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

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    MODIFICATION TO CD HORIZON SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·April 20, 2023

    OXYGEN TREATMENT HOOD

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ECHOCOM, IMAGECOM, DOKUCOM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARTIAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HSX·July 25, 2022

    INLAY OPTIMA URETERAL STENT

    FDA Adverse Event
    Malfunction ·PRODUCTOS PARA EL CUIDADO DE LA SALUD·Product code FAD·April 11, 2013

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 18, 2011

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 17, 2008

    cobas 8000 Modular Analyzer Series; Part Numbers: 1. 05964067001 cobas 8000 c 502 module

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015