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

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    Javelin Tailor's Bunion Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    1628664-2017-00233

    FDA Adverse Event
    Malfunction ·May 25, 2017

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112922·CORNEAL TREPHINE BLADE7.75MM

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112502·BARRON VACUUM TREPHINE 7.75MM

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113462·SCLEROTOME BLADE #57 (BX/5)

    CONCENTRIC BALLOON GUIDE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SmartGuard Anti-Snoring Device

    FDA 510(k)
    FDA Class 2 ·Dental

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 27, 2014

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 11, 2011

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code LKK·July 2, 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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021