Sunder Biomedical Tech. Co., Ltd.
Sunder Biomedical Tech. Co., Ltd. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Sep 13, 2017 · OAI
- Latest 510(k)
- Jul 14, 2003
Reviewing Sunder Biomedical Tech. Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check Sunder Biomedical Tech. Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 13, 2017 | Yunlin, Taiwan | Devices | Official Action Indicated (OAI) | 3003656001 |
- 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 3003656001 | Yunlin, Taiwan | 1 | Sep 13, 2017 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K024007 | SUNDER CENTRAL VENOUS CATHETER KIT, MODELS SD-3L55F30J AND SD-3L70F30J | Jul 14, 2003 |
| K014140 | RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET | Nov 18, 2002 |
| K003123 | RENAX A.V. FISTULA NEEDLE SETS | May 4, 2001 |
Need more than this page shows? Ask about Sunder Biomedical Tech. Co., Ltd. in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.