Subtle Medical, Inc. — FDA PCCPs

Subtle Medical, Inc. holds 2 FDA-authorized PCCPs in this tracker, 2 AI/SaMD. Here is the full list, newest first.

Other companies

Thermo Fisher Scientific — FDA PCCPs (10)Medtronic Minimed, Inc. — FDA PCCPs (5)Hardy Diagnostics — FDA PCCPs (4)Anumana, Inc. — FDA PCCPs (4)Clarius Mobile Health Corp. — FDA PCCPs (4)Liofilchem s.r.l. — FDA PCCPs (3)Centers for Disease Control and Prevention — FDA PCCPs (3)Ceribell, Inc. — FDA PCCPs (3)Therapixel — FDA PCCPs (3)Beckman Coulter, Inc. — FDA PCCPs (3)TriMed, Inc. — FDA PCCPs (3)Artera, Inc. — FDA PCCPs (2)

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We read the Subtle Medical, Inc. PCCPs in this list, then map the post-market monitoring that its modification protocol requires, including the deployment-period evidence most teams can't reconstruct at modification time. Sentir is the independent system of record that produces it.

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Source: U.S. FDA public records (openFDA 510(k)/De Novo databases and accessdata.fda.gov). PCCP type and category are editorial classifications based on public documents, not official FDA designations.

This page is a factual summary of public FDA records. Sentir Health is not affiliated with or endorsed by the named companies or the U.S. Food and Drug Administration. Spot an error? Request a correction.