1 device · 1 company · 2019
Product code MRZ: Accessories, Pump, Infusion
1 device under product code MRZ, 2019, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Accessories, Pump, Infusion. 21 CFR 880.5725, Class II. MAUDE held 543 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 |
|---|---|---|---|---|
| WellDoc BlueStarK190013 · 510(k) | WellDoc, Inc. | General Hospital | 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.