BEUDAMED
    9 results · 36ms · Sources: EU EUDAMED, US FDA

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    L1 SYSTEM

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

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    FDA Adverse Event
    Malfunction ·Product code LSZ·February 27, 1997

    STAURENGHI WIDE FIELD SCANNING LASER LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·March 27, 2013

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·March 18, 2011

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 25, 2008

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·August 1, 2024

    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