BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vivid ZirDisc Zircon Zahn System

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724Q2500781·95x18mm 03HT (Translucent)

    AMC

    FDA UDI
    Advantage Medical Electronics, LLC·00849593023498·5 Lead GE Hyperbaric Chamber Cable (Inner)8'

    Corkscrew Head Extractor - Reg

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215057893·

    ROC LUMBAR PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IMP,TSV,4.1MM,SBM,10

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·June 13, 2023

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 8, 2025

    Widex

    FDA UDI
    Widex A/S·05706069895032·WIDEX EVOKE ERB0 (Mediterranean turquise ) 100,...

    Widex

    FDA UDI
    Widex A/S·05706069896459·WIDEX EVOKE E-FS (Mediterranean turquise ) 100,...

    Widex

    FDA UDI
    Widex A/S·05706069896190·WIDEX EVOKE EBB3D (Mediterranean turquise ) 100...

    PARIETENE LIGHT PP 15X10CM X3

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code FTL·September 9, 2011

    OBTRYX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013

    MP90 INTELLIVUE PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN·Product code MHX·August 21, 2013

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013