Cyberonics, Inc
FDA Regulatory Profile
Cyberonics, Inc appears in FDA public data with 9 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0555-2018, Class II) was initiated on December 2, 2017. Its most recent 510(k) clearance was granted on November 3, 2009.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0555-2018 | Class II | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United S | December 2, 2017 |
| Z-2255-2018 | Class II | VNS Therapy Programmer, Model 3000, v1.0 System | November 13, 2017 |
| Z-3019-2017 | Class II | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage | June 13, 2017 |
| Z-3020-2017 | Class II | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage | June 13, 2017 |
| Z-0659-2016 | Class II | VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing | December 18, 2015 |
| Z-0645-2016 | Class II | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 | November 18, 2015 |
| Z-0280-2016 | Class II | Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 | October 7, 2015 |
| Z-1526-2015 | Class II | VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERON | March 6, 2015 |
| Z-0858-2015 | Class II | Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of | November 20, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K092364 | MODEL 220 PATIENT MAGNET | November 3, 2009 |