FDA 510(k) Decisions During May, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K121265 05/22/2012 AMPHIRION PLUS PTA CATHETER MEDTRONIC INC. NAINESH SUREJA
K120612 05/25/2012 MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT MEDTRONIC INC. KELLEY BREHEIM
K120704 05/03/2012 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM 3M COMPANY JON PLATT
K120438 05/02/2012 FLASH (DIFFERENT MATERIALS) 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K112083 05/03/2012 LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES INTL., INC. MICHAEL D CECCHI
K121314 05/17/2012 ARCHITECT B12 ABBOTT LABORATORIES DARLA A ABANO
K121015 05/04/2012 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR IVALEE COHEN
K112585 05/24/2012 TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM ADIN DENTAL IMPLANTS SYSTEM LTD YANA PRUS-GALYNSKY
K120631 05/25/2012 PATIENT MONITOR ADVANCED INSTRUMENTS, INC. JORGE MILLAN
K120559 05/24/2012 AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM AESCULAP, INC. KATHY A RACOSKY
K112671 05/04/2012 STERILCONTAINER SYSTEM AESCULAP, LTD. DENISE ADAMS
K110212 05/01/2012 INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE MARA CALER
K113253 05/17/2012 ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113511 05/02/2012 ECHOSTAR SPICA 1.5T MR SYSTEM ALLTECH MEDICAL SYSTEMS AMERICA, INC. MICHAELEEN DOM
K113639 05/08/2012 C2 MEDICAL GLOVES AMERCARE, INC. ANDREW LOWERY
K120394 05/08/2012 LIFESTYLES ZERO LUBRICATED LATEX CONDOM ANSELL HEATHCARE PRODUCTS LLC CYNTHIA INGRAM
K120620 05/31/2012 CLEAN AND BOOST APEX DENTAL MATERIALS, INC. CHRIS KULTON
K120035 05/16/2012 APEX MEDICAL ICH CPAP SERIES (9S-007XXX) APEX MEDICAL CORP. ALAN CHANG
K112165 05/24/2012 RHEA CUP APEX MEDICAL TECHNOLOGIES, INC. SCOTT HERRICK
K120106 05/07/2012 APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM APIXIA INC. ERIC HUANG
K120587 05/25/2012 AMT T-FASTENER ANCHOR KIT APPLIED MEDICAL TECHNOLOGY, INC. ELIZABETH MEYER
K120412 05/30/2012 3M SPOTON TEMPERATURE MONITORING SYSTEM ARIZANT HEALTHCARE INC. DAVID WESTLIN
K112457 05/18/2012 LEFORTE SYSTEM BONE PLATE & SCREW ARKIN CONSULTING GROUP PAUL SUMNER
K112896 05/10/2012 ARRW EVOLUTION ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) TRACY MADDOCK
K121124 05/16/2012 ARTHREX MIXING AND DELIVERY SYSTEM ARTHREX, INC. CHRISTINA FLORES
K112669 05/11/2012 TATTOOSTAR EFFECT Y ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K113812 05/03/2012 ATAL-8 ATLAIM DANIEL KAMM
K112790 05/07/2012 AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON AXIS-SHIELD DIAGNOSTICS, LTD. KAREN HILL
K120150 05/24/2012 DUAL SPIKE TRANSFER DEVICE B. BRAUN MEDICAL, INC. BONNIE KINCAID
K120882 05/30/2012 SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE BARD ACCESS SYSTEMS, INC. HENRY BOLAND
K120431 05/03/2012 HALO90 ULTRA ABLATION CATHETER BARRX MEDICAL, INC. DAWN CHANG
K120443 05/22/2012 NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE BAXTER HEALTHCARE CORPORATION - RENAL DIVISION NANETTE HEDDEN
K121283 05/30/2012 BD EMERALD SAF-T SINGLE USE, HYPODERMIC BECTON, DICKINSON AND COMPANY KIMBERLY LANE
K121143 05/18/2012 LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) BIO-RAD LABORATORIES SUZSNNE PARSONS
K121149 05/16/2012 VANGUARD SSK 360 REVISION KNEE SYSTEM BIOMET MANUFACTURING CORP. GARY BAKER, M.S. RAC
K113271 05/18/2012 METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS BIOMET MANUFACTURING, INC. GARY BAKER
K112905 05/24/2012 COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM BIOMET ORTHOPEDICS LLC. GARY BAKER
K120335 05/03/2012 EMBRACE THERMOPLASTIC BIONIX DEVELOPMENT CORP. JAMES HUTTNER M.D., PH.D.
K120057 05/11/2012 ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) BIOPTIGEN, INC. DAWN REILLY-O'DELL
K120550 05/07/2012 CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD) BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K120425 05/24/2012 PENTARAY NAV HIGH-DENSITY MAPPING CATHETER BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K120353 05/09/2012 SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM BM KOREA CO., LTD. PRISCILLA CHUNG
K120495 05/21/2012 IMPULSE AND EXPO ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. YUMI WACKERFUSS
K121186 05/16/2012 RADIAL JAW 4 PULMONARY BIOPSY FORCEPS BOSTON SCIENTIFIC CORP. CORRIE GOODING
K120983 05/02/2012 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORPORATION JANIS F TARANTO
K113732 05/07/2012 IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) BRAINLAB AG ALEXANDER SCHWIERSCH
K120533 05/22/2012 BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K120183 05/11/2012 ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM BROADMASTER BIOTECH CORPERATION ROGER LAI
K121167 05/02/2012 CAIRE COMPANION 5 OXYGEN CONCENTRATOR CAIRE INC. BEN KADRLIK
K120327 05/10/2012 VERTESSA CALDERA MEDICAL, INC. VICKI GAIL
K120798 05/14/2012 DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR CANOPUS MEDICAL SUPPLY CO., LTD. GLORIA CHANG
K120543 05/30/2012 TANDEMHEART FEMORAL ARTERIAL CANNULA SET CARDIACASSIST INC. KATIE DILLON
K120934 05/23/2012 PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS CARDINAL HEALTH, INC. TATYANA BOGDAN
K121009 05/17/2012 HEARTCHECK ECG PEN WITH GEMS HOME CARDIO COMM SOLUTIONS, INC. JONATHAN WARD
K120518 05/04/2012 END TIDAL CO2 NASAL CANNULA CAREFUSION ERIKA FERNANDEZ
K113813 05/10/2012 SENTRYSUITE PRODUCT LINE CAREFUSION GERMANY 234 GMBH ELMAR NIEDERMEYER
K111382 05/31/2012 CELVER CELLULOSE CONCEPTS LLC MARIA F GRIFFIN
DEN120012 05/24/2012 CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
K113336 05/24/2012 CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
K113440 05/23/2012 HIGH FIVE CENTRAL MEDICARE SDN BHD NICK WANG
K120911 05/18/2012 XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) CEPHEID KERRY J FLOM
K121339 05/17/2012 CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS CHEMTRON BIOTECH, INC. JANE ZHANG
K120059 05/17/2012 LIQUID BANDAGE CHESSON LABORATORY ASSOCIATES, INC. SCOTT E NEUVILLE
K111941 05/25/2012 CHOYANG THERMAL MASSAGER CHOYANG MEDICAL INSTRUMENT CO., LTD. SHIN KUK YOO
K120287 05/16/2012 TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT CHURCH & DWIGHT CO., INC. JOSEPH CICCONE
K120249 05/11/2012 TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT CHURCH & DWIGHT VIRGINIA CO., INC. JOSEPH CICCONE
K113384 05/01/2012 EXTERNAL FIXATOR ST.A R 90 F4 CITIEFFE CLAUDE BERTHOIN
K121237 05/18/2012 BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE CLINIQA CORPORATION DAWN GAST
K112378 05/08/2012 COBES SURGICAL DRAPE COBES INDUSTRIES CO., LTD. LEON LU
K120284 05/23/2012 DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX COLOPLAST A/S JANELL COLLEY
K112322 05/17/2012 RESTORELLE POLYPROPYLENE Y MESH COLOPLAST A/S TIM CRABTREE
K121263 05/22/2012 TAPER SET HIP SYSTEM RDP STEM CONSENSUS ORTHOPEDICS, INC.
K111476 05/23/2012 CONTOUR TECHNOLOGY MUSCLE STIMULATOR CONTOUR TECHNOLOGY SARA PETRIE
K113510 05/17/2012 EVOLUTION COLONIC STENT SYSTEM COOK IRELAND LTD JACINTA KILMARTIN
K121039 05/25/2012 COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM COPAN FLOCK TECHNOLOGIES CYNTHIA SINCLAIR
K112797 05/04/2012 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER CORDIS CORP. DANNA MARSHALL
K121037 05/03/2012 LOSPA TIBIAL BASE PLATE CORENTEC CO., LTD J.S. DANIEL
K120362 05/04/2012 METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY CORIN U.S.A. LUCINDA GERBER, BA (HONS)
K112549 05/04/2012 IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER COVALON TECHNOLOGIES, INC. KIM CROOKS
K121194 05/03/2012 ENDO CLIP III 5MM CLIP APPLIER COVIDIEN ANGELA VAN ARSDALE
K120944 05/31/2012 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN JENNIFER SULLIVAN
K121139 05/02/2012 ACCUMESH DEPLOYMENT SYSTEM COVIDIEN LLC JAMES MCMAHON
K120605 05/18/2012 PERMACOL SURGICAL IMPLANT COVIDIEN LLC JAMES MCMAHON
K112511 05/11/2012 DOBBHOFF DUAL PORT FEEDING TUBE COVIDIEN LP, FORMERLY REGISTERED AS KENDALL DEBORA STAPLETON
K113660 05/03/2012 COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL CRYOTHERAPY PRODUCTS INC. JORGE CABALLERO
K121127 05/13/2012 SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS CYNOSURE, INC. IRINA KULINETS
K120077 05/14/2012 COMED K-SERIES MANUAL WHEELCHAIR DANYANG COMED HEALTHCARE CO., LTD RHONDA ALEXANDER
K120449 05/11/2012 HEALIX ADVANCE PEEK ANCHOR DEPUY MITEK YAYOI FUJIMAKI
K121020 05/03/2012 VIPER SYSTEM DEPUY SPINE, INC. KIRSTEN LEHMULLER
K113689 05/04/2012 DUKAL LUBRICATING JELLY DUKAL CORPORATION PATRICK J LAMB
K113050 05/16/2012 CLEARPATH LOWER GI EASYGLIDE LTD. PAUL DRYDEN
K113166 05/16/2012 CLEARPATH UPPER GI EASYGLIDE LTD. PAUL DRYDEN
K120173 05/16/2012 PATIENT MONITOR EDAN INSTRUMENTS INC RANDY JIANG
K113565 05/18/2012 MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN EDWARDS LIFESCIENCES, LLC. MARGUEITE THOMLINSON
K120072 05/08/2012 VENOUS DRAINAGE CANNULA WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC. KAREN JONES
K120811 05/24/2012 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB VIVEKA WRETMAN
K120604 05/25/2012 K-LASER ELTECH S.R.L RICHARD ALBRIGHT
K120184 05/02/2012 POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED ENCOMPASS MEDICAL SUPPLIES ONC LIMITED CJ ANG
K120513 05/08/2012 GLOW BY ENDYMED ENDYMED MEDICAL LTD YORAM LEVY
K121174 05/17/2012 XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. KAREN E PETERSON
K121207 05/18/2012 EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. CYNTHIA HUNG
K120257 05/14/2012 MLS, ZERONA-AD ERCHONIA MEDICAL, INC. KEVIN WALLS
K121384 05/23/2012 MYLABSOGNO ESAOTE, S.P.A. ALLISON SCOTT, RAC
K120748 05/01/2012 SPEEDUP SOFTWARE OPTION ESAOTE, S.P.A. ALLISON SCOTT, RAC
K120729 05/17/2012 HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 ETHICON ENDO-SURGERY, LLC DONOVAN MAY
K113576 05/18/2012 DOUBLE LUMEN VIDEO TRACHEOSDOPE (DLVT) SYSTEM ETVIEW LTD. YORAM LEVY
K121307 05/31/2012 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ EXACTECH, INC. PATRICK HUGHES
K110734 05/31/2012 NCI SPATULA FISCHER SURGICAL INC. JESSICA DIXON
K102577 05/03/2012 FORCE MEDICAL IM NAIL SYSTEM FORCE MEDICAL, INC AL LIPPINCOTT
K112621 05/30/2012 WIS1000 FORESEESON CUSTOM DISPLAYS, INC. DANIEL TOMLINSON
K113713 05/07/2012 GEN_2 MECHANICAL WHEELCHAIR FREE WHEELCHAIR MISSION SHARON ROCKWELL
K120637 05/08/2012 SYNAPSE 3D BRAIN PERFUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K120333 05/25/2012 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY GAMBRO RENAL PRODUCTS FEI LAW
K120521 05/10/2012 GC BLUE SILICONE GC AMERICA, INC. MARK HEISS
K120601 05/24/2012 GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O GEISTLICH PHARMA AG DANIEL A KRACOV
K111409 05/03/2012 APTIMA COMBO 2 ASSAY GEN-PROBE, INC. JODY J FLEMING
K112856 05/10/2012 LUCINA-MELODI GENADYNE BIOTECHNOLOGIES, INC. CHIEN-MING GOH
K120216 05/16/2012 GENOSYL MV-1000 GENO LLC PAUL DRYDEN
K120441 05/31/2012 GETINGE 700HC-E SERIES STEAM STERILIZER GETINGE SOURCING LLC BARB SMITH
K113853 05/08/2012 G+ SYSTEM GLYTEC, LLC WILLIAM MATTHEWS
K113833 05/01/2012 VITAL SIGNS MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD DIANA HONG
K121166 05/08/2012 WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K121466 05/31/2012 GUIDEMIA GUIDEMIA TECHNOLOGIES, LLC FEI GAO
K120586 05/22/2012 CELL SAVER ELITE HAEMONETICS CORP. GREG CALDER
K120574 05/30/2012 HAMILTON-C1 HAMILTON MEDICAL AG RALPH AGUILA
K111004 05/29/2012 HANSEN MEDICAL VASCULAR CATHETER CONTROL SYSTEM AND CATHETER HANSEN MEDICAL, INC. KATE WHITIN
K120894 05/17/2012 HAYMAX HAYMAX LIMITED MAX WISEBERG
K110074 05/25/2012 HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM HEALTH & LIFE CO., LTD. SARAH SU
K120548 05/04/2012 HLIC NEEDLE-LESS VALVE HEALTH LINE INTERNATIONAL CORPORATION NOLA BENSTOG
K113622 05/18/2012 ORION II CT CVC HEALTH LINE INTERNATIONAL CORPORATION (HLIC) NOLA BENSTOG
K120369 05/10/2012 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) HITACHI CHEMICAL DIAGNOSTICS, INC. BUNICHIRO NAKAJIMA
K113145 05/01/2012 ECHELON OVAL MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K113341 05/03/2012 GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K112800 05/23/2012 SUNTOUCH TOPICAL HEMOSTATIC DRESSING HUIZHOU FORYOU MEDICAL DEVICES CO, LTD CHENGYU SHEN
K121132 05/10/2012 EZSENSOR P DIGITAL INTRAORAL SENSOR HUMANRAY CO,LTD DAVE KIM
K120351 05/03/2012 CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA I-SENS, INC. HYUN JOON OH
K120267 05/15/2012 FILMARRAY RP PANEL IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K113670 05/08/2012 ELEMENT BLOOD GLUCOSE MONITORING SYSTEM INFOPIA CO., LTD PRISCILLA CHUNG
K113088 05/02/2012 HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) INNERSPACE, INC DON BOBO
K120493 05/17/2012 MINI CANNULATED HEADED AND HEADLESS SCREW SET INSTRATEK, INC. JEFF SEAVEY
K112995 05/03/2012 GEM PREMIER 4000 INSTRUMENTATION LABORATORY CO. CARL MARBLE
K120633 05/24/2012 MAYFIELD SKULL CLAMP INTEGRA LIFESCIENCES CORPORATION LINDSAY MIGNONE
K112986 05/01/2012 LATERAL FUSION DEVICE INTEGRA SPINE (INTEGRA LIFESCIENCES) DALE DAVISON
K120895 05/24/2012 REMOTE PRESENCE SYSTEM INTOUCH HEALTH, INC. STEVE SIDWELL
K121023 05/31/2012 SPECTRUM V.0 INTRINSIC MEDICAL IMAGING STEPHEN J GOLDNER, JD, RAC
K111450 05/18/2012 MIROCAM CAPSULE ENDOSCOPE SYSTEM INTROMEDIC CO., LTD JEFFREY ROBERTS
K120736 05/14/2012 SR PHONARES II IVOCLAR VIVADENT AG DONNA M HARTNETT
K112665 05/04/2012 TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE J. MORITA USA, INC. KEITH A BARRITT
K113355 05/02/2012 POSEY BED J. T. POSEY CO. BONNIE BISHOP
K120099 05/18/2012 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. NANCY GIEZEN
K120899 05/25/2012 RANGE SPINAL SYSTEM, UNIT ROD K2M, INC. NANCY GIEZEN
K121232 05/24/2012 K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR KAMIYA BIOMEDICAL COMPANY SHAWN KAPLAN
K120033 05/31/2012 ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT KCI USA, INC. SHANNON SCOTT
K120141 05/04/2012 KENSEY NASH BONE VOID FILLER XC KENSEY NASH CORORATION SUSAN PILEGGI
K113340 05/04/2012 KIMBERLY-CLARK CHILD'S FACEMASK KIMBERLY-CLARK ANN WATERHOUSE
K113333 05/11/2012 KIMBERLY-CLARK KIM VENT MICROCUFF ENDOTRACHEAL TUBE FOR ADULTS KIMBERLY-CLARK CORPORATION MARCIA JOHNSON
K121109 05/23/2012 AERODR X70 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHIGEYUKI KOJIMA
K111956 05/30/2012 KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K120879 05/23/2012 LEXUS CERVICAL FIXATION SYSTEM L & K BIOMED CO., LTD KI HYANG KIM
K120840 05/24/2012 LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED CO., LTD KI HYANG KIM
K121116 05/08/2012 PLATEAU SPACER SYSTEM LIFE SPINE RANDY LEWIS
K112158 05/10/2012 MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K120761 05/08/2012 LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K121227 05/23/2012 MANUKA FILL LINKS MEDICAL PRODUCTS, INC. JAMES SMITH
K120976 05/23/2012 MANUKA IG LINKS MEDICAL PRODUCTS, INC. JAMES SMITH
K113739 05/30/2012 SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM MATERIALISE DENTAL NV GEERT APPELTANS
K121322 05/31/2012 CLOSER TO NATURE MAYBORN GROUP LIMITED NEIL HEWITT
K120497 05/14/2012 EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL MEDICA CORP. PHOTIOS MAKRIS
K120980 05/02/2012 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC MEDICAL COMPONENTS INC JEAN CALLOW
K120981 05/02/2012 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC MEDICAL COMPONENTS INC JEAN CALLOW
K120860 05/08/2012 INFU BOX TYPE 0412A MEDICAL RESCUE EQUIPMENT HOLDING AS KNUT FANGBERGET
K112921 05/16/2012 MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM MEDICAL.GORITHMICS S.A. MARTIN JASINSKI
K120130 05/21/2012 FALLER TROCAR MEDIGROUP, INC. IRENE NAVIS
K120299 05/18/2012 SRS ENDOSCOPIC STAPLING SYSTEM MEDIGUS, LTD. JONATHAN S KAHAN
K111049 05/25/2012 MOBILE VERSA LIGHT MEDTEK LIGHTING CORP ROBERT WAGNER
K120537 05/10/2012 AQUAMANTYS3 9.5 XL BIPOLAR SEALER MEDTRONIC INC. TARA N TURNEY, RAC
K110472 05/29/2012 SI-FIX SACROILIAC JOINT FUSION SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K120271 05/30/2012 ARTISAN SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. LIN WU
K120978 05/02/2012 OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K121044 05/01/2012 ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K112527 05/22/2012 UNIVERSAL DIGITAL INTERFACE (UDI) 1717 MERIDIAN MEDICAL SYSTEMS, LLC ARIEL MARCIANO
K113577 05/08/2012 MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K120404 05/21/2012 MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH MERZ DENTAL GMBH RICHARD G HUNTER
K120171 05/04/2012 ACCUSONIC ADVANTAGE METRON MEDICAL AUSTRALIA PTY LTD DAVID MITCHELL
K111008 05/02/2012 MICROWARE BONE PLATES AND BONE SCREW MICROWARE PRECISION CO., LTD. HARRISON DU
K120821 05/11/2012 LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM MISDER, LLC NANCY SAUER
K120515 05/23/2012 TEMPUS CERVICAL PLATE SYSTEM NEUROSTRUCTURES, LLC MEREDITH MAY
K112881 05/22/2012 NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM) NEXSTIM OY RAINER HARJUNPAA
K113451 05/08/2012 NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX NIDEK TECHNOLOGIES SRL ENRICO BISSON
K113215 05/14/2012 MODEL 7600 REGIONAL OXIMETER SYSTEM WITH EQUANOX TECHNOLOGY NONIN MEDICAL, INC. BRODIE PEDERSON
K120619 05/21/2012 ORTHODONTIC FLOWABLE BRACKET ADHESIVE NOVOCOL, INC. STEVE RUDOLPH
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