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Data / Medical devices / Device, Monitoring, Intracranial Pressure / United States

FDA-registered makers of Device, Monitoring, Intracranial Pressure in the United States: 20 establishments

20 establishments in the United States are registered with the FDA to make Device, Monitoring, Intracranial Pressure (product code GWM). 7 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
Device, Monitoring, Intracranial Pressure
Product code
GWM
Country
United States

Makers of Device, Monitoring, Intracranial Pressure in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer16February 4, 2024000api.fda.gov
Natus Medical IncorporatedSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6March 6, 2014020api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer5May 26, 2020011api.fda.gov
BranchpointPlacentia, CA, United StatesComplaint file establishment, Specification developer1May 18, 2018000api.fda.gov
ClearPoint Neuro Inc.Carlsbad, CA, United StatesManufacturer1September 29, 2009000api.fda.gov
Hemedex IncorporatedNorth Waltham, MA, United StatesManufacturer1October 10, 2014000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer1May 20, 2002010api.fda.gov
Blueprint Manufacturing CorporationIrvine, CA, United StatesContract manufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
BRAINSPACE IncBothell, WA, United StatesManufacturer0000api.fda.gov
CEA Medical Manufacturing, Inc.Colorado Springs, CO, United StatesContract manufacturer0000api.fda.gov
Global Interconnect, Inc.Pocasset, MA, United StatesContract manufacturer0000api.fda.gov
Isomedix Operations Inc.San Diego, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Liberty Engineering IncNewton, MA, United StatesContract manufacturer0000api.fda.gov
Medeologix LLCSan Jose, CA, United StatesContract manufacturer0000api.fda.gov
Millar LLC.Houston, TX, United StatesContract manufacturer0000api.fda.gov
Natus Neurology IncorporatedMiddleton, WI, United StatesContract manufacturer0000api.fda.gov
Qualitel CorporationEverett, WA, United StatesContract manufacturer0000api.fda.gov
Resolution MedicalMinneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Rose MedicalGrand Rapids, MI, 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.