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

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    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA

    Responsive Respiratory

    FDA UDI
    RESPONSIVE RESPIRATORY, INC.·00851440007797·Adult Oxygen Mask, High Concentration, Non Rebr...

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022

    RETISCAN, RETIPORT

    FDA 510(k)
    FDA Class 2 ·Neurology

    VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code QKP·October 13, 2020

    NA

    FDA Adverse Event
    Malfunction ·ARROW INTL. INC.·Product code DSP·October 17, 2008

    ATTAIN ABILITY MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·August 11, 2011

    STERRAD 100NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 2, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021