BEUDAMED
    5 results · 13ms · 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 FDA Recall × Status: Open, Classified × Clear all

    TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.

    FDA Recall
    Open, Classified ·Innovasis, Inc·Product code MAX·August 14, 2024

    Multi-Mode Stimulator, Transcutaneous Electrical Nerve Stimulation

    FDA Recall
    Open, Classified ·Liberty Medical Solutions, LLC·Product code IPF·November 3, 2023

    BVI Leos Laser and Endoscopy System. Model Number: OME6000U.

    FDA Recall
    Open, Classified ·Beaver-Visitec International, Inc.·Product code HQF·December 5, 2025

    Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC

    FDA Recall
    Open, Classified ·Dutch Ophthalmic USA, Inc.·Product code HQF·April 14, 2021

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    FDA Recall
    Open, Classified ·Ellex Medical Pty Ltd.·Product code HQF·March 16, 2023