Data / Medical devices / Irrigator, Ostomy
Irrigator, Ostomy (EXD): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Irrigator, Ostomy (product code EXD, Class 2, 21 CFR 876.5895). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on July 16, 2012, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EXD
- Device class
- 2
- Regulation
- 876.5895
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 2 |
| Dominican Republic | 1 |
| United Kingdom | 1 |
| Denmark | 1 |
| Hungary | 1 |
| India | 1 |
Makers of Irrigator, Ostomy
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 |
|---|---|---|---|---|---|---|---|---|
| Convatec Dominican Republic, Inc. | Haina San Cristobal, Dominican Republic | Manufacturer | 2 | August 26, 1983 | 0 | 0 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 2 | August 26, 1983 | 0 | 0 | 0 | api.fda.gov |
| Coloplast A/S | HUMLEBAEK Hovedstaden, Denmark | Specification developer | 1 | July 16, 2012 | 0 | 0 | 0 | api.fda.gov |
| Coloplast Hungary KFT | TATABANYA Komarom-Esztergom, Hungary | Manufacturer | 1 | July 16, 2012 | 0 | 0 | 0 | api.fda.gov |
| Applied Medical Technology, Inc. | Brecksville, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinisupplies (nanjing) Co., Ltd | Nanjing Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cofoe Medical Technology Co.,ltd | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Stuarts Draft, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Medical India Private Limited | Bawal, Rewari Haryana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marlen MFG. & Development Co. | Bedford, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 16, 2012. 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.