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

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    Filters Regulation: Us FDA ×

    AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ACCESS HYBRITECH P2PSA

    FDA Adverse Event
    Injury ·BECKMAN COULTER·Product code OYA·June 20, 2023

    VerteLoc Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2025

    CERTAIN® GOLD-TITE® HEXED SCREW

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·April 1, 2022

    Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·July 5, 2023

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·November 7, 2014

    EAGLE PLUS SELF TAPPING SCREW 16MM

    FDA Adverse Event
    Malfunction ·DEPUY RAYNHAM·Product code KWQ·September 6, 2011

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·July 16, 2013