FDA clearance — either through the 510(k) pathway for Class II devices or the PMA pathway for Class III — is the most demanding of the three major regulatory milestones, reflecting the scale and scrutiny of the US market. The subset of medical robots in the Chinese market with confirmed FDA clearance is small but notable; it tends to include international systems with a China market presence (da Vinci, Ion Bronchoscopy, Monarch, MAKO, etc.) and a growing number of domestic Chinese manufacturers pursuing US expansion.
This list shows products in this database with a confirmed FDA clearance value. Empty, “No”, or “Not Applied” values are excluded.
See data methodology for how regulatory data is sourced and maintained.