BEUDAMED
    14 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 ×

    TandemLung Oxygenator

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUICKSCREEN COCAINE 150 SCREENING TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    RHYTHM VIEW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUCLEUS 24 CONTOUR ADVANCE

    FDA Adverse Event
    Injury ·COCHLEAR LTD·Product code MCM·July 25, 2019

    ROI-A INSET MEDIAN IMPLANT H14MM 27X36MM

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code OVD·November 13, 2019

    EASYTRAK 3

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·January 4, 2011

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    STRAUMANN BONE CERAMIC

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code LYC·June 30, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·September 8, 2008

    ROI-A INSET MEDIAN IMPLANT H16MM 27X36MM 14

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·April 23, 2019

    ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·January 27, 2023

    ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM

    FDA Adverse Event
    Malfunction ·LDR MÉDICAL·Product code MAX·May 13, 2023

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019