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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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VNS Therapy® Model 250 v10.0 Programming Software - 05425025750382

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750375

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v11.0 Programming Software - 05425025750368

Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer

VITARIA™ Patient Essentials, Model 7220 - 05425025750313

Patient Magnet
LIVANOVA USA, INC.
7220
In Commercial Distribution

  • 05425025750313 ()


  • Active implantable device control magnet

Cyberonics® Patient Magnet - 05425025750252

Patient Magnet
LIVANOVA USA, INC.
220
In Commercial Distribution

  • 05425025750252 ()


  • Active implantable device control magnet

VNS Therapy® Model 502 Accessory Pack - 05425025750245

Accessory Pack
LIVANOVA USA, INC.
502
In Commercial Distribution

  • 05425025750245 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

Cyberonics® Tunneler Model 402 - 05425025750238

Tunneler
LIVANOVA USA, INC.
402
In Commercial Distribution

  • 05425025750238 ()


  • Vascular graft tunneller

VNS Therapy® Model 250 v10.0 Programming Software - 05425025750214

Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X5) - 05425025750191

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Model 250 v8.1 Programming Software (X50) - 05425025750184

Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® Programming Wand Model 2000 - 05425025750177

Programming Wand
LIVANOVA USA, INC.
2000
In Commercial Distribution

  • 05425025750177 ()


  • Vagus nerve electrical stimulation system programmer

NCP® Programming Wand Model 201 - 05425025750160

Programming Wand
LIVANOVA USA, INC.
201
In Commercial Distribution

  • 05425025750160 ()


  • Vagus nerve electrical stimulation system programmer

VNS Therapy® AspireSR® Model 106 Generator - 05425025750061

Implantable Pulse Generator
LIVANOVA USA, INC.
106
In Commercial Distribution

  • 05425025750061 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

VNS Therapy® AspireHC® Model 105 Generator - 05425025750054

Implantable Pulse Generator
LIVANOVA USA, INC.
105
In Commercial Distribution

  • 05425025750054 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

VNS Therapy® Demipulse Duo® Model 104 Generator - 05425025750047

Implantable Pulse Generator
LIVANOVA USA, INC.
104
In Commercial Distribution

  • 05425025750047 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

VNS Therapy® Demipulse® Model 103 Generator - 05425025750030

Implantable Pulse Generator
LIVANOVA USA, INC.
103
In Commercial Distribution

  • 05425025750030 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

VNS Therapy® Pulse Duo Model 102R Generator - 05425025750023

Implantable Pulse Generator
LIVANOVA USA, INC.
102R
In Commercial Distribution

  • 05425025750023 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

VNS Therapy® Pulse Model 102 Generator - 05425025750016

Implantable Pulse Generator
LIVANOVA USA, INC.
102
In Commercial Distribution

  • 05425025750016 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system

Cefaly® - 05425018850334

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

Cefaly® - 05425018850310

Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes)
Cefaly Technology SPRL
11302
In Commercial Distribution

  • 05425018850181 ()
  • 05425018850310 ()


  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850303

CEFALY Enhanced Electrode Kit .3 electrodes
Cefaly Technology SPRL
11301
In Commercial Distribution

  • 05425018850174 ()
  • 05425018850303 ()


  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850297

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® - 05425018850280

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® - 05425018850273

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

Cefaly® - 05425018850266

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

Cefaly® - 05425018850259

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

Cefaly® - 05425018850242

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

Cefaly® - 05425018850150

Kit 3 Electrodes Blue Gel for Cefaly II
Cefaly Technology SPRL
11202
In Commercial Distribution

  • 05425018850150 ()
  • 05425018850181 ()


  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850143

Kit 3 electrodes for Cefaly II
Cefaly Technology SPRL
11201
In Commercial Distribution

  • 05425018850143 ()
  • 05425018850174 ()


  • Craniofacial analgesia electrical stimulator

Cefaly® - 05425018850129

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
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