FDA 510(k) Applications Received During June, 2010

FDA 510(k) Number Submission Date Device Name Applicant Contact
K101528 06/02/2010 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM 3M COMPANY SUZANNE LEUNG
K101648 06/11/2010 HI-TORQUE WINN GUIDE WIRE FAMILY ABBOTT VASCULAR INC. LAARNI RICAFORT
K101794 06/28/2010 ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA ADVANCED SURGICAL CONCEPTS ROSINA ROBINSON
K101555 06/04/2010 CO2 LASER SYSTEM ADVANCED TECHNOLOGY LASER CO., LTD. Diana Hong
K101558 06/04/2010 GNR TRAFFIC LIGHT PNA FISH ADVANDX, INC. HENRIK STENDER
K101717 06/18/2010 DENTAL HANDPIECES, MODELS: KARAM STD/MINI; BREEZE STD/MINI: KARAM 45; DEXOR 45; KARAM 4H COUPLING AEROBINE, INC YONG W KIM
K101815 06/30/2010 ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS KATHY A RACOSKY
K101641 06/10/2010 AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301 AG DIGITAL TECHNOLOGY CORP. JENNIFER REICH
K101597 06/08/2010 WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 AGAMATRIX CONNIE HERTEL
K101806 06/28/2010 AIDERA DIASEND SYSTEM AIDERA AB ANDERS SONESSON
K101755 06/23/2010 AIDI DENTAL IMPLANT SYSTEM AIDI BIOMEDICAL LLC WILLIAM Y.S. HUNG
K101774 06/24/2010 MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4) ALCON MANUFACTURING, LTD. Catherine Goble
K101654 06/11/2010 IMPROVIS IMAGING SYSTEM AMERICAN DENTAL PARTNERS, INC TIMOTHY RODENBERGER
K101561 06/04/2010 TX1 TISSUE REMOVAL SYSTEM AMERICAN OPTISURGICAL, INC. DAVID SALZBERG
K101507 06/01/2010 AMIGO CLASSIC FD AMIGO MOBILITY INTL., INC. MIKE LABRAKE
K101735 06/21/2010 ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY ANGIOSCORE, INC. KIMBERLEY KLINE
K101588 06/07/2010 ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL APOLLO SPINE, INC. CHRISTINE SANTAGATE
K101574 06/07/2010 ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K101679 06/15/2010 ARTHREX PUSHLOCK ANCHORS ARTHREX, INC. COURTNEY SMITH
K101823 06/30/2010 ARTHREX SWIVELOCK ANCHORS ARTHREX, INC. SALLY FOUST
K101732 06/21/2010 ASTRA TECH IMPLANT SYSTEM ASTRA TECH AB LINDA K SCHULZ
K101674 06/15/2010 WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 ATHENA GTX SEAN MAHONEY
K101568 06/02/2010 MODEL SB100II FINGER PULSE OXIMETER ATLANTEAN PAUL DRYDEN
K101683 06/15/2010 INFINITI CYP2C19 ASSAY AUTOGENOMICS, INCORPORATED EVELYN G LOPEZ
K101647 06/11/2010 WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 AVINGER, INC. HIMANSHU PATEL
K101615 06/09/2010 POWERWIRE RADIOFREQUENCY GUIDEWIRE BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K101529 06/02/2010 BD DIRECTIGEN EZ FLU A+B ASSAY BECTON DICKINSON & CO. Gregory P Payne
K101514 06/02/2010 BD DIRECTIGEN EZ RSV BECTON DICKINSON & CO. Gregory P Payne
K101502 06/01/2010 BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 BECTON DICKINSON & CO. MARY ANNE ALSBERGE
K101577 06/07/2010 MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Diana Hong
K101594 06/08/2010 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE BETTER CARE PLASTIC TECHNOLOGY CP., LTD JIE LIU\
K101595 06/08/2010 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE BETTER CARE PLASTIC TECHNOLOGY CP., LTD JIE LIU
K101658 06/11/2010 WATERLASE MD TURBO PLUS MODEL 7200XXX BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K101712 06/18/2010 ENDOVASCULAR LAER VEIN SYSTEM KIT BIOLITEC, INC. HARRY HAYES
K101566 06/04/2010 VITEK 2 YEAST CASPOFUNGIN BIOMERIEUX, INC. Nancy Weaver
K101607 06/08/2010 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS BIOMET 3I, INC. JOSE E CABRERA
K101608 06/08/2010 BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS BIOMET 3I, INC. JOSE E CABRERA
K101582 06/07/2010 CAM STRUCTSURE BARS BIOMET 3I, INC. JOSE E CABRERA
K101669 06/14/2010 THERMODILUTION CATHETER BIOSENSORS INTL. PTE. LTD. MOSES THAM
K101776 06/25/2010 SCOUTPRO ACS BIOTRONIK, INC. Jon Brumbaugh
K101787 06/25/2010 DUOLINK II BISCO, INC. Michelle Schiltz-Taing
K101786 06/25/2010 ADVANIX DOUBLE PIGTAIL BILIARY STENT BOSTON SCIENTIFIC CORP. ELENA NIEVES
K101657 06/11/2010 RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 BOSTON SCIENTIFIC CORP. ASHLEY PYLE
K101627 06/09/2010 IPLAN BRAINLAB AG ALEXANDER SCHWIERSCH
K101591 06/07/2010 STINGRAY ORIENTING BALLOON CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K101537 06/03/2010 AIM 200, MAJOR SURGICAL LIGHT BURTON MEDICAL PRODUCTS CORP. SCOT KINGHORN
K101722 06/18/2010 ALYTE Y-MESH GRAFT C.R. BARD, INC. SCOTT ROBIRDS
K101769 06/24/2010 EPISIL CAMURUS AB MAUREEN O'CONNELL
K101814 06/29/2010 DIRECT CROWN NATURAL 1 CANDULOR USA, INC. DONNA MARIE HARTNETT
K101639 06/10/2010 CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. CLAY ANSELMO
K101703 06/17/2010 MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 CARD GUARD SCIENTIFIC SURVIVAL, LTD. CLAY ANESELMO
K101811 06/29/2010 PROTEGRITY SMT LATEX SURGICALGLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K101643 06/10/2010 MODEL LTV 1100 VENTILATOR CAREFUSION MONTHER ABUSHABAN
K101661 06/14/2010 MYRAY HYPERION CEFLA DENTAL GROUP CYNTHIA J NOLTE, PH.D.
K101564 06/04/2010 CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
K101592 06/07/2010 ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM CHENG MEDICAL, CORPORATION MARY P GALLUP
K101589 06/07/2010 BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS CINCINNATI SUB-ZERO PRODUCTS, INC. STEVEN J BERKE
K101567 06/04/2010 SHARPS CONTAINER CIXI LEINUO PLASTIC CO. LTD CHARLES MACK
K101534 06/03/2010 CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM CONMED CORP. SHAWN REIDEL
K101692 06/16/2010 PATIENT MONITOR CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K101530 06/03/2010 EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D COOK IRELAND LTD Jacinta Kilmartin
K101728 06/21/2010 FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE COOK, INC. SEAN WERNER
K101651 06/11/2010 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE CORDIS CORP. JOAN MARTIN
K101797 06/28/2010 SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO DAVID M HORTON
K101602 06/08/2010 VITAL SIGNS MONITOR CRITICARE SYSTEMS, INC. ALEX KAPLAN
K101587 06/07/2010 PROPATCH SOFT TISSUE REPAIR MATRIX CRYOLIFE, INC. BRYAN BROSSEAU
K101601 06/08/2010 AFFIRM DO DIODE LASER CYNOSURE, INC. ANTHONY BURNS
K101611 06/08/2010 RELAY POWER WHEELCHAIR DALTON INSTRUMENT CORP. JENNIFER YU
K101719 06/18/2010 TACAMO MANUAL WHEELCHAIR DALTON INSTRUMENT CORP. MEI LEIN
K101551 06/04/2010 PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M DELMA MEDICAL INSTRUMENT (GUANGZHOU) CO., LTD. LEON LU
K101493 06/01/2010 ADVANCED GLASS IONOMER (K-130) RESTORATIVE DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K101762 06/22/2010 VIPER F2 FACET FIXATION SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K101793 06/28/2010 MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. RONALD S WARREN
K101723 06/18/2010 COMPACT WHEELCHAIR PLATFORM DESIGN SPECIFIC FLETCHER RICHARD FLETCHER
K101523 06/02/2010 CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. RUTH WU
K101741 06/22/2010 DIATRON PICTUS 400 DIATRON GROUP JIM SCHEPP
K101763 06/23/2010 DIOPSYS NOVA VEP VISION TESTING SYSTEM DIOPSYS INC. RICHARD HETTENBACH
K101612 06/09/2010 ZEN CORDLESS PROPHY SYSTEM DISCUS DENTAL, LLC WINKIE WONG
K101614 06/09/2010 HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 DM SYSTEMS, INCORPORATED MICHAEL ZMUDA
K101710 06/17/2010 LUXATEMP ULTRA /STAR DMG USA, INC. PAMELA PAPINEAU
K101539 06/03/2010 VITAL SIGNS MONITOR MODEL M3B EDAN INSTRUMENTS, INC. RANDY JIANG
K101510 06/01/2010 FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR ENDYMED MEDICAL LTD YORAM LEVY
K101605 06/08/2010 MYLABONE ULTRASOUND SYSTEM ESAOTE EUROPE B.V. Allison Scott
K101504 06/01/2010 TI-CORE FLOW ESSENTIAL DENTAL SYSTEMS, INC. JEFFREY WAN
K101557 06/04/2010 GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN ETEX CORP. CHRISTOPHER KLACZYK
K101520 06/02/2010 ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH ETHICON ENDO-SURGERY, INC. RUTH WOOD
K101689 06/16/2010 EMM EQUIPMENT COVER-POLYTHYLENE EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K101598 06/08/2010 EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K101688 06/16/2010 EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K101593 06/08/2010 EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K101761 06/23/2010 EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 EXACTECH, INC. DARRELL KASSNER
K101700 06/17/2010 IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K101552 06/04/2010 FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. S.DAVID PIPER, PE
K101693 06/16/2010 GAUNYING INFRARED LAMP MODEL IL50 FOSHAN GAUNYING ELECTRONICS CO., LTD. GUENTER GINSBERG
K101817 06/30/2010 LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N FOTONA D.D. STOJAN TROST
K101715 06/18/2010 FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE RANDOLPH QUINN
K101686 06/16/2010 FDR IMAGE STITCHING OPTION FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K101662 06/14/2010 SYNAPSE 3D BASIC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K101809 06/29/2010 FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 FUJIREBIO DIAGNOSTICS, INC STACEY DOLAN
K101707 06/17/2010 FULACCESS MODEL 1.0 FULCRUM MEDICAL, INC SCOTT BRAME
K101492 06/01/2010 8 CHANNEL CARDIAC PHASED ARRAY COIL GE HEALTHCARE COILS (USA INSTRUMENTS INC.) MICHAEL S PRETO
K101629 06/10/2010 FIL 1520 GLENN MEDICAL SYSTEMS, INC. GARY CLEVINGER
K101784 06/25/2010 MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX Greatbatch Medical Kristi Fox
K101694 06/16/2010 HANDHELD PULSE OXIMETER MODEL M800 GUANGDONG BIOLIGHT MEDITECH CO., LTD. Diana Hong
K101716 06/18/2010 HVR PAIN RELIEF DEVICE H.V.R., INC. JESSANY GARRETT
K101663 06/14/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI EXCELLENT PLASTIC CO., LTD. CHU XIAOAN
K101664 06/14/2010 POWDERED VINYL PATIENT EXAMINATION GLOVES HEBEI EXCELLENT PLASTIC CO., LTD. CHU XIAOAN
K101547 06/03/2010 HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) HENKE-SASS WOLF, GMBH. LYNETTE HOWARD
K101617 06/09/2010 FLEXITIME XTREME 2 HEAVY TRAY CARTRIDGE REFILL, FEXITIME XTREME 2 LIGHT TRAY CARTRIDGE REFILL HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K101677 06/15/2010 HOSPIRA INFUSION BLOOD SETS HOSPIRA, INC. KAREN KEENER
K101713 06/18/2010 LIPCOLLECTOR II HUMAN MED AG INGE MATTHIESEN
K101796 06/28/2010 PACSMATE MMD-5201M MONITOR IEI TECHNOLOGY CORP. HUI-CHEN KAI
K101813 06/29/2010 IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO IMRIS, INC. THOMAS M TSAKERIS
K101644 06/10/2010 QUANTA FLASH H-TTG IGG INOVA DIAGNOSTICS, INC. RUFUS BURLINGAME
K101685 06/16/2010 IP-SET INTEGRAL PROCESS SAS CHRISTIAN BERTHON
K101743 06/22/2010 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 INTUITIVE SURGICAL, INC. KAREN UYESUGI
K101581 06/07/2010 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 INTUITIVE SURGICAL, INC. BRANDON HANSEN
K101508 06/01/2010 MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K101563 06/04/2010 SMARTO JEIL MEDICAL CORPORATION KIM SEONG NAM
K101585 06/07/2010 K-Y BRAND LONG LASTING VAGINAL MOISTURIZER JOHNSON & JOHNSON CONSUMER & PERSONAL PRODUCTS WOR BRAD LAMOTTE,PHARM.D.
K101779 06/25/2010 CLEARVISION DR 2000 DIGITAL RADIOGRAPHY X-RAY SYSTEM JPI HEALTHCARE CO., LTD WILLIAM LITTLE
K101747 06/22/2010 BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE KAZ USA, INC (A SUBSIDIARYOF KAZ INC) RAJ KASBEKAR
K101660 06/14/2010 ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 KEPLER MEDTEC F. DAVID ROTHKOPF
K101756 06/23/2010 TSC KERR CORPORATION Wendy Garman
K101545 06/03/2010 GENESIS IMPLANT SYSTEM KEYSTONE DENTAL JOHN CAPONE
K101596 06/08/2010 KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- KIMBERLY-CLARK LESTER F PADILLA
K101609 06/08/2010 SELF RETAINING SOFT TISSUE RETRACTOR KOROS USA, INC. TIBOR KOROS
K101628 06/10/2010 KOWA NONMYD WX KOWA CO. LTD. SATOHIKO TAKANASHI
K101645 06/11/2010 NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF LATEXX MANUFACTURING SDN.BHD. TERENCE LIM SIN KOOI
K101740 06/21/2010 ALBOSURE POLYESTER VASCULAR PATCH LEMAITRE VASCULAR, INC. VIC ZHANG
K101626 06/09/2010 LENSX LASER SYSTEM LENSX LASERS, INC. Judy Gordon
K101691 06/16/2010 LIFELINES PHOTIC STIMULATOR LIFELINES LTD. E. J AMITH
K101792 06/28/2010 LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 LINDE GAS NORTH AMERICA LLC MICHAEL PIACENZA
K101573 06/07/2010 ACCUSCULPT II LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K101771 06/24/2010 RELINE-IT MODEL RELINE-IT MAJESTIC DRUG CO., INC. ROGER S MASTRONY
K101503 06/01/2010 DUSIMETRY CHECK MATH RESOLUTIONS, LLC. WENDEL D RENNER
K101606 06/08/2010 MICROMED PD-8K INSULATION DEFECT DETECTOR MCGAN TECHNOLOGY, LLC JACK GANIS
K101560 06/04/2010 MEDLINE RETRACTABLE SAFETY SYRINGE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K101808 06/29/2010 SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER MEDSHAPE SOLUTIONS JACK GRIFFS
K101791 06/28/2010 ROSA SURGICAL DEVICE MEDTECH SAS BERTIN NAHUM
K101772 06/24/2010 TSRH(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LILA JOE
K101765 06/23/2010 KYPHON ANCHOR FACET SCREW SYSTEM MEDTRONIC SPINE LLC. ERICA HOFFMAN
K101777 06/25/2010 PIONEER PLUS CATHETER, MODEL PLUS 120 MEDTRONIC VASCULAR LUCINDA L FOX
K101546 06/03/2010 ENDOFORM DENTAL TEMPLATE MESYNTHES LTD MARY MCNAMARA
K101570 06/04/2010 HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR LAURIE CARTWRIGHT
K101745 06/22/2010 THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101744 06/22/2010 THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101742 06/22/2010 THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101753 06/22/2010 THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101752 06/22/2010 THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS MICROGENICS CORP. LISA CHARTER
K101754 06/22/2010 THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101746 06/22/2010 THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101512 06/01/2010 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN GOLDSTEIN-FALK
K101542 06/03/2010 HEADWAY 17 ADVANCED MICROCATHETER MICROVENTION, INC. Naomi Gong
K101702 06/17/2010 MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS MIDWEST REPROCESSING CENTER LLC JEROME JAMES
K101768 06/23/2010 MIE SCINTRON GAMMA CAMERA SYSTEMS MIE GMBH THOMAS KUHL
K101653 06/11/2010 MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTES MILTEX, INC. JENNIFER BOSLEY, MBA, RAC
K101805 06/28/2010 HYDROFIX VASO SHIELD MIMEDX GROUP, INC SALLY THORSEN
K101518 06/02/2010 COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE MIRADOR BIOMEDICAL, INC. JUSTIN HULVERSHORN MD, PHD
K101801 06/28/2010 MONICA AN24 MONICA HEALTHCARE IAN HOW
K101729 06/21/2010 NEOWIRE PTA/PTCA GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K101632 06/10/2010 METAFLEXCOIL NEOCOIL, LLC BRIAN BROWN
K101580 06/07/2010 NEV'S INK AUTOCLAVE TAPES NEV'S INK, INC DAVE MAROSE
K101783 06/25/2010 COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE NEW STAR LASERS, INC. NATALIE R VOLLRATH
K101803 06/28/2010 NEWPORT E360 VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. TOM COLONNA
K101714 06/18/2010 NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS NOBEL BIOCARE AB HERBERT CRANE
K101633 06/10/2010 NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K101540 06/03/2010 GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC STEVE RUDOLPH
K101711 06/18/2010 CERULEAU ELECTROSURGICAL PROBE NUORTHO SURGICAL, INC MARTIN J LEIGHTON
K101699 06/16/2010 WIDEXLINK IN CLEAR SERIES HEARING AIDS OFFICE RESEARCH IN CLINICAL AMPLIFICTION FRANCIS KUK
K101778 06/25/2010 GIRAFFE INCUBATOR OHMEDA MEDICAL AGATA SMIEJA
K101788 06/25/2010 GIRAFFE OMNIBED OHMEDA MEDICAL AGATA SMIEJA
K101804 06/28/2010 GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., AGATA SMIEJA
K101575 06/07/2010 APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 OMNLIFE SCIENCE RADHIKA PONDICHERRY
K101505 06/01/2010 RTVUE MODEL RTVUE 100 OPTOVUE, INC. JOHN TALARICO
K101676 06/15/2010 CLEARARCH ORMCO CORP. Wendy Garman
K101812 06/29/2010 CONSTRUX MINI PEEK SPACER SYSTEM ORTHOFIX INC. RUSSELL JOHNSON
K101497 06/01/2010 DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY Oscor Inc. MILA DOSKOCIL
K101524 06/02/2010 C2000 POWERED WHEELCHAIR OTTO BOCK HEALTH CARE, LP WILLIAM KABITZ
K101506 06/01/2010 LUX1540, LUX1440 & LUX2940 LASER HANDPIECES PALOMAR MEDICAL TECHNOLOGIES, INC. Sharon Timberlake
K101532 06/03/2010 NESSI OTC SPACER PHARMACARIBE PAUL DRYDEN
K101538 06/03/2010 HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) PHILIPS ELECTRONICS UK LIMITED DIANA KORDA HEWITT
K101521 06/02/2010 ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O PHILIPS MEDICAL SYSTEMS LOIS GIEGERICH
K101600 06/08/2010 INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K101525 06/02/2010 PIONEER SPINOUS PROCESS FUSION PLATE PIONEER SURGICAL TECHNOLOGY BARRY E SANDS
K101790 06/28/2010 QUANTUM SPINAL SYSTEM, QUANTUM MIS PIONEER SURGICAL TECHNOLOGY BARRY E SANDS
K101760 06/23/2010 ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES PROFIT POINT MANUFACTURING SDN BHD ROBERT HILL
K101630 06/10/2010 POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE PT. SMART GLOVE INDONESIA CHO SOW FONG
K101759 06/23/2010 QUANTUM RING FIXATION SYSTEM MODEL ISF QUANTUM MEDICAL CONCEPTS, LLC. ALEXANDER SHAEVITZ
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