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

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    AXSYM DIGOXIN III

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BioQuick®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR70612491·BioQuick-Brackets FACE Evolution II System .022...

    QUALITROL DHP IMMUNOASSAY CONTROL, LEVELS 1,2, AND 3

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SURGASSIST FLEXSHAFT 2, MODEL FS2 14

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PLUM XLD 110V L.A.

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 10, 2013

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·MERZ AESTHETICS, INC. (FORMERLY BIOFORM MEDICAL, INC.)·Product code LMH·April 11, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2008

    PIPELINE FLEX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·May 22, 2026

    PIPELINE FLEX

    FDA Adverse Event
    Malfunction ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·January 26, 2026

    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    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

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

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

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·October 10, 2018

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015