BEUDAMED
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    MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA

    FDA 510(k)
    FDA Class 2 ·Radiology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014606347·MIDMARK 7100 3.25" DELUXE GEL

    Conformis Hip System

    FDA UDI
    Conformis, Inc.·00850268007668·TRIAL HEAD, UNIVERSAL, 36MM

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 21, 2021

    ACON STREP A RAPID TEST STRIP

    FDA 510(k)
    FDA Class 1 ·Microbiology

    FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, CAT NO 11001

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STREP A RAPID TEST STRIP (THROAT SWAB)

    FDA Adverse Event
    Death ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code GTY·March 25, 2024

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code NBW·December 27, 2016

    T25 STARDRIVE SHAFT F/MATRIX STANDARD

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·April 26, 2013

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·April 22, 2011

    RELION 1CC INS SYR 31X5/16

    FDA Adverse Event
    Malfunction ·TYCO HEALTHCARE/KENDALL·Product code FMF·July 17, 2008

    Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.

    FDA Enforcement
    Class III ·Terminated·Spinal Elements, Inc·May 15, 2013

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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