2 devices · 2 companies · 2024 to 2025
Procept Biorobotics: AI-enabled devices on FDA's list
2 devices from Procept Biorobotics, 2024 to 2025, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| HYDROS Robotic SystemK251082 · 510(k) | General and Plastic Surgery | PZP | database entry | |
| HYDROS Robotic SystemK240200 · 510(k) | General and Plastic Surgery | PZP | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.