BEUDAMED
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    ERBECRYO 2 Cryosurgical Unit and Accessories

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

    4261806

    FDA Adverse Event
    Injury ·November 12, 2014

    3ML, 5ML, AND 10ML SYRINGES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMF·October 29, 2024

    Reprocessed PentaRay Nav eco High-Density Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC MINIMED·Product code MDS·September 20, 2011

    CS100

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 30, 2013

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    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