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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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5" Alligator Rongeur
SIGNAL MEDICAL CORPORATION
5"
In Commercial Distribution

  • B046BIO110410 ()
BIO-1-1041

  • Orthopaedic joint/limb rongeur
Cutaneous Electrode Garment Released as revision 5 on 2017-11-28
AXIOBIONICS
5
In Commercial Distribution

  • B3673350 ()
  • B3673340 ()
33

  • Transcutaneous electrical stimulation electrode, single-use
No Description
Fivos, Inc.
5
Not in Commercial Distribution

  • B159FIVOSPACS0 ()


  • Radiological PACS software
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system
No Description
MATH RESOLUTIONS, LLC
5
In Commercial Distribution

  • B229DC051 ()


  • Radiation therapy software
MAC Strap-XL
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14217 ()
  • B547RF14210 ()
  • B547RF1440219 ()

  • Length: 743 Millimeter
RF1421

  • Intermittent venous compression system
MAC Strap-Standard
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14208 ()
  • B547RF14200 ()
  • B547RF1440209 ()

  • Length: 565 Millimeter
RF1420

  • Intermittent venous compression system
AirSep FreeStyle 5 Portable Oxygen Concentrator, 1-5LPM, External Battery, Re-Manufactured
CAIRE INC.
AS077-101CU
In Commercial Distribution

  • M766AS077101CU0 ()


  • Mobile/portable oxygen concentrator
No Description
PREVEST DENPRO LIMITED
Economy Pack
In Commercial Distribution

  • D96710004 ()
10004

  • Dental acrylic resin kit
No Description
PREVEST DENPRO LIMITED
Intro Pack
In Commercial Distribution

  • D96710003 ()
10003

  • Dental acrylic resin kit
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