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

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    ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DRX HBA1C

    FDA 510(k)
    FDA Class 2 ·Hematology

    INSULIN PEN NEEDLE ADAPTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 13, 2017

    NEWPORT

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·May 16, 2017

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·September 15, 2014

    SOLETRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 26, 2011

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; 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

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025