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Data / Medical devices / Transducer, Blood-Pressure, Extravascular

Transducer, Blood-Pressure, Extravascular (DRS): 41 FDA-registered makers in 14 countries

41 establishments in 14 countries are registered with the FDA to make Transducer, Blood-Pressure, Extravascular (product code DRS, Class 2, 21 CFR 870.2850). 23 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 149 510(k) clearances under this code, the latest on September 10, 2026, and lists 12 recall events (1 Class I). FDA data exported November 2, 2026.

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Product code
DRS
Device class
2
Regulation
870.2850
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States16
China6
Mexico4
Germany3
Singapore2
Israel2
Dominican Republic1
Norway1
Costa Rica1
Brazil1
Romania1
India1
Malaysia1
Ireland1

Makers of Transducer, Blood-Pressure, Extravascular

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
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer5November 9, 2017040api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer, Repackager or relabeler5November 9, 2017000api.fda.gov
Bioptimal International Pte. Ltd.SINGAPORE South East, SingaporeManufacturer4April 19, 2007000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer4November 22, 2016000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer4September 19, 2006000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer4March 25, 1996000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer4November 22, 2016000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer3March 21, 2025000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer3March 21, 2025000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler3September 19, 2006000api.fda.gov
ICU Medical, Inc.Dublin, OH, United StatesManufacturer3June 27, 1996010api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer2May 8, 2013021api.fda.gov
Merit Medical Singapore Pte. Ltd.SINGAPORE Central Singapore, SingaporeManufacturer2February 26, 1986000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer2March 25, 1985010api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer1July 14, 1980000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer1July 14, 1980000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1March 21, 2025000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler1February 5, 1999000api.fda.gov
Memscap ASSKOPPUM Vestfold, NorwayManufacturer1December 7, 1979000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1December 11, 1992000api.fda.gov
Shenzhen Antmed Co. LtdDongguan Guangdong, ChinaManufacturer1August 18, 2009000api.fda.gov
Terumo Cardiovascular Costa Rica LLCZona Franca La Lima Cartago, Costa RicaManufacturer1December 10, 2009000api.fda.gov
Zhejiang Haisheng Medical Device Co., Ltd.Shaoxing Zhejiang, ChinaManufacturer1October 31, 2016000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer0010api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Bioxin Medical Co., LtdWeihai Shandong, ChinaContract manufacturer0000api.fda.gov
Elcam Medical A.C.A.L.D.N. MEROM HAGALIL Northern, IsraelContract manufacturer0000api.fda.gov
Elcam Medical AcalDALTON INDUSTRIAL PARK, P.O BOX 9 Northern, IsraelContract manufacturer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Nicolay GMBHNAGOLD Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips Medical Systems LtdaVarginha Minas Gerais, BrazilSpecification developer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Quest Medical, Inc.Allen, TX, United StatesManufacturer0000api.fda.gov
SC Euromedica SRLIasi, RomaniaContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Utah Medical Products, Ltd.ATHLONE CO. Leinster, IrelandContract manufacturer0000api.fda.gov

Updated September 10, 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.