FDA 510(k) Applications Received During November, 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
K103277 11/05/2010 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER 3M COMPANY-3M HEALTH CARE SUZANNE LEUNG
K103403 11/19/2010 MULTICONSTITUENT CALIBRATOR ABBOTT LABORATORIES LINDA MORRIS
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
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
K103284 11/05/2010 LAMINOPLASY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K103445 11/24/2010 ALACER SURGICAL SCAFFOLD ALACER BIOMEDICAL INC CONNIE GARRISON
K103501 11/29/2010 ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES ALMA LASERS, INC. TATIANA EPSTEIN
K103205 11/01/2010 BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM ALPHATEC SPINE, INC. OLGA LEWIS
K103252 11/03/2010 CAMLOG VARIO SR ABUTMENTS ALTATEC GMBH LINDA SCHULZ
K103282 11/05/2010 LAPAROSCOPIC DISSECTOR APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K103421 11/22/2010 ARSTASIS DILATOR ADAPTER ARSTASIS, INC. DEBRA COGAN
K103466 11/24/2010 ARTHREX UNIVERS II SHOULDER PROSTHESIS ARTHREX, INC. SALLY FOUST, RAC
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
K103317 11/10/2010 RESUSCITATION UNIT 105 ATOM MEDICAL CORPORATION PAUL DRYDEN
K103412 11/22/2010 AXIOM FASCIAL CLOSURE SYSTEM AXIOM TECHNOLOGY PARTNERS, LLC RICHARD RUSH
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
K103373 11/17/2010 SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 BECKMAN COULTER, INC. YVETTE LLOYD
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
K103291 11/08/2010 BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARE BIOHORIZONS IMPLANT SYSTEMS, INC. MICHAEL DAVIS
K103393 11/19/2010 POLARIS SPINAL SYSTEM BIOMET SPINE VIVIAN KELLY
K103343 11/15/2010 L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) BIONESS INC. ADELE SHOUSTAL
K103514 11/30/2010 PRO-V COAT BISCO, INC. MICHELLE SCHILTZ-TAING
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
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
K103359 11/16/2010 FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) C.R. BARD, INC. CINDY MOSS
K103418 11/22/2010 DESARA MINI CALDERA MEDICAL, INC. VICKI GAIL
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
K103211 11/01/2010 AVEA VENTILATOR CAREFUSION FAROKH ETEMADIEH
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
K103461 11/24/2010 COLGATE DESENSITIZING DENTAL CREAM COLGATE-PALMOLIVE CO. CHARLES P IRELAND
K103254 11/03/2010 PERISTEEN ANAL IRRIGATION SYSTEM, IRRIGATION ACCESSORY UNIT, IRRIGATION RECTAL CATHETER, SYSTEM STRAP, IRRIGATION TUBE COLOPLAST A/S BRIAN SCHMIDT
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
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
K103408 11/19/2010 POSTERIOR LATERAL PLATES DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K103364 11/16/2010 MISSION CLINICHECK ASSAYED CHEMISTRY CONTROLS, LEVEL 1, LEVEL 2, DUAL LEVEL DIAMOND DIAGNOSTICS, INC LIANN VOO
K103285 11/08/2010 DIXTAL DZ-4100 SERIES PULSE OXIMETER DIXTAL MEDICAL, INC. ROBERT H SCHIFFMAN
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
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
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
K103322 11/12/2010 EVERCROSS 0.035 OTW PTA DILATION CATHETER EV3 INC DAVID WORRELL, MS, RAC
K103419 11/22/2010 EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM EXACTECH, INC. PATRICK HUGHES
K103336 11/15/2010 MPS450 MULTIPARAMETER SIMULATOR FLUKE BIOMEDICAL JOHN NELSON
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
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
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
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
K103512 11/30/2010 AFFIRM BREAST BIOPSY GUIDANCE SYSTEM HOLOGIC, INC. GAIL YAEKER-DAUNI
K103265 11/26/2010 NHANES WHOLE BODY DXA REFERENCE DATABASE HOLOGIC, INC. CHRISTINA HURTON
K103385 11/18/2010 SECURVIEW DX DIAGNOSTIC WORKSTATION HOLOGIC, INC. GAIL YAEKER-DAUNIS
K103344 11/15/2010 INFUSION SETS HOSPIRA, INC. REBECCA ANDERSEN
K103233 11/02/2010 MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT HOWMEDICA OSTEONICS CORP AVITAL MERL-MARGULIES
K103278 11/05/2010 ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION I-SENS, INC. HYUN JOON OH
K103396 11/19/2010 COOL BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE METER, COOL CONTROL SOLUTION I-SENS, INC. STANLEY R GOODMAN
K103207 11/01/2010 JBAIDS Q FEVER DETECTION KIT IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K103337 11/15/2010 MULTIPLE NAME IDEAL QUALITY SDN., BHD. SH TAN
K103325 11/12/2010 IDS-ISYS INTACT PTH IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON
K102664 11/29/2010 HEMA SCREEN ER IMMUNOSTICS, INC. RICHARD M PEOPLES
K103318 11/12/2010 UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR IMPACT INSTRUMENTATION, INC. SUSAN MCNEVIN
K103506 11/29/2010 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) IMRIS, INC. THOMAS M TASKERIS
K103493 11/29/2010 HEAD FIATION DEVICE (HFD 100) IMRIS, INC. THOMAS M TSKERIS
K103416 11/22/2010 NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM INFIMED, INC. JIGAR SHAH
K103268 11/04/2010 OMNI EXPRESS INFINIUM MEDICAL JOHN OBRIEN
K103516 11/30/2010 AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 INOVISE MEDICAL, INC. EARL ANDERSON
K103392 11/19/2010 CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER INOVO, INC. MICHAEL T DILDINE
K103248 11/03/2010 INTEGRITY SPINAL CARE SYSTEM INTEGRA LIFE SCIENCES JAMES J GIBSON
K103276 11/05/2010 INTEL HEALTH GUIDE INTEL CORPORATION DIGITAL HEALTH GROUP MAUREEN GYLNN
K103347 11/15/2010 CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES INTERVASCULAR, SAS PHILIPPE BENSIMON
K103528 11/30/2010 IPS EMPRESS DIRECT FLOW IVOCLAR VIVADENT, INC. DONNA HARTNETT
K103391 11/19/2010 IVOBASE HYBRID, IVOBASE HIGH IMPACT IVOCLAR VIVADENT, INC. DONNA HARTNETT
K103379 11/17/2010 TELIO CS INLAY & TELIO CS ONLAY IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K103232 11/04/2010 CASPIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K103440 11/23/2010 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K103467 11/24/2010 CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM KARL STORZ ENDOSCOPY-AMERICA, INC. SHIVEN GANDHI
K103351 11/16/2010 DMC COMPOSITE 2 KERR CORPORATION WENDY GARMAN
K103311 11/10/2010 U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS KIMBERLY CLARK CORPORATION CHERYL SANZARE
K103406 11/19/2010 MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS KIMBERLY-CLARK CORP. DAVID M LEE
K103348 11/15/2010 DIGIVIEW 250 KUB TECHNOLOGIES, INC VIKRAM BUTANI
K103414 11/22/2010 VENUS CERVICAL SPINAL FIXATION SYSTEM L&K BIOMED CO.,LTD. SUN YI LEE
K103498 11/29/2010 LAKONG ULTRASONIC SCALER LAKONG MEDICAL DEVICE COMPANY, LTD DANNY WANG
K103237 11/02/2010 LANX SPINAL SYSTEM LANX, INC. DAMON BELLONI
K103356 11/16/2010 PRUITT CAROTID KIT LEMAITRE VASCULAR, INC. VIC ZHANG
K103368 11/17/2010 HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC CASPER E ULDRIKS ESQ.
K103423 11/22/2010 MIS ANTERIOR CERVICAL PLATING SYSTEM LIFE SPINE RANDY LEWIS
K103302 11/09/2010 STEMPRO MSC SFM LIFE TECHNOLOGIES CORPORATION KELLI TANZELLA
K103357 11/23/2010 LIFEBRIDGE LIFEBRIDGE MEDIZINTECHNIK AG KATHLEEN JOHNSON
K103214 11/01/2010 M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 LIFELINE SYSTEMS, INC. CARLOS O ACOSTA
K103217 11/01/2010 LITE-MED LM-9200 ELMA LITE-MED INC WALT HSU
K103511 11/30/2010 LITECURE THERAPY SYSTEM LITECURE, LLC LIANG LU
K103455 11/23/2010 SPECTRA LASER SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K102845 11/09/2010 MAHE FIXATION PLATE AND SCREW SYSTEM MAHE MEDICAL GMBH ANDREA PECSI
K103271 11/05/2010 MSC LIPID CONTROL MAINE STANDARDS CO. HOLLY CRESSMAN
K103352 11/16/2010 VERSAFITCUP CC TRIO MEDACTA INTERNATIONAL NATALIE J KENNEL
K103332 11/12/2010 APTUS ULNA PLATES MEDARTIS AG KEVIN A THOMAS
K103507 11/29/2010 MEDICAL VISORS MV100 MEDICAL VISORS, INC BRAIN HUGHES
K103397 11/19/2010 ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYEONG-MI PARK
K103375 11/16/2010 PLUMEPEN INTEGRATED SMOKE EVACUATION PENCIL MEDTEK DEVICES, INC. GREG PEPE
K103231 11/01/2010 KYPHON INFLATION SYRINGE MEDTRONIC SPINE LLC HETAL JAWAHAR THAKKER
K103272 11/05/2010 ZENIUS SPINAL SYSTEM MEDYSSEY CO., LTD. PATRICK MOORE
K103427 11/22/2010 MOBILEECG SYSTEM MEMTEC CORP. DENNIS GARBOSKI
K103474 11/26/2010 ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT) MICERIUM S.P.A. SSA CARLA TAZZER
K103209 11/01/2010 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) NANOSPHERE, INC. GREGORY W SHIPP
K103354 11/16/2010 EBONY PTA .035 PERIPHERAL DILATATION CATHETER NATEC MEDICAL LTD E.J. SMITH
K103353 11/16/2010 MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER NAVILYST MEDICAL, INC. WANDA CARPINELLA
K103342 11/15/2010 3.0T METAFLEXCOIL NEOCOIL, LLC BRIAN BROWN
K103338 11/15/2010 COOLTOUCH NEW STAR LASERS, INC. NATALIE R VOLLRATH
K103515 11/30/2010 EQUAL DOSE NUCLETRON CORPORATION MANAL YOUSOF
K103264 11/04/2010 ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELL KLUESNER, MS, RAC
K103478 11/26/2010 SINGLE USE BILIARY DRAINAGE STENT V OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K103312 11/10/2010 UPD-Y0003 OLYMPUS MEDICAL SYSTEMS CORPORATION STACY KLUESNER
K103475 11/24/2010 SPINEANALYER MODEL SAPOC OPTASIA MEDICAL ANTHONY HOLMES
K103384 11/18/2010 ESCALADE ACETABULAR CUP SYSTEM ORTHO DEVELOPMENT TOM HAUETER
K103305 11/09/2010 PENUMBRA EMBOLIZATION COIL SYSTEM PENUMBRA, INC. SETH A SCHULMAN
K103477 11/26/2010 PERMOBIL M300 / M400 PERMOBIL AB JAN ASTROM
K103295 11/09/2010 QUICKSCREEN COCAINE 150 SCREENING TEST PHAMATECH INC. CARL MONGIOVI
K103415 11/22/2010 TANDA MAX PHAROS LIFE CORPORATION GORDON WEHNER
K103483 11/26/2010 INGENUITY TF PET/MR PHILIPS HEALTHCARE (CLEVELAND) EDUARD TOEREK
K103349 11/16/2010 BACKSTOP CATHETER PLUROMED, INC. JAMES WILKIE
K103269 11/04/2010 PATCHASSIST LARGE POLYTOUCH MEDICAL LTD LEO BASTA
K103339 11/15/2010 TDS ABUTMENT FOR FRIADENT XIVE POU YU BIOTECHNOLOGY CO., LTD. DANIEL TSAO
K103324 11/12/2010 PRECISION LIQUID OXYGEN SYSTEM PRECISION MEDICAL, INC. JAMES PARKER
K103206 11/01/2010 RAUMEDIC- ICP-MONITORING SYSTEM RAUMEDIC AG REINER THIEM
K103242 11/02/2010 REDSENSE-ALARM UNIT AND SENSOR REDSENSE MEDICAL AB CONSTANCE G BUNDY
K103395 11/19/2010 PERFORMAX TOTAL FACE MASK RESPIRONICS, INC. MICHELLE BRINKER
K103428 11/22/2010 THE ARTAS SYSTEM FROM RESTORATION ROBOTICS RESTORATION ROBOTICS, INC KIT CARIQUITAN
K103370 11/17/2010 RT200 RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K103366 11/16/2010 RT600 RESTORATIVE THERAPIES INC. SCOTT SIMCOX
K103200 11/12/2010 PROPEP DELIVERY DEVICE RHYTHMLINK INTERNATIONAL, LLC JAMES M MEWBORNE
K103449 11/23/2010 BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS RIVERPOINT MEDICAL DOUG ROWLEY
K103402 11/19/2010 ELECSYS DHEA-S CALCHECK 5 ROCHE DIAGNOSTICS KELLY C O'MAINE ADAMS
K103221 11/01/2010 ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 ROCHE DIAGNOSTICS KELLY C O'MAINE ADAMS
K103297 11/08/2010 REDONDO-L SEASPINE, INC. ETHEL BERNAL
K103274 11/05/2010 SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING SENTINELLE MEDICAL, INC. CAMERON PIRON
K103376 11/17/2010 ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL SEPPIM S.A.S. DEBRA K HUTSON
K103346 11/15/2010 DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY SHERPA KOREA RAYMOND KELLY
K103360 11/16/2010 DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL SIEMENS CORP. ROSE T MARINELLI
K103429 11/22/2010 BIOGRAPH MMR SIEMENS MEDICAL SOLUTIONS USA INC. ALAINE MEDIO
K103424 11/22/2010 SAFIRE SIEMENS MEDICAL SOLUTIONS USA, INC. ALICIA BUSTOS-JUERGENSEN
K103275 11/05/2010 SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS SIEMENS MEDICAL SOLUTIONS USA, INC. ALICIA BUSTOS-JUERGENSEN
K103409 11/22/2010 ALLERGEAZE R CLEAR SMARTPRACTICE KIM SULLIVAN
K103309 11/10/2010 OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS SMITH & NEPHEW ENDOSCOPY, INC. KATHLEEN SOLOMON
K103256 11/03/2010 SMITH & NEPHEW SMF HIP STEM SMITH & NEPHEW, INC. NATALIE P WILLIAMS
K103389 11/18/2010 TRUCLEAR INCISOR PLUS BLADE 2.9 SMITH & NEPHEW, INC. JANICE HASELTON
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K103283 11/05/2010 PHYSIOFLOW ENDURO VASOCOM, INC. JAMES GUNNERSON
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K103500 11/29/2010 GORE EMBOLIC FILTER W.L. GORE & ASSOCIATES,INC MICHELLE A WELLS
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