Company ยท US
Cyberonics, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2009. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
23recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2017 | Cyberonics, Inc VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2
Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive ther Terminated |
LYJ | None listed |
| Nov 13, 2017 | Cyberonics, Inc VNS Therapy Programmer, Model 3000, v1.0 System Terminated |
MUZ | None listed |
| Jun 13, 2017 | Cyberonics, Inc VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 106.
Product Usage:
United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use Terminated |
LYJ | None listed |
| Jun 13, 2017 | Cyberonics, Inc VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105.
Product Usage:
United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use Terminated |
LYJ | None listed |
| Jan 15, 2016 | Cyberonics, Inc VNS Therapy AspireSR Generator Model 106.
Indicated for use as an adjunctive therapy in reducing the frequency of seizures. Terminated |
LYJ | None listed |
| Jan 13, 2016 | Cyberonics, Inc Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 Terminated |
LYJ | None listed |
| Nov 17, 2015 | Cyberonics, Inc Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 Terminated |
LYJ | None listed |
| Apr 27, 2015 | Cyberonics, Inc VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC. Terminated |
LYJ | None listed |
| Dec 23, 2014 | Cyberonics, Inc Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system use Terminated |
LYJ | None listed |
| Nov 18, 2011 | Cyberonics, Inc VNS Therapy Aspire HC Generator and VNS, Model 105
Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058
For implantation in humans to treat Epilepsy and Depression. Terminated |
LYJ | None listed |
| Oct 4, 2011 | Cyberonics, Inc Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling m Terminated |
LYJ | None listed |
| Oct 4, 2011 | Cyberonics, Inc VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may b Terminated |
LYJ | None listed |
| May 10, 2010 | Cyberonics, Inc VNS Therapy Demipulse Generator, Model 103 and
VNS Therapy Demipulse Duo Generator, Model 104
VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software Terminated |
LYJ | None listed |
| Jan 14, 2010 | Cyberonics, Inc VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104.
The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Le Terminated |
LYJ | None listed |
| Nov 16, 2009 | Cyberonics, Inc Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes o Terminated |
LYJ | None listed |
| Apr 22, 2009 | Cyberonics, Inc Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator. Terminated |
LYJ | None listed |
| Apr 22, 2009 | Cyberonics, Inc Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator. Terminated |
LYJ | None listed |
| Jan 29, 2008 | Cyberonics, Inc Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher; manufactured by Cyberonics, Inc., Houston, TX. Terminated |
LYJ | None listed |
| Nov 28, 2007 | Cyberonics, Inc Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058. Terminated |
LYJ | None listed |
| Nov 28, 2007 | Cyberonics, Inc Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058. Terminated |
LYJ | None listed |
| Nov 28, 2007 | Cyberonics, Inc Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058. Terminated |
LYJ | None listed |
| Jan 25, 2007 | Cyberonics, Inc Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX. Terminated |
LYJ | None listed |
| Jan 25, 2007 | Cyberonics, Inc Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX. Terminated |
LYJ | None listed |