCE |
MEGAN BURNS |
| K111136 |
06/14/2012 |
EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K113152 |
06/14/2012 |
ULTRASONIC SURGERY MACHINE |
DMETEC CO., LTD. |
DANIEL NAM |
| K120048 |
06/20/2012 |
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S |
DRFP LTD. |
DAGMAR MAESER |
| K120465 |
06/08/2012 |
EARLYSENSE (EVERON) SYSTEM |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K113459 |
06/29/2012 |
ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING |
EDWARDS LIFESCIENCES, LLC. |
DANNETTE CROOMS |
| K120780 |
06/27/2012 |
EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE |
EDWARDS LIFESCIENCES, LLC. |
DANNETTE CROOMS |
| K113411 |
06/11/2012 |
EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA |
EDWARDS LIFESCIENCES, LLC. |
DANNETTE CROOMS |
| K120624 |
06/08/2012 |
ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) |
ELCAM MEDICAL A.C.A.L |
AHARON COHEN |
| K121328 |
06/12/2012 |
AGILITY |
ELEKTA LTD. |
Patrick Hull |
| K112937 |
06/01/2012 |
MRSA/SA ELITE MGB |
ELITECH |
DEBRA K HUTSON |
| K121024 |
06/19/2012 |
LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K113767 |
06/29/2012 |
MOUNTED MEDICAL OXYGEN SYSTEM |
ESSEX INDUSTRIES, INC. |
KEN SEISE |
| K113205 |
06/11/2012 |
ARTISYN Y-SHAPED MESH |
ETHICON, INC. |
SARAH MCMANUS |
| K121028 |
06/21/2012 |
ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)) |
ETVIEW LTD. |
YORAM LEVY |
| K120334 |
06/08/2012 |
VIVA EB |
ETVIEW LTD. |
YORAM LEVY |
| K121468 |
06/22/2012 |
EUROTROL GAS-ISE METABOLITES |
EUROTROL B.V. |
PAUL B.P. KOOIJMANS |
| K120045 |
06/12/2012 |
EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV |
EXACT MEDICAL MANUFACTURING, INC |
ROBERT O DEAN |
| K120260 |
06/29/2012 |
ICTA |
EXCEL-TECH LTD. (XLTEK) |
DANIEL RAMIREZ |
| K113383 |
06/26/2012 |
XTRAFIX EXTERNAL FIXATION SYSTEM |
EXTRAORTHO, INC. |
MARCOS VELEZ-DURAN |
| K112766 |
06/04/2012 |
SNORKEL |
FELLMAR COMPANY |
WAYNE MARSHALL |
| K120810 |
06/28/2012 |
FIBEROPTIC LASER DELIVERY SYSTEM |
FIBEROPTIC FABRICATIONS INC |
CAROL J MORELLO |
| K121118 |
06/15/2012 |
FORA COMFORTSCAN EAR THERMOMETER |
FORA CARE INC. |
PINJUNG CHEN |
| K120823 |
06/15/2012 |
BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS |
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE |
DENISE OPPERMANN |
| K121035 |
06/04/2012 |
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
GINA WALLJASPER |
| K120648 |
06/14/2012 |
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
JYH-SHYAN LIN |
| K120679 |
06/01/2012 |
SYNAPSE 3D NODULE ANALYSIS |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
JYH-SHYAN LIN |
| K121274 |
06/27/2012 |
PIXEL APP |
GAUSS SURGICAL, INC. |
PEGGY MCLAUGHLIN |
| K120243 |
06/27/2012 |
GAM-200 |
GC AMERICA INC. |
MARK HEISS |
| K113456 |
06/15/2012 |
READY VIEW |
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS) |
ELIZABETH MATHEW |
| K121387 |
06/05/2012 |
CENTRICITY PACS-IW |
GE HEALTHCARE INTEGRATED IT SOLUTIONS |
JOHN MANARIK |
| K120910 |
06/18/2012 |
CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL |
GE MEDICAL SYSTEMS SCS |
STEPHEN SLAVENS |
| K120833 |
06/12/2012 |
DISCOVERY CT750 HD |
GE MEDICAL SYSTEMS, LLC |
JOHN JAECKLE |
| K113395 |
06/14/2012 |
REVERE 4.5 STABILIZATION SYSTEM |
GLOBUS MEDICAL INC. |
SARAH M FITZGERALD |
| K121049 |
06/27/2012 |
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL INC. |
MERIAM YOUSSEF |
| K113846 |
06/01/2012 |
BORRELIA BURGDORFERI IGM BLOT TEST |
GOLD STANDARD DIAGNOSTICS |
NAPOLEON MONCE |
| K120193 |
06/29/2012 |
ANY VIEW PATIENT MONITORS |
GUANGDONG BIOLIGHT MEDITECH CO., LTD |
Diana Hong |
| K120567 |
06/20/2012 |
GYRUS AMCI PK BUTTON ELECTRODE |
GYRUS ACMI, INC. |
NEIL KELLY |
| K121345 |
06/01/2012 |
SR SUITE 1.0 |
HALIFAX BIOMEDICAL, INC. |
DANIEL KAMM |
| K120336 |
06/25/2012 |
NITRILE POWDER FREE EXAMINATION GLOVES (VIO) TESTED FOR USE WITH CHENITRILE POWDER FREE EXAMINATION (ABLU) TESTED FOR U |
HARTALEGA SDN BHD |
NURUL AISYAH KONG |
| K111369 |
06/26/2012 |
THE HELENA V8 IMMUNODISPLACEMENT KIT |
HELENA LABORATORIES UK LTD |
PATRICIA FRANKS |
| K121532 |
06/22/2012 |
HERO GRAFT |
HEMOSPHERE INC |
LAURIE LYNCH |
| K120472 |
06/22/2012 |
QUANTRA |
HOLOGIC, INC. |
CATHERINE A WILLIAMS |
| K121032 |
06/21/2012 |
PRIMARY SYMBIQ SET, DITAL MICROBORE TUBING, 0.2 MICRON FILTER, NON-DEHP |
HOSPIRA, INC. |
Yuliya Matlin |
| K120759 |
06/05/2012 |
CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION |
i-SENS, Inc. |
HYUN JOON OH |
| K113449 |
06/14/2012 |
FUSION FLAT PANEL |
ICRCO INC. |
GREG WACHTLER |
| K120783 |
06/20/2012 |
ABLE-X |
IM-ABLE LTD |
SIGI CARON |
| K121554 |
06/08/2012 |
Q-FLO CLOSED MALE LUER CONNECTOR |
INFUSION INNOVATIONS, INC. |
BABAK NEMATI |
| K120339 |
06/21/2012 |
PROCOLL |
INNOCOLL PHARMACEUTICALS |
AARON WYSE |
| K120600 |
06/15/2012 |
DURAGEN SECURE DURAL REGNERATION MATRIX |
INTEGRA LIFESCIENCES |
AAKASH JAIN |
| K120702 |
06/20/2012 |
E.G. SCAN II ESPHAGOSCOPE SYSTEM |
INTROMEDIC CO., LTD |
JIN YOUNG LEE |
| K121424 |
06/13/2012 |
EXPRESSION INFORMATION PORTAL |
INVIVO CORPORATION |
RUSTY KELLY |
| K121128 |
06/06/2012 |
MULTIPURPOSE HANDLING MEDIUM |
IRVINE SCIENTIFIC SALES CO., INC. |
JAYME YAMAGUCHI-OWENS |
| K120134 |
06/25/2012 |
IPS E.MAX PRESS MULTI |
IVOCLAR VIVADENT AG |
DONNA M HARTNETT |
| K120432 |
06/08/2012 |
TELIO CS CEM IMPLANT |
IVOCLAR VIVADENT AG |
DONNA MARIE HARTNETT |
| K121016 |
06/27/2012 |
RANGE SPINAL SYSTEM (MESA AND DENALI) |
K2M, INC. |
NANCY GIEZEN |
| K103467 |
06/28/2012 |
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SHIVEN GANDHI |
| K120769 |
06/12/2012 |
MODULTH SLK |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
LEIGH SPOTTEN |
| K120852 |
06/06/2012 |
ZIRCONIA BLANKS (ZIRCOSTAR) |
KEROX LTD |
SANGRAM YADAV |
| K120841 |
06/07/2012 |
APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR |
KFX MEDICAL |
GAYLE HIROTA |
| K112805 |
06/22/2012 |
KIMGUARD ONE-STEP STERILIZATION WRAP |
KIMBERLY-CLARK CORP. |
Brenda Shelkey |
| K120752 |
06/08/2012 |
AERODR STITCHING SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSEL MUNVES |
| K120760 |
06/27/2012 |
LDR SPINE SPINETUNE TL SPINAL SYSTEM |
LDR SPINE USA INC. |
KIERSTEN SODERMAN |
| K120775 |
06/04/2012 |
LIGHT FOR WRINKLES |
LED INTELLECTUAL PROPERTIES, LLC |
STEVE MARCHESE |
| K120214 |
06/08/2012 |
TBD |
LENSAR, INC. |
SHIRLEY MCGARVEY |
| K113566 |
06/21/2012 |
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM |
LIFE TECHNOLOGIES, INC. |
KELLI L TANZELLA |
| K112900 |
06/01/2012 |
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS |
LIMACORPORATE S.P.A. |
CHERYL HASTINGS |
| K120763 |
06/01/2012 |
LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K121487 |
06/12/2012 |
LITECURE THERAPY COMPACT |
LITECURE, LLC |
LIANG LU |
| K120820 |
06/08/2012 |
GIRAFFE BLUE SPOT PT LITE |
LUMITEX, INC. |
DAVID FELTY |
| K113668 |
06/19/2012 |
HEALITE II SYSTEM |
LUTRONIC CORPORATION |
JHUNG WON VOJIR |
| K121064 |
06/06/2012 |
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM |
MAKO SURGICAL CORPORATION |
DIONNE SANDERS |
| K111863 |
06/15/2012 |
SIGNATURE PLANNER,SIGNATURE GUIDES |
MATERIALISE N.V. |
ALAXANDRA RAZZHIVINA |
| K111785 |
06/29/2012 |
FREEDOM(R) STEMMED TIBIAL COMPONENTS |
MAXX ORTHOPEDICS, INC. |
NACHE DAVE |
| K113080 |
06/29/2012 |
TUBALGATOR |
MECTRA LABS, INC. |
CHARLES E ALLGOOD |
| K121011 |
06/08/2012 |
AMISTEM AND QUADRA - LINE EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K120790 |
06/08/2012 |
GMK - LINE EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K120573 |
06/13/2012 |
MEDART 620 |
MEDART A/S |
DARREN THOMAS |
| K121094 |
06/06/2012 |
MEDCOMP VASCU-PICC & MIDLINE CATHETERS |
MEDICAL COMPONENTS INC |
JEAN CALLOW |
| K121530 |
06/20/2012 |
BODYFIX SYSTEM |
MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH |
MICHAEL WOLFF |
| K113363 |
06/06/2012 |
ANGIOJET SOLENT DISTA THROMBECTOMY SET |
MEDRAD, INC. |
MIKE BURNSIDE |
| K121545 |
06/08/2012 |
BELLYBOARD, SBRT ACCESSORIES |
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS |
AMANDA STAHLE |
| K120963 |
06/29/2012 |
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES |
MEDTEXX MANUFACTURING SDN. BHD. |
OOI LOON SENG |
| K121290 |
06/25/2012 |
AQUAMANTRYS3 BSC 9.1S |
MEDTRONIC INC. |
TARA N TURNEY |
| K121451 |
06/14/2012 |
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE |
MEDTRONIC INC. |
MARY DONLIN |
| K120987 |
06/06/2012 |
DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF |
MEDTRONIC INC. |
EMILY BLUS |
| K120808 |
06/07/2012 |
EXPORT XT CATHETER, EXPORT AP CATHETER |
MEDTRONIC INC. |
ANU GAUR |
| K121191 |
06/29/2012 |
VERTEX RCCONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
CLAIRE EVANS |
| K112686 |
06/27/2012 |
NEXT GEN EMG ENDOTRACHEAL TUBE |
MEDTRONIC XOMED, INC. |
MAREK PAWLOWSKI |
| K121246 |
06/15/2012 |
MEDYSSY LT CAGE SYSTEM |
MEDYSSEY CO., LTD. |
MICHAEL KVITNISKY |
| K121051 |
06/13/2012 |
CONCIERGE GUIDING CATHETER |
MERIT MEDICAL SYSTEMS, INC. |
MICHAELA RIVKOWICH |
| K113017 |
06/26/2012 |
SYS*STIM 240 |
METTLER ELECTRONICS CORP. |
CHRISTINA CAYUELA |
| K120676 |
06/04/2012 |
S-250 PROTON BEAM RADIATION THERAPY SYSTEM |
MEVION MEDICAL SYSTEMS |
THOMAS H FARIS |
| K112627 |
06/06/2012 |
MILLENIUM ANTI-SNORING DEVICE |
MILLENIUM DENTAL LABORATORY, INC |
NGHIEP V NGUYEN |
| K113597 |
06/03/2012 |
MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES |
MINILAP TECHNOLOGIES |
ALLAN ALWARD |
| K120524 |
06/21/2012 |
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM |
MUI SCIENTIFIC |
TAMMY MUI |
| K120415 |
06/22/2012 |
CRYO-TOUCH III |
MYOSCIENCE INC |
TRACEY HENRY |
| K112024 |
06/20/2012 |
TI-MAX X450 |
NAKANISHI, INC. |
DIANE RUTHERFORD |
| K111949 |
06/29/2012 |
AC WOUND TREATMENT SYSTEM |
NANO VIBRONIX, INC. |
E J SMITH |
| DEN120014 |
06/26/2012 |
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) |
NANOSPHERE, INC |
MARK DEL VECCHIO |
| K120877 |
06/20/2012 |
MICROMANIPULATOR SET |
NARISHIGE CO., LTD. |
MITSUKO YONEYAMA |
| K120503 |
06/18/2012 |
CMI IMPLANT IS II ACTIVE |
NEOBIOTECH CO., LTD. |
APRIL LEE |
| K121362 |
06/15/2012 |
1.5T 16CH FLEX SPEEDER LARGE |
NEOCOIL, LLC |
STEVEN NICHOLS |
| K113033 |
06/19/2012 |
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML |
NEPHRON PHARMACEUTICALS CORP. |
MARCUS JULIANO |
| K120345 |
06/13/2012 |
HONOUR SPACER SYSTEM |
NEXXT SPINE LLC |
KAREN E WARDEN |
| K120691 |
06/05/2012 |
BRAIN PORT |
NICO CORPORATION |
JAY DITTMAN |
| K120581 |
06/29/2012 |
SC TIP CLEANER |
NSI |
GORDON WEHNER |
| DEN080015 |
06/11/2012 |
NUCLEUS-X PTV CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
| K120918 |
06/28/2012 |
NUVASIVE COROENT TITANIUM SYSTEM |
NUVASIVE, INC. |
Sheila Bruschi |
| K121701 |
06/29/2012 |
SYSTEMS INTEGRATION |
OLYMPUS MEDICAL SYSTEMS CORP. |
KATHY ANDERSON |
| K120418 |
06/20/2012 |
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES |
OLYMPUS WINTER & IBE GMBH |
SHERI MUSGNUNG |
| K113326 |
06/27/2012 |
ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARD |
ORALABS, INC. |
TERESA PURDUE |
| K121437 |
06/13/2012 |
MINI MAXLOCK EXTREME PLATING SYSTEM |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K121250 |
06/19/2012 |
OP SPINE SYSTEM |
ORTHOPEDIATRICS, CORP. |
MARK FOX |
| K120459 |
06/29/2012 |
STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO |
Oscor Inc. |
MILA DOSKOCIL |
| K113582 |
06/29/2012 |
ARCHSTENT BILIARY SYSTEM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
| K121175 |
06/29/2012 |
FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
| K113775 |
06/29/2012 |
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM |
OSTIAL CORPORATION |
KAITLIN VON HOFFMANN |
| K120054 |
06/05/2012 |
ULTIMA NEO |
PAIN MANAGEMENT TECHNOLOGIES |
JOSHUA LEFKOVITZ |
| K120218 |
06/29/2012 |
TEK USA E-GENERATOR INTEGRATED LED HANDPIECE (HIGH & LOW SPEED AIR TURBNINE DENTAL HANDPIECE) |
PALM BEACH DENTAL SUPPLY D/B/A TEK USA |
MICHAEL CALHOUN |
| K120996 |
06/28/2012 |
FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN |
PARAGON VISION SCIENCES |
WILLIAM E MEYERS |
| K121249 |
06/12/2012 |
MULTIARRAY KIT |
PARAMED SRL |
LUISELLA DE BENEDETTI |
| K113873 |
06/22/2012 |
PENTAX EPK-I5020 VIDEO PROCESSOR |
PENTAX OF AMERICA, INC. |
ROBERT SCHIFF |
| K121318 |
06/06/2012 |
PROSOFT |
PERMA LABORATORIES |
|
| K112414 |
06/22/2012 |
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY |
PHADIA US INC. |
MARTIN ROBERT MANN |
| K120855 |
06/29/2012 |
INTELLISPACE ECG |
PHILIPS HEALTHCARE |
GRETEL LUMLEY |
| K120245 |
06/21/2012 |
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS |
PLAYTEX, INC. |
PUSHPA RAO |
| K121522 |
06/27/2012 |
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) |
POLYREMEDY, INC. |
GARY MOCNIK |
| K112763 |
06/18/2012 |
MATRIXBRUSH ENDOMETRIAL SAMPLER |
POST OAK INNOVATIONS, INC. |
HEATHER CRAWFORD |
| K121378 |
06/21/2012 |
AIRTRAQ SP AIRTRAQ AVANT |
PRODOL MEDITEC LTD. |
PAUL DRYDEN |
| K112318 |
06/29/2012 |
CLEARPATH 24 |
PROMEDIC, INC. |
PAUL DRYDEN |
| K120784 |
06/08/2012 |
TUFF-TEMP 2.0 |
PULPDENT CORPORATION |
KENNETH J BERK |
| K120846 |
06/08/2012 |
TRANSPORT CULTURE MEDIUM DEVICE |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K112809 |
06/20/2012 |
BLUE MOUNTAIN CERVICAL PLATE |
QUALGENIX LLC |
RICHARD DESLAURIERS |
| K112824 |
06/21/2012 |
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER |
QUALITY LIFE TECHNOLOGIES CO;LTD |
LEON LU |
| K121385 |
06/14/2012 |
VECTOR |
R4 VASCULAR, INC. |
MICHAEL HOCH |
| K121588 |
06/20/2012 |
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K112897 |
06/13/2012 |
RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS |
RENOVIS SURGICAL TECHNOLOGIES, LLC |
DAVID A TEICHER |
| K121145 |
06/12/2012 |
RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME |
RENU MEDICAL, INC. |
BRUCE PIERSON |
| K120346 |
06/01/2012 |
CLEANER ROTATIONAL THROMBECTOMY SYSTEM |
REX MEDICAL |
SUSAN D GOLDSTEIN-FALK |
| K120342 |
06/22/2012 |
EMG RECORDING ELECTRODE ASSEMBLY |
RHYTHMLINK INTERNATIONAL, LLC |
JAMES MEWBORNE |
| K113793 |
06/05/2012 |
HOMOCYSTEINE TEST |
ROCHE |
Susan Hollandbeck |
| K112508 |
06/19/2012 |
I-ROOT 100 |
S-DENTI CO., LTD. |
TAE K NAM |
| K113613 |
06/15/2012 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
FLOWER CAI |
| K112827 |
06/22/2012 |
SHEATHES ULTRASOND GEL |
SHEATHING TECHNOLOGIES, INC. |
JENNIFER DOWNING |
| K121527 |
06/28/2012 |
WI-FI BODY SCALE |
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD |
YANG WANG |
| K120159 |
06/18/2012 |
BEAUTICEM SA |
SHOFU DENTAL CORPORATION |
DAVID P MORAIS |
| K121699 |
06/22/2012 |
ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K121295 |
06/27/2012 |
ARTISTETM SOLUTION WITH SYS VCIO |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K121074 |
06/08/2012 |
SCENIUM 2.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELAINE CHANG |
| K121459 |
06/22/2012 |
SYNGO.MR NEUROLOGY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
MICHELLE L BYRNE |
| K121646 |
06/22/2012 |
ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO |
SHELLY PEARCE |
| K113008 |
06/14/2012 |
KODAMA INTRAVASCULAR ULRASOUND CATHETER |
SILICON VALLY MEDICAL INSTRUMENTS, INC. |
RICHARD E ANDERSON |
| K120551 |
06/08/2012 |
SIMUPLAN TREATMENT PLANNING SYSTEM |
SIMUPLAN S.L. |
LU ANNE JOHNSON |
| K113022 |
06/11/2012 |
PURESLEEP |
SLEEP SCIENCE PARTNERS, INC. |
HEATHER FLICK |
| K121018 |
06/22/2012 |
BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN |
SMITH & NEPHEW, INC. |
JOHN CONNOR |
| K120871 |
06/07/2012 |
SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K120506 |
06/13/2012 |
PARIETEX COMPOSITE VENTRAL PATCH |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K120897 |
06/29/2012 |
PROGRIP LAPARSCOPIC SELF-FIXATING MESH |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K121515 |
06/05/2012 |
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM |
SOLTA MEDICAL, INC. |
KRISTINE FOSS |
| K120611 |
06/28/2012 |
SONY PVM-2551MD OLED MONITOR |
SONY ELECTRONICS, INC. |
CYNTHIA SINCLAIR |
| K121480 |
06/06/2012 |
ARIATELE TELEMETRY TRANSMITTER (96281) |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K112729 |
06/11/2012 |
BLEASE700/900 SERIES VENTILATORS |
SPACELABS HEALTHCARE |
THOMAS KROENKE |
| K120494 |
06/11/2012 |
DISPOSABLE ADHESIVE SURFACE ELECTRODE |
SPES MEDICA S.R.L. |
ALFREDO SPADAVECHIA |
| K120680 |
06/26/2012 |
ENSPIRE DISCECTOMY SYSTEM |
SPINE VIEW, INC. |
Diana DeGregorio |
| K120646 |
06/07/2012 |
CAPSURE(R) PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K121129 |
06/13/2012 |
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE |
SPINEOLOGY, INC. |
BRYAN BECKER |
| K112607 |
06/07/2012 |
SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... |
SPINEVISION, S.A. |
DONALD W GUTHNER |
| K121381 |
06/07/2012 |
VIEWFLEX XTRA ICE CATHETER |
ST. JUDE MEDICAL |
LOUCINDA BJORKLUND |
| K121240 |
06/11/2012 |
REPROCESSED ENDOSCOPIC TROCARS |
STERILMED, INC. |
JASON SKRAMSTED, RAC |
| K120632 |
06/26/2012 |
AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM |
STERIS Corporation |
BILL BRODBECK |
| K120435 |
06/04/2012 |
BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR |
STERIS Corporation |
BILL BRODBECK |
| K111798 |
06/01/2012 |
STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... |
STERNGOLD DENTAL LLC. |
MARIA RAO |
| K121131 |
06/06/2012 |
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM |
STRAUMANN USA |
ELAINE ALAN |
| K120352 |
06/11/2012 |
STRYKER QUIKFLAP STERILE PROCEDURE PACK |
Stryker |
JAMSHED BADARPURA |
| K121342 |
06/22/2012 |
XIA 4.5 SPINAL SYSTEM |
STRYKER CORP |
TIFFANI ROGERS |
| K121677 |
06/14/2012 |
SUREFIRE HI-FLOW MICROCATHETER |
SUREFIRE MEDICAL, INC. |
MARIO ARBESU |
| K121675 |
06/21/2012 |
VERSAVIT |
SYNERGETICS, INC |
DAN REGAN |
| K113868 |
06/11/2012 |
EPLUS SKIN TREATMENT SYSTEM |
SYNERON, LTD. |
YORAM LEVY |
| K120689 |
06/04/2012 |
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM |
SYNTHES (USA) PRODUCTS LLC |
THOMAS N SHEA |
| K121574 |
06/29/2012 |
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM |
SYNTHES INC |
ALAN T HALEY |
| K111048 |
06/14/2012 |
SYNTHES SCOUT TACK FIXATION |
SYNTHES SPINE |
HEATHER GUERIN |
| K120854 |
06/18/2012 |
SYNTHES VA LCP ANKLE TRAUMA SYSTEM |
SYNTHES USA |
ANGELA F LASSANDRO |
| K112030 |
06/19/2012 |
SYNTHES RADIAL HEAD PROSTHESIS SYSTEM |
SYNTHES USA, LLC |
ANGELA F LASSANDRO |
| K120712 |
06/06/2012 |
FORA COMFORTSCAN EAR THERMOMETER |
TaiDoc Technology Corporation |
PINJUNG CHEN |
| K121403 |
06/20/2012 |
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET |
TELEFLEX, INC. |
PAUL AMUDALA |
| K121135 |
06/01/2012 |
THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE |
THD SPA |
GUIDO BONAPACE |
| K121211 |
06/27/2012 |
VU APOD INTERVERTEBRAL BODY FUSION DEVICE |
THEKEN SPINE, LLC |
DALE DAVISON |
| K120690 |
06/22/2012 |
INSULIN PEN NEEDLE |
TIGER MEDICAL PRODUCTS LTD |
DAVID WANG |
| K121493 |
06/20/2012 |
ASCEND SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K120638 |
06/01/2012 |
VANTAGE TITAN |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K121577 |
06/22/2012 |
APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
CHARLEMAGNE CHUA |
| K120546 |
06/13/2012 |
AQUILION PREMIUM |
TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
PAUL BIGGINS |
| K121533 |
06/15/2012 |
ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET |
Tosoh BioScience, Inc. |
ROBERT WICK |
| K121008 |
06/04/2012 |
TRILLIANT SURGICAL K-WIRES |
TRILLIANT SURGICAL LTD |
J.D. WEBB |
| K121402 |
06/08/2012 |
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K121681 |
06/26/2012 |
GLIDER PTCA BALLOON CATHETER |
TRIREME MEDICAL, INC. |
SHIVA ARDAKANI |
| K120975 |
06/22/2012 |
CS 8100 CS 8100 ACCESS |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K111718 |
06/08/2012 |
LANO-E |
UG GLOBAL RESOURCES SDN BHD |
KENNETH STANTON |
| K111604 |
06/08/2012 |
LANO-E |
UG GLOBAL RESOURCES SDN BHD |
KENNETH STANTON |
| K111818 |
06/13/2012 |
SONIXGPS NEEDLE SENSOR |
UltraSonix Medical Corporation |
CHAS YU |
| K120731 |
06/06/2012 |
TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K121412 |
06/08/2012 |
PAX-FLEX3D, PHT-7000 |
VATECH CO., LTD. |
DAVE KIM |
| K121350 |
06/01/2012 |
VIRTUSO SYSTEM FOR IHC (DO-7) |
VENTANA MEDICAL SYSTEMS, INC. |
ERIKA AMMIRATI |
| K120665 |
06/12/2012 |
INVENT SNORING DEVICE |
VENTUS MEDICAL, INC. |
CINDY DOMECUS |
| K112754 |
06/15/2012 |
IVENT101 |
VERSAMED MEDICAL SYSTEMS LTD. |
SHLOMI DELER |
| K120661 |
06/03/2012 |
THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE |
VIDACARE CORPORATION |
GRACE HOLLAND |
| K120247 |
06/21/2012 |
EASYDEX |
VINELAND SYRUP INC. |
ERIC FEERST |
| K120779 |
06/01/2012 |
STRUCTUR 3 |
VOCO GMBH |
T. GERKENSMEIER |
| K120470 |
06/08/2012 |
MIPAL |
WATERMARK MEDICAL |
MICHAEL J LEIGH |
| K120916 |
06/20/2012 |
QFIX RADIOTHERAPY CHAIR |
WFR/AQUAPLAST CORP. |
TIM WADE |
| K120471 |
06/04/2012 |
MACH BRACKETS BRIGHT BRACKETS |
WORLD BIO TECH CO., LTD |
PETER CHUNG |
| K120198 |
06/06/2012 |
LOCATOR OVERDENTURE IMPLANT SYSTEM |
ZEST ANCHORS, LLC |
ANNIE WRIGHT |
| K120772 |
06/12/2012 |
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE |
ZIMMER GMBH |
ROMIL SHETH |
| K120990 |
06/29/2012 |
NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL |
ZIMMER TRABECULAR METAL TECHNOLOGY |
JUDITH ROSEN |
| K120203 |
06/15/2012 |
TM-400 DEVICE |
ZIMMER TRABECULAR METAL TECHNOLOGY, INC. |
KATHLEEN RUTHERFORD |
| K120370 |
06/04/2012 |
VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS |
ZIMMER, INC. |
REBECCA BROOK |
| K121367 |
06/21/2012 |
ZOLL PROPAQ XM |
ZOLL MEDICAL CORPORATION |
CHARLES W KOLIFRATH |
