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Data / Medical devices / Endoscopic Irrigation/Suction System / United States

FDA-registered makers of Endoscopic Irrigation/Suction System in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Endoscopic Irrigation/Suction System (product code OCX). 16 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Endoscopic Irrigation/Suction System
Product code
OCX
Country
United States

Makers of Endoscopic Irrigation/Suction System in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Diversatek Healthcare IncMilwaukee, WI, United StatesComplaint file establishment, Manufacturer, Specification developer6July 7, 2023000api.fda.gov
Medivators IncConroe, TX, United StatesManufacturer, Specification developer5August 14, 2023000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler5September 6, 2019020api.fda.gov
Erbe Medical, LLCTempe, AZ, United StatesManufacturer, Specification developer4August 11, 2022010api.fda.gov
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler4April 28, 2004000api.fda.gov
Hobbs Medical, Inc.Stafford Springs, CT, United StatesManufacturer3September 24, 2024010api.fda.gov
The Ruhof CorporationMineola, NY, United StatesComplaint file establishment, Manufacturer, Specification developer3April 17, 2019000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer2September 13, 2018000api.fda.gov
Biotex, Inc.Houston, TX, United StatesManufacturer1May 21, 2024000api.fda.gov
Boston Scientific CorporationJohns Creek, GA, United StatesManufacturer1September 13, 2018000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1May 16, 2013000api.fda.gov
C.R. Bard, Inc.Covington, GA, United StatesContract sterilizer, Specification developer1April 9, 1991000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer1June 2, 1989000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1February 21, 2014000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1November 22, 2019000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer1February 1, 2019000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesContract manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
MFG One, LLCChantilly, VA, United StatesContract manufacturer0000api.fda.gov
Nolato ContourBaldwin, WI, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.