BEUDAMED
    15 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 PROVIDENT HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DURA-CUF

    FDA UDI
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.·00840682110495·DURA-CUF, THIGH, 2 TB SCREW, 38 - 50 CM, SINGLE

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470027961·GRADIA® DIRECT X Syringes -1 syringe 2.7 mL/5 g...

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161322355·GRADIA® DIRECT X Syringes -1 syringe 2.7 mL/5 g...

    MAGIC MOBILITY 4 X 4 WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GYROSCAN INTERA (R7.5)

    FDA 510(k)
    FDA Class 2 ·Radiology

    VARISOFT

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 17, 2025

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 13, 2013

    VOYAGER NC CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·February 28, 2011

    CELL DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELL DYN·Product code GKZ·February 26, 2008

    Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - 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

    SMR CTA HUMERAL HEAD 46 MM

    FDA Adverse Event
    Malfunction ·LIMACORPORATE SPA·Product code HSD·June 17, 2020

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·March 3, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024