BEUDAMED
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    Smart Neck Stimulator

    FDA 510(k)
    FDA Class 2 ·Neurology

    TruForm

    FDA UDI
    Rmo, Inc.·00885797100016·MN 1MOL BD KT STD NO/L R&L 218

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319721667·Jansen-Middleton Septum Forceps 6-3/4" (17.2cm)...

    ACUMED

    FDA UDI
    Acumed LLC·10806378014505·2.7mm x 16.0mm Locking Cortical Screw

    ACUMED

    FDA UDI
    Acumed LLC·10806378014512·2.7mm x 16.0mm Locking Cortical Screw

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·December 21, 2012

    LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNTHES (USA) WRIST FUSION PLATES (WFP)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 11, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 24, 2014

    5.0 INTERNAL CAPTURE

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code HWC·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 1, 2013

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 3, 2023

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    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

    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