393 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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One Step K in vitro diagnostic test REF: 81A4
FDA Recall
Open, Classified
·DFI Co., Ltd. 388-25 Gomo-Ro Jillye-Myeon Gimhae Korea (the Republic of)·Product code JIN·April 2, 2026
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 2025
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
FDA Recall
Open, Classified
·OSSTEM Implant Co., Ltd. 66-16 Bansong-Ro 513beon-Gil Busan City Haeundae District Korea (the Republic of)·Product code OAS·August 26, 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
Portable X-ray system
FDA Recall
Open, Classified
·DIGIMED CO., LTD
401, 402, 406~411-ho, A-dong 101, Gasan digital 2-ro, Geumcheon-Gu
Seoul Korea (the Republic of)·Product code EHD·June 19, 2025