ClearanceBrief
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)
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Top companies in HGM

DateFirm and productCodeLinked 510(k)
Jun 22, 2026Philips North America Llc
Philips Avalon Fetal Monitor, FM 30 Part numberM2703A
Open, Classified
HGMK140535
Jun 22, 2026Philips North America Llc
Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A
Open, Classified
HGMK140535
Jan 22, 2026Edan 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
HGMK171178
Jan 22, 2026Edan 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
HGMK150901
K173042
Jan 22, 2026Edan 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
HGMK102140
K173042
Jun 28, 2024Philips North America Llc
Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heart rate.
Open, Classified
HGMK140535
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
Open, Classified
HGMK140535
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
Open, Classified
HGMK140535
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
Open, Classified
HGMK012718
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Open, Classified
HGMK012718
Sep 19, 2019Pacific Medical Group Inc.
Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
Open, Classified
HGMK012718
Oct 21, 2014Philips 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
HGMK111083
Nov 18, 2013GE 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
HGMK111614
Dec 17, 2009Philips Healthcare Inc.
Philips Avalon Fetal Monitor FM 50 Catalog Number: M2705A.
Terminated
HGMNone listed
Dec 17, 2009Philips Healthcare Inc.
Philips Avalon Fetal Monitor FM 40 Catalog Number: M2704A.
Terminated
HGMNone listed
Dec 17, 2009Philips Healthcare Inc.
Philips Avalon Fetal Monitor FM 30 Catalog Number: M2703A.
Terminated
HGMK052795
K062137 +1
Dec 17, 2009Philips Healthcare Inc.
Philips Avalon Fetal Monitor FM 20 Catalog Number: M2702A.
Terminated
HGMK062137
K071800
Jun 26, 2009Philips Healthcare Inc.
Philips Avalon Fetal Monitor FM30; Model Number: M2703A.
Terminated
HGMK071800
Jun 26, 2009Philips Healthcare Inc.
Philips Avalon Fetal Monitor FM20; Model Number: M2702A.
Terminated
HGMK071800
Dec 3, 2008GE 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
HGMK993008
Oct 15, 2008GE 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
HGMK993008
Aug 26, 2008Datex 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
HGMNone listed
Jul 30, 2008GE 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
HGMK993008
Apr 27, 2006LMS 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
HGMNone listed
Nov 1, 2005Spacelabs Medical Incorporated
BirthNet OB Data Management System 91861
Terminated
HGMK965008
Oct 12, 2005Analogic Corporation
FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Terminated
HGMNone listed
Oct 12, 2005Analogic Corporation
FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Terminated
HGMNone listed
Sep 23, 2003GE Medical Systems Information Technologies
GE Medical Systems COROMETRICS Maternal/Fetal Monitoring Systems, Models 2126is, 2128is, 2129is
Terminated
HGMK021135

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