BEUDAMED
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    DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE

    FDA 510(k)
    FDA Class 2 ·Neurology

    MANI, INC. (TAKANEZAWA FACILITY)

    FDA registration
    MANI, INC. (TAKANEZAWA FACILITY)·8 products·🇯🇵 Japan

    NAC Y-ADP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316

    FDA 510(k)
    FDA Class 2 ·Dental

    LOGIC CC TIB INSERT SIZE 3, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·March 12, 2024

    ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 29, 2018

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·April 2, 2013

    PORTEX CONTINUOUS EPIDURAL TRAY

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code CAZ·March 21, 2011

    INFANT BIAS FLOW BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2008

    PHENOM CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·March 30, 2026

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016