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

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    CLEVER TD-1107 EAR/SKIN/SURFACE IR THERMOMETER, CLEVER TD-1110 EAR/SKIN/SURFACE IR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 8, 2013

    CCU BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 15, 2011

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008

    IntelliSpace Cardiovascular, Software 8.0.0.4.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·September 17, 2025

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015