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Data / Medical devices / Device, Hemostasis, Vascular

Device, Hemostasis, Vascular (MGB): 18 FDA-registered makers in 4 countries

18 establishments in 4 countries are registered with the FDA to make Device, Hemostasis, Vascular (product code MGB, Class 3). 12 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 11 recall events (0 Class I). FDA data exported November 2, 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
MGB
Device class
3
Medical specialty
Unknown

Makers by country

CountryMakers
United States12
Mexico3
Ireland2
Poland1

Makers of Device, Hemostasis, Vascular

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Abbott VascularSanta Clara, CA, United StatesSpecification developer0200api.fda.gov
Abbott VascularCLONMEL Tipperary, IrelandExporter to the US, Manufacturer0200api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer0220api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0210api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer0200api.fda.gov
Cardiva Medical, Inc.Guaymas Sonora, MexicoManufacturer0100api.fda.gov
Cardiva Medical, Inc.Santa Clara, CA, United StatesComplaint file establishment, Specification developer0100api.fda.gov
Cordis US Corp.Santa Clara, CA, United StatesManufacturer, Specification developer0110api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesSpecification developer0100api.fda.gov
Terumo Medical Corp.Somerset, NJ, United StatesManufacturer for export, Specification developer0110api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoContract manufacturer, Manufacturer0100api.fda.gov
VasorumDublin Dublin(County), IrelandManufacturer, Specification developer0100api.fda.gov
Cardinal Health Mexico 244 S de RL de CVCiudad Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Isomedix Operations Inc.S Plainfield, NJ, United StatesManufacturer for export0000api.fda.gov
Rose MedicalGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Steripack Medical Poland SP. Z O.O.Jelcz-Laskowice Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Tesco Associates, Inc.Tyngsboro, MA, United StatesContract manufacturer0000api.fda.gov
Terumo Puerto Rico LLCCaguas, PR, United StatesContract manufacturer0000api.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.