BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Overjet Caries Assist-Pediatric

    FDA 510(k)
    FDA Class 2 ·Radiology

    OC-Auto

    FDA UDI
    POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC·00816917021799·Personal Use Kit OC-Auto, for Harlingen, TX

    NOVOFINE PLUS 32G 4 MM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MONITORING SYSTEM, MODEL ARGUS PB-2200

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 27, 2023

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 3, 2011

    MERSILENE POLYESTER FIBER MESH

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·July 18, 2013

    TENDRIL SDX LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVN·November 18, 2015

    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·September 3, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

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

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025