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

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    Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517086256·

    MORELAND

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295123170·MORELAND REV INST U OSTEOTOME 10.5mm 8 IN

    ONE TOUCH II

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 31, 2002

    JADE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES

    FDA 510(k)
    FDA Class 2 ·Neurology

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·August 26, 2024

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·November 19, 2008

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·September 9, 2011

    PFC SIGMARP STB TB IN 6 10.0

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code NJL·July 23, 2013

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It 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·Abbott·May 1, 2019

    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    Giraffe Warmer. Device sold under the following product names: Giraffe Warmer and Giraffe Bedded Warmer. infant radiant warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026