BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    EMOTENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    APNEARX

    FDA 510(k)
    FDA Class 2 ·Dental

    ORTHOPILOT 2

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNKNOWN GEL IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·February 27, 2024

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·March 26, 2014

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    ATTAIN OTW

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010

    Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007

    Terumo TenderFlow Pediatric Arterial Cannulae, 2.7mm (8 Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813569. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008