Cyberonics, Inc

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
1
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0555-2018Class IIVNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United SDecember 2, 2017
Z-2255-2018Class IIVNS Therapy Programmer, Model 3000, v1.0 SystemNovember 13, 2017
Z-3019-2017Class IIVNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product UsageJune 13, 2017
Z-3020-2017Class IIVNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product UsageJune 13, 2017
Z-0659-2016Class IIVNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing December 18, 2015
Z-0645-2016Class IICyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106November 18, 2015
Z-0280-2016Class IICyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106October 7, 2015
Z-1526-2015Class IIVNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONMarch 6, 2015
Z-0858-2015Class IICyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of November 20, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K092364MODEL 220 PATIENT MAGNETNovember 3, 2009