BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    BIOTROL AMYLASE CNPG3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    EARPROBE

    FDA 510(k)
    FDA Class 2 ·Neurology

    UNSPECIFIED SAFESET TRANSPAC SETS

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code DRS·January 2, 2025

    DUROM US ACETABULAR COMPONENT

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·January 22, 2013

    ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORP.·Product code LZG·December 8, 2010

    5.5MM TI MATRIX SCREW 35MM THREAD LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code NKB·July 14, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

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

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015