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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    GELX ORAL GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    X-FLOW CATHETER

    FDA Adverse Event
    Malfunction ·COLOPLAST A/S·Product code EZL·June 2, 2020

    AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE

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

    E-Z LINK CROSS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DUROM ACETABULAR COMPONENT 50/44 CODE J

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·April 28, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·April 26, 2013

    GORE PROPATEN VASCULAR GRAFT

    FDA Adverse Event
    Other ·W.L. GORE & ASSOCIATES, INC·Product code DSY·July 23, 2008

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018