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

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    MAGNETOM AERA; MAGNETOM SKYRA

    FDA 510(k)
    FDA Class 2 ·Radiology

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

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

    Medline Industries, Inc.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10889942395446·BIOPSY TRAY

    Intuit Roll Transducer Cover

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436112113·Sterile (14 x 147cm) rolled CIV-Flex™ cover

    Indus

    FDA UDI
    SPINEFRONTIER, INC.·00190361035558·Indus Invue MAX Symmetrical ACP, 2 Level, 47mm

    EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MERIDIAN-II AND MERDIAN-PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Injury ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 18, 2018

    DERMAGRAFT-TC

    FDA Adverse Event
    Injury ·ADVANCED TISSUE SCIENCES·Product code MGR·July 1, 1997

    SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code MAI·May 9, 2013

    LUMAX 340 HF-T

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code MRM·August 5, 2008

    CELL-DYN 1800 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·May 24, 2011

    COREVALVE TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 5, 2020

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ANGIODYNAMICS / VORTEX

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code LJT·October 9, 2017

    DELTAFILL18 10MM X 40CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Death ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 25, 2018

    ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE WITH ENFIT CONNECTION

    FDA Adverse Event
    Malfunction ·XERIDIEM MEDICAL DEVICES·Product code PIF·April 26, 2018