BEUDAMED
    13 results · 30ms · 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 ×

    FreeStyle Libre 2 Flash Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FREESTYLE LIBRE 14 DAY

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC·Product code PZE·September 5, 2023

    FREE STYLE LIBRE 2

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code QLG·June 10, 2022

    EarQ

    FDA UDI
    Oticon A/S·05707131342355·G10, BTE 13 2.4G 85 C091 EARQ

    MODEL DGH 6000 SCANMATE A

    FDA 510(k)
    FDA Class 2 ·Radiology

    COUDE/ OR TIEMANN

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COMP RVRS 25MM BSPLT HA+ADPTR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 8, 2021

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·June 25, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 29, 2011

    SUNBEAM

    FDA Adverse Event
    Malfunction ·JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS·Product code IRT·October 7, 2008

    AlignRT Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024