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Data / Medical devices / Lavage, Jet

Lavage, Jet (FQH): 91 FDA-registered makers in 15 countries

91 establishments in 15 countries are registered with the FDA to make Lavage, Jet (product code FQH, Class 2, 21 CFR 880.5475). 14 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on February 25, 2026, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
FQH
Device class
2
Regulation
880.5475
Medical specialty
General Hospital

Makers by country

CountryMakers
United States46
China18
Germany8
Mexico3
Switzerland3
United Kingdom2
Ireland2
Israel2
India1
Taiwan1
Singapore1
South Korea1
Hungary1
France1
Costa Rica1

Makers of Lavage, Jet

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
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer3February 25, 2026000api.fda.gov
Brasseler U.S.A. Medical, LLCSavannah, GA, United StatesManufacturer2June 20, 1997000api.fda.gov
Erbe Elektromedizin GMBHTUEBINGEN Baden-Wurttemberg, GermanyManufacturer, Specification developer2June 15, 2023000api.fda.gov
ERBE Elektromedizin GmbHRangendingen Baden-Wurttemberg, GermanyManufacturer2June 15, 2023000api.fda.gov
Irrimax CorporationLawrenceville, GA, United StatesComplaint file establishment, Specification developer2September 22, 2022010api.fda.gov
Armis Biopharma, Inc.Fort Collins, CO, United StatesComplaint file establishment, Specification developer1May 25, 2023000api.fda.gov
Enablecv, LLCMidvale, UT, United StatesSpecification developer1January 29, 1993000api.fda.gov
Human Med AGSCHWERIN Mecklenburg-Western Pomerania, GermanyManufacturer1October 10, 2001000api.fda.gov
KDL Medical, Inc.Richardson, TX, United StatesComplaint file establishment, Manufacturer1January 6, 1998000api.fda.gov
Kinamed, Inc.Camarillo, CA, United StatesManufacturer1June 11, 1993000api.fda.gov
Medtronic Perfusion SystemsMinneapolis, MN, United StatesSpecification developer1December 8, 1997010api.fda.gov
Medtronic Grand RapidsGrand Rapids, MI, United StatesManufacturer1December 8, 1997000api.fda.gov
Osartis GMBHMuenster Hesse, GermanySpecification developer1January 23, 2020000api.fda.gov
Smith & Nephew Medical LtdHULL East Riding of Yorkshire, United KingdomSpecification developer1July 15, 2015000api.fda.gov
American Spraytech, L.L.C.Branchburg, NJ, United StatesContract manufacturer0000api.fda.gov
Anqing Changfan Medical Instrument Co., LtdAnqing Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Arobella Medical, LLCMinnetonka, MN, United StatesManufacturer0000api.fda.gov
Atrion Medical Products, Inc.Arab, AL, United StatesContract manufacturer0000api.fda.gov
Alkem MedTech Pvt. Ltd.Thane Maharashtra, IndiaManufacturer0000api.fda.gov
Amsino Healthcare (USA) Inc.Vernon Hills, IL, United StatesContract manufacturer0010api.fda.gov
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Beijing Hangtian Kadi Technology R&D InstituteBeijing, ChinaManufacturer0000api.fda.gov
Beijing Yuewei Medical Technology Co., LtdBeijing, ChinaManufacturer0000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Bioware Technologies Co., Ltd.New Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
BM Medical Technology Co.,ltdWuxi Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Bothwin Medical Technology (SG) Pte. Ltd.Singapore Central Singapore, SingaporeSpecification developer0000api.fda.gov
Biomerics MebaneMebane, NC, United StatesContract manufacturer0000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer0000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer0000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer0000api.fda.gov
Bothwin (Beijing) Medical Technology Co., Ltd.Beijng Beijing, ChinaManufacturer0000api.fda.gov
Caleb Co., Ltd.Won-Ju-Si Gangwon, South KoreaManufacturer0000api.fda.gov
Coloplast Hungary KFTTATABANYA Komarom-Esztergom, HungaryManufacturer0000api.fda.gov
Coloplast Manufacturing France, SASSarlat la Caneda Cedex Dordogne, FranceManufacturer0000api.fda.gov
ClensTech Inc.dba ASEPT PAK INC.Malone, NY, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
De Soutter Medical Ltd.ASTON CLINTON Buckinghamshire, United KingdomManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Dongguan Kaiser Technology Co., LtdDongguan city Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dvl-Op Medico IncValencia, CA, United StatesManufacturer0000api.fda.gov
Dongguan Hong De Medical Plastic Products Co. Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Elite Medtek(jiangsu) Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Guangzhou Clean Medical Products Manufacturing CorpGuangzhou Guangdong, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
Innovacyn, Inc.Rialto, CA, United StatesManufacturer0000api.fda.gov
Joimax GMBHKARLSRUHE Baden-Wurttemberg, GermanyExporter to the US, Manufacturer0000api.fda.gov
Laboratorios PiSA, S. A. de C.V.Tlajomulco de Zuniga Jalisco, MexicoContract manufacturer, Contract sterilizer0000api.fda.gov
LivaNova USA, INC.Arvada, CO, United StatesManufacturer0000api.fda.gov
Med Michigan Holdings LLCLake Odessa, MI, United StatesManufacturer0000api.fda.gov
Medaxis AGBaar Zug, SwitzerlandManufacturer, Specification developer0000api.fda.gov
Medela AGBAAR Zug, SwitzerlandContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Microaire Surgical Instruments LLCCharlottesville, VA, United StatesManufacturer0000api.fda.gov
Microport Orthopedics Inc.Arlington, TN, United StatesSpecification developer0000api.fda.gov
Misonix, LLCFarmingdale, NY, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Moeller Medical GMBHFULDA Hesse, GermanyContract manufacturer0000api.fda.gov
Maquet Cardiovascular LLCWayne, NJ, United StatesManufacturer0010api.fda.gov
Medline Industries - Arlington HeightsArlington Heights, IL, United StatesContract manufacturer0000api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Ontogen Manufacturing LLCLisle, IL, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
Robling Medical, LLCYoungsville, NC, United StatesContract manufacturer0000api.fda.gov
Rochal Technologies LLCSan Antonio, TX, United StatesSpecification developer0000api.fda.gov
Shanghai Bojin Medical Instrument Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shenzhen Hugemed Medical Technical Development Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Relish Technology Co.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Smith & Nephew Inc.Oklahoma City, OK, United StatesContract manufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stiehl TechLisle, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Stryker Manufacturing KalamazooPortage, MI, United StatesContract manufacturer0000api.fda.gov
Stryker Puerto Rico, LLC.Arroyo, PR, United StatesContract manufacturer0000api.fda.gov
Sutter Medizintechnik GMBHEmmendingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Smith & Nephew, Inc.Memphis, TN, United StatesManufacturer0000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Tavtech, Ltd.YEHUD Central, IsraelManufacturer0000api.fda.gov
Tavger Ltd.Katzrin Ha Zafon Haifa, IsraelManufacturer0000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Viant Costa Rica, S.A.Barreal De Heredia, Costa RicaContract manufacturer0000api.fda.gov
Viant Mexicana de Servicios, S. de R.L. de C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Well Lead Medical Co. LtdGUANGZHOU Guangdong, ChinaManufacturer0000api.fda.gov
Zimmer Manufacturing B.V.Mercedita, PR, United StatesContract manufacturer0000api.fda.gov
Zimmer Surgical, Inc.Dover, OH, United StatesManufacturer, Specification developer0010api.fda.gov

Updated February 25, 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.