BEUDAMED
    8 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 ×

    LSP AUTOMATIC VENTILATOR, MODEL 456

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OXYGEN TWMER, MODEL SST

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    LUNDIA PLATE DISP.

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    WALKMED® 150 ML RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·WALKMED TECHNOLOGIES, LLC·Product code FRN·September 5, 2025

    SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DYG·June 12, 2014

    LCS COMPLETE M/B PAT CEM LG

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code NJL·October 11, 2010

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code DRM·November 13, 2012

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021