BEUDAMED
    11 results · 35ms · 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.

    PILLAR MALAR IMPLANT

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

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517234834·Armada Ti 3CO Osteotome, 7mm Lum

    PICCOLO BASIC METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·October 22, 2020

    PICCOLO COMPREHENSIVE METABOLIC PANEL

    FDA Adverse Event
    Malfunction ·ABAXIS, INC.·Product code CGX·November 3, 2020

    ACUPUNCTURE NEEDLES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RAPIDPoint 500e Blood Gas System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EARIGATOR

    FDA Adverse Event
    Malfunction ·SURYA TECHNOLOGIES INTERNATIONAL·Product code JYH·January 4, 2001

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·March 7, 2013

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    ADAPTA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·August 8, 2014

    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