BEUDAMED
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    PASS LP Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GENERATION 4 HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304253582·

    WELL-LIFE OTC EMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

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

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·June 27, 2024

    MULTI-MED CENTRAL VENOUS CATHETER SET WITH AMC THROMBOSHIELD

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code FOZ·July 15, 2011

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·September 16, 2008

    SPECIFIC DEVICE NOT REPORTED

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code HSD·January 9, 2024

    DEKA MOTUS AX

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 25, 2018

    EQUINOXE PRESERVE STEM 12MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·May 29, 2019

    DEKA MOTUS AX

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·March 9, 2023

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·July 2, 2019

    Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

    FDA Enforcement
    Class I ·Ongoing·Medline Industries, LP·May 20, 2026

    DEKA MOTUS AX

    FDA Adverse Event
    Malfunction ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 6, 2024

    EQUINOXE REVERSE 46MM GLENOSPHERE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·October 2, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012