BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16721312118000·

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702421149·Elvarex 3/Thigh High/Slant-Open Toe-Elephantias...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702886061·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/DOTTED 5 CM...

    EYEVAN7285

    FDA UDI
    EYEVAN INC.·04582667985624·

    VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    POINT 500 HD POINT500C HD

    FDA 510(k)
    FDA Class 2 ·Dental

    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

    INTELLIVUE INFO CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 19, 2023

    PATIENT INFORMATION CENTER IX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·May 1, 2024

    CAPTURE-R READY-SCREEN (POOLED)

    FDA Adverse Event
    Malfunction ·IMMUCOR·Product code KSZ·January 13, 2010

    LEGEND FOOTED ATTACHMENT

    FDA Adverse Event
    Malfunction ·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·August 15, 2011

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 29, 2014

    DEXTRUS SMALL ACCESS RETRACTOR

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

    POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN

    FDA Adverse Event
    Malfunction ·C.R. BARD, INC. (BASD) -3006260740·Product code FPA·January 6, 2022

    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

    Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and added a food data base to allow users to better manage dietary requirements in conjunction with the use of their insulin pump. Reorder Numbers: 21-1801-81 21-1803-81 21-1804-81 21-1805-49/51/81 21-1806-49/51/81 21-1807-49/51/81 21-1815-01/50 21-1816-01/50 21-1817-01/50

    FDA Recall
    Terminated ·Smiths Medical MD, Inc.·Product code LZG·February 22, 2008