Butterfly Network, Inc.
Butterfly Network, Inc. holds FDA 510(k) medical device clearances, first cleared 2017, most recent 2026, with 2 FDA device recalls on record.
Top product codes for Butterfly Network, Inc.
FDA recalls by Butterfly Network, Inc.
- Z-1601-2020 — Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended use: Diagnostic ultrasound imaging and measurement of anatomical structures.
- Z-1600-2020 — Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Butterfly Network, Inc.
Data sourced from openFDA. This site is unofficial and independent of the FDA.