BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    RII INFRARED EAR THERMOMETER, MODELS THXXN SERIES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201503195·Leksell MPS Arc w Counter Scale - ARC ENGRAVED

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257128893·15-20 MV FOR MEN CLSC EW STD NAVY VII

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 8, 2021

    MASIF POWDER-FREE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRECISION NOVI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 24, 2021

    PELVICOL 2CM X 7CM 1.0MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE·Product code FTL·March 25, 2013

    CR-35X SYSTEM WITH NX WORKSTATION

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE GMBH·Product code MQB·February 15, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIQ·May 6, 2008

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024