BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092130605·Astra®-compatible Aqua 3.5/4.0 mm Straight Mult...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102503·Astra®-compatible Aqua 3.5/4.0mm Straight Multi...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002176·artVeneer life upper posteriors, S, BL2

    DISPOSABLE MICROKERATOME BLADES-PE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MEDICAL IMAGE MERGE (MIM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 5, 2026

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code LFL·June 15, 2006

    ULTRACISION SURG DEV, BLADES 5MM, OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code LFL·June 19, 2006

    THV 1000-21 3F AORTIC BIO 21MM

    FDA Adverse Event
    Injury ·MEDTRONIC ATS 3F THERAPEUTICS·Product code LWR·March 13, 2013

    COMFILCON A/BIOFINITY SPHERE

    FDA Adverse Event
    Injury ·COOPER VISION CARRIBBEAN CORP·Product code LPM·July 25, 2014

    ALTRX NEUT 36IDX60OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·February 18, 2011

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    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