Biomatlante FDA Record
Biomatlante has 0 FDA recalls, 3 inspections, 8 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Biomatlante" is on file.
- Latest inspection
- Nov 16, 2018 · NAI
- Latest 510(k)
- Mar 15, 2010
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 8 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 3 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 16, 2018 | Vigneux De Bretagne, France | Devices | No Action Indicated (NAI) | 3002673655 |
| Sep 17, 2015 | Vigneux De Bretagne, France | Devices | No Action Indicated (NAI) | 3002673655 |
| Sep 13, 2012 | Vigneux De Bretagne, France | Devices | No Action Indicated (NAI) | 3002673655 |
- 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 3002673655 | Vigneux De Bretagne, France | 3 | Nov 16, 2018 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K093122 | MBCP+ | Mar 15, 2010 |
| K071121 | TRIBONE 80 | Sep 11, 2007 |
| K063527 | MBCP+ | Jul 30, 2007 |
| K060732 | MBCP GEL | Jun 2, 2006 |
| K051774 | MBCP | Jan 20, 2006 |
| K051885 | MBCP | Sep 16, 2005 |
| K043005 | MODIFICATION TO MBCP | May 3, 2005 |
| K032268 | MBCP | Dec 11, 2003 |
Biomatlante and the FDA: common questions
Has Biomatlante received an FDA warning letter?
No FDA warning letter addressed to the name "Biomatlante" 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 Biomatlante received an FDA Form 483?
FDA has not published a Form 483 for "Biomatlante" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Biomatlante?
The most recent FDA inspection on file ended Nov 16, 2018 at Vigneux De Bretagne, France and was classified NAI. FDA has 3 inspections of Biomatlante on file.
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