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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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Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(SWISS)
In Commercial Distribution

  • 00850015266997 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) German
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(GER)
In Commercial Distribution

  • 00850015266980 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(SWISS)
In Commercial Distribution

  • 00850015266973 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler LE Device Kit Swiss
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(SWISS)
In Commercial Distribution

  • 00850015266966 ()


  • Electroencephalograph
Sleep Profiler LE Device Kit French
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(FRE)
In Commercial Distribution

  • 00850015266959 ()


  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(FRE)
In Commercial Distribution

  • 00850015266942 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
X24 LE Stat Device Kit Stratus
ADVANCED BRAIN MONITORING, INC.
XS30-1006.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266898 ()


  • Electroencephalograph
X24 LE Stat Device Kit Clinical
ADVANCED BRAIN MONITORING, INC.
XS30-1007.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266690 ()


  • Electroencephalograph
X24 LE Stat Device Kit
ADVANCED BRAIN MONITORING, INC.
XS30-1001.LE
In Commercial Distribution

  • 00850015266683 ()
  • 00850015266249 ()


  • Electroencephalograph
Sleep Profiler LE Device Kit Dutch
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(DUT)
In Commercial Distribution

  • 00850015266676 ()


  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850015266669 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler LE Device Kit (Arm&Chin EMG) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1014.LE(ITA)
In Commercial Distribution

  • 00850015266607 ()


  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(GER)
In Commercial Distribution

  • 00850015266546 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler LE Device Kit German
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(GER)
In Commercial Distribution

  • 00850015266539 ()


  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit (No Belts / PM3) with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE, SP29-1007.LE
In Commercial Distribution

  • 00850015266256 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
The Myocene device is intended to provide objective measures of muscle fatigue to inform athletic training decisions by coaches and athletes. It is for applications in sport practice, to be used on healthy individuals (athletes), 15 years of age or older, to carry out tests of the extensor muscles of the knee by quantitatively measuring the force of contraction of the healthy quadriceps muscles generated by voluntary contractions and induced by a specific associated powered muscle stimulator, and by using these forces to compute objective measures of quadriceps muscle fatigue
Myocene
1-U
In Commercial Distribution

  • 05430004268000 ()


  • Quadriceps fatigue electrostimulation analyser
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 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
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