Invent Medical Corporation FDA Record
Invent Medical Corporation has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Invent Medical Corporation" is on file.
- Latest inspection
- Apr 23, 2025 · NAI
- Latest 510(k)
- Jun 14, 2024
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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 23, 2025 | Carlsbad, CA | Devices | No Action Indicated (NAI) | 3016052406 |
- 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 3016052406 | Carlsbad, CA | 1 | Apr 23, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K233707 | HFT150 | Jun 14, 2024 |
Invent Medical Corporation and the FDA: common questions
Has Invent Medical Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Invent Medical Corporation" 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 Invent Medical Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Invent Medical Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Invent Medical Corporation?
The most recent FDA inspection on file ended Apr 23, 2025 at Carlsbad, CA and was classified NAI. FDA has 1 inspection of Invent Medical Corporation on file.
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