Imedicom Co., Ltd. FDA Record
- Latest inspection NAI · Jun 2, 2016
- No warning letters matched by name
Imedicom Co., Ltd. has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Imedicom Co., Ltd." is on file.
- Latest inspection
- Jun 2, 2016 · NAI
- Latest 510(k)
- Apr 6, 2019
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 7 | Nov 15, 2026 | File dated Nov 9, 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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jun 2, 2016 | Gunpo-Si, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3009599228 |
- 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 3009599228 | Gunpo-Si, Korea (The Republic Of) | 1 | Jun 2, 2016 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K182287 | MEDINAUT Plus | Apr 6, 2019 |
| K173541 | EPINAUT | Aug 24, 2018 |
| K153296 | MEDINAUT Kyphoplasty System | Jul 29, 2016 |
| K150915 | SPINAUT-P | Mar 18, 2016 |
| K151268 | SPINAUT-V, SPINAUT-S, SPINAUT-I | Mar 16, 2016 |
| K150789 | SPINAUT-E, SPINAUT-I | Mar 1, 2016 |
| K133669 | MEDINAUT KYPHOPLASTY SYSTEM | Apr 4, 2014 |
Imedicom Co., Ltd. and the FDA: common questions
Has Imedicom Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Imedicom 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 Imedicom Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Imedicom Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Imedicom Co., Ltd.?
The most recent FDA inspection on file ended Jun 2, 2016 at Gunpo-Si, Korea (The Republic Of) and was classified NAI. FDA has 1 inspection of Imedicom Co., Ltd. on file.
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