BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PALADON(R) 65

    FDA 510(k)
    FDA Class 2 ·Dental

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083017521·STR, 10 electrode, MPD-CS-L2, 2-8-2mm electrode...

    CARTO RMT EP NAVIGATION SYSTEM V8

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014

    SOLUTION ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·November 17, 2010

    POWERED WHEELCHAIR

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

    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