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Data / Medical devices / System, Monitoring, Perinatal / United States

FDA-registered makers of System, Monitoring, Perinatal in the United States: 23 establishments

23 establishments in the United States are registered with the FDA to make System, Monitoring, Perinatal (product code HGM). 19 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device
System, Monitoring, Perinatal
Product code
HGM
Country
United States

Makers of System, Monitoring, Perinatal in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer, Manufacturer for export, Specification developer3November 19, 2014000api.fda.gov
Cerner CorporationKansas City, MO, United StatesComplaint file establishment, Manufacturer2October 9, 2012000api.fda.gov
Datex-Ohmeda, Inc.Waukesha, WI, United StatesSpecification developer2August 10, 2026000api.fda.gov
Ge HealthcareChicago, IL, United StatesManufacturer2June 23, 2022040api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer2June 23, 2022000api.fda.gov
American I.V. Products, Inc.Harmans, MD, United StatesManufacturer1August 16, 2004000api.fda.gov
AirStrip Technologies, Inc.San Antonio, TX, United StatesManufacturer1February 13, 2009000api.fda.gov
B'orze IncBoise, ID, United StatesSpecification developer1March 21, 2013000api.fda.gov
Cetro AmericaMeriden, CT, United StatesSpecification developer1April 10, 2006000api.fda.gov
Clinical Computer Systems, Inc.Hoffman Est, IL, United StatesComplaint file establishment, Manufacturer1June 14, 2012000api.fda.gov
Clinicomp Intl., Inc.San Diego, CA, United StatesManufacturer1March 29, 1995000api.fda.gov
Datex-Ohmeda, Inc.Wauwatosa, WI, United StatesSpecification developer1December 8, 2023000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer1June 23, 2022000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesManufacturer1April 18, 2002000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer1November 25, 2014030api.fda.gov
R & D Batteries, Inc.Burnsville, MN, United StatesManufacturer1December 5, 1994000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer1February 26, 2026000api.fda.gov
Tenacore LLCCosta Mesa, CA, United StatesSpecification developer1August 18, 2005000api.fda.gov
Watchchild, LLCCary, NC, United StatesManufacturer1April 9, 2008000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0010api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.