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Data / Medical devices / Pump, Air, Non-Manual, For Endoscope

Pump, Air, Non-Manual, For Endoscope (FEQ): 23 FDA-registered makers in 7 countries

23 establishments in 7 countries are registered with the FDA to make Pump, Air, Non-Manual, For Endoscope (product code FEQ, Class 2, 21 CFR 876.1500). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 21 510(k) clearances under this code, the latest on March 11, 2022, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
FEQ
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States10
Germany5
United Kingdom4
Ireland1
Vietnam1
China1
Estonia1

Makers of Pump, Air, Non-Manual, For Endoscope

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
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer4August 1, 2019000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer2June 27, 2016000api.fda.gov
Boston Scientific CorporationJohns Creek, GA, United StatesManufacturer2June 27, 2016000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer2June 27, 2016000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer2June 27, 2016000api.fda.gov
Erbe Medical, LLCTempe, AZ, United StatesManufacturer, Specification developer2August 31, 2016010api.fda.gov
Medivators IncConroe, TX, United StatesManufacturer, Specification developer2March 11, 2022000api.fda.gov
Algram Group LtdPlymouth Devon, United KingdomManufacturer1September 13, 2010000api.fda.gov
KEYMED (Medical & Industrial Equipment) LtdSOUTHEND-ON-SEA Essex, United KingdomManufacturer, Specification developer1September 13, 2010000api.fda.gov
Biotex, Inc.Houston, TX, United StatesManufacturer0000api.fda.gov
Cipher Surgical LtdCoventry, United KingdomComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Diversatek Healthcare IncMilwaukee, WI, United StatesSpecification developer0000api.fda.gov
Diversatek Vietnam Company LimitedHo Chi Minh City, VietnamContract manufacturer0000api.fda.gov
Jiangsu JianYu Health Medical Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
MEDOVATE LtdMildenhall Suffolk, United KingdomContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
MFG One, LLCChantilly, VA, United StatesContract manufacturer0000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Olympus Winter & Ibe GmbHTELTOW Brandenburg, GermanyManufacturer0000api.fda.gov
RAUMEDIC - MuenchbergHelmbrechts Bavaria, GermanyContract manufacturer0000api.fda.gov
RAUMEDIC Estonia ASTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov

Updated March 11, 2022. 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.