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Data / Medical devices / Plethysmograph, Impedance

Plethysmograph, Impedance (DSB): 53 FDA-registered makers in 16 countries

53 establishments in 16 countries are registered with the FDA to make Plethysmograph, Impedance (product code DSB, Class 2, 21 CFR 870.2770). 17 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 115 510(k) clearances under this code, the latest on August 17, 2026, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
DSB
Device class
2
Regulation
870.2770
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States27
China6
Netherlands3
Australia2
Germany2
Israel2
Japan2
France1
Switzerland1
Austria1
Mexico1
Dominican Republic1
Finland1
United Kingdom1
Malaysia1
Taiwan1

Makers of Plethysmograph, Impedance

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
Seemedx, IncLas Vegas, NV, United StatesSpecification developer5January 22, 2014000api.fda.gov
Impedimed LimitedLindfield New South Wales, AustraliaManufacturer3October 17, 2023000api.fda.gov
ManatecPoissy Ile-de-France, FranceManufacturer3February 12, 2014000api.fda.gov
Bracco Injeneering S.A.LAUSANNE Vaud, SwitzerlandManufacturer, Specification developer2January 27, 1998000api.fda.gov
Innovamed Sphere IncFall River, MA, United StatesComplaint file establishment, Specification developer2June 18, 2009000api.fda.gov
Osypka Medical GMBHBerlin, GermanyManufacturer2October 8, 2008000api.fda.gov
SENSIBLE MEDICAL INNOVATIONS Ltd.Netanya Central, IsraelManufacturer2February 28, 2019000api.fda.gov
Aci Medical, LLCSan Marcos, CA, United StatesManufacturer1October 14, 1988000api.fda.gov
Bodyport Inc.San Francisco, CA, United StatesComplaint file establishment, Specification developer1July 29, 2022000api.fda.gov
Baxter Healthcare - AvivTel Aviv, IsraelComplaint file establishment, Exporter to the US, Manufacturer, Specification developer1January 25, 2011000api.fda.gov
CNSYSTEMS MEDIZINTECHNIK GmbHGraz Steiermark, AustriaManufacturer1February 7, 2002000api.fda.gov
D. E. Hokanson, Inc.Bellevue, WA, United StatesManufacturer1January 18, 1990000api.fda.gov
Fujifilm Sonosite,inc.Bothell, WA, United StatesRemanufacturer1June 3, 2011000api.fda.gov
Impedimed, Inc.Carlsbad, CA, United StatesSpecification developer1October 17, 2023000api.fda.gov
Tanita Corp.ITABASHI-KU Tokyo, JapanSpecification developer1November 1, 1994000api.fda.gov
Tanita Corporation of Akita, LtdDaisen City Akita, JapanManufacturer1November 1, 1994000api.fda.gov
Valhalla Scientific, Inc.Poway, CA, United StatesManufacturer1January 5, 1987000api.fda.gov
Acist Medical Systems, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Analog DevicesWilmington, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer0000api.fda.gov
BENCHMARK ELECTRONICS San JorgeTlajomulco de Zuniga Jalisco, MexicoContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer0000api.fda.gov
CDR Manufacturing, Inc., DBA KeytronicOakdale, MN, United StatesContract manufacturer0000api.fda.gov
Demcon Production B.V.Enschede Overijssel, NetherlandsContract manufacturer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Edwards Lifesciences Holding B.V.AMSTERDAM Noord-Holland, NetherlandsSpecification developer0000api.fda.gov
Finapres Medical Systems B.V.Enschede Overijssel, NetherlandsManufacturer0000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer0000api.fda.gov
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesBuffalo, NY, United StatesContract manufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices, LLCMansfield, MA, United StatesContract manufacturer0000api.fda.gov
OnCore ManufacturingWestborough, MA, United StatesContract manufacturer0000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Remote Diagnostic Technologies Ltd.FARNBOROUGH Hampshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer0000api.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
Supercomal Medical Products, Sdn BhdSUNGAI PETANI Kedah, MalaysiaContract manufacturer0000api.fda.gov
SwemcoMoorestown, NJ, United StatesContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
Uscom LimitedSYDNEY New South Wales, AustraliaManufacturer0000api.fda.gov
Welch Allyn, Inc.Skaneateles Falls, NY, United StatesSpecification developer0000api.fda.gov
ZOLL Manufacturing CorporationPittsburgh, PA, United StatesManufacturer0000api.fda.gov

Updated August 17, 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.