BEUDAMED
    9 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.

    REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MGB Alert Platinum Master Mix-480rxn

    FDA UDI
    Elitechgroup Mdx LLC·03661540951800·The MGB Alert Platinum Master Mix is intended f...

    STAT DL 9.5 FR. 40 CC. IAB

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 15, 1998

    VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT CHISELS, VULCAN EFLEX LIGAMENT CHISELS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C-QUR EDGE MESH V-PATCH

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    M2A-MAGNUM MOD HD SZ 46MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 8, 2014

    ASR ACETABULAR IMPLANT 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·October 22, 2012

    TRIAGE CARDIAC PANEL 25 TEST

    FDA Adverse Event
    Malfunction ·BIOSITE INCORPORATED·Product code MMI·August 4, 2010

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023