BEUDAMED
    12 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 ×

    IDYS LIF CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SurgiMac

    FDA UDI
    Surgimac LLC·D105SKU1311780·Automatic Crown Remover

    SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO INTEL HEALTH GUIDE PHS6000

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TWINFIX AB ANCHOR

    FDA Adverse Event
    Injury ·SMITH AND NEPHEW·Product code MBI·August 12, 2023

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·October 1, 2014

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    HUMIDIFIER, RESPIRATORY GAS

    FDA Adverse Event
    FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 18, 2008

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

    ASLOT TINA-QUANT ANTISTREPTOLYSIN O

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GTQ·April 3, 2017

    dS Breast 7ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025