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 ×

    GLASS POST

    FDA 510(k)
    FDA Class 1 ·Dental

    GC Initial™

    FDA UDI
    Gc America Inc.·D0470128491·Initial LiSi Press Ingot LT-C3 (3gx5)

    EYE SENTIAL

    FDA UDI
    FGX INTERNATIONAL INC.·00193033444528·

    VERTEX ETCHANT

    FDA 510(k)
    FDA Class 2 ·Dental

    PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·February 5, 2013

    TI PANGEA LOCKING CAP

    FDA Adverse Event
    Injury ·SYNTHES BRANDYWINE·Product code KWP·March 1, 2011

    DORADO PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code LIT·March 12, 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