BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    CLEARFIL PROTECT BOND

    FDA 510(k)
    FDA Class 2 ·Dental

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033938·Baltic Denture System BDLoad BDLoad Ln6 PLSEbi...

    IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TRAK BACK II

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RAD-5V HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·July 10, 2015

    RAD-5 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 13, 2018

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·April 3, 2013

    ADJ WIRE COLLET 0.7-1.8MM

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·March 23, 2011

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INT'L, LTD.·Product code KWA·April 24, 2008

    POLYMOBIL PLUS

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE GMBH·Product code IZL·July 27, 2023

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013