Home › Device types › HGM
System, Monitoring, Perinatal
FDA product code HGM · Class 2 · Obstetrics/Gynecology
522
Registered devices
1,183
Adverse events
28
Recalls
215
510(k) clearances
Devices with this code
OBIX — HUNTLEIGH HEALTHCARE LIMITEDADVANCED FETAL MONITOR — ADVANCED INSTRUMENTATIONS, INC.R&D Batteries, Inc. — R & D Batteries, Inc.PeriWatch Surveillance — PERIGEN INC.R&D Batteries, Inc. — R & D Batteries, Inc.NA — Edan Instruments, Inc.AirStrip OB Legacy Server — Airstrip Technologies, Inc.Remote Event Marker — Philips Medizin Systeme Böblingen GmbHSONICAID — HUNTLEIGH HEALTHCARE LIMITEDPeriWatch Vigilance® Curve™ — PERIGEN SOLUTIONS LTDPeriWatch Vigilance® HUB™ — PERIGEN SOLUTIONS LTDHi-dop — Bistos Co., Ltd.SONICAID — HUNTLEIGH HEALTHCARE LIMITEDR&D Batteries, Inc. — R & D Batteries, Inc.SONICAID — HUNTLEIGH HEALTHCARE LIMITEDR&D Batteries, Inc. — R & D Batteries, Inc.Cetro America Ultrasound Transducer 1.5 Mhz for Oxford SonicAid, Waterproof — CETRO AMERICA INCR&D Batteries, Inc. — R & D Batteries, Inc.Fetal Monitor Remote Display — CLINICOMP INTERNATIONAL, INC.R&D Batteries, Inc. — R & D Batteries, Inc.R&D Batteries, Inc. — R & D Batteries, Inc.R&D Batteries, Inc. — R & D Batteries, Inc.OBIX — HUNTLEIGH HEALTHCARE LIMITEDUniversal Data Acquisition System — CLINICOMP INTERNATIONAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-26 | Philips North America Llc | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or p |
| 2026-05-26 | Philips North America Llc | Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or p |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2025-10-24 | Edan Diagnostics | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. |
| 2024-05-22 | Philips North America Llc | Potential for inaccurate fetal heart rate measurements when monitoring multiples. |
| 2019-09-19 | Pacific Medical Group Inc. | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| 2019-09-19 | Pacific Medical Group Inc. | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| 2019-09-19 | Pacific Medical Group Inc. | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
| 2019-09-19 | Pacific Medical Group Inc. | Fetal transducers distributed in advance of receiving 510(k) and international clearances. |
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