BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Neurology

    ARCHITECT HAVAB-G

    FDA 510(k)
    FDA Class 2 ·Microbiology

    REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP

    FDA 510(k)
    FDA Class 2 ·Dental

    ARCHITECT HAVAB-IGG

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·May 8, 2026

    ARCHITECT HAVAB-IGG

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·April 3, 2026

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 7, 2011

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 8, 2013

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·November 26, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·August 20, 2025

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·July 22, 2025

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023

    ALINITY I HAVAB-IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·June 25, 2025

    ARCHITECT HAVAB-IGG

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·February 4, 2026

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 23, 2026

    ALINITY I HAVAB IGG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LOL·January 16, 2026

    ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300, PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W, PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W I-DXA-1127-023, PSCupA-12TBU.

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

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

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