BEUDAMED
    9 results · 18ms · 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.

    CONCERT CRANIOPLAST

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 1, 2023

    MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KPS-I, THE KIDNEY PERFUSION SOLUTION

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

    IN TOUCH EU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 27, 2013

    ARCHITECT HAVAB IGM REAGENT

    FDA Adverse Event
    Malfunction ·ABBOTT·Product code LOL·March 18, 2011

    CLINICAL INFO CENTER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·April 2, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty

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