BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    SHADOW TRAYS

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295253693·INFERIOR JAW DEEP

    Plexus

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM

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

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    ACCESSORIES

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code DQX·March 20, 2025

    UNKNOWN PTN NAIL

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code HSB·March 6, 2013

    CRYSTALENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code NAA·February 7, 2011

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·August 8, 2014

    ACIST

    FDA Adverse Event
    Malfunction ·ACIST MEDICAL SYSTEMS, INC.·Product code DXT·April 20, 2007

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·February 27, 2024

    INDEFLATOR

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code MAV·March 21, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021