BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    BTL-899ST

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

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112786·BARRON VACUUM PUNCH 8.25MM

    OnX Tough 2 - Hollywood White - 3kg

    FDA UDI
    Sprintray, Inc.·00850070544580·SprintRay OnX Tough 2 is a tooth shade ceramic-...

    ENDIUS ATAVI SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code NIQ·October 16, 2008

    PLV-100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 28, 2013

    SPRINT QUATTRO

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·January 4, 2021

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·March 14, 2022

    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