BEUDAMED
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    LVM QUALITY CONTROL SERUM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LEADER

    FDA UDI
    Cardinal Health 110, Inc.·00096295123975·Antibacterial Sheer Adhesive Pads Bandages; Act...

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978080154·DISTRACTOR 902-235 DBL BARREL OS 16/8MM

    BEYONDIMAGE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    HORIZONS ERCP CANNULA

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

    ACCU-CHEK ® FLEXLINK INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FPA·June 30, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·November 15, 2010

    TOTAL ASR FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·January 8, 2013

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·June 13, 2019

    BD PLASTIPAK SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 15, 2019

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 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