Cervilenz, Inc. FDA Record
Cervilenz, Inc. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Cervilenz, Inc." is on file.
- Latest inspection
- Apr 28, 2015 · NAI
- Latest 510(k)
- Aug 10, 2001
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 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Reviewing Cervilenz, Inc. 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 Cervilenz, Inc. 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 |
|---|---|---|---|---|
| Apr 28, 2015 | Chagrin Falls, OH | Devices | No Action Indicated (NAI) | 3008492440 |
- 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 3008492440 | Chagrin Falls, OH | 1 | Apr 28, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K011840 | CERVILENZ UTERINE MEASURING SOUND | Aug 10, 2001 |
Cervilenz, Inc. and the FDA: common questions
Has Cervilenz, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Cervilenz, Inc." 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 Cervilenz, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Cervilenz, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Cervilenz, Inc.?
The most recent FDA inspection on file ended Apr 28, 2015 at Chagrin Falls, OH and was classified NAI. FDA has 1 inspection of Cervilenz, Inc. on file.
Need more than this page shows? Ask about Cervilenz, Inc. 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.