BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

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

    Stainless Steel Rectangular Wire

    FDA UDI
    Ortho Arch Company Inc·D9092500981·.012 STAINLESS STEEL ARCHES RIGHT FORM GOLDTONE...

    LightStim Professional 2-Panel Light

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

    DDAT OMT

    FDA 510(k)
    FDA Class 2 ·Neurology

    NA

    FDA Adverse Event
    Injury ·FOOTPRINT MEDICAL, INC.·Product code LJS·August 21, 2025

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·September 15, 2011

    4D DC SENSOR, MEDIUM

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·August 22, 2013

    AP SM W/RAPIDPORT EZ

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·July 23, 2013

    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

    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 Recall
    Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code GEI·August 21, 2025