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Data / Medical devices / Tourniquet, Pneumatic / United States

FDA-registered makers of Tourniquet, Pneumatic in the United States: 23 establishments

23 establishments in the United States are registered with the FDA to make Tourniquet, Pneumatic (product code KCY). 4 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Tourniquet, Pneumatic
Product code
KCY
Country
United States

Makers of Tourniquet, Pneumatic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Zimmer Surgical, Inc.Dover, OH, United StatesManufacturer, Repackager or relabeler, Specification developer2May 20, 2021050api.fda.gov
Stryker Sustainability SolutionsTempe, AZ, United StatesSpecification developer1February 19, 1991070api.fda.gov
Stryker Sustainability Solutions - ChandlerChandler, AZ, United StatesReprocessor1February 19, 1991000api.fda.gov
Terumo BCT, Inc..Lakewood, CO, United StatesManufacturer1February 16, 2017000api.fda.gov
ASP Global, LLCAustell, GA, United StatesComplaint file establishment, Specification developer0010api.fda.gov
AlphapointeJamaica, NY, United StatesManufacturer0000api.fda.gov
Bezalel InnovationsPalo Cedro, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Criterion Tool & Die Inc DBA Criterion Precision MachiningBrookpark, OH, United StatesContract manufacturer0000api.fda.gov
Depuy Orthopaedics, Inc.Warsaw, IN, United StatesManufacturer, Specification developer0000api.fda.gov
Dielectrics, Inc.Chicopee, MA, United StatesContract manufacturer0000api.fda.gov
GCX CorporationEl Paso, TX, United StatesContract manufacturer0000api.fda.gov
Iilabco LLCBrea, CA, United StatesSpecification developer0000api.fda.gov
Implant Resource, Inc.Eagan, MN, United StatesSpecification developer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
Medline ReNewalRedmond, OR, United StatesReprocessor0000api.fda.gov
Renovo, Inc.Bend, OR, United StatesReprocessor0000api.fda.gov
Renu Medical, Inc.Everett, WA, United StatesComplaint file establishment, Repackager or relabeler, Reprocessor0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesManufacturer0000api.fda.gov
Smart Tools Plus LlcNorth Royalton, OH, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0020api.fda.gov
Zimmer, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler, Specification developer0010api.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.