BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    C-Zero Pedicle Screw System, Freedom Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GRAFT DELIVERY SYSTEM MODEL SA-6115

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CRYOPEN CRYOSURGICAL SYSTEM, K102214

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

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 17, 2014

    FREESTYLE FREEDOM

    FDA Adverse Event
    Malfunction ·Product code NBW·June 20, 2013

    ACROBAT SUB VACUUM STABILIZER SYSTEM, ST

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code DWS·April 29, 2011

    ASAHI GLADIUS MG14 PV ES

    FDA Adverse Event
    Injury ·ASAHI INTECC CO., LTD.·Product code DQX·November 9, 2023

    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