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

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    HEMO-CATH 10F, HEMO-CATH 12.5F

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

    Oticon

    FDA UDI
    Oticon A/S·05707131234636·GET,ITCP PB DIR R BE KIT

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750002955·76 V2 ASSY SMALL 22OD W/HG

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154755080·DRILL, WL 8MM, DENTAL-SHAFT

    FLEXIBLE CARDIAC COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code PJS·March 18, 2025

    SECURE II MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 15, 2013

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·May 24, 2011

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025