Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Butterfly Network, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2026-03-27

SEC Filings: 1 filings on record. Latest: 8-K (2026-07-30). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K252148 Butterfly Gestational Age ToolIYN2026-03-27 View
510(k) K232808 Butterfly iQ3 Ultrasound SystemIYN2024-01-04 View
510(k) K220068 Butterfly iQ/iQ+ Ultrasound SystemIYO2023-03-31 View
510(k) K202406 Butterfly iQ Ultrasound SystemIYN2020-09-16 View
510(k) K200980 Auto 3D Bladder Volume ToolIYO2020-06-11 View
510(k) K163510 Poseidon Ultrasound SystemIYN2017-09-06 View
↑