BEUDAMED
    14 results · 28ms · Sources: EU EUDAMED, US FDA

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

    SKINTACT

    FDA Adverse Event
    Injury ·LEONHARD LANG GMBH·Product code GEI·January 25, 2022

    AGXO

    FDA UDI
    Oticon A/S·05707131306005·H110V2, BTE 13 WL 105 CBE DEMO AGXO

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A162828120·16mm x 28mm W x 28mm L x 12 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A162828150·16mm H x 28mm W x 28mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A16282880·16mm H x 28mm W x 28mm L x 8 degrees ALIF

    REVIVE INTERMEDIATE CATHETER (REVIVE IC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOUTHGUARD AND ALIGNER MATERIALS

    FDA 510(k)
    FDA Unclassified ·Unknown

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 11, 2020

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 13, 2013

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·September 9, 2008

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

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