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 ×

    DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER

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

    Getinge GSS67N Series Steam Sterilizer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEKA SMARTXIDE WITH DOT SCANNER

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·November 14, 2023

    PERCISION PLUS SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP·Product code LGW·June 9, 2014

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FPO·October 12, 2010

    SOFTCLIX ® LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·December 13, 2012

    Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017