Smisson-Cartledge Biomedical, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 3 (3 Class I)
- 510(k) Clearances
- 2
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1259-2021 | Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapi | February 18, 2021 |
| Z-1260-2021 | Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapi | February 18, 2021 |
| Z-1258-2021 | Class I | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapi | February 18, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | August 12, 2022 |
| K052055 | SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 | October 26, 2006 |