Silex Medical, LLC

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1900-2025Class IISignature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar ElectrJanuary 9, 2024
Z-1896-2025Class IISignature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar ElectrosurJanuary 9, 2024
Z-1897-2025Class IISignature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar ElectrosurgJanuary 9, 2024
Z-1894-2025Class IISignature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar ElectrosurJanuary 9, 2024
Z-1899-2025Class IISignature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar ElectrosurgJanuary 9, 2024
Z-1898-2025Class IISignature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar ElectrosurgiJanuary 9, 2024
Z-1893-2025Class IISignature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar ElectrosuJanuary 9, 2024
Z-1895-2025Class IISignature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar ElectrosurgicaJanuary 9, 2024