FDA 510(k) Decisions During September, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K122569 09/12/2012 LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR 3M COMPANY GINGER CANTOR
K113648 09/06/2012 LOQTEQ LARGE FRAGMENT SET LOQTEQ CORTICAL SCREW 4.5, SMALL HEAD, T25, SELF TAPPING LOQTEQ CORTICAL SCREW 4.5, T25, SELF AAP IMPLANTATE AG MARC SEEGERS
K120009 09/11/2012 TESTOSTERONE TEST SYSTEM; CALIBRATOR; AND QUALITY CONTROL MATERIAL (ASSAYED AND UNASSAYED) ABBOTT LABORATORIES JOHN RIZOS
K112892 09/06/2012 IMPELLA 2.5 PLUS CATHETER ABIOMED, INC. CAROLYN PEKAR
K121568 09/21/2012 DALI SPINAL FIXATION SYSTEM ACCEL SPINE DANIEL CHON
K121567 09/26/2012 ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM ACCEL SPINE DANIEL CHON
K121078 09/13/2012 VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM ACCEL SPINE DANIEL CHON
K120730 09/06/2012 LOUTREX TOPICAL CREAM ACELLA PHARMACEUTICALS, LLC LARA NOAH
K120450 09/19/2012 SLEEP PROFILER ADVANCED BRAIN MONITORING, INC. ADRIENNE LENZ
K122623 09/26/2012 SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ALLYSON PARKS
K111391 09/26/2012 STERRAD (R) 100NX DUO CYCLE TEST PACK ADVANCED STERILIZATION PRODUCTS NANCY CHU
K111375 09/14/2012 STERRAD (R) CYCLESURE (R) 24 BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS NANCY CHU
K111377 09/13/2012 STERRAD(R) 100NX STERILIZER DUO CYCLE ADVANCED STERILIZATION PRODUCTS NANCY CHU
K121309 09/06/2012 ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS JONATHAN KAHAN
K120235 09/17/2012 MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP AEROLASE MEDICAL LASERS LLC JENNIFER A HENDERSON
K121801 09/11/2012 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC Lisa Boyle
K122119 09/13/2012 DX-D FULL LEG FULL SPINE AFGA HEALTHCARE N.V. DAVID LEDWIG
K120732 09/06/2012 LENSSX LASER SYSTEM ALCON LENSX, INC. Judy Gordon
K122047 09/04/2012 ALAMO P ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K121150 09/21/2012 ALMA LASERS FAMILY OF PIXEL RF TIPS ALMA LASERS INC. KATHY MAYNOR
K121729 09/20/2012 E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD YUCHI CHU
K121641 09/07/2012 MINIARC PRO SINGLE-INCISION SLING SYSTEM AMERICAN MEDICAL SYSTEMS RENEE MELLUM
K121822 09/10/2012 DELICOT AMERICAN SURGICAL COMPANY, LLC ERIK PIASIO
K121022 09/17/2012 AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV AMERIWATER BRIAN BOWMAN
K121372 09/10/2012 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO., LTD LIU YI
K122270 09/28/2012 OVERTUBE ENDOSCOPIC ACCESS SYSTEM APOLLO ENDOSURGERY, INC. HEATHER CRAWFORD, RAC
K120814 09/06/2012 PADLOCK CLIP-12 APONOS MEDICAL CORP. JOHN FEE
K121305 09/25/2012 STERLING MEDICAL IMPULSE 3 STIMULATOR ARMSTRONG INDUSTRIES, INC. DHA MEDIQUIP INT. DHA S RALPH H ARMSTRONG
K121941 09/07/2012 ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) ELIZABETH DUNCAN
K122545 09/20/2012 CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) ELIZABETH DUNCAN
K122374 09/25/2012 ARTHREX SUTURE (UHMWPE) ARTHREX, INC. IVETTE GALMEZ
K120943 09/21/2012 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER ARTHROCARE CORPORATION CHERYL FREDRICK
K122022 09/26/2012 ATHEROEDGE ATHEROPOINT LLC JASJIT S SURI
K122611 09/26/2012 COOLRAIL LINEAR PEN MODEL MCRI ATRICURE, INC. JIM LUCKY, RAC
K113836 09/24/2012 BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM) AVERY DENNISON BELGIE, BVBA JERZY WOJCIK
K122260 09/12/2012 AYCAN MOBILE AYCAN DIGITALSYSTEME GMBH MATTHIAS BROENNER
K120875 09/07/2012 B&W DENTAL IMPLANT SYSTEM B&W SRL PRIYA BHUTANI
K120126 09/10/2012 BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE BAROSENSE, INC SHELIA STEVENS, PHD
K113852 09/28/2012 BAUSCH & LOMB IOL INJECTOR BAUSCH & LOMB, INC. JASON SMITH
K120384 09/12/2012 PROTECTOR, INJECTOR, CONNECTOR BD MEDICAL-MEDICAL SURGICAL SYSTEMS JOHN ROBERTS
K121492 09/11/2012 UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K121797 09/07/2012 BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B Becton, Dickinson and Company GREGORY P PAYNE, RAC
K121633 09/18/2012 BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV Becton, Dickinson and Company Gregory P Payne
K121983 09/07/2012 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA BENQ MEDICAL TECHNOLOGY CORPATION BOB LEIKER
K121787 09/05/2012 BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K121286 09/28/2012 EPIC 10 BIOLASE TECHNOLOGY, INC. ROBERT YANG
K121773 09/21/2012 NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE BIOMERICS EMILY MADSEN
K120776 09/11/2012 ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION BIOMET 3I TAMARA WEST
K121589 09/21/2012 BIOMET MICROFIXATION FACIAL PLATING SYSTEM BIOMET MICROFIXATION LAUREN JASPER
K121302 09/19/2012 BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM BIOMET MICROFIXATION SHERYL MALMBERG
K122378 09/20/2012 NEXTGEN ALTIUS OCT SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY
K122565 09/04/2012 ARC ENDOCUFF BODDINGTONS PLASTICS LTD JOHN BOVIS
K121694 09/14/2012 IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. HOLLY RAMIREZ
K121614 09/18/2012 NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. LAUREN ANDERSON
K121774 09/13/2012 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS BOSTON SCIENTIFIC CORP. BETH TOROK
K122072 09/28/2012 WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE Boston Scientific Corporation LAURIE PANNELLA
K122451 09/28/2012 EXACTRAC VERO BRAINLAB AG ALEXANDER SCHWIERSCH
K121519 09/18/2012 ISIGHT C & E GP SPECIALISTS, INC. MARTIN DALSING
K121590 09/20/2012 VESTIBULAR ANALYSIS APPARATUS CAPACITY SPORTS, LLC PAMELA M BUCKMAN
K122507 09/26/2012 DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION CARDINAL HEALTH 200, LLC LAVENIA FORD
K113407 09/07/2012 SNOWDEN PENCER LAPAROSCOPIC ERGONOMIC REPOSABLE SCISSORS CAREFUSION 2200, INC. KATE FULLER
K122427 09/12/2012 CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE CARESTREAM DENTAL LLC DANIEL HOEFER
K111128 09/13/2012 LABONACHECK A1C CERAGEM INTERNATIONAL, INC. RAYMOND CHUNG
K121256 09/12/2012 ALCO-SCREEN 02 CHEMATICS, INC. CARL REYNOLDS
K121850 09/20/2012 CHOICE SPINE FIXATION SYSTEM CHOICE SPINE, LP KIM FINCH
K113731 09/10/2012 ESENSOR RESPIRATORY VIRAL PANEL CLINICAL MICRO SENSORS, INC. JOEL CENTENO
K121580 09/25/2012 SURELASE CO2 LASER SYSTEM CLINICON CORP. GERALD PALECKI
K121974 09/06/2012 CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K122033 09/27/2012 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K121935 09/10/2012 TAPERSET HIP SMALL STEMS CONSENSUS ORTHOPEDICS, INC. MATTHEW M HULL
K120501 09/20/2012 CHAMP CHAMP TRANSIT CONVAID PRODUCTS, INC. MERVYN WATKINS
K121665 09/25/2012 BENCOX FORET & BENCOX DELTA CORENTEC CO., LTD J.S. DANIEL
K120924 09/10/2012 BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG CORENTEC CO., LTD J.S. DANIEL
K121439 09/14/2012 METAFIX FEMORAL HIP STEM SIZE 1 CORIN U.S.A. LUCINDA GERBER
K113060 09/10/2012 UNITY TOATAL KNEE SYSTEM CORIN U.S.A. LUCINDA GERBER
K121806 09/28/2012 BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE COVIDIEN ELIZABETH MALO
K113572 09/05/2012 LIGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H JOHN VAN HOVEN
K121880 09/25/2012 DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID DANVILLE MATERIALS, INC. LINDSAY TILTON
K122628 09/06/2012 SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES DATASCOPE CORP., CARDIAC ASSIST DIVISION CARLA S CERQUEIRA
K122030 09/05/2012 LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON DEGANIA SILICONE, LTD. ZOYA LEE
K122442 09/06/2012 DEPUY CTA REVERSE SHOULDER SYSTEM DEPUY FRANCE MEGAN BURNS
K122397 09/06/2012 LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM DIASORIN, INC. CAROL A DEPOUW
K121558 09/21/2012 DIAZYME HSCRP POC TEST KIT DIAZYME LABORATORIES Abhijit Datta
K121915 09/28/2012 BRIGHT RESTORATIVE MATERIALS DMP LTD DIMITRIS PRANTSIDIS
K121656 09/24/2012 GEMINI LITHOTRIPTER DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K121885 09/10/2012 EARLYSENSE CENTRAL DISPLAY SYSTEM EARLYSENSE LTD. DALIA ARGAMAN
K111142 09/21/2012 ECHOSOFT(TM) ECHOMETRIX LLC LARRY A KROGER
K120288 09/19/2012 ORTHOCAD SOFTWARE OPTION ESAOTE, S.P.A. ALLISON SCOTT, RAC
K112223 09/11/2012 EUROIMMUN ANTI-LKM-1 ELISA(LGG) EUROIMMUN US KATHRYN KOHL
K112221 09/11/2012 EUROIMMUN ANTI-SLA/LP ELISA(LGG) EUROIMMUN US KATHRYN KOHL
K121462 09/28/2012 EZ-BLOCKER EZ-BLOCKER B.V. LEWIS WARD
K113761 09/07/2012 INFRARED THERMOMETER FAMIDOC TECHNOLOGY CO., LTD LEON CAO
K122428 09/25/2012 FAXITRON SPECIEN RADIOGRAPHY SYSTEM FAXITRON BIOPTICS LLC DOUGLAS C WIEGMAN
K122413 09/13/2012 PATIENT POSITIONING SYSTEM FORTE AUTOMATION SYSTEMS, INC. PHIL REECE
K121674 09/21/2012 ASPIRE HD PLUS, ASPIRE HD-S FUJIFILM MEDICAL SYSTEM U.S.A., INC. PETER ALTMAN
K122515 09/11/2012 C2-9-D ULTRASOUND TRANSDUCER GE HEALTHCARE BRYAN BEHN
K122327 09/21/2012 VOLUSON E6/E8/E8EXPERT/E10 GE HEALTHCARE BRYAN BEHN
K122387 09/11/2012 VOLUSON P6, VOLUSON P8 GE HEALTHCARE BRYAN BEHN
K121827 09/13/2012 GSI VIEWER WITH VUE OPTION GE MEDICAL SYSTEMS SCS HELEN PENG
K122164 09/07/2012 MR VESSELLQ XPRESS GE MEDICAL SYSTEMS SCS HELEN PENG
K121676 09/20/2012 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT GE MEDICAL SYSTEMS, LLC SHASHIDHAR CS
K122067 09/27/2012 TYPE 1077 ACCUSCREEN GN OTOMETRICS TOM RINIKER
K122259 09/24/2012 BLOOD PRESSURE MONITOR WITH STETHOSCOPE HANGZHOU RELI-ON CO., LTD CHARILE MACK
K121005 09/21/2012 ADIPREP ADIPOSE TRANSFER SYSTEM HARVEST TECHNOLOGIES, CORP. GABRIEL J MURACA, JR.
K122341 09/26/2012 PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 HITACHI ALOKA MEDICAL, LTD.
K120064 09/05/2012 TEST, BLOOD GLUCOSE SYSTEM HMD BIOMEDICAL, INC. JESSICA TUNG
K122563 09/19/2012 MYOSURE XL ROD LENS HYSTEROSCOPE, MYOSURE XL OUTLFOW CHANNEL HOLOGIC, INC. SARAH FAIRFIELD
K122498 09/10/2012 MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K121335 09/13/2012 G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE HUTCHINSON SANTE S.N.C. RAFFI KRIKORIAN
K121654 09/05/2012 AUTO-CHEK BLOOD GLUCOSE MONITORING SYSTEM, METER, TEST STRIP. AUTO-CHECK CONTROL SOLUTION i-SENS, Inc. HYUN JOON OH
K121034 09/04/2012 IOI TOTAL HIP ICONACY ORTHOPEDIC IMPLANTS, LLC ROY Y HORI, PHD
K121541 09/13/2012 JAZZ SYSTEM IMPLANET S.A. JANICE M HOGAN
K121366 09/07/2012 HEMOCUE HBA1C 501 INFOPIA CO., LTD MARIA F GRIFFIN
K121479 09/13/2012 AIM INNEROPTIC TECHNOLOGY, INC CAROLINE GREEN
K121021 09/24/2012 INOMAX DS (DELIVERY SYSTEM) INO THERAPEUTICS DAVID TRUEBLOOD
K113863 09/20/2012 QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K120462 09/20/2012 AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) INOVISE MEDICAL, INC. EARL ANDERSON
K120012 09/11/2012 INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS INTEGRA LIFESCIENCES CORPORATION STEPHANIE SHEESLEY
K120052 09/04/2012 CVINSIGHT INTELOMED, INC JAN BERKOW
K112200 09/06/2012 FOCUS TOUCH CONCEPTION SYSTEM INTIMATE BRIDGE 2 CONCEPTION, INC NIKI C SPANIEL
K121573 09/10/2012 INTEGRA CAMINO ICP MONITOR INTRGRA LIFESCIENCES CORPORATION Erin Doyle
K121630 09/11/2012 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K122096 09/27/2012 KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K121187 09/17/2012 KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES KATALYST SURGICAL, LLC MICHELLE MCDONOUGH
K121755 09/25/2012 CUSTOM CRANIOFACIAL IMPLANT (CCI) KELYNIAM GLOBAL, INC. NICHOLAS BREAULT
K121316 09/10/2012 LANX SPINAL FIZATION SYSTEM LANX, INC. WILLIAM SANDUL
K120792 09/05/2012 TIXOS IMPLANT SYSTEM LEADER ITALIA S.R.L. STUART R GOLDMAN
K121415 09/05/2012 MOLLRING MULTITASC LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K112741 09/13/2012 POWDER FREE VINYL PATIENT EXAMINATION GLOVE LIFESTYLE SAFTY PRODUCTS (HUI ZHOU) CO. LTD RHONDA T ALEXANDER
K122622 09/19/2012 ENDURAMESH LUCERO MEDICAL, LLC JENNIFER PALINCHIK
K120277 09/12/2012 VITAL COUGH LUNG ASSIST, INC. LEWIS WARD
K113843 09/27/2012 FREEDOM ND: YAG LASER SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K122612 09/10/2012 HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX MAQUET CARDIOVASCULAR, LLC MARYLOU INSINGA
K120657 09/19/2012 MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS MASIMO CORPORATION PATRICIA MILBANK
K121914 09/07/2012 MASIMO SET USPO2 PULSE OXIMETRY CABLE MASIMO CORPORATION DAVID COLLETTE
K122042 09/04/2012 CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES MAUNA KEA TECHNOLOGIES MICHAEL DANIEL
K122232 09/28/2012 GMK NARROW MEDACTA INTERNATIONAL ADAM GROSS
K122641 09/28/2012 MPACT EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K121262 09/20/2012 MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY MEDEFIL, INC. PRADEEP AGGARWAL
K120281 09/17/2012 DIGNITY POWER INJECTABLE TITANIUM PORT MEDICAL COMPONENTS INC ROSANNA SEVERINI
K121383 09/05/2012 PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS) MEDICAL COMPONENTS INC JEAN CALLOW
K121848 09/21/2012 SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM MEDICAL COMPONENTS INC JEAN CALLOW
K120982 09/28/2012 DIGITAL EYE-FUNDUS CAMERA MEDIMAGING INTEGRATED SOLUTIONS, INC. (MIIS) CHIH-LU HSU
K120867 09/20/2012 VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS MEDOS INTERNATIONAL SARL LAURA BLEYENDAAL
K100645 09/14/2012 AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE MEDTRONIC INC. JESSICA SIXBERRY
K121219 09/25/2012 ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER MEDTRONIC INC. WENDY SAUNDERS
K122433 09/28/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. CHRIS MCKEE
K122591 09/18/2012 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. BECKY RONNER
K122019 09/13/2012 STREPTOCOCCUS APP. SEROLOGICAL REAGENTS MERIDIAN BIOSCIENCE, INC. Michelle L Smith
K120644 09/19/2012 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K122089 09/21/2012 OSTIAL PRO STENT POSITIONING SYSTEM MERIT MEDICAL SYSTEMS, INC. DAVID THOMAS
K120018 09/19/2012 MINDCHILD MERIDIAN FETAL HEART RATE MONITOR MINDCHILD MEDICAL LEO BASTA
K120306 09/27/2012 RAPICIDE OPA-28 MINNTECH CORP. BRENT GREIGER, MS, RAC
K122514 09/19/2012 VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST NANOSPHERE, INC MARK DEL VECCHIO
K120635 09/27/2012 EASYONE PRO RESPIRATORY TESTING DEVICE NDD MEDIZITECHNIK AG GERARD MASIELLO
K122373 09/20/2012 NEOMED ORAL/ENTERAL SYRINGE NEOMED, INC. MELINDA HARRISON
K113376 09/05/2012 NEOSS PROACTIVE TAPERED IMPLANT NEOSS LTD CHERITA JAMES
K120397 09/19/2012 MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM NIHON KOHDEN CORP. STEVE GEERDES
K112628 09/28/2012 NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET NIPRO MEDICAL CORPORATION JESSICA OSWALD
K121926 09/20/2012 BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K121947 09/10/2012 ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES NORTHSTAR HEALTHCARE HOLDINGS WESLEY TOAVS
K122352 09/11/2012 NUVASIVE PRECEPT SPINAL SYSTEM NUVASIVE, INC. Elias Ketchum
K113725 09/13/2012 VIRTUOST O.N. DIAGNOSTICS DAVID KOPPERDAHL
K113120 09/25/2012 CHF-Y0005 OLYMPUS MEDICAL SYSTEMS CORP. SHERI MUSGNUNG
K122593 09/13/2012 PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 OPTIM LLC JEFF BARRETT
K120136 09/26/2012 EMBRYOGEN ORIGIO A/S ERIC GRUFF
K121575 09/14/2012 OXFORD ANKLE FUSION NAIL(AFN) SYSTEM ORTHO SOLUTIONS LIMITED AL LIPPINCOTT
K120609 09/07/2012 VITROS CHEMISTRY PRODUCTS DHDL SLIDES Ortho-Clinical Diagnostics, Inc. MARLENE A HANNA
K122541 09/20/2012 ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) ORTHOFIX SRL CANDACE F CEDERMAN
K113770 09/04/2012 ORTHOFIX GALAXY FIXATION SYSTEM ORTHOFIX SRL CANDACE F CEDERMAN
K122005 09/06/2012 MAXLOCK EXTREME SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K122379 09/05/2012 FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM OSTIAL CORPORATION KAITLIN VON HOFFMANN
K121228 09/07/2012 PONTO BONE ANCHORED HEARING SYSTEM OTICON MEDICAL AB KAROLIN ISBERG JERNBY
K121707 09/24/2012 LEW MDI O-BALL COLLARED IMPLANT, PARK DENTAL RESEARCH CORP. RONALD BULARD
K120289 09/28/2012 PEERSCOPE SYSTEM PEERMEDICAL DAN LAOR
K121917 09/19/2012 PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM PENUMBRA, INC. MICHAELA MAHL
K113841 09/13/2012 IMMUNOCAP ALLERGEN COMPONENTS BUNDLE PHADIA US INC. MARTIN MANN
K113483 09/26/2012 ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION PHILIPS HEALTHCARE (CLEVELAND) CHRISTINE ANDERSON
K122026 09/21/2012 PRISM ACQUIRE PRISM PROCESS PRISM VIEW PRISM CLINICAL IMAGING, INC. JAMES L REUSS
K120766 09/11/2012 ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM (MODIFICATION) PROSURG, INC. A. DESAI
K121713 09/27/2012 PMT BONE SCREWS PROVIDENCE MEDICAL TECHNOLOGY, INC. GLEN MANGSETH
K122638 09/25/2012 TOSHIBA 3T 32CH HEAD SPEEDER COIL, QUALITY ELECTRODYNAMICS Kathleen Aras
K120825 09/14/2012 SUPRA SCAN DELIVERY SYSTEM QUANTEL MEDICAL MAUREEN O'CONNELL
K113720 09/20/2012 RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3 RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K122216 09/05/2012 RELIANCE ANTERIOR CERVICAL PLATE SYSTEM Reliance Medical Systems, LLC Bret M Berry
K120087 09/26/2012 EXSPIRON RESPIRATORY MOTION, INC. CHAS BURR
K121724 09/20/2012 ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 RICHARD WOLF MEDICAL INSTRUMENTS CORP. RON HASELHORST
K113282 09/20/2012 CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO RIEMSER ARZEIMITTEL AG James M Clinton
K112624 09/10/2012 ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 Roche Diagnostics JANE PHILLIPS
K122021 09/20/2012 STERISPINE LC CAGE SAFE ORTHOPAEDICS P. DUMOUCHEL
K122558 09/20/2012 ULTRASAFE PASSIVE NEEDLE GUARD SAFETY SYRINGES, INC. SUZANNE RICHARDSON
K122583 09/05/2012 UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM SAMSUNG MEDISON CO., LTD
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