BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono

    FDA 510(k)
    FDA Class 2 ·Dental

    ALTIS SINGLE INCISION CLING SYSTEM

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

    D3 HEMATOLOGY ANALYZER, MODEL D3

    FDA 510(k)
    FDA Class 2 ·Hematology

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011

    PFNA-II BLADE L90 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·June 15, 2013

    ETS FLEX ARTICNG LNR CUTR 45MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·September 18, 2008

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    OPEN-END FLEXI-TIP URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 6, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 7, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·December 5, 2019

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

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

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020