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

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    COULTER COUNTER MODEL S PLUS

    FDA 510(k)
    FDA Class 2 ·Hematology

    AUTOMATIC ELECTRONIC SPHYMOMONOMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540

    FDA 510(k)
    FDA Class 2 ·Dental

    LIGACLIP** ENDOSCOPIC CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·October 16, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 31, 2013

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2010

    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