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Data / Medical devices / Computer, Blood-Pressure

Computer, Blood-Pressure (DSK): 67 FDA-registered makers in 17 countries

67 establishments in 17 countries are registered with the FDA to make Computer, Blood-Pressure (product code DSK, Class 2, 21 CFR 870.1110). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 77 510(k) clearances under this code, the latest on November 3, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
DSK
Device class
2
Regulation
870.1110
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States30
China12
Germany5
Australia2
Singapore2
Finland2
Taiwan2
Japan2
Norway2
Canada1
Mexico1
Poland1
South Korea1
Dominican Republic1
Brazil1
United Kingdom1
India1

Makers of Computer, 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
ATCOR MEDICAL Pty LtdSYDNEY New South Wales, AustraliaManufacturer, Specification developer3April 23, 2008000api.fda.gov
Merit Medical Singapore Pte. Ltd.SINGAPORE Central Singapore, SingaporeManufacturer1January 25, 1989000api.fda.gov
Scottcare CorporationCleveland, OH, United StatesManufacturer1July 24, 2002000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Amphenol DC ElectronicsSan Jose, CA, United StatesManufacturer0000api.fda.gov
Andon Health Co., LtdTianjin, ChinaContract manufacturer0000api.fda.gov
Abbott MedicalWestford, MA, United StatesManufacturer, Specification developer0000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandComplaint file establishment, Specification developer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Cadex Electronics, Inc.RICHMOND British Columbia, CanadaContract manufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Contec Medical Systems Co., LtdQinhuangdao Hebei, ChinaManufacturer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
DT Research, Inc Taiwan BranchNew Taipei City, TaiwanContract manufacturer, Exporter to the US0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Emi (dongguan) Asia LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Fukuda Denshi Co., Ltd.Shiroi-shi Chiba, JapanManufacturer0000api.fda.gov
Fukuda Denshi Co., Ltd.Bunkyo-ku Tokyo, JapanSpecification developer0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Repackager or relabeler, Specification developer0000api.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
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
GWWGaertringen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Jabil Circuit (Shanghai) Ltd.Shanghai, ChinaContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Kimball Solutions Jasper, Inc.Jasper, IN, United StatesContract manufacturer0000api.fda.gov
Mediana Co., Ltd.Wonju-Si, Gangwon-do, South KoreaManufacturer0000api.fda.gov
Medistim AsaHORTEN Vestfold, NorwayManufacturer0000api.fda.gov
Medistim AsaOslo, NorwaySpecification developer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Microtek Dominicana, S.A.S.Las Americas Santo Domingo, Dominican RepublicContract manufacturer0000api.fda.gov
Nicolay GMBHNAGOLD Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips Goldway (Shenzhen) Industrial Inc.SHENZHEN Guangdong, ChinaSpecification developer0000api.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 LLCCambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Remote Diagnostic Technologies Ltd.FARNBOROUGH Hampshire, United KingdomComplaint file establishment, 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, ChinaManufacturer, Specification developer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Siemens Healthineers AGFORCHHEIM Bavaria, GermanyExporter to the US, Manufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Terumo Cardiovascular Systems CorporationAnn Arbor, MI, United StatesManufacturer0000api.fda.gov
Tresmine Pty Ltd T/A Circuitwise ElectronicsBella vista New South Wales, AustraliaContract manufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer0000api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Zurich Medical IncPlymouth, MN, United StatesManufacturer0000api.fda.gov

Updated November 3, 2023. 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.