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
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2026 | K254036 | Novii+ Wireless Patch System Datex Ohmeda, Inc. | HGM |
| Feb 26, 2026 | K253021 | ANNE Maternal Sibel Health, Inc. | HGM |
| Sep 19, 2025 | K250777 | Sonicaid Team3 Huntleigh Healthcare , Ltd., GB | HGM |
| Aug 27, 2025 | K241882 | Fetal & Maternal Monitor (F15A, F15A Air) Edan Instruments, Inc., CN | HGM |
| Feb 3, 2025 | K241368 | Sonicaid Team3 Huntleigh Healthcare , Ltd., GB | HGM |
| Jan 10, 2025 | K241009 | PeriCALM Patterns 3.0 Perigen, Inc., IL | HGM |
| Jul 2, 2024 | K233440 | Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Dec 8, 2023 | K231964 | Novii+ Wireless Patch System Datex Ohmeda | HGM |
| Feb 13, 2023 | K222327 | Bloomlife MFM-Pro Bloom Technologies NV, BE | HGM |
| Jun 23, 2022 | K220732 | Mural Perinatal Surveillance Ge Medical Systems Information Technologies, Inc. | HGM |
| Jun 24, 2020 | K200975 | Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum Huntleigh Healthcare Limited, GB | HGM |
| Sep 10, 2018 | K173941 | IntelliSpace Perinatal Rev.K.00 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Aug 30, 2018 | K173042 | Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 Edan Instruments, Inc., CN | HGM |
| Apr 23, 2018 | K173715 | AlertWatch:OB Alertwatch, Inc. | HGM |
| Sep 6, 2017 | K171178 | Central Monitoring System Edan Instruments, Inc., CN | HGM |
| Aug 24, 2017 | K171865 | F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring Farus, LLC | HGM |
| Jan 12, 2017 | K161902 | Meridian M110 Fetal Monitoring System Mindchild Medical | HGM |
| Sep 7, 2016 | K153580 | Central Monitoring System Guangdong Biolight Meditech Co., Ltd., CN | HGM |
| Aug 6, 2015 | K150398 | EUM 100Pro Ob Tools, Ltd., IL | HGM |
| Jul 9, 2015 | K142799 | Model BT-220L and BT-220C Bistos Co., Ltd. | HGM |
| Jul 1, 2015 | K150901 | Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express Edan Instruments, Inc., CN | HGM |
| Apr 17, 2015 | K142883 | MindChild Meridian M100 Fetal Heart Rate Monitor Mindchild Medical | HGM |
| Mar 30, 2015 | K143695 | CENTRAL MONITORING SYSTEM Edan Instruments, Inc., CN | HGM |
| Nov 25, 2014 | K140535 | PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50 Philips Medizin Systeme Boblingen GmbH, DE | HGM |
| Nov 19, 2014 | K141194 | FM-3000 FETAL MONITOR Advanced Instrumentations, Inc. | HGM |
| May 15, 2014 | K131941 | FETAL MONITORS Guangdong Biolight Meditech Co., Ltd., CN | HGM |
| Feb 7, 2014 | K132650 | SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM Huntleigh Healthcare Limited, GB | HGM |
| Nov 22, 2013 | K132918 | SENSE-4BABY SYSTEM Sense4baby , Inc. | HGM |
| Mar 21, 2013 | K123335 | SUNRAY FETAL MONITOR Sunray Medical Apparatus Co., Ltd., CN | HGM |
| Oct 9, 2012 | K121758 | CERNER FETALINK+(VERSION1.0) Cerner Corp. | HGM |
| Sep 19, 2012 | K120018 | MINDCHILD MERIDIAN FETAL HEART RATE MONITOR Mindchild Medical | HGM |
| Aug 2, 2012 | K121267 | BT-200V VASCULAR DOPPLER Bistos Co., Ltd. | HGM |
| Jun 14, 2012 | K121208 | OBIX PERINATAL DATA SYSTEM 7.0 Clinical Computer Systems, Inc. | HGM |
| Dec 21, 2011 | K112317 | FM-9000 PLUS FETAL AND MATERNAL MONITOR Advanced Instrumentations, Inc. | HGM |
| Nov 8, 2011 | K110612 | FM20 Mediana Co., Ltd., KR | HGM |
| Sep 26, 2011 | K111614 | CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE Ge Healthcare Integrated IT Solutions | HGM |
| Sep 21, 2011 | K112187 | FM-1000 PLUS FETAL MONITOR Advanced Instrumentations, Inc. | HGM |
| Sep 21, 2011 | K112159 | CMS-1000FM CENTRAL MONITORING SYSTEM Advanced Instrumentations, Inc. | HGM |
| Aug 17, 2011 | K111083 | PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE | HGM |
| Jul 19, 2011 | K110556 | MINI TELEMETRY SYSTEM Wipro GE Healthcare Private, Ltd. | HGM |
| May 13, 2011 | K103545 | BT-350 Bistos Co., Ltd. | HGM |
| May 5, 2011 | K102263 | HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0 Mckesson Information Solutions, LLC | HGM |
| Mar 18, 2011 | K102958 | PHILIPS AVALON FETAL MONITOR Philips Medizin Systeme Boblingen GmbH, DE | HGM |
| Mar 11, 2011 | K103172 | CIV-OB (PLUS) Civnet Communication, Ltd., IL | HGM |
| Jan 13, 2011 | K102140 | FETAL MONITORS, MODELS F2 AND F3 Edan Instruments, Inc., CN | HGM |
| Jan 6, 2011 | K100358 | CENTRAL MONITORING SYSTEM Edan Instruments, Inc. | HGM |
| Nov 10, 2010 | K100797 | FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS Edan Instruments, Inc. | HGM |
| Jul 26, 2010 | K100420 | PHILIPS OBTRACEVUE MODEL SW REV. G.00 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
| Jun 7, 2010 | K100885 | FETAL MONITOR MODEL: BT-200T Bistos Co., Ltd. | HGM |
| Feb 17, 2010 | K092028 | PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50 Philips Medizin Systeme Boeblingen GmbH, DE | HGM |
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