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

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    DCI Edge Dental Chair with Operative Unit

    FDA 510(k)
    FDA Class 1 ·Dental

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    GII PS HI FLEX ISRT SZ 7-8 9

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·July 19, 2017

    COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 15, 2024

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017

    GII ARTICULAR INSERTER/EXTRACT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·June 7, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023