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Bolder Surgical, LLC FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
CoolSeal Trinity510(k)Nov 15, 2023General, Plastic Surgery
CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)510(k)Sep 7, 2021General, Plastic Surgery
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)510(k)May 6, 2021General, Plastic Surgery
CoolSeal Reveal510(k)May 6, 2021General, Plastic Surgery

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