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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ORTHO* ROTAVIRUS ANTIGEN ELISA TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MODIFICATION MICROTRAK DIRECT SPECIMEN TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MICRO JOIN, CROWN & BRIDGE ADHESIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DTK·June 13, 2014

    BRAVO

    FDA Adverse Event
    Malfunction ·GIVEN IMAGING LTD.·Product code FFT·October 21, 2010

    PENUMBRA MICROCATHETER 025 SLIM

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·December 21, 2012

    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