BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Rampart One Lumbar Interbody Fusion System

    FDA UDI
    SPINEOLOGY INC.·M7404901807·Straight Awl

    TISSUE MARKER

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

    MEDPOR FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    TITANIUM SCREW LOW PROFILE 5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·November 18, 2016

    WALLFLEX? BILIARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·June 30, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·January 8, 2013

    LOW PROFILE SELF-TAPPING BONE SCREW

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LPH·November 17, 2010

    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

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021