Smisson-Cartledge Biomedical, LLC

FDA Regulatory Profile

Smisson-Cartledge Biomedical, LLC appears in FDA public data with 3 recalls — including 3 Class I (most serious) —, 2 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1259-2021, Class I) was initiated on February 18, 2021. Its most recent 510(k) clearance was granted on August 12, 2022.

Summary

Total Recalls
3 (3 Class I)
510(k) Clearances
2
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1259-2021Class IThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 RapiFebruary 18, 2021
Z-1258-2021Class IThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 RapiFebruary 18, 2021
Z-1260-2021Class IThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 RapiFebruary 18, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemAugust 12, 2022
K052055SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200October 26, 2006