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

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    Tryptik Ti

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    HEALTH WATCH PERSONAL RESPONSE SYSTEM

    FDA Adverse Event
    Death ·Product code IQA·November 4, 2008

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Death ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code LPB·July 16, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    CODMAN Disposable Perforator, 14mm. Cranial perforator.

    FDA Enforcement
    Class I ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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