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

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    Exactech Equinoxe Small Reverse Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·April 26, 2022

    LUCENT OR LUCENT MAGNUM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BLUNT TIP SCREW, ÿ 4X40MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·May 14, 2024

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    COVIDIEN

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH, INC.·Product code KNT·July 24, 2024

    KANGAROO

    FDA Adverse Event
    Malfunction ·CARDINAL HEALTH 200, LLC·Product code KNT·January 28, 2026

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014

    HAKIM PROGRAMMABLE VALVE WITH SIPHONGUARD

    FDA Adverse Event
    Malfunction ·CODMAN & SHURTLEFF, INC·Product code JXG·July 22, 2011

    TAXUS® LIBERTÉ®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 20, 2013

    PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·May 14, 2024

    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025