HGM
AIRSTRIP OB
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 214
Adverse events under product code HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HGM
1–100 of 214- K253021 — ANNE Maternal
- K250777 — Sonicaid Team3
- K241882 — Fetal & Maternal Monitor (F15A, F15A Air)
- K241368 — Sonicaid Team3
- K241009 — PeriCALM Patterns 3.0
- K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
- K231964 — Novii+ Wireless Patch System
- K222327 — Bloomlife MFM-Pro
- K220732 — Mural Perinatal Surveillance
- K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum
- K173941 — IntelliSpace Perinatal Rev.K.00
- K173042 — Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
- K173715 — AlertWatch:OB
- K171178 — Central Monitoring System
- K171865 — F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring
- K161902 — Meridian M110 Fetal Monitoring System
- K153580 — Central Monitoring System
- K150398 — EUM 100Pro
- K142799 — Model BT-220L and BT-220C
- K150901 — Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
- K142883 — MindChild Meridian M100 Fetal Heart Rate Monitor
- K143695 — CENTRAL MONITORING SYSTEM
- K140535 — PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- K141194 — FM-3000 FETAL MONITOR
- K131941 — FETAL MONITORS
- K132650 — SONICAID FREEDOM WIRELESS FETAL MONITORING SYSTEM
- K132918 — SENSE-4BABY SYSTEM
- K123335 — SUNRAY FETAL MONITOR
- K121758 — CERNER FETALINK+(VERSION1.0)
- K120018 — MINDCHILD MERIDIAN FETAL HEART RATE MONITOR
- K121267 — BT-200V VASCULAR DOPPLER
- K121208 — OBIX PERINATAL DATA SYSTEM 7.0
- K112317 — FM-9000 PLUS FETAL AND MATERNAL MONITOR
- K110612 — FM20
- K111614 — CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
- K112159 — CMS-1000FM CENTRAL MONITORING SYSTEM
- K112187 — FM-1000 PLUS FETAL MONITOR
- K111083 — PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- K110556 — MINI TELEMETRY SYSTEM
- K103545 — BT-350
- K102263 — HORIZON PERINATAL CARE SURVEILLANCE AND ARCHIVAL MODEL VERSON 4.0
- K102958 — PHILIPS AVALON FETAL MONITOR
- K103172 — CIV-OB (PLUS)
- K102140 — FETAL MONITORS, MODELS F2 AND F3
- K100358 — CENTRAL MONITORING SYSTEM
- K100797 — FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
- K100420 — PHILIPS OBTRACEVUE MODEL SW REV. G.00
- K100885 — FETAL MONITOR MODEL: BT-200T
- K092028 — PHILIPS AVALON FETAL MONITORS FM20, FM30, FM40, AND FM50
- K091251 — CERNER FETALINK (VERSION 1.0)
- K090285 — SONICAID FM820 AND FM830 ENCORE
- K090269 — AIRSTRIP OB
- K090061 — AIRSTRIP OB
- K082602 — FETAL & MATERNAL MONITOR, MODEL F6, F9
- K082369 — CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
- K081203 — OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00
- K080226 — NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912
- K073221 — CADENCE II
- K072976 — MODEL 250CX SERIES MATERNAL/FETAL MONITOR
- K071800 — PHILIPS AVALON FETAL MONITORS FM20 AND FM30
- K062137 — MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30
- K050826 — FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
- K060230 — DOPPLEX CENTRALE
- K051175 — CIV-OB OBSTRICAL MONITORING SOFTWARE APPLICATION
- K052795 — PHILIPS AVALON FETAL MONITOR, MODELS FM20 AND FM30
- K052715 — CALM CURVE, VERSION 01.00
- K043597 — FC 700 FETAL MONITOR
- K043598 — FC 1400 FETAL MONITOR
- K052190 — FETAL MONITOR, MODELS BT-300 AND BT-200
- K050234 — REMOTE CARE
- K043075 — TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- K050583 — MODEL 250 SERIES MATERNAL/FETAL MONITOR
- K040788 — CALM PATTERNS, VERSION 01.00.00
- K042082 — AIRSTRIP OB
- K040903 — CADENCE, MODELS 2001 AND 2002
- K040819 — TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834
- K032772 — MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM
- K032252 — MODEL 120 SERIES MATERNAL/FETAL MONITOR
- K030261 — BATTERY, RECHARGEABLE
- K023931 — PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEM, MODELS M2720A, M2725A, M2726A, M2727A
- K023618 — SONICAID ONE
- K021574 — TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER
- K021135 — MODEL 2120IS SERIES MATERNAL/FETAL MONITOR
- K013281 — VERSALAB APM
- K014094 — MODIFICATION TO THE WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM
- K012718 — MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM.
- K011304 — OB-1 FETAL MONITOR
- K010552 — CG-900P FETAL/MATERNAL MONITOR
- K992607 — SONICAID SYSTEM 8002
- K010889 — BABY DOPPLEX 3000 MK 2 (BD3000)
- K010894 — BABY DOPPLEX 3002 (BD3002)
- K002150 — SONICAID FM820, SONICAID FM830
- K002548 — FETAL ASSIST
- K002503 — FETALGARD LITE
- K994008 — BIOSYS FETAL MONITOR, MODEL IFM-500
- K001882 — BABY DOPPLEX 4002-TWINS, MODEL BD4002
- K001677 — BABY DOPPLEX 4000 (BD4000)
- K993751 — COROMETRICS MODEL 173 FETAL MONITOR
- K990569 — BABY DOPPLEX 4000, MODEL BD 4000
- K993008 — QUANTITATIVE SENTINEL SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.