Perigen, Inc. is one of 267 FDA 510(k) medical device manufacturers from Israel in the dataset, ranked by real submission volume.
Perigen, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PeriCALM Patterns 3.0
1
Total
1
Cleared
0
Denied
Perigen, Inc. develops perinatal software solutions designed to support maternal and fetal safety during labor and delivery. The company creates advanced technology platforms that help clinical teams identify potential risks early and improve patient outcomes. Perigen operates with a manufacturing facility in Rishon Letziyon, IL.
Perigen has received 1 FDA 510(k) clearance from 1 total submission. The company specializes exclusively in Obstetrics & Gynecology devices. First cleared in 2025, Perigen remains actively engaged in regulatory submissions and product development.
The company's cleared device, PeriCALM Patterns 3.0, represents its focus on clinical decision support and surveillance systems for obstetric care. Perigen supports over 750,000 births annually across the United States and Canada through solutions deployed in more than 500 hospitals. The company is now part of Halma plc, a global group of purpose-driven technology companies.
Explore the complete regulatory record, including device names, product codes, and clearance dates, in the 510(k) database.
FDA 510(k) Regulatory Record - Perigen, Inc.
1 devices