14 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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