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

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    PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh

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

    EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACE STAPLER AND CARTRIDGE

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

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·February 11, 2020

    UNIVERSAL STRAIGHT SET 2Y MLL

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·November 21, 2007

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 20, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 1, 2011

    LEVEEN COACCESS ELECTRODE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GEI·September 23, 2008

    ROSA Brain 3.0 Application-Brain

    FDA Enforcement
    Class II ·Terminated·MEDTECH SAS·February 19, 2020

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022