BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SafeAir Smoke Evacuator compact

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814213·GENUMEDI PT SILVER L IV

    DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC

    FDA 510(k)
    FDA Class 2 ·Radiology

    PIXI PEDIATRIC MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 2, 2021

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·February 22, 2021

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 135X12CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    EKOSONIC ENDOVASCULAR DEVICE, 106X12CM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023

    EKOSONIC KIT 106CM 12CM TZ

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021

    PCA PLS II

    FDA Adverse Event
    Injury ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 14, 2013

    CARDIOVASCULAR PROCEDURE KIT

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·Product code OEZ·July 12, 2011

    GIA 80 3.5MM BLUE

    FDA Adverse Event
    Malfunction ·COVIDIEN UNITED STATES SURGICAL·Product code GDW·September 12, 2008

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·November 7, 2025

    EKOSONIC ENDOVASCULAR DEVICE, 106X18CM

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014