BEUDAMED
    18 results · 25ms · Sources: EU EUDAMED, US FDA

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    Aria System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Anatomic PEEK™ Cervical Fusion System with Nanotechnology

    FDA UDI
    NANOVIS SPINE, LLC·00814216027948·ANATOMIC PEEK w/ Nano 16 x 14 x 5 x 10°

    TruForm

    FDA UDI
    Rmo, Inc.·00885797100030·MN 2MOL BD KT STD NO/L R&L 178

    ACUMED

    FDA UDI
    Acumed LLC·10806378014628·2.7mm x 28.0mm Locking Cortical Screw

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450155547·

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517070637·

    ACUMED

    FDA UDI
    Acumed LLC·10806378014635·2.7mm x 28.0mm Locking Cortical Screw

    CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY

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

    EAV KINDLING 2000S GSR DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BD POSIFLUSH¿ SF SALINE SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code NGT·January 26, 2023

    PROGRAMMABLE DRUG DELIVERY DEVICES

    FDA Adverse Event
    Other ·MEDTRONIC NEUROMODULATION·Product code LKK·September 21, 2007

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 24, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·July 1, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 13, 2011

    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

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021