Panels › Obstetrics/Gynecology › Product code HGM · Class 2
System, Monitoring, Perinatal
Regulation 884.2740
2510(k)s in 12 months (215 all time)
5recalls in 12 months (28 all time)
22recalls that name a 510(k)
Top companies in HGM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2026 | Philips North America Llc Philips Avalon Fetal Monitor, FM 30 Part numberM2703A Open, Classified |
HGM | K140535 |
| Jun 22, 2026 | Philips North America Llc Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A Open, Classified |
HGM | K140535 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Central Monitoring System
Model/Catalog Number: MFM-CNS, MFM-CNS Lite
Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Open, Classified |
HGM | K171178 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Fetal & Maternal Monitor
Model/Catalog Number: F6, F9, F6 Express, F9 Express
Product Description: The devices are bedside fetal and maternal monitors, which are used to Open, Classified |
HGM | K150901 K173042 |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Fetal Monitor
Model/Catalog Number: F2, F3
Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological paramete Open, Classified |
HGM | K102140 K173042 |
| Jun 28, 2024 | Philips North America Llc Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate. Open, Classified |
HGM | K140535 |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250 Open, Classified |
HGM | K140535 |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250 Open, Classified |
HGM | K140535 |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260 Open, Classified |
HGM | K012718 |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660 Open, Classified |
HGM | K012718 |
| Sep 19, 2019 | Pacific Medical Group Inc. Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205 Open, Classified |
HGM | K012718 |
| Oct 21, 2014 | Philips Medical Systems, Inc. Philips Avalon Monitors with software revision J.30.58:
Model Product
FM20 M2702A ;
FM30 M2703A ;
FM50 M2705A
Intended for: " Monitoring the physiological parameters of pregnant women " Non-inv Terminated |
HGM | K111083 |
| Nov 18, 2013 | GE Healthcare It Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, c Terminated |
HGM | K111614 |
| Dec 17, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM 50
Catalog Number: M2705A. Terminated |
HGM | None listed |
| Dec 17, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM 40
Catalog Number: M2704A. Terminated |
HGM | None listed |
| Dec 17, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM 30
Catalog Number: M2703A. Terminated |
HGM | K052795 K062137 +1 |
| Dec 17, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM 20
Catalog Number: M2702A. Terminated |
HGM | K062137 K071800 |
| Jun 26, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM30; Model Number: M2703A. Terminated |
HGM | K071800 |
| Jun 26, 2009 | Philips Healthcare Inc. Philips Avalon Fetal Monitor FM20; Model Number: M2702A. Terminated |
HGM | K071800 |
| Dec 3, 2008 | GE Healthcare Integrated IT Solutions GE Healthcare Centricity Perinatal (formerly Quantitative Sentinel) System - Alert and Reminder software; automatic patient data management providing clinical information at the bedside in Labor & Del Terminated |
HGM | K993008 |
| Oct 15, 2008 | GE Healthcare Integrated IT Solutions Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Moth Terminated |
HGM | K993008 |
| Aug 26, 2008 | Datex Ohmeda, Inc. dba GE Healthcare Corometrics MODEL 250 Series Maternal/ Fetal Monitor, Models 256 and 259, part number 2024489-002.
Intended for monitoring fetal and maternal vital signs: fetal heart rate; optional fetal movement de Terminated |
HGM | None listed |
| Jul 30, 2008 | GE Healthcare Integrated IT Solutions GE Healthcare Centricity Perinatal (formerly QS) System - PFILS (Patient File Server) software; automatic patient data management providing clinical information at the bedside in Labor & Delivery, Mot Terminated |
HGM | K993008 |
| Apr 27, 2006 | LMS Medical Systems Ltd CALM software, version 02.09.01 This software is intended for use as a central monitoring system with signal analysis and remote repeaters in the perinatal clinical environment. It interfaces with s Terminated |
HGM | None listed |
| Nov 1, 2005 | Spacelabs Medical Incorporated BirthNet OB Data Management System 91861 Terminated |
HGM | K965008 |
| Oct 12, 2005 | Analogic Corporation FETALGARD Lite Fetal Monitors, Model HCS
(Home Care Single Fetus Monitoring) Terminated |
HGM | None listed |
| Oct 12, 2005 | Analogic Corporation FETALGARD Lite Fetal Monitors, Model AP1S
(Single Fetus Monitoring) Terminated |
HGM | None listed |
| Sep 23, 2003 | GE Medical Systems Information Technologies GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is Terminated |
HGM | K021135 |
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