FDA 510(k) Decisions During August, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K113652 08/30/2012 LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T AAP IMPLANTATE AG MARC SEEGERS
K121352 08/15/2012 ARMADA 14XXT PTA CATHETER ABBOTT VASCULAR IVALEE COHEN
K120714 08/09/2012 PICASSO MIS SPINAL FIXATION SYSTEM ACCEL SPINE DANIEL CHON
K121136 08/09/2012 RENOIR POSTERIOR CERVIAL FIXATION SYSTEM ACCEL SPINE DANIEL CHON
K121934 08/29/2012 TOMOTHERAPY TREATMENT SYSTEM ACCURAY INCORPORATED GREG BANGE
K121324 08/23/2012 AVT NATURASOFT ADVANCED VISION TECHNOLOGIES MARTIN DALSING
K122353 08/30/2012 CRAINFIX 2 TITANIUM CLAMP SYSTEM AESCULAP, INC. DENISE ADAMS
K121611 08/23/2012 AMPLATZER TORQVUE FX AGA MEDICAL CORPORATION SHERRY KOLLMANN
K121095 08/16/2012 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. DAVID LEDWIG
K121429 08/10/2012 AIMAGO EASYLDI MICROCIRCULATION CAMERA AIMAGO SA MARC ANDRE
K113389 08/10/2012 ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113437 08/06/2012 ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K122302 08/27/2012 ACE MAGNESIUM REGENT ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC HYMAN KATZ
K121181 08/22/2012 SWANNSHIDI BONE MARROW ASPIRATION NEEDLE ALLIANCE PARTNERS, LLC JENNIFER PALINCHIK
K112548 08/15/2012 ALTOMEC ARTHROSCOPE ALTOMEC ENDOSCOPY INC DARREN REEVES
K121892 08/24/2012 PHANTOM PLUS CERAMIC CAGE SYSTEM AMEDICA CORP. ROBERT M WOLFARTH
K121168 08/08/2012 APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH APTUS ENDOSYSTEMS, INC. BURT GOODSON
K110954 08/24/2012 ARJORAD STERILE WRAP ARJO WIGGINS MEDICAL, INC. JON WARD
K113508 08/31/2012 DACRYOCATH ARMADILLO BIOMEDICAL, LLC ROBYN SCOPIS
K111246 08/10/2012 SPIRALE DRUG DELIVERY SYSTEM ARMSTRONG MEDICAL LTD. IAN STEWART
K122027 08/28/2012 ARROW FLEXBLOCK CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER ARROW INTERNATIONAL, INC. PAUL AMUDALA
K122276 08/29/2012 ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP ATRICURE, INC. JAMES LUCKY
K122138 08/17/2012 ATRIUM FLIXENE IFG VASCULAR GRAFT ATRIUM MEDICAL CORP. MEGAN MCCAGH
K122297 08/28/2012 ENLUXTRA HUMIFIBER WOUND DRESSING BASF VENTURE CAPITAL AMERICA INC. NADI ERGENC, PH.D.
K120994 08/07/2012 BD BACTEC PLUS PRIME AEROBIC/F BECTON, DICKINSON AND COMPANY PAUL SWIFT
K121854 08/22/2012 SYSTEM, X-RAY, STATIONARY BEIJING SINOPHARM HUNDRIC MEDILINE INFO. TECH. CO., LTD DIANA HONG
K122281 08/29/2012 PADNET 2.0 BIOMEDIX, INC. GREG HOCKING
K113783 08/07/2012 VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. ELIZABETH LANDON
K121863 08/16/2012 VITEK 2 AST-ST CEFOTAXIME BIOMERIEUX, INC. ELIZABETH LANDON
K122359 08/28/2012 VITEK 2 STRPTOCOCCUS CEFTRIAXONE BIOMERIEUX, INC. THI MY LAN DANG
K120030 08/17/2012 TAPERLOC COMPLETE SIZE 4MM AND XR 123 BIOMET MANUFACTURING CORP. BECKY EARL
K120423 08/03/2012 BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 BIONIME CORPORATION FENG-YU LEE
K121267 08/02/2012 BT-200V VASCULAR DOPPLER BISTOS CO., LTD. YOUNG CHI
K121196 08/31/2012 EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) BOSTON SCIENTIFIC CORP. VICKY L HAGENS
K121667 08/13/2012 NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) BOSTON SCIENTIFIC CORP. LAURA J LIND
K122394 08/30/2012 RUBICON 18 SUPPORT CATHETER BOSTON SCIENTIFIC CORP. DIANE NELSON
K122203 08/17/2012 TRUETOME BOSTON SCIENTIFIC CORP. LAURIE PANNELLA
K121048 08/03/2012 ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED BOSTON SCIENTIFIC CORP. JANIS F TARANTO
K120789 08/14/2012 EXACTRAC X-RAY X-RAY BRAINLAB AG ALEXANDER SCHWIERSCH
K113472 08/30/2012 PRECISE SHP DIODE LASER CAO GROUP, INC. ROB K LARSEN
K121176 08/17/2012 STGC CARDINAL SPINE, LLC KEVIN A THOMAS
K122285 08/14/2012 TABLET COMMANDER CARDIOCOM LLC DANIEL L COSENTINO
K120246 08/28/2012 KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN) CARESTREAM HEALTH,INC. KATHERINE HONSINGER
K122246 08/13/2012 MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12 CELLERATION, INC. KATHY SIMPSON
K120819 08/31/2012 STALIF C CENTINEL SPINE, INC. JOHN PARRY
K120004 08/23/2012 (MULTIPLE) DIGITAL THERMOMETER CHINA SHENYANG MED-LAND IMP/EXP CORP., LTD. ANN D MCGONIGLE
K121867 08/02/2012 SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS CHISON MEDICAL IMAGING CO., LTD.
K112864 08/02/2012 SOFTSEAL-C CHITOGEN, INC. JAMES F DRAKE
K120469 08/13/2012 ERISMA-LP CLARIANCE WILLIAM JACKSON
K121311 08/30/2012 THIXO-GEL ULTRASOUND SPRAY CLOVERLINE INTERNATIONAL PHARMA SERVICES GMBH CHRISTINA BERNSTEIN
K121776 08/14/2012 AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE CODMAN & SHURTLEFF, INC. JOAN BARTLE
K122118 08/03/2012 HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM CODMAN & SHURTLEFF, INC. KATHY STRANGE
K122179 08/20/2012 VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) COMPRESSION THERAPY CONCEPTS LEONARD NASS
K120961 08/03/2012 TREVO RETRIEVER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K121819 08/13/2012 SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER COVALON TECHNOLOGIES, INC. CHRISTOPHER FREDRIC
K120997 08/27/2012 BAROSTAT SOFTWARE OPTION CROSPON, LTD. PAUL DRYDEN
K121718 08/17/2012 A-V FOOT PUMP DALIAN LABTEK SCIENCE & DEVELOPMENT CO., LTD. DORIS DONG
K121698 08/06/2012 NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN DENTSPLY INTERNATIONAL INC. HELEN LEWIS
K121140 08/22/2012 PROLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC KATHY CRUZ
K121040 08/30/2012 SMARTLYTE ELECTROLYTE ANALYZER DIAMOND DIAGNOSTICS, INC. KATHY CRUZ
K111534 08/02/2012 ABACUS 3CP DIATRON US INC MICHAEL SWITZER
K121938 08/01/2012 MEDILAS H RFID LASER FIBER DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K121396 08/14/2012 DYNAFLEX DYNA FLEX MATTHEW MALABEY
K120835 08/20/2012 DYNATRON THERMOSTIM PROBE-DONE DYNATRONICS CORPORATION DOUGLAS SAMPSON
K121996 08/03/2012 BE PLUS LTM AMPLIFIER GWI AMPLIFIER EB NEURO, S.P.A. ALLISON SCOTT
K121185 08/22/2012 EDWARDS PERCUTANEOUS SHEATH INTRODUCER EDWARDS LIFESCIENCES, LLC. SPENCER WALKER
K122444 08/30/2012 CERVICAL CAGE EISERTECH, LLC LUKAS EISERMANN
K120451 08/03/2012 8MP COLOR LCD MONITOR, REDIFORCE RX840 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K122083 08/22/2012 ELITECH CLINICAL SYSTEMS CK NAC SL ELITECHGROUP DEBRA K HUTSON
K121727 08/15/2012 MOVATION KNEE SYSTEM ENCORE MEDICAL, L.P. WILLIAM GARZON
K113062 08/21/2012 ENDOSERVICE ENDOSCOPIC INSTRUMENTS & ACCESSORIES AND MINIMALLY INVASIVE GI AND GU DEVICES ENDOSERVICE OPTICAL INSTRUMENTS GMBH ANDREA PECSI
K121943 08/22/2012 XPRESS MULTI-SINUS DILATION TOOL ENTELLUS MEDICAL, INC. KAREN E PETERSON
K121351 08/29/2012 SINUS DILATION SYSTEM ENTRIGUE SURGICAL, INC. GABRIELE G NIEDERAUER, PH.D.
K111603 08/23/2012 LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM EP DYNAMICS, INC. ALBERT REGO
K121695 08/23/2012 ERCHONIA ZERONA ERCHONIA CORPORATION KEVIN WALLS
K121690 08/23/2012 ETCHONIA ZERONA ARMS ERCHONIA CORPORATION KEVIN WALLS
K122006 08/06/2012 G-SCAN BRIO ESAOTE, S.P.A. ALLISON SCOTT, RAC
K121550 08/22/2012 HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY ETHICON ENDO-SURGERY, LLC MARCIA ARETZ
K122205 08/15/2012 EXINI EXINI DIAGNOSTICS AB ALLISON SCOTT
K121142 08/09/2012 CRAWFORD BIOCANALICULUS INTUBATION FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) BARBARA FANT
K113536 08/03/2012 MASTERKA 40 MASTERKA 35 MASTERKA 30 FCI SAS (FRANCE CHIRURGIE INSTRUMENTATION) BARBARA FRANT
K120986 08/16/2012 STRATIFY JCV DXSELECT FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K121154 08/20/2012 ULTRASONIC NEBULIZER FOSHAN GAUNYING ELECTRONICS CO., LTD. GUENTER GINSBERG
K120781 08/09/2012 CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH FUJI SYSTEMS CORP. PAUL MASON
K120629 08/28/2012 FDR GO FLEX FUJIFILM MEDICAL SYSTEM U.S.A., INC. PETER ALTMAN
K120446 08/13/2012 FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2 FUJINON, INC. MARK JOB
K121251 08/28/2012 ICEROD CX CRYOABLATION NEEDLE ICEROD CX CRYOABLATION NEEDLE MULTIPACK GALIL MEDICAL LTD. LYNNE DAVIES
K122234 08/16/2012 OEC 9900 ELITE GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC GERALD BUSS
K121062 08/17/2012 VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K121063 08/21/2012 VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. BRYAN BEHN
K113607 08/10/2012 BIOPSY DIGIT S BIOPSY SL GIOTTO USA, LLC NICOLAAS BESSELING
K120169 08/24/2012 INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT GRIFOLS USA, LLC GARY LEHNUS
K121987 08/01/2012 WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K121678 08/30/2012 DTAD GYRUS ACMI, INC. DOLAN MILLS
K122275 08/29/2012 ARTISAN EXTEND CONTROL CATHETER HANSEN MEDICAL HASSAN LABAY
K120536 08/06/2012 HEART SYNC PEDIATRIC PHYSIO AED PAD HEART SYNC INC. DANIEL KAMM
K121485 08/21/2012 GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING HEMCON MEDICAL TECHNOLOGIES EUROPE LTD BARBARA MCGRATH
K112532 08/06/2012 ET II BIO-SA FIXTURE SYSTEM HIOSSEN INC. PATRICK LIM
K113809 08/17/2012 HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) HITACHI CHEMICAL DIAGNOSTICS, INC. ERICKA B AMMIRATI
K120500 08/20/2012 THE PAIN PILOT (A.K.A PAIN PILOT) HOLLYWOG, LLC MICHAEL W TREAS
K120398 08/16/2012 WITOUCH PRO HOLLYWOG, LLC MICHAEL W TREAS
K112692 08/03/2012 IDENTIFY HUMEDIQ GMBH MORITZ HOYER
K111627 08/21/2012 SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. DARLENE GARNER
K122141 08/07/2012 IDS-ISYS IGF-I CALIBRATION VERIFIERS IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K121997 08/10/2012 IMRIS ONCOLOGY PACKAGE IMRIS, INC. SANJAY SHAH
K112373 08/17/2012 CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION INNOVA VISION INC. JENNIFER REICH
K121012 08/31/2012 FLEXLAB 3.6, ACCELERATOR A3600 INPECO S.P.A. ROBERTO TAMBORRA
K113552 08/23/2012 FREEDOM INGUINAL HERNIA IMPLANT INSIGHTRA MEDICAL WAYNE NODA
K113210 08/10/2012 ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT ISOAID, L.L.C. BENJAMIN ROEDELL
K121230 08/29/2012 IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K122329 08/16/2012 BIOJET JET SOFT SRL PETER-M KLEWS
K113507 08/08/2012 KENT CAMERA KENT IMAGING INC. DARRELL BARNHART
K113685 08/10/2012 POWDER FREE LATEX EXAMINATION GLOVES KHAI HOAN JOINT STOCK COMPANY TERENCE LIM
K112787 08/08/2012 KERATOR KJ MEDITECH CO., LTD PRICILLA CHUNG
K121940 08/02/2012 LANX SPINAL FIXATION SYSTEM LANX, INC. PATRICK HUNT
K122145 08/17/2012 LANX SPINAL FIXATION SYSTEM LANX, INC. MICHAEL FUNK
K121824 08/23/2012 ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 LASCOD SPA BLIX WINSTON
K121103 08/24/2012 LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S LDR SPINE USA INC. BRADLEY W STRASSER
K121839 08/08/2012 UNBALLOON NON-OCCLUSIVE MODELING CATHETER LEMAITRE VASCULAR INC. ANDREW HODGKINSON
K111953 08/07/2012 NAUTILUS SPINAL SYSTEM LIFE SPINE RANDY LEWIS
K112534 08/10/2012 LIFECELL TISSUE EXPANDER LIFECELL CORP. KRISTEN MEANY
K121289 08/03/2012 LTM-LABAROSCOPIC SURGICAL MESH LIFECELL CORP. MARK R JAKUBOWSKI
K121890 08/22/2012 GENESYS PRESSFT SUTURE ANCHOR LINVATEC CORPORATION D/B/A CONMED LINVATEC LORNA K LINVILLE
K113830 08/30/2012 VANTERA CLINICAL ANALYZER LIPOSCIENCE SUZETTE WARNER
K121368 08/10/2012 NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE) MATANG MFG. SDN. BHD. LESLIE LEONG
K122201 08/30/2012 PROTURA COUCH SOFTWARE MED-TEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS AMANDA STAHLE
K121148 08/20/2012 SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D MEDICAL DESIGN LLC. KRISTI VONDRA
K121014 08/01/2012 SOLAR GI MEDICAL MEASUREMENT SYSTEMS,B.V. K. OGINK SOMHORST
K113673 08/03/2012 MYSAFETY SYRINGE MEDICALCHAIN INTERNARTIONAL CORPORATION ROBIN HWANG
K120008 08/17/2012 MEDLINE HIGH PRESSURE INJECTION TUBING MEDLINE, INDUSTRIES, INC. MATT CLAUSEN
K113560 08/01/2012 CELOX GAUZE PRO MEDTRADE PRODUCTS LTD. CLAIRE RYAN
K121760 08/29/2012 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K121764 08/21/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. BRAD SHEALS
K121264 08/27/2012 TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE MEDTRONIC SURGICAL TECHNOLOGIES RISHI SINHA
K121320 08/10/2012 C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE MEDYSSEY CO., LTD. MICHAEL KVITNITSKY
K122240 08/21/2012 BONE PLUS BCP EAGLE EYE MEGAGEN IMPLANT CO., LTD APRIL LEE
K122190 08/17/2012 PRELUDE 7F SHORT SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. DAN CLARK
K113289 08/01/2012 ORION MICRO CATHETER MICRO THERAPEUTICS, INC. ANALIA NIETO
K121785 08/10/2012 SCEPTER C OCCLUSION BALLOON CATHETER MICRO VENTION, INC. NAOMI GONG
K113128 08/17/2012 MICROAIRE SURGICAL INSTRUMENTS LLC MICROAIRE SURGICAL INSTRUMENTS, LLC DARREN REEVES
K122291 08/31/2012 THERMO SCIENTIFIC MAS OMNI-CARDIO MICROGENICS CORPORATION KAREN LEE
K120430 08/02/2012 MICROLIFE WRIST WATCH BLOOD PREEURE MONITOR, BP3MO1-3P MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN GOLDSTEIN-FALK
K122086 08/23/2012 THERMAL LIGATING SHEARS MICROLINE SURGICAL, INC WILLIAM MCCALLUM
K120734 08/02/2012 MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE MICROSOFT CORP. ADRIENNE LENZ
K122316 08/29/2012 AZUR DETACHABLE 35 MICROVENTION, INC. CYNTHIA VALENZUELA
K120917 08/02/2012 HEADWAY DUO MICROCATHETER MICROVENTION, INC. NAOMI GONG
K120239 08/24/2012 ELEVANCE MIDMARK ROBYN SCOPIS
K112162 08/08/2012 CONICAL CONNECTION IMPLANTS MIS IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K122073 08/02/2012 ELI 280 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. AMY YANG
K121089 08/23/2012 NMI PICC III NAVILYST MEDICAL, INC. LORRAINE M HANLEY
K121990 08/03/2012 PICC CONVENIENCE KIT NAVILYST MEDICAL, INC. MARION W GORDON
K121184 08/02/2012 SENSUS NEUROMETRIX, INC. RAINER MAAS
K121276 08/29/2012 NEURO VENTION LAMINPLASTY PLATING SYSTEM NEUROVENTION LLC MEREDITH MAY
K112620 08/02/2012 DISITAL BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K120553 08/09/2012 ESPIN NLT SPINE LTD JOHN J SMITH
K113795 08/07/2012 SUCTION LIPOLASTY ACCESSORIES NORMAN M. BLACK III NORMAN BLACK
K120151 08/17/2012 NEBULAE I NORTHGATE TECHNOLOGIES INC. CASEY KUREK
K113820 08/08/2012 NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER NOVABAY PHARMACEUTICALS SHEILA W PICKERING
K121859 08/31/2012 TYSHAK NUCLEUS NUMED, INC. NICHELLE LAFLESH
K121390 08/10/2012 LUBE JELLY SURINGE NURSE ASSIST, INC. BILL KANEWSKE
K121619 08/24/2012 NUVASIVE POLYAXIAL SPINAL SCREWS NUVASIVE, INC. ELIAS KETCHUM
K111914 08/21/2012 VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP SHERI L MUSGNUNG
K120278 08/10/2012 WIRELESS IMAGE TRANSMITTER UNIT OLYMPUS MEDICAL SYSTEMS CORP. SHERI MUSGNUNG
K121932 08/29/2012 HEM-7200-Z (BP742) OMRON HEALTHCARE, INC. PAUL DRYDEN
K121173 08/16/2012 CHORD-X EPTFE SUTURE ON-XLIFETECHNOLOGIES JOHN ELY
K121091 08/28/2012 CATALYS PRECISION LASER SYSTEM OPTIMEDICA CORPORATION ALAN MARQUARDT
K111460 08/20/2012 OPTO HYALUS GREEN LASER OPTO ELETRONICA S/A PAULO ANEAS LICHTI
K113338 08/10/2012 MEDICAL AIR COMPRESSOR ORICARE, INC. DAVID JAMISON
K121524 08/09/2012 INSIGNIA ORMCO CORP. WENDY GARMAN
K122084 08/29/2012 INTRODUCER SET, MODEL ADELANTE-S SERIES OSCOR INC. MILA DOSKOCIL
K120847 08/10/2012 ET/SS IMPLANT SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K121304 08/22/2012 OSTEOMED CRANIAL DISTRACTION SYSTEM OSTEOMED PIEDAD PENA
K121102 08/08/2012 OSTEOSYMBIONICS PEEK CRANIAL IMPLANT OSTEOSYMBIONICS, LLC ELAINE DUNCAN
K113312 08/21/2012 HY-CHLO(TM)WOUND SCRUB PATRIN PHARMA JAY S TRIVEDI
K113568 08/21/2012 MTA-FILLAPEX PAXMED INTERNATIONAL ALLISON KOMIYAMA
K120585 08/08/2012 CONVEY GUIDING CATHETER PENDRACARE INTERNATIONAL, B.V. TOM NOLAN
K122439 08/29/2012 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH HERBERT VAN DYK
K121542 08/27/2012 PICIS WEIGHT BASED DOSE CONVERTER PICIS INC. JANICE HOGAN
K121476 08/29/2012 INFILL GRAFT DELIVERY SYSTEM PINNACLE SPINE GROUP, LLC REBECCA K PINE
K113705 08/31/2012 PINTLER PATIENT WARMING SYSTEM PINTLER MEDICAL MARIBETH MACINTYRE-ELLIS
K112967 08/28/2012 PMMA CAD/CAM DISC POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY JANJA LIPUSCEK
K121197 08/10/2012 BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT PREVENTICE, INC. DREW PALIN
K122121 08/02/2012 PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE PULSION MEDICAL SYSTEMS SE JAMIE SULLEY
K122126 08/14/2012 DIRECT LDL/HDL CHOLESTEROL CALIBRATOR RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K113747 08/24/2012 RANDOX OPIATES ASSAY RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K122182 08/16/2012 DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC RAYENCE CO., LTD DAVE KIM
K121497 08/17/2012 VENOFER PUMP RENAL SOLUTIONS INC. DAVID VANELLA
K120898 08/03/2012 KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA RICHARD WOLF MEDICAL INSTRUMENTS CORP. RON HASELHORST
K120152 08/13/2012 CERASORB PLUS RIEMSER ARZNEIMITTEL AG JAMES M CLINTON
K121895 08/24/2012 ELECSYS HSV-2 IGG IMMUNOASSAY ROCHE DIAGNOSTICS K. COLLEEN ADAMS
K121410 08/02/2012 DRAGON LW SEDECAL SA DANIEL KAMM
K120554 08/10/2012 ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K121526 08/03/2012 POWER-FREE NITRILE PATIENT EXAMINATION GLOVES SHANDONG JUNCHI MEDICAL PRODUCTS CO., LTD. CECILY SHENG
K120890 08/17/2012 POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE SHEN WEI (USA), INC. ALBERT LI
K121157 08/02/2012 POWDER-FREE VIVYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJAZHUANG JIUYUAN PLASTIC CO., LTD CHU XIAOAN
K122323 08/28/2012 DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
K121513 08/10/2012 MULTIX FUSION SIEMENS MEDICAL SOLUTION PATRICIA D JONES
K122317 08/29/2012 TETRIS II SIGNUS MEDIZINTECHNIK GMBH KAREN E WARDEN
K112362 08/14/2012 C100 WRINKLE REDUCTION DEVICE SILVER BAY, LLC ROBERT WAGNER
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