BEUDAMED
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    RFP-100A Connector Cable (Single Use)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925028388·ENDOSCOPIC SINUS SURGERY INSTRUMENT TRAY NO. 2 ...

    DEVON CIRONA 6100 DVT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUVANCE PLUS SAFETY IV CATHETER, PROTECTIV PLUS SAFETY IV CATHETER, OPTIVA IV CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Injury ·ROCHE DIAGNOSTICS·Product code CEM·November 13, 2008

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·September 1, 2011

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·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