Poly Medicure Limited
FDA Regulatory Profile
Poly Medicure Limited has 0 FDA recalls, 1 inspection, 7 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 22, 2010 · VAI
- Latest 510(k)
- Oct 23, 2026
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 7 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 1 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jul 22, 2010 | Faridabad, India | Devices | Voluntary Action Indicated (VAI) | 3003205539 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003205539 | Faridabad, India | 1 | Jul 22, 2010 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261670 | Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR… | Oct 23, 2026 |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm… | Apr 1, 2026 |
| K252677 | Polyshield Safety IV Catheters | Nov 5, 2025 |
| K232234 | Nouvo Safety Set | Mar 15, 2024 |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva | Sep 21, 2023 |
| K230616 | Polyguard and Polyshield Safety IV Catheters | May 5, 2023 |
| K220312 | Polyfusion IV Administration Sets | Apr 12, 2023 |