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

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    Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896009714·FUKUSHIMA SUCTION TUBE

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0991803780·FUKUSHIMA SUCTION TUBE

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC·Product code QJR·April 22, 2022

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·June 22, 2022

    IMPRESSION COMPOUND

    FDA 510(k)
    FDA Class 2 ·Dental

    1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4

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

    TRANSCEND 365 MINICPAP SYSTEM

    FDA Adverse Event
    Injury ·SOMNETICS INTERNATIONAL, INC.·Product code BZD·October 6, 2021

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ILS·October 17, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·June 20, 2013

    Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022

    Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging and interventional procedures. Model: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022

    syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·July 13, 2022