Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Implantable Pulse Generator
LIVANOVA USA, INC.
8103
In Commercial Distribution

  • 05425025750504 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750481 ()


  • Vagus nerve electrical stimulation system programmer
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750443 ()


  • Vagus nerve electrical stimulation system programmer
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750429 ()


  • Vagus nerve electrical stimulation system programmer
Implantable Pulse Generator
LIVANOVA USA, INC.
1000
In Commercial Distribution

  • 05425025750405 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750399 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer
Patient Magnet
LIVANOVA USA, INC.
7220
In Commercial Distribution

  • 05425025750313 ()


  • Active implantable device control magnet
Patient Magnet
LIVANOVA USA, INC.
220
In Commercial Distribution

  • 05425025750252 ()


  • Active implantable device control magnet
Accessory Pack
LIVANOVA USA, INC.
502
In Commercial Distribution

  • 05425025750245 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Tunneler
LIVANOVA USA, INC.
402
In Commercial Distribution

  • 05425025750238 ()


  • Vascular graft tunneller
Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer
Programming Wand
LIVANOVA USA, INC.
2000
In Commercial Distribution

  • 05425025750177 ()


  • Vagus nerve electrical stimulation system programmer
Programming Wand
LIVANOVA USA, INC.
201
In Commercial Distribution

  • 05425025750160 ()


  • Vagus nerve electrical stimulation system programmer
Implantable Lead
LIVANOVA USA, INC.
304-30
In Commercial Distribution

  • 05425025750153 ()

  • Outer Diameter: 3.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
304-20
In Commercial Distribution

  • 05425025750139 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
303-30
In Commercial Distribution

  • 05425025750122 ()

  • Outer Diameter: 3.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
303-20
In Commercial Distribution

  • 05425025750115 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Bipolar Lead
LIVANOVA USA, INC.
302-30
In Commercial Distribution

  • 05425025750108 ()

  • Outer Diameter: 3.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Bipolar Lead
LIVANOVA USA, INC.
302-20
In Commercial Distribution

  • 05425025750092 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Pulse Generator
LIVANOVA USA, INC.
106
In Commercial Distribution

  • 05425025750061 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Implantable Pulse Generator
LIVANOVA USA, INC.
105
In Commercial Distribution

  • 05425025750054 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Implantable Pulse Generator
LIVANOVA USA, INC.
104
In Commercial Distribution

  • 05425025750047 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Implantable Pulse Generator
LIVANOVA USA, INC.
103
In Commercial Distribution

  • 05425025750030 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Implantable Pulse Generator
LIVANOVA USA, INC.
102R
In Commercial Distribution

  • 05425025750023 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Implantable Pulse Generator
LIVANOVA USA, INC.
102
In Commercial Distribution

  • 05425025750016 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Indications for Use: CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Prophylactic treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Connected Bundle VA
In Commercial Distribution

  • 05425018850334 ()
10811

  • Craniofacial analgesia electrical stimulator
Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes)
Cefaly Technology SPRL
11302
In Commercial Distribution

  • 05425018850181 ()
  • 05425018850310 ()


  • Craniofacial analgesia electrical stimulator
CEFALY Enhanced Electrode Kit .3 electrodes
Cefaly Technology SPRL
11301
In Commercial Distribution

  • 05425018850174 ()
  • 05425018850303 ()


  • Craniofacial analgesia electrical stimulator
CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Connected
In Commercial Distribution

  • 05425018850297 ()
10801

  • Craniofacial analgesia electrical stimulator
CEFALY Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY Enhanced is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY Enhanced
In Commercial Distribution

  • 05425018850280 ()
10701

  • Craniofacial analgesia electrical stimulator
Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use: CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use. CEFALY DUAL Enhanced is indicated to be used for: The acute treatment of migraine with or without aura in patients 18 years of age or older. The preventative treatment of episodic migraine in patients 18 years of age or older.
Cefaly Technology SPRL
CEFALY DUAL Enhanced
In Commercial Distribution

  • 05425018850273 ()
10601

  • Craniofacial analgesia electrical stimulator
The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults.
Cefaly Technology SPRL
Prevent
In Commercial Distribution

10230

  • Craniofacial analgesia electrical stimulator
The Cefaly® Dual device is indicated for: - The acute treatment of migraine with or without aura in patients 18 years of age or older. - The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Cefaly Technology SPRL
Dual
In Commercial Distribution

  • 05425018850259 ()
10505

  • Craniofacial analgesia electrical stimulator
The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.
Cefaly Technology SPRL
Acute
In Commercial Distribution

  • 05425018850242 ()
10405

  • Craniofacial analgesia electrical stimulator
Kit 3 Electrodes Blue Gel for Cefaly II
Cefaly Technology SPRL
11202
In Commercial Distribution

  • 05425018850150 ()
  • 05425018850181 ()


  • Craniofacial analgesia electrical stimulator
Kit 3 electrodes for Cefaly II
Cefaly Technology SPRL
11201
In Commercial Distribution

  • 05425018850143 ()
  • 05425018850174 ()


  • Craniofacial analgesia electrical stimulator
Set Cefaly® : - Instruction manual - Cefaly® device - Cefaly® electrode - Storage box - Power adapter + cable
Cefaly Technology SPRL
10205
In Commercial Distribution

  • 05425018850129 ()


  • Craniofacial analgesia electrical stimulator
Kit 3 electrodes Blue Gel for Cefaly I
Cefaly Technology SPRL
11106
In Commercial Distribution

  • 05425018850105 ()
  • 05425018850204 ()


  • Craniofacial analgesia electrical stimulator
Kit 3 electrodes for Cefaly I
Cefaly Technology SPRL
11101
In Commercial Distribution

  • 05425018850044 ()
  • 05425018850198 ()


  • Craniofacial analgesia electrical stimulator
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Gynetics Medical Products NV
#4551 FAS XD-BCB2
In Commercial Distribution

  • 25425017505840 ()
  • 05425017505846 ()
  • 15425017505843 ()


  • IVF oocyte aspiration needle, single-use
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Gynetics Medical Products NV
#4551 FAS FD
In Commercial Distribution

  • 25425017503228 ()
  • 05425017503224 ()
  • 15425017503221 ()


  • IVF oocyte aspiration needle, single-use
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Gynetics Medical Products NV
#4551 FAS C2
In Commercial Distribution

  • 25425017503044 ()
  • 05425017503040 ()
  • 15425017503047 ()


  • IVF oocyte aspiration needle, single-use
Intrauterine insemination cannula
Gynetics Medical Products NV
#4220 Plus
In Commercial Distribution

  • 15425017502088 ()
  • 05425017502081 ()
  • 25425017502085 ()


  • Assisted reproduction transfer catheter/set
Intrauterine insemination cannula
Gynetics Medical Products NV
#4502 B Seminor Flexible
In Commercial Distribution

  • 25425017502061 ()
  • 05425017502067 ()
  • 15425017502064 ()


  • Assisted reproduction transfer catheter/set
Intrauterine insemination cannula
Gynetics Medical Products NV
#4502 A Seminor Rigid
In Commercial Distribution

  • 25425017502054 ()
  • 05425017502050 ()
  • 15425017502057 ()


  • Assisted reproduction transfer catheter/set
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