ClearanceBrief
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

CodeDeviceRecords
LYJStimulator, Autonomic Nerve, Implanted For Epilepsy22
DTGMagnet, Test, Pacemaker1
MUZStimulator, Autonomic Nerve, Implanted (Depression)1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 3, 2009K092364MODEL 220 PATIENT MAGNET
Cyberonics, Inc.
DTG

Latest recalls

DateFirm and productCodeLinked 510(k)
Dec 2, 2017Cyberonics, 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
LYJNone listed
Nov 13, 2017Cyberonics, Inc
VNS Therapy Programmer, Model 3000, v1.0 System
Terminated
MUZNone listed
Jun 13, 2017Cyberonics, 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
LYJNone listed
Jun 13, 2017Cyberonics, 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
LYJNone listed
Jan 15, 2016Cyberonics, Inc
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Terminated
LYJNone listed
Jan 13, 2016Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Terminated
LYJNone listed
Nov 17, 2015Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Terminated
LYJNone listed
Apr 27, 2015Cyberonics, Inc
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Terminated
LYJNone listed
Dec 23, 2014Cyberonics, 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
LYJNone listed
Nov 18, 2011Cyberonics, 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
LYJNone listed
Oct 4, 2011Cyberonics, 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
LYJNone listed
Oct 4, 2011Cyberonics, 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
LYJNone listed
May 10, 2010Cyberonics, 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
LYJNone listed
Jan 14, 2010Cyberonics, 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
LYJNone listed
Nov 16, 2009Cyberonics, 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
LYJNone listed
Apr 22, 2009Cyberonics, Inc
Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.
Terminated
LYJNone listed
Apr 22, 2009Cyberonics, Inc
Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator.
Terminated
LYJNone listed
Jan 29, 2008Cyberonics, 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
LYJNone listed
Nov 28, 2007Cyberonics, Inc
Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058.
Terminated
LYJNone listed
Nov 28, 2007Cyberonics, Inc
Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.
Terminated
LYJNone listed
Nov 28, 2007Cyberonics, Inc
Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.
Terminated
LYJNone listed
Jan 25, 2007Cyberonics, 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
LYJNone listed
Jan 25, 2007Cyberonics, 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
LYJNone listed
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