BEUDAMED
    14 results · 13ms · Sources: EU EUDAMED, US FDA

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    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

    Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.

    FDA Recall
    Open, Classified ·Ohio Medical Corporation·Product code BTA·November 16, 2021

    MINISCAV (tm) Vacuum Pump

    FDA Recall
    Open, Classified ·R A Medical Services Holmes House Skipton Road Keighley United Kingdom·Product code BTA·August 23, 2023

    iLet Bionic Pancreas, REF: BB1001

    FDA Recall
    Open, Classified ·Beta Bionics, Inc.·Product code QFG·September 23, 2025

    iLet Bionic Pancreas, REF: BB1001

    FDA Recall
    Open, Classified ·Beta Bionics, Inc.·Product code QFG·March 12, 2026

    iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software

    FDA Recall
    Open, Classified ·Beta Bionics, Inc.·Product code QFG·August 13, 2025

    AlternatiV+ Screw-In Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Fixone Hybrid Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Screw-In Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Dual Thread Screw-In Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    AlternatiV+ Max Knotless Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Fixone Biocomposite Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Push-In Suture Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Knotless Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025