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.
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- Product code
- FQH
- Device class
- 2
- Regulation
- 880.5475
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 46 |
| China | 18 |
| Germany | 8 |
| Mexico | 3 |
| Switzerland | 3 |
| United Kingdom | 2 |
| Ireland | 2 |
| Israel | 2 |
| India | 1 |
| Taiwan | 1 |
| Singapore | 1 |
| South Korea | 1 |
| Hungary | 1 |
| France | 1 |
| Costa Rica | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Carefusion 2200, Inc. | Vernon Hills, IL, United States | Complaint file establishment, Specification developer | 3 | February 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Brasseler U.S.A. Medical, LLC | Savannah, GA, United States | Manufacturer | 2 | June 20, 1997 | 0 | 0 | 0 | api.fda.gov |
| Erbe Elektromedizin GMBH | TUEBINGEN Baden-Wurttemberg, Germany | Manufacturer, Specification developer | 2 | June 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| ERBE Elektromedizin GmbH | Rangendingen Baden-Wurttemberg, Germany | Manufacturer | 2 | June 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Irrimax Corporation | Lawrenceville, GA, United States | Complaint file establishment, Specification developer | 2 | September 22, 2022 | 0 | 1 | 0 | api.fda.gov |
| Armis Biopharma, Inc. | Fort Collins, CO, United States | Complaint file establishment, Specification developer | 1 | May 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Enablecv, LLC | Midvale, UT, United States | Specification developer | 1 | January 29, 1993 | 0 | 0 | 0 | api.fda.gov |
| Human Med AG | SCHWERIN Mecklenburg-Western Pomerania, Germany | Manufacturer | 1 | October 10, 2001 | 0 | 0 | 0 | api.fda.gov |
| KDL Medical, Inc. | Richardson, TX, United States | Complaint file establishment, Manufacturer | 1 | January 6, 1998 | 0 | 0 | 0 | api.fda.gov |
| Kinamed, Inc. | Camarillo, CA, United States | Manufacturer | 1 | June 11, 1993 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Specification developer | 1 | December 8, 1997 | 0 | 1 | 0 | api.fda.gov |
| Medtronic Grand Rapids | Grand Rapids, MI, United States | Manufacturer | 1 | December 8, 1997 | 0 | 0 | 0 | api.fda.gov |
| Osartis GMBH | Muenster Hesse, Germany | Specification developer | 1 | January 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Smith & Nephew Medical Ltd | HULL East Riding of Yorkshire, United Kingdom | Specification developer | 1 | July 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| American Spraytech, L.L.C. | Branchburg, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Changfan Medical Instrument Co., Ltd | Anqing Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arobella Medical, LLC | Minnetonka, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Atrion Medical Products, Inc. | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alkem MedTech Pvt. Ltd. | Thane Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Healthcare (USA) Inc. | Vernon Hills, IL, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Yuewei Medical Technology Co., Ltd | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing ZKSK Technology Co., Ltd. | beijing, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioware Technologies Co., Ltd. | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BM Medical Technology Co.,ltd | Wuxi Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bothwin Medical Technology (SG) Pte. Ltd. | Singapore Central Singapore, Singapore | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Mebane | Mebane, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caleb Co., Ltd. | Won-Ju-Si Gangwon, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast Hungary KFT | TATABANYA Komarom-Esztergom, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast Manufacturing France, SAS | Sarlat la Caneda Cedex Dordogne, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ClensTech Inc.dba ASEPT PAK INC. | Malone, NY, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| De Soutter Medical Ltd. | ASTON CLINTON Buckinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Depuy Spine, Inc. | Raynham, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Kaiser Technology Co., Ltd | Dongguan city Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dvl-Op Medico Inc | Valencia, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Hong De Medical Plastic Products Co. Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medtek(jiangsu) Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eurofins STERIPAC GMBH | Calw-Altburg Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Clean Medical Products Manufacturing Corp | Guangzhou Guangdong, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovacyn, Inc. | Rialto, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Joimax GMBH | KARLSRUHE Baden-Wurttemberg, Germany | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Laboratorios PiSA, S. A. de C.V. | Tlajomulco de Zuniga Jalisco, Mexico | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LivaNova USA, INC. | Arvada, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med Michigan Holdings LLC | Lake Odessa, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medaxis AG | Baar Zug, Switzerland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medela AG | BAAR Zug, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microaire Surgical Instruments LLC | Charlottesville, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microport Orthopedics Inc. | Arlington, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Misonix, LLC | Farmingdale, NY, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Moeller Medical GMBH | FULDA Hesse, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet Cardiovascular LLC | Wayne, NJ, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Medline Industries - Arlington Heights | Arlington Heights, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro-Tech (Nanjing) Co., Ltd. | NAN JING Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ontogen Manufacturing LLC | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PRO-TECH Design & Mfg, Inc. | Arlington, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Robling Medical, LLC | Youngsville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rochal Technologies LLC | San Antonio, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Bojin Medical Instrument Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hugemed Medical Technical Development Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Relish Technology Co.,ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew Inc. | Oklahoma City, OK, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stiehl Tech | Lisle, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Manufacturing Kalamazoo | Portage, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Puerto Rico, LLC. | Arroyo, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sutter Medizintechnik GMBH | Emmendingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smith & Nephew, Inc. | Memphis, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Instruments | Portage, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tavtech, Ltd. | YEHUD Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tavger Ltd. | Katzrin Ha Zafon Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Costa Rica, S.A. | Barreal De Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Mexicana de Servicios, S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Manufacturing B.V. | Mercedita, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zimmer Surgical, Inc. | Dover, OH, United States | Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.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.