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

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    EVA5 Insufflator

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

    PH BUFFERING PLASTIC APPLICATOR TAMPON

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SURGISEAL TOPICAL SKIN ADHESIVE

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    UNK_SMART TOUCH BIDIRECTIONAL

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code LPB·March 21, 2024

    ALARIS SE ADMINISTARTION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·October 22, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 15, 2011

    INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 16, 2013

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025