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

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    Filters Regulation: Us FDA ×

    H3+ Holter Recorder

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01

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

    SMARTSUCTION HARMONY DEVICE

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

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 7, 2013

    UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 7, 2011

    AXSYM RUBELLA IGG ANTIBODY

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code LFX·September 10, 2008

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    SCREWDRIVER BIT T15, AO FITTING

    FDA Adverse Event
    Malfunction ·STRYKER GMBH·Product code HWC·October 6, 2017

    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

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017