BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    GoBack Crossing Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·December 23, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·November 21, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·April 30, 2025

    BEBACK CROSSING CATHETER

    FDA Adverse Event
    Malfunction ·BENTLEY INNOMED GMBH·Product code PDU·March 6, 2025

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857320857·Removal Tool Size 15 mm

    Grappler Suture Anchor System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SV BRAIN ARRAY, SIEMENS 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code DTQ·June 7, 2024

    MAX PS DCM TIB BRNG 10X79/83MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·October 29, 2014

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 10, 2011

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 8, 2013

    2.5MM DRILL BIT/QC/GOLD/110MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HWE·August 28, 2017

    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

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020