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

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    Pre-Sure

    FDA 510(k)
    FDA Class 2 ·Radiology

    LessRay

    FDA UDI
    Nuvasive, Inc.·00887517994813·Lessray Touchscreen Monitor

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    EXTENDED RANGE HS CRP KIT, CAT NO:9200

    FDA 510(k)
    FDA Class 2 ·Immunology

    SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    Alfapump System

    FDA Pre-Market Approval
    FDA Class 3 ·alfapump System

    LONG NAIL KIT R1.5, LEFT 10X260MM X 125

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·June 16, 2010

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 12, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 31, 2011

    INTERLOCK?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·July 16, 2013

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDMS).

    FDA Enforcement
    Class II ·Ongoing·SenTec AG·September 27, 2023