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Administrative Safe Moderate Evidence
OpenFDA search device 510k
by Harvard MIMS Lab (ToolUniverse)
Description
Search the FDA 510(k) premarket notification database via openFDA. Contains clearances for medical devices through the 510(k) pathway (substantial equivalence). Returns device names, applicant companies, decision dates, advisory committee classifications, and FDA decision types. Useful for medical device research, competitive landscape analysis, and understanding regulatory pathways for specific device categories.
Installation
pip install tooluniverseStatus
Published
Reviewer
Automated import
Date Added
2026-03-30
Tags
tooluniverse openfda fda regulatory-data