BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    Simpleware ScanIP Medical

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Cannula

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113806·VISCO CANNULA 30GA ANGLE 8MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113868·ROBINS ANTERIOR CHAMBER CANNULA, 30GA

    GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAGLIFE C/MAGLIFE C PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 9, 2022

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2024

    RESOLUTION CLIP DEVICE

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

    CAPSURE SP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    COULTER AC*T DIFF HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 2, 2013

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 24, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·October 19, 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

    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

    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