Urgo Medical North America, LLC FDA Record
- Latest inspection NAI · May 1, 2019
- No warning letters matched by name
Urgo Medical North America, LLC has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Urgo Medical North America, LLC" is on file.
- Latest inspection
- May 1, 2019 · NAI
- Latest 510(k)
- Aug 11, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Urgo Medical North America, LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Urgo Medical North America, LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 1, 2019 | Fort Worth, TX | Devices | No Action Indicated (NAI) | 3010060216 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010060216 | Fort Worth, TX | 1 | May 1, 2019 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K253665 | Vashe Plus Antimicrobial Solution | Aug 11, 2026 |
Urgo Medical North America, LLC and the FDA: common questions
Has Urgo Medical North America, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Urgo Medical North America, LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Urgo Medical North America, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Urgo Medical North America, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Urgo Medical North America, LLC?
The most recent FDA inspection on file ended May 1, 2019 at Fort Worth, TX and was classified NAI. FDA has 1 inspection of Urgo Medical North America, LLC on file.
Need more than this page shows? Ask about Urgo Medical North America, LLC in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.