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  1. Development & Approval Process (CBER)

2024 Biological Device Application Approvals

This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance.

2024 Biological Device Application Approvals
Tradename/Common Name Description and Indication for Device Submission ID Manufacturer Clearance Date
Aeon ACKit
Platelet And Plasma Separator For Bone Graft Handling
The Aeon ACKit is designed to be used for the safe and rapid preparation of autologous platelet rich plasma (PRP) from a small sample of peripheral blood at the patient’s point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect to improve handling characteristics. BK231016/0 Aeon Biotherapeutics Corp.
12F., No. 58, Ruihu St.
Taipei City, Neihu District
Taiwan, 11494


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