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

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    VITREA, VERSION 3.9

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXPEDIO 500D R&F X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

    FDA 510(k)
    FDA Unclassified ·Unknown

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·February 19, 2026

    EXTERNAL PADDLES

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013

    VIRTUOSO VR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code LWS·April 18, 2011

    SOLETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·June 17, 2008

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024