Sam Medical Products

FDA Regulatory Profile

Sam Medical Products appears in FDA public data with 2 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0789-2022, Class II) was initiated on January 28, 2022. Its most recent 510(k) clearance was granted on May 22, 2014.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Known Names

sam medical products, sam® medical products

Recent Recalls

NumberClassProductDate
Z-0789-2022Class IISAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09January 28, 2022
Z-0133-2015Class IISAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific inAugust 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K133121CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITOMay 22, 2014
K131561SAM JUNCTIONAL TOURNIQUETJuly 24, 2013
K123694SAM JUNCTIONAL TOURNIQUETMarch 7, 2013
K102403SAM CHEST SEAL WITH VAVLE; SAM CHEST SEALMarch 3, 2011