BEUDAMED
    14 results · 24ms · Sources: EU EUDAMED, US FDA

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    ivWatch Model 400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383507776·Gutta Percha Points is used to root canal filin...

    SMARTFLOW CATHETER

    FDA 510(k)
    FDA Class 2 ·Neurology

    AEROECLIPSE II BREATH ACTUATED NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    BD VACUTAINER® K2E 5.4MG PLUS BLOOD COLLECTION TUBE

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·April 17, 2018

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Death ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·October 8, 2014

    RELIA DR

    FDA Adverse Event
    Injury ·MEDTRONIC SINGAPORE OPERATIONS·Product code NVZ·June 8, 2013

    COMPOUNDERS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code NEP·July 7, 2011

    VERSAFITCUP ACETABULAR SHELL Ø 46

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2017

    SCANLAN Premier Jacobson Micro Scissors, spring style, flat handle, V-neck, 125-degree angled nano blades, 6-1/8'', 15.5 cm. Catalog no. 7007-548.

    FDA Recall
    Terminated ·Product code DXY·July 27, 2005

    ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024