BEUDAMED
    9 results · 19ms · 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 ×

    ROUND FILTERS W/INDICATOR

    FDA Adverse Event
    Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

    CONTAINER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FULL-SIZE LID W/RETENTION PLATE SILVER

    FDA Adverse Event
    Malfunction ·AESCULAP AG·Product code FRG·March 10, 2016

    Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·January 2, 2014

    1020279-2012-00565

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 16, 2012

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code MNT·August 11, 2010

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025