BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MINNIE SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 10, 2013

    DBS LEAD

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 11, 2011

    LOW PRESS BLACK MAX HANDPIECE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBB·October 17, 2014

    MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·October 24, 2019

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·April 30, 2025

    MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·January 10, 2020

    CPX4 PLUS SMOOTH TALL HEIGHT 550CC

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·April 19, 2022

    CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code LCJ·February 22, 2021

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024

    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 5, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012