Data / Medical devices / Catheter, Retention, Barium Enema With Bag
Catheter, Retention, Barium Enema With Bag (FGD): 11 FDA-registered makers in 5 countries
11 establishments in 5 countries are registered with the FDA to make Catheter, Retention, Barium Enema With Bag (product code FGD, Class 2, 21 CFR 876.5980). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on June 16, 2023, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- FGD
- Device class
- 2
- Regulation
- 876.5980
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| Mexico | 2 |
| United States | 2 |
| Canada | 1 |
| Taiwan | 1 |
Makers of Catheter, Retention, Barium Enema With Bag
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 |
|---|---|---|---|---|---|---|---|---|
| Agile MV | Montreal Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alger Technology Co., Ltd. | Taichung City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E-Z-Em, Inc. | Princeton, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | SUZHOU Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Zuoyou Medical Technoloyg Co.,ltd. | Wenzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 16, 2023. 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.