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

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    MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)

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

    DIMENSION ALDL CALIBRATOR, MODEL DC131

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FILMARRAY® TORCH MODULE

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code NSU·November 15, 2024

    PRECISION®

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 10, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    EPIC II HF CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·May 27, 2008

    FILMARRAY® TORCH MODULE

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code NSU·November 15, 2024

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015