BEUDAMED
    11 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 ×

    Nipro SafeTouch IV Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REPICCI II METAL BACK INLAY UNICOMPARTMENTAL TIBIAL BEARING COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·August 5, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·July 14, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 3, 2013

    VIVA S

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·October 10, 2014

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    SHORELINE ACS, WAVEFORM C

    FDA Adverse Event
    Injury ·SEASPINE ORTHOPEDICS CORPORATION·Product code OVE·November 12, 2025

    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