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

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    Blood Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EasyNet

    FDA UDI
    CADWELL INDUSTRIES, INC.·00840067100462·EasyNet Nasal Pressure

    NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    COVIDIEN

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code GDO·October 6, 2008

    OPTETRAK

    FDA Adverse Event
    Other ·EXACTECH, INC.·Product code JWH·June 18, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·May 30, 2023

    STEALTHSTATION® S7¿

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·September 24, 2022

    BD MICROLANCE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·July 1, 2019

    Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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