Data / Medical devices / Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) / United States
FDA-registered makers of Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) (product code FCM). 7 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Device
- Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- Product code
- FCM
- Country
- United States
Makers of Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 3 | May 9, 2001 | 0 | 1 | 0 | api.fda.gov |
| C.R. Bard, Inc. | Covington, GA, United States | Specification developer | 2 | May 29, 2026 | 0 | 0 | 0 | api.fda.gov |
| Greystone Medical, LLC | Waterford, MI, United States | Specification developer | 2 | May 23, 2003 | 0 | 0 | 0 | api.fda.gov |
| Customed, Inc. | Fajardo, PR, United States | Manufacturer | 1 | May 9, 1996 | 0 | 1 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | October 4, 1990 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 1 | April 21, 1995 | 0 | 0 | 0 | api.fda.gov |
| Nurse Assist, LLC | Haltom City, TX, United States | Manufacturer | 1 | November 29, 1990 | 0 | 1 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hollister Incorporated | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.