BEUDAMED
    27 results · 29ms · Sources: EU EUDAMED, US FDA

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    Venclose digiRF Generator (VCRFG1)

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

    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

    Vivid ZirDisc Zircon Zahn System

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724Q2500681·95x12mm SHT (Super Translucent)

    PlaquePRO Interdental Proxy Brush

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063755741·PlaquePRO Interdental Proxy Brush Singles - Tig...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197161411·Williams Dissectomy Forceps 140mm lengh 1 mm j...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197161527·Ferris-Smith Rongeur, cup jaw rongeur with R...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197161503·Ferris-Smith Rongeur, cup jaw rongeur with R...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197437288·Williams Dissectomy Forceps 230mm lengh 1 mm j...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197161510·Ferris-Smith Rongeur, cup jaw rongeur with R...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197544702·Ferris-Smith Rongeur, cup jaw rongeur with R...

    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

    JP DRAIN 10F DRAIN JACKSON-PRATT 10F

    FDA Adverse Event
    Injury ·CARDINAL / CARDINAL HEALTH 200, LLC·Product code GBX·June 3, 2025

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·October 6, 2022

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·October 5, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 27, 2024

    LNOP MP12 PATIENT CABLE

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

    Widex

    FDA UDI
    Widex A/S·05706069896138·WIDEX EVOKE EBB3D (Pearl white ) 100, Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069896398·WIDEX EVOKE E-FS (Pearl white ) 100, Telecoil, ...