Data / Medical devices / Catheter, Coude
Catheter, Coude (EZC): 13 FDA-registered makers in 10 countries
13 establishments in 10 countries are registered with the FDA to make Catheter, Coude (product code EZC, Class 2, 21 CFR 876.5130). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on August 29, 2022, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EZC
- Device class
- 2
- Regulation
- 876.5130
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Malaysia | 2 |
| Dominican Republic | 1 |
| Taiwan | 1 |
| China | 1 |
| Netherlands | 1 |
| Mexico | 1 |
| Israel | 1 |
| Sweden | 1 |
| Turkey | 1 |
Makers of Catheter, Coude
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 |
|---|---|---|---|---|---|---|---|---|
| C.R. Bard, Inc. | Covington, GA, United States | Contract sterilizer, Manufacturer, Specification developer | 4 | January 27, 1992 | 0 | 5 | 0 | api.fda.gov |
| Teleflex Medical Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer | 1 | August 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Dominican Republic Inc. | SANTO DOMINGO Distrito Nacional, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Sdn. Bhd. | KULIM Kedah, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bard Shannon Limited | Humacao, PR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Compactcath, Inc | Palo Alto, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Medical Manufacturing Co. | Zhunan Township, Miaoli County, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med Pro Medical B.V | Veenendaal Utrecht, Netherlands | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Para El Cuidado De La Salud | NOGALES Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Urogen Pharma Ltd. | Ra'anana Central, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellspect Healthcare | Molndal Vastra Gotaland, Sweden | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellspect Medikal A.S. | Kahramankazan Ankara, Turkey | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 29, 2022. 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.