FDA 510(k) Decisions During October, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K103434 10/13/2011 3B FLEX-LITE 3B PRODUCTS, LLC ALBERT ALEXANDER LUCIO
K110471 10/07/2011 BABI PLUS INFANT NASAL CANNULA SYSTEM A PLUS MEDICAL THOMAS C LOESCHER
K111883 10/18/2011 SMARTLOC SPINAL FIXATION SYSTEM A-SPINE ASIA, CO., LTD FRANK HSU
K110579 10/06/2011 ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS ABBOTT LABORATORIES DARLA ABANO
K103627 10/14/2011 ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS ABBOTT LABORATORIES JUDITH R WALLACH
K111899 10/03/2011 ARMADA 35/35LL PTA CATHETER ABBOTT VASCULAR LAARNI RICAFORT
K111875 10/11/2011 RELIEVA SPIN SINUS DILATION SYSTEM ACCLARENT, INC. KERI YEN
K110687 10/07/2011 RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) ACCLARENT, INC. DEAN KNIGHT
K111371 10/06/2011 ON CALL CHOSEN BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES, INC. QIYI XIE
K112529 10/27/2011 TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K110979 10/20/2011 DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGS ADVANCED MEDICAL PRODUCTS SDN BHD ZAHARI DARUS
K103513 10/24/2011 LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA ADVANCED ORTHOPAEDIC SOLUTIONS, INC. JULIE GLENDRANGE
K110206 10/27/2011 AESCULAP- MEITHKE SHUNT SYSTEM AESCULAP, INC. KATHY A RACOSKY
K110432 10/20/2011 VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN AFFINITY BIOLOGICALS INC. DENISE FOULON
K112670 10/27/2011 DX-D 600 AGFA HEALTHCARE N.V. PHIL CUSCUNA
K112222 10/27/2011 ALCATRON AND / OR MULTIPLE BRAND ALCATRON GLOVES FACTORY SHUQIN GAO
K101774 10/13/2011 MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) ALCON MANUFACTURING, LTD. CATHERINE GOBLE
K110951 10/17/2011 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA ALCON RESEARCH, LTD. MARTIN A KAUFMAN
K111587 10/20/2011 ALERKAN SPIROMETRY FILTER ALERKAN LTD GLEN FEYE
K110998 10/25/2011 AFFIRM (TM) VCF SYSTEM ALGEA THERAPIES KELLY J BAKER
K102063 10/11/2011 HEALTH-E-CONNECT SYSTEM ALR TECHNOLOGIES PAUL DRYDEN
K112842 10/25/2011 AMS ELEVATE PC AMERICAN MEDICAL SYSTEMS, INC. MATTHEW D STEPANEK
K111740 10/05/2011 AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION AMERIWATER BRIAN R BOWMAN
K112116 10/04/2011 DIGITAL CLINICAL THERMOMETER MODEL V901US AMPEROR-ELECTRONIC(SZ) CO., LTD RAJ KASBEKAR
K102329 10/24/2011 NANOKNIFE SYSTEM ANGIODYNAMICS, INC. KIT CARIQUITAN
K111532 10/07/2011 MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE ANTHOGYR SAS BRAYETTE SABINE
K112849 10/27/2011 FIXATE TISSUE BAND ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K112254 10/11/2011 APEX KIRSCHNER WIRES AND STEINMANN PINS APEX TOOLS & ORTHOPEDICS CO. SCOTT LIANG
K103155 10/28/2011 SUMO ACCESS AND TISSUE RESECTION SYSTEM APOLLO ENDOSURGERY, INC. GREG MATHISON
K110804 10/19/2011 AMT G-J TUBE APPLIED MEDICAL TECHNOLOGY, INC. JOSHUA D MEINKE
K110345 10/19/2011 SCANVIEW SYSTEM APPLIED SPECTRAL IMAGING DAN LAOR
K111904 10/18/2011 ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN ARK DIAGNOSTICS,INC KENNETH C KASPER
K103643 10/06/2011 ASCOT HOME MEDICAL MONITORING SYSTEM (HMMS) ASCOT TECHNOLOGIES, INC. MARY E RANDALL
K103251 10/28/2011 DUOCENTRIC REVERSED ASTON MEDICAL CATHERINE GLOSTER
K111828 10/26/2011 CLEARSPLINT ES ASTRON DENTAL CORPORATION DOUGLAS S MULLER
K112759 10/18/2011 APCLO PEDICLE SCREW SYSTEMS ATLAS SPINE INC. THOMAS G SMITH
K112579 10/06/2011 WILDCAT 5F GUIDEWIRE SUPPORT CATHETER AVINGER, INC. SEVRINA CIUCCI
K111990 10/17/2011 CORONIS 5MP BARCO NV LIEVEN DE WANDEL
K111662 10/04/2011 VENOTRAIN CURAFLOW BAUERFEIND AG INES EXNER
K112192 10/25/2011 NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS BAUSCH & LOMB, INC. TRICIA GARRETT
K112893 10/18/2011 CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETS BAXTER HEALTHCARE CORPORATION NANETTE HEDDEN
K102416 10/20/2011 BD GENEOHM VANR ASSAY BD DIAGNOSTICS SCIENCE RAYMOND BOULE
K110646 10/12/2011 BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER BEAM-MED LTD RITA KOREMBLUM
K112586 10/18/2011 CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM) BECTON DICKINSON AND COMPANY (BD) KATIE COYLE
K112277 10/28/2011 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B BECTON, DICKINSON AND COMPANY GREGORY P PAYNE
K112911 10/27/2011 FETAL DOPPLER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K103684 10/21/2011 VRESELECT CULTURE MEDIUM BIO-RAD FRAN WHITE
K112810 10/26/2011 MULTI-ANALYTE DETECTION SYSTEMS BIO-RAD LABORATORIES JUANG WANG
K111979 10/18/2011 RADIOACTIVE SEED LOCALIZATION NEEDLE BIOCOMPATIBLES INC. WAYNE RICHARDSON
K111909 10/18/2011 VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE BIOMERIEUX, INC. NATHAN HARDESTY
K112228 10/03/2011 VITEK 2 STREPTOCOCCUS LEVOFLOXACIN BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K112000 10/26/2011 VITEK 2 STREPTOCOCCUS PENICILLIN BIOMERIEUX, INC. JOLYN TENLLADO
K103752 10/14/2011 VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE BIOMERIEUX, INC. JOLYN TENLLADO
K112014 10/17/2011 ZYSTON STRAIGHT SPACER SYSTEM BIOMET SPINE JULIE A RYAN
K112007 10/05/2011 CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K112701 10/25/2011 CHARGER BALLOON DILATATION CATHETER BOSTON SCIENTIFIC GLENN JACQUES
K112745 10/18/2011 V-14 CONTROL WIRE GUIDEWIRE BOSTON SCIENTIFIC CORPORATION SHANNON PETTIT
K110021 10/18/2011 DASH HIP BRAINLAB, AG ALEXANDER SCHWIERSCH
K111436 10/14/2011 PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX BRENNEN MEDICAL, LLC KENNETH B HERLAND
K102316 10/07/2011 GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM BROADMASTER BIOTECH CORPORATION ROGER LAI
K112051 10/12/2011 LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE BRONCUS TECHNOLOGIES, INC. MAHTAB FATEMI
K112497 10/24/2011 MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT C.R. BARD, INC. JONI CREAL
K112744 10/20/2011 SAPIENS TIP CONFIRMATION SYSTEM C.R. BARD, INC. HENRY BOLAND
K112715 10/05/2011 CANDELA GENTLEMAX FAMILY OF LASERS CANDELA CORP. SAM WADE
K112211 10/20/2011 DURA BLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K112283 10/20/2011 DURA BLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K103651 10/04/2011 CARDIOMED CARDIO MEDICAL PRODUCTS, INC. NICK MENDISE
K111320 10/07/2011 GLOBALCARDIO CARDIOCOMM SOLUTIONS, INC. JON WARD
K111408 10/17/2011 MICROGARD II CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K110919 10/20/2011 CARESTREAM PACS CARESTREAM HEALTH, INC. LINDA STEWART
K111566 10/06/2011 DRYVIEW CHROMA IMAGING SYSTEM CARESTREAM HEALTH,INC. CHRISTINE EHAMNN
K101592 10/06/2011 ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM CHENG MEDICAL, CORPORATION MARY P GALLUP
K103675 10/03/2011 CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE CHIENMAX VIETNAM CO. LTD JIGAR SHAH
K112335 10/12/2011 BANTAM CATHETER (280MM BALLOON LENGTHS) CLEAR STREAM TECHNOLOGIES, LTD. FIONA NI MHULLAIN
K112828 10/25/2011 REVIVE INTERMEDIATE CATHETER (REVIVE IC) CODMAN & SHURTLEFF, INC. CATHERINE KILSHAW
K103791 10/21/2011 PHYSIOGLOVE ES WITH ECG ANALYSIS COMMWELL LTD. IRVING LEVY
K112384 10/18/2011 ABDOMINAL TOURNIQUET SYSTEM COMPRESSION WORKS LLC RUTH FORSTADT
K112019 10/12/2011 BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP CORENTEC CO., LTD J.S. DANIEL
K111825 10/25/2011 ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H FRANK GIANELLI
K110531 10/06/2011 ENDOFLIP ECD CROSPON, LTD. PAUL DRYDEN
K111343 10/06/2011 CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS CROSSTEX INTERNATIONAL, INC. RICHARD M ORMSBEE
K111120 10/14/2011 CSM SUBMERGED-R IMPLANT SYSTEM CSMIMPLANT APRIL LEE
K112974 10/20/2011 PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM CURVE DENTAL, INC. GEORGE STANTCHEV
K110912 10/20/2011 SMART TOUCH UVTHERAPY MULTIPLE MACHINE DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K111542 10/20/2011 DELTEX MEDICAL CARDIOQ EDM DELTEX MEDICAL LIMITED NEIL R ARMSTRONG
K112249 10/25/2011 HEALIX KNOTLESS(TM) ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K111822 10/26/2011 STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH DIAGNOSTICA STAGO, INC. CARLO D'ALESSANDRO
K112746 10/21/2011 DIOSLIMON IMPLANT SYSTEM DIO CORPORATION TIMOTHY LEE
K112874 10/17/2011 EZ VEIN INFLATABLE TOURNIQUET DOMINION MEDICAL DEVICES, LLC ELAINE DUNCAN
K103625 10/06/2011 OXYLOG 3000 PLUS WORKSTATION, OXYLOG 3000 PLUS BASIC DEVICE DRAEGER MEDICAL SYSTEMS, INC. JOYCE KILROY
K111583 10/04/2011 FLAATZ 560 DRTECH CORP. CHOUL-WOO SHIN
K112694 10/14/2011 EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K112466 10/27/2011 4MP COLOR LCD MONITOR, RADIFORCERX430 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K110780 10/07/2011 ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II ELITECH GROUP DEBRA K HUTSON
K111735 10/03/2011 REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER ENCORE MEDICAL, L.P. TEFFANY HUTTO
K111010 10/27/2011 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC BRENDA JOHNSON
K111723 10/27/2011 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM EV3 INC BRENDA JOHNSON
K110716 10/18/2011 EVERYWAY LOW BACK PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K112415 10/21/2011 LIFECARE ARM & LEG PAIN RELIEF SYSTEM EVERYWAY MEDICAL INSTRUMENTS CO., LTD. ROBERT TU
K111155 10/20/2011 XTRAFIX EXTERNAL FIXATION SYSTEM EXTRAORTHO INC MARCOS VELEZ-DURAN
K110993 10/12/2011 FEMCHEC PRESSURE MANAGEMET DEVICE FEMASYS INC. LISA PEACOCK
K111683 10/31/2011 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. SHOSHANA FRIEDMAN
K111639 10/21/2011 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE DENISE OPPERMANN
K112439 10/17/2011 SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0 FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K111859 10/07/2011 ICEEDGE 2.4 CRYOABLATION NEEDLE,ICEEDGE 2.4 CRYOABLATION NEEDLE MULTIPACK GALIL MEDICAL INC. AMY MCKINNEY
K111200 10/12/2011 MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM GE HEALTHCARE CAROL ALLOIAN
K111551 10/04/2011 OEC(R) 9800, OEC(R) 9800 PLUS GE OEC MEDICAL SYSTEMS, INC GERALD BUSS
K103485 10/06/2011 SENOGRAPH DS, SENOGRAPH ESSENSTIAL GENERAL ELECTRIC COMPANY STEVEN KACHELMEYER
K111434 10/27/2011 GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L GIOTTO USA, LLC PATRICK MOONEY
K112756 10/07/2011 FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS GLOBUS MEDICAL, INC. KELLY J BAKER
K102278 10/20/2011 QUADRA BLOC TENS PLUS GRADIENT TECHNOLOGIES, LLC JOHN TOWNSEND
K111644 10/03/2011 MOBICATH TRANSSEPTAL NEEDLE GREATBATCH MEDICAL KRISTI FOX
K103757 10/13/2011 IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT GRIFOLS GARY LEHNUS
K111354 10/17/2011 GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) GS MEDICAL CO., LTD. DONALD W GUTHNER
K112803 10/24/2011 PATIENT MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K112844 10/27/2011 REHASTIM 2, REHAMOVE 2 HASOMED GMBH MATTHIAS WEBER
K111988 10/28/2011 EASYSCAN MODEL 1.2 I-OPTICS BV WILLIAM GREENROSE
K103278 10/28/2011 ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION I-SENS, INC. HYUN JOON OH
K111766 10/19/2011 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS IDEV TECHNOLOGIES, INC. DARENE GARNER
K111647 10/06/2011 C2 NERVEMONITOR SYSTEM WITH ACCESSORIES INOMED MEDIZINTECHNIK GMBH SASCHKA BUSCH
K111414 10/20/2011 QUANTA FLASH (TM) DGP SCREEN INOVA DIAGNOSTICS, INC. RUFUS BURLINGAME
K110569 10/24/2011 AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) INOVISE MEDICAL, INC. EARL ANDERSON
K112250 10/28/2011 CHX=CHX PLUS INTER-MED, INC. JOHN BAETEN
K111030 10/21/2011 E.G. SCAN (TM) ESOPHAGOSCOPE SYSTEM INTROMEDIC CO., LTD JINYOUNG LEE
K112263 10/07/2011 MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY INTUITIVE SURGICAL, INC. BRANDON HANSEN
K112520 10/26/2011 US-101L, US-103S ITO CO., LTD. HARUHISA OKADA
K111958 10/14/2011 TETRIC EVOCERAM BULK FILL IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K110819 10/05/2011 SINGHMED ROOLIP MANIPULATOR J.SINGH INSTRUMENTS CAROLINE TONTINI
K113091 10/28/2011 SYRINGES AND NEEDLES JIANGYIN CAINA TECHNOLOGY CO., LTD DIANA HONG
K112178 10/27/2011 JMS APHERESIS NEEDLE SET "WINGEATER(R)" V2 JMS NORTH AMERICA CORPORATION E.J. SMITH
K111948 10/24/2011 WINGEATER V2 JMS NORTH AMERICA CORPORATION E J SMITH
K110694 10/11/2011 CONCORDE BULLET SPINAL SYSTEM JOHNSON & JOHNSON DAPHNEY GERMAIN-KOLAWOLE
K110551 10/26/2011 EXPEDIUM SPINE SYSTEM JOHNSON & JOHNSON FRANK JURCZAK
K112037 10/06/2011 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. NANCY GIEZEN
K111402 10/20/2011 KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL KIMBERLY-CLARK ANN WATERHOUSE, RAC
K112635 10/07/2011 U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS KIMBERLY-CLARK CORP. SWARNA MUKUND
K110153 10/12/2011 SFC VERTEBRAL BODY REPLACEMENT KONIGSEE IMPLANTATE GMBH JUSTIN EGGLETON
K111772 10/20/2011 POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED AND WHITE (NON-COLORED). NON-STERILE KOSSAN LATEX INDUSTRIES(M)SDN BHD CHO SOW FONG
K103348 10/20/2011 DIGIVIEW 250 KUB TECHNOLOGIES, INC VIKRAM BUTANI
K111980 10/14/2011 CLEARFIL TRI-S BOND PLUS KURARAY AMERICA, INC. KIYOYUKI ARIKAWA
K111975 10/14/2011 CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK KURARAY MEDICAL INC. MICHIO TAKIGAWA
K111169 10/03/2011 PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF KWANG MYUNG DAICOM INC PRISCILLA CHUNG
K110783 10/24/2011 VENUS INTERBODY FIXATION SYSTEM- VENUS PLIF/TLIF, ALIF PEEK CAGE L & K BIOMED CO., LTD HEE KYEONG JOO
K112460 10/07/2011 MULTIPLE LARSON MEDICAL PRODUCTS, INC. PETER LARSON
K112098 10/19/2011 TBD LENSAR, INC. SHIRLEY MCGARVEY
K101286 10/20/2011 SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 LINDE HEALTHCARE AB ANDERS PALM
K110655 10/27/2011 MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM MAHE MEDICAL GMBH ANDREA PECSI
K111621 10/26/2011 MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS MASIMO CORPORATION ANIL BHALANI
K111492 10/13/2011 ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTS MATERIALISE N.V. ALEXANDRA RAZZHIVINA
K112703 10/04/2011 SHAKER DIGITAL THERMOMETER MEASURE TECHNOLOGY CO. LTD. RACK YU
K112115 10/07/2011 MECTACER BIOLOX(R) DELTA FEMORAL HEADS MEDACTA INTERNATIONAL ADAM GROSS
K112788 10/20/2011 EASTLYTE NA/K/CA/PH MEDICA CORP. PHOTIOS MAKRIS
K112626 10/20/2011 LIPSONIX(R) SYSTEM MODEL 2 MEDICIS TECHNOLOGIES CORPORATION MICHAEL A HOFFMAN
K102387 10/24/2011 MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES MEDISCOPE MANUFACTURING, INC. DIANE SUDDUTH MS, DVM, MPH
K112156 10/17/2011 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM MEDOS INTERNATIONAL SARL JOCELYN RAPOSO
K112345 10/31/2011 DISTAL VOLAR RADIUS PLATING SYSTEMS MEDOS INTERNATIONAL SARL SUZANA OTANO
K112086 10/14/2011 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE MEDRAD, INC. MIKE BURNSIDE
K111264 10/12/2011 CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA REGINA HOLMES
K112473 10/21/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CHRIS MCKEE
K110063 10/04/2011 SOVEREIGN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. MIKE SCOTT
K111520 10/26/2011 IPC POWEREASE SYSTEM MEDTRONIC XOMED, INC. RISHI SINHA
K112917 10/27/2011 ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID MEDTRONIC, INC. DEBORAH KIDDER
K112323 10/18/2011 CARDIA-CATH MILLAR INSTRUMENTS, INC. FATMA M ALI
K110057 10/28/2011 MINI MASSEUSE MJ SPECIALTY RETAIL CHARLES MACK
K110003 10/13/2011 MTF NEW BONE VOID FILLER MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY JOY
K112107 10/28/2011 BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS NEUROVIRTUAL USA, INC. EDUARDO FARIA
K110315 10/20/2011 NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE NEXGEN MEDICAL SYSTEMS, INC. CRAIG PAGAN
K110594 10/28/2011 GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS NIHON KOHDEN CORP. STEVE GEERDES
K112259 10/28/2011 NOBELACTIVE 3.0 GOLDADAPT ABUTMENTS NOBEL BIOCARE AB HERBERT CRANE
K112713 10/27/2011 NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS NORFOLK MEDICAL PRODUCTS, INC. MICHAEL DALTON
K112773 10/14/2011 NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GAISSER
K111597 10/13/2011 DISPOSABLE STIMULATING ELECTRODE NUVASIVE, INC. SHEILA BRUSCHI
K111311 10/17/2011 SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING OMISA INC. (SEGASIST TECHNOLOGIES) ALLISON MANNERS
K112629 10/11/2011 ONSET ACCESS CATHETER SYSTEM ONSET MEDICAL CORPORATION JOSEPH BISHOP
K111965 10/25/2011 VUSION(R) OS ORTHO DEVELOPMENT TOM HAUETER
K110326 10/27/2011 OSRAM ITOS OSRAM SYLVANIA, INC. MARIE A SCHROEDER
K110308 10/03/2011 PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K112269 10/20/2011 OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE OSTAR MEDITECH CORP. STEVEN CHANG
K111419 10/07/2011 OSTEOMED HAND FUSION SYSTEM OSTEOMED L.P. SUZANNE CHEANG
K111693 10/28/2011 PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR PHILIPS MEDICAL SYSTEMS TAMARA YOUNT
K112652 10/11/2011 SURESIGNS VS2+ -SURESIGNS VSI PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K111905 10/04/2011 INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K111378 10/04/2011 OXIMETRY INTERFACE KIT PHILIPS RESPIRONICS, INC ELAINE LARKIN
K102871 10/03/2011 SILVER CARE ANITBACTERIAL TOOTHBRUSH PIAVE SPAZZOLIFICIO S.P.A. KEILA LACOURT
K112267 10/20/2011 NEUROLAC(R) NERVE GUIDE POLYGANICS BV BETTY IJMKER
K103115 10/12/2011 PRODIGY DIABETES MANAGEMENT SOFTWARE PRODIGY DIABETES CARE, LLC. E.J. SMITH
K111978 10/13/2011 SULCUS BLUE PRODUITS DENTAIRES PIERRE ROLLAND RICK ROSATI
K111993 10/24/2011 FRAMEWALKER QUANTUM MEDICAL CONCEPTS, LLC. ALICIA BACH
K112177 10/24/2011 SOFIA ANALYZER AND INFLUENZA A+B FIA QUIDEL CORP. JOHN D TAMERIUS
K102346 10/14/2011 RANDOX DIGOXIN ASSAY RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K112017 10/11/2011 RAUMEDIC ICP MONITORING SYSTEM RAUMEDIC AG REINER THIEM
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