Domain Surgical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0690-2017Class IIFMsealer Open Shears. Model FM3001October 24, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K142229Laparoscopic FMsealerJanuary 2, 2015
K141484OPEN FMSEALERJuly 30, 2014
K140384FMWAND HANDPIECE SEMay 23, 2014
K130606FMWAND FERROMAGNETIC SURGICAL SYSTEMJanuary 3, 2014
K121881DOMAIN SURGICAL SYSTEMOctober 18, 2012
K110439DOMAIN SURGICAL SYSTEMJuly 18, 2011