FDA 510(k) Applications Received During June, 2013

FDA 510(k) Number Submission Date Device Name Applicant Contact
K131964 06/27/2013 BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE MEDTRONIC INC. LISA STONE
K131707 06/14/2013 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS 3B MEDICAL, INC ALEX LUCIO
K131459 06/17/2013 AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K131782 06/17/2013 LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K131753 06/14/2013 MERIDIAN AB ARDENT DONNA MARIE HARTNETT
K131625 06/13/2013 ANYSCAN-S SPECT IMAGING SYSTEM ABSOLUTE IMAGING SOLUTIONS MARK SHINA
K131845 06/21/2013 ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC ACUMED LLC KARA BUDOR
K131764 06/17/2013 ACUMED WRIST SPANNING PLATE ACUMED LLC NATHAN WOLF
K131636 06/10/2013 POLARUS CONNECT ACUMED LLC BRITTANY CUNNINGHAM
K131571 06/03/2013 AVD RIGHT RADIAL DRAPE ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K131786 06/18/2013 AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER AIRSTRIP TECHNOLOGIES, LP ROBERT ANDREW MILLER
K131893 06/25/2013 AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS AJW TECHNOLOGY CONSULTANTS, INC. JANET DOUGLAS
K131645 06/10/2013 INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K131975 06/28/2013 ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K131814 06/20/2013 AMECATH DUAL LUMEN IMPLANTED HEMODIALYSIS CATHETER AMECO MEDICAL INDUSTRIES RAY KELLY
K131622 06/05/2013 MROZ REVERSE OSMOSIS SYSTEM AMERIWATER BRIAN R BOWMAN
K131939 06/27/2013 AMICO DH-W35 OPHTHALMOSCOPE SERIES AMICO DIAGNOSTIC INCORPORATED LAUREN CHRAPOWITZKY
K131766 06/19/2013 PLATINUM DRF IMAGING SYSTEM APELEM-DMS GROUP SHARYN ORTON
DEN130034 06/17/2013 REWALK ARGO MEDICAL TECHNOLOGIES, INC. JOHN V HAMILTON
K131798 06/17/2013 REWALK ARGO MEDICAL TECHNOLOGIES, INC. JOHN V HAMILTON
K131633 06/05/2013 ARTHREX UNIVERS APEX ARTHREX, INC. COURTNEY SMITH
K131709 06/11/2013 SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT ARTHROCARE CORP. ASHLEY DAWSON
K131987 06/28/2013 MULTIPULSE HOPLUS ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K131757 06/26/2013 TATTOOSTAR EFFECT COMBO ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
DEN130031 06/05/2013 NEPHROCHECK TEST SYSTEM ASTUTE MEDICAL, INC KARIN HUGHES
K131877 06/26/2013 SAVE II, SAVE II BASIC AUTOMEDX INC. PAUL DRYDEN
K131842 06/21/2013 STERICAN CANNULA B. BRAUN MEDICAL, INC. KIMBERLY SMITH
K131423 06/13/2013 G-ARM MULTISCAN SYSTEM BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. BETTER LI
K131837 06/26/2013 CO2 FRACTIONAL LASER BEIJING HONKON TECHNOLOGIES CO., LTD MIKE GU
K131838 06/26/2013 DIODE LASER FOR HIAR REMOVAL BEIJING HONKON TECHNOLOGIES CO., LTD MIKE GU
K131859 06/24/2013 MULTIFUNCTIONAL SERIES BEIJING HONKON TECHNOLOGIES CO., LTD DIANA HONG
K131857 06/27/2013 Q-SWITCHED ND:YAG LASER BEIJING HONKON TECHNOLOGIES CO., LTD DIANA HONG
K131930 06/28/2013 JBAIDS ANTHRAX DETECTION KIT BIOFIRE DIAGNOSTICS, INC. CYNTHIA PHILLIPS
K131729 06/14/2013 JBAIDS PLAGUE DETECTION KIT BIOFIRE DIAGNOSTICS, INC. CYNTHIA PHILLIPS
K131936 06/27/2013 JBAIDS TULAREMIA DETECTION KIT BIOFIRE DIAGNOSTICS, INC. CYNTHIA PHILIPS
K131640 06/04/2013 SMOOTH OR THREADED METALLIC BONE FASTENER BIOMEDICAL ENT., INC. JOE SOWARD
K131779 06/21/2013 VITEK 2 AST-ST TIGECYCLINE BIOMERIEUX, INC. NATHAN HARDESTY
K131674 06/19/2013 PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING BIOMET MICROFIXATION ELIZABETH WHEELER
K131615 06/03/2013 POLARIS SPINAL SYSTEM BIOMET SPINE (AKA EBI, LLC) VIVIAN KELLY
K131867 06/24/2013 2.5MM INLINE FUSION PLATE BIOMET, INC. SUZANA OTANO
K131684 06/10/2013 BIOLOX(R) DELTA CERAMIC HEADS BIOMET, INC. BECKY EARL
K131670 06/07/2013 LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) BIOMET, INC. SUZANA OTANO
K131978 06/28/2013 SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL BIOTRONIK, INC. JON BRUMBAUGH
K131734 06/13/2013 ALL-BOND UNIVERSAL SC (NOT FINALIZED) BISCO, INC. MICHELLE SCHILTZ-TAING
K131905 06/26/2013 SOLID GEL PAD BLUEMTECH PRISCILLA CHUNG
K131914 06/26/2013 OFFROAD RE-ENTRY CATHETER SYSTEM BOSTON SCIENTIFIC CORP. CAROL TIFFANY
K131700 06/11/2013 SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES BOSTON SCIENTIFIC CORP. JANIS F TARANTO
K131496 06/11/2013 BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) BSN MEDICAL, INC. CARROLL D HOYLE
K131660 06/21/2013 SMART (SMART-D, SMART-DX) BTS SPA ENRICO BISSON
K131689 06/12/2013 MRI MARKER C4 IMAGING LLC STEPHEN J GOLDNER, JD, RAC
K131824 06/20/2013 AVAFLEX VERTEBRAL BALLOON SYSTEM CAREFUSION JOY GREIDANUS
K131820 06/20/2013 AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G CAREFUSION JOY GREIDANUS
DEN130032 06/11/2013 XPERT MTB/RIF ASSAY CEPHEID KERRY J FLOM
K131706 06/11/2013 XPERT MTB/RIF ASSAY CEPHEID KERRY J FLOM
K131727 06/17/2013 CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM CERAGEM MEDISYS INC. HAKSUNG KIM
K131931 06/27/2013 CHEMTRUE(R) HCG PREGNANCY URINE MIDSTREAM TEST CHEMTRON BIOTECH, INC. JANE ZHANG
K131305 06/28/2013 CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K131887 06/27/2013 TROJAN JAGUAR MALE NATURAL RUBBER LATEX CONDOM WITH WARMING AND TINGLING LUBRICANT CHURCH & DWIGHT CO., INC. EMILY PEREZ
K131781 06/17/2013 CLEARVIEW TOTAL CLINICAL INNOVATIONS, LLC BRIAN MCROBERTS
K131721 06/12/2013 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1 COMED MEDICAL SYSTEMS CO., LTD J. HARVEY KNAUSS
K131765 06/17/2013 ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM CONMED CORPORATION LISA ANDERSON
K131900 06/26/2013 CONTEC ELECTROCARDIOGRAPH CONTEC MEDICAL SYSTEM CO., LTD. DIANA HONG
K131772 06/17/2013 CANTATA(R) 2.9 MICROCATHETER COOK, INC. JENNIFER A RICHARDSON
K131986 06/28/2013 CORIN MINIHIP STEM CORIN USA LUCINDA GERBER
K131647 06/05/2013 TRINITY ACETABULAR SYSTEM CORIN USA DIANA L MARTONE
K131614 06/03/2013 REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 60CM, REPROCESSED CLOSUREFAST RADIOFREQUENCY CATHETER 100CM COVIDIEN DANIEL CAMPION
K131705 06/11/2013 ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE KATHERINE ROBERTSON
K131702 06/11/2013 K SERIES CPAP SYSTEMS CURATIVE MEDICAL INC. AMY MCKINNEY
K131850 06/21/2013 TENSYN BAND DALLEN MEDICAL, INC. AL MEMMOLO
K131839 06/26/2013 DC 7 DC INTERNATIONAL, LLC DAVID BOEGLER
K131644 06/05/2013 ANKYLOS SYNCONE ABUTMENT 5(DEGREE) DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K131683 06/10/2013 HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY KRISTINE CHRISTO
K131974 06/28/2013 HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K131802 06/21/2013 EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON COMPANY KIRSTEN LEHMULLER
K131743 06/18/2013 CIRONA DVT FOOT GARMENT DEVON MEDICAL INC. RUTH WU
K131572 06/05/2013 MICRO AMBULATORY ECG RECORDER DIMETEK DIGITAL MEDICAL TECHNOLOGIES LTD JIMMY GUAN
K131830 06/20/2013 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. CHERRY SUN
K131971 06/28/2013 IM60/IM70 PATIENT MONITOR EDAN INSTRUMENTS, INC. CHERRY SUN
K131819 06/26/2013 PC ECG EDAN INSTRUMENTS, INC. QUEENA CHEN
K131818 06/25/2013 VITAL SIGNS MONITOR EDAN INSTRUMENTS, INC. QUEENA CHEN
K131627 06/04/2013 CATHETER INTRODUCER SHEATH EDWARDS LIFESCIENCES, LLC. LUKE MEIDELL
K131892 06/27/2013 EV1000 CLINICAL PLATFORM EDWARDS LIFESCIENCES, LLC. SALLY MAHER
K131588 06/05/2013 VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR; VIGILEO APCO/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. SALLY MAHER
K131396 06/06/2013 WIRED MOUTH PROTECTOR (WMP) ELBA LABORATORIES, INC. RICHARD A HAMER
K131882 06/25/2013 GEODESICEEG SYSTEM 400 SERIES (GES 400) ELECTRICAL GEODESICS, INC. LINDA J BOVARD
K131965 06/27/2013 XVI R5.0 ELEKTA LIMITED ANDREW HEDGES
K131677 06/10/2013 PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM ELLIPSE TECHNOLOGIES INC. JOHN MCINTYRE
K131949 06/27/2013 AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES ENCISION, INC. JIM LEWIS
K131675 06/07/2013 BODIHEALTH SYSTEM EPRT TECHNOLOGIES, INC. JEFF MORGAN
K131996 06/28/2013 S-SCAN ESAOTE, S.P.A. ALLISON SCOTT, RAC
K131990 06/28/2013 OXYGEN GENERATOR LIQUEFIER - (OGL) ESSEX CRYOGENICS OF MISSOURI, INC. PAUL DRYDEN
K131663 06/10/2013 ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK ETHICON ENDO-SURGERY, LLC CHRISTINA CANTER
K131656 06/07/2013 MORCELLEX SIGMA GENERATOR ETHICON, INC. SARAH MCMANUS
K131791 06/21/2013 IFA 40: HEP-20-10 EUROIMMUN US MICHAEL LOCKE
K131595 06/21/2013 EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM EUROTROL B.V. PAUL KOOIJMANS
K131616 06/03/2013 EZ3D-I, E3 EWOO SOFT CO., LTD DAVE KIM
K131594 06/03/2013 EZDENTI-I; E2; PRORA VIEW EWOO SOFT CO., LTD DAVE KIM
K131575 06/04/2013 EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT EXACTECH, INC. PATRICK HUGHES
K131626 06/04/2013 EXCELERON BACTERIAL FILTERS EXCELERON MEDICAL BERNARD HORWATH
K131530 06/05/2013 DYNAMESH -CICAT FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL NEIL R ARMSTRONG
K131895 06/25/2013 AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K131657 06/11/2013 FLOWER SMALL AND MEDIUM IMPLANT SET FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K131875 06/24/2013 MENICON NECT CONTACT LENS CASE FORESIGHT REGULATORY STRATEGIES ELLEN M BEUCLER
K131611 06/03/2013 FRESENIUS DRY ACID DISSOLUTION UNITS FRESENIUS MEDICAL CARE NORTH AMERICA DENISE OPPERMANN
K131908 06/26/2013 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC) FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC DENISE OPPERMANN
K131977 06/28/2013 CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT GE HEALTHCARE NICOLE LANDREVILLE
K131937 06/27/2013 VOLUSON I/E GE HEALTHCARE BRYAN BEHN
K131685 06/10/2013 GE ECHOPAC GE VINGMED ULTRASOUND AS BRYAN BEHN
K131612 06/10/2013 ANYPLUS; ALIF PEEK CAGES, PLIF PEEK CAGES, T-PLIF PEEK CAGES, TLIF PEEK CAGES GS MEDICAL CO., LTD. DONALD W GUTHNER
K131941 06/27/2013 FETAL MONITORS GUANGDONG BIOLIGHT MEDITECH CO., LTD DIANA HONG
K131898 06/25/2013 A SERIES AND Q SERIES PATIENT MONITORS GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K131858 06/24/2013 DIGITAL ELECTROCARDIOGRAPH GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K131762 06/17/2013 HANDHELD MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K131763 06/17/2013 TRUSCOPE SERIES PATIENT MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K131754 06/18/2013 WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K131925 06/26/2013 HS NOTA H.S. HOSPITAL SERVICES S.P.A. LUCIO IMPROTA
K131774 06/17/2013 HAMILTON-G5 HAMILTON MEDICAL AG RALPH AGUILA
K131956 06/27/2013 QUICK RELAX PRO HEALTHCARE INNOVATIONS, LLC SHEPARD G BENTLEY, RAC
K131916 06/26/2013 BPROSOFT CASP PC SOFTWARE HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K131788 06/19/2013 HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K131745 06/13/2013 BLOM-SINGER SEPTAL PERFORATION PROSTHESIS HELIX MEDICAL, LLC PAUL DRYDEN
K131424 06/11/2013 MIPLATFORM MEDICAL IMAGING SUITE HINACOM SOFTWARE AND TECHNOLOGY, LTD. YI ISABELLE SUN
K131720 06/12/2013 HIVOX SELF ADHESIVE ELECTRODE GEL PADS HIVOX BIOTEK, INC. Ke-Min Jen
K131866 06/24/2013 SUSTAIN HOLLENDER SUSTAINABLE BRANDS LLC E.J. SMITH
K131581 06/05/2013 MYOSURE TISSUE REMOVAL DEVICE (1 PACK AND 3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K131736 06/13/2013 MYOSURE TISSUE REMOVAL DEVICE (1 PACK), MYOSURE TISSUE REMOVAL DEVICE (3 PACK) HOLOGIC, INC. SARAH FAIRFIELD
K131870 06/24/2013 GLIDE DEVICE HOME SKINOVATIONS LTD. AHAVA STEIN
K131777 06/21/2013 HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM HYPER TECHNOLOGY INC DIANA HONG
K131722 06/28/2013 I.T.S. EXTREMITY FIXATION SYSTEMS I.T.S. GMBH AL LIPPINCOTT
K131917 06/28/2013 NEURODYN COMPACT, NEURODYN II IBRAMED EQUIPAMENTOS MEDICOS TARA CONRAD
K131629 06/04/2013 NEURODYN MULTIWAVE, AUSSIE SPORT IBRAMED EQUIPAMENTOS MEDICOS LILIAN LLULL
K131926 06/26/2013 THERMOPULSE IBRAMED EQUIPAMENTOS MEDICOS TARA CONRAD
K131805 06/19/2013 INPULSE LASER INCISIVE INC. KATHY MAYNOR
K131661 06/07/2013 INFUSION SYRINGE SET INNOVATIVE MEDICAL MANUFACTURING CO. LUCY HUANG
K131686 06/10/2013 INOMAX DSIR (DELIVERY SYSTEM) INO THERAPEUTICS/IKARIA ROBERT BOVY
K131883 06/25/2013 AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) INOVISE MEDICAL, INC. EARL ANDERSON
K131620 06/05/2013 JONES-FX FRACTURE SYSTEM INSTRATEK, INC. JEFF SEAVEY
K131585 06/07/2013 INTEL-GE CARE INNOVATIONS QUIETCARE INTEL-GE CARE INNOVATIONS LLC MAUREEN GLYNN
K131681 06/10/2013 EYESEECAM VHIT INTERACOUSTICS A/S ERIK NIELSEN
K131962 06/27/2013 DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES INTUITIVE SURGICAL, INC. MIKE YRAMATEGUI
K131861 06/24/2013 DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES INTUITIVE SURGICAL, INC. BRANDON HANSEN
K131566 06/12/2013 ARIX HAND SYSTEM JEIL MEDICAL CORPORATION JI-EUN KIM
K131784 06/18/2013 RANGE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K131953 06/27/2013 IMAGE1 SPIES KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K131787 06/27/2013 CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES KEELER LTD. EUGENE R VANARSDALE
K131589 06/13/2013 KEELER SLIT LAMP H-SERIES KEELER LTD. NICKIE POWER
K131879 06/24/2013 KC 300 SURGICAL MASK KIMBERLY-CLARK CORP. MONICA KING
K131841 06/27/2013 KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE KIMBERLY-CLARK CORP. CHRISTINE L MACAULEY
K131448 06/03/2013 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION KOELIS LAETITIA GERVAIS
K131623 06/10/2013 SMARTDOP XT KOVEN TECHNOLOGY, INC. HARVEY KNAUSS
K131737 06/13/2013 SUPERNOVA C5 MRI SYSTEM LIAONING KAMPO MEDICAL SYSTEM CO., LTD. SHAO KAI
K131653 06/10/2013 LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K131652 06/10/2013 LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K131796 06/20/2013 MANUKA FILL WOUND DRESSING LINKS MEDICAL PRODUCTS, INC. JAMES SMITH, PH.D.
K131797 06/18/2013 3B LASER NEEDLE LIVETEC GMBH KEVIN WALLS
K131968 06/28/2013 LONGFIAN OXYGEN CONCENTRATOR LONGFIAN SCITECH CO., LTD. JUN PENG
K131751 06/14/2013 FINESSIS VIOLET ELEMENT POLYISOPRENE POWDERFREE STERILE SURGICAL GLOVES LUCENXIA PRESCIENCE AG ROBERT HILL
K131666 06/07/2013 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG SARAH BETZ
K131778 06/21/2013 FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT MAQUET CARDIOVASCULAR LLC MARYLOU INSINGA
K131692 06/12/2013 BLOSSOM SALINE DELIVERY ASSIST DEVICE MARZ MEDICAL, INC MARY PASCUAL GALLUP
K131481 06/07/2013 FREEDOM PCK COMPONENTS MAXX ORTHOPEDICS, INC. NACH DAVE
K131497 06/06/2013 MCKESSON CARDIOLOGY HEMO MCKESSON ISRAEL LTD. PAUL SUMNER
K131671 06/07/2013 MECTALIF MEDACTA INTERNATIONAL ADAM GROSS
K131687 06/11/2013 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET MEDICAL COMPONENTS INC JESSICA LEO
K131682 06/10/2013 UD IMPLANT SYSTEM MEDIMECCA CO., LTD. PRISCILLA CHUNG
K131673 06/07/2013 MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC. KELLY ANGLIN
K131669 06/07/2013 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK USA, INC. LAUREN KAMER
K131888 06/25/2013 T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE MEDTRONIC SOFAMOR DANEK, INC. BECKY RONNER
K131878 06/27/2013 LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM MEDYSSEY USA, INC. RICH JANSEN
K131699 06/11/2013 EMOTION ECG MOBILE MEGA ELECTRONICS LTD. ANDRE KINDSVATER
K131789 06/24/2013 CEREBRALOGIK- AEEG MENNEN MEDICAL LTD. IFAT SHWARTS
K131853 06/21/2013 MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER MENTOR WORLDWIDE LLC MANCHI CHEUNG
K131710 06/14/2013 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. MARTHA FOLAN
K131873 06/27/2013 NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD) METHODSENSE, INC. RITA KING
K131799 06/27/2013 QUICKNIT MICROCOPY, DIV. OF NEO-FLO INC. PEGGY GOBER
K131948 06/27/2013 MICROPLEX COIL SYSTEM (MCS) MICROVENTION, INC. LARAINE PANGELINA
K131876 06/24/2013 M SERIES PATIENT MONITOR MID-LINK CONSULTING CO., LTD DIANA HONG
K131659 06/06/2013 MOERAE VEIN PREPARATION KIT MOERAE MATRIX, INC. ROBERT J CHIN
K131929 06/28/2013 SURVEYOR CENTRAL STATION MORTARA INSTRUMENT, INC. AMY YANG
K131694 06/12/2013 NMI PORT II CATHETER NAVILYST MEDICAL, INC. BRANDON M BRACKETT
K131688 06/18/2013 NEOCLOSE HASSON, NEOCLOSE UNIVERSAL NEOSURGICAL LTD ORLA BRENNAN
K131894 06/25/2013 NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT NIDEK CO., LTD. YONEJI MIZUNO
K131935 06/27/2013 ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER NIPRO MEDICAL CORPORATION CAROLYN GEORGE
K131641 06/04/2013 MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) NIPRO MEDICAL CORPORATION JESSICA OSWALD-MCLEOD
K131703 06/14/2013 NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM NOVA BIOMEDICAL CORPORATION PAUL W MCDONALD
K131869 06/26/2013 PTS-X SIZING BALLOON CATHETER NUMED, INC. NICHELLE LAFLESH
K131723 06/12/2013 COROENT SINGLE TAB SYSTEM NUVASIVE, INC. JEREMY MARKOVICH
K131739 06/13/2013 NXSTAGE CONNECTED HEALTH SYSTEM NXSTAGE MEDICAL, INC. MARY LOU STROUMBOS
K131672 06/13/2013 MICROCYN SCAR MANAGEMENT HYDROGEL OCULUS INNOVATIVE SCIENCES BRIAN W MARTIN
K131780 06/19/2013 EVIS EXERA III VIDEO SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. DAPHNEY GERMAIN-KOLAWOLE
K131742 06/13/2013 HEM-6131 OMRON HEALTHCARE, INC. PAUL DRYDEN
K131749 06/14/2013 HEM-6221 OMRON HEALTHCARE, INC. PAUL DRYDEN
K131795 06/28/2013 NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS ORFIT INDUSTRIES NV EDDY MARIVOET
K131790 06/21/2013 A9800 ANESTHESIA WORKSTATION ORICARE, INC. KURTIS MONTEGNA
K131785 06/18/2013 PAGODA PEDICLE SCREW SYSTEM ORTHO DEVELOPMENT CORP. TOM HAUETER
K131833 06/20/2013 CENTURION POCT SYSTEM ORTHOFIX, INC. JACKI GEREN
K131767 06/17/2013 ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM ORTHOSENSOR, INC. MARTHA I GARAY
K131817 06/20/2013 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER OSMUNDA MEDICAL DEVICE CONSULTING CO., LTD. MIKE GU
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K131617 06/03/2013 COLONGLIDE(R) LUBRICANT PEDIATRIC PHARMACEUTICALS, INC. ROBERT M HARRIS
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K131946 06/27/2013 ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS PENTAX MEDICAL COMPANY KRISHNA GOVINDARAJAN
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K131902 06/28/2013 PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) PENTAX MEDICAL COMPANY KRISHNA GOVINDARAJAN
K131738 06/13/2013 IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND IMMUNOCAP SPECIFIC IGE CONTROL H PHADIA AB CARINA MAGNUSSON
K131821 06/20/2013 ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY PHADIA US INC. MARTIN R MANN
K131773 06/17/2013 BRILLIANCE ICT PHILIPS HEALTHCARE (CLEVELAND) CATHERINE M CONNELL
K131590 06/04/2013 INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBE PHILIPS MEDICAL SYSTEMS CHRISTINE TREFETHEN
K131829 06/26/2013 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HERBERT VAN DYK
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K131529 06/17/2013 SHENGGUANG MANUAL WHEELCHAIR PINGDINGSHAN SHENXING HEALTHCARE TECHNOLOGY CO., LTD. WANG QING
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K131769 06/21/2013 CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM PIVOT MEDICAL INC. JON COOK
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K131758 06/17/2013 SURGEN U POLLOGEN LTD JONATHAN S KAHAN
K131889 06/25/2013 EUM 100PRO PROMEDIC, INC. PAUL DRYDEN
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K131630 06/11/2013 PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM PURITAN MEDICAL PRODUCTS LLC MEHDI KARAMCHI
K131619 06/03/2013 QUICKVUE INFLUENZA A+B QUIDEL CORP. JOHN D TAMERIUS
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K131988 06/28/2013 ABL90 FLEX ANALYZER RADIOMETER MEDICAL APS GITTE JUEL FRIIS
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K131693 06/14/2013 RAYSCAN A-EXPERT RAY CO., LTD ANDREW PAENG
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K131804 06/19/2013 REMEL XPECT FLU A&B REMEL, INC. CINDY KNAPP
K131932 06/27/2013 APNEALINK PRO RESMED GERMANY INC. SANDRA GRUNWALD
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K131906 06/27/2013 SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE SATELEC-ACTEON GROUP RICK ROSATI
K131655 06/07/2013 LIGHTHOUSE(TM) URINARY CATHETER SEEDINGS LIFE SCIENCE VENTURES, LLC KEN SOLOVAY
K131654 06/06/2013 STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER SENORX, INC. SARAH MCCARTNEY
K131582 06/04/2013 SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM SENSUS HEALTHCARE KAL FISHMAN
K131832 06/20/2013 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHANDONG BINXIANG MEDICAL PRODUCTS CO., LTD. RAY ZHOU
K131646 06/11/2013 DISPOSABLE INFUSION SET SHANGHAI JINTA MEDICAL CO., LTD WANG CHANGQING
K131690 06/24/2013 M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANG ZHAOHUI
K131662 06/07/2013 IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS INC. GARO MIMARYAN
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K131803 06/21/2013 GUARDIAN URETHRAL SHEATH SOLACE THERAPEUTICS WILLIAM GRUBER
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K131521 06/06/2013 VELOX ANTERIOR CERVICAL PLATE SYSTEM SPINECRAFT LLC AMI AKALLAL-ASAAD
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K131548 06/04/2013 SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM SYNTHES (USA) PRODUCTS, LLC HEMAL MEHTA
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K131963 06/27/2013 TAUTONA INJECTOR DEVICE TAUTONA GROUP, LLC JOE RIMSA
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K131891 06/28/2013 ECLIPSE TREATMENT PLANNING SYSTEM VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K131807 06/19/2013 HIGH ENERGY LINEAR ACCELERATOR VARIAN MEDICAL SYSTEMS, INC. PETER J CORONADO
K131783 06/20/2013 POLAROID CONTACTSPOD VIOPTI LTD EDWIN LINDSAY
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K131701 06/11/2013 Z5MLB, Z5MLC Z-SYSTEMS AG LINDA K SCHULZ
K131884 06/25/2013 AVENIR CEMENTED HIP STEM ZIMMER GMBH KAREN O'LEARY
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