BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    LOW PROFILE PASSPORT PUSH & PULL KITS & PEG TUBE

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

    AARON ARTHROSCOPY ELECTRODE, CATALOG NUMBERS AR00, AR01, AR02, AND AR03

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

    SOMATOM DEFINITION EDGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Other ·INSULET CORPORATION·Product code LZG·December 7, 2010

    CONFIRM

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code MXC·July 8, 2014

    ENDOTRACHEAL TUBE- AIRWAY MANAGMENT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code BTR·December 27, 2012

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015