Kem Medical Products Corp.
Kem Medical Products Corp. has 0 FDA recalls, 5 inspections, 4 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 21, 2022 · VAI
- Latest 510(k)
- Sep 30, 2024
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 4 | Oct 4, 2026 | Not stated | Current |
| Inspections | 5 | Oct 26, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 21, 2022 | Hauppauge, NY | Devices | Voluntary Action Indicated (VAI) | 2432141 |
| Jan 15, 2020 | Hauppauge, NY | Devices | Voluntary Action Indicated (VAI) | 2432141 |
| Feb 21, 2017 | Hauppauge, NY | Devices | No Action Indicated (NAI) | 2432141 |
| Jul 10, 2012 | Hauppauge, NY | Devices | No Action Indicated (NAI) | 2432141 |
| Oct 27, 2009 | Hauppauge, NY | Devices | Voluntary Action Indicated (VAI) | 2432141 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam Sterilization | Sep 30, 2024 |
| K181788 | Lead-free Chemical Indicators for Steam Sterilization | Mar 1, 2019 |
| K802228 | BIOLOGICAL INDICATOR - KEMMED & BIOSURE | Dec 9, 1980 |
| K802229 | CHEMICAL INDICATOR - KEM MED & BIO SURE | Dec 9, 1980 |