BEUDAMED
    15 results · 25ms · Sources: EU EUDAMED, US FDA

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    TRULY AUTOMATIC ARM BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARTO XP EP NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AGILIS ES STEERABLE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 8, 2021

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30, SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    EXTENSION SET WITH T-CONN. SL

    FDA Adverse Event
    Malfunction ·HOSPIRA LTD.·Product code FPA·October 3, 2013

    BIPAP A30

    FDA Adverse Event
    Death ·RESPIRONICS, INC.·Product code MNS·September 13, 2023

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 9, 2013

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON·Product code FTL·June 3, 2011

    LIFECARE PLUM

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES, INC.·Product code FRN·August 1, 2008

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025