BEUDAMED
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    KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Uscan Sector Probe - Refurbished (Japan)

    FDA UDI
    ECHONOUS, INC.·09353278000403·Extracorporeal ultrasound imaging system transd...

    Uscan Sector Probe (Japan)

    FDA UDI
    ECHONOUS, INC.·09369999064099·Extracorporeal ultrasound imaging system transd...

    SCANLAN® Legacy Micro Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033588·Legacy FRCP FH 1X2MT 1MM DD 9"

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 20, 2026

    BIPAP DUET LX BI-LEVEL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EEI SLUSH PAN DRAPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TE Ø 4.1MM RN, SLACTIVE® 10MM, TIZR, NTP

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·March 17, 2026

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·March 14, 2013

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·March 1, 2011

    IAB : 7.5 FR -30 CC

    FDA Adverse Event
    Injury ·ARROW INTL., INC.·Product code DSP·February 25, 2008

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 1, 2024

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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