BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    XenMatrix AB Surgical Graft

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

    AGXO

    FDA UDI
    Oticon A/S·05707131280015·H160, DESIGNRITE 10 WL CRED AGXO

    PVC AND SILICONE MANUAL RESUSCITATORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    APEXNRG RIDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·June 20, 2019

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·March 17, 2023

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 9, 2008

    BRIGHTVIEW GAMMA CAMERA SYSTEM

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code KPS·June 21, 2011

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 7, 2026

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025