BEUDAMED
    20 results · 21ms · Sources: EU EUDAMED, US FDA

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    Flex-THOR scope

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

    Padded Arm Sling

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357832644·

    AGILE NAIL

    FDA UDI
    ORTHOFIX SRL·18054242519157·REDUCTION TOOL

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515028364·Balfour Center Blade, 3 1/8"x 3 1/8"

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575176748·Standard UHMWPE Insert - shouldered 5 mm

    MobileLink Acetabular Cup System

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575176724·Standard UHMWPE Insert - shouldered 5 mm

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 15, 2014

    RAYAUTOPLAN 1.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENDOSCOPE REPROCESSOR OER-PRO MODEL OER-PRO

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

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 21, 2013

    1043534-2010-00457

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC·July 28, 2011

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·LABSTYLE INNOVATIONS LTD.·Product code NBW·November 9, 2023

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 30, 2023

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·LABSTYLE INNOVATIONS LTD.·Product code NBW·November 23, 2023

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·LABSTYLE INNOVATIONS LTD.·Product code NBW·January 27, 2024

    DARIO BLOOD GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·LABSTYLE INNOVATIONS LTD.·Product code NBW·November 9, 2023

    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