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

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    Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i

    FDA 510(k)
    FDA Class 2 ·Radiology

    Pressure Sentinel®

    FDA UDI
    Zimmer, Inc.·00889024038998·

    Pressure Sentinel®

    FDA UDI
    Zimmer, Inc.·00889024039001·

    Disposable Biopsy Refill Needle

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NELLCOR N-200 PULSE OXIMETER, MODEL N-200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE

    FDA Adverse Event
    Malfunction ·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018