1 device · 1 company · 2025
Product code HGM: System, Monitoring, Perinatal
1 device under product code HGM, 2025, 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.
System, Monitoring, Perinatal. 21 CFR 884.2740, Class II. MAUDE held 1,221 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 |
|---|---|---|---|---|
| PeriCALM Patterns 3.0K241009 · 510(k) | PeriGen, Inc. | Obstetrics and Gynecology | database entry |
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