Tytek Medical Inc

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-2610-2023Class IITyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the boOctober 5, 2020
Z-2612-2023Class IITyTek PneumoDart- Intended for introduction into the body to facilitate removal of air from the pleuOctober 5, 2020
Z-2611-2023Class IITyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into thOctober 5, 2020
Z-0930-2020Class IPneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction November 15, 2019