22 devices · 16 companies · 2001 to 2026
AI-enabled hematology devices on FDA's list
22 devices in the Hematology panel, 2001 to 2026, from 16 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (15 of 22 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes in the Hematology panel
Companies with more than one device here
Every device, newest decision first
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.