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Beta Bionics, Inc. FDA Approvals

0 new drug approvals and 8 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
Mint ACE Pump510(k)Sep 11, 2026Clinical Chemistry
iLet Dosing Decision Software510(k)Sep 11, 2026Clinical Chemistry
iLet ACE Pump510(k)Apr 30, 2026Clinical Chemistry
iLet ACE Pump510(k)Sep 29, 2025Clinical Chemistry
iLet® Dosing Decision Software510(k)Sep 22, 2023Clinical Chemistry
iLet® ACE Pump510(k)Jun 21, 2023Clinical Chemistry
iLet® Dosing Decision Software510(k)May 19, 2023Clinical Chemistry
iLet® ACE Pump510(k)May 19, 2023Clinical Chemistry

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