BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    LYDUS Nitrile Examination Gloves, Powder Free

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113776·AIR INJECT CANNULA 27GA

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113950·JOHN INTRALASIK CANNULA 27GA

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113882·VISCO INJECTION CANNULA 27GA

    MIS IMPLANT SYSTEM DECIVE

    FDA 510(k)
    FDA Class 2 ·Dental

    QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·October 28, 2020

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·October 14, 2022

    RESOLUTION CLIP DEVICE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MND·October 17, 2008

    ENRHYTHM DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 2, 2013

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 8, 2013

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·March 25, 2025

    SENSOR MMT-5100CLX CLINICAL 5PK US

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code PQF·July 3, 2025

    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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025