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GE Healthcare Finland Oy FDA Approvals
0 new drug approvals and 7 device clearances on file. Matched by name to GEHC.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M510(k)Sep 1, 2026Cardiovascular |
| Carescape Canvas 1000; Carescape Canvas Smart Display510(k)Aug 28, 2026Cardiovascular |
| CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)510(k)Apr 6, 2023Cardiovascular |
| CARESCAPE B650, E-musb510(k)Apr 13, 2022Cardiovascular |
| CARESCAPE B450, E-musb510(k)Apr 13, 2022Cardiovascular |
| Carescape B850, E-musb510(k)Apr 13, 2022Cardiovascular |
| CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories510(k)Oct 21, 2021Anesthesiology |