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

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    DIGI-X

    FDA 510(k)
    FDA Class 1 ·Radiology

    COONS SOFT STENT

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

    SAVE-A-BAKE PORCELAIN POLISH

    FDA 510(k)
    FDA Class 2 ·Dental

    THERAKOS CELLEX SYSTEM

    FDA Adverse Event
    Injury ·THERAKOS INC.·Product code LNR·May 2, 2014

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·November 15, 2012

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·September 10, 2010

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022