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Data / Medical devices / Alarm, Blood-Pressure

Alarm, Blood-Pressure (DSJ): 35 FDA-registered makers in 9 countries

35 establishments in 9 countries are registered with the FDA to make Alarm, Blood-Pressure (product code DSJ, Class 2, 21 CFR 870.1100). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on October 27, 2019, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
DSJ
Device class
2
Regulation
870.1100
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States14
China7
Germany5
Mexico3
India2
Finland1
Poland1
Brazil1
Taiwan1

Makers of Alarm, Blood-Pressure

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
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer3March 31, 2017020api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer2September 29, 2015000api.fda.gov
Philips Goldway (Shenzhen) Industrial Inc.SHENZHEN Guangdong, ChinaSpecification developer1October 27, 2019000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer1October 27, 2019000api.fda.gov
Terumo Cardiovascular Systems CorporationAnn Arbor, MI, United StatesManufacturer1June 4, 1996000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
GWWGaertringen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer0000api.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 North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Shenzhen Comen Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Sibel Health Inc.Chicago, IL, United StatesManufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Siemens Healthineers AGFORCHHEIM Bavaria, GermanyManufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov

Updated October 27, 2019. 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.