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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No Description
BTL INDUSTRIES LIMITED
EMTONE
In Commercial Distribution

  • B108784POEMTENUS0100 ()


  • Multi-modality hyperthermia system
No Description
BTL INDUSTRIES LIMITED
BTL-703
In Commercial Distribution

  • B108703POENUS0100 ()


  • Multi-modality hyperthermia system
No Description
BTL INDUSTRIES LIMITED
BTL-284-01
In Commercial Distribution

  • B108284AP01ENUS0100 ()


  • Multi-modality hyperthermia system
No Description
BTL INDUSTRIES LIMITED
BTL-284-01
In Commercial Distribution

  • B108284AP01EMTENUS0100 ()


  • Multi-modality hyperthermia system
Red/Infrared LED & Laser Therapy Device for Pain Relief.
MIESSENTIA MEDICAL USA LLC
Painbuster
Not in Commercial Distribution

  • 00860003478103 ()
  • 10860003478100 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Luminance Medical Ventures Incorporated
BE-NQUQ-FSF8
In Commercial Distribution

  • 00860002593074 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
No Description
Luminance Medical Ventures Incorporated
TN1927C
In Commercial Distribution

  • 00860002593050 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Luminance Medical Ventures Incorporated
TN1927B
In Commercial Distribution

  • 00860002593043 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
Luminance Medical Ventures Incorporated
TN1927A
In Commercial Distribution

  • 00860002593005 ()


  • Musculoskeletal/physical therapy laser, home-use
No Description
HILL LABORATORIES CO.
Electro Light Therapy
In Commercial Distribution

  • 00860001452549 ()


  • Blue/red/infrared phototherapy lamp
No Description
Rst- Sanexas
55105
In Commercial Distribution

  • 00860000214056 ()


  • Blue/red/infrared phototherapy lamp
No Description
Rst- Sanexas
55105
In Commercial Distribution

  • 00860000214025 ()
  • 10860000214022 ()


  • Blue/red/infrared phototherapy lamp
No Description
IVIMEA
IR-20
In Commercial Distribution

  • 00866085000409 ()


  • Musculoskeletal/physical therapy laser, professional
Lumiwave Double, 400 LED's, 2x4 Pods
BIOCARE SYSTEMS INC
DLW2X4
In Commercial Distribution

  • 00862662000213 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Lumiwave Single LED, 200 LED's, 1x4 Pods
BIOCARE SYSTEMS INC
SLW1X4
In Commercial Distribution

  • 00862662000206 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
LED infrared light therapy wrap for amputees
PHYSIOHAB LLC
OLKA3003
In Commercial Distribution

  • 00860013229085 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy wrap for the elbow
PHYSIOHAB LLC
OLE3006
In Commercial Distribution

  • 00860013229078 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the foot
PHYSIOHAB LLC
OLF3009
In Commercial Distribution

  • 00860013229061 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared light therapy wrap for the ankle
PHYSIOHAB LLC
OLA3001
In Commercial Distribution

  • 00860013229054 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared light therapy wrap for the Knee
PHYSIOHAB LLC
OLK3002
In Commercial Distribution

  • 00860013229047 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the Neck
PHYSIOHAB LLC
OLN3004
In Commercial Distribution

  • 00860013229030 ()


  • Blue/red/infrared phototherapy lamp
ONLUX Shoulder LED Infrared therapy device
PHYSIOHAB LLC
OLS3005
In Commercial Distribution

  • 00860013229023 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared Therapy device for the hand
PHYSIOHAB LLC
OLH3007
In Commercial Distribution

  • 00860013229016 ()


  • Blue/red/infrared phototherapy lamp
LED Infrared therapy device for the lumbar
PHYSIOHAB LLC
OLL3003
In Commercial Distribution

  • 00860013229009 ()


  • Blue/red/infrared phototherapy lamp
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
75W
In Commercial Distribution

  • 00860012594986 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
35W
In Commercial Distribution

  • 00860012594979 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
75W
In Commercial Distribution

  • 00860012594962 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012594955 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012594948 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012594931 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
75W
In Commercial Distribution

  • 00860012594924 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
75W
In Commercial Distribution

  • 00860012594917 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012594900 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012325092 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
75W
In Commercial Distribution

  • 00860012325085 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012325078 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
75W
In Commercial Distribution

  • 00860012325054 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012325030 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012325023 ()


  • Musculoskeletal/physical therapy laser, professional
No Description
PHOENIX THERA-LASE SYSTEMS, LLC
70W
In Commercial Distribution

  • 00860012325016 ()


  • Musculoskeletal/physical therapy laser, professional
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