Gyrus Acmi, Incorporated

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1952-2018Class IIGyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700April 17, 2018
Z-1753-2015Class IIGyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal May 8, 2015
Z-1752-2015Class IIGyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal May 8, 2015
Z-0419-2015Class IIGyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mmOctober 21, 2014
Z-1439-2013Class IIGYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO,May 24, 2013
Z-0411-2013Class IIPARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INOctober 17, 2012