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

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    Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EMPOWERMR INJECTOR SYSTEM, MODEL 9730

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENUMBRA MAX PUMP - INDIGO SYSTEM

    FDA Adverse Event
    Malfunction ·PENUMBRA INC., USA·Product code NRY·August 23, 2018

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·March 8, 2018

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 220

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·April 9, 2018

    PROTECTA CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·October 10, 2014

    POWERPICC SHRELOCK 4F SINGLE-LUMEN POLYURETHANE CATHETER

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code LJS·June 6, 2013

    PT 2 (TM)

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·July 14, 2011

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025