Home › 2026 FDA Medical Device Calendar
2026 FDA Medical Device Calendar Updated August 2, 2026 ยท next FDA decision on the calendar Upcoming medical-device FDA milestones, PMA, 510(k), De Novo submissions/decisions and pivotal device readouts. Company, product, indication and the source filing. Tap any row for the source.
July 2026
H2 2026 (est.)
Q2 2026 (est.)
2026 (est.)
Q2 2027 (est.)
2027 (est.)
11 upcoming device milestones. Sources: company filings / curated device seed. Many device dates are quarter/half-year windows.
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