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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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Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.
INNOVATIVE NEUROLOGICAL DEVICES LLC
Cervella CES
In Commercial Distribution

  • 00860001493306 ()
Cervella

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
RestoreX Kit - penile traction therapy device for the treatment of Peyronie's disease. Contains RestoreX device, extension rods, self-adherent wrap, Instructions for Use
PATHRIGHT MEDICAL INC.
117
In Commercial Distribution

  • 00860001453805 ()
117

  • Penile traction splint
No Description
HILL LABORATORIES CO.
HF54, Horizon
In Commercial Distribution

  • 00860001452532 ()


  • Physical therapy ultrasound system
FlowerRope
TENSYN MEDICAL, INC.
DLF 001
Not in Commercial Distribution

  • 00860001412215 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
FlowerRope
TENSYN MEDICAL, INC.
FOR 001
Not in Commercial Distribution

  • 00860001412208 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
TrueSpin
MEDTOX DIAGNOSTICS, INC.
S001
In Commercial Distribution

  • 00860001286564 ()


  • General-purpose centrifuge IVD
CABLE FMET-IM-RSC
MEDTRONIC, INC.
FMET-IM-RSC
In Commercial Distribution

  • 00860001276138 ()


  • Laser speckle blood flowmeter
SYSTEM FMET-IM-SYS
MEDTRONIC, INC.
FMET-IM-SYS
In Commercial Distribution

  • 00860001276121 ()


  • Laser speckle blood flowmeter
SENSOR FMET-IM-SENS-5
MEDTRONIC, INC.
FMET-IM-SENS-5
In Commercial Distribution

  • 10860001276111 ()
  • 00860001276114 ()


  • Laser speckle blood flowmeter
AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.
MAXQ AI LTD
V2.3 and subsequent minor V2.x releases
In Commercial Distribution

  • 00860001219531 ()


  • Radiology DICOM image processing application software
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