BEUDAMED
    25 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 ×

    CLYDESDALE SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019

    Non-Locking Screw, 2.7mm x 26mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665026351·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694008730·3.0mm x 26mm Lag Screw

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A08302680·8mm H x 30mm W x 26mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A083026150·8mm H x 30mm W x 26mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A083026120·8mm H x 30mm W x 26mm L x 12 degrees ALIF

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035279·3.0 x 26mm Lag Screw, Sterile

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380260·Handle, Stream Line, Threaded, Impact, Cannulated

    K083526

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 7, 2018

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694067584·3.0 x 26mm Lag Screw Sterile Qty 5

    PFC SIGMA LUGGED TIBIAL TRAY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWDERED LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INFINION? CX

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 3, 2025

    SINAI HSP BALTIMORE MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·July 6, 2011

    LAKELAND REG LAKELAND FL 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·May 3, 2010

    WA ADVENT TAKOMA PARK MD 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·November 22, 2011

    Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K08-PI (Custom Fluid Management Kit), REF: K08-02042 K08-02948 K08-03026 K08-03119 An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

    FDA Enforcement
    Class II ·Ongoing·Merit Medical Systems, Inc.·August 21, 2024

    IOWA METH DES MOINES IA1

    FDA Adverse Event
    Malfunction ·SORIN GROUP USA, INC.·Product code DTZ·March 7, 2011

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code KDJ·April 29, 2013