Olea Medical
Olea Medical holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2023, with 1 FDA device recall on record.
Top product codes for Olea Medical
FDA recalls by Olea Medical
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 Olea Medical
- K223091 — CT Perfusion V1.0
- K223532 — Olea S.I.A. Neurovascular V1.0
- K230552 — MR DWI/FLAIR Measurement V1.0
- K223502 — MR Diffusion Perfusion Mismatch V1.0
- K211431 — breastscape v1.0
- K152602 — Olea Sphere V3.0
- K132095 — OLEA SPHERE
- K120196 — OLEA SPHERE
- K111161 — PERFSCAPE V2.0
- K091444 — PERFSCAPE
- K083491 — NEUROSCAPE
Data sourced from openFDA. This site is unofficial and independent of the FDA.