Home › Device types › HGM
System, Monitoring, Perinatal
FDA product code HGM · Class 2 · Obstetrics/Gynecology
524
Registered devices
1,221
Adverse events
28
Recalls
215
510(k) clearances
Devices with this code
Fetal Measurements — Philips Medical Systems HsgAvalon Toco+ Transducer — Philips Medizin Systeme Böblingen GmbHOBIX — HUNTLEIGH HEALTHCARE LIMITEDCompact FM — AvanteOBIX — HUNTLEIGH HEALTHCARE LIMITEDR&D Batteries, Inc. — R & D Batteries, Inc.DOPPLEX — HUNTLEIGH HEALTHCARE LIMITEDCetro America Toco Transducer for all Coro models, Waterproof — CETRO AMERICA INCCetro America Ultrasound Transducer for HP1350, Waterproof — CETRO AMERICA INCAmeritus Transducer — KENTEC MEDICAL, INC.R&D Batteries, Inc. — R & D Batteries, Inc.R&D Batteries, Inc. — R & D Batteries, Inc.Fetal Measurements — Philips Medizin Systeme Böblingen GmbHOBIX — HUNTLEIGH HEALTHCARE LIMITEDOBIX — HUNTLEIGH HEALTHCARE LIMITEDMini Telemetry System — WIPRO GE HEALTHCARE PRIVATE LIMITEDSONICAID — HUNTLEIGH HEALTHCARE LIMITEDAmeritus Transducer — KENTEC MEDICAL, INC.Fetal Measurements — Philips Medical Systems HsgPeriWatch Surveillance — PERIGEN INC.PeriWatch Surveillance — PERIGEN INC.SONICAID — HUNTLEIGH HEALTHCARE LIMITEDFetaLink+ — Cerner CorporationCetro America Ultrasound Transducer for IM77/AM67, Waterproof — CETRO AMERICA 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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