FDA 510(k) Decisions During March, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K121593 03/15/2013 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK 3M COMPANY SUZANNE LEUNG
K123546 03/18/2013 3M ATTEST(TM) AUTO-READER 3M COMPANY SUZANNE LEUNG
K130157 03/19/2013 AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K123225 03/15/2013 BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60 AAP BIOMATERIALS GMBH & CO. KG VOLKER STIRNAL
K123081 03/07/2013 BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 AAP BIOMATERIALS GMBH & CO. KG VOLKER STIRNAL
K123875 03/11/2013 AAP RADIUS SET 2.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K130113 03/11/2013 PICCOLO LACTATE TEST SYSTEM ABAXIS, INC. Dennis M Bleile
K123890 03/18/2013 ACUMED CANNULATED SCREW SYSTEM ACUMED LLC KARA BUDOR
K130625 03/28/2013 12MM AND 13MM TIBIAL NAILS ADVANCED ORTHOPAEDIC SOLUTIONS, INC. ALLYSON PARKS
K123939 03/12/2013 S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K130596 03/22/2013 CAIMAN SEAL AND CUT TECHNOLOGY AESCULAP, INC. DENISE ADAMS
K123645 03/28/2013 AGE AUTOMATIC WRIST BLOOD PRESSURE MONITOR AGELESS HEALTH INDUSTRIAL VICTOR WAN
K122736 03/11/2013 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. DAVID LEDWIG
K123993 03/05/2013 SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM ALPHATEC SPINE, INC. TREVOR DENBO
K122501 03/29/2013 AEI DR. TERAUCHI ULTRASONIC TIPS AMERICAN EAGLE INSTRUMENTS, INC. KRISTEN SCHALLIOL
K122098 03/21/2013 APPS-HEALTH01 ANDON HEALTH CO., LTD YI LIU
K130671 03/26/2013 VENACURE EVLT NEVERTOUCH PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K122476 03/07/2013 LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT ANSELL HEALTHCARE PRODUCTS, LLC DONNA DI GANGI
K122415 03/15/2013 X-FIX DYNAMIC EXTERNAL DISTRACTOR AREX USA LLC CHARLES HOKANSON
K123618 03/24/2013 AXERA 2 ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K122469 03/08/2013 ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ ASAHI INTECC CO., LTD. YOSHI TERAI
K122468 03/08/2013 ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO ASAHI INTECC CO., LTD. YOSHI TERAI
K130520 03/13/2013 CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR ASHITAKA FACTORY OF TERUMO CORP. EILEEN DORSEY
K123139 03/28/2013 ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES ASI MEDICAL, INC. JOHN MCPEEK
K130142 03/15/2013 FLIXENE IFG VASCULAR GRAFT ATRIUM MEDICAL CORPORATION MEGAN MCCAGH, RAC, CTBS
K121946 03/22/2013 AXIS-SHIELD ACVTIVE-B12 AXIS-SHIELD DIAGNOSTICS, LTD. SIMON JOHN RICHARDS
K130245 03/01/2013 LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K120771 03/22/2013 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. ERIC GRACE
K121655 03/20/2013 BD ALCOHOL SWAB BECTON DICKINSON & CO. AVITAL LAKES
K123929 03/14/2013 BEGOPAL+ BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO HEIKE GUSTKE
K130162 03/01/2013 LIQUID ASSAYED MULTIQUAL PREMIUM Bio-Rad Laboratories SUZANNE PARSONS
K123512 03/28/2013 BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM BIODENTA SWISS AG DAVID EILER
K123415 03/19/2013 BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED BIODENTA SWISS AG DAVID EILER
K120089 03/13/2013 BIOGENESIS IMPLANT SYSTEM BIOGENESIS CO., LTD. Priscilla Chung
K121825 03/11/2013 CS-MAG II BIOMAGNETIK-PARK GMBH THOMAS WEBER
K123745 03/25/2013 SP2 FEMORAL LOCKING NAIL, SP2 TIBIAL LOCKING NAIL BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO TARA CONRAD
K122986 03/05/2013 VIDAS LYME IGG BIOMERIEUX SA CATHERINE FRITSCH
K122770 03/28/2013 BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K122160 03/20/2013 VANGUARD XP KNEE SYSTEM BIOMET MANUFACTURING CORP. TRACY BICKEL JOHNSON
K123485 03/18/2013 JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF BIOMET SPORTS MEDICINE ELIZABETH WRAY
K123449 03/05/2013 BIOMONDE LARVAE BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED) ROSINA ROBINSON RN, MED, RAC
K123411 03/07/2013 LITTLE ANGELS SWADDLING BLANKET BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K130537 03/29/2013 BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER BIOPSY SCIENCES, LLC SHARON ROCKWELL
K123837 03/05/2013 PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K123228 03/08/2013 INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) BIOSPACE CORPORATION LIMITED DANIEL KAMM
K123338 03/28/2013 BARRICADE EMBOLIZATION COIL SYSTEM BLOCKADE MEDICAL Rebecca K Pine
K130483 03/28/2013 BOEHRINGER GASTRIC SIZING TUBE BOEHRINGER LABORATORIES, LLC CHRISTOPHER RADL, ENGINEERING
K123765 03/19/2013 GUIDEZILLA GUIDE EXTENSION CATHETER BOSTON SCIENTIFIC HOLLY RAMIREZ
K130243 03/01/2013 ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. LORI R SMITH
K123589 03/19/2013 CADWELL DISPOSABLE PROBE HANDLE CADWELL CHRIS BOLKAN
K123186 03/14/2013 RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31 CALGARY SCIENTIFIC, INC. KYLE PETERSON
K123208 03/19/2013 DIGITAL RETINAL CAMERA CANON, INC.-MEDICAL EQUIPMENT GROUP IZUMI MARUO
K130124 03/14/2013 CATALYST II AND III CARDIVA MEDICAL, INC. MICHAEL A DANIEL
K123464 03/05/2013 CALLISTO EYE CARL ZEISS MEDITEC AG JUDY BRIMACOMBE
K124053 03/13/2013 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL, INC. Tanya Eberle
K130307 03/04/2013 ONCOZENE MICROSPHERES 40UM, 2ML, ONCOZENE MICROSPHERES 75UM, 2ML, ONCOZENE MICROSPHERES 100UM, 2ML, ONCOZENE MICROSPHERE CELONOVA BIOSCIENCES, INC. NICOLE BARBER
K121247 03/22/2013 ALCO-SCREEN CHEMATICS, INC. CARL REYNOLDS
K123675 03/01/2013 RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR COLOPLAST A/S BRIAN SCHMIDT
K123914 03/05/2013 RESTORELLE Y CONTOUR COLOPLAST A/S TIM CRABTREE
K121430 03/01/2013 EVOLUTION BILIARY STENT SYSTEM COOK IRELAND LTD Jacinta Kilmartin
K122940 03/19/2013 ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 COOK, INC. ELYSIA EASTON
K130128 03/08/2013 TRINITY ACETABULAR SYSTEM CORIN MEDICAL LUCINDA GERBER
K130435 03/14/2013 VERSAPORT V2 BLADELESS OPTICAL TROCAR COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H SARAH RIZK
K123893 03/04/2013 CURA COLLIMATOR CURA MEDICAL TECHNOLOGIES, LLC THOMAS H FARIS
K123897 03/13/2013 K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. AMY MCKINNEY
K123818 03/04/2013 URSA ANGIOGRAPHIC CATHETER CURATIVE MEDICAL TECHNOLOGY, INC. AMY MCKINNEY
K123407 03/29/2013 CELLULAZE LASER CYNOSURE, INC. IRINA KULINETS
K123924 03/01/2013 DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS DEPUY ORTHOPAEDICS CORRENE RAMY
K120014 03/14/2013 STA- COAG CONTROL (N+ABN) PLUS DIAGNOSTICA STAGO, INC. KEVIN WYCKOFF
K130344 03/21/2013 DORNIER MEDILAS UROPULSE DORNIER MEDTECH AMERICA, INC. JOHN HOFFER
K123188 03/04/2013 DORNOCH DUO SUCTION CART WITH DL2800 LID MODEL UL-DU2800, DORNOCH DUO SUCTION CART WITH CL500 LID MODEL UL-DU500, DORNOC DORNOCH MEDICAL SYSTEMS, INC. LARRY SMITH
K123776 03/08/2013 POLARIS 100/200 DRAGER MEDICAL GMBH BETH ZIS
K123370 03/13/2013 EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA EDWARDS LIFESCIENCES, LLC. KAREN JONES
K123298 03/15/2013 FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K123303 03/22/2013 FEMORAL ACCESS VENOUS CANNULAE EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K130336 03/28/2013 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K123151 03/08/2013 ENDOSEE MODEL 8000 U-SCOPE ENDOSEE CORP XIAOLONG(BRUCE) OUYANG
K130395 03/11/2013 STEREOS WORKSTATION EOS IMAGING INC. JOHN J SMITH
K130653 03/29/2013 ECHELON FLEX 45 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER; ECHELON FLEX 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CU ETHICON ENDO-SURGERY, LLC CAROL HUBBARD
K123212 03/08/2013 ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS ETHICON ENDO-SURGERY, LLC LIPING WU
K123687 03/20/2013 OPTETRAK LOGIC POROUS FEMORAL COMPONENT EXACTECH, INC. PATRICK HUGHES
K130283 03/07/2013 EVRF SYSTEM F CARE SYSTEMS NV E. J SMITH
K122702 03/18/2013 BIOFRIEND BIOMASK N95 SURGICAL RESPIRATOR FILLIGENT LIMITED KAI DEUSCH
K123562 03/29/2013 FLOWER SMALL AND MEDIUM BONE IMPLANTS FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K123169 03/13/2013 ORALID FORWARD SCIENCE LLC BRIAN PIKKULA
K120740 03/05/2013 COLS« FIXATION SYSTEM FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K130173 03/25/2013 SONOSITE MAXX SERIES ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. SCOTT PAULSON
K122206 03/21/2013 GARAVENTA X3 INCLINED PLATFORM LIFT GARAVENTA (CANADA) LTD [DBA GARAVENTA LIFT] JAY MANSOUR
K123522 03/13/2013 OPTIMA MR450W GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) MICHELLE HUETTNER
K122253 03/22/2013 PROCARE MONITOR B20 GE MEDICAL SYSTEMS CHINA CO., LTD. ROBERT CASARSA
K130155 03/01/2013 MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. KRISTIN PABST
K123136 03/07/2013 GENESIS HEALTH RECORD SYSTEM, (GHRS) GENESIS HEALTH TECHNOLOGIES KATHLEEN JOHNSON
K122272 03/28/2013 CARDIOMEM GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG SUSAN D GOLDSTEIN-FALK
K122071 03/12/2013 GETINGE 400HC-E / SERIES STEAM STERILIZER GETINGE SOURCING LLC BARB SMITH
K123782 03/14/2013 PARAGON HIP SYSTEM GLOBAL MANUFACTURING TECHNOLOGY HOLLACE S RHODES
K123783 03/14/2013 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS GLOBUS MEDICAL, INC. SARAH M FITZGERALD
K123487 03/11/2013 GSO GS1 CANNULATED SCREW SYSTEM GOLD STANDARD ORTHOPAEDICS, LLC DAVID BAUGHMAN
K123073 03/11/2013 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0 GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K130034 03/08/2013 UNI-PICC HEALTH LINE INTERNATIONAL CORPORATION NOLA BENSTOG
K123587 03/22/2013 HEINE MINI 3000 LED OPHTHALMOSCOPE HEINE OPTOTECHNIK GMBH & CO. KG. JOERG ROENNAU
K124039 03/07/2013 HERO GRAFT HEMOSHPERE, INC., A CRYOLIFE COMPANY LAURIE LYNCH
K122494 03/27/2013 POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT HEMOSTASIS, LLC BERNARD HORWATH
K130141 03/22/2013 S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA B AMMIRATI, RAC, MT (ASCP)
K123509 03/29/2013 SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K123108 03/15/2013 TVC IMAGING SYSTEM MODEL NIRS-MC7-70 Infraredx, Inc. STEVEN J CHARTIER
K123761 03/01/2013 VITA ENAMIC STAINS INNOVATION MEDITECH GMBH ELIZABETH WOLFSEN
K122584 03/24/2013 HEMOSIL READIPLAS TIN INSTRUMENTATION LABORATORY CO. Jacqueline Emery
K122480 03/27/2013 INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST INTERNATIONAL BIOPHYSICS CORPORATION H. DAVID SHOCKLEY JR.
K121747 03/14/2013 FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS INTERSURGICAL INCORPORATED MICHAEL ZALEWSKI
K123330 03/19/2013 IOGYN ENDOSCOPE IOGYN, INC. Mary J Edwards
K121769 03/05/2013 DENTOCORE/DENTOCORE BODY ITENA CLINICAL LOUIS- PAUL MARIN
K122522 03/19/2013 DEUTOETCH QUICKBOND BOND ACTIRATOR ITENA CLINICAL LOUIS-PAUL MARIN
K124008 03/29/2013 IPS E. MAX PRESS ABUTMENT SOLUTIONS FOR NOBEL BIOCARE IVOCLAR VIVADENT, AGIN DONNA MARIE HARTNETT
K121488 03/05/2013 JMS SAFE WING CATH (SWC) JMS NORTH AMERICA CORPORATION YOLANDA SMITH
K121520 03/15/2013 ULTRASONIC NEBULIZER (MESH TYPE) K-JUMP HEALTH CO., LTD. JM LIN
K123100 03/28/2013 INTESS LUMBAR CAGE KALITEC DIRECT, LLC J D WEBB
K123344 03/07/2013 K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS) KAWASUMI LABORATORIES, INC. CHRISTINA HENZA
K123468 03/20/2013 DEMI ULTRA KERR CORPORATION Wendy Garman
K123749 03/01/2013 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, GREEN, NON-STERILE KOSSAN LATEX INDUSTRIES(M)SDN BHD CHO SOW FONG
K123665 03/25/2013 LIFELINES IEEG KVIKNA EHF YOLANDA SMITH
K123219 03/18/2013 URGOCLEAN ABSORBENT WOUND DRESSING LABORATOIRES URGO SOPHIE FORTIN
K123767 03/18/2013 LANX FUSION SYSTEM- SA LANX, INC. Alan Burkholder
K124059 03/25/2013 AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT) LAUER MEMBRAN WASSERTECHNIK GMBH STEPHAN KRIETEMEYER
K123859 03/27/2013 TBD LENSAR, INC. SHIRLEY K MCGARVEY
K122247 03/20/2013 LIDCORAPID V2 MONITOR LIDCO LTD. GREGORY SPELLER
K123373 03/06/2013 NAUTILUS SPINAL SYSTEM LIFE SPINE RANDY LEWIS
K123955 03/08/2013 QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT LIFE TECHNOLOGIES CORPORATION DEANNA VELLA
K130497 03/29/2013 D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION LINVATEC CORPORATION D/B/A CONMED LINVATEC JONATHAN WERNER
K123014 03/29/2013 LITECURE THERAPY SYSTEM MODEL LTS-1500 LITECURE, LLC LIANG LU
K123628 03/18/2013 STERILE LATEX SURGICAL GLOVE LUCENXIA PRESCIENCE AG ROBERT HILL
K130164 03/24/2013 FIBERLASE ENDURE CO2 FIBER LUMENIS LTD. YORAM LEVY
K121894 03/21/2013 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX LUMINEX MOLECULAR DIAGNOSTICS, INC. LUBNA SYED
K121511 03/07/2013 MACLIN POWER INTRAVASCULAR ADMINISTRATION SET MACLIN POWER INC. ENRICO BISSON
K121933 03/14/2013 NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM) MARVAO MEDICAL DEVICES, LTD. Marybeth Gamber
K130210 03/15/2013 MEDELA THOPAZ MEDELA AG MARKUS BUETLER
K123802 03/01/2013 EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT MEDICA CORP. Photios Makris
K121979 03/21/2013 PASS OCT SPINAL SYSTEM MEDICREA INTERNATIONAL LAURA AVIRON-VIOLET
K130221 03/21/2013 HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM MEDIMECCA CO., LTD. Priscilla Chung
K122850 03/28/2013 TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES MEDITECH ADVISORS, LLC Sharyn Orton
K123350 03/07/2013 ECLIPSE SOFT TISSUE FASTENER MEDSHAPE, INC JACK C GRIFFIS III
K123762 03/27/2013 DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF MEDTRONIC INC. CHELSEA PIOSKE
K124004 03/22/2013 NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS MEDTRONIC NAVIGATION, INC. MICHAEL BLASCO
K123351 03/19/2013 AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE MEDTRONIC PERFUSION SYSTEMS JULIA A NELSON
K122037 03/22/2013 ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST MEDTRONIC SOFAMOR DANEK, INC. BECKY RONNER
K122513 03/06/2013 CLEARED UNDER GRAFTON II EDBM MEDTRONIC SOFAMOR DANEK, INC. KELLY ANGLIN
K123870 03/27/2013 XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM MEGAGEN IMPLANT CO., LTD. APRIL LEE
K122362 03/26/2013 SMART-WELL INCUBATOR MESA LABORATORIES, INC. JOLE WILSON
K122016 03/01/2013 REXTAR, REXTAR LCD META BIOMED, INC. BLIX WINSTON
K130229 03/20/2013 PALM BLADDER SCANNER MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. HELEN NAN
K122806 03/08/2013 IMAGE WORKS PANOURA MIC INTERNATIONAL IZUMI MARUO
K124007 03/07/2013 SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY MICRO THERAPEUTICS, INC D/B/A: EV3 INC ANALIA STAUBLY
K124029 03/27/2013 MICROLINE FLEXIBLE LIGATING SHEARS MICROLINE SURGICAL, INC DEAN CIPORKIN
K123624 03/28/2013 OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM MIMOSA ACOUSTICS, INC. PATRICIA S JENG
K130393 03/20/2013 MIRADA RTX MIRADA MEDICAL LTD. GWILYM OWEN
K123980 03/05/2013 SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES MISONIX, INC. RONALD MANNA
K123556 03/22/2013 MORTARA SURVEYOR PATIENT MONITOR MORTARA INSTRUMENT, INC. AMY YANG
K122456 03/22/2013 MRII CRAINIAL DRILL MRI INTERVENTIONS, INC. E.F. WADDELL
K113717 03/05/2013 ULTRASONIC SCALER NAKANISHI, INC. DIANE RUTHERFORD
K130609 03/21/2013 VEEDA 100% COTTON MENSTRUAL TAMPON NATURALENA BRANDS, INC. JOSH ELLIS
K123272 03/28/2013 1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM NEOCOIL, LLC KATIE GONZALEZ
K130228 03/20/2013 SUITEHEART NEOSOFT, LLC JACKIE SCHWABE
K123554 03/07/2013 SHUNTCHECK NEURODX DEVELOPMENT LLC FREDERICK J FRITZ
K121285 03/08/2013 ORAVAN OSA NEW JERSEY SNORING SOLUTIONS DEBORAH STEIN
K121622 03/14/2013 NIDEK RS-3000 NIDEK CO., LTD. LENA SATTLER
K123642 03/29/2013 MUSCLE STIMULATION SYSTEM NIVEUS MEDICAL, INC. CINDY DOMECUS, R.A.C. (US & EU)
K123976 03/26/2013 NOBELCLINICIAN NOBEL BIOCARE AB PHUONG NGUYEN
K122602 03/13/2013 NOBELPROCERA TI ABUTMENT CAMLOG PLATFORMS NOBEL BIOCARE AB PHUONG NGUYEN SON
K123013 03/22/2013 ENDOSCOPIC INTRODUCER NOVADAQ TECHNOLOGIES, INC. TIM VERSPAGEN
K130413 03/21/2013 PINPOINTE FOOTLASER NUVOLASE, INC. KATHY MAYNOR
K130234 03/13/2013 NUVON VITALS CHARTING SYSTEM NUVON, INC. JONATHAN S KAHAN
K123395 03/07/2013 NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K123365 03/01/2013 OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190 OLYMPUS MEDICAL SYSTEMS CORP. SHERI L MUSGNUNG
K123498 03/21/2013 BP652N (HEM-6300-Z) OMRON HEALTHCARE, INC. PAUL DRYDEN
K123118 03/26/2013 INSIGNIA DIGICAST ORMCO CORP. Wendy Garman
K123416 03/13/2013 INSIGNIA WITH ITERO ORMCO CORP. Wendy Garman
K123426 03/01/2013 MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS ORPHEUS MEDICAL, LTD. CLAY ANSELMO
K123457 03/22/2013 BALANCED KNEE SYSTEM HIGH FLEX PS ORTHO DEVELOPMENT CORP. TOM HAUETER
K130176 03/28/2013 FIREBIRD SPINAL FIXATION SYSTEM ORTHOFIX JACKI GEREN
K113164 03/11/2013 DISCOVERY TMAX MANUAL WHEELCHAIR OTTO BOCK HEALTHCARE, LP WILLIAM KABITZ
K122560 03/26/2013 VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 PAN-AMERICA HYPERBARICS, INC. WILLIAM M GATES, RRT
K130206 03/20/2013 PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS PENTAX OF AMERICA, INC. KRISHNA GOVINDARAJAN
K130247 03/20/2013 PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS PENTAX OF AMERICA, INC. KRISHNA GOVINDARAJAN
K121864 03/12/2013 PERKINELMER 226 SAMPLE COLLECTION DEVICES PERKINELMER, INC. KAY A TAYLOR
K121156 03/13/2013 AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES PHADIA AB MARTIN MANN
K130091 03/13/2013 PULMOSAL PHARMACARIBE PAUL DRYDEN
K130153 03/12/2013 HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST PHILIPS MEDICAL SYSTEMS MARK PUOPOLO
K120815 03/06/2013 INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE PHILIPS MEDICAL SYSTEMS PETER SCHIPELLITI
K121772 03/21/2013 ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. FRANS JACOBS
K113636 03/08/2013 BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) PHILOSYS CO. LTD. LINDA CHAN
K130351 03/14/2013 NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER PIVOT MEDICAL INC. Jon Cook
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K122847 03/06/2013 KANGAROO NASAL MASK RESPIRONICS INC. MICHELLE BRINKER
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K122534 03/14/2013 IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL Siemens Healthcare Diagnostics Inc. Garo Mimaryan
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K120354 03/21/2013 BETA-TCP GRANULES SKELETAL KINETICS, LLC CHRISTINE KUO
K123161 03/14/2013 SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITE SMARTGUARD, INC. SHELLY GARG
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K121743 03/28/2013 EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN SUNMED LLC WU TINGJIE
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K130251 03/13/2013 ESOPHAGUS BOUGIE SET VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K123815 03/11/2013 SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
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K122955 03/01/2013 DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM WRIGHT HEALTH GROUP LTD. STEPHEN T MLCOCH
K122218 03/21/2013 ADVANCE TOTAL KNEE SYSTEM-PATELLA WRIGHT MEDICAL TECHNOLOGY, INC. Danielle Mueller
K123059 03/04/2013 INBONE ( I AND II) TOTAL ANKLE SYSTEMS WRIGHT MEDICAL TECHNOLOGY, INC. RYAN BORMANN
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K123780 03/01/2013 TRANSTEK BLOOD PRESSURE MONITOR ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. LEO WANG
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