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

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    Symphion Endoscope and Symphion Cervical Sheath

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AMISTEM H, HA COATED STEM 5 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 11, 2017

    V.A.C. GRANUFOAM DRESSING

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·May 6, 2020

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code JJE·June 10, 2013

    AC POWER MODULE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 23, 2014

    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