BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

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    PicoLO Nd: YAG Picosecond Laser System

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

    SKYLINE ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JFM·October 17, 2008

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·July 2, 2013

    BD AUTOSHIELD¿ DUO PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·May 6, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·March 25, 2025

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 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