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

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    Natus NeuroWorks

    FDA 510(k)
    FDA Class 2 ·Neurology

    ZenFlex

    FDA UDI
    Kerr Corporation·00195062030048·Rotary Files

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HEART SYNC, MODELS C-100 AND T-100

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PINN STRAIGHT CUP IMPACTOR

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·October 17, 2014

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 20, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·July 27, 2011

    OPTILENE 6/0 (0,7) 75CM 2XDRC13 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    OPTILENE 7/0 (0,5) 60CM 2XDRC8 CV2 RCP

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL, S.A.·Product code GAW·December 9, 2025

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020