DeviceClearance

Product code HGM— Obstetrics/Gynecology

AIRSTRIP OB

Classification name
System, Monitoring, Perinatal
Device class
Class 2
Regulation
21 CFR 884.2740
Advisory panel
Obstetrics/Gynecology
Total cleared
215
First cleared
Most recent

Market context for product code HGM

FDA has cleared 215 devices under product code HGM between 1976 and 2026, filed by 94 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HGM

Adverse events under product code HGM

product code HGM
Death
35
Malfunction
478
Total
513

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HGM

1–100 of 215

Data sourced from openFDA. This site is unofficial and independent of the FDA.