BEUDAMED
    19 results · 18ms · Sources: EU EUDAMED, US FDA

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    HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040011324·Zirlux 16+ D3 95X10

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00031568691638·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00070135642642·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033320228·

    BETSEY JOHNSON

    FDA UDI
    FGX INTERNATIONAL INC.·00193033320204·

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00031568642647·

    ARTIFICIAL URINARY SPHINCTER

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·March 7, 1997

    SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ULTRA-THIN SDS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP.·Product code DQY·December 8, 2006

    SUMMIT DUOFIX TAP SZ5 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 12, 2015

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·March 19, 2013

    SPEEDSCREW 5.5 MM KNOTLESS FIXATION DEVICE

    FDA Adverse Event
    Other ·ARTHROCARE CORP·Product code HWC·March 1, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2008

    Monitor with one Blood Parameter Module and one HSat Probe; 500AHCT Monitor with two Blood Parameter modules and one HSat Probe; 500AVHCT Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    CDI Blood parameter monitoring system 500 H/SAT, Part No. 145883 Product Usage: The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37¿C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·August 22, 2018

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014