BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    CONTROL AND LINEARITY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756379601·GYN MINOR PACK

    UNIGLOVE POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ULTRASONIC SURGICAL UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    PENTA SURGICAL LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code LGW·November 23, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 2, 2014

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code NIP·December 3, 2012

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023