BEUDAMED
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    Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEBAKEY NEEDLE PULLING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084551·DEBAKEY NEEDLE PULLING FORCEPS FINE TUNGSTEN CA...

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113967·HYDRO-DISSECT CANNULA 25GA ANGLED 7MM

    TMC PSI Cut Guide System

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222730·Cut Guide

    METRISCAN BONE DENSITY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BRAND NAME PHYSICA KNEE - FIXED TIBIAL PLATE CEMENTED #7

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code JWH·December 1, 2023

    Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 12, 2013

    1628664-2017-00093

    FDA Adverse Event
    Malfunction ·April 5, 2017

    TRUERESULT

    FDA Adverse Event
    Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·October 21, 2014

    CAPSURE SP NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 1, 2013

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S5 RM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSX·March 8, 2024

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014