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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    AVS PL PEEK SPACERS, MODELS 48351 AND 48353

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607313·SKYTRON 3501B 5.25" SOFTCARE PLUS

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450182741·

    HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696

    FDA 510(k)
    FDA Class 2 ·Immunology

    VISION HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011

    ENDURANT

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 26, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 6, 2011

    *

    FDA Adverse Event
    Injury ·B. BRAUN MEDICAL, INC.·Product code NGT·July 25, 2008

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018