BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    ALGO 5 NEWBORN HEARING SCREENER

    FDA 510(k)
    FDA Class 2 ·Neurology

    FADASSI MEDICAL FM-1 NO BLENDER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PYRAMID ANTERIOR PLATE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDO SMARTCAP

    FDA Adverse Event
    MEDIVATORS·Product code KOG·February 2, 2015

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    TRIMA ACCEL

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·April 23, 2013

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·April 13, 2011

    INVACARE MANUAL WHEELCHAIR

    FDA Adverse Event
    Injury ·INVAMEX - INVACRE MEXICO·Product code IOR·July 9, 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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015