BEUDAMED
    20 results · 24ms · 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 ×

    SenoBright HD

    FDA 510(k)
    FDA Class 2 ·Radiology

    ERBE ERBEJET 2 SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

    FDA 510(k)
    FDA Class 2 ·Dental

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 19, 2022

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

    PCA EMPTY STERILE

    FDA Adverse Event
    Malfunction ·HOSPIRA INC.·Product code MEA·June 5, 2013

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 17, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·September 19, 2008

    BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BD CARIBE LTD.·Product code JKA·April 26, 2022

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 15, 2023

    EXPRESS SD RENAL/BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·June 28, 2023

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2021

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012