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Data / Medical devices / Plasma, Coagulation Control / United States

FDA-registered makers of Plasma, Coagulation Control in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Plasma, Coagulation Control (product code GGN). 13 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Plasma, Coagulation Control
Product code
GGN
Country
United States

Makers of Plasma, Coagulation Control in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Instrumentation Laboratory Co.Orangeburg, NY, United StatesManufacturer, Manufacturer for export7January 4, 2012000api.fda.gov
INSTRUMENTATION LABORATORY CO. - DevensDevens, MA, United StatesManufacturer for export, Repackager or relabeler7August 15, 2014000api.fda.gov
Diagnostica Stago, Inc.Parsippany, NJ, United StatesComplaint file establishment, Manufacturer, Manufacturer for export6December 12, 2014020api.fda.gov
Instrumentation Laboratory Co.Bedford, MA, United StatesComplaint file establishment, Manufacturer for export, Specification developer4August 15, 2014010api.fda.gov
Accriva Diagnostics, Inc.San Diego, CA, United StatesManufacturer3July 3, 2013020api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer3February 27, 2004000api.fda.gov
Bio-Rad Laboratories Inc.Irvine, CA, United StatesManufacturer3February 27, 2004000api.fda.gov
Fisher DiagnosticsMiddletown, VA, United StatesManufacturer3September 7, 2001000api.fda.gov
George King Bio-Medical, Inc.Overland Park, KS, United StatesManufacturer3February 23, 2017000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer3October 18, 2004000api.fda.gov
Medtronic Perfusion SystemsParker, CO, United StatesManufacturer3October 18, 2004000api.fda.gov
Helena Laboratories, Corp.Beaumont, TX, United StatesManufacturer, Manufacturer for export2September 14, 1994000api.fda.gov
Cliniqa CorporationSan Marcos, CA, United StatesContract manufacturer, Manufacturer1May 31, 2013000api.fda.gov
Aalto Scientific Ltd.Eatonton, GA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Bionostics, Inc.Devens, MA, United StatesContract manufacturer0000api.fda.gov
Haemonetics CorporationBoston, MA, United StatesSpecification developer0000api.fda.gov
Haemonetics CorporationClinton, PA, United StatesManufacturer0000api.fda.gov
HiArcMerrimack, NH, United StatesContract manufacturer0000api.fda.gov
STS CorporationDuluth, GA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov

Updated November 2, 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.