Meta Biomed Co., Ltd. FDA Record
- Latest inspection VAI · Nov 19, 2009
- No warning letters matched by name
Meta Biomed Co., Ltd. has 0 FDA recalls, 1 inspection, 25 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Meta Biomed Co., Ltd." is on file.
- Latest inspection
- Nov 19, 2009 · VAI
- Latest 510(k)
- Oct 8, 2024
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 | 25 | 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 |
|---|---|---|---|---|
| Nov 19, 2009 | Cheongju, Korea (The Republic Of) | Devices | Voluntary Action Indicated (VAI) | 3005907356 |
- 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 3005907356 | Cheongju, Korea (The Republic Of) | 1 | Nov 19, 2009 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K242014 | Jet Flow Bulk | Oct 8, 2024 |
| K232299 | CeraPutty | Sep 29, 2023 |
| K230010 | ADSEAL Plus | Apr 13, 2023 |
| K230009 | EZ Bond Universal | Mar 3, 2023 |
| K210904 | Metapaste Plus | Jun 30, 2021 |
| K202617 | Metapex Plus | Apr 14, 2021 |
| K191991 | Ezfil | Mar 5, 2020 |
| K190724 | MD-Temp Plus | Jul 3, 2019 |
| K190503 | CeraSeal | Jun 7, 2019 |
| K190510 | GuttaSil | May 29, 2019 |
| K181689 | Nexcomp | Nov 15, 2018 |
| K180802 | Meta P&Bond | Aug 29, 2018 |
| K171449 | Metacem | May 15, 2018 |
| K133298 | ENDO SMART | Sep 19, 2014 |
| K134008 | MD-FLEX HEAVY BODY | Apr 9, 2014 |
| K132041 | REXTAR X | Jul 31, 2013 |
| K122016 | REXTAR, REXTAR LCD | Mar 1, 2013 |
| K081913 | METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER | Sep 5, 2008 |
| K080772 | BONEMEDIK-DM | Jun 3, 2008 |
| K080305 | NEXCOMP AND META ETCHANT | Apr 7, 2008 |
Meta Biomed Co., Ltd. and the FDA: common questions
Has Meta Biomed Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Meta Biomed 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 Meta Biomed Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Meta Biomed Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Meta Biomed Co., Ltd.?
The most recent FDA inspection on file ended Nov 19, 2009 at Cheongju, Korea (The Republic Of) and was classified VAI. FDA has 1 inspection of Meta Biomed Co., Ltd. on file.
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