FDA 510(k) Decisions During April, 2011  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K101468 04/14/2011 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE 3M COMPANY CORP LINDA JOHNSON
K103277 04/19/2011 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER 3M COMPANY-3M HEALTH CARE SUZANNE LEUNG
K102699 04/01/2011 ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS ABBOTT LABORATORIES JUDITH WALLACH
K110909 04/29/2011 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. ABBOTT LABORATORIES CHERECE L JONES
K110845 04/27/2011 IMPELLA CONTROLLER WITH FLOW CONTROL ABIOMED, INC. ROBERT STEWART
K103595 04/01/2011 ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM ACCLARENT, INC. GURVINDER SINGH NANDA
K103298 04/08/2011 ACAM 5 AUDIOMETER SYSTEM ACOUSTICON GMBH Maureen Garner
K110705 04/14/2011 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING INC. ADRIENNE LENZ
K103362 04/18/2011 AOI CRANIAL HELMET ADVANCED ORTHOPRO INC. MOHAMAD MANSOORI
K103218 04/01/2011 STERRAD CHEMICAL INDICATOR STRIP ADVANCED STERILIZATION PRODUCTS NANCY CHU
K103219 04/01/2011 STERRAD SEALSURE CHEMICAL INDICATOR TAPE ADVANCED STERILIZATION PRODUCTS NANCY CHU
K101348 04/29/2011 AGACHAMBER SPACER AGAPLASTIC IND. COM. LTDA. MARIA F GRIFFIN
K102225 04/06/2011 ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST ALCOPRO, INC. PERRY RUCKER
K102557 04/26/2011 NOVAKONE SPHERICAL AND TORIC LENSES ALDEN OPTICAL LABS., INC. CHARLES H CREIGHTON
K110767 04/15/2011 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. JONATHAN S KAHAN
K102481 04/28/2011 AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP APEX BIOTECHNOLOGY CORP. LISA LIU
K110123 04/28/2011 PCL TIGHTROPE ARTHREX, INC. COURTNEY SMITH
K101332 04/11/2011 AMC-20 PORTABLE DENTAL CART MODEL AMC-20 ASEPTICO, INC. CHERIE A TREGONING
K103759 04/08/2011 ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT ASTRA TECH, INC. BETSY A BROWN
K103042 04/15/2011 ATMOS E 201 THORAX AND ATMOS S 201 THORAX ATMOS INC. MARCO SCHLEGEL
K102542 04/06/2011 RESUSCI FLOW; RESUSCI FLOW 104 ATOM MEDICAL CORPORATION PAUL DRYDEN
K103317 04/20/2011 RESUSCITATION UNIT 105 ATOM MEDICAL CORPORATION PAUL DRYDEN
K110117 04/08/2011 ATRICURE BIPOLAR SYSTEM ATRICURE, INC. JAMES LUCKY, RAC
K102194 04/25/2011 SOLCART B B. BRAUN AVITUM AG ANGELA CARAVELLA
K110744 04/06/2011 PRONTOSAN WOUND IRRIGATION SOLUTION B. BRAUN MEDICAL, INC. NANCY SKOCYPEC
K102033 04/07/2011 COMBITRANS MONITORING SETS AND ACCESSORIES B. BRAUN MELSUNGEN AG LISA GIAQUINTO
K102948 04/01/2011 TORFLEX TRANSSEPTAL GUIDING SHEATH BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K103842 04/27/2011 UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 BECKMAN COULTER, INC. MARINE BOYAJIAN
K110105 04/28/2011 BD PEN NEEDLE BECTON DICKINSON AND COMPANY (BD) PASQUALE AMATO
K110434 04/19/2011 TRIXEL CO2 LASER BEIJING SYNTECH LASER CO., LTD. Diana Hong
K100724 04/01/2011 OSSEOTITE II MODEL XIFOSSXXX BIOMET 3I, INC. JOSE E CABRERA
K103343 04/29/2011 L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) BIONESS INC. ADELE SHOUSTAL
K110461 04/20/2011 SELECTRA CS LEAD INTRODUCER SYSTEM BIOTRONIK, INC. Jon Brumbaugh
K102034 04/19/2011 BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC ALBERT ZICKMANN
K110479 04/08/2011 ACUITY WHISPER VIEW GUIDE WIRES BOSTON SCIENTIFIC CORP. KIRSTIN JOHNSTON
K110833 04/20/2011 CRE BALLOON DILATATION CATHETER Boston Scientific Corporation JANIS TARANTO
K110887 04/14/2011 INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER Boston Scientific Corporation ASHLEY PYLE
K102990 04/04/2011 BRAINLAB KNEE BRAINLAB AG ALEXANDER SCHWIERSCH
K101722 04/01/2011 ALYTE Y-MESH GRAFT C.R. BARD, INC. SCOTT ROBIRDS
K110820 04/01/2011 VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM C.R. BARD, INC. KETI SINO
K110395 04/22/2011 C.T.M. MOBILITY SCOOTER - MODEL HS 118 C.T.M. HOMECARE PRODUCT, INC. SHEILA RAMERMAN
K110567 04/22/2011 C.T.M. MOBILITY SCOOTER HS515(3W) C.T.M. HOMECARE PRODUCT, INC. SHEILA RAMERMAN
K110772 04/28/2011 BIOMARC FIDUCIAL MARKER CARBON MEDICAL TECHNOLOGIES, INC. ANDREW J ADAMS
K110499 04/06/2011 CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR CARD GUARD SCIENTIFIC SURVIVAL LTD. CLAY ANSELMO
K110921 04/15/2011 NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS CARDINAL HEALTH, INC. TATYANA BOGDAN
K103140 04/08/2011 NICOLET WIRELESS EEG CAREFUSION 209, INC. ROBERT BURDGE
K110023 04/12/2011 INFUSION ADAPTER C100 CARMEL PHARMA AB. KJELL ANDREASSON
K100714 04/01/2011 CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01 CEDARS-SINAI MEDICAL CENTER DAVID R DILLS
K110203 04/07/2011 XPERT C. DIFFICLE/EPI ASSAY CEPHEID RUSSEL K ENNS
K103766 04/21/2011 XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0 CEPHEID KERRY J FLOM
K103196 04/29/2011 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES CHANGDA PLASTIC PRODUCT CO., LTD WANG LIN
K100767 04/05/2011 TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM CHURCH & DWIGHT CO., INC. JOSEPH CICCONE
K102859 04/20/2011 RETCAM 3 OPTHALMIC IMAGING SYSTEM CLARITY MEDICAL SYSTEMS GARY A SEEGER
K110849 04/26/2011 PRESTODR 4143 CMT MEDICAL TECHNOLOGIES, LTD. SHLOMI DINES
K110270 04/07/2011 ACCULIF CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K110483 04/04/2011 MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K110542 04/01/2011 CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD CONSENSUS ORTHOPEDICS, INC. MATTHEW HULL
K102943 04/12/2011 CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 CORELEADER BIOTECH CO., LTD. IAN LI
K110139 04/21/2011 CURVE IMAGE CURVE DENTAL, INC. CAROLINE TONTINI
K103626 04/05/2011 CUTERA GENESISPLUS LASER SYSTEM CUTERA, INC. Connie Hoy
K102957 04/28/2011 CUTTING EDGE SPINE INTERBODY FUSION DEVICE CUTTING EDGE SPINE, LLC JOHN KAPITAN
K101484 04/01/2011 COMPRESSYN BAND DALLEN MEDICAL AL MEMMOLO
K110253 04/29/2011 REUSABLE TEST PACK FOR DANA EMULATING INDICATORS DANA PRODUCTS, INC. HARRY BALA
K103549 04/08/2011 DENOVO TEDDY GEL INFANT HEEL WARMER DENOVO PRODUCTS LLC DALE WALTERS
K110216 04/01/2011 EXPEDIUM SYSTEM, VIPER SYSTEM DEPUY SPINE, INC. EUGENE BANG
K110353 04/07/2011 MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. LUKE BULINO
K103557 04/27/2011 DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET DIAZYME LABORATORIES Abhijit Datta
K103600 04/08/2011 PORTABLE X-RAY SYSTEM DIGIMED CORPORATION KIM ANTOL
K110521 04/19/2011 EVERON CENTRAL DISPLAY STATION (CDS) EARLYSENSE LTD. DALIA ARGAMAN
K110999 04/26/2011 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM EDAN INSTRUMENTS, INC. RANDY JIANG
K093640 04/29/2011 DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA ELECTRON JSCO. TANMAY SHUKLA
K110173 04/07/2011 EMS AIR-FLOW MASTER PIEZON EMS ELECTRO MEDICAL SYSTEMS SA CYNTHIA J M. NOLTE, PH.D, RAC
K110802 04/08/2011 A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18 ESAOTE S.P.A. Allison Scott
K110373 04/06/2011 TEMPOROMANIBULAR COIL 15 ESAOTE S.P.A. DONATELLA RAGGHIANTI
K103672 04/08/2011 REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET ETHICON ENDO-SURGERY, LLC DENNIS HAHN
K110319 04/14/2011 EVERCROSS 0.035 OTW PTA DILATATION CATHETER EV3 INC PAULA CORDERO
K110547 04/14/2011 OPTERTRAK LOGIC PSC TIBIAL INSERT EXACTECH SARASOTA PATRICK HUGHES
K110708 04/01/2011 EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... EXACTECH, INC. LINDY KNISELY
K090277 04/19/2011 NATUS SLEEPWORKS, MODEL 104017 EXCEL-TECH LTD. (XLTEK) GOLDY SINGH
K110288 04/28/2011 FEMVUE SALINE-AIR DEVICE FEMASYS INC. LISA PEACOCK
K103336 04/13/2011 MPS450 MULTIPARAMETER SIMULATOR FLUKE BIOMEDICAL JOHN NELSON
K110186 04/07/2011 SYNAPSE 3D LIVER ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC. KIMERLY A SHARP
K110436 04/20/2011 FDI GLUCOSE CONTROL SOLUTION FOR AVIVA FUJIREBIO DIAGNOSTICS, INC KENT PRUETT
K110920 04/08/2011 UF-760AG FUKUDA DENSHI CO., LTD. LORAN VAN NOY
K110834 04/26/2011 AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION GE HEALTHCARE HELEN PENG
K110266 04/29/2011 MAC 5500 HD, MAC 3500 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC PATRICIA TAIGE
K110610 04/01/2011 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL GE MEDICAL SYSTEMS, LLC MICHELLE SCHEIDT
K093581 04/19/2011 DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS GE MEDICAL SYSTEMS, LLC TRACEY ORTIZ
DEN110012 04/19/2011 APTIMA TRICHOMONAS VAGINALIS ASSAY GEN-PROBE INCORPORATED MARIA CARMELITA S BALUYOT
K110286 04/28/2011 GN OTOMETRICS TYPE 1053 FREEFIT GN OTOMETRICS A/S TOM RINIKER
K102152 04/28/2011 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES HEBEI TENGDA PLASTIC CO., LTD CHU XIAOAN
K102151 04/27/2011 POWDERED VINYL PATIENT EXAMINATION GLOVES HEBEI TENGDA PLASTIC CO., LTD CHU XIAOAN
K110037 04/29/2011 PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID HERAEUS KULZER, LLC CHERYL ZIMMERMAN
K101888 04/08/2011 SCENARIA WHOLE-BODY X-RAY CT SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K110862 04/26/2011 VAPRO PLUS INTERMITTENT CATHETER HOLLISTER, INCORPORATED CHRIS STUKEL
K100496 04/25/2011 INVADER MTHFR 1298 HOLOGIC, INC. RANDALL J COVILL
K101072 04/11/2011 TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K110764 04/27/2011 FILMARRAY RP PANEL IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K103318 04/07/2011 UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR IMPACT INSTRUMENTATION, INC. SUSAN MCNEVIN
DEN100020 04/08/2011 DENV DETECT IGM CAPTURE ELISA INBIOS INTL., INC. ESTELA I RAYCHAUDHURI
K102552 04/05/2011 HEMOSIL LA POSITIVE CONTROL INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K103248 04/05/2011 INTEGRITY SPINAL CARE SYSTEM INTEGRA LIFE SCIENCES JAMES J GIBSON
K103527 04/15/2011 AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX INTERNATIONAL BIOMEDICAL, LTD. AMY PIEPER
K103524 04/15/2011 VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX INTERNATIONAL BIOMEDICAL, LTD. AMY PIEPER
K103194 04/21/2011 INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM INTRA-LOCK INTERNATIONAL, INC. ANGELA BLACKWELL
K101581 04/08/2011 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 INTUITIVE SURGICAL, INC. BRANDON HANSEN
K103556 04/13/2011 IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K103817 04/22/2011 POSEY BED J. T. POSEY CO. ROBERT KELLEHER
K102847 04/14/2011 DISPOSABLE ENDOMETRIAL SUCTION CURETTE JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. Diana Hong
K102480 04/19/2011 INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA JIEYING LABORATORY INC. GRACE HOLLAND
K103617 04/04/2011 DIGITAL FOREHEAD THERMOMETER K-JUMP HEALTH CO., LTD. JASON CHENG
K101201 04/13/2011 STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064, KAT IMPLANTS, LLC VITALI BONDAR
K103582 04/14/2011 KELYNIAM CUSTOM SKULL IMPLANT (CSI) KELYNIAM GLOBAL, INC JAMES KETNER
K110092 04/08/2011 TAKE 1 ADVANCED RIGID TRAY KERR CORPORATION Wendy Garman
K110455 04/29/2011 KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS KIMBERLY-CLARK CORP. ANN WATERHOUSE
K103091 04/15/2011 LANX SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K110487 04/19/2011 FLEXIBLE CARDIAC COIL LBDS HOLDING COMPANY RICHARD BRYANT
K103368 04/06/2011 HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC CASPER E ULDRIKS ESQ.
K110116 04/08/2011 XEROS DRY MOUTH PUMP LORIN TECHNOLOGIES CORPORATION AL TOMAN
K103455 04/28/2011 SPECTRA LASER SYSTEM LUTRONIC CORPORATION JHUNG WON VOJIR
K102726 04/04/2011 CARDIOHELP SYSTEM MAQUET CARDIOPULMONARY AG ROLAND JEHLE
K110911 04/28/2011 RENAISSANCE SYSTEM MAZOR ROBOTICS LTD AHAVA STEIN
K111021 04/27/2011 CUBESCAN / BIOCON-700 MCUBE TECHNOLOGY CO., LTD. SEUNGTAI KIM
K110377 04/25/2011 PROTECTIVE RESTRAINT MEDI-TECH INTL. CORP. MARILYN GEIGER
K101088 04/04/2011 EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT MEDICA CORP. Photios Makris
K110675 04/21/2011 EASYRA UREA NITROGEN AND CREATININE REAGENTS MEDICA CORP. Photios Makris
K102222 04/08/2011 ULTIMATE VIT ENHAMCER (UVE) MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. LINDA UPTON
K103602 04/21/2011 EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K110259 04/13/2011 ARCHITEX SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. KELLY DAVIDSON
K110522 04/01/2011 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. NICHOLAS TABRIZI
K103565 04/12/2011 MEDVOXEL HEARTPRO SOFTWARE APPLICATION MEDVOXEL SYSTEMS INC BONNIE SEWLOCHAN
K110282 04/27/2011 LIGHTY DD INFUSION SET MEDX-SET LTD RAYMOND KELLY
K110067 04/08/2011 LP CAGE MEDYSSEY CO., LTD. RICH JANSEN
K102895 04/28/2011 ONE DAY FLAT PACK MENICON CO. LTD. MARTIN DALSING
K103599 04/27/2011 UNIVERSAL DIGITAL INTERFACE (UDI) 1717 MERIDIAN MEDICAL SYSTEMS, LLC ARIEL MARCIANO
K101745 04/08/2011 THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101744 04/08/2011 THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101742 04/08/2011 THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101753 04/08/2011 THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101752 04/08/2011 THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS MICROGENICS CORP. LISA CHARTER
K101754 04/08/2011 THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY MICROGENICS CORP. LISA CHARTER
K101746 04/08/2011 THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY MICROGENICS CORP. LISA CHARTER
K103680 04/06/2011 MICROLIFE DIGITAL UNDERARM THERMOMETER MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K110148 04/19/2011 WEXLER VASCULAR CLAMP SERIES MICROSURGICAL LABORATORIES,INC.DBA WEXLER SURGICAL LISA S JONES
K103758 04/28/2011 MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10 MICROVENTION, INC. LARAINE PANGELINA
K101805 04/08/2011 HYDROFIX VASO SHIELD MIMEDX GROUP, INC SALLY THORSEN
K110750 04/28/2011 PERIOPATCH MIS IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K110411 04/08/2011 ATAMA SYSTEM MONTERIS MEDICAL, INC. JEFF WILSON
K103784 04/13/2011 DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY JOY
K103795 04/13/2011 DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY JOY
K103833 04/20/2011 NEOPIP PATIENT CIRCUIT WITH PEEP NEOFORCE GROUP, INC. MONICA FERRANTE
K110138 04/08/2011 PAIRED HYDROGEL ELECTRODE NEUROVISION MEDICAL PRODUCTS, INC. CHRISTINE VERGELY
K110210 04/20/2011 SATURN 8000-GS NEW MEDICAL CO., LTD. JUN-HSIUNG LIN
K093914 04/14/2011 NEWDEAL COMPRESSION PLATES NEWDEAL SAS STEPHEN BEIER
K110262 04/05/2011 SHARPS CONTAINER NOBLE MARKETING Allison Scott
K110368 04/14/2011 NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT NovaBone Products, LLC DAVID M GAISSER
K110903 04/29/2011 PTS-X SIZING BALLOON CATHETER NUMED, INC. NICHELLE LAFLESH
K103829 04/04/2011 KNEEALIGN SYSTEM ORTHALIGN, INC AMY WALTERS
K110787 04/21/2011 TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15) ORTHOGEM LIMITED WE-JEN LO
K103015 04/13/2011 ODRC-DYNAMIC HIP SCREW SYSTEM ORTHOPAEDIC DEVICE RESEARCH CENTER CHENG-KUNG CHENG
K110626 04/20/2011 JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM PATHWAY MEDICAL TECHNOLOGIES, INC. BRIAN CLEARY
K103604 04/06/2011 ISA CO2, ISA AX+, ISA OR+ PHASEIN AB DAVID WEISSBURG
K111024 04/21/2011 JETPACK 2.0 PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. LORI R PETERSON
K100862 04/21/2011 BODYFLOW P2CH PHYSIOMED ELEKTROMEDIZIN AG BIRGIT SCHMID
K103729 04/18/2011 INFILL INTERVERTEBRAL BODY FUSION DEVICE PINNACLE SPINE GROUP, LLC Rebecca K Pine
K110561 04/29/2011 FORTROSS BONE VOID FILLER PIONEER SURGICAL TECHNOLOGY DAVID J COLLETTE
K110727 04/01/2011 HYLATOPICPLUS CREAM PRECISION DERMATOLOGY INCORPORATED RONALD M GURGE
K103324 04/21/2011 PRECISION LIQUID OXYGEN SYSTEM PRECISION MEDICAL, INC. JAMES PARKER
K110260 04/06/2011 NEWTOM 5G / NEWTOM 5G VERSION FP QR S.R.L. LORENZO BORTOLOTTI
K101578 04/28/2011 R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL R & D SYSTEMS, INC. NANCY RING
K092269 04/08/2011 CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET RANDOX LABORATORIES, LTD. P ARMSTRONG
K102985 04/05/2011 V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS Respironics Inc. TAMATHA LEY
K103428 04/04/2011 THE ARTAS SYSTEM FROM RESTORATION ROBOTICS RESTORATION ROBOTICS, INC KIT CARIQUITAN
K103370 04/05/2011 RT200 RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K103366 04/04/2011 RT600 RESTORATIVE THERAPIES INC. SCOTT SIMCOX
K110055 04/05/2011 REVERSE MEDICAL REFLEX GUIDE CATHETER REVERSE MEDICAL CORPORATION AMY ESKINA
K102418 04/15/2011 REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM REVERSE MEDICAL CORPORATION AMY ESKINA
K103200 04/12/2011 PROPEP DELIVERY DEVICE RHYTHMLINK INTERNATIONAL, LLC JAMES M MEWBORNE
K110112 04/20/2011 CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE RONGSHAN LI RONGSHAN LI
K110177 04/21/2011 HELENA SYSTEM ROYAL OAK MEDICAL DEVICES MATTHEW KROLL
K102902 04/22/2011 RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR RUBBERCARE PROTECTION PRODUCTS SDN BHD LIM KWEE SHYAN
K101057 04/05/2011 AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1 SALIENT SURGICAL TECHNOLOGIES KERRI MORTON
K110304 04/08/2011 APEX ER. YAG / IPL SYSTEM SANDSTONE MEDICAL TECHNOLOGIES LLC MARK ROHRER
K110502 04/27/2011 TRIPLEX ER. YAG / ND: YAG SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LLC MARK ROHRER
K110768 04/20/2011 COMPUTED DENTAL RADIOGRAPHY SCHICK TECHNOLOGIES, INC. SCOTT DOYLE
K110025 04/28/2011 SECTRA MICRODOSE MAMMOGRAPHY SECTRA IMTEC AB ALEXANDER ASKLOV
K110841 04/15/2011 DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI FLOWER CAI
K102085 04/14/2011 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG GLORY PLASTIC CO., LTD. CHU XIAOAN
K110838 04/21/2011 IFUSE IMPLANT SYSTEM SI-BONE, INC. JANICE M HOGAN
K110366 04/12/2011 SYNGO.CT CARDIAC FUNCTION SIEMENS AG RALF HOFFMANN
K110169 04/07/2011 DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN ANN DRAY-LYONS
K100321 04/12/2011 DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604 SIEMENS HEALTHCARE DIAGNOSTICS ROSE MARINELLI
K100344 04/18/2011 DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 SIEMENS HEALTHCARE DIAGNOSTICS ROSE MARINELLI
K103683 04/28/2011 IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) SIEMENS HEALTHCARE DIAGNOSTICS Garo Mimaryan
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