BEUDAMED
    7 results · 23ms · 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 ×

    EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX; VOLCANO VH-IVUS SYSTEM, MODEL 8049XX-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DANIELS SHARPSMART REUSABLE SHARPS CONTAINER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·April 10, 2013

    OLYMPUS SURGMASTER ELECTROSURGICAL UNIT

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·April 1, 2011

    COSMODERM 2 COLLAGEN IMPLANT (0.5ML)

    FDA Adverse Event
    Other ·INAMED CORP. (FREMONT)·Product code LMH·May 20, 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