FDA 510(k) Decisions During February, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K080428 12/09/2008 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY MEDTRONIC INC. MARLENE PETERSON
K082670 12/04/2008 MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET MEDTRONIC INC. BETH CLAAS
K072733 02/15/2008 3M ESPE ADULT CROWN 3M COMPANY SCOTT ERICKSON
K083610 12/17/2008 FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE 3M COMPANY SCOTT ERICKSON
K072055 02/26/2008 LAVA FRAME, LAVA FRAME SHADE 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K073697 02/15/2008 TRANSBOND SUPREME ADHESIVE 3M UNITEK L. MARLYN SCHEFF
K082985 12/17/2008 A-DEC 334/335 DELIVERY SYSTEM A-DEC, INC. THOMAS H LOUISELL
K073322 02/22/2008 FOX 1-980, FOX Q-1064, FOX-Q-810 A.R.C. LASER GMBH KIRSTEN H PAULSON
K073120 02/29/2008 ACCIN PATELLOFEMORAL SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K073531 02/04/2008 ACCIN PEDICLE SCREW SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K081697 12/04/2008 THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K080074 02/14/2008 ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX ACE SURGICAL SUPPLY CO., INC. J. EDWARD CARCHIDI
K082993 12/19/2008 SURGISEAL TOPICAL SKIN ADHESIVE ADHEZION BIOMEDICAL RICHARD G JONES
K081751 12/19/2008 ADIN DENTAL IMPLANTS SYSTEM ADIN DENTAL IMPLANTS SYSTEM LTD BENNY ARAZY
K071532 02/19/2008 ALPHA INFUSION PUMP, MODEL A200, A450 ADVANCED INFUSION, INC. JAMES CHRISTENSEN
K081309 12/19/2008 E.COLI/P. AERUGINOSA PNA FISH ADVANDX, INC. HENRIK STENDER
K072993 02/08/2008 REUSABLE HEADREST WITH NASAL SEAL AEIOMED, INC. GARY SYRING
K072899 02/06/2008 ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0 AESCULAP IMPLANT SYSTEMS, INC. MATTHEW M HULL
K081960 12/17/2008 INVISALIGN SYSTEM ALIGN TECHNOLOGY SANGEETA SACHDEVA
K071849 12/04/2008 ALLOFUSE GEL AND PUTTY ALLOSOURCE, INC. PAMELA VETTER
K080176 02/29/2008 ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K083254 12/19/2008 ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K082956 12/18/2008 ALPHA ORTHOPAEDICS AT2 SYSTEM ALPHA ORTHOPAEDICS GINA TO
K082898 12/19/2008 AMEDICA DRUG SCREEN TEST CUP AMEDICA BIOTECH, INC. JEFF CHEN
K083549 12/22/2008 ABT GLUCOSE CONTROL SOLUTION AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GORMLEY
K080069 02/13/2008 DIMERTEST AMERICAN DIAGNOSTICA, INC. LEIGH AYRES
K082387 12/04/2008 APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS SARAH PETERSON
K082677 12/23/2008 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE AMERICAN MEDICAL SYSTEMS, INC. MONA INMAN
K080290 02/22/2008 XVIEWNET AMERICAN RADIOLOGIST NETWORK, INC. IAN GORDON
K082180 12/17/2008 PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LINDA K SCHULZ
K082729 12/19/2008 RIMCLOSE BONE ANCHOR ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K082114 12/19/2008 ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 APOLLO ENDOSURGERY, INC. DENNIS MCWILLIAMS
K083638 12/23/2008 FIXATION TROCARS APPLIED MEDICAL RESOURCES CORP.
K073446 02/08/2008 GRIND GUARD ARCHTEK, INC. IAN P GORDON
K083370 12/12/2008 D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 ARTEGRAFT, INC. LAURENCE A POTTER
K080111 02/13/2008 ARTHREX COMPRESSION STAPLE ARTHREX, INC. SALLY FOUST
K082999 12/30/2008 ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART ARTHREX, INC. NANCY HOFT
K073149 02/11/2008 MENISCAL CINCH ARTHREX, INC. SALLY FOUST
K080282 02/15/2008 ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; ARTHROCARE CORP. VALERIE DEFIESTA-NG
K083306 12/10/2008 MODIFICATION TO ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K081551 12/24/2008 TWIN NEUROTRAC-III ASTRO-MED, INC. ALFREDO BUSTAMANTE
K073258 02/14/2008 ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI + ABUTMENT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K073540 02/29/2008 ATLANTIS ABUTMENT IN ZIRCONIA FOR BIOHORIZONS IMPLANT ATLANTIS COMPONENTS, INC. BETSY A BROWN
K072409 02/12/2008 AFINION ACR AND ACR CONTROL AXIS-SHIELD POC AS JORUNN GREVIE LOLLAND
K073007 02/14/2008 CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL BARCOVIEW, MEDICAL IMAGING SYSTEMS NEIL PHILLIPS
K082749 12/04/2008 OMNI-TIGHT BASIC DENTAL IMPLANT SYSTEMS, INC. DAN BLACKLOCK
K073184 02/21/2008 BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS BAUSCH & LOMB, INC. DEBRA KETCHUM
K081920 12/19/2008 BD GENEOHM CDIFF ASSAY BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) RAYMOND BOULE
K081930 12/19/2008 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. LOURDES COBA
K083572 12/24/2008 BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM BECTON, DICKINSON & CO. DENNIS MERTZ
K082913 12/05/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K081824 12/11/2008 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. KATHRYN B CARR
K081825 12/11/2008 BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. KATHRYN B CARR
K070259 02/21/2008 EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR BEDFONT SCIENTIFIC LTD. E.J. SMITH
K072274 02/29/2008 MAJOR III BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP. JEN KE-MIN
K081522 12/05/2008 BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY BIO NUCLEAR DIAGNOSTICS, INC. SURENDER CHOUDHRY
K073438 02/07/2008 PROSTIM 1000/2000 BIO PROTECH, INC. E.J. SMITH
K073626 02/05/2008 BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM BIO-LOGIC SYSTEMS CORP. NICOHL WILDING
K083164 12/16/2008 SYSTEM-ARMS, MODELS 390, X60 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K081498 12/17/2008 TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 BIOCOMFORT DIAGNOSTICS GMBH & CO. KG MARTIN GABLER
K083091 12/24/2008 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K073268 02/08/2008 BIOHORIZONS INTERNAL IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K073282 02/15/2008 BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K082953 12/22/2008 ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 BIOKIT S.A. JOAN GUIXER
K082938 12/22/2008 EZLASE BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K071363 02/12/2008 WATERLASE AND WATERLASE MD BIOLASE TECHNOLOGY, INC. IOANA RIZOU
K073063 02/27/2008 15W CERALAS D 1470NM DIODE LASER BIOLITEC, INC. JONATHAN S KAHAN
K082225 12/03/2008 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 BIOLITEC, INC. JONATHAN S KAHAN
K073091 02/29/2008 VIDAS NT-PROBNP ASSAY, MODEL: 30 449 BIOMERIEUX, INC. NIKITA S MAPP
K080766 12/23/2008 VIDAS RUB IGG BIOMERIEUX, INC. NIKITA S MAPP
K080107 02/28/2008 VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM BIOMERIEUX, INC. NANCY WEAVER
K070961 02/25/2008 BIOMERIX SURGICAL MESH, MODEL: RCR-01 BIOMERIX CORPORATION CHRISTINA L KICHULA
K083070 12/16/2008 TOGGLELOC SYSTEM BIOMET SPORTS MEDICINE ROBERT FRIDDLE
K082008 12/11/2008 BIONET BM3PLUS PATIENT MONITOR BIONET CO., LTD. YINGCHAO XIAO
K072054 02/28/2008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K082705 12/15/2008 BIOPRO BIPOLAR HEAD, MODELS 18130-18152 BIOPRO, INC. DAVID MRAK
K082935 12/04/2008 VISION WIRE CORONARY GUIDEWIRE BIOTRONIK, INC. JON BRUMBAUGH
K072123 02/01/2008 HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE BIOWAVE CORPORATION MARY MCNAMARA-CULLINANE
K073263 02/14/2008 PRO-V BISCO, INC. BENJAMIN LICHTENWALNER
K082652 12/30/2008 BITTAR ZIRCONIA BLOCKS BITTAR ZIRCONIA BLOCK, LLC STUART R GOLDMAN
K073420 02/14/2008 BLACKSTONE ASCENT MULTIAXIAL SCREWS BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K083355 12/29/2008 WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 BLAIREX LABORATORIES, INC. CAREY BOTTOM
K081739 12/03/2008 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT BOSTON SCIENTIFIC CORP. MARYBETH GAMBER
K073266 02/27/2008 WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM BOSTON SCIENTIFIC CORP. NEIL KELLY
K071702 02/15/2008 BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40 BREAS MEDICAL AB IBB JESSEN
K082297 12/09/2008 BUSSE SURGICAL DRAPE BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K082094 12/17/2008 BARD PTFE (TEFLON) COATED GUIDE WIRES C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION DEBORAH L HERRINGTON
K083657 12/24/2008 CONQUEST PTA BALLOON DILATATION CATHETER C.R. BARD, INC. GENEVIEVE BALUTOWSKI
K073686 02/27/2008 C.T.M. POWER CHAIR, MODEL HS-1500 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K081855 12/19/2008 IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) CANADA, INC. FEDERICO FORERO
K080333 02/22/2008 IMAGEGRID CANDELIS, INC. CARL ALLETTO
K082090 12/12/2008 9131 DEFIBRILLATION ELECTRODES CARDIAC SCIENCE CORPORATION BEVERLY MAGRANE
K082539 12/02/2008 MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT CARDINAL HEALTH GERMANY 234 GMBH THOMAS RUST
K072964 12/30/2008 NICOLET CORTICAL STIMULATOR CARDINAL HEALTH, INC. GARY SYRING
K073194 02/14/2008 CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS CARDIOVASCULAR IMAGING SOLUTIONS LTD. CARL THOMAS
K083673 12/30/2008 CARESTREAM PACS, MODEL CARESTREAM PACS VII CARESTREAM HEALTH, INC. LINDA STEWART
K082829 12/22/2008 AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) CARLETON LIFE SUPPORT SYSTEMS INC. GARY BYRD
K073036 02/25/2008 FORE-SIGHT, MC-2000 SERIES CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K080558 12/05/2008 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K073426 02/19/2008 APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-12 MM X 30 MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K080595 12/05/2008 CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CELLAVISION AB CONSTANCE G BUNDY
K073417 12/15/2008 EMBOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC. THOMAS A GORDY
K083093 12/15/2008 CHEETAH RELIANT CHEETAH MEDICAL INC. RHONA SHANKER
K073669 02/13/2008 ORIA NATURA SPACER CHOICE SPINE, LP KAREN E WARDEN
K073459 02/28/2008 CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K072947 02/08/2008 SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS CLEARSTREAM TECHNOLOGIES, LTD. IAN P GORDON
K072851 02/20/2008 POLYSTAR 79 DENTURE BASE RESIN CMP INDUSTRIES LLC. DEVON O HOWE
K071663 02/15/2008 VF GEL PLUS COAPT SYSTEMS, INC. LINDA RUEDY
K073061 02/29/2008 THE PROXIVENT KIT COLL PARTNERS LTD. ELI M ORBACH
K071557 02/08/2008 COLLAWOUND HYDROGEL COLLAMATRIX CO., INC. DENNIS J.N. SEAH
K081768 12/23/2008 COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES COOK INCORPORATED SUSANNE GALIN
K073528 02/27/2008 VENA CAVA FILTER COOK INCORPORATED MOLLY BUSENBANK
K062798 02/06/2008 SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB CORDIS CORP. KAREN WILK
K081060 12/24/2008 FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 CORE ESSENCE ORTHOPAEDICS, LLC SHAWN T HUXEL
K083210 12/29/2008 CORFLO ANTI IV ENTERAL FEEDING TUBE CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K073557 02/28/2008 EEG NEUROAMP, MODEL CS10137 CORSCIENCE GMBH & CO. KG CHRISTINE BAUMANN
K071148 02/06/2008 ATLAS IMPLANT SYSTEM COWELL MEDI CO., LTD. CHANG D KYU
K033484 02/07/2008 HUMAN HEART VALVE, CRYOVALVE SG CRYOLIFE, INC. DAVID M FRONK
K080006 02/28/2008 AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE CYNOSURE, INC. GEORGE CHO
K083379 12/12/2008 CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE CYNOSURE, INC. GEORGE CHO
K082731 12/17/2008 ML24000 UVA-1 PHOTOTHERAPY CABINET DAAVLIN DISTRIBUTING CO. TARA MANSUR
K073072 02/21/2008 DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B DADE BEHRING, INC. PAMELA A JURGA
K073561 02/26/2008 DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR DADE BEHRING, INC. HELEN M LEE
K080114 02/15/2008 HUAYI H035 BASIC WHEELCHAIR DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD NORMAN F ESTRIN
K073681 12/09/2008 NANOBEAM 940, MODEL 940-900-02 DAVARAY, INC. DAVID J ARNDT
K083400 12/11/2008 CUSTOM COMFORT NIGHTGUARD DENTEK ORAL CARE, INC. HOWARD M HOLSTEIN
K082408 12/03/2008 LEDEX, MODEL: WL-070 DENTMATE TECHNOLOGY CO., LTD. CHENG-FENG CHOU
K073067 02/15/2008 ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K073073 02/12/2008 ANKYLOS TEMPORARY ABUTMENT BALANCE DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K082643 12/19/2008 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K083364 12/11/2008 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K082585 12/04/2008 DEPUY ASPHERE M-SPEC HEAD DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K082715 12/18/2008 DEPUY GLOBAL AP CTA HUMERAL HEAD DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K073570 02/21/2008 DEPUY TRI-LOCK BONE PRESERVATION STEM DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K081746 12/23/2008 D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K081928 12/23/2008 D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K082248 12/12/2008 STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K082049 12/05/2008 LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV DIASORIN, INC. CAROL A DEPOUW
K080485 12/04/2008 ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS DIASYS DIAGNOSTICS SYSTEMS GMBH STEPHANIE KLEIN
K072270 02/01/2008 DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) DIAZYME LABORATORIES CHARLES YU
K082001 12/05/2008 DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B DIAZYME LABORATORIES ABHIJIT DATTA
K082904 12/17/2008 STASYS MOTION CORRECTION SOFTWARE DIGIRAD CORP. JOEL TUCKEY
K073163 02/28/2008 LIMITED ARTIFACT SKULL PIN, MODEL 0107 DINKLER SURGICAL DEVICES, INC. CHARLES E DINKLER II
K083050 12/29/2008 EVITE XL DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K072412 02/06/2008 OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 DRAGER MEDICAL AG & CO. KGAA KATHY ANDERSON
K073331 02/19/2008 DVO EXTENDED ARTICULATION HUMERAL HEADS DVO EXTREMITY SOLUTIONS, LLC JEFF ONDRLA
K073116 02/28/2008 EBI INTERNAL IMPLANT SYSTEM EBI, INC. DANIEL KAMM
K082308 12/09/2008 MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. JASON SMITH
K071343 02/28/2008 ELLMAN NOBLE ALLOY ELECTRODES ELLMAN INTERNATIONAL, INC. JOSEPH AZARY
K082421 12/17/2008 HEARTSUITE HEMODYNAMICS 7.10 EMAGEON INC.
K083555 12/16/2008 PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION EMSOMA CO., LTD. WEONBUM LEE
K073510 02/11/2008 ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM ENDIUS, INC. REGINA WAGNER
K082233 12/18/2008 VIKY ENDOCONTROL CARINE HUGUEL
K082380 12/03/2008 VICARDIO 12B ENERGY-LAB TECHNOLOGIES GMBH GEORGE MYERS
K080032 02/28/2008 ENVOYCEM, MODEL 1640 ENVOY MEDICAL CORPORATION BERNARD (BUD) HORWATH
K072005 02/07/2008 RK EPIDURAL NEEDLE EPIMED INTERNATIONAL KATIE ALEXANDER
K073096 02/07/2008 ANCHORAGE CLOSURE DEVICE EPITEK, INC. WERNER HAMPL
K083452 12/31/2008 ERBE MODEL VIO 300 D WITH ACCESSORIES ERBE USA, INC. JULIE STEPHENS
K080119 02/21/2008 CLEARSCAN ESI, INC. GEORGE MYERS
K082893 12/05/2008 PRAGER SHELL ESI, INC. GEORGE MYERS
K082278 12/16/2008 MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS ETHICON ENDO-SUGERY, LLC CAROL HUBBARD
K073046 02/25/2008 ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504 ETHICON ENDO-SURGERY, INC. GLENDA C MARSH
K082854 12/04/2008 NANOCORSS .014 OTW PTA DILATATION CATHETER EV3 INC. DAVID WORRELL
K073688 02/29/2008 EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW EXACTECH, INC. GRAHAM CUTHBERT
K083392 12/17/2008 NOVATION 12/14 CEMENTED FEMORAL STEMS EXACTECH, INC. GRAHAM L CUTHBERT
K082837 12/18/2008 STERILE FIELD SALINE PRE-FILLED SYRINGE(S) EXCELSIOR MEDICAL CORP. JOHN LINFANTE
K081990 12/05/2008 LUBRICANO STERILE GEL FARCO PHARMA GMBH SETH A MAILHOT
K071573 12/09/2008 RUGALIFT, MODEL# V.2.1 FATROTEK S.R.L. FRANSICO PELUSO
K083347 12/24/2008 IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS FLUKE BIOMEDICAL COLLEEN BOSWELL
K071432 02/12/2008 SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE FOX HOLLOW TECHNOLOGIES MELISSA S MURPHY
K083542 12/29/2008 FRESENIUS STERILE STAY SAFE CAP FRESENIUS MEDICAL CARE NORTH AMERICA JANET KAY
K073650 02/06/2008 FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371 FUJIFILM MEDICAL SYSTEMS USA, INC. DANIEL KAMM
K072093 02/01/2008 PRISMAFLEX SYSTEM, VERSION 3.20 GAMBRO THOMAS B DOWELL
K072908 02/04/2008 PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY GAMBRO RENAL PRODUCTS FEI LAW
K072100 02/14/2008 GC AADVA ABUTMENT GC AMERICA, INC. H. CARL JENKINS
K073283 02/20/2008 GC GAM-100 GC AMERICA, INC. MARK HEISS
K073588 02/15/2008 GC MODELS OPA-100 AND JC-50 GC AMERICA, INC. MARK HEISS
K073138 02/26/2008 CARDIQ EXPRESS VERSION 2.0 GE MEDICAL SYSTEMS STEPHEN SLAVENS
K083504 12/12/2008 GE DISCOVERY NM/CT 570C GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K073153 02/26/2008 CARDIQ FUNCTION XPRESS GE MEDICAL SYSTEMS SCS
K082676 12/18/2008 GENADYNE A4 WOUND VACUUM SYSTEM GENADYNE BIOTECHNOLOGIES, INC. CHIEN-MING GOH
K082210 12/16/2008 TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 GENZYME DIAGNOSTICS P.E.I. INC. PENNY J WHITE
K073154 02/14/2008 FACTS HAND AND PINCH GRIP COMBO GLOBAL SERVICES GROUP, LLC RAY GAGNE
K083272 12/16/2008 SKINCLEAR Q-SWITCHED ND:YAG LASER GLOBAL USA DISTRIBUTION, LLC. MATT MAKOUSKY
K083232 12/24/2008 MODIFICATION TO:MICROFUSE BONE VOID FILLER GLOBUS MEDICAL INC. KELLY J BAKER
K081929 12/16/2008 VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K080169 02/08/2008 HEARTSTRING III PROXIMAL SEAL SYSTEM GUIDANT CORPORATION, CARDIAC SURGERY ELIZABETH TRUJILLO
K083013 12/09/2008 PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
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K070541 12/11/2008 IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II IVIVI TECHNOLOGIES, INC. ANDRE DIMINO
K073704 02/21/2008 I-DIXEL J. MORITA USA, INC. KEITH A BARRITT
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K080229 02/29/2008 5.5 MM SUTURE LOCK BONE SCREW ANCHOR KFX MEDICAL GAYLE HIROTA
K080253 02/26/2008 KIMBERLY-CLARK INTRODUCER KITS KIMBERLY-CLARK CORP. SHERRY SAURINI
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K082590 12/17/2008 SYMPHONY METER REMOTE LIFESCAN, INC. MARTHA MURARI
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K081008 12/22/2008 BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS LIN-ZHI INTERNATIONAL, INC. MARIE LIN
K081848 12/04/2008 LIPOSE FAT TRANSFER SYSTEM LIPOSE CORP. ALAN CURTIS
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K082700 12/09/2008 TEMPORARY COLD.V AND SELF-CURE DENTINE MAJOR PRODOTTI DENTARI S.P.A. MONICA FUNAI
K082725 12/17/2008 GRAFTGUARD PRESSURE CONTROLLING SYRINGE MAQUET CARDIOVASCULAR, LLC CHRISTINA L ROWE
K082818 12/23/2008 SUBCUTANEOUS NEEDLE INFUSION SET MARCAL MEDICAL, INC. ARTHUR WARD
K073024 02/08/2008 MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES MASIMO CORPORATION MARGUERITE THOMLINSON
K073337 02/13/2008 MECTACER BIOLOX FORTE-FEMORAL HEADS MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
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K083472 12/09/2008 MEDEGEN PRESSURE RATED EXTENSION SETS MEDEGEN INC. TIM L TRUITT
K083765 12/30/2008 MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL MEDEGEN MEDICAL MANUFACTURING SERVICES MATTHEW FRIED
K072494 02/12/2008 AG-CLASSIC MEDEL S.P.A. TERRANCE M O'BRIEN
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K083308 12/10/2008 PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
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K081355 12/18/2008 BIOFLEX LD-R100 TREATMENT HEAD MEDITECH INTERNATIONAL, INC. FRED KAHN
K072942 02/08/2008 MEDLINE DISPOSABLE VAGINAL SPECULUM MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K080334 02/21/2008 INSTARAD MEDSPHERE TECHNOLOGIES PVT LTD. CARL ALLETTO
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K080288 02/15/2008 TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114 MEGA MOTION, INC. TOM AMICO
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K083063 12/16/2008 BIS INTERFACE FOR VITALOGIK PATIENT MONITORS MENNEN MEDICAL LTD. IFAT OREN
K081962 12/29/2008 LAPEX BCS MERIDIAN CO., LTD. DANIEL KAMM
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K083576 12/23/2008 MISER CONTRAST MANAGEMENT SYSTEM MERIT MEDICAL SYSTEMS, INC. STEPHANIE ERSKINE
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K073079 02/14/2008 THUMPER, MODEL: 1008 MICHIGAN INSTRUMENTS, INC. HOWARD M HOSTEIN
K082385 12/11/2008 CHAPERON GUIDING CATHETER MICROVENTION, INC. FLORIN TRUUVERT
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K073442 02/26/2008 MICRUS MICROCOIL SYSTEMS MICRUS ENDOVASCULAR CORPORATION JULIA GROSS
K072563 02/12/2008 MILTEX RIGID CONTAINER SYSTEMS MILTEX, INC. PATRICIA KIHN
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K080458 12/17/2008 MIS CREST WIDENER MIS - IMPLANT TECHNOLOGIES LTD. IMAN KHORSHID
K072189 02/05/2008 PATHFAST NTPROBNP AND D-DIMER TESTS MITSUBISHI KAGAKU IATRON HELEN LANDICHO
K082946 12/29/2008 MORTARA ELI 350 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHARLES MORREALE
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K073329 02/28/2008 SYGNAL DBM MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY BENNEWITZ
K073521 02/04/2008 MUSMATE WALKING AID MUSMATE LTD ANDREW JAMES WYND
K082203 12/30/2008 NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 NCONTACT SURGICAL, INC. JANE RICUPERO
K080320 02/21/2008 PRIMEVUE 21" 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 NDS SURGICAL IMAGING JIM LANG
K073596 02/22/2008 NEOMED SINGLE LUMEN UMBILICAL CATHETER NEOMED, INC. PENNY NORTHCUTT
K073651 02/01/2008 NEOTRACT ANCHOR SYSTEM NEOTRACT, INC. SUZAN MOSER
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K083538 12/16/2008 NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 NEURONETICS JUDY P WAYS
K072831 12/12/2008 FROG NEWBY-COOMBS, LLC KARLA COOMBS
K073375 02/21/2008 NEWDEAL TIBIAXYS SYSTEM NEWDEAL SAS JUDITH O'GRADY
K082724 12/16/2008 NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM NEWPORT MEDICAL INSTRUMENTS, INC. DIANA RODRIGUEZ
K082566 12/03/2008 MARK 5 NUVO LITE OCSI AND STD NIDEK MEDICAL PRODUCTS, INC. JENNIFER MCWILLIAMS
K083271 12/24/2008 BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY NIHON KOHDEN AMERICA, INC. JACK COGGAN
K080342 02/26/2008 NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES NIHON KOHDEN AMERICA, INC. JACK COGGAN
K071596 02/15/2008 POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 NIHON SEIMITSU SOKKI CO., LTD. KOJI KUBO
K072988 02/21/2008 NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 NIPRO MEDICAL CORPORATION JESSICA OSWALD
K081972 12/11/2008 BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES NITRITEX (M) SDN. BHD. DEREK WATTS
K081971 12/23/2008 BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES NITRITEX (M) SDN. BHD. DEREK WATTS
K072129 02/22/2008 NOBELACTIVE ZIRCONIA ABUTMENT NOBEL BIOCARE AB HERBERT CRANE
K083476 12/22/2008 NOVEON MODEL LS1100-03 NOMIR MEDICAL TECHNOLOGIES, INC. RICHARD F BURTT
K081861 12/04/2008 HOLTER LX ANALYSIS NORTH EAST MONITORING INC. JOSEPH AZARY
K082672 12/09/2008 NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GALSSER
K082878 12/30/2008 NEVONI CLASSIC, MODEL 6600-PO NSR COMERCIO E REPRESENTACOES LTDA POLLY SCHERMAN
K083042 12/18/2008 WOUND FLUSH, STERILE WATER & NORMAL SALINE NURSE ASSIST, INC. DENICE GALLAGHER
K073489 02/11/2008 OLYMPUS IGA REAGENT OLYMPUS AMERICA INC. STEPHANIE G DONNELLY
K073490 02/11/2008 OLYMPUS IGG REAGENT OLYMPUS AMERICA INC. STEPHANIE G DONNELLY
K073487 02/11/2008 OLYMPUS IGM REAGENT OLYMPUS AMERICA INC. STEPHANIE G DONNELLY
K081173 12/23/2008 ENDOSCOPIC CO2 REGULATION UNIT UCR OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K073150 02/27/2008 APEX-LNK POLY ACETABULAR CUP LINERS OMNI LIFE SCIENCE, INC. EDWARD J CHEAL
K083335 12/15/2008 MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM OMNISONICS MEDICAL TECHNOLOGIES ANNE M KULIS
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K080289 02/26/2008 1500 PRO OMRON HEALTHCARE, INC. PAUL DRYDEN
K080048 02/06/2008 MSK EXTREME MR SCANNER, MODEL AA5000 ONI MEDICAL SYSTEMS, INC. MARK PUOPOLO
K073407 02/28/2008 PACIFICA OR-NIM MEDICAL LTD. CAMPBELL HUTTON
K083173 12/22/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM ORTHO-CLINICAL DIAGNOSTICS LEAH VAN DE WATER
K082574 12/08/2008 MAXTORQUE MINI CANNULATED SCREW SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K082950 12/05/2008 STARBAND ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K073344 02/19/2008 ORTHOPEDIATRICS PLATING SYSTEM ORTHOPEDIATRICS, LLC GARY BARNETT
K073228 02/29/2008 DC ULNAR SHORTENING SYSTEM ORTHOPRO LLC J.D. WEBB
K081786 12/02/2008 ZIOCERA & CONVERTIBLE SYSTEM OSSTEM IMPLANT CO LTD MINJOO KIM
K072959 02/04/2008 MS SYSTEM (DENTURE) OSSTEM IMPLANT CO.,LTD MIN JOO KIM
K073065 02/21/2008 OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM OSTEOMED L.P. PIEDAD PENA
K070985 02/01/2008 AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC OSYPKA MEDICAL, INC. MARKUS OSYPKA
K073568 02/06/2008 PSL BIOZIR BLOCK P.S.L. INTERNATIONAL INC. CATHERINE FENG
K080149 12/18/2008 HEATER BASE, MODEL PMH7000 PACIFIC MEDICO CO., LTD. YOSHIMO TOYAMA
K063350 02/01/2008 DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K081073 12/05/2008 HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F PAUSCH LLC JUSTIN TICE
K082786 12/03/2008 PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES PEAK SURGICAL, INC. GRACE CARLSON
K083413 12/18/2008 COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM PHILIPS MEDICAL SYSTEMS TERESA SCHMIDT
K072812 02/26/2008 PHILIPS HEARTSTART SMARTPADS III PHILIPS MEDICAL SYSTEMS LARRY WALKER
K083498 12/17/2008 PHILIPS MODEL MX 16 SLICE CT SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MICHAEL CHILBERT
K072228 02/08/2008 SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) PINNACLE CO., LTD. DAVID DING
K072227 02/15/2008 VINYL EXAMINATION GLOVE POWDER FREE PINNACLE CO., LTD. DAVID DING
K072223 02/21/2008 VINYL EXAMINATION GLOVE, POWDERED PINNACLE CO., LTD. DAVID DING
K080794 12/17/2008 POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR POLYVUE DISTRIBUTION, INC. GAROLD L EDWARDS
K082382 12/12/2008 ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 POSSIS MEDICAL, INC. MARK STENOIEN
K083527 12/18/2008 INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K080145 02/28/2008 PRIMAEVA MEDICAL SYSTEM PRIMAEVA MEDICAL, INC. BRIAN GRIGSBY
K073224 02/06/2008 ORAL-B "SUB-BRAND" MANUAL TOOTHBRUSH PROCTER & GAMBLE MICHAEL A KAMINSKI
K080240 02/07/2008 CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE PROMIDENT LLC GARY KRIS
K073542 02/14/2008 CYCLETRAC CT-5000 PT PRODUCTS, LLC MICHELE CONWAY
K082302 12/09/2008 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
K072487 02/13/2008 FAST1 INTRAOSSEOUS INFUSION SYSTEM PYNG MEDICAL CORP. MAYA BUTTERFIELD
K081592 12/03/2008 POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES QUALITY GALLANT SDN. BHD. SEAH BEE HOON
K073549 02/28/2008 Q-PLUS T QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K083613 12/23/2008 QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY QUANTA SYSTEM, S.P.A. ISABELLA CARRER
K081095 12/12/2008 PROLITE III TOWER AND PR AND HR HANDPIECE QUANTEL S.A. MICHAEL JOHNSON
K080455 12/31/2008 RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 QUANTRX BIOMEDICAL CORPORATION NATALIE J KENNEL
K082631 12/17/2008 THROMBO TEK PSE, MODEL 90-480 R2 DIAGNOSTICS, INC. MARC D GOLDFORD
K080206 02/26/2008 MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM RADI MEDICAL SYSTEMS AB HELENE EKSTRAND
K082423 12/03/2008 NO!NO! SKIN RADIANCY (ISRAEL) LTD. ZVI LADIN
K083029 12/05/2008 MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR RALCO S.R.L. DANIEL KAMM
K071839 02/27/2008 SOCT COPERNICUS, MODEL 15205 REICHERT, INC. SANDRA BROWN
K073349 02/13/2008 RELIANCE BUTTRESS WASHER SYSTEM RELIANCE MEDICAL SYSTEMS, LLC BRET M BERRY
K073243 02/08/2008 LED PRO SEAL RELIANCE ORTHODONTIC PRODUCTS, INC. PAUL GANGE
K082603 12/12/2008 TRIMIRA OCS 3000 REMICALM, LLC DAVID B JONES
K082448 12/10/2008 DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED RICH MOUNTAIN MEDICAL PRODUCTS, INC. MICHELLE SHIH
K072534 02/08/2008 BIO-MAT 2000 RICHWAY INTL., INC. LEROY KLIMA
K073419 02/14/2008 PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIENCE KIT PVA EMBOLIZATION PARTICLES RJ MEDICAL, INC. JIM INNES
K072437 02/05/2008 ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET ROCHE DIAGNOSTICS KAY TAYLOR
K080147 02/27/2008 ELECSYS PROBNP II CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K072617 12/05/2008 ELECSYS RUBELLA IGG IMMUNOASSAY ROCHE DIAGNOSTICS CORP. THERESA A BUSH
K082970 12/12/2008 MARVEL WHEELCHAIR, MODEL EDCAL01 ROGUE WHEELS INC KATHRYN RONALDS
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