BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    GORE DrySeal Flex Introducer Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016

    GORE® DRYSEAL FLEX INTRODUCER SHEATH

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017842·K-Wire, Double Ended, Trocar Point, Diameter Si...

    Denovo general purpose dental molar band

    FDA UDI
    Denovo Dental, Inc.·00810059290471·Denovo general purpose dental molar band - Mand...

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221044761·Unitek(TM) Molar Band General Purpose Narrow Re...

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017859·K-Wire, Double Ended, Trocar Point, Diameter 0....

    REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO INFINITY EXPLORER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GOLDEN COMFORTER

    FDA Adverse Event
    Malfunction ·GOLDEN TECHNOLOGIES, INC.·Product code INO·October 3, 2012

    PK DISSECTING FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 10, 2013

    XPOSE 4 DEVICE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code MWS·June 2, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·September 16, 2008

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024