Rapid Biomedical GmbH
Rapid Biomedical GmbH has 0 FDA recalls, 2 inspections, 7 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Jul 5, 2018 · VAI
- Latest 510(k)
- Feb 1, 2023
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 7 | Oct 4, 2026 | Not stated | Current |
| Inspections | 2 | Oct 25, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 5, 2018 | Rimpar, Germany | Devices | Voluntary Action Indicated (VAI) | 3005049692 |
| Jun 28, 2012 | Rimpar, Germany | Devices | Voluntary Action Indicated (VAI) | 3005049692 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | Feb 1, 2023 |
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | Jan 31, 2020 |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | Nov 16, 2018 |
| K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil | Mar 21, 2018 |
| K102748 | 31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T | May 13, 2011 |
| K102348 | 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE… | Dec 22, 2010 |
| K083255 | 16CH AI BREAST COILS 1.5 T AND 3 T | Nov 21, 2008 |