FDA 510(k) Applications Received During May, 2007

FDA 510(k) Number Submission Date Device Name Applicant Contact
K071260 05/07/2007 HERMES BOND 3 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K071230 05/04/2007 APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 ADVANCED BRAIN MONITORING, INC. DANIEL J LEVENDOWSKI
K071385 05/21/2007 STERRAD 100NX STERILIZER ADVANCED STERILIZATION PRODUCTS REUBEN LAWSON
K071220 05/10/2007 COLUMBUS TOTAL KNEE SYSTEM AS AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K071499 05/31/2007 COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K071393 05/21/2007 JAZZ BLOOD GLUCOSE MONITORING SYSTEM AGAMATRIX CONNIE HERTEL
K071297 05/09/2007 IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION) AGFA HEALTHCARE CORP. TOM HOLBROOK
K071236 05/03/2007 ALCON MULTI-PURPOSE SOLUTION ALCON, INC. KIM B KRACKE
K071380 05/17/2007 MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM ALPHATEC SPINE, INC. PAULA MORGAN
K071213 05/01/2007 CAMLOG LOGFIT PROSTHETIC SYSTEM ALTATEC GMBH FLOYD G LARSON
K071164 05/07/2007 LIFE+CEL BATTERY AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. ALEX HENDERSON
K071242 05/22/2007 DBEST ONE STEP OCCULT BLOOD TEST KITS AMERITEK USA, INC. K.C. YEE
K071430 05/23/2007 SYNERAD OMNI, MODELS AN6255 AND AN6265 ANALOGIC CORP. DONALD J SHERRATT
K071195 05/02/2007 KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5 ANI-KAL II, LLC GERBAIL T KRISHNAMURTHY, MD
K071206 05/01/2007 ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K071398 05/21/2007 SCANVIEW, MODEL SC-300 APPLIED SPECTRAL IMAGING, LTD. SILVIA STOLARSKI
K071491 05/30/2007 ARROW INTERNATIONAL, INC., SURGICAL DRAPES ARROW INTL., INC. KARL J NITTINGER
K071456 05/25/2007 ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT ARTHREX, INC. MARIELA CABARCAS
K071374 05/16/2007 OPUS TWINLOCK KNOTLESS FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K071413 05/21/2007 HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM ARTHROSURFACE, INC. DAWN J WILSON
K071451 05/24/2007 TATTOOSTAR Y ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K071497 05/31/2007 ATLAS SPINE VERTEBRAL BODY REPLACEMENT ATLAS SPINE INC. JEANNETTE G DAILEY
K071221 05/09/2007 SAVE-SIMPLIFIED AUTOMATED VENTILATOR, MODELS: 550X10, 600X10 AND 600X12 AUTOMEDX INC. JAMES D EVANS
K071459 05/25/2007 B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES B. BRAUN MEDICAL, INC. CHRISTINE FORD
K071266 05/07/2007 BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS BAUSCH & LOMB, INC. MICHAEL A SANTALUCIA
K071222 05/02/2007 INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K071280 05/07/2007 SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS BECKMAN COULTER, INC. TARA M VIVIANI
K071277 05/07/2007 SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS BECKMAN COULTER, INC. TARA M VIVIANI
K071283 05/07/2007 SYNCHRON SYSTEMS CREATININE REAGENT BECKMAN COULTER, INC. TARA M VIVIANI
K071321 05/10/2007 POCKETCPR BIO-DETEK, INC. MARK TOTMAN
K071319 05/10/2007 I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 BIO-RAD, DIAGNOSTICS GRP. MARIA ZEBALLOS
K071363 05/16/2007 WATERLASE AND WATERLASE MD BIOLASE TECHNOLOGY, INC. IOANA RIZOU
K071295 05/08/2007 100W CERALAS D 980NM DIODE LASER BIOLITEC, INC. JONATHAN S KAHAN
K071210 05/16/2007 MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K071395 05/21/2007 BIOMET VISION FOOTRING SYSTEM BIOMET MANUFACTURING CORP. ROBERT FRIDDLE
K071271 05/07/2007 BIOMET CABLE SYSTEM BIOMET MANUFACTURING, INC. BECKY EARL
K071377 05/17/2007 POLARIS BE RODS BIOMET SPINE DEBRA BING
K071498 05/31/2007 SUBTALAR IMPLANT BIOMET SPORTS MEDICINE, INC. ELIZABETH WRAY
K071325 05/10/2007 BIOMET VARIABLE LOCKING PLATE SYSTEM BIOMET TRAUMA SUSAN ALEXANDER
K071328 05/16/2007 VISUALASE THERMAL THERAPY SYSTEM BIOTEX, INC. MATTHEW FOX
K071309 05/09/2007 BLUE MAX BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. KARI CHRISTIANSON
K071042 05/16/2007 POLARCATH PERIPHERAL DILATATION SYSTEM BOSTON SCIENTIFIC CORP. MONICA MORRISON
K071449 05/24/2007 BRM3 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. CHRIS MANDER
K071365 05/15/2007 AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE C.R. BARD, INC. MICHELLE R GUDITH
K071204 05/01/2007 SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 C.R. BARD, INC. KIMBERLY GEISLER
K071469 05/29/2007 INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM CANDELA CORP. JEFFREY ROBERTS
K071396 05/29/2007 CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS CAPINTEC, INC. MARY ANNE DELL
K071400 05/21/2007 SMARTSITE STOPCOCK CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K071350 05/14/2007 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS, INC. MICHAEL J KALLOK
K071427 05/23/2007 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS CARDIOVASCULAR SYSTEMS, INC. CINDY SETUM
K071272 05/07/2007 TROJAN THINTENSITY BRAND MALE LATEX CONDOM CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K071313 05/14/2007 TROJAN-ENZ BRAND CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K071355 05/15/2007 SMARTSPONGE SYSTEM CLEARCOUNT MEDICAL SOLUTIONS, INC. STEVEN FLECK
K071496 05/31/2007 ICATH, STERILESURE COLORADO CATHETER COMPANY, INC. DOUG WILSON
K071444 05/24/2007 MECHANICAL WHEELCHAIR - L-FRAME SERIES COLOURS 'N MOTION VICTOR R BOX
K071461 05/25/2007 MODEL 300D HOME OXYGEN LIQUEFIER COPD PARTNERS, INC. PAUL DRYDEN
K071477 05/29/2007 REVERTO 55 AND 37 SHAPE MEMORY STAPLES CORE ESSENCE ORTHOPAEDICS, LLC SHAWN T HUXEL
K071483 05/30/2007 TETRIX CREAM CORIA LABORATORIES, LTD AMY CAMPBELL
K071224 05/02/2007 DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K071317 05/10/2007 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN DADE BEHRING, INC. ROBERT EUSEBIO
K071316 05/10/2007 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN DADE BEHRING, INC. ROBERT EUSEBIO
K071268 05/07/2007 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE DADE BEHRING, INC. ROBERT EUSEBIO
K071247 05/04/2007 N LATEX RF KIT DADE BEHRING, INC. HELEN LEE
K071284 05/08/2007 MODEL SEGAEGO 3D SCOOTER DALTON MEDICAL CORP. WILL RIDGWAY
K071282 05/08/2007 MODEL SEGAEGO 4D SCOOTER DALTON MEDICAL CORP. WILL RIDGWAY
K071481 05/29/2007 HEALIX ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K071257 05/04/2007 MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K071379 05/17/2007 DELTA XTEND REVERSE SHOULDER MODULAR STEM DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K071334 05/11/2007 DEPUY CAS HEMI ASR HIP INSTRUMENTS DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K071417 05/21/2007 DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K071495 05/31/2007 EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, A JOHNSON & JOHNSON COMPANY CHRISTOPHER KLACZYK
K071202 05/01/2007 DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS) DERMAPORT, INC GARY SYRING
K071480 05/29/2007 LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602 DIASORIN, INC. CHARLES D KAFADER II
K071299 05/09/2007 IP SYSTEM, OCULAB IP, OPTOMIZE IP, RETASURE IP DIGITAL HEALTHCARE, LTD. GERRY SKEWS
K071375 05/16/2007 MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE) DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHAN
K071431 05/23/2007 GLOBUS GENESY 1100 STIMULATOR DOMINO S.R.L. GIOVANNI M CIRIANI
K071378 05/17/2007 MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES E-Z-EM, INC. STEVEN HARTMAN
K071446 05/24/2007 ELECTRODE ARRAY CAP ELECTRODE ARRAYS ELVIRA GARCIA
K071343 05/14/2007 ELLMAN NOBLE ALLOY ELECTRODES ELLMAN INTERNATIONAL, INC. JOSEPH AZARY
K071445 05/29/2007 TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS ESCADA INTERNATIONAL, INC. KEVIN WALLS
K071249 05/07/2007 ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV ETHICON, INC. PATRICE NAPODA
K071320 05/10/2007 EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 EVERLIFE MEDICAL EQUIPMENT CO., LTD. JEN KE-MIN
K071364 05/16/2007 MICROTARGETING GUIDELINE 4000 FHC, INC. LEE D MARGOLIN
K071432 05/24/2007 SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE FOX HOLLOW TECHNOLOGIES MELISSA S MURPHY
K071387 05/18/2007 FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K071330 05/14/2007 GALTSTICK INTRODUCER SYSTEM GALT MEDICAL CORP. DAVID CATLIN
K071352 05/15/2007 CERADRILL GEBR. BRASSELER GMBH & CO. KG OLAF BRAND
K071214 05/03/2007 ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING GENESEE BIOMEDICAL, INC. JOHN T WRIGHT
K071388 05/18/2007 GENTIAN CYSTATIN C IMMUNOASSAY GENTIAN AS RONALD G LEONARDI
K071484 05/30/2007 PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 GLUSTITCH, INC. DON BLACKLOCK
K071274 05/07/2007 GSO GS1 SPACER GOLD STANDARD ORTHOPEDICS LLC DAVID BAUGHMAN
K071209 05/01/2007 MASTER GUARD LATEX POWDER FREE EXAMINATION GLOVES HIGH MOMENTUM SDN BHD HUE K FAH
K071208 05/01/2007 MASTER GUARD NITRILE BLUE POWDER FREE EXAMINATION GLOVES HIGH MOMENTUM SDN BHD HUE K FAH
K071207 05/01/2007 MASTER GUARD NITRILE BLUE POWDERED EXAMINATION GLOVES HIGH MOMENTUM SDN BHD HUE K FAH
K071471 05/29/2007 CORIN ADAPTOR SLEEVE HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K071255 05/10/2007 ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A HYPHEN BIOMED OLA ANDERSON
K071408 05/21/2007 X3C 1100 RADIOGRAPHIC TABLE WITH DIGITAL RADIOGRAPHIC DETECTOR IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K071409 05/21/2007 X3C 1590 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K071403 05/21/2007 X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHAN SAMARAPPULI
K071402 05/21/2007 X3C 1600 PLUS DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K071401 05/21/2007 X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM IMAGING DYNAMICS COMPANY LTD. SHIRANTHA SAMARAPPULI
K071346 05/22/2007 IMMULISA INTRINSIC FACTOR ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K071470 05/30/2007 IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX IMPLANTECH ASSOCIATES INC. STEPHEN MEADE
K071240 05/03/2007 IMPLASA-HOECHST GMBH IMPLANTS IMPLASA-HOECHST GMBH BENNY ARAZY
K071464 05/29/2007 INION HEXALON BIODEGRADABLE ACL/PCL SCREW INION OY KATI MARTTINEN
K071225 05/02/2007 INNOVASA STAT*SEAL TOPICAL HEMOSTAT INNOVASA, INC. ROBERTA HINES
K071390 05/18/2007 WHEELCHAIR MODEL STS INNOVATIVE PRODUCTS, INC. JIM STEINKE
K071301 05/09/2007 ANTLIA I WOUND IRRIGATION SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K071458 05/29/2007 MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS INTEGRA LIFESCIENCES CORPORATION DONNA WALLACE
K071405 05/21/2007 PROBE HOLDER SYSTEM INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K071265 05/07/2007 SMARTCHECK INR SYSTEM INVERNESS MEDICAL INNOVATIONS, INC. LESLEY MOORE
K071307 05/09/2007 INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003 INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K071428 05/23/2007 INQU ISTO TECHNOLOGIES, INC. PATSY J TRISLER
K071237 05/03/2007 COPIOS BONE VOID FILLER SPONGE AND PASTE KENSEY NASH CORP. JENNIFER J BOSLEY
K071251 05/04/2007 DEMI KERR CORPORATION COLLEEN BOSWELL
K071429 05/23/2007 TI2200 TRANSILLUMINATION CABLE KERR CORPORATION COLLEEN BOSWELL
K071436 05/23/2007 REGIUS UNITEA KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSELL MUNVES
K071338 05/14/2007 FLEX ARM RETRACTOR SYSTEM KOROS USA, INC. GABRIEL KOROS
K071233 05/03/2007 XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM KUB TECHNOLOGIES, INC JOSEPH M AZARY
K071169 05/03/2007 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC. KOJI NISHIDA
K071472 05/29/2007 PLANET 55 LARSEN & TOUBRO LIMITED HARRY P GUGNANI
K071367 05/16/2007 FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05 LEMAITRE VASCULAR, INC. MINNIE MILDWOFF
K071490 05/30/2007 LEONE ORTHODONTIC MINI IMPLANT LEONE SPA ELIA LADANI
K071231 05/03/2007 EDAC QUANTIFIER LUNA INNOVATIONS, INC. KRISTINE RICHARDSON
K071241 05/03/2007 LMS-LIVER MEDIAN TECHNOLOGIES CHAS BURR
K071341 05/14/2007 MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 MEDIVANCE, INC. LYNNE ARONSON
K071423 05/25/2007 MEDLINE LATEX FOLEY CATHETER MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K071244 05/03/2007 MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K071416 05/21/2007 PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRISTINE SCIFERT
K071253 05/04/2007 AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 MEDTRONIC VASCULAR JESSICA SIXBERRY
K071348 05/14/2007 EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM MENNEN MEDICAL LTD. MICHA OESTEREICH
K071246 05/03/2007 MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K071298 05/10/2007 HF JUNIOR HEMOFILTER MINNTECH CORP. LYNN LUEDERS
K071354 05/29/2007 MEPILEX AG DRESSING MONLYCKE HEALTH CARE STEVEN DOWDLEY
K071447 05/30/2007 VARIOS 75 NAKANISHI, INC. TOMOKO HIRABAYASHI
K071311 05/09/2007 NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL NEOCOIL BRIAN BROWN
DEN070003 05/24/2007 NEUROSTAR TMS SYSTEM NEURONETICS JUDY P WAYS
K071308 05/09/2007 MODIFICATION TO NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K071384 05/23/2007 MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K071370 05/16/2007 NOBELACTIVE INTERNAL CONNECTION IMPLANT NOBEL BIOCARE AB PHUONG NGUYEN SON
K071285 05/17/2007 DIGITAL PULSE OXIMETER, MODEL 7500 NONIN MEDICAL, INC. LORI M ROTH
K071415 05/21/2007 DIGITAL PULSE OXIMETER, MODEL 7500FO NONIN MEDICAL, INC. LORI M ROTH
K071267 05/07/2007 PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN NOVAMIN TECHNOLOGY, INC. ROBERT G ROTHFRITZ
K071488 05/30/2007 REALHAND HIGH DEXTERITY (HD) INSTRUMENTS NOVARE SURGICAL SYSTEMS, INC. GREGORY MATHISON
K071329 05/11/2007 NUVASIVE HELIX ACP SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K071435 05/23/2007 NUVASIVE OCT SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K071263 05/07/2007 NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 NXSTAGE MEDICAL, INC. NORMA LEMAY
K071254 05/14/2007 SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K071203 05/01/2007 SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES OPTIKEM INTERNATIONAL, INC. MARTIN DALSING
K071250 05/04/2007 CA, MODEL: CAM OPTOVUE, INC. JAY WEI
K071216 05/02/2007 VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 ORTHO-CLINICAL DIAGNOSTICS, INC. MICHAEL M BYRNE
K071215 05/02/2007 VITROS CHEMISTRY PRODUCTS URCR SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2722, 195 7927 ORTHO-CLINICAL DIAGNOSTICS, INC. MICHAEL M BYRNE
K071243 05/03/2007 METAL HEMI IMPLANT ORTHOPRO LLC J.D. WEBB
K071425 05/23/2007 UNITE BIOMATRIX PEGASUS BIOLOGICS, INC. PAMELA MISAJON
K071500 05/31/2007 NANO-BOND II ADHESIVE SYSTEM PENTRON CLINICAL TECHNOLOGIES FLOYD G LARSON
K071281 05/07/2007 UNIRING - ANNULOPLASTY RING WITH SIZERS PETERS SURGICAL ROBERT RENAULT
K071391 05/18/2007 PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521 PHILIPS MEDICAL SYSTEMS, INC. PAUL SCHRADER
K071426 05/23/2007 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K071335 05/14/2007 MEDPOR ATTRACTOR IMPLANT POREX SURGICAL, INC. JERRI L DAVIS
K071342 05/14/2007 ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039 POSSIS MEDICAL, INC. MARK STENOIEN
K071336 05/11/2007 ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307 POSSIS MEDICAL, INC. FRANK B FREEDMAN
K071404 05/21/2007 SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE POWER PRODUCTS, INC.-SPLINTEK MALANIE HASEK
K071421 05/22/2007 PROMEPLA INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET PROMEPLA PATSY J TRISLER
K071278 05/07/2007 EMBRACE DUAL CURE COMPOSITE MATERIALS PULPDENT CORPORATION KENNETH J BERK
K071322 05/10/2007 POWDER FREE LATEX EXAMINATION GLOVES QUALITY GALLANT SDN. BHD. SEAH B HOON
K071323 05/10/2007 POWDERED LATEX EXAMINATION GLOVES QUALITY GALLANT SDN. BHD. SEAH B HOON
DEN070002 05/10/2007 QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING QUICK-MED TECHNOLOGIES, INC. ROY CARR
K071361 05/16/2007 R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 R4 VASCULAR, INC. MICHAEL SARAJIAN
K071358 05/16/2007 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM RADIANT MEDICAL SCOTT A WILSON
K071457 05/29/2007 MODIFICATION TO RADIUS SNARE RADIUS MEDICAL TECHNOLOGIES, INC. MAUREEN FINLAYSON
K071212 05/01/2007 ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 RESPIRONICS CALIFORNIA, INC. MARA CALER
K071422 05/22/2007 15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET REX MEDICAL SUSAN D GOLDSTEIN-FALK
K071292 05/14/2007 VIEW MD OFFICE SYSTEM, MODEL 41066.5540 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K071492 05/30/2007 FIRSTVIEW RIVERAIN MEDICAL GROUP,LLC JENNIFER STEINKE
K071211 05/01/2007 COBAS C 111 ANALYZER ROCHE DIAGNOSTICS CORINA HARPER
K071239 05/03/2007 TOTAL PROTEIN URINE/CSF GEN.3 ROCHE DIAGNOSTICS CORINA HARPER
K071372 05/16/2007 MODIFICATION TO: INTERPLATE VBR SYSTEM RSB SPINE LLC. KAREN WARDEN
K071424 05/23/2007 PMAX NEWTRON XS SATELEC-ACTEON GROUP STEVE SALESKY
K071261 05/04/2007 ISOBAR SEMI-RIGID DUAL DAMPENER SCIENT'X JOHN SANDERS
K071229 05/03/2007 SENORAD MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRANCHYTHERAPY SENORX, INC. EBEN GORDON
K071353 05/22/2007 FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD. WILLIAM MCLAIN
K071382 05/17/2007 SCM CATH ( SIZES ARE VARYING BETWEEN 16G X 2'' AND 24G X 3/4'' ), MODEL 1.50", 1.77",1.88',2", 1.25", 1.50", 1.77", SHIN CHANG MEDICAL CO., LTD. JAN J FRANK
K071452 05/25/2007 FL BOND II SHOFU DENTAL CORP. DAVID MORAIS
K071399 05/22/2007 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 05/09/2007 SYNGO CT ONCOLOGY SOFTWARE PACKAGE SIEMENS AG KRISTIN FROWEIN
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K071462 05/25/2007 UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) SIEMENS HEARING INSTRUMENTS, INC. JON SCHIRADO
K071455 05/25/2007 ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS MARY SEEGER
K071466 05/29/2007 DCA VANTAGE, MODEL 5075 SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS NOOR MALKI
K071234 05/03/2007 ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F SIEMENS MEDICAL SOLUTIONS USA, INC. SHEILA W PICKERING
K071314 05/10/2007 SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. MARTINA VOGT
K071228 05/03/2007 FIDELITY 200 CARDIAC EVENT RECORDER SIGNALIFE, INC. WILLIAM MATTHEWS
K071394 05/21/2007 MODIFICATION TO:SBI RINGFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071656 05/29/2007 SBI ARTFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071479 05/29/2007 SBI STAFIX SMALL BONE INNOVATIONS INC. ROBERT HOEHN
K071300 05/09/2007 MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE SMITH & NEPHEW, INC. KATHY REDDIG
K071269 05/07/2007 HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM SMITHS MEDICAL ASD, INC. BARBARA LAW
K071418 05/22/2007 DANA 3CC SYRINGE INSULIN RESERVOIR SOOIL DEVELOPMENT CO., LTD. CYNTHIA NOLTE, PH.D
K071327 05/11/2007 MEMO 3D SEMIRIGID ANNULOPLASTY RING SORIN BIOMEDICA CARDIO S.R.L. HEATHER CRAWFORD
K071318 05/10/2007 MODIFICATION TO: STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH ROSINA ROBINSON
K071392 05/21/2007 PXS-810, PODIATRY X-RAY SYSTEM SOURCE-RAY, INC. RAY MANEZ
K071442 05/23/2007 SUPRASORB A +AG SPECIALTY FIBRES AND MATERIALS LTD. COLIN LUDFORD
K071433 05/23/2007 SMS GLUCOSE CONTROL, MODEL 2120059 SPECIALTY MEDICAL SUPPLIES JOHN C GORMLEY
K071226 05/03/2007 8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 SPECTRANETICS CORP. MICHAEL K HANDLEY
K071227 05/03/2007 CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 SPECTRANETICS CORP. MICHAEL K HANDLEY
K071438 05/23/2007 PSS SYSTEM SPINAL USA JEFFREY JOHNSON
K071420 05/29/2007 CHAMELEON FIXATION SYSTEM SPINEFRONTIER, INC. THOMAS CARLSON
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K071473 05/29/2007 MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 2 SUPERDIMENSION, LTD. CLAY ANSELMO
K071288 05/08/2007 MODIFICATION TO KAVO QUATTROCARE SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K071482 05/30/2007 STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000 SYNERGETICS, INC DAN REGAN
K071264 05/04/2007 SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE SYNTHES (USA) DEBORAH L JACKSON
K071476 05/29/2007 SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP SYNTHES (USA) ANGELA SILVESTRI
K071493 05/30/2007 CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225 TAIDOC TECHNOLOGY CORPORATION ERICA LI
K071245 05/03/2007 TALON AND REVERE TALON ACRYLICS, INC. SHERMAN WATSON
K071494 05/30/2007 CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER TERUMO CORP. GARY COURTNEY
K071410 05/21/2007 ARGEN PEARL BRAND ZIRCONIA THE ARGEN CORPORATION PAUL CASCONE
K071349 05/15/2007 NEUROSIGN LARYNGEAL ELECTRODES THE MAGSTIM COMPANY LTD. ANWEN EVANS
K071340 05/14/2007 CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL THERMO FISHER SCIENTIFIC OY PAIVI SORMUNEN
K071453 05/25/2007 SPI EASY 4.0 ABUTMENT THOMMEN MEDICAL, AG LINDA K SCHULZ
K071489 05/30/2007 HOMECHECK MULTIPLE DRUG CUP TEST TIANJIN NEW BAY BIORESEARCH CO., LTD. ARMANDO A TORRESCANO
K071232 05/07/2007 IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS TOMTEC IMAGING SYSTEMS, GMBH INGE SCHEIDT
K071485 05/30/2007 TPC ADVANCECAM INTRA ORAL CAMERA SYSTEM, MODEL AIC 888 TPC ADVANCED TECHNOLOGY, INC. SCOTT BECKLEY
K071371 05/16/2007 COPA AMD ANTIMICROBIAL WOUND DRESSING TYCO HEALTHCARE GROUP, LP JAMES WALSH
K071406 05/21/2007 AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC JENNIFER BRENNAN
K071381 05/17/2007 GAMMAMEDPLUS IX SERIES HDR AFTERLOADER VARIAN MEDICAL SYSTEMS VY TRAN
K071360 05/15/2007 OPTICAL GUIDANCE PLATFORM VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K071467 05/29/2007 VARISOURCE IX HDR AFTERLOADER VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K071468 05/29/2007 CLARIVEIN CATHETER VASCULAR INSIGHTS LLC JOHN P MARANO
K071347 05/14/2007 VAX-D GENESIS G2 SYSTEM VAX-D MEDICAL TECHNOLOGIES LLC LAWRENCE DYER
K071217 05/02/2007 BLADDERSCAN BVI 9400 ULTRASOUND VERATHON INCORPORATED RUSS GARRISON
K071376 05/17/2007 MODIFICATION TO VERTEBRON PSS PEDICLE SCREW SYSTEM VERTEBRON, INC. LUIS NESPRIDO
K071362 05/15/2007 VITAL CONNECT 4.1 VITAL IMAGES, INC. TIMOTHY J KAPPERS, MBA,RAC
K071331 05/11/2007 VITREA VERSION 4.0 VITAL IMAGES, INC. TIMOTHY J KAPPERS
K071199 05/02/2007 BONALIVE GRANULES VIVOXID LTD. CONSTANCE G BUNDY
K071386 05/18/2007 AMARIS/AMARIS FLOW VOCO GMBH MANFRED THOMAS PLAUMANN
K071218 05/02/2007 PROXENON 350, MODEL 902XX WELCH ALLYN, INC. JOHN E SAWYER
K071219 05/07/2007 ATHENA MULTI-LYTE GBM TEST SYSTEM ZEUS SCIENTIFIC, INC. EWA NADOLCZAK
K071235 05/03/2007 ZIMMER ONE PIECE IMPLANT, 3.0MM ANGLED, MODELS ZOP30A10, ZOP30A11 AND ZOP30A13 ZIMMER DENTAL INC. WILLIAM FISHER
K071439 05/23/2007 ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM ZIMMER DENTAL INC. ERIN MCVEY
K071025 05/22/2007 ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS EILEEN M BOYLE


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