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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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Keypoint - 00382830049122

AMPLIFIER ARM, SINGLE
NATUS MANUFACTURING LIMITED
9031B0521
In Commercial Distribution

  • 00382830049122 ()
9031B0521

  • Electromyograph

Leadpoint - 00382830049092

Micro Electrode Cable, 5ch
NATUS MANUFACTURING LIMITED
9013C0551
In Commercial Distribution

  • 00382830049092 ()
9013C0551

  • Electromyograph

Leadpoint - 00382830049085

Micro Electrode Cable, 3ch
NATUS MANUFACTURING LIMITED
9013C0541
In Commercial Distribution

  • 00382830049085 ()
9013C0541

  • Electromyograph

Keypoint - 00382830049078

Goggles for VEP including 5m Cable
NATUS MANUFACTURING LIMITED
9031E0223
In Commercial Distribution

  • 00382830049078 ()
9031E0223

  • Electromyograph

Keypoint - 00382830049061

Advanced Stimulation Handgrip
NATUS MANUFACTURING LIMITED
9031E0172
In Commercial Distribution

  • 00382830049061 ()
9031E0172

  • Electromyograph

XLTEK - 00382830048651

P32 - STIM EXT 2 (A-D) - 9'
XLTEK
017868
In Commercial Distribution

  • 00382830048651 ()


  • Electromyograph

Keypoint - 00382830047746

Tremor Sensor - Reusable
NATUS MANUFACTURING LIMITED
9013L0241
In Commercial Distribution

  • 00382830047746 ()
9013L0241

  • Electromyograph

Natus - 00382830041928

EMGWorks for XCalibur DVD  
XLTEK
007878
In Commercial Distribution

  • 00382830041928 ()


  • Electromyograph

Natus - 00382830041621

Endeavor CR Mini Control Panel
NATUS NEUROLOGY INCORPORATED
515-013400
In Commercial Distribution

  • 00382830041621 ()


  • Electromyograph

Natus - 00382830041560

EMG USB Control Panel
NATUS NEUROLOGY INCORPORATED
515-016700
In Commercial Distribution

  • 00382830041560 ()


  • Electromyograph

Alpine BioMed - 00613994242297

KEYPOINT WS UKXP-OS
Alpine Biomed ApS
9031A006501
Not in Commercial Distribution

  • 00613994242297 ()


  • Electromyograph

N/A - 04961333241903

BULB, HALOGEN
PENTAX OF AMERICA, INC.
2140-0031
In Commercial Distribution

  • 04961333241903 ()


  • Laryngostroboscope system

ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGE - 04953170373848

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2190
In Commercial Distribution

  • 14953170373845 ()
  • 04953170373848 ()
N5400540

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 LIGHT - 04953170373800

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2189
In Commercial Distribution

  • 14953170373807 ()
  • 04953170373800 ()
N5400440

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 - 04953170373763

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2188
In Commercial Distribution

  • 14953170373760 ()
  • 04953170373763 ()
N5400340

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENT - 04953170360817

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2038
Not in Commercial Distribution

  • 04953170360817 ()
N5368840

  • Video capsule endoscopy system application software

ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENT - 04953170360824

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2039
Not in Commercial Distribution

  • 04953170360824 ()
N5368940

  • Video capsule endoscopy system application software

PORTRAIT SBT01 - 00195278120014

SENSOR BATTERY DEVICE ASSEMBLY
GE Healthcare Finland Oy
SBT01
In Commercial Distribution

  • 00195278366085 ()
  • 00195278120014 ()
2096442-001

  • Multiple vital physiological parameter monitoring system transceiver

Richmar EMG Software - 00092237626573

Richmar EMG Software
COMPASS HEALTH BRANDS CORP.
EMG-SW
In Commercial Distribution

  • 00092237626573 ()


  • Electromyograph

Richmar EMG Pro - 00092237626054

Richmar EMG Pro Rectal Probe
COMPASS HEALTH BRANDS CORP.
EMG-RP
In Commercial Distribution

  • 00092237626054 ()


  • Electromyograph
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