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

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    QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PB560 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 22, 2011

    OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ROCHE COBAS TAQMAN ANALYZER

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PB560 VENTILATOR X1

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011

    INFINION CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 12, 2022

    HOLDING SLEEVE-LONG FOR MATRIX

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·April 17, 2013

    GO BED PLUS

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·April 11, 2011

    9617604-2008-00081

    FDA Adverse Event
    Injury ·Product code CBH·June 13, 2008

    AXON ECLIPSE CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·October 4, 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

    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