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

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    MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CLINICSELECT Green X-ray Film

    FDA UDI
    CARESTREAM HEALTH, INC.·40889976041976·CS GREEN X-RAY FILM 18X43-7X17 100SH

    EZ-ON CONDOM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SENSAID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·May 20, 2020

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·November 25, 2025

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·June 26, 2019

    PINNACLE MTL INS NEUT40IDX58OD

    FDA Adverse Event
    Injury ·DEPUY IRELAND 9616671·Product code KWA·April 9, 2013

    V.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KCI USA, INC.·Product code OMP·March 31, 2011

    VITALITY 2 DR EL

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    IMPELLA

    FDA Adverse Event
    Malfunction ·ABIOMED, INC. - 1220648·Product code OZD·March 19, 2026

    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4

    FDA Recall
    Terminated ·ICU Medical, Inc.·Product code DQE·January 2, 2020

    ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.

    FDA Enforcement
    Class II ·Terminated·Arjo Hospital Equipment AB·October 15, 2014

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018