FDA 510(k) Applications Received During May, 2010

FDA 510(k) Number Submission Date Device Name Applicant Contact
K101249 05/04/2010 STERIGAGE MODEL 1243RA, 1243RB, 1243RE 3M COMPANY SUZANNE LEUNG
K101468 05/27/2010 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE 3M COMPANY CORP LINDA JOHNSON
K101427 05/21/2010 AUDIT MICROCV HS-CRP LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K101434 05/21/2010 AUDIT MICROCV PROCALCITONIN LINEARITY AALTO SCIENTIFIC LTD. DESSI LYAKOV
K101226 05/03/2010 AUDIT MICROCV RF/CRP LINEARITY SET AALTO SCIENTIFIC LTD. DESSI LYAKOV
K101374 05/17/2010 AAXTER A3 POSTERIOR SPINAL SYSTEM AAXTER CO., LTD JACK CHEN
K101422 05/20/2010 THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K101371 05/17/2010 ON CALL PLUS DIABETES MONITORING SOFTWARE ACON LABORATORIES, INC. RICHARD LENART
K101281 05/06/2010 VEGA KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. KATHY A RACOSKY
K101348 05/13/2010 AGACHAMBER SPACER AGAPLASTIC IND. COM. LTDA. MARIA F GRIFFIN
K101454 05/25/2010 MAMMAPRINT AGENDIA Guido Brink
K101289 05/07/2010 SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB AIR TECHNIQUES, INC. PABLO MARTINEZ
K101285 05/07/2010 CONSTELLATION VISION SYSTEM ALCON MANUFACTURING, LTD. MARTIN KAUFMAN
K101255 05/04/2010 ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM ALPHATEC SPINE, INC. KARLA SCHAFFNER
K101220 05/03/2010 EXPLORER 4D TREATMENT PLANNING SYSTEM AMERICAN RADIOSURGERY, INC. DAN OLIVER
K101307 05/10/2010 BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951 ANDON MEDICAL CO., LTD. YI LIU
K101291 05/07/2010 SCANVIEW HER2/NEU FISH SYSTEM APPLIED SPECTRAL IMAGING, LTD. DAN LAOR
K101305 05/10/2010 ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL ARK DIAGNOSTICS,INC JOHNNY VALDEZ
DEN100016 05/21/2010 PROSTATE MECHANICAL IMAGER ARTANN LABORATORIES, INC GERARD J PRUD'HOMME
K101448 05/24/2010 OPUS SPEEDSCREW SYSTEM ARTHROCARE CORP. LAURA N KASPEROWICZ
K101437 05/24/2010 SPEEDFIX SUTURE SYSTEM ARTHROCARE CORP. LAURA N KASPEROWICZ
K101351 05/14/2010 NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT ASCEND EAGLE, INC. JANNA P TUCKER
K101332 05/12/2010 AMC-20 PORTABLE DENTAL CART MODEL AMC-20 ASEPTICO, INC. CHERIE A TREGONING
K101392 05/18/2010 NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D ASTORIA-PACIFIC,INC. JASON C REYNOLDS
K101355 05/14/2010 AUGEASE VASCULAR AUGMENTATION DEVICE AUGDVT LLC E. J. SMITH
K101325 05/12/2010 STELLARIS PC VISION ENHANCEMENT SYSTEM BAUSCH & LOMB, INC. NED LUCE
K101385 05/18/2010 DUAL LUER LOCK CAP, MODEL 2C6250 BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K101372 05/17/2010 DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20 BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K101461 05/26/2010 BD DIRECTIGEN EX FLU A+B Becton, Dickinson and Company GREGORY PAYNE
K101481 05/28/2010 BIOMERS TRANSLUCENT ORTHODONTIC BRACKET BIOMERS PRODUCTS, LLC GEORGE ALIPHTIRAS
K101475 05/28/2010 COMPRESS ANTI-ROTATION SPINDLES BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K101336 05/12/2010 E1 AVANTAGE HEAD BIOMET MANUFACTURING CORP. BECKY EARL
K101345 05/13/2010 WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04, BIOSENSE WEBSTER, INC. Balaka Das
K101398 05/18/2010 STEREOS WORKSTATION BIOSPACE MED JOHN J SMITH
K101282 05/06/2010 SCOUTPRO HEMOSTATIC VALVE BIOTRONIK, INC. Jon Brumbaugh
K101485 05/28/2010 ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E BISCO, INC. MICHELLE SCHULTZ- TAING
K101314 05/11/2010 ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM BOSTON SCIENTIFIC CORP. ELENA NIEVES
K101331 05/11/2010 LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION ANASTASIA C RANDALL
K101261 05/05/2010 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. Mark Nelson
K101431 05/21/2010 ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS C.R. BARD, INC. Joni Creal
K101231 05/03/2010 CABOCHON SYSTEM CABOCHON AESTHETICS, INC. BEN BRIAN
K101462 05/26/2010 ASCEND BLUE AC MESH; ASCEND BLUE PC MESH CALDERA MEDICAL, INC. VICKI GAIL
K101452 05/25/2010 CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW CAPINTEC, INC. MARY ANNE DELL
K101301 05/10/2010 STALIF MIDLINE CENTINEL SPINE JUSTIN EGGLETON
K101429 05/21/2010 ECO SUPERGEL CERACARTA SPA ELAINE DUNCAN
K101400 05/18/2010 LOCKING COMPRESSION PLATE CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. Diana Hong
K101487 05/28/2010 CHEETAH NICOM SYSTEM CHEETAH MEDICAL INC. Rhona Shanker
K101276 05/06/2010 DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404 CHEMENCE MEDICAL PRODUCTS INC. PATRICIA LEHMAN
K101366 05/17/2010 I-LIPO, MODELS A00-1238 (230V), A00-1239 (120V) CHROMOGENEX TECHNOLOGIES LTD PETER R BEVAN
K101411 05/19/2010 SAVI PREPARATION DEVICE CIANNA MEDICAL, INC. GARY MOCNIK
K101361 05/14/2010 REEFLEX PTA CATHETER CLEARSTREAM TECHNOLOGIES, LTD. FIONA N MHULLAIN
K101439 05/24/2010 CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P CODONICS, INC. GARY W ENOS
K101297 05/10/2010 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 COLOPLAST A/S ANGELA BYLAND
K101273 05/06/2010 DYNAMIC ECG SYSTEM MODEL TLC5000 CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K101450 05/24/2010 CANTATA MICROCATHETER COOK, INC. MIRONDA CARPENTER
K101484 05/28/2010 COMPRESSYN BAND DALLEN MEDICAL AL MEMMOLO
K101240 05/04/2010 CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K101433 05/21/2010 DEPUY ATTUNE KNEE SYSTEM DEPUY ORTHOPAEDICS, INC. KATHY BOGGS
K101421 05/20/2010 MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K101368 05/17/2010 D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES DRAGON HEART MEDICAL, INC. JINA YU
K101482 05/28/2010 EM-9000 ELITE MEDICAL INC STEVEN J DE BROCK
K101333 05/12/2010 CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. DEVONNE PAVLAK
K101298 05/10/2010 ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPS ENDOCHOICE, INC. THERON GOBER
K101457 05/26/2010 EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K101430 05/21/2010 MLS-AC DERMA SCANNER ERCHONIA CORPORATION Kevin Walls
K101272 05/06/2010 MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 ESSEX INDUSTRIES, INC. KEN SEISE
K101413 05/20/2010 EUROMI EVA SP6 EUROMI SA CURTIS RAYMOND
K101270 05/06/2010 SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 EXCELSIOR MEDICAL CORP. NANCY RUTH
K101309 05/10/2010 EXELINT ALUMINUM HUB BLUNT NEEDLES EXELINT INTERNATIONAL CO. ARMAND HAMID
K101306 05/10/2010 SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A FOTONA D.D. STOJAN TROST
K101387 05/18/2010 DIGITAL THERMOMETER, MODELS BT-A11CN, BT-A21CN, BT-A41CN FUDAKANG INDUSTRIES CO., LTD STEPHEN LING
K101277 05/06/2010 ORION II (HEAVY DUTY 350 LBS AND 500 LBS) FUTURE MOBILITY HEALTHCARE INC. ABDULSAMAD PANCHBHAYA
K101420 05/20/2010 GC FUJI TEMP GC AMERICA, INC. MARK HEISS
K101346 05/13/2010 GC ORAL MOISTURIZING GEL GC AMERICA, INC. MARK HEISS
K101236 05/03/2010 VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM GE HEALTHCARE BRYAN BEHN
K101324 05/11/2010 GE ECHOPAC MODEL BT10 GE VINGMED ULTRASOUND AS BRYAN BEHN
K101440 05/24/2010 GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 GENERIC MEDICAL DEVICES, INC. JEFF MORGAN
K101250 05/04/2010 GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULES GIVEN IMAGING LTD. Tim Thomas
K101477 05/28/2010 BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) WENDY MCMANUS
K101344 05/13/2010 G+ SYSTEM GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.) WILLIAM MATTHEWS
K101224 05/03/2010 SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS GRIFFITHS AND NIELSEN LTD EDWIN LINDSAY
K101329 05/12/2010 SYNERGY CT PICC HEALTH LINE INTERNATIONAL CORPORATION NOLA BENSTOG
K101358 05/14/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K101362 05/14/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) HEBEI HANDFORM PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K101223 05/03/2010 SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA HEIDELBERG ENGINEERING DIANE MANDELL-HORWITZ
K101242 05/03/2010 GENESIS DM MODEL: 6053000A1 HONEYWELL HOMMED, LLC EMILY HEI
K101438 05/24/2010 T2 GREATER TROCHANTER NAIL HOWMEDICA OSTEONICS CORP MELISSA MATARESE
K101435 05/21/2010 IMIX PANORAD AND SOMARAD IMIX ADR FINLAND OY DANIEL KAMM, P.E.
K101319 05/11/2010 IMMULISA DSDNA ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K101407 05/19/2010 ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 IMMUNO-MYCOLOGICS, INC. SEAN K BAUMAN, PH.D
K101386 05/18/2010 VIGILANT EEG MONITOR MODEL VIGILANT 2.0 INFINITE BIOMEDICAL TECHNOLOGIES, LLC MANAN HATHI
K101465 05/26/2010 STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR INSTITUT STRAUMANN AG JANET KAY
K101381 05/17/2010 HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS INTEGRA LIFESCIENCES CORPORATION DONNA MILLISKY
K101279 05/06/2010 CORRIDOR4DM V2010 MODEL: V2010 INVIA DAVID ROTHKOPF
K101359 05/14/2010 INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML) INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K101373 05/17/2010 EMBRACE IZI MEDICAL PRODUCTS INC. HELEN SHAFER
K101232 05/03/2010 JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001 JOINSOON ELECTRONICS MFG CO LTD JIGAR SHAH
K101322 05/11/2010 JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001 JOINSOON ELECTRONICS MFG CO LTD JIGAR SHAH
K101302 05/10/2010 ALEUTIAN IBF SYSTEM K2M, INC. NANCY GIEZEN
K101423 05/20/2010 OPTIBOND XTR KERR CORPORATION Wendy Garman
K101364 05/14/2010 LANX FACET SCREW SYSTEM LANX, INC. MICHAEL FUNK
K101382 05/17/2010 DPL NUVE LED TECHNOLOGIES, LLC LEWIS WARD
K101320 05/11/2010 VASOVAPOR LEXION MEDICAL, LLC. BERNARD HORWATH
K101241 05/04/2010 REPLENS LONG-LASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) LIL DRUG STORE PRODUCTS, INC. PATRICIA L MILLER
K101263 05/05/2010 LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES, LIMA-LTO S.P.A. CHERYL HASTINGS
K101458 05/26/2010 LINA XCISE MODEL MOR-1515 LINA MEDICAL APS WALT BRITTLE
K101286 05/07/2010 SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 LINDE HEALTHCARE AB ANDERS PALM
K101274 05/06/2010 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING SYSTEM MAQUET CARDIOVASCULAR, LLC MARK H SMITH
K101399 05/18/2010 COAXIAL INTRODUCER SET MARTECH MEDICAL PRODUCTS Susan Pileggi
K101426 05/21/2010 CEROS TCP GRANULES MATHYS LTD LINDA SCHULZ
K101446 05/24/2010 EMERALD SPINAL SYSTEM MAZOR SURGICAL TECHNOLOGIES LTD. JUSTIN EGGLETON
K101417 05/20/2010 BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 MEDIPURPOSE PTE. LTD. JULIE STEPHENS
K101455 05/25/2010 EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K101406 05/19/2010 ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001 MEDRAD INTERVENTIONAL/POSSIS Doug Atkins
K101354 05/14/2010 FETCH 2 ASPIRATION CATHETER MODEL 109400-001 MEDRAD INTERVENTIONAL/POSSIS Doug Atkins
K101339 05/12/2010 ARCHER SUPER STIFF GUIDEWIRES MEDTRONIC INC. COLLEEN MULLINS
K101271 05/06/2010 HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX MEDTRONIC INC. JEFFREY L KOLL
K101275 05/06/2010 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS). MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K101330 05/12/2010 MIDWEST REPROCESSING CENTER REPROCESSED SCD EXPRESS SLEEVES/ FOOT CUFFS, MIDWEST REPROCESSING CENTER REPROCESSED ALP SLE MIDWEST REPROCESSING CENTER LLC JEROME JAMES
K101280 05/06/2010 MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE MIDWEST REPROCESSING CENTER LLC JEROME JAMES
K101228 05/03/2010 MIRADA XD MIRADA MEDICAL LTD. GWILYM OWEN
K101403 05/19/2010 ELI 250 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHIEN HUI (AMY) YANG
K101363 05/14/2010 VU CPOD INTERVERTEBRAL BODU FUSION DEVICE MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS Glenn Stiegman
K101257 05/04/2010 ADVANCED TRAUMA DRESSING (ATD) NANOSYS, INC. HUGH DANIELS
K101326 05/11/2010 NMI IC NAVILYST MEDICAL, INC. NICHOLAS CONDAKES
K101235 05/03/2010 CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM NEOS SURGERY S.L. MARCOS VELEZ-DURAN
K101252 05/04/2010 NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 NEOTRACT, INC. KEVIN MACDONALD
K101278 05/06/2010 INERTIA PEDICLE SCREW SYSTEM NEXXT SPINE LLC KAREN WARDEN
K101380 05/17/2010 RXPEAKFLOW NOBLE MARKETING LAURA LYONS
K101312 05/11/2010 NUVUE COLORMARK9TM) NEEDLE NU VUE THERAPEUTICS, INC ROGER S KOLASINSKI
K101284 05/07/2010 FACET SCREW SYSTEM NUVASIVE, INC. Sheila Bruschi
K101453 05/25/2010 VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE OBI BIOLOGICS, INC. DUSTYN WEBB
K101451 05/25/2010 APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD OMNI LIFE SCIENCE, INC. RADHIKA PONDICHERRY
K101472 05/27/2010 MULTIFIT TOTAL HIP SYSTEM OTIS BIOTECH CO., LTD SRINIVASAREDDY KROTHA
K101428 05/21/2010 OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET OVESCO ENDOSCOPY AG ARNE BRIEST
K101295 05/10/2010 MROPEN PARAMED SRL RICHARD R GLASHEEN
K101334 05/12/2010 JETSTREAM G3 SE SYSTEM, JETSTREAM G3 SF SYSTEM MODEL PV31230 (JETSTREAM G3 SE CATHETER AND CONTROL POD); PVCN100 (PV CON PATHWAY MEDICAL TECHNOLOGIES, INC. CYNDY ADAMS
K101221 05/03/2010 JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100 PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K101474 05/28/2010 MD VISION SYSTEM PERKINS HEALTHCARE TECHNOLOGIES ANDREW C KYLE
K101251 05/04/2010 IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN PHADIA AB MARTIN MANN
K101424 05/20/2010 PHARMACARIBE INHALED SALINE SOLUTIONS PHARMACARIBE PAUL DRYDEN
K101311 05/11/2010 EP NAVIGATOR R3 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K101449 05/24/2010 INTELLIVUE PATIENT MONITOR PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN ANDREAS SUCHI
K101342 05/13/2010 OSIRIX MD PIXMEO SARL CARL ALLETTO
K101262 05/05/2010 FLEXI-LITE PRESSURE-TECH, INC. MARIA GRIFFIN
K101225 05/03/2010 PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 PROMIMIC AB KARIN BREDING
K101293 05/10/2010 POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE) PT. SMART GLOVE INDONESIA CHO S FONG
K101388 05/17/2010 FASTPACK TESTO IMMUNOASSAY Qualigen, Inc. MICHAEL S POIRIER
K101390 05/17/2010 FASTPACK TSH IMMUNOASSAY Qualigen, Inc. MICHAEL S POIRIER
K101253 05/04/2010 RII INFRARED EAR THERMOMETER, MODEL: TH60N RADIANT INNOVATION INC. JAMES HUANG
K101350 05/14/2010 RADSCAN EQUIPMENT SLICKER RADSCAN MEDICAL EQUIPMENT, INC. ORAN R BROWN
K101479 05/28/2010 WINGMAN EXTENDABLE TIP SUPPORT CATHETER REFLOW MEDICAL REBECCA PINE
K101264 05/05/2010 TEMPUS IC PROFESSIONAL PATIENT MONITOR REMOTE DIAGNOSTIC TECHNOLOGIES LTD. CHRIS HANNAN
K101233 05/03/2010 SAFE'N'SOUND PASSIVE DELIVERY SYSTEM REXAM PHARMA JEFFREY BURRIS
K101299 05/10/2010 ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM Roche Diagnostics ANDRENE HERON
K101456 05/26/2010 ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM Roche Diagnostics Susan Hollandbeck
K101365 05/17/2010 ELECSYS CA 19-9 CALCHECK 5 ROCHE DIAGNOSTICS CORP. KELLY O'MAINE ADAMS
K101391 05/18/2010 SCANDIA-45 GAMMA CAMERA SYSTEM SCANDIA CORPORATION DAVID ASKEW
K101267 05/05/2010 PREMIO 10 MOXA SEDATELEC Kevin Walls
K101436 05/24/2010 PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) SHEN WEI (USA), INC. ABLERT LI
K101343 05/12/2010 POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG STAR PLASTIC CO., LTD CHU XIAOAN
K101341 05/12/2010 POWDERED VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG UNIVERSAL CHANNEL PLASTIC CO., LTD CHU XIAOAN
K101460 05/26/2010 LOCI 8 CALIBRATOR, MODEL KC 646 SIEMENS HEALTHCARE DIAGNOSTICS ANNA MARIE ENNIS
K101425 05/20/2010 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES SIEMENS HEALTHCARE DIAGNOSTICS Elisabeth Warriner
K101347 05/13/2010 MAGNETOM AERA; MAGNETOM SKYRA SIEMENS MEDICAL SOLUTIONS USA INC. KIM RENDON
K101459 05/26/2010 OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 SMITH & NEPHEW, INC. JULIE ACKER
K101377 05/17/2010 SMITH & NEWPHEW ULTRABRAID II SUTURE SMITH & NEWPHEW, INC CHRISTINA FLORES
K101337 05/12/2010 A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM SONOSCAPE COMPANY LIMITED Diana Hong
K101288 05/07/2010 STAXX XD SYSTEM SPINE WAVE, INC. ROAIDA RIZKALLAH
K101328 05/11/2010 ENSITE VELOCITY SYSTEM ST. JUDE MEDICAL DONNA R LUNAK
K101419 05/20/2010 ENSITE VELOCITY SYSTEM, MODEL EE3000 ST. JUDE MEDICAL DONNA R LUNAK
K101239 05/03/2010 VIEWFLEX PLUS ICE CATHETER ST. JUDE MEDICAL LOUCINDA BJORKLUND
K101409 05/19/2010 SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM STERIS Corporation ROBERT SULLIVAN
K101335 05/12/2010 CELL-CHEX Streck KERRIE OETTER
K101444 05/24/2010 AUTOSUTURE ENDO GIA SINGLE USE TAN RELOAD WITH TRI-STAPLE TECHNOLOGY SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO FRANK GIANELLI
K101378 05/17/2010 FRANKENMAN SURGICAL STAPLERS SUZHOU FRANKENMAN MEDICAL EQUIPMENT CO., LTD. JEAN ASQUITH
K101321 05/11/2010 EMATRIX CO2 SYNERON MEDICAL LTD. AVI HIRSHNZON
K101259 05/04/2010 V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002 TaiDoc Technology Corporation DEBRA LIANG
K101338 05/12/2010 NEWFIX EXTERNAL FIXATION SYSTEM TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V ROBERT BARD
K101401 05/18/2010 NEUMOVENT GRAPHNET MODEL 3179L1V TECME S.A. RAYMOND KELLY
K101254 05/04/2010 NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM TECNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V ROBERT J BARD, JD
K101356 05/14/2010 SPACER-K, SPACER-G, SPACER-S TECRES SPA CHRISTINE BRAUER
K101287 05/07/2010 TEPHAFLEX COMPOSITE MESH TEPHA, INC. MARY P LEGRAW
K101310 05/11/2010 VU APOD INTERVERTEBRAL BODY FUSION DEVICE THEKEN SPINE LLC Glenn Stiegman
K101415 05/20/2010 THERACLEAR THERAVANT CORPORATION Marcy Moore
K101375 05/17/2010 TRIMED X-FIX TRIMED, INC. KELLI ANDERSON
K101244 05/04/2010 SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE TRUER MEDICAL INC. TIM TRUITT
K101353 05/14/2010 GOLDEN GATE ANTERIOR PLATE SYSTEM ULRICH GMBH & CO. KG HANS STOVER
K101245 05/04/2010 ULTRASEAL ID ULTRADENT PRODUCTS, INC. DIANE ROGERS
K101412 05/20/2010 EVA TPN BAG VALMED S.R.L. WALTER SVANOSIO
K101294 05/10/2010 PT2 VARIAN PROTON THERAPY SYSTEM VARIAN MEDICAL SYSTEMS, ONCOLOGY SYSTEMS VY TRAN
K101234 05/03/2010 VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY VENTANA MEDICAL SYSTEMS, INC. Judy Howe
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