BEUDAMED
    23 results · 23ms · Sources: EU EUDAMED, US FDA

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    3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197417938·Perkins Retractor 11cm, full b...

    GRAFT DELIVERY SYSTEM MODEL SA-6115

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 31, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 11, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 30, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·March 5, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·June 5, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 28, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·July 28, 2025

    ALARIS PCA MODULE

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FRN·May 22, 2013

    GEM PREMIER 4000

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code CHL·June 22, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 15, 2008

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

    MONTERIS MEDICAL NEUROBLATE SYSTEM

    FDA Adverse Event
    Malfunction ·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·September 30, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·May 12, 2025

    CRE PULMONARY

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KTI·January 10, 2025

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025