FDA 510(k) Applications Received During August, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K112271 08/08/2011 3B WILLOW 3B PRODUCTS, LLC ALEX LUCIO
K112316 08/11/2011 4-WEB ALIF SPINAL TRUSS SYSTEM (STS) 4-WEB, INC. RICH JANSEN, PHARM. D.
K112440 08/24/2011 AB DENTAL DEVICES IMPLANTS AND ACCESSORIES A.B. DENTAL DEVICES, LTD. CHARLES HURWITZ
K112430 08/24/2011 I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE ABBOTT PONT OF CARE INC YUKO HARTLEY
K112239 08/04/2011 STEERABLE GUIDE CATHETER Abbott Vascular CYNTHIA MORROW
K112273 08/08/2011 ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR ACCUMED HEALTHCARE (SHANGHAI) INC. CYNTHIA (CINDY) GREEN
K112270 08/08/2011 ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR ACCUMED HEALTHCARE (SHANGHAI) INC. CYNTHIA (CINDY) GREEN
K112409 08/22/2011 MATRISTEM WOUND MATRIX ACELL, INC DEBORAH A BAKER-JANIS
K112514 08/30/2011 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K112317 08/11/2011 FM-9000 PLUS FETAL AND MATERNAL MONITOR ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112529 08/31/2011 TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112465 08/26/2011 VITAL SIGNS MONITOR ADVANCED INSTRUMENTS, INC. JORGE MILLAN
K112235 08/04/2011 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING AIRSTRIP TECHNOLOGIES, LP ANDY MILLER
K112222 08/02/2011 ALCATRON AND / OR MULTIPLE BRAND ALCATRON GLOVES FACTORY SHUQIN GAO
K112425 08/23/2011 INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE ALCON MANUFACTURING, LTD. MARTIN A KAUFMAN
K112361 08/17/2011 ALAMO C ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K112452 08/25/2011 ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS ANGIODYNAMICS, INC. TERI JUCKETT
K112254 08/05/2011 APEX KIRSCHNER WIRES AND STEINMANN PINS APEX TOOLS & ORTHOPEDICS CO. SCOTT LIANG
K112331 08/12/2011 BIOPURE PORTABLE RO SYSTEMS ARION WATER, INC. ROBERT LIVINGSTION
K112457 08/26/2011 LEFORTE SYSTEM BONE PLATE & SCREW ARKIN CONSULTING GROUP PAUL SUMNER
K112437 08/24/2011 ARTHREX FRACTURE SYSTEM ARTHREX, INC. COURTNEY SMITH
K112237 08/04/2011 MICROSUTURE ANCHORS ARTHREX, INC. COURTNEY SMITH
K112278 08/09/2011 ASCENSION NUGRIP CMC IMPLANT ASCENSION ORTHOPEDIC BRADLEY W STRASSER
K112481 08/29/2011 FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT ASCENSION ORTHOPEDIC BRADLEY W STRASSER
K112438 08/24/2011 TITAN MODULAR TOTAL SHOULDER SYSTEM ASCENSION ORTHOPEDIC SUSAN WALTON
K112488 08/29/2011 HOTDOG PATIENT WARMING SYSTEM AUGUSTINE BIOMEDICAL & DESIGN, LLC WENDY NELSON
K112209 08/01/2011 PREFILLED CATHETER INFLATION SYRINGE AVAIL MEDICAL PRODUCTS, INC. STEVEN A HOWELL
K112443 08/24/2011 ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) AXIS-SHIELD DIAGNOSTICS, LTD. CLAIRE I DORA
K112515 08/30/2011 PENCAN SPINAL NEEDLE B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K112454 08/25/2011 HALO60 ABLATION CATHETER BARRX MEDICAL, INC. DAWN CHANG
K112333 08/12/2011 LRT ATTACHMENT BCF CERTIFICATION INC. LOUIS-PAUL MARIN
K112434 08/24/2011 BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION BD MEDICAL SURGICAL JOHN ROBERTS
K112412 08/22/2011 AU5800(R) CHEMISTRY ANALYZER BECKMAN COULTER, INC. DAVID G DAVIS
K112277 08/09/2011 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B Becton, Dickinson and Company Gregory P Payne
K112258 08/05/2011 NEUROTECH PLUS BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K112324 08/12/2011 CERALAS 980NM DIODE LASER FAMILY BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K112299 08/10/2011 ENDOVASCULAR LASER VEIN SYSTEM KIT BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K112442 08/24/2011 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K112253 08/05/2011 CERALAS 147NM DIODE LASER SYSTEM BIOLITEC, INC. HARRY HAYES
K112228 08/03/2011 VITEK 2 STREPTOCOCCUS LEVOFLOXACIN BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K112499 08/30/2011 BIOMERIX COMPOSITE SURGICAL MESH BIOMERIX CORPORATION CHRISTINA L KICHULA
K112352 08/16/2011 GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT BIONOSTICS, INC. RANDY BYRD
K112356 08/16/2011 GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE BIONOSTICS, INC. RANDY BYRD
K112482 08/29/2011 SELECTRA SLITTER TOOL BIOTRONIK, INC. Jon Brumbaugh
K112303 08/11/2011 RUBICON SUPPORT CATHETER BOSTON SCIENTIFIC GLENN JACQUES
K112198 08/01/2011 EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE Boston Scientific Corporation ASHLEY PYLE
K112233 08/04/2011 BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE BOVIE MEDICAL CORPORATION RICHARD A KOZLOFF
K112308 08/11/2011 CROSSER RECANALIZATION SYSTEM C.R. BARD, INC. TIMOTHY WADE
K112497 08/29/2011 MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT C.R. BARD, INC. Joni Creal
K112309 08/11/2011 DIGITAL RADIOGRAPHY CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K112372 08/17/2011 CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC HELDER A SOUSA
K112327 08/12/2011 SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC HELDER A SOUSA
K112211 08/02/2011 DURA BLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K112283 08/09/2011 DURA BLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K112321 08/12/2011 CS 1200 CARESTREAM HEALTH,INC. DANIEL HOEFER
K112474 08/26/2011 CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE CEDARS-SINAI MEDICAL CENTER GEOFF POLLARD
K112376 08/17/2011 S-CATH ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM CIRCA SCIENTIFIC, LLC FRED PIAZZA
K112335 08/12/2011 BANTAM CATHETER (280MM BALLOON LENGTHS) CLEAR STREAM TECHNOLOGIES, LTD. FIONA NI MHULLAIN
K112378 08/18/2011 COBES SURGICAL DRAPE COBES INDUSTRIES CO., LTD. LEON LU
K112268 08/08/2011 CODAN SAFEFEED ENTERAL FEEDING RESERVOIR CODAN US CORP. JEFF NIELSEN
K112322 08/12/2011 RESTORELLE POLYPROPYLENE Y MESH COLOPLAST A/S TIM CRABTREE
K112386 08/18/2011 EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM COLOPLAST CORP. TIM CRABTREE
K112384 08/18/2011 ABDOMINAL TOURNIQUET SYSTEM COMPRESSION WORKS LLC Ruth Forstadt
K112404 08/22/2011 CONCENTRIC BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K112205 08/01/2011 SNORERX 9.0 CONSUMER HEALTH PRODUCTS, INC GARY MOCNIK
K112342 08/15/2011 FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM CONVATEC INC KATRINA FIEDLER
K112302 08/11/2011 PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES COOPER VISION, INC. LISA HAHN
K112477 08/29/2011 PALINDROME H, SI, HSI CHRONIC CATHETER COVIDIEN WING NG
K112511 08/30/2011 DOBBHOFF DUAL PORT FEEDING TUBE COVIDIEN LP, FORMERLY REGISTERED AS KENDALL DEBORA STAPLETON
K112349 08/16/2011 VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H ANGELA V ARSDALE
K112311 08/11/2011 ALP 501 RB PUMP SYSTEM CURRIE MEDICAL SPECIALTIES, INC. BERNICE NAVARRO
K112441 08/24/2011 COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM DAESUNG MAREF CO., LTD. DANIEL NAM
K112196 08/01/2011 OCTOTMPORT DALIM SURGNET CORPORATION APRIL LEE
K112249 08/05/2011 HEALIX KNOTLESS(TM) ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K112417 08/23/2011 VARIOUS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K112218 08/02/2011 ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K112411 08/22/2011 MAMMOTOME ELITE BIOPSY SYSTEM DEVICOR MEDICAL PRODUCTS INC. SHAWNA M ROSE
K112220 08/02/2011 DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL DEVILBISS HEALTHCARE LLC JAMES P FROEHLICH
K112429 08/23/2011 GIZA(R) VERTEBRAL BODY REPLACEMENT EDEN SPINE, LLC RICH JANSEN
K112466 08/26/2011 4MP COLOR LCD MONITOR, RADIFORCERX430 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K112354 08/16/2011 5MP MONOCHROME LCD MONITOR, RADIFORCE GX530 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K112353 08/16/2011 GEODESIC EEG MOBILE 100 (GEM 100) ELECTRICAL GEODESICS, INC. LINDA J BOVARD
K112319 08/11/2011 ELECTRO-CAP SYSTEM ELECTRO-CAP INTL., INC. AMY B SWALLOWS
K112485 08/29/2011 H-WAVE ELECTRONIC WAVEFORM LAB, INC. RYAN P HEANEY
K112421 08/23/2011 EMG SUCTION UNIT EMG TECHNOLOGY CO., LTD. PAUL CHO
K112506 08/30/2011 XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. KAREN E PETERSON
K112272 08/08/2011 EM44 SELF MONITORING BLOOD GLUCOSE SYSTEM, EM44 PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. YC LEI
K112223 08/02/2011 EUROIMMUN ANTI-LKM-1 ELISA(LGG) EUROIMMUN US KATHRYN KOHL
K112221 08/02/2011 EUROIMMUN ANTI-SLA/LP ELISA(LGG) EUROIMMUN US KATHRYN KOHL
K112415 08/22/2011 LIFECARE ARM & LEG PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K112522 08/31/2011 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM FLEXIBLE STENTING SOLUTIONS, INC. JOSEPH C GRIFFIN III
K112394 08/19/2011 STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K112439 08/24/2011 SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K112391 08/19/2011 FUJINON COLONOSCOPES FUJINON, INC. GINA WALLJASPER
K112521 08/31/2011 FUKUDA DENSHI VASERA MODEL VS-1500 FUKUDA DENSHI USA, INC. DOUG BLAKELY
K112398 08/19/2011 TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT GALT MEDICAL BETSY CORTELLONI
K112371 08/17/2011 LOGIQ P3 GE HEALTHCARE BRYAN BEHN
K112213 08/02/2011 VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM GE HEALTHCARE BRYAN BEHN
K112310 08/10/2011 WONDFO METHADONE URINE TEST,OPIATE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K112236 08/04/2011 WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K112395 08/19/2011 WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K112320 08/11/2011 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K112215 08/02/2011 HEMCON HEMOSTATIC GEL HEMCON MEDICAL TECHNOLOGIES EUROPE, LTD. KENDRA RATHKEY
K112501 08/30/2011 VENUS PEARL PLT REFILL A1 HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K112502 08/30/2011 PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 HILL-ROM CO. CHAD HODSON
K112532 08/31/2011 ET II BIO-SA FIXTURE SYSTEM HIOSSEN INC. PATRICK LIM
K112392 08/18/2011 HIVOX BIOTEK INC. HIVOX BIOTEK, INC. JEN KE-MIN
K112455 08/25/2011 AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STEPHANIE FITTS
K112422 08/23/2011 CRAG LATERAL FLOW ASSAY (LFA) IMMUNO-MYCOLOGICS, INC. SEAN K BAUMAN
K112329 08/12/2011 OMNI PATIENT MONITOR INFINIUM MEDICAL JOHN O'BRIEN
K112373 08/17/2011 CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION INNOVA VISION INC. JENNIFER REICH
K112250 08/04/2011 CHX=CHX PLUS INTER-MED, INC. JOHN BAETEN
K112200 08/01/2011 FOCUS TOUCH CONCEPTION SYSTEM INTIMATE BRIDGE 2 CONCEPTION, INC NIKI C SPANIEL
K112208 08/01/2011 INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES INTUITIVE SURGICAL, INC. BRANDON HANSEN
K112263 08/08/2011 MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY INTUITIVE SURGICAL, INC. BRANDON HANSEN
K112427 08/23/2011 BICARB MIXING AND DISTRIBUTION SYSTEM ISOPURE CORP. KEVIN C GILLESPIE
K112520 08/31/2011 US-101L, US-103S ITO CO., LTD. HARUHISA OKADA
K112351 08/16/2011 ULTRA BEAUTY JOHARI DIGITAL HEALTHCARE, LTD. POOJA JOHARI
K112289 08/09/2011 DISPOSABLE THERMOMETER COVERS AND SHEATHS KANG ZE INDUSTRIAL CO. LIMITED DORIS DONG
K112480 08/29/2011 VIEW 1 IMAGING KARL STORZ ENDOSCOPY AMERICA, INC. WINKIE WONG
K112300 08/10/2011 KIMGUARD SMART-FOLD* STERILIZATION WRAP KIMBERLY-CLARK CORP. Brenda Shelkey
K112396 08/19/2011 IUI CATHETERS KITAZATO MEDICAL CO., LTD. RICHARD VINCINS
K112462 08/26/2011 KITAZATO OPU NEEDLE KITAZATO MEDICAL CO., LTD. RICHARD VINCINS
K112330 08/12/2011 KOWA VX-20 KOWA CO. LTD. HIROYUKI KOIDE
K112381 08/17/2011 HI TORQUE CONNECT GUIDEWIRE LAKE REGION MEDICAL KENNY WALSH
K112397 08/19/2011 ORTHO-JET CRYSTAL LANG DENTAL MFG. CO., INC. DAVID LANG
K112388 08/18/2011 LANX CERVICAL SA LANx, Inc MICHAEL FUNK
K112460 08/26/2011 MULTIPLE LARSON MEDICAL PRODUCTS, INC. PETER LARSON
K112231 08/04/2011 LCCS INSULATED SPINAL NEEDLE (RF CANNULA) LCCS PRODUCTS LIMITED FIELD FU
K112524 08/31/2011 HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC DAVID MICHAELS
K112357 08/16/2011 VESSEL GUARDIAN LEXION MEDICAL, LLC. BERNARD HORWATH
K112199 08/01/2011 XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K112507 08/30/2011 RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION DIONNE SANDERS
K112470 08/26/2011 2GC HIP/KNEE MODULAR SPACER MANDELL HORWITZ CONSULTANTS LLC DIANE M HORWITZ
K112360 08/17/2011 QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K112389 08/18/2011 SURGICASE CONNECT, SURGICASE GUIDE MATERIALISE N.V. Alexandra Razzhivina
K112301 08/10/2011 ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MATERIALISE N.V. Alexandra Razzhivina
K112402 08/22/2011 ULTRAMAXO2 OXYGEN ANALYER MAXTEC, LLC TAMMY LAVERY
K112458 08/26/2011 PROSPERA PRO-I, PRO-II AND PRO-III NEGATIVE PRESSURE WOUND THERAPY SYSTEM MEDICA-RENTS CO., LTD. DINA L WEISSMAN, J.D.
K112210 08/01/2011 FRAXION MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH MICHAEL WOLFF
K112493 08/29/2011 PASS LP SPINAL SYSTEM MEDICREA INTERNATIONAL J.D. WEBB
K112345 08/15/2011 DISTAL VOLAR RADIUS PLATING SYSTEMS MEDOS INTERNATIONAL SARL SUZANA OTANO
K112444 08/24/2011 ANATOMIC PEEK CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANCK USA, INC. BECKY RONNER
K112405 08/22/2011 CLYDESDALES SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. JULIE BASSETT
K112473 08/26/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CHRIS MCKEE
K112479 08/29/2011 DSJ MASSAGER MEGO AFEK AC LTD JAMES R RAVITZ, ESQ.
K112197 08/01/2011 MEMOMETAL INTRA-MEDULLARY BONE FASTENER MEMOMETAL TECHNOLOGIES GILLES AUDIC
K112527 08/31/2011 UNIVERSAL DIGITAL INTERFACE (UDI) 1717 MERIDIAN MEDICAL SYSTEMS, LLC ARIEL MARCIANO
K112226 08/03/2011 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K112380 08/17/2011 CLEARVISION MIDMARK CORP. LISA BARTAKOVICS
K112323 08/12/2011 CARDIA-CATH MILLAR INSTRUMENTS, INC. FATMA M ALI
K112203 08/01/2011 COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST MIRADOR BIOMEDICAL, INC. JUSTIN HULVERSHORN
K112257 08/05/2011 BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE MOLNLYCKE HEALTH CARE US, LLC ANGELA L BUNN
K112390 08/18/2011 MONICA AN24 MONICA HEALTHCARE LTD. IAN HOW
K112282 08/09/2011 M VISUM ALERT ALARM MANAGEMENT SYSTEM MVISUM, INC. PRAVEEN DALA
K112424 08/23/2011 VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) NANOSPHERE, INC MARK DEL VECCHIO
K112513 08/30/2011 EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER NATEC MEDICAL LTD E.J. Smith
K112247 08/04/2011 A BAER WITH ABAER I/O FUNCTION NATUS MEDICAL INCORPORATED CHARLES L MORIN
K112314 08/11/2011 NEPHROS OLPUR H2H HEMODIAFILTRATION (HDF) MODULE AND OLPUR MD 220 HEMODIAFILTER NEPHROS, INC. GREG COLLINS
K112286 08/09/2011 NOVAC 11 NEW RADIANT TECHNOLOGY S.P.A. MAUREEN O'CONNEL
K112315 08/11/2011 HOME PREGNANCY TEST NEWSCEN COAST BIO-PHARMACEUTICAL CO., LTD CHANDRAVADAN PATEL
K112359 08/16/2011 PROW FUSION NLT SPINE LTD JOHN J SMITH
K112259 08/08/2011 NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS NOBEL BIOCARE AB HERBERT CRANE
K112428 08/23/2011 NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT NovaBone Products, LLC DAVID M GAISSER
K112420 08/23/2011 ONCENTRA PROSTATE 4.0 NUCLETRON MICHAEL PAUL
K112400 08/19/2011 SMARTSHEARS NUSCIENCE CONSULTING AND MANAGEMENT GROUP, LLC NIKOLE GOLDSMITH
K112368 08/17/2011 CAPNOSTREAM20P WITH AI/ODI ORIDION MEDICAL 1987 LTD. RACHEL WEISSBROD
K112269 08/08/2011 OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE OSTAR MEDITECH CORP. STEVEN CHANG
K112525 08/31/2011 D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS PAREXELINTERNATIONAL BARRY SALL
K112414 08/22/2011 ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY PHADIA US INC. MARTIN ROBERT MANN
K112312 08/11/2011 THERATRODE PHOENIX MEDICAL DEVICES, LLP JIM KLETT
K112496 08/29/2011 PIONEER CROSSFUSE II IBF/VBR SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. EMILY M DOWNS
K112217 08/02/2011 ME AGAIN(R) LONG LASTING VAGINAL MOISTURIZER, VH ESSENTIALS (R) LONG LASTING VAGINAL MOISTURIZER POLICHEM S.A. JOHN NYGAARD
K112267 08/08/2011 NEUROLAC(R) NERVE GUIDE Polyganics BV BETTY IJMKER
K112408 08/22/2011 POLY-CHEM 90 ISE MODULE POLYMEDCO, INC. HELEN LANDICHO
K112318 08/11/2011 CLEARPATH 24 PROMEDIC, INC. PAUL DRYDEN
K112448 08/25/2011 PULSIOFLEX PULSION MEDICAL SYSTEMS, INC. Jamie Sulley
K112313 08/11/2011 TOSHIBA 3T EXTRA LARGE KNEE COIL QUALITY ELECTRODYNAMICS CHRISTIE ZYDYK
K112279 08/09/2011 QUANTUM DENTAL IMPLANT SYSTEM QUANTUM BIOENGINEERING, LTD. LINDA SCHULZ
K112490 08/29/2011 QUIDEL MOLECULAR HMPV ASSAY QUIDEL CORP. Ronald H Lollar
K112337 08/15/2011 RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K112334 08/12/2011 VEIN-GOGH INSTRUMENT REFINE USA, LLC BRIAN SMITH
K112505 08/30/2011 ETHEREA REGULATORY INSIGHT, INC. Kevin Walls
K112468 08/26/2011 THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE REGULATORY SPECIALISTS, INC. GRACE HOLLAND
K112413 08/22/2011 RI MSC (MIGRATION SEDIMENTATION CHAMBER) RESEARCH INSTRUMENTS LTD. DAVID LANSDOWNE
K112489 08/29/2011 SWIFT FX BELLA RESMED LTD. KIM K LEE
K112393 08/19/2011 TASMAN RESMED LTD. DAVID D'CRUZ
K112512 08/30/2011 VANISHPOINT BLOOD COLLECTION SET RETRACTABLE TECHNOLOGIES, INC. RHONDA WELLS
K112262 08/08/2011 REFLEX BALLON GUIDE CATHETER REVERSE MEDICAL CORPORATION JEFFREY VALKO
K112435 08/24/2011 RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT RHYTHMLINK INTERNATIONAL, LLC JAMES MEWBORNE
K112528 08/31/2011 ELECSYS T4 CALCHECK 5 ROCHE DIAGNOSTICS CORPORATION Michael Leuther
K112423 08/23/2011 COLLAGEN TENDON SHEET ROTATION MEDICAL, INC. JEFF SIMS
K112348 08/16/2011 RS-4I MUSCLE STIMULATOR RS MEDICAL PATRICK COUGILL
K112508 08/30/2011 I-ROOT 100 S-DENTI CO., LTD. TAE K NAM
K112453 08/25/2011 STERISPINEPS PEDICLE SCREW SAFE ORTHOPAEDICS PIERRE DUMOUCHEL
K112339 08/15/2011 ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD KYEONG-MI PARK
K112206 08/01/2011 CARDIFF ANTERIOR CERVICAL PLATE SYSTEM SEASPINE, INC. DAN MILLER
K112491 08/29/2011 SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 SEBIA KAREN ANDERSON
K112294 08/10/2011 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD. FRANK LIU
K112266 08/08/2011 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR SHANDONG ZHIYUAN MEDICAL PRODUCTS CO., LTD. FRANK LIU
K112204 08/01/2011 KDL DISPOSABLE INFUSION SET SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. Diana Hong
K112431 08/23/2011 DIGITAL ELECTROCARDIOGRAPH SHENZHEN BIOCARE ELECTRONICS CO., LTD Diana Hong
K112377 08/17/2011 BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K112530 08/31/2011 3DI INCLUDING CSCORE SHINA SYSTEMS LTD. DAN LAOR
K112307 08/11/2011 RESIGLASS PASTE SHOFU DENTAL CORPORATION DAVID P MORAIS
K112523 08/31/2011 IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT Siemens Healthcare Diagnostics Inc. Garo Mimaryan
K112343 08/15/2011 TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS; QUALITY CONTROL MATERIALS SIEMENS HEALTHCARE DIAGNOSTICS, INC. KIRA GORDON
K112362 08/17/2011 C100 WRINKLE REDUCTION DEVICE SILVER BAY, LLC ROBERT WAGNER
K112387 08/18/2011 PROCEDURE REHEARSAL STUDIO(TM) SIMBIONIX LTD. SHOSHANA FRIEDMAN
K112383 08/18/2011 CALLOS PROMODEL BONE VOID FILLER, SKAFFOLD MP (MACRO POROUS) BONE VOID FILLER SKELETAL KINETICS, LLC CHRISTINE KUO
K112406 08/22/2011 PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES SMITH & NEPHEW, INC. DAVID HENLY
K112526 08/31/2011 TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS SMITH & NEPHEW, INC. MELISSA EGAN
K112407 08/22/2011 SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS SMITHS MEDICAL MD, INC. TOM BLISS
K112451 08/25/2011 S8 DIAGNOSTIC ULTRASOUND SYSTEM SONOSCAPE COMPANY LIMITED Diana Hong
K112469 08/26/2011 GENERAL PRUPOSE LOCALIZERS AND ADAPTERS-NEW ACCESSORIES FOR SONOWAND SYSTEM SONOWAND AS CONSTANCE G BUNDY
K112225 08/03/2011 SORIN CENTRIFUGAL PUMP 5 (CP5) SORIN GROUP DEUTSCHLAND GMBH ROSINA ROBINSON
K112245 08/04/2011 XTRA SORIN GROUP ITALIA S.R.L BARRY SALL
K112478 08/29/2011 VISI MOBILE MONITORING SYSTEM SOTERA WIRELESS, INC EBEN GORDON
K112341 08/15/2011 SNAP WOUND CARE SYSTEM SPIRACUR, INC. SARAH CANIO
K112214 08/02/2011 OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS ST. JUDE MEDICAL NEUROMODULATION PENNY HOUSTON
K112403 08/22/2011 AMSCO CHIMERON MEDIUM STEAM STERLILZER STERIS Corporation ROBERT F SULLIVAN
K112256 08/05/2011 STERIS STEAM PI STERIS Corporation ROBERT SULLIVAN
DEN110002 08/01/2011 SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT STERIS Corporation ROBERT SULLIVAN
K112280 08/09/2011 STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM STRAUMANN USA ELAINE ALAN
K112385 08/18/2011 TRAGET DETACHABLE COIL STRYKER NEUROVASCULAR JAMES LEATHLEY
K112292 08/10/2011 REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER STRYKER SUSTAINABILITY SOLUTIONS RAMONA KULIK
K112232 08/04/2011 REPROCESSED ELECTROPHYSIOLOGY CATHETERS STRYKER SUSTAINABILITY SOLUTIONS AMANDA BABCOCK
K112255 08/05/2011 AIXPLORER SUPERSONIC IMAGINE JACQUES SOUQUET
K112251 08/05/2011 SWISSMEDA DENTAL PLANNING SYSTEM SWISSMEDA AG JORG DANZBERG
K112399 08/19/2011 UNITE BIOMATRIX SYNOVIS ORTHOPEDIC & WOUNDCARE AMY BOUCLY
K112459 08/26/2011 SYNTHES ZERO-P SYNTHES SPINE CO.LP STACEY BONNELL
K112296 08/09/2011 LATERAL BUTTON T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. GEORGE J HATTUB
K112275 08/08/2011 FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM TaiDoc Technology Corporation LINDA KO
K112216 08/02/2011 U-RIGHT TD-3128 BLOOD PRESSURE MONITORING SYSTEM TaiDoc Technology Corporation LINDA KO
K112274 08/08/2011 U-RIGHT TD-3135 BLOOD PRESSURE MONITORING SYSTEM TaiDoc Technology Corporation LINDA KO
K112456 08/25/2011 ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT Teleflex Medical, Inc. NATALIE SMITH
K112229 08/03/2011 SARN CENTRIFUGAL PUMP TERUMO CARDIOVASCULAR SYSTEMS REBECCA ANDERSEN
K112382 08/18/2011 TERUMO ASPRIATION CATHETER Terumo Medical Corporation DANIEL R PLONSKI
K112285 08/09/2011 MILESTONE KNEE SYSTEM, FEMORAL COMPONENT, POSTERIOR STABLIZED, UNOCATED / RLP, UNCOATED; TIBIAL INSERT / BASEPLATE... TGM MEDICAL, INC. DENNIS H CRANE
K112219 08/02/2011 TAPAS CATHETER THERMOPEUTIX INC. THOMAS SCHROEDER
K112305 08/11/2011 VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES THUNDER TIGER CORP. JO LEE
K112449 08/25/2011 QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST Tianjin New Bay Bioresearch Co., Ltd. HANN-PING WANG
K112293 08/10/2011 HTS EXTREMITY COIL, HTS SURFACE COIL TIME MEDICAL SYSTEMS INC JOHN BABY
K112290 08/09/2011 SUPERCATH Z3V TOGO MEDIKIT CO., LTD. FUMIAKI KANAI
K112445 08/24/2011 SOFRELINER TOUGH S TOKUYAMA DENTAL CORPORATION KEITH A BARRITT
K112446 08/24/2011 TOMOTHERAPY TREATMENT SYSTEM TOMOTHERAPY INCORPORATED GREG BANGE
K112366 08/17/2011 4CH FLEX SPEEDER TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN PAUL BIGGINS
K112276 08/09/2011 VIZION TREK DIAGNOSTIC SYSTEMS CYNTHIA C KNAPP
K112509 08/30/2011 TRIMED CLAVICLE FIXATION SYSTEM TRIMED, INC. DOUG STEINBERGER
K112281 08/09/2011 GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX TRIREME MEDICAL, INC. SHIVA ARDAKANI
K112332 08/12/2011 FINE JECT INSULIN PEN NEEDLE TWOBIENS CO., LTD. PETER CHUNG
K112240 08/04/2011 DYNA LOCKING CANNULATED SCREW U&I CORP. GYEONG-JE KWON
K112517 08/31/2011 ULTRASEAL XT HYDRO ULTRADENT PRODUCTS, INC. DIANE ROGERS
K112358 08/16/2011 UNIMAX TROCAR SYSTEM UNIMAX MEDICAL SYSTEMS, INC. MICHAEL LEE
K112463 08/26/2011 UNITED 36MM CERAMIC FEMORAL HEAD, DELTA UNITED ORTHOPEDIC CORPORATION FANG-YUAN HO
K112494 08/29/2011 VARAYA AR , VARAYA SPORT VARAYA PHOTOCEUTICALS, LLC MYK LUM
K112347 08/15/2011 RAPID INTRAVASCULAR CATHETER START SYSTEM 22 GAUGE / 20 GAUGE / 18 GAUGE VASCULAR PATHWAYS, INC. MICHAEL A DANIEL
K112416 08/22/2011 CPK REAGENT VITAL DIAGNOSTICS (MANUFACTURING) PTYLTD MELITA LAMBIRIS
K112531 08/31/2011 VITREA CT MYOCARDIAL ANALYSIS VITAL IMAGES, INC. Daniel Biank
K112447 08/25/2011 GRANDIO CORE DUAL CURE VOCO GMBH T. GERKENSMEIER
K112374 08/17/2011 X-TRA BASE VOCO GMBH T. GERKENSMEIER
K112370 08/17/2011 WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM WELLDOC, INC LAUREN BRONICH-HALL
K112288 08/09/2011 JIAJIAN TENS WUXI JIAJIAN MEDICAL INSTRUMENT CO., LTD. DORIS DONG
K112426 08/23/2011 XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES XIAN FRIENDSHIP MEDICAL ELECTRONICS CO., LTD. CHU XIAOAN
K112475 08/29/2011 XTRACT SYRINGE KEY SYSTEM XTRACT SOLUTIONS KEITH LOWREY
K112533 08/29/2011 ZAVATION CERVICAL PLATE SYSTEM ZAVATION LLC JOHN WALKER
K112484 08/29/2011 ZAVATION SPINAL SYSTEM ZAVATION LLC JOHN WALKER
K112432 08/23/2011 ZOLL X SERIES ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS CHARLES W KOLIFRATH


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact