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

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    SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID

    FDA 510(k)
    FDA Class 2 ·Microbiology

    7062705

    FDA Adverse Event
    Malfunction ·November 28, 2017

    CLEARFIL PHOTO CORE

    FDA 510(k)
    FDA Class 2 ·Dental

    EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 13, 2022

    VENTED MICRO VOL.INLET, N/S

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·March 28, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·April 7, 2022

    VALVE SET, EM2400

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·August 8, 2022

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 17, 2013

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·June 16, 2008

    4.0MM TI QUICK LOCK CANCELLOUS SCREW

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code KWQ·April 12, 2011

    250 ML TPN BAG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code LHI·May 21, 2021

    EXACTA-MIX 2400 COMPOUNDING SYSTEM

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code NEP·February 27, 2023

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

    8100 ALARIS PUMP MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·December 29, 2020

    Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

    Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.

    FDA Recall
    Terminated ·Heraeus Kulzer Inc.·Product code ELW·November 1, 2003

    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