BEUDAMED
    30 results · 20ms · 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.

    MEDI BUTLER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DETACHOL

    FDA UDI
    FERNDALE LABORATORIES, INC.·00304960513243·ADHESIVE REMOVER

    SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI SYNAMPS (129-256 CHANNELS)

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KURIN BLOOD CULTURE COLLECTION SET

    FDA Adverse Event
    Malfunction ·KURIN, INC.·Product code JKA·January 24, 2025

    KURIN BLOOD CULTURE COLLECTION SET

    FDA Adverse Event
    Malfunction ·KURIN INC·Product code JKA·February 20, 2025

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 20, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 28, 2018

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 12, 2018

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·April 10, 2013

    SUSTAIN R SPACER, OBLIQUE, 10X26, 9MM

    FDA Adverse Event
    Malfunction ·GLOBUS MEDICAL, INC.·Product code MQP·May 22, 2008

    EON MINI RECHARGEABLE IPG

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 7, 2011

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 25, 2011

    LABOR & DELIVERY PACK, Model Nos LLLD19H

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·March 26, 2025

    smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD.·Product code FGE·April 11, 2011

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 5, 2012

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·January 4, 2018

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems Inc·September 3, 2025

    ZILVER 635 SELF EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·June 13, 2014