BEUDAMED
    11 results · 36ms · Sources: EU EUDAMED, US FDA

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    ON-Q* Pump with Bolus

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517575968·CoRoent Ant TLIF Ti, 8x11x36mm 0°

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704512717·

    Asymmetric Keel Punch Guide Size 6

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215118082·

    PATHFAST CK-MB-II, PATHFAST MYO-II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SHEAUMANN PL-980

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LAP-BAND

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·June 19, 2013

    LAMITRODE S8 SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 21, 2011

    S-ICD SYSTEM

    FDA Adverse Event
    Injury ·CAMERON HEALTH·Product code NVY·August 20, 2014

    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.

    FDA Enforcement
    Class II ·Terminated·Northern Digital Inc.·July 22, 2015

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021