BEUDAMED
    14 results · 27ms · Sources: EU EUDAMED, US FDA

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    PSI SKULL CLAMP

    FDA 510(k)
    FDA Class 2 ·Neurology

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102718·Astra®-compatible Lilac 4.5/5.0mm Straight Mult...

    Procure

    FDA UDI
    Twin Med, LLC·10840330700129·Oxygen Cannula Adult Standard Prongs W/ 21' Kin...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092130636·Astra®-compatible Aqua 4.5/5.0 mm Straight Mult...

    MPT 24 AND VITAL VIEW 24

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDICAL IMAGE MERGE (MIM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    FOUNDATION KNEE

    FDA Adverse Event
    ENCORE MEDICAL, L.P.·Product code JWH·March 13, 2013

    ASR UNI FEMORAL IMPL SIZE 39

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·February 18, 2011

    SYNCHROMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·February 22, 2008

    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

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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