Sweden & Martina S.P.A.
Sweden & Martina S.P.A. has 0 FDA recalls, 1 inspection, 8 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Aug 1, 2024 · VAI
- Latest 510(k)
- May 26, 2023
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Summary
- Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 1
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Aug 1, 2024 | Due Carrare, Italy | Devices | Voluntary Action Indicated (VAI) | 3001082453 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K222640 | Sweden & Martina Surgical Trays | May 26, 2023 |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | Nov 4, 2020 |
| K180365 | PRAMA White Implant Systems | Jul 8, 2019 |
| K161989 | PREMIUM Implant Systems SHELTA Implant Systems | Feb 1, 2018 |
| K172560 | PREMIUM ONE Implant Systems | Dec 21, 2017 |
| K162028 | PREMIUM - SHELTA Prosthetic Components | Mar 24, 2017 |
| K162004 | PREMIUM Implant Systems SHELTA Implant Systems | Dec 5, 2016 |
| K142242 | PREMIUM, SHELTA Implant Systems | Feb 2, 2015 |