BEUDAMED
    21 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.
    Filters Regulation: Us FDA ×

    MODIFICATION TO EXPEDIUM SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Symmetry Rhoton®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482140703·Rhoton Forceps; Bayonet Bipolar; Round Handle; ...

    Symmetry Olsen

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00841785113253·

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·00842331101298·Rhoton Bipolar Bayonet Forceps, round handle, 2...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450426623·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103130·Shaver, Closed, 13mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024083·Paddle Shaver, 13mm

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481477528·

    Welch Allyn, Inc.

    FDA UDI
    WELCH ALLYN, INC.·00732094035711·ECG Cable, 5 Attached Snap Leads, AAMI, 12'

    TEARAWAY INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIMENSION CTNI FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NA

    FDA UDI
    STRYKER CORPORATION·07613327052862·Insert, Blunt Grasper with Spoon

    REBOUND HRD

    FDA Adverse Event
    Malfunction ·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011

    ALIGN RS URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code FTL·April 24, 2013

    COULTER LH500

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·May 6, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 18, 2025

    1000317571-2021-00127

    FDA Adverse Event
    Injury ·CONVATEC LTD·Product code FRO·March 17, 2021

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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