GEO MEDICAL CO., LTD. FDA Record
GEO MEDICAL CO., LTD. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GEO MEDICAL CO., LTD." is on file.
- Latest inspection
- Apr 13, 2023 · VAI
- Latest 510(k)
- Apr 29, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 2 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | 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 13, 2023 | Buk, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3008585940 |
| Jan 31, 2013 | Buk, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3008585940 |
- 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 3008585940 | Buk, Korea (The Republic Of) | 2 | Apr 13, 2023 |
GEO MEDICAL CO., LTD. and the FDA: common questions
Has GEO MEDICAL CO., LTD. received an FDA warning letter?
No FDA warning letter addressed to the name "GEO MEDICAL CO., LTD." 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 GEO MEDICAL CO., LTD. received an FDA Form 483?
FDA has not published a Form 483 for "GEO MEDICAL CO., LTD." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect GEO MEDICAL CO., LTD.?
The most recent FDA inspection on file ended Apr 13, 2023 at Buk, Korea (The Republic Of) and was classified VAI. FDA has 2 inspections of GEO MEDICAL CO., LTD. on file.
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