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

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    REAGENTS USED-QUAN. MEASURE OF SERUM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112892·CORNEAL TREPHINE BLADE7.0MM

    K.E.A.T.

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

    TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    QUICK SET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·May 29, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·May 22, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A DE C.V·Product code FPA·May 8, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·April 23, 2026

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·April 29, 2026

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·October 23, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·August 22, 2007

    MENTOR SMOOTH ROUND MODERATE PLUS PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·April 27, 2018

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012