FDA 510(k) Decisions During June, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K063526 06/29/2007 A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER A-M SYSTEMS, INC. JAY MANSOUR
K063753 06/20/2007 GFX NERVE ABLATION SYSTEM ACI, INC. CLAY ANSELMO
K070490 06/20/2007 CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) ADVANCED CIRCULATORY SYSTEMS, INC. PAUL DRYDEN
K062878 06/27/2007 EZPACS, VERSION 3.0 ADVANCED IMAGING SOLUTIONS, LLC RAY HASHEMI
K070444 06/14/2007 AOS TIBIAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K071220 06/01/2007 COLUMBUS TOTAL KNEE SYSTEM AS AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K071125 06/18/2007 AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016 AGA MEDICAL CORP. JODI L RAUS
K070675 06/22/2007 MAMMAPRINT AGENDIA BV GUIDO BRINK
K071297 06/22/2007 IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) AGFA HEALTHCARE CORP. TOM HOLBROOK
K070660 06/21/2007 INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST ALFA SCIENTIFIC DESIGNS, INC. MAJID PAJOUH
K070460 06/11/2007 ALLEZ SPINE CROSS CONNECTORS ALLEZ SPINE, LLC HARTMUT LOCH
K070924 06/21/2007 FLEXGUARD ALLMED SYSTEMS INC. PETER ALLEN
K070891 06/11/2007 ALTIVA CLASSIC ACP SYSTEM ALTIVA CORP. JOHN KAPITAN
K071430 06/21/2007 SYNERAD OMNI, MODELS AN6255 AND AN6265 ANALOGIC CORP. DONALD J SHERRATT
K070613 06/29/2007 ANGIODYNAMICS, INC., MORPHEUS CT PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K070610 06/21/2007 SKATER BILIARY CATHETER ANGIOTECH TRUDY ESTRIDGE
K071195 06/20/2007 KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 ANI-KAL II, LLC GERBAIL T KRISHNAMURTHY, MD
K070921 06/29/2007 BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG APPLIED DNA TECHNOLOGIES, INC. FENG-YU LEE
K071030 06/29/2007 BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC APPLIED DNA TECHNOLOGIES, INC. FENG-YU LEE
K070426 06/29/2007 SILHOUETTE, MODEL 1000.01 ARANZ MEDICAL LIMITED SHANE GOODWIN
K071177 06/29/2007 ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW ARTHREX, INC. MARIELA CABARCAS
K061954 06/01/2007 ARTELON CMC SPACER ARTHRO ARTIMPLANT AB RUSSELL PAGANO
K061956 06/07/2007 ARTELON STT SPACER ARTIMPLANT AB RUSSELL PAGANO
K062885 06/13/2007 STRIDE MICROCATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K071064 06/22/2007 ASCENSION HUMERAL RESURFACING ARTHOPLASTY (HRA) SYSTEM TPS/HA ASCENSION ORTHOPEDICS, INC. GLEN NEALLY
K070572 06/26/2007 ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS; 15FR X 24CM, 15FR X 28CM, 15FR X 32CM ASH ACCESS TECHNOLOGY, INC. ROLAND WINGER
K062613 06/18/2007 BIS EEG MONITOR VIEW ASPECT MEDICAL SYSTEMS, INC. VIKRAM VERMA
K070833 06/22/2007 ATLANTIS ABUTMENT FOR ASTRA IMPLANT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K071497 06/29/2007 ATLAS SPINE VERTEBRAL BODY REPLACEMENT ATLAS SPINE INC. JEANNETTE G DAILEY
K063282 06/20/2007 CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET B. BRAUN MEDICAL, INC. REBECCA STOLARICK
K070533 06/21/2007 BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ;EYRE Z HERNANDO
K071543 06/29/2007 HALO360' COAGULATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K071141 06/06/2007 BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402 BD BIOSCIENCES NOBUKO NAKAJIMA
K071143 06/06/2007 BD TRITEST CD3/CD4/CD45, MODEL 340383 BD BIOSCIENCES NOBUKO NAKAJIMA
K071002 06/21/2007 IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT BECKMAN COULTER, INC. TARA VIVIANI
K071280 06/01/2007 SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS BECKMAN COULTER, INC. TARA M VIVIANI
K071277 06/01/2007 SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS BECKMAN COULTER, INC. TARA M VIVIANI
K071283 06/01/2007 SYNCHRON SYSTEMS CREATININE REAGENT BECKMAN COULTER, INC. TARA M VIVIANI
K070654 06/08/2007 HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K070819 06/25/2007 VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716, BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI JACKIE H BUCKLEY
K071319 06/26/2007 I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 BIO-RAD, DIAGNOSTICS GRP. MARIA ZEBALLOS
K070810 06/08/2007 ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) BIOKIT S.A. JOAN GUIXER
K063232 06/19/2007 ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 BIOKIT S.A. JOAN GUIXER
K062558 06/20/2007 MESOSFOL SURGICAL FILM BIOMET MANUFACTURING CORP. ERIKA MARTIN
K070864 06/01/2007 BONEPLAST QS CALCIUM SULFATE BONE VOID FILLER BIOMET OSTEOBIOLOGICS PALANISWAMY VIJAY
K063393 06/25/2007 SMALL STATURE SPACERS BIOMET SPINE SUSAN ALEXANDER
K071053 06/29/2007 RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD BIOMET, INC. BECKY EARL
K070901 06/15/2007 MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. JESUS T FARINAS
K070951 06/04/2007 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS BOSTON SCIENTIFIC BRIAN PARK
K071042 06/13/2007 POLARCATH PERIPHERAL DILATATION SYSTEM BOSTON SCIENTIFIC CORP. MONICA MORRISON
K071066 06/29/2007 SPYCATCH STONE RETRIEVAL BASKET BOSTON SCIENTIFIC CORP. NEIL KELLY
K071086 06/01/2007 RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 CALGARY SCIENTIFIC, INC. PIERRE LEMIRE
K070524 06/22/2007 MICRODOT BLOOD GLUCOSE MONITORING SYSTEM CAMBRIDGE SENSORS LIMITED WARREN REEVES
K071396 06/28/2007 CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS CAPINTEC, INC. MARY ANNE DELL
K070647 06/22/2007 TRIFLEX SELECT CARDINAL HEALTH, INC. AMY HOYD
K070380 06/08/2007 PORTACLAMP FLEX CARDIO LIFE RESEARCH, S.A. WILLIAM GREENROSE
K070425 06/11/2007 VITALSTIM EXPERIA CHATTANOOGA GROUP MICHAEL TREAS
K070939 06/01/2007 SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM COLOPLAST MANUFACTURING US, LLC REBEKA STOLTMAN
K071050 06/29/2007 GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM COOLSYSTEMS, INC. MARIANNE BALDWIN
K063106 06/11/2007 REVOIS IMPLANT SYSTEM CURASAN AG ERIC WEICHERT
K070281 06/11/2007 ISSYS LP SPINAL FIXATION SYSTEM CUSTOM SPINE, INC. RICHARD JANSEN
K070853 06/13/2007 DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 DADE BEHRING, INC. VICTOR M CARRIO
K071268 06/26/2007 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE DADE BEHRING, INC. ROBERT EUSEBIO
K071142 06/06/2007 GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM DATEX-OHMEDA DAN KOSEDNAR
K071158 06/05/2007 AURALAY PIT & FISSURE SEALANT DENALI CORPORATION JAN G STANNARD
K070869 06/15/2007 PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 DENTALEZ, INC. WILLIAM GUSCOTT
K071257 06/29/2007 MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K070849 06/26/2007 DEPUY GCK FEMORAL AND TIBIAL COMPONENTS DEPUY ORTHOPAEDICS, INC. NANCY FRIDDLE
K071495 06/29/2007 EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON COMPANY CHRISTOPHER KLACZYK
K070760 06/07/2007 POWDER FREE CHLORINATED LATEX PATIENT EXAMINATION GLOVE DERMA CARE PLUS PRODUCTS LLC JOSEPH NEUSER
K070351 06/29/2007 SPACE 360 DELIVERY SYSTEM DFINE, INC. ROBERT POSER
K070383 06/22/2007 ENZYMATIC CREATININE ASSAY (265 SERIES) DIAGNOSTIC CHEMICALS LTD. DEBBIE M MURRAY
K070566 06/04/2007 INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL DRAEGER MEDICAL SYSTEMS, INC. MARK KIERAS
K071378 06/13/2007 MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES E-Z-EM, INC. STEVEN HARTMAN
K070320 06/07/2007 EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 EDWARDS LIFESCIENCES SERVICES GMBH NEIL R ARMSTRONG
K071103 06/27/2007 HABIB HEXABLATE EMCISION, LTD. NAGY HABIB
K071180 06/20/2007 SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 ENGINEERED MEDICAL SOLUTIONS CO. LLC WILLIAM G MCLAIN
K062630 06/28/2007 OSSIPRO BONE SUBSTITUTE MATERIAL ETEX CORP. FRANCES A FLORENCE
K070198 06/13/2007 ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES AND ENDOPATH DEXTRUS FIXED-LENGTH ACCESS RETRACTORS, HAP02 ETHICON ENDO-SURGERY, LLC WENDY TURNER
K071249 06/05/2007 ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV ETHICON, INC. PATRICE NAPODA
K070880 06/07/2007 ER35 ERO-SCAN PRO HEARING TEST SYSTEM ETYMOTIC RESEARCH, INC. CAMPBELL L TUSKEY
K061239 06/28/2007 EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT EUROIMMUN US LLC KATHRYN KOHL
K070890 06/29/2007 EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-100507 EVERLIFE MEDICAL EQUIPMENT CO., LTD. KE-MIN JEN
K063685 06/07/2007 OPTECURE; OPTECURE + CCC EXACTECH, INC. MARITZA ELIAS
K070917 06/20/2007 FEEL-JECT INSULIN SYRINGE FEEL TECH DANIEL KAMM
K062484 06/08/2007 FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS FLAEM NUOVA S.P.A. MAUREEN O'CONNELL
K070617 06/14/2007 CANNULATED SCREW FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K071387 06/15/2007 FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K070815 06/20/2007 THD G.F. S.R.L. MAUREEN O'CONNELL
K071020 06/18/2007 DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE GE HEALTHCARE JOEL KENT
K071570 06/27/2007 GE LUNAR BODY COMPOSITION SOFTWARE GE MEDICAL SYSTEMS LUNAR JAMES P RASKOB
K071352 06/29/2007 CERADRILL GEBR. BRASSELER GMBH & CO. KG OLAF BRAND
K071523 06/26/2007 FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODELS BP1600, BP1650, BP1700 AND BP1750 GENEXEL-SEIN, INC. JAY MANSOUR
K062883 06/13/2007 GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR GEREONICS, INC. GERALD ROST
K071153 06/11/2007 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K071506 06/28/2007 ECHELON SPECTROSCOPY PACKAGE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K060434 06/05/2007 ABX PENTRA ALBUMIN CP, ABX PENTRA MICRO-ALBUMIN CP, ABX PENTRA TOTAL PROTEIN CP, ABX PENTRA MULTICAL HORIBA ABX TIM LAWTON
K062737 06/12/2007 CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER HORIBA ABX TIM LAWTON
K070095 06/01/2007 TRIATHLON TS KNEE SYSTEM HOWMEDICA OSTEONICS CORP TIFFANI ROGERS
K070975 06/21/2007 SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES HU-FRIEDY MFG. CO., INC KEITH DUNN
K070633 06/05/2007 GENIE, MODEL CH-200 ICU MEDICAL, INC TRACY BEST
K071408 06/13/2007 X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K071409 06/08/2007 X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K071403 06/11/2007 X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHAN SAMARAPPULI
K071402 06/08/2007 X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K071401 06/22/2007 X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K062636 06/01/2007 OSSEOTITE, OSSEOTITE NY, CERTAIN, CERTAIN NT, PREVAIL, CERTAIN PREVAIL, XP, MICROMINIPLANT, DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K062541 06/07/2007 CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS INNOVA VISION INC. JENNIFER REICH
K063818 06/20/2007 QUANTA PLEX CELIAC IGA PROFILE INOVA DIAGNOSTICS, INC. BRYS C MYERS
DEN060002 06/13/2007 INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM INRANGE SYSTEMS, INC. CHRISTOPHER E BOSSI
K051338 06/13/2007 INRANGE REMOTE MEDICATION MANAGEMENT SYSTEM INRANGE SYSTEMS, INC. CHRISTOPHER E BOSSI
K070744 06/29/2007 NARROW NECK TEMPORARY COPING INSTITUT STRAUMANN AG ELAINE ALAN
K071458 06/13/2007 MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS INTEGRA LIFESCIENCES CORPORATION DONNA WALLACE
K070696 06/29/2007 INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME) INTERACOUSTICS A/S DANIEL EGGAN
DEN070006 06/13/2007 BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX Anne Jepson
K061542 06/13/2007 BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS-BINAX ANNE JEPSON
K070491 06/21/2007 DIGITAL FOREHEAD THERMOMETER, MODEL# KD-2200 K-JUMP HEALTH CO., LTD. DANIEL WANG
K063740 06/07/2007 V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766 KCI USA, INC. MARGARET MARSH
K063692 06/07/2007 V.A.C. THERAPY SYSTEMS-ACTI V.A.C. THERAPY UNIT MODEL# 340000 KCI USA, INC. MARGARET MARSH
K071237 06/01/2007 COPIOS BONE VOID FILLER SPONGE AND PASTE KENSEY NASH CORP. JENNIFER J BOSLEY
K070395 06/07/2007 KD-525E FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K071436 06/27/2007 REGIUS UNITEA KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K071233 06/20/2007 XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM KUB TECHNOLOGIES, INC JOSEPH M AZARY
K071169 06/20/2007 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC. KOJI NISHIDA
K071192 06/22/2007 BLUGOO HD LANCER ORTHODONTICS, INC. GRACE HOLLAND
K070995 06/22/2007 ARX-LINK CROSS CONNECTOR LIFE SPINE REBECCA M BROOKS
K070560 06/11/2007 LRTM SURGICAL MESH LIFECELL CORP. LORRAINE T MONTEMURRO
K071047 06/08/2007 MASIMO PATIENT SAFETY NET MASIMO CORPORATION MARGUERITE THOMLINSON
K071024 06/29/2007 MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS MASIMO CORPORATION JAMES J CRONIN
K071241 06/08/2007 LMS-LIVER MEDIAN TECHNOLOGIES CHAS BURR
K063376 06/25/2007 EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER MEDICA CORP. PHOTIOS MAKRIS
K063339 06/29/2007 MEDICK MHM200 PERSONAL HEART MONITOR MEDICK HEALTHCARE LTD. JAMES W SANDBERG
K063681 06/29/2007 TECNO-GAZ ANDROMEDA VACUUM CS AUTOCLAVE MEDILINE ITALIA S.R.L. PANTALEONI MAURIZIO
K063876 06/14/2007 MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING MEDIVATORS REPROCESSING SYSTEMS LYNN LUEDERS
K063670 06/28/2007 MODIFICATIONS TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK CHRISTINE SCIFERT
K070288 06/18/2007 CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 MEDTRONIC VASCULAR SCOTT CUNDY
K070648 06/29/2007 THE INHIBITOR, MODEL 001 MELMEDTRONICS, INC. DAVID W HOLMES
K070159 06/21/2007 PRELUDE SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. JERRIE HENDRICKSON
K070672 06/26/2007 MASSAGE MATTRESS VM9100RM METEK GMBH STEFAN ZIEGENFUB
K070656 06/15/2007 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. VINCENT CUTARELLI
K071246 06/01/2007 MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K071611 06/28/2007 NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL NEOCOIL BRIAN BROWN
K071058 06/29/2007 MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K070255 06/13/2007 NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002 NOVA BIOMEDICAL CORP. PAUL W MACDONALD, PHD
K071488 06/29/2007 REALHAND HIGH DEXTERITY (HD) INSTRUMENTS NOVARE SURGICAL SYSTEMS, INC. GREGORY MATHISON
K063699 06/01/2007 IMDX SYSTEMS NOVX SYSTEMS INC. THOMAS TSAKERIS
K070835 06/04/2007 OLYMPUS CK-MB REAGENT OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH STEPHANIE G SCHWARTZ
K070453 06/11/2007 OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH STEPHANIE G SCHWARTZ
K071203 06/13/2007 SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES OPTIKEM INTERNATIONAL, INC. MARTIN DALSING
K070926 06/07/2007 ELECTRODE/EXTENSION CABLES, MODELS ATAR OSCOR INC. MILA DOSKOCIL
K071178 06/22/2007 OTOMEDICS SOFT TYMPANOSTOMY TUBE OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD. AHAVA STEIN
K062902 06/07/2007 PAJUNKS EPILONG SET PEDIATRIC PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K061123 06/29/2007 PALM ECG RECORDER, MODEL EP-201/202 PARAMA-TECH COMPANY., LTD RICHARD KEEN
K071425 06/20/2007 UNITE BIOMATRIX PEGASUS BIOLOGICS, INC. PAMELA MISAJON
K070699 06/29/2007 AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN PENTRON CERAMICS, INC. MEGAN VERNAK
K070666 06/20/2007 GENESISCS COMPONENT CONCENTRATING SYSTEM PERFUSION PARTNERS & ASSOC. INC. NANCY LORD MD. ESQ
K071426 06/13/2007 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K070559 06/29/2007 POLYMAP PWR-08-03 POLYMAP WIRELESS PIERRE LANDAU
K071278 06/29/2007 EMBRACE DUAL CURE COMPOSITE MATERIALS PULPDENT CORPORATION KENNETH J BERK
K071323 06/22/2007 POWDERED LATEX EXAMINATION GLOVES QUALITY GALLANT SDN. BHD. SEAH B HOON
K071358 06/01/2007 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM RADIANT MEDICAL SCOTT A WILSON
K070263 06/15/2007 APNEALINK RESMED GERMANY INC. DAVID D'CRUZ
K070878 06/05/2007 DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 RG MEDICAL DIAGNOSTICS RONALD G LE TOURNEAU
K071372 06/11/2007 MODIFICATION TO: INTERPLATE VBR SYSTEM RSB SPINE LLC. KAREN WARDEN
K061496 06/28/2007 SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST SA SCIENTIFIC LTD. RICARDO R MARTINEZ
K071109 06/07/2007 SACS EEG WORKSTATION A7 SACS MEDICAL AB SHEILA RAMERMAN
K070933 06/13/2007 LOWTOP PEDICLE SCREW SYSTEM SANACOR MICHAEL ENSIGN
K063498 06/11/2007 HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) SEBIA KAREN ANDERSON
K070596 06/21/2007 TOPICAL APPLICATOR SHARN, INC. PAUL DRYDEN
K063407 06/11/2007 BC-3200 AUTO HEMATOLOGY ANALYZER SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K070791 06/26/2007 PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K070639 06/15/2007 NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING SIAM SEMPERMED CORP. LTD. WILLIAM E HARRIS
K071399 06/20/2007 DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100 SICEL TECHNOLOGIES, INC. TAMMY B CARREA
K071310 06/08/2007 SYNGO CT ONCOLOGY SOFTWARE PACKAGE SIEMENS AG KRISTIN FROWEIN
K071462 06/05/2007 UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) SIEMENS HEARING INSTRUMENTS, INC. JON SCHIRADO
K071513 06/26/2007 INSPACE 4D SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY SIEMENS MEDICAL SOLUTIONS RALF HOFMANN
K071234 06/29/2007 ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA W PICKERING
K071179 06/13/2007 NORAS OR HEAD HOLDER SIEMENS MEDICAL SOLUTIONS USA, INC. JUDITH CAMPBELL
K071394 06/29/2007 MODIFICATION TO:SBI RINGFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K070756 06/06/2007 SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM SMITH & NEPHEW, INC. NICHOLAS TABRIZI
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K070991 06/01/2007 VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310 VITA ELIZABETH WOLFSEN
K070055 06/25/2007 BONALIVE GRANULES AND BONALIVE PLATES VIVOXID LTD. CONSTANCE G BUNDY
K071386 06/05/2007 AMARIS/AMARIS FLOW VOCO GMBH MANFRED THOMAS PLAUMANN
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