BEUDAMED
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    CARBON FIBER COUCH INSERT

    FDA 510(k)
    FDA Class 2 ·Radiology

    RESORBABLE BONE SCREW

    FDA UDI
    Biomet Orthopedics, LLC·00880304416420·

    LNOPV AD-L AND PD-L OXIMETRY SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimicro Veress Needle

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

    DURASUL, ALPHA INSERT, HH/32

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code KWZ·December 14, 2018

    LNOP MP12 PATIENT CABLE

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·May 15, 2015

    DASHER -14 STEERABLE GUIDEWIRE

    FDA Adverse Event
    Injury ·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORP·Product code DQX·January 9, 2007

    FRESENIUS 2008K

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 27, 2014

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·Product code HQL·February 6, 2013

    FIBER ONE

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER-SILICON VALLEY·Product code GEX·December 7, 2010

    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