FDA 510(k) Applications Received During May, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K121451 05/16/2012 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE MEDTRONIC INC. MARY DONLIN
K121593 05/31/2012 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK 3M COMPANY SUZANNE LEUNG
K121484 05/18/2012 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER 3M COMPANY SUZANNE LEUNG
K121494 05/21/2012 LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING AAP IMPLANTATE AG MARC SEEGERS
K121495 05/21/2012 LOQTEQ PROXIMAL HUMERUS PLATE 3.5, SHORT LOQTEQ PROXIMAL HUMERUS PLATE 3.5, LONG AAP IMPLANTATE AG MARC SEEGERS
K121314 05/02/2012 ARCHITECT B12 ABBOTT LABORATORIES DARLA A ABANO
K121352 05/17/2012 ARMADA 14XXT PTA CATHETER ABBOTT VASCULAR IVALEE COHEN
K121568 05/31/2012 DALI SPINAL FIXATION SYSTEM ACCEL SPINE DANIEL CHON
K121569 05/31/2012 MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM ACCEL SPINE DANIEL CHON
K121567 05/31/2012 ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM ACCEL SPINE DANIEL CHON
K120714 05/21/2012 PICASSO MIS SPINAL FIXATION SYSTEM ACCEL SPINE DANIEL CHON
K121136 05/21/2012 RENOIR POSTERIOR CERVIAL FIXATION SYSTEM ACCEL SPINE DANIEL CHON
K121078 05/23/2012 VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM ACCEL SPINE DANIEL CHON
K121571 05/29/2012 TUBECLEAR ACTUATED MEDICAL, INC DEBORA DEMERS
K121288 05/31/2012 FUSE CAGE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K121332 05/03/2012 LOOP CAGE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K121333 05/31/2012 WAVE D CAGE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K121330 05/03/2012 WAVE O CAGE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K121309 05/01/2012 ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS JONATHAN KAHAN
K121324 05/02/2012 AVT NATURASOFT ADVANCED VISION TECHNOLOGIES MARTIN DALSING
K121453 05/16/2012 A-GRIX TE RESORABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K121429 05/14/2012 AIMAGO EASYLDI MICROCIRCULATION CAMERA AIMAGO SA MARC ANDRE
K121379 05/08/2012 PNEUTON MINI VENTILATOR PNEUTON MINI NON-INVASIVE VENTILATION (NIV) KIT ACCESSORY AIRON CORPORATION G. ERIC GJERDE
K121555 05/25/2012 CENTURION VISION SYSTEM ALCON LABORATORIES, INC. CHARLES OGBONNA
K121483 05/18/2012 REUSABLE CUTANEOUS ELECTRODE AMPCARE, LLC DIANE RUTHERFORD
K121372 05/07/2012 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD LIU YI
K121470 05/17/2012 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR ANDON HEALTH CO., LTD LIU YI
K121354 05/04/2012 MICRO/MINI N-PK(F) BONE ANCHOR ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K121356 05/04/2012 MICRO/MINI N-PK(H) BONE ANCHOR ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K121456 05/16/2012 AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROL ARKRAY, INC. ADAM ETTL
K121305 05/01/2012 STERLING MEDICAL IMPULSE 3 STIMULATOR ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT. DHA STERLING ME RALPH H ARMSTRONG
K121501 05/21/2012 ARROW JUGULAR AXILLO-SUBCLAVIAN CENTRAL CATHETER (JACC) ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K121521 05/23/2012 AXERA ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K121306 05/07/2012 SMARTSTITCH M-CONNECTOR ULTRA SMARTSTITCH SUTURE DEVICE HANDLE SMARTSTITCH SUTURE DEVICE HANDLE ARTHOCARE CORPORATION CHERYL FREDERICK
K121409 05/11/2012 ASAHI REXEED-SX/LX SERIES DIALYZER ASAHI KASEI MEDICAL CO., LTD. PATSY TRISLER
K121343 05/04/2012 MODULAP LOOP ATC TECHNOLOGIES, INC. JOHN GILLESPIE
K121507 05/21/2012 ATRICURE CRYO MODULE SYSTEM (ACM, CRYO1, AND CRYOICE) ATRICURE, INC. JAMES LUCKY
K121445 05/15/2012 TETRACHROME REAGENTS AND TETRACXP SYSTEM BECKMAN COULTER, INC. NANCY NADLER
K121492 05/21/2012 UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K121512 05/21/2012 SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM BIO-LOGIC SYSTEMS CORP. DON WILLIAMS
K121578 05/30/2012 ATOM 1 (MODEL: BRC 2200) BIOELECTRIC RESEARCH CORPORATION STEVEN KAYE
K121327 05/02/2012 DIOLASE 10S BIOLASE TECHNOLOGY, INC. ROBERT YANG
K121286 05/09/2012 EPIC 10 BIOLASE TECHNOLOGY, INC. ROBERT YANG
K121461 05/17/2012 BACT/ALERT FA PLUS CULTURE BOTTLE BIOMERIEUX, INC. JOCELYN JENNINGS
K121455 05/16/2012 BACT/ALERT FN PLUS CULTURE BOTTLE BIOMERIEUX, INC. PATRICIA MURPHY
K121446 05/15/2012 BACT/ALERT PF PLUS CULTURE BOTTLE BIOMERIEUX, INC. ELIZABETH LANDON
K121546 05/25/2012 VITEK 2 GRAM NEGATIVE DOXYCYCLINE BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K121183 05/08/2012 COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS BIOMET CORPORATION PATRICIA SANDBORN BERES
K121441 05/15/2012 CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP) BOVIE MEDICAL CORPORATION RICHARD A KOZLOFF
K121519 05/22/2012 ISIGHT C & E GP SPECIALISTS, INC. MARTIN DALSING
K121444 05/15/2012 FLAT PANEL DETECTOR CANON, INC. - MEDICAL EQUPMENT GROUP DIANE RUTHERFORD
K121303 05/01/2012 MOBILE C-ARM CANON, INC.-MEDICAL EQUIPMENT GROUP DIANE RUTHERFORD
K121590 05/31/2012 VESTIBULAR ANALYSIS APPARATUS CAPACITY SPORTS, LLC PAMELA M BUCKMAN
K121413 05/11/2012 CROSSFIX II MEMISCAL REPAIR DEVICE CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K121539 05/24/2012 XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) CEPHEID KERRY J FLOM
K121474 05/18/2012 DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. CHARLES MACK
K121587 05/31/2012 BREATH SHAKE CHEEN HOUNG ENT. CO. LTD. PAUL DRYDEN
K121339 05/03/2012 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS CHEMTRON BIOTECH, INC. JANE ZHANG
K121580 05/30/2012 SURELASE CO2 LASER SYSTEM CLINICON CORP. GERALD PALECKI
K121311 05/01/2012 THIXO-GEL ULTRASOUND SPRAY CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH CHRISTINA BERNSTEIN
K121317 05/02/2012 COCHLEAR BAHA IMPLANT SYSTEM COCHLEAR AMERICAS SEAN BUNDY
K121562 05/29/2012 ALTIS SINGLE INCISION CLING SYSTEM COLOPLAST A/S JANELL A COLLEY
K121458 05/16/2012 SPEEDICATH COMPACT SET (12/18 FR) COLOPLAST A/S BRIAN SCHMIDT
K121457 05/16/2012 SPEEDICATH COMPACT SET (12 FR) COLOPLAST CORP. BRIAN SCHMIDT
K121534 05/24/2012 CONE-TROL HEMOGLOBIN A1C CONTROL SET CONE BIOPRODUCTS GAIL SCHIEVELBEIN
K121360 05/07/2012 BIODESIGN ENT REPAIR GRAFT COOK BIOTECH INCORPRATED MARY A FADERAN, PH.D., RAC
K121430 05/14/2012 EVOLUTION BILIARY STENT SYSTEM COOK IRELAND LTD JACINTA KILMARTIN
K121442 05/15/2012 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER CORDIS CORPORATION DONNA MARSHALL
K121514 05/22/2012 ANODYNE ANTERIOR CERVICAL PLATE SYSTEM CORELINK LLC JUSTIN EGGLETON
K121439 05/15/2012 METAFIX FEMORAL HIP STEM SIZE 1 CORIN U.S.A. LUCINDA GERBER
K121563 05/29/2012 CORIN TRIFIT TS HIP CORIN USA LUCINDA GERBER
K121510 05/21/2012 IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE SARAH RIZK
K121361 05/07/2012 CURALINE POLYURETHANE FOAM AWC DRESSING CURALINE INC HAITHAM MATLOUB
K121449 05/15/2012 DIRECTPATH CYBERNET SYSTEMS CO., LTD. DIANE SUDDUTH
K121346 05/04/2012 PICOSURE WORKSTATION CYNOSURE, INC. IRINA KULINETS
K121436 05/15/2012 DAS MEDICAL EQUIPMENT DRAPES DAS MEDICAL, LLC ARMOND GROVES
K121374 05/07/2012 ZI BLOWER DESHUM MEDICAL MAUREEN O'CONNELL
K121558 05/29/2012 DIAZYME HSCRP POC TEST KIT DIAZYME LABORATORIES ABHIJIT DATTA
K121396 05/09/2012 DYNAFLEX DYNA FLEX MATTHEW MALABEY
K120727 05/30/2012 MFM-CMS CENTRAL MONITORING SYSTEM EDAN INSTRUMENTS INC RANDY JIANG
K121448 05/15/2012 ONCENTRA, ONCENTRA EXTERNAL BEAM, ONCENTRA BRACHY ELEKTA INC. D/B/A NUCLETRON CORPORATION THOMAS VALENTINE
K121328 05/03/2012 AGILITY ELEKTA LTD. PATRICK HULL
K121351 05/04/2012 SINUS DILATION SYSTEM ENTRIGUE SURGICAL, INC. GABRIELE G NIEDERAUER, PH.D.
K121384 05/08/2012 MYLABSOGNO ESAOTE, S.P.A. ALLISON SCOTT, RAC
K121550 05/25/2012 HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY ETHICON ENDO-SURGERY, LLC MARCIA ARETZ
K121468 05/17/2012 EUROTROL GAS-ISE METABOLITES EUROTROL B.V. PAUL B.P. KOOIJMANS
K121467 05/17/2012 EUROTROL HEMATOCRIT CONTROL EUROTROL B.V. PAUL B.P. KOOIJMANS
K121392 05/09/2012 NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE EXACTECH, INC. LINDY KNISELY
K121307 05/01/2012 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ EXACTECH, INC. PATRICK HUGHES
K121349 05/04/2012 IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER EXTREMITY MEDICAL LLC JAMY GANNOE
K121417 05/11/2012 XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K121462 05/17/2012 EZ-BLOCKER EZ-BLOCKER B.V. LEWIS WARD
K121597 05/31/2012 ESON NASAL MASK FISHER & PAYKEL HEALTHCARE LIMITED JAMES THOMPSON
K121508 05/21/2012 LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N FOTONA D.D. STOJAN TOST
K121421 05/14/2012 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE COLLEEN DURRAN
K121341 05/03/2012 FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM FRESENIUS MEDICAL CARE, NORTH AMERICA DENISE OPPERMANN
K121499 05/21/2012 FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM FUJIFILM MEDICAL SYSTEM U.S.A., INC. KATHERINE Y CHOI
K121387 05/08/2012 CENTRICITY PACS-IW GE HEALTHCARE INTEGRATED IT SOLUTIONS JOHN MANARIK
K121365 05/07/2012 THERMOFORMED MOUTHGUARDS GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP ARMIN ZEHTABCHI
K121557 05/25/2012 WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K121466 05/17/2012 GUIDEMIA GUIDEMIA TECHNOLOGIES, LLC FEI GAO
K121398 05/09/2012 CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF) GUIDEPATH MEDICAL, INC. JOHN MITCHELL TATUM
K121345 05/04/2012 SR SUITE 1.0 HALIFAX BIOMEDICAL, INC. DANIEL KAMM
K121485 05/18/2012 GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING HEMCON MEDICAL TECHNOLOGIES EUROPE LTD BARBARA MCGRATH
K121532 05/24/2012 HERO GRAFT HEMOSPHERE INC LAURIE LYNCH
K121433 05/14/2012 GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) BLOOD GLUCOSE MONITORING SYSTEMS HMD BIOMEDICAL, INC. JESSICA TUNG
K121435 05/14/2012 SILKN BLUE HOME SKINOVATIONS LTD. AMIR WALDMAN
K121308 05/01/2012 HIP SYSTEMS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K121315 05/02/2012 STRYKER CMF MEDPOR CUSTOMIZED IMPLANT HOWMEDICA OSTEONICS CORP. STEPHANIE FULLARD
K121369 05/07/2012 NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR IBRAMED EQUIPAMENTOS MEDICOS LILIAN LLULL
K121517 05/22/2012 VERSAVUE ENTERPRISE SUITE ICAD, INC. MICHAEL A PATZ
K121541 05/24/2012 JAZZ SYSTEM IMPLANET S.A. JANICE M HOGAN
K121366 05/07/2012 HEMOCUE HBA1C 501 INFOPIA CO., LTD MARIA F GRIFFIN
K121554 05/25/2012 Q-FLO CLOSED MALE LUER CONNECTOR INFUSION INNOVATIONS, INC. BABAK NEMATI
K121479 05/18/2012 AIM INNEROPTIC TECHNOLOGY, INC CAROLINE GREEN
K121581 05/30/2012 BOX PEEK VBR SYSTEM, INNOVASIS, INC. MARSHALL C MCCARTY
K121573 05/29/2012 INTEGRA CAMINO ICP MONITOR INTRGRA LIFESCIENCES CORPORATION ERIN DOYLE
K121582 05/30/2012 INVENDO C25 COLONOSCOPY SYSTEM INVENDO MEDICAL GBMH OLIVER V RUEPPRECHT
K121424 05/14/2012 EXPRESSION INFORMATION PORTAL INVIVO CORPORATION RUSTY KELLY
K121319 05/02/2012 ZIO PATCH IRHYTHM TECHNOLOGIES, INC. MICHAEL RIGHTER
K121475 05/18/2012 TXCELL SCANNING LASER DELIVERY SYSTEM IRIDEX CORP. PAUL H HARDIMAN
K121572 05/29/2012 CONTINUOUS SINGLE CULTURE COMPLETE IRVINE SCIENTIFIC SALES CO., INC. JAYME YAMAGUCHI-OWENS
K121447 05/15/2012 ISCHEMA VIEW RAPID ISCHEMA VIEW, INC. MARC GOODMAN
K121338 05/03/2012 ZEOBI IVIVI HEALTH SCIENCE, LLC KATHRYN CLUBB
K121359 05/07/2012 IPS 99 ONE AND IPS 99 CERAM IVOCLAR VIVADENT AG DONNA MARIE HARTNETT
K121488 05/18/2012 JMS SAFE WING CATH (SWC) JMS NORTH AMERICA CORPORATION YOLANDA SMITH
K121520 05/22/2012 ULTRASONIC NEBULIZER (MESH TYPE) K-JUMP HEALTH CO., LTD. JM LIN
K121301 05/01/2012 XPRESSWAY RX CATHETER (6F LD-VERISON) KANEKA PHARMA AMERICA LLC JOSEPH DEPAOLO
K121310 05/01/2012 MESOTHELIUM DENTAL MEMBRANE KENSEY NASH CORPORATION LORI BURNS, MS, RAC
K121583 05/30/2012 CLEARFIL MAJESTY FLOW KURARAY NORITAKE DENTAL INC. KIYOYUKI ARIKAWA
K121326 05/02/2012 LANTOS 3D EAR SCANNER LANTOS TECHNOLOGIES JOHN GREENBAUM
K121316 05/08/2012 LANX SPINAL FIZATION SYSTEM LANX, INC. WILLIAM SANDUL
K121415 05/11/2012 MOLLRING MULTITASC LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K121471 05/18/2012 LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS LIGHTSCALPEL LLC GERALD S PALECKI
K121487 05/18/2012 LITECURE THERAPY COMPACT LITECURE, LLC LIANG LU
K121399 05/09/2012 LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P LUMINEX CORP. OLIVER MEEK
K121454 05/16/2012 XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K121481 05/22/2012 INFINI RADIOFREQUENCY SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K121511 05/21/2012 MACLIN POWER INTRAVASCULAR ADMINISTRATION SET MACLIN POWER INC. ENRICO BISSON
K121478 05/18/2012 NUK EXPRESSIVETM DOUBLE ELECTRIC BREAST PUMP MAPA GMBH MARK WOZNIAK
K121368 05/07/2012 NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) MATANG MFG. SDN. BHD. LESLIE LEONG
K121322 05/02/2012 CLOSER TO NATURE MAYBORN GROUP LIMITED NEIL HEWITT
K121416 05/11/2012 GMK SPHERE MEDACTA INTERNATIONAL ADAM GROSS
K121383 05/08/2012 PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) MEDICAL COMPONENTS INC JEAN CALLOW
K121530 05/24/2012 BODYFIX SYSTEM MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K121376 05/17/2012 COMPRESSION CARE FLIGHT MEDICAL MINDS LLC DAVID PLATT
K121323 05/02/2012 MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE MEDICREA INTERNATIONAL LAURE AVIRON-VIOLET
K121545 05/25/2012 BELLYBOARD, SBRT ACCESSORIES MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS AMANDA STAHLE
K121320 05/02/2012 C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE MEDYSSEY CO., LTD. MICHAEL KVITNITSKY
K121313 05/02/2012 MTF NEW BONE VOID FILLER MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY JOY
K121362 05/07/2012 1.5T 16CH FLEX SPEEDER LARGE NEOCOIL, LLC STEVEN NICHOLS
K120831 05/30/2012 ANCHORSURE NEOMEDIC INTERNATIONAL S.L. JEFFREY R SHIDEMAN
K121551 05/30/2012 RESOLUTE FACET SCREW SYSTEM NEUROSTRUCTURES, LLC MEREDITH MAY
K121529 05/24/2012 BLACK NITRILE POWDER-FREE EXAMINATION GLOVES NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K121464 05/17/2012 BLUE POWER FREE NITRILE EXAMINATION GLOVE NORTHSTAR HEALTHCARE HOLDINGS MICHAEL RIORDAN
K121506 05/21/2012 UTB BLUE POWDER FREE NITRILE NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K121390 05/09/2012 LUBE JELLY SURINGE NURSE ASSIST, INC. BILL KANEWSKE
K121407 05/10/2012 OXYBAND WOUND DRESSING O2S, LLC DAVID E PETKO, P.E.
K121564 05/29/2012 ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 OLYMPUS MEDICAL SYSTEMS CORP. LAURA STORMS-TYLER
K121293 05/01/2012 CS-SERIES-FP WITH 3030+OPTION OMEGA MEDICAL IMAGING, LLC BRIAN J FLEMING
K121404 05/31/2012 SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM ONSET MEDICAL CORPORATION JOSEPH BISHOP
K121524 05/23/2012 INSIGNIA ORMCO CORP. WENDY GARMAN
K121575 05/30/2012 OXFORD ANKLE FUSION NAIL(AFN) SYSTEM ORTHO SOLUTIONS LIMITED AL LIPPINCOTT
K121437 05/15/2012 MINI MAXLOCK EXTREME PLATING SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K121585 05/31/2012 TS IMPLANT SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K121304 05/01/2012 OSTEOMED CRANIAL DISTRACTION SYSTEM OSTEOMED PIEDAD PENA
K121228 05/17/2012 PONTO BONE ANCHORED HEARING SYSTEM OTICON MEDICAL AB KAROLIN ISBERG JERNBY
K121318 05/02/2012 PROSOFT PERMA LABORATORIES
K121498 05/21/2012 PERCUNAV PHILIPS HEALTHCARE TARA MACKINNON
K121542 05/24/2012 PICIS WEIGHT BASED DOSE CONVERTER PICIS INC. JANICE HOGAN
K121476 05/18/2012 INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC REBECCA K PINE
K121566 05/29/2012 PLANER BT37 INCUBATOR PLANER PLC ERIC GRUFF
K121418 05/11/2012 PLANMED VERITY PLANMED OY LARS MORING
K121522 05/23/2012 POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC) POLYREMEDY, INC. GARY MOCNIK
K121559 05/29/2012 HYLATOPICPLUS LOTION PRECISION DERMATOLOGY INCORPORATED RONALD M GURGE
K121406 05/10/2012 INCLUSIVE TAPERED IMPLANT SYSTEM PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K121391 05/09/2012 INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS PRISMATIK DENTALCRAFT, INC. ARMIN ZEHTABCHI
K121378 05/21/2012 AIRTRAQ SP AIRTRAQ AVANT PRODOL MEDITEC LTD. PAUL DRYDEN
K120766 05/08/2012 ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) PROSURG, INC. A. DESAI
DEN120011 05/11/2012 PROTEUS INGESTION CONFINMATION SYSTEMS PROTEUS BIOMEDICAL, INC. JAFAR SHENASA
K121385 05/08/2012 VECTOR R4 VASCULAR, INC. MICHAEL HOCH
K121428 05/14/2012 NON-CONTACT CLINICAL THERMOMETER RADIANT INNOVATION INC. JAMES HUANG
K121588 05/31/2012 RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K121497 05/21/2012 VENOFER PUMP RENAL SOLUTIONS INC. DAVID VANELLA
K121344 05/04/2012 NU SLEEP RH ASSOCIATES LLC DANIELA LEVY
K121347 05/01/2012 PRESSON ELECTRODE RHYTHMLINK INTERNATIONAL, LLC JAMES MEWBORNE
K121410 05/23/2012 DRAGON LW SEDECAL SA DANIEL KAMM
K121355 05/04/2012 WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K121397 05/09/2012 OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT SEKISUI DIAGNOSTICS, LLC MARK STAVRO
K121526 05/23/2012 POWER-FREE NITRILE PATIENT EXAMINATION GLOVES SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD. CECILY SHENG
K121144 05/30/2012 ELECTRONIC STETHOSCOPE SHARP CORPORATION DIANE RUTHERFORD
K121528 05/23/2012 POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR SHEN WEI (USA), INC. ALBERT LI
K121527 05/30/2012 WI-FI BODY SCALE SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD YANG WANG
K121549 05/25/2012 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE SIAM SEMPERMED CORP. LTD. WILLIAM E HARRIS
K121576 05/30/2012 IMMULITE 2000 ANTI-CCP IGG ASSAY SIEMENS HEALTHCARE DIAGNOSTICS INC. SUSAN BROCCHI
K121513 05/21/2012 MULTIX FUSION SIEMENS MEDICAL SOLUTION PATRICIA D JONES
K121459 05/17/2012 SYNGO.MR NEUROLOGY SIEMENS MEDICAL SOLUTIONS USA, INC. MICHELLE L BYRNE
K121434 05/14/2012 SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO SIEMENS MEDICAL SOLUTIONS, INC. MICHELLE L BYRNE
K121440 05/15/2012 ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT SIESTA MEDICAL, INC. MICHAEL KOLBER
K121321 05/02/2012 HARD SHELL VENTED NASAL MASK SLEEPNET CORPORATION PAUL DRYDEN
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K121525 05/23/2012 PERIFUSE CATHETER SMITHS MEDICAL ASD, INC. CHRISTINE LLOYD
K121515 05/22/2012 ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM SOLTA MEDICAL, INC. KRISTINE FOSS
K121401 05/10/2012 TENDER TOUCH SOMETECH CORPORATION KI HAN
K121340 05/03/2012 SOMNODENT G2 SOMNOMED INC. KATHRYN JAYNE
K121536 05/24/2012 INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR SORIN GROUP ITALIA S.R.L. SCOTT LIGHT
K121480 05/18/2012 ARIATELE TELEMETRY TRANSMITTER (96281) SPACELABS HEALTHCARE THOMAS KROENKE
K121548 05/25/2012 SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS) SPINE VIEW, INC. DIANA DEGREGORIO
K121381 05/08/2012 VIEWFLEX XTRA ICE CATHETER ST. JUDE MEDICAL LOUCINDA BJORKLUND
K121570 05/29/2012 AURIGA QI STARMEDTEC GMBH GREGOR WEIDEMANN
K121342 05/04/2012 XIA 4.5 SPINAL SYSTEM STRYKER CORP TIFFANI ROGERS
K121329 05/02/2012 AIXPLORER SUPERSONIC IMAGINE JACQUES SOUQUET
K121336 05/03/2012 MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 SURGIQUEST, INC. DANIEL DONOVAN
K121426 05/17/2012 AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPS SYNERGETICS, INC GARY OLIVEROS
K121598 05/31/2012 ME HAIR2GO SYNERON MEDICAL LTD. JANICE M HOGAN
K121502 05/21/2012 SYNTHES CURVILINEAR DISTRACTION SYSTEM SYNTHES INC ALAN T HALEY
K121574 05/30/2012 SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM SYNTHES INC ALAN T HALEY
K121224 05/09/2012 GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION LINDA KO
K121579 05/30/2012 EK DELIVERY DEVICE TDAK MEDICAL, INC GREG HOLLAND
K121411 05/11/2012 SHIGA TOXIN CHEK TECHLAB INC., CORPORATE RESEARCH CENTER DONNA T LINK
K121364 05/07/2012 SHIGA TOXIN QUIK CHEK TECHLAB INC., CORPORATE RESEARCH CENTER DONNA T LINK
K121363 05/07/2012 DIOWAVE LOW LEVEL COLD LASER SYSTEM TECHNOLOGICAL MEDICAL ADVANCMENTS, INC. (TMA) BRUCE COREN
K121591 05/31/2012 FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY) TEKMEDIC (M) SDN BHD PATRICK LEONG
K121380 05/08/2012 WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT TELEFLEX MEDICAL, INC. NATALIE SMITH
K121403 05/21/2012 CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET TELEFLEX, INC. PAUL AMUDALA
K121509 05/21/2012 TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT TGM MEDICAL, INC. PRAKASH PAI
K121482 05/18/2012 INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY THEKEN SPINE LLC DALE DAVISON
K121463 05/17/2012 IMMUNOCAP ALLERGEN K82 THERMO FISHER SCIENTIFIC MARTIN MANN
K121334 05/03/2012 VARIOECO THOMMEN MEDICAL, AG LINDA K SCHULZ
K121561 05/29/2012 FLOW2, SWING THYSSENKRUPP ACCESSIBILITY B.V. ARNOLD HEIDEN
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K121504 05/21/2012 SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS TOGO MEDIKIT CO., LTD. HEATHER CRAWFORD
K121493 05/21/2012 ASCEND SHOULDER SYSTEM TORNIER, INC. BRAHIM HADRI
K121422 05/14/2012 APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN CHARLEMAGNE CHUA
K121553 05/25/2012 AQUILION RXL TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K121577 05/30/2012 APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN CHARLEMAGNE CHUA
K121533 05/25/2012 ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET TOSOH BIOSCIENCE, INC. ROBERT WICK
K121452 05/16/2012 GRIDLOCK PLATING SYSTEM TRILLIANT SURGICAL LTD J.D. WEBB
K121565 05/29/2012 UNI-GOLD CRYPTOSPORIDIUM TRINITY BIOTECH LUPE KAGAN
K121402 05/11/2012 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
K121427 05/14/2012 UNIMED TEMPERATURE PROBE UNIMED MEDICAL SUPPLIES INC. XINMEI TAN
K121337 05/03/2012 UROPLASTY RIGID ENDOSCPIC NEEDLES UROPLASTY, INC. EMILY METCALFE
K121412 05/11/2012 PAX-FLEX3D, PHT-7000 VATECH CO., LTD. DAVE KIM
K121400 05/10/2012 PAX-UNI3D, PHT-7500 VATECH CO., LTD. DAVE KIM
K121370 05/07/2012 VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE VECTEC DIANE HORWITZ
K121516 05/22/2012 VIRTUOSO SYSTEM FOR IHC HER2 (4B5) VENTANA MEDICAL SYSTEMS, INC. ERIKA AMMIRATI
K121350 05/04/2012 VIRTUSO SYSTEM FOR IHC (DO-7) VENTANA MEDICAL SYSTEMS, INC. ERIKA AMMIRATI
K121312 05/01/2012 INTRAMEDULLARY NAIL SYSTEM WEIGAO ORTHOPAEDIC DEVICE CO., LTD DIANA HONG
K121405 05/10/2012 PANOPTIC WELCH ALLYN, INC. KEVIN CROSSEN
K121353 05/04/2012 MINI PATCH WELL-LIFE HEALTHCARE LIMITED CHIN-CHIN HSIEH
K121382 05/08/2012 WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] WESTMED, INC. R. JOHN MCKINNON
K121505 05/21/2012 DISPOSABLE HEMOSTASIS CHIP WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY SCOTTIE FARIOLE
K121544 05/30/2012 DYNASTY BIOFOAM SHELL WRIGHT MEDICAL TECHNOLOGY, INC. YUAN LI
K121425 05/14/2012 ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. SAMIR IBRAHIM
K121221 05/07/2012 PROFEMUR Z REVISION HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. YUAN LI
K121531 05/24/2012 A&J 5L POCA SERIES OXYGEN CONCENTRATOR ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. JUNHONG AN
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K121367 05/07/2012 ZOLL PROPAQ XM ZOLL MEDICAL CORPORATION CHARLES W KOLIFRATH


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