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

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    Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

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

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM

    AGGREGUIDE

    FDA 510(k)
    FDA Class 2 ·Hematology

    STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA

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

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 3, 2014

    PROXIMATE*LINEAR STAP RELOAD

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 24, 2011

    4000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 2, 2013

    Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

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

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024