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

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    CO Check Pro, CO Screen

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331137358·dressing forceps, standard pattern, serrated ha...

    ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISA CO2

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code MWI·December 30, 2022

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·June 14, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·July 11, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Injury ·BIOENTERICS CORP·Product code LTI·September 18, 2008

    11.0MM/8.0MM PROTECTION SLEEVE153MM

    FDA Adverse Event
    Malfunction ·SYNTHES BRANDYWINE·Product code FZX·August 31, 2017

    INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·September 26, 2019

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020

    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