2 devices · 2 companies · 2015 to 2019
Product code NDC: Calculator, Drug Dose
2 devices under product code NDC, 2015 to 2019, from 2 companies. 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.
Calculator, Drug Dose. 21 CFR 868.1890, Class II. MAUDE held 2,093 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| d-Nav SystemK181916 · 510(k) | Hygieia, Inc | Anesthesiology | database entry | |
| EndoTool SubQK142918 · 510(k) | MONARCH MEDICAL TECHNOLOGIES | Anesthesiology | database entry |
Every product code in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.