FDA 510(k) Applications Received During January, 2010

FDA 510(k) Number Submission Date Device Name Applicant Contact
K103314 11/10/2010 CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL MEDTRONIC INC. JEFFREY L KOLL
K103313 11/10/2010 HEPARIN ASSAY CONTROLS MEDTRONIC INC. JEFFREY L KOLL
K103386 11/18/2010 MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS MEDTRONIC INC. ANU GAUR
K103464 11/24/2010 PACIFIC XTREME PTCA BALLOON DILATATION CATHETER MEDTRONIC INC. HEATHER MOROSE
K103434 11/26/2010 3B FLEX-LITE 3B PRODUCTS, LLC ALBERT ALEXANDER LUCIO
K103310 11/10/2010 CRYONIZE TM 3JT ENTERPRISES LLC ANTHONY GOLDBOSS
K100235 01/26/2010 FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE 3M COMPANY SCOTT ERICKSON
K103277 11/05/2010 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER 3M COMPANY-3M HEALTH CARE SUZANNE LEUNG
K100145 01/21/2010 A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 A&E BIOCERAMIC CO., LTD. MARZ CHIU
K103403 11/19/2010 MULTICONSTITUENT CALIBRATOR ABBOTT LABORATORIES LINDA MORRIS
K100015 01/04/2010 VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 ABBOTT MOLECULAR, INC. PAMELA L SWATKOWSKI
K103471 11/24/2010 UBM PLUS ACCUTOME, INC. BRIAN T.S. BARRETT
K103387 11/18/2010 MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL ACON LABORATORIES, INC. RICHARD LENART
K103298 11/08/2010 ACAM 5 AUDIOMETER SYSTEM ACOUSTICON GMBH MAUREEN GARNER
K103499 11/29/2010 A SCOPE ACTIVE SIGNAL TECHNOLOGIES, INC. HARVEY KNAUSS
K100123 01/15/2010 ACUMED WRIST ARTHRODESIS PLATE SYSTEM ACUMED LLC LINO TSAI
K103513 11/30/2010 LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA ADVANCED ORTHOPAEDIC SOLUTIONS, INC. JULIE GLENDRANGE
K103362 11/17/2010 AOI CRANIAL HELMET ADVANCED ORTHOPRO INC. MOHAMAD MANSOORI
K103218 11/01/2010 STERRAD CHEMICAL INDICATOR STRIP ADVANCED STERILIZATION PRODUCTS NANCY CHU
K103222 11/01/2010 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS YOGI SHAH
K103219 11/01/2010 STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS NANCY CHU
K103210 11/01/2010 TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS ADVANCED STERILIZATION PRODUCTS NANCY CHU
K100037 01/06/2010 ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD ADVANCED VERTEBRAL SOLUTIONS, LLC MIKE DUGERY
K100121 01/15/2010 MODEL 300157 CPAP SYSTEM AEIOMED, INC. DARIN BUSCH
K100147 01/19/2010 S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA BOYLE
K103284 11/05/2010 LAMINOPLASY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K100243 01/27/2010 QUINTEX CERVICAL PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC LISA BOYLE
K100133 01/19/2010 AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 AIRSTRIP TECHNOLOGIES, LP WILLIAM CAMERON POWELL
K103445 11/24/2010 ALACER SURGICAL SCAFFOLD ALACER BIOMEDICAL INC CONNIE GARRISON
K100051 01/08/2010 INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP) ALFA SCIENTIFIC DESIGNS, INC. NASISHU WANG
K103501 11/29/2010 ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES ALMA LASERS, INC. TATIANA EPSTEIN
K100001 01/04/2010 MOBIVISION ALMANA MEDICAL IMAGING DANIEL KAMM, P.E.
K103205 11/01/2010 BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. OLGA LEWIS
K100138 01/19/2010 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K103252 11/03/2010 CAMLOG VARIO SR ABUTMENTS ALTATEC GMBH LINDA SCHULZ
K100129 01/19/2010 AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X AMBU A/S SANJAY PARIKH
K100108 01/14/2010 AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA AMEDICA BIOTECH, INC. JEFF CHEN
K100265 01/29/2010 DIAMOND ANTERIOR CERVICAL PLATE SYSTEM AMENDIA, INC. TIM LUSBY
K100014 01/04/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 ANDON HEALTH CO.,LTD LIU YI
K100199 01/22/2010 ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K100120 01/26/2010 ALEXIS ORTHOPAEDIC WOUND RETRACTOR APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K103282 11/05/2010 LAPAROSCOPIC DISSECTOR APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K100215 01/25/2010 ARCHIMED REMEDY CERVICAL PLATE ARCHIMED, INC. BARRY AIKEN
K103421 11/22/2010 ARSTASIS DILATOR ADAPTER ARSTASIS, INC. DEBRA COGAN
K100221 01/26/2010 INTELLIWAVE3 ART OPTICAL CONTACT LENS, INC. MARTIN DALSING
K103466 11/24/2010 ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC. SALLY FOUST, RAC
K100176 01/28/2010 ASCENSION ANKLE FUSION PLATE SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K100254 01/28/2010 REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K100080 01/12/2010 REPROCESSED TROCARS, MODEL B5LT AND CB5LT ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON-VARTY
K103399 11/30/2010 GENERAL DENISTRY MOTOR ASEPTICO, INC. CHERIE TREGONING
K103495 11/29/2010 ASICO SOFTIP INJECTOR SYSTEM ASICO LLC RAVI NALLAKRISHNAN
K103251 11/03/2010 DUOCENTRIC REVERSED ASTON MEDICAL CATHERINE GLOSTER
K093780 01/08/2010 ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT ASTRA TECH, INC. BETSY A BROWN
K103317 11/10/2010 RESUSCITATION UNIT 105 ATOM MEDICAL CORPORATION PAUL DRYDEN
K100076 01/21/2010 ATRIUM C-QUR OVT MESH ATRIUM MEDICAL CORP. JACQUELINE EMERY
K100016 01/04/2010 AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 AVITA CORPORATION JENNIFER REICH
K103412 11/22/2010 AXIOM FASCIAL CLOSURE SYSTEM AXIOM TECHNOLOGY PARTNERS, LLC RICHARD RUSH
K100241 01/27/2010 CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 B. BRAUN MEDICAL, INC. LISA GIAQUINTO
K103470 11/26/2010 PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP B.J.ZH.F. PANTHER MEDICAL EQUIPMENT CO., LTD CHU XIAOAN
K103367 11/16/2010 SEEKER CROSSING SUPPORT CATHETER BARD PERIPHERAL VASCULAR, INC. CANDACE WADE
K103245 11/02/2010 CELSTAT BAXTER HEALTHCARE CORP. SAMUEL MATHEW
K100010 01/04/2010 HDL CHOLESTEROL (HDLX) ASSAY BECKMAN COULTER, INC. YVETTE LLOYD
K103373 11/17/2010 SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 BECKMAN COULTER, INC. YVETTE LLOYD
K100209 01/25/2010 BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY BECTON DICKINSON & CO. PASQUALE AMATO
K100005 01/04/2010 BD PEN NEEDLE BECTON, DICKINSON AND CO. JAMES HAYNES
K100203 01/25/2010 HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K100092 01/13/2010 CORVUS RADIATION THERAPY PLANNING SYSTEM BEST NOMOS CHI PALKO
K103230 11/01/2010 AP-3000 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION BESTGEN BIOTECH CORP. STEVEN SHEN
K103280 11/05/2010 BHDENTAL IMPLANT SYSTEM BHDENTAL LTD EILAT EZRA
K100246 01/27/2010 MAX-IF1000 BIO PROTECH, INC. JUDY BURTON
K100150 01/19/2010 CERAMICS2IN1 BIODENTA SWISS AG DAVID EILER
K100162 01/20/2010 MULTIPLE PRIVATE LABEL BIOGREEN YIELDS SDN.BHD TIONG CHIONG KIENG
K103291 11/08/2010 BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K100155 01/20/2010 TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM BIOMEDICAL SYSTEMS CORP. MICHAEL KROEHNKE
K100048 01/08/2010 E1 ANTIOXIDANT INFUSED TECHNOLOGY BIOMET MANUFACTURING CORP. BECKY EARL
K103393 11/19/2010 POLARIS SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K100114 01/15/2010 FAT CONCENTRATION SYSTEM BIOMET, INC. LONNIE WITHAM
K103343 11/15/2010 L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) BIONESS INC. ADELE SHOUSTAL
K100264 01/28/2010 T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K103514 11/30/2010 PRO-V COAT BISCO, INC. MICHELLE SCHILTZ-TAING
K100044 01/08/2010 FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY BLACKSTONE WHITNEY TORNING
K103355 11/16/2010 GDC 360 DETEACHABLE COIL BOSTON SCIENTIFIC CORP. RHODA M SANTOS
K103426 11/22/2010 LITE PELVIC FLOOR REPAIR KITS BOSTON SCIENTIFIC CORP. MICHELLE BERRY
K100078 01/12/2010 MODIFIED STRAIGHT FIRE LASER FIBER BOSTON SCIENTIFIC CORP. JANET A MCGRATH
K100038 01/07/2010 DISPOSABLE REFLECTIVE MARKER SPHERES BRAINLAB, AG ALEXANDER SCHWIERSCH
K103246 11/26/2010 IPLAN RT BRAINLAB, AG ALEXANDER SCHWIERSCH
K103227 11/01/2010 ORATECT ORAL FLUID DRUG SCREEN DEVICES BRANAN MEDICAL CORPORATION HUIYING WANG
K103345 11/15/2010 BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) BREATHE TECHNOLOGIES, INC. JOSEPH CIPILLONE
K103377 11/17/2010 CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 BRIVANT, LTD. TOMAS FUREY
K103459 11/24/2010 VASCUTRAK PTA DILATATION CATHETER C. R. BARD, INC. CANDACE WADE
K093927 01/05/2010 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER C.R. BARD, INC. SARABJYOT MANKOO
K103359 11/16/2010 FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) C.R. BARD, INC. CINDY MOSS
K100229 01/26/2010 VENTRIO HERNIA PATCH C.R. BARD, INC. MICHELLE GODIN
K103418 11/22/2010 DESARA MINI CALDERA MEDICAL, INC. VICKI GAIL
K100266 01/29/2010 ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 CAMNTECH, LTD HOWARD SMITH
K100143 01/19/2010 PILOT DIODE LASER, MODEL 002-00139 CAO GROUP, INC. ROBERT LARSEN
K103249 11/03/2010 NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM CARDINAL HEALTH, INC. TATYANA BOGDAN
K103334 11/15/2010 CARDIO MED CARDIO MEDICAL PRODUCTS, INC. NICK MENDISE
K100008 01/04/2010 CARDO MEDICAL CERAMIC HIP SYSTEM CARDO MEDICAL, INC DAVE LAMB
K103211 11/01/2010 AVEA VENTILATOR CAREFUSION FAROKH ETEMADIEH
K100094 01/13/2010 CARESTREAM IMAGE SUITE CARESTREAM HEATLH, INC. JOHN PARDO
K100035 01/06/2010 MODEL VISULAS 532S LASER WITH THE VITE OPTION CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K100253 01/28/2010 VISUMAX LASER KERATOME CARL ZEISS MEDITEC AG JUDITH A BRIMACOMBE
K103472 11/24/2010 NUFACE PLUS CAROL COLE COMPANY BOB DUFFY
K103410 11/22/2010 NEOPAP SYSTEM CHILDRENS MEDICAL VENTURES LLC SCOTT WRIGHT
K103215 11/01/2010 CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT CIANNA MEDICAL GARY MOCNIK
K100055 01/08/2010 BLOOD PRESSURE METER, MODEL CH-609 CITIZEN SYSTEMS JAPAN CO., LTD. NATHAN A BEAVER
K094022 01/07/2010 THE WATER LILY CLEARWATER PRODUCTS, LLC E.J. SMITH
K103461 11/24/2010 COLGATE DESENSITIZING DENTAL CREAM COLGATE-PALMOLIVE CO. CHARLES P IRELAND
K100156 01/20/2010 COLLAGEN DENTAL MEMBRANE V COLLAGEN MATRIX, INC. PEGGY HANSEN
K100218 01/26/2010 BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM COLOPLAST A/S REBEKA STOLTMAN
K103254 11/03/2010 PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE COLOPLAST A/S BRIAN SCHMIDT
K094050 01/05/2010 ITOTAL CR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K100047 01/08/2010 SUREFIT DUAL DISPERSIVE ELECTRODE CONMED CORPORATION SHAWN RIEDEL
K103431 11/23/2010 COREN TOTAL HIP SYSTEM CORENTEC CO., LTD KEVIN A THOMAS
K103518 11/30/2010 TRINITY ACETABULAR SYSTEM CORIN U.S.A. LUCINDA GERBER, BA (HONS)
K103407 11/19/2010 COTRONIC DIGITAL THERMOMETER COTRONIC MANUFACTURING YAN DUR LIN
K103253 11/30/2010 SILS PORT COVIDEN (FORMERLY REGISTERED AS US SURGICAL, A DIV TIM M LOHNES
K103263 11/04/2010 ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H FRANK GIANELLI
K103303 11/09/2010 CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE CROSSTEX INTERNATIONAL, INC. RICHARD M ORMSBEE
K100045 01/08/2010 OCTO DALIM SURGNET CORPORATION PETER CHUNG
K103321 11/12/2010 DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES DANA PRODUCTS, INC. HARRY BALA
K103371 11/17/2010 COUDE/ OR TIEMANN DEGANIA SILICONE, LTD. ZOYA LEE
K103220 11/01/2010 VOYAGER PERITONEAL DIALYSIS SYSTEM DEKA RESEARCH & DEVELOPMENT CORP. ROGER A LEROUX
K103329 11/12/2010 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION DELBIO INCORPORATION NICKY PAN
K103244 11/02/2010 QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION DENTSPLY INTL., INC. HELEN LEWIS
K100012 01/04/2010 GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K100238 01/27/2010 HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K103408 11/19/2010 POSTERIOR LATERAL PLATES DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K100070 01/11/2010 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. CHRISTOPHER ROGERS
K100247 01/27/2010 DETAX IMPLANTLINK SEMI DETAX GMBH & CO. KG DAGMAR MAESER
K103364 11/16/2010 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL DIAMOND DIAGNOSTICS, INC LIANN VOO
K100042 01/08/2010 DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM DIFUSION TECHNOLOGIES JAMI HAFIZ
K100100 01/12/2010 DIO STEADY EXTERNAL IMPLANT SYSTEM DIO CORPORATION TIMOTHY LEE
K100020 01/05/2010 DX SERIES FINGER SENSOR DIXTAL MEDICAL INC. ROBERT SCHIFFMAN
K103285 11/08/2010 DIXTAL DZ-4100 SERIES PULSE OXIMETER DIXTAL MEDICAL, INC. ROBERT H SCHIFFMAN
K100062 01/15/2010 INFILTRATION KIT DMG USA, INC. PAMELA PAPINEAU
K100248 01/27/2010 DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S DRFP LTD DAGMAR MAESER
K100220 01/26/2010 POLARIS SPINAL SYSTEM EBI, L.P. SHIKHA GOLA
K103290 11/08/2010 EDLEN IMAGING - GEMINI DUSB EDLEN IMAGING LLC FELIX HOVSEPIAN
K103520 11/30/2010 CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING EDWARDS LIFESCIENCES, LLC. DARYL RICHARDSON
K103288 11/08/2010 DEKA SYNCHRO FT EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K100115 01/15/2010 XVI R4.5 ELEKTA LTD. ANDREW HEDGES
K100230 01/26/2010 SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V ELEME MEDICAL, INC. WILLIAM MCGRAIL
K100071 01/11/2010 EMCOOLSPAD EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG MICHAEL KUEHLING
K103223 11/04/2010 HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS ENCORE MEDICAL, L.P. ALBERT E ALONSO
K103208 11/04/2010 REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM ENCORE MEDICAL, L.P. TEFFANY HUTTO
K100224 01/28/2010 ESTECH COBRA BIPOLSR II ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K103213 11/01/2010 FINESS ENDOSCOPE STERILIZATION TRAY ENTELLUS MEDICAL, INC. KAREN E PETERSON
K103235 11/02/2010 ERBEFLO 2 DISPOSABLE TUBING SYSTEM ERBE USA, INC. JOHN TARTAL
K100017 01/04/2010 EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM EUROIMMUN US INC KATHRYN KOHL
K103322 11/12/2010 EVERCROSS 0.035 OTW PTA DILATION CATHETER EV3 INC DAVID WORRELL, MS, RAC
K100063 01/15/2010 HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL EV3 INC LAURA HEATON
K103419 11/22/2010 EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM EXACTECH, INC. PATRICK HUGHES
K100269 01/29/2010 NOVATION CROWN CUP GXL LINERS EXACTECH, INC. GRAHAM L CUTHBERT
K093863 01/08/2010 EPIDRUM EXMOOR PLASTICS LTD. MARGARET BLACKMORE
K100011 01/04/2010 FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K103336 11/15/2010 MPS450 MULTIPARAMETER SIMULATOR FLUKE BIOMEDICAL JOHN NELSON
K100148 01/19/2010 SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K100205 01/25/2010 FRONTIER DEVICES NEURO SYSTEM FOLSOM METAL PRODUCTS, INC. DON PETERSON
K103465 11/24/2010 SYNAPSE 3D CARDIAC TOOLS FUJIFILM MEDICAL SYSTEMS U.S.A., INC. DEBBIE PEACOCK
K103450 11/24/2010 FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE FUJIREBIO DIAGNOSTICS, INC KENT PRUETT
K103358 11/16/2010 ROMA (HE4 EIA + ARCHITECT CA 125 II) FUJIREBIO DIAGNOSTICS, INC. DIANA L DICKSON
K092853 01/26/2010 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM GALIX BIOMEDICAL INSTRUMENTATION, INC. YOEL PALOMINO
K103234 11/02/2010 GC AADVA BO AC ABUTMENTS GC AMERICA, INC. CARL JENKINS
K103330 11/12/2010 BRIVO MR355, OPTIMA MR360 GE HANGWEI MEDICAL SYSTEMS CO., LTD. RUOQIAN LIU
K103335 11/15/2010 GEM OPTION FOR 1.5 MRI SYSTEMS GE HEALTHCARE MICHAEL S PRETO
K103365 11/18/2010 DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A GE HEALTHCARE COILS (USA INSTRUMENTS INC.) MICHAEL S PRETO
K103327 11/15/2010 DISCOVERY MR750W 3.0T GE HEALTHCARE JAPAN CORPORATION TORU SHIMIZU
K103411 11/22/2010 IDEAL IQ SOFTWARE OPTION GE MEDICAL SYSTEMS TRACEY FOX
K103432 11/29/2010 UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC ROBERT CASARSA
K103238 11/02/2010 1.5T OPTIMA MR430S GE MEDICAL SYSTEMS, LLC NORMA LEMAY
K103448 11/24/2010 BRIVO XR385 GE MEDICAL SYSTEMS, LLC JOHN L SCHMIDT
K103476 11/24/2010 BRIVOXR285AMX, OPTIMA XR200AMX, OPTIMAXR220AMX GE MEDICAL SYSTEMS, LLC NIDHI CHAUDHARY
K103480 11/26/2010 THORACIC VCAR GE MEDICAL SYSTEMS, LLC STEPHEN SLAVENS
K103489 11/26/2010 GE VEO RECONSTRUCTION OPTION GENERAL ELECTRIC CO. ANDREW J MENDEN
K103485 11/26/2010 SENOGRAPH DS, SENOGRAPH ESSENSTIAL GENERAL ELECTRIC COMPANY STEVEN KACHELMEYER
K100090 01/12/2010 IMPLANTABLE CLIP GENICON GARY HABERLAND
K103425 11/22/2010 ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM GENORAY AMERICA INC. JAE KIM
K103504 11/26/2010 GETINGE 400HC/500HC SERIES STEAM STERILIZER GETINGE SOURCING, LLC BARB SMITH
K103382 11/18/2010 INTERCONTINENTAL PLATE-SPACER GLOBUS MEDICAL INC. KELLY J BAKER
K100046 01/08/2010 M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 GUANGDONG BIOLIGHT MEDITECH CO., LTD. DIANA HONG
K100135 01/19/2010 GDS-DC12 GUIDED DELIVERY SYSTEMS BONNIE L MCINERNEY
K093179 01/13/2010 MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002) H&H RESEARCH COMPANY JONG HUANG
K100202 01/25/2010 SLIT LAMP BO 900, BQ 900, BP900 HAAG-STREIT AG OSCAR BANZ
K103417 11/22/2010 HALIFAX BIOMEDICAL TANATLUM BEAD SET HALIFAX BIOMEDICAL, INC. ROBERT A POGGIE, PHD
K103340 11/15/2010 SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM HARVEST TECHNOLOGIES, CORP. JOHN D BONASERA
K102817 11/17/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. RICHARD LU
K102819 11/17/2010 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI HONGTAI PLASTIC PRODUCTS CO., LTD. RICHARD LU
K100103 01/13/2010 SPECIALTY ASSAYED CONTROL-2 HELENA LABORATORIES PATRICIA FRANKS
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K100095 01/13/2010 CENTRAL VISION ANALYZER MODEL 1000 VIMETRICS,LLC. STEPHEN H H SINCLAIR,MD
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K100163 01/20/2010 NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX VYGON CORP. CINDY VARUGHESE
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