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.

    CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MAGLIFE C/MAGLIFE C PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    I-STAT 1 WIRELESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MECTALIF OBLIQUE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MAX·May 29, 2026

    INTERCHANGEABLE ULNAR ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 21, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    MINIARC

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·June 10, 2011

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

    INTERCHANGEABLE HUMERAL ASSEMBLY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDC·October 22, 2019

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015