Nipro Diabetes Systems, Inc.
Nipro Diabetes Systems, Inc. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Mar 19, 2009 · NAI
- Latest 510(k)
- Dec 14, 2007
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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 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 19, 2009 | Miramar, FL | Devices | No Action Indicated (NAI) | 3003352163 |
- 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 3003352163 | Miramar, FL | 1 | Mar 19, 2009 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K071613 | AMIGO INSULIN PUMP | Dec 14, 2007 |
| K050312 | AMIGO INSULIN PUMP | May 9, 2005 |
| K014114 | GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX | Jun 26, 2002 |
| K013309 | GLUCOPRO EVO INFUSION PUMP | Jun 24, 2002 |
| K011120 | GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES | May 8, 2001 |
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