Data / Medical devices / Rod, Colostomy
Rod, Colostomy (EZP): 10 FDA-registered makers in 6 countries
10 establishments in 6 countries are registered with the FDA to make Rod, Colostomy (product code EZP, Class 2, 21 CFR 876.4270). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on October 13, 2006, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EZP
- Device class
- 2
- Regulation
- 876.4270
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 2 |
| Denmark | 1 |
| Hungary | 1 |
| Dominican Republic | 1 |
| China | 1 |
Makers of Rod, Colostomy
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 |
|---|---|---|---|---|---|---|---|---|
| Coloplast A/S | HUMLEBAEK Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coloplast Hungary KFT | NYIRBATOR Szabolcs-Szatmar-Bereg, Hungary | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convatec Dominican Republic, Inc. | Haina San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convatec Limited | Deeside Flintshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Rollmed Co.,ltd. | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marlen MFG. & Development Co. | Bedford, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SP-Meditec | Peachtree City, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tools For Surgery, LLC | Stony Brook, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 13, 2006. 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.