Terumo (Philippines) Corporation FDA Record
Terumo (Philippines) Corporation has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Terumo (Philippines) Corporation" is on file.
- Latest inspection
- Mar 21, 2013 · NAI
- Latest 510(k)
- Oct 16, 2015
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 5 | 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 |
|---|---|---|---|---|
| Mar 21, 2013 | Binan, Philippines | Devices | No Action Indicated (NAI) | 3003902955 |
- 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 3003902955 | Binan, Philippines | 1 | Mar 21, 2013 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K152362 | Terumo SurGuard 3 Safety Hypodermic Needle | Oct 16, 2015 |
| K133280 | TERUMO SURFLO I.V. CATHETER | Jun 12, 2014 |
| K121607 | TERUMO(R) NEEDLE | Nov 8, 2012 |
| K122249 | TERUMO SURGUARD3 SAFETY NEEDLE & HYPODERMIC SYRINGE WITH SAFETY NEEDLE | Aug 28, 2012 |
| K113422 | TERUMO SURGUARD 3 SAFETY NEEDLE TERUMO SURGUARD 3 HYPODERMIC SYRINGE WITH SAFETY NEEDLE | Mar 5, 2012 |
Terumo (Philippines) Corporation and the FDA: common questions
Has Terumo (Philippines) Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Terumo (Philippines) 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 Terumo (Philippines) Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Terumo (Philippines) Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Terumo (Philippines) Corporation?
The most recent FDA inspection on file ended Mar 21, 2013 at Binan, Philippines and was classified NAI. FDA has 1 inspection of Terumo (Philippines) Corporation on file.
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