FDA 510(k) Decisions During July, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K100536 07/27/2010 TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE 3M UNITEK NIEDRE M HECKMAN
K100647 07/09/2010 A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM A-DEC, INC. THOMAS H LOUISELL
K101434 07/22/2010 AUDIT MICROCV PROCALCITONIN LINEARITY AALTO SCIENTIFIC LTD. DESSI LYAKOV
K101648 07/08/2010 HI-TORQUE WINN GUIDE WIRE FAMILY ABBOTT VASCULAR INC. LAARNI RICAFORT
K093801 07/08/2010 IMPELLA CONTROLLER ABIOMED, INC. ROBERT STEWART
K102050 07/29/2010 Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 ADVANCED TECHNOLOGY LASER CO., LTD. DIANA HONG
K093024 07/15/2010 YEAST TRAFFIC LIGHT PNA FISH ADVANDX, INC. HENRIK STENDER
K100121 07/13/2010 MODEL 300157 CPAP SYSTEM AEIOMED, INC. DARIN BUSCH
K100147 07/23/2010 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA BOYLE
K101281 07/30/2010 VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. KATHY A RACOSKY
K100802 07/20/2010 AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K100876 07/14/2010 AESCULAP MONOMAX ABSORBABLE SUTURE AESCULAP, INC. KATHY A RACOSKY
K093493 07/27/2010 AESCULAP STERILCONTAINER S AESCULAP, INC. KATHY RACOSKY
K100133 07/23/2010 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 AIRSTRIP TECHNOLOGIES, LP WILLIAM CAMERON POWELL
K101206 07/23/2010 TGS UNICOMPARTMENTAL KNEE ARTHROPLASTY (TGS UKA) MODULAR TIBIA SYSTEM ALEXANDRIA RESEARCH TECHNOLOGIES, LLC MICHAEL LARSON
K100051 07/06/2010 INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) ALFA SCIENTIFIC DESIGNS, INC. NASISHU WANG
K100956 07/09/2010 SPONDY SPINAL FIXATION SYSTEM ALLURE SPINE L.L.C. JULIA ELLER
K101255 07/21/2010 ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM ALPHATEC SPINE, INC. KARLA SCHAFFNER
K101507 07/30/2010 AMIGO CLASSIC FD AMIGO MOBILITY INTL., INC. MIKE LABRAKE
K101010 07/30/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL: KD-5963NU, KD-5008 ANDON HEALTH CO.,LTD LIU YI
K093262 07/13/2010 AG-608 BLOOD GLUCOSE MONITORING SYSTEM AND AG-610 BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD. YI LIU
K101735 07/14/2010 ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2155-XXYY ANGIOSCORE, INC. KIMBERLEY KLINE
K091018 07/30/2010 ARTHREX BIOWIRE ARTHREX, INC. SALLY FOUST
K100925 07/12/2010 ASCENSION ANKLE FUSION NAIL SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K100909 07/23/2010 REPROCESSED COMPRESSION SLEEVES ASCENT HEALTHCARE SOLUTIONS RAMONA KULIK
K101087 07/16/2010 REPROCESSED RESTEP COMPRESSION SLEEVES ASCENT HEATLHCARE SOLUTIONS AMANDA BOBCOCK
K101674 07/21/2010 WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 ATHENA GTX SEAN MAHONEY
K100640 07/22/2010 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 B. BRAUN MEDICAL, INC. MATTHEW HOMA
K092328 07/26/2010 MED-SEG, MODEL BTMS 1000 BARTRON MEDICAL IMAGING, INC. ZVI LADIN
K100958 07/23/2010 MODIFICATION TO: MICROBLADE SHAVER AND ACCESSORIES BAXANO, INC. EDWARD J SINCLAIR
K101117 07/16/2010 LEV-OR DILATION CATHETER OTW BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K101615 07/28/2010 POWERWIRE RADIOFREQUENCY GUIDEWIRE BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K101514 07/09/2010 BD DIRECTIGEN EZ RSV BECTON DICKINSON & CO. GREGORY P PAYNE
K100740 07/09/2010 MD2000B VITAL SIGN MONITOR, MODEL MD2000B BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANG HONG
K101102 07/16/2010 POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K101103 07/16/2010 POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1 BEST PUTRA GLOVES SDN BHD EFFENDI TENANG
K093342 07/29/2010 BIOGENNIX RPC BIOGENNIX, LLC EDWIN C SHORS
K093383 07/06/2010 NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG BIOMERIEUX, INC. MARIA OYASKI
K100805 07/20/2010 GALLERY LAMINOPLASTY FIXATION SYSTEM BIOMET SPINE (AKA EBI, LLC) SHIKHA GOLA
K101669 07/01/2010 THERMODILUTION CATHETER BIOSENSORS INTL. PTE. LTD. MOSES THAM
K101776 07/23/2010 SCOUTPRO ACS BIOTRONIK, INC. JON BRUMBAUGH
K101282 07/21/2010 SCOUTPRO HEMOSTATIC VALVE BIOTRONIK, INC. JON BRUMBAUGH
K093926 07/28/2010 FIREBIRD SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. RUSSELL JOHNSON
K101314 07/23/2010 ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. ELENA NIEVES
K101786 07/23/2010 ADVANIX DOUBLE PIGTAIL BILIARY STENT BOSTON SCIENTIFIC CORP. ELENA NIEVES
K100038 07/14/2010 DISPOSABLE REFLECTIVE MARKER SPHERES BRAINLAB, AG ALEXANDER SCHWIERSCH
K101261 07/29/2010 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. MARK NELSON
K101703 07/13/2010 MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 CARD GUARD SCIENTIFIC SURVIVAL, LTD. CLAY ANESELMO
K101032 07/08/2010 CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX CARDO MEDICAL, INC MICHAEL KVITNITSKY
K100253 07/08/2010 VISUMAX LASER KERATOME CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K101879 07/28/2010 XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10 CEPHEID RUSSEL K ENNS, PH.D.
K101043 07/21/2010 ECT DIGITAL THERMOMETER CHANGSHAN ESTAR ELECTRONICS CO., LTD. JACOB CHANG
K101487 07/02/2010 CHEETAH NICOM SYSTEM CHEETAH MEDICAL INC. RHONA SHANKER
K101276 07/28/2010 DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 CHEMENCE MEDICAL PRODUCTS INC. PATRICIA LEHMAN
K101411 07/12/2010 SAVI PREPARATION DEVICE CIANNA MEDICAL, INC. GARY MOCNIK
K093981 07/22/2010 YRNSORTIP OXIMANOMETER CNOGA MEDICAL LTD TALI HAZAN
K100360 07/13/2010 BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT COCHLEAR AMERICAS SEAN BUNDY
K101651 07/09/2010 ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE CORDIS CORP. JOAN MARTIN
K100511 07/09/2010 COTEC DENTAL IMPLANT SYSTEM COTEC IMPLANT CO., LTD. JOYCE BANG
K101866 07/23/2010 CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH CRYOLIFE, INC. JOHN D FERROS
K101851 07/15/2010 VENTRALIGHT ST MESH DAVOL INC., SUB. C.R. BARD, INC. MICHELLE GODIN
K101140 07/15/2010 DENTLIGHT ORAL EXAM LIGHT KIT DENTLIGHT INC. RICHARD LIU
K101240 07/23/2010 CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K100247 07/23/2010 DETAX IMPLANTLINK SEMI DETAX GMBH & CO. KG DAGMAR MAESER
K100765 07/19/2010 FIXPINE II SYSTEM DIO MEDICAL CO., LTD. JOYCE BANG
K100595 07/09/2010 ECLERIS MICROSTAR COLPOSCOPE ECLERIS USA RAYMOND J KELLY IV
K093877 07/01/2010 RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 EDWARDS LIFESCIENCES, LLC. JASON K LYON
K093000 07/30/2010 EMS PIEZON MASTER 700 EMS ELECTRO MEDICAL SYSTEMS SA CYNTHIA J.M NOLTE
K101457 07/01/2010 EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K101108 07/16/2010 ERBE ESU MODEL VIO 100 C WITH ACCESSORIES ERBE USA, INC. JOHN TARTAL
K101557 07/01/2010 GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN ETEX CORP. CHRISTOPHER KLACZYK
K100936 07/01/2010 GYNECARE TVT ABBREVO CONTINENCE SYSTEM ETHICON, INC. SUSAN LIN
K092860 07/16/2010 LASEMAR 800, 1000, 1500 EUFOTON S.R.L. PAOLO COSSICH
K083418 07/22/2010 CPR MASK FIRSTAR HEALTHCARE CO., LTD. YOVETTE MUMFORD
K101662 07/26/2010 SYNAPSE 3D BASIC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K100762 07/15/2010 FLAT PANEL DETECTOR, MODEL FDR D-EVO FUJIFILM MEDICAL SYSTEMS U.S.A., INC. DEBBIE PEACOCK
K092853 07/09/2010 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM GALIX BIOMEDICAL INSTRUMENTATION, INC. YOEL PALOMINO
K093608 07/29/2010 GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H GAMBRO RENAL PRODUCTS, INC. KAE MILLER
K101855 07/23/2010 PROFAST+ ASSAY GEN-PROBE PRODESSE, INC KAREN HARRINGTON
K093903 07/15/2010 ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC GENESEE BIOMEDICAL, INC. JOHN T.M. WRIGHT
K100757 07/01/2010 TILOCK PEDICLE SCREW SYSTEM GENESYS SPINE JOSH KAUFMANN
K093189 07/02/2010 ACTIPROTECT UC N95 RESPIRATOR GLAXOSMITHKLINE CONSUMER HEALTHCARE ZINATARA MANJI
K101629 07/09/2010 FIL 1520 GLENN MEDICAL SYSTEMS, INC. GARY CLEVINGER
K100411 07/28/2010 VARIOUS DENTAL IMPLANTS GRUNDY ADVANCED BIOMEDICAL SYSTEMS LLC WILLIAM SIMMONS
K093910 07/12/2010 IMPROVACUTER GEL & CLOT ACTIVATOR TUBE GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. DIANA HONG
K100816 07/01/2010 PK SUPERPULSE SYSEM GENERATOR MODEL 744000 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K093179 07/14/2010 MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) H&H RESEARCH COMPANY JONG HUANG
K100620 07/02/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 HARVARD MEDICAL DEVICES LTD. MARTIN MA
K100531 07/21/2010 VISCOPE, MODEL 100P,100S HD MEDICAL SERVICES (INDIA) PVT.LTD BILL MURPHY
K101663 07/27/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI EXCELLENT PLASTIC CO., LTD. CHU XIAOAN
K101664 07/27/2010 POWDERED VINYL PATIENT EXAMINATION GLOVES HEBEI EXCELLENT PLASTIC CO., LTD. CHU XIAOAN
K100964 07/16/2010 POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HEBEI SHENZICHEN PLASTIC & RUBBER PRODUCTS CO., LT CHU XIAOAN
K100234 07/08/2010 HM-LAMP II HILLUSA, INC. MARIA GUMA
K101132 07/01/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (BLUE, WHITE, PINK) HONG DI PLASTIC PRODUCTS CO., LTD. JIE LIU
K101135 07/01/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK) HONGZE PLASTIC TECHNOLOGY CO., LTD KATHY LIU
K100840 07/12/2010 EMBO PLUS EMBOLECTOMY CATHETER HOTSPUR TECHNOLOGIES ERIC ANKERUD
K101047 07/13/2010 PTA-DUO PTA BALLOON CATHETER HOTSPUR TECHNOLOGIES ERIC P ANKERUD
K100842 07/12/2010 PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM HOTSPUR TECHNOLOGIES ERIC ANKERUD
K100702 07/20/2010 STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS HUOT INSTRUMENTS, LLC ANNE WARD
K100434 07/09/2010 CLAVE NEUTRON ICU MEDICAL, INC. TRACY BEST
K101796 07/15/2010 PACSMATE MMD-5201M MONITOR IEI TECHNOLOGY CORP. HUI-CHEN KAI
K092261 07/23/2010 DEFCON TSA/TSH DENTAL IMPLANT SYSTEM IMPLADENT, S.L. JOSE-RAMON GUTIERREZ
K100031 07/19/2010 IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 IND DIAGNOSTIC INC. JASON PENG
K101833 07/23/2010 INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 INFIMED, INC. JIGAR SHAH
K101386 07/30/2010 VIGILANT EEG MONITOR MODEL VIGILANT 2.0 INFINITE BIOMEDICAL TECHNOLOGIES, LLC MANAN HATHI
K101857 07/22/2010 RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V INSTRUMENTATION INDUSTRIES, INC. DORIS F WALTER
K101685 07/01/2010 IP-SET INTEGRAL PROCESS SAS CHRISTIAN BERTHON
K100441 07/15/2010 XINIWAVE, MODEL XW-18 INTERNATIONAL TRADE GROUP, INC. BRENT C REIDER
K092306 07/09/2010 SECURACATH UNIVERSAL INTERRAD MEDICAL, INC. JONATHAN KAHAN
K100766 07/21/2010 IBA PROTON THERAPY SYSTEM, MODEL PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K100979 07/02/2010 NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR WHITE, NITRILE EXAM GLOVE, POWDER-FREE MODEL COLOR BLUE JIANGSU SUNSHINE PLASTIC PRODUCTS, CO. LTD MICHAEL LEE
K101232 07/21/2010 JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 JOINSOON ELECTRONICS MFG CO LTD JIGAR SHAH
K101322 07/28/2010 JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 JOINSOON ELECTRONICS MFG CO LTD JIGAR SHAH
K101302 07/22/2010 ALEUTIAN IBF SYSTEM K2M, INC. NANCY GIEZEN
K101022 07/09/2010 PULMOTRACK 5050 WHOLTER, MODEL 5050 KARMELSONIX YORAM LEVY
K093473 07/02/2010 KMD-MARK1 TISSUE MARKER KENT MEDICAL DEVICES, INC. JUSTIN EGGLETON
K101423 07/30/2010 OPTIBOND XTR KERR CORPORATION WENDY GARMAN
K101596 07/21/2010 KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER- KIMBERLY-CLARK LESTER F PADILLA
K100706 07/22/2010 VENUS BASIC SPINAL FIXATION SYSTEM L & K BIOMED CO., LTD HEE KYEONG JOO
K101190 07/01/2010 LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC LED INTELLECTUAL PROPERTIES, LLC ROBERT T WAGNER
K101195 07/06/2010 6-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K093266 07/27/2010 MAM COOLER MAM INTERNATIONAL AG MICHAEL TEDESCO
K102002 07/28/2010 TALYMED MARINE POLYMER TECHNOLOGIES SERGIO FINKIELSZTEIN
K100428 07/09/2010 MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER MASIMO CORPORATION MARGUERITE THOMLINSON
K101214 07/23/2010 GUARDIAN CONNECTION MAULIN MEDICAL LLC SARA OWENS
K100544 07/22/2010 IMPIX LUMBAR INTERBODY DEVICE MEDICREA TECHNOLOGIES JD WEBB
K100543 07/23/2010 MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01 MEDISISS BRANDI JAMES
K101455 07/19/2010 EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K101829 07/16/2010 THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K101092 07/16/2010 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 MEDIVANCE, INC. LYNNE ARONSON
K100302 07/02/2010 MEDLINE PVC URETHRAL CATHETER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K100432 07/09/2010 POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS MEDTRONIC MINIMED MARK FAILLACE
K101777 07/23/2010 PIONEER PLUS CATHETER, MODEL PLUS 120 MEDTRONIC VASCULAR LUCINDA L FOX
K090950 07/02/2010 BONE PLUS BCP MEGAGEN IMPLANT CO., LTD JOYCE BANG
K100414 07/02/2010 PROTOE ENDOSORB SMALL HAMMER TOE PIN MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K100818 07/09/2010 ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920 MERIDIAN BIOSCIENCE, INC. MICHELLE L SMITH
K092859 07/02/2010 MERITS MODEL N SERIES NEBULIZER COMPRESSORS MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K101570 07/13/2010 HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR LAURIE CARTWRIGHT
K101512 07/01/2010 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4). MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN GOLDSTEIN-FALK
K101826 07/28/2010 HYDROFIX VASO SHIELD, MODEL HVS-001-0610 MIMEDX GROUP, INC SALLY THORSEN
K101101 07/23/2010 MINI-TONG MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K101403 07/02/2010 ELI 250 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHIEN HUI (AMY) YANG
K101252 07/15/2010 NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 NEOTRACT, INC. KEVIN MACDONALD
K101580 07/01/2010 NEV'S INK AUTOCLAVE TAPES NEV'S INK, INC DAVE MAROSE
K092573 07/09/2010 NIHON KOHDEN QP-160AK EEG TREND PROGRAM NIHON KOHDEN AMERICA, INC. STEVE GEERDES
K090661 07/21/2010 NES REPROCESSED VARICOSE VEIN RF CATHETER NORTHEAST SCIENTIFIC, INC. CRAIG ALLMENDINGER
K101711 07/01/2010 CERULEAU ELECTROSURGICAL PROBE NUORTHO SURGICAL, INC MARTIN J LEIGHTON
K101284 07/15/2010 FACET SCREW SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K101778 07/21/2010 GIRAFFE INCUBATOR OHMEDA MEDICAL AGATA SMIEJA
K101788 07/21/2010 GIRAFFE OMNIBED OHMEDA MEDICAL AGATA SMIEJA
K101804 07/21/2010 GIRAFFE AND PANDA WARMERS OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC., AGATA SMIEJA
K100584 07/02/2010 EVIS EXERAII 180 SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION STACY A KLUESNER
K101053 07/14/2010 OLYMPUS CF TYPE Y0023-L, Y0023I OLYMPUS MEDICAL SYSTEMS CORPORATION STACY A KLUESNER
K100275 07/01/2010 WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS OLYMPUS WINTER & IBE GMBH STACY KLUESNER
K101059 07/12/2010 OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE OMEGA LABORATORIES, INC. ROBERT J BARD
K100644 07/15/2010 OPTOS LIMITED PANORAMIC 200CAF OPTOS PLC HOWARD M HOLSTEIN
K092399 07/01/2010 ANTI-MUTATED CITRULLINATED VIMENTIN EIA ORGENTEC DIAGNOSTIKA GMBH GARY LEHNUS
K092981 07/22/2010 PANPAC VAGINAL PESSARY PANPAC MEDICAL CORPORATION YEN-MING PAN
K092982 07/26/2010 THE PANPAC SUCTION CURETTE PANPAC MEDICAL CORPORATION YEN-MING PAN
K101083 07/02/2010 DSS STABILIZATION SYSTEM PARADIGM SPINE LLC MICHELLE MCDONOUGH
K101295 07/28/2010 MROPEN PARAMED SRL RICHARD R GLASHEEN
K100661 07/01/2010 EARPROBE PATH MEDICAL GMBH KURT RENTEL
K100826 07/13/2010 PENUMBRA CATHERER 025 PENUMBRA, INC. SETH A SCHULMAN
K101474 07/02/2010 MD VISION SYSTEM PERKINS HEALTHCARE TECHNOLOGIES ANDREW C KYLE
K101521 07/29/2010 ST/AR ST AND ARRHYTHMIA SOFTWARE MODEL: RELEASE K.O PHILIPS MEDICAL SYSTEMS LOIS GIEGERICH
K100420 07/26/2010 PHILIPS OBTRACEVUE MODEL SW REV. G.00 PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH MICHAEL ASMALSKY
K100817 07/01/2010 BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST PRINCETON BIOMEDITECH CORP. JEMO KANG, PH.D.
K101076 07/27/2010 PROWESS PANTHER PROARC, MODEL VERSION 5.0 PROWESS, INC. RACHEL SCARANO
K101293 07/01/2010 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) PT. SMART GLOVE INDONESIA CHO S FONG
K100813 07/23/2010 QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB PULSE BIOMEDICAL, INC. SALEEM HASAN
K100558 07/22/2010 QUANTA DIODE LASER SYSTEM QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K100678 07/21/2010 SUPRA SCAN DELIVERY SYSTEM QUANTEL MEDICAL PATRICK QUERO
K101172 07/27/2010 RDT3 HANDPIECE HEAD MODEL RDT3 REDENT NOVA LTD JONATHAN S KAHAN
K093964 07/09/2010 VENOFER PUMP RENAL SOLUTIONS INC. DAVID VANELLA
K100461 07/08/2010 PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT RIVERPOINT MEDICAL DOUG ROWLEY
K100611 07/16/2010 RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K100603 07/16/2010 RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE) RIVERSTONE RESOURCES SDN. BHD. CHONG CHU MEE
K093664 07/28/2010 AMPHETAMINES II ASSAY ROCHE DIAGNOSTICS CORP. MICHELLE L NEFF
K091409 07/06/2010 LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 ROCHE MOLECULAR SYSTEMS, INC. LARRY PIETRELLI
K093775 07/15/2010 EVGUIDE TIP LOCATION SYSTEM ROMEDEX INTERNATIONAL SRL SORIN GRUNWALD
K093489 07/29/2010 IN VISION-PLUS NANO WITH NEUTRAL ADVANTAGE TECHNOLOGY RYMED TECHNOLOGIES, INC. JOSEPH AZARY
K082573 07/21/2010 SARGON NON-EXPANDABLE DENTAL IMPLANT SARGON ENT., INC. DANIEL J MANELLI
K092813 07/16/2010 ASTRASONIC SPIROMETER, MODEL 29-8000 SDI DIAGNOSTICS, INC. COSIMO CARIOLO
K100439 07/16/2010 MEDIWORKS SLIT LAMP SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. LISA ZHANG
K101949 07/28/2010 PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD JIE HUANG
K101858 07/14/2010 PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD JIE HUANG
K100488 07/22/2010 IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081 SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ZHIGANG ZHAO
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