FDA 510(k) Decisions During June, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
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
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) ELEAM 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
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
K113450 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
K082776 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
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