VATECH Co., Ltd. FDA Record
VATECH Co., Ltd. has 0 FDA recalls, 2 inspections, 40 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "VATECH Co., Ltd." is on file.
- Latest inspection
- Feb 2, 2014 · NAI
- Latest 510(k)
- Mar 31, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 40 | 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 |
|---|---|---|---|---|
| Feb 2, 2014 | Hwaseong, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3004706313 |
| Jun 10, 2011 | Hwaseong, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3004706313 |
- 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 3004706313 | Hwaseong, Korea (The Republic Of) | 2 | Feb 2, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | Mar 31, 2026 |
| K243088 | Green X 12 SE (PHT-40CHS) | Feb 21, 2025 |
| K243081 | Green X 21 (PHT-90CHO) | Feb 14, 2025 |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0… | Oct 25, 2024 |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | Jul 19, 2023 |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | Oct 26, 2022 |
| K213462 | EzRay M18 (Model: VMX-P400) | Feb 11, 2022 |
| K210329 | Green X 18(Model : PHT-75CHS) | Feb 18, 2021 |
| K203667 | EzRay M (Model: VMX-P300) | Feb 2, 2021 |
| K203797 | vatech A9 (Model : PHT-30CSS) | Jan 25, 2021 |
| K201627 | Dental Computed Tomography X-Ray System, Green X | Oct 27, 2020 |
| K200182 | EzRay Air Portable (Model: VEX-P300) | Feb 11, 2020 |
| K170066 | Green16/Green18 (Model: PHT-65LHS) | Jun 16, 2017 |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | Apr 4, 2017 |
| K163705 | EzRay Air W | Jan 24, 2017 |
| K160882 | PaX-i3D Green Premium (Model: PCT-90LH) | Oct 28, 2016 |
| K162660 | Green Smart (Model: PHT-35LHS) | Oct 20, 2016 |
| K161063 | EzRay Air (Model VEX-P300) | Sep 1, 2016 |
| K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | Oct 23, 2015 |
| K132983 | TON-95LH, PAX-I3D ORTHO | Aug 7, 2014 |
VATECH Co., Ltd. and the FDA: common questions
Has VATECH Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "VATECH 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 VATECH Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "VATECH Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect VATECH Co., Ltd.?
The most recent FDA inspection on file ended Feb 2, 2014 at Hwaseong, Korea (The Republic Of) and was classified NAI. FDA has 2 inspections of VATECH Co., Ltd. on file.
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