BEUDAMED
    15 results · 18ms · 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.

    2P-QDA FOOT PRESSURE SYSTEMS REAL TIME

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Modulus

    FDA UDI
    Nuvasive, Inc.·00887517023605·Modulus ALIF Trial, 10x34x28mm 30°SmDeep

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331137488·bone hook, grip handle, sharp, 13.0 mm, 9" (23....

    EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXTi Titanium Stand-Alone ALIF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 7, 2024

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 18, 2014

    RENAL - DISPOSABLE

    FDA Adverse Event
    Injury ·Product code KDJ·October 25, 2010

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·December 20, 2012

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

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

    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025