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
Body Balance System, LLC
LITE
In Commercial Distribution

  • 00860009854567 ()


  • Red/infrared light phototherapy unit
No Description
Body Balance System, LLC
GLOW
In Commercial Distribution

  • 00860009854550 ()


  • Red/infrared light phototherapy unit
No Description
ANODYNE THERAPY, L.L.C.
120-2 LARGE THERAPY PADS
In Commercial Distribution

  • 00859101006103 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
480
In Commercial Distribution

  • 00859101006035 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120 Professional
In Commercial Distribution

  • 00859101006028 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120 Recertified
In Commercial Distribution

  • 00859101006011 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120
In Commercial Distribution

  • 00859101006004 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
120-2
In Commercial Distribution

  • 00859101006097 ()
498011

  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
480 Recertified
In Commercial Distribution

  • 00859101006042 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
Silhouet-Tone Corporation
411560
In Commercial Distribution

  • 00667259001952 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Santamedical Sports/Aviation Pulse Oximeter
GURIN PRODUCTS LLC
SM-150Y
In Commercial Distribution

  • 10858759005602 ()
  • 00858759005605 ()


  • Pulse oximeter
Santamedical Sports/Aviation Pulse Oximeter
GURIN PRODUCTS LLC
SM-150G
In Commercial Distribution

  • 10858759005596 ()
  • 00858759005599 ()


  • Pulse oximeter
Santamedical Sports/Aviation Pulse Oximeter
GURIN PRODUCTS LLC
SM-150B
In Commercial Distribution

  • 10858759005589 ()
  • 00858759005582 ()


  • Pulse oximeter
Santamedical Sports/Aviation Pulse Oximeter
GURIN PRODUCTS LLC
SM-1100P
In Commercial Distribution

  • 00858759005513 ()


  • Pulse oximeter
Santamedical Sports/Aviation Pulse Oximeter
GURIN PRODUCTS LLC
SM-1100BL
In Commercial Distribution

  • 10858759005503 ()
  • 00858759005506 ()


  • Pulse oximeter
Santamedical Sports/Aviation Pulse Oximeter
GURIN PRODUCTS LLC
SM-1100S
In Commercial Distribution

  • 10858759005497 ()
  • 00858759005490 ()


  • Pulse oximeter
Santamedical Sports/Aviation Pulse Oximeter
GURIN PRODUCTS LLC
SM-110
In Commercial Distribution

  • 00858759005483 ()


  • Pulse oximeter
No Description
GURIN PRODUCTS LLC
SM-165
In Commercial Distribution

  • 00858759005391 ()
  • 10858759005398 ()


  • Pulse oximeter
Two Port CAREController - Infrared Phototherapy control device for up to 2 phototherapy emitters
HEALTHLIGHT LLC
CL-C2J
In Commercial Distribution

  • 00858935006686 ()
602017

  • Musculoskeletal infrared phototherapy unit, non-wearable
204-LED Red/IR Knee CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-KneeR
In Commercial Distribution

  • 00858935006662 ()
602034

  • Musculoskeletal infrared phototherapy unit, non-wearable
204-LED Red/IR Knee Pad - Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-KneeR
In Commercial Distribution

  • 00858935006655 ()
502052

  • Musculoskeletal infrared phototherapy unit, non-wearable
CAREPad 64 Red-IR and controller LED Infrared Phototherapy System
HEALTHLIGHT LLC
CL-64R-E
In Commercial Distribution

  • 00858935006648 ()
602033

  • Musculoskeletal infrared phototherapy unit, non-wearable
CAREPad 180R Red-IR and controller Infrared LED Phototherapy System
HEALTHLIGHT LLC
CL-180R-E
In Commercial Distribution

  • 00858935006631 ()
602032

  • Musculoskeletal infrared phototherapy unit, non-wearable
261-LED Red/IR T-shape Pad - Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-T-padR
In Commercial Distribution

  • 00858935006617 ()
502046

  • Musculoskeletal infrared phototherapy unit, non-wearable
261-LED Red/IR T-shape CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-T-padR
In Commercial Distribution

  • 00858935006600 ()
602026

  • Musculoskeletal infrared phototherapy unit, non-wearable
HealthLight 180 Tricolor Blue/IR/Red LED System - Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-180T-S
In Commercial Distribution

  • 00858935006587 ()
502044

  • Musculoskeletal infrared phototherapy unit, non-wearable
HealthLight 132 Blue/IR LED Medium Pad System - Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-132B-S
In Commercial Distribution

  • 00858935006570 ()
502043

  • Musculoskeletal infrared phototherapy unit, non-wearable
HealthLight 264 Blue/IR LED Large Pad System - Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-264B-S
In Commercial Distribution

  • 00858935006563 ()
502042

  • Musculoskeletal infrared phototherapy unit, non-wearable
180 Tricolor Blue/IR/Red LED Pad, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-180T
In Commercial Distribution

  • 00858935006556 ()
502041

  • Musculoskeletal infrared phototherapy unit, non-wearable
132 Blue/IR LED Pad, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-132B
In Commercial Distribution

  • 00858935006549 ()
502040

  • Musculoskeletal infrared phototherapy unit, non-wearable
264 Blue/IR LED Pad, Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-264B
In Commercial Distribution

  • 00858935006532 ()
502037

  • Musculoskeletal infrared phototherapy unit, non-wearable
HealthLight 180 & 264 LED Combo Pad System - Infrared Phototherapy Device
HEALTHLIGHT LLC
HL-444-S
In Commercial Distribution

  • 00858935006525 ()
502036

  • Musculoskeletal infrared phototherapy unit, non-wearable
Three Port CAREController - Phototherapy Control Device for up to 3 separate phototherapy emitters
HEALTHLIGHT LLC
CL-C3
In Commercial Distribution

  • 00858935006501 ()
602023, 602030

  • Musculoskeletal infrared phototherapy unit, non-wearable
180-LED Tricolor Blue/IR/Red CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-180T
In Commercial Distribution

  • 00858935006495 ()
602022

  • Musculoskeletal infrared phototherapy unit, non-wearable
Face Mask CAREPad - Phototherapy Device
HEALTHLIGHT LLC
CL-FM
In Commercial Distribution

  • 00858935006471 ()
602020

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot & Ankle Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-PB
In Commercial Distribution

  • 00858935006464 ()
602019

  • Musculoskeletal infrared phototherapy unit, non-wearable
Two Port CAREController - Infrared Phototherapy control device for up to 2 phototherapy emitters
HEALTHLIGHT LLC
CL-C2
In Commercial Distribution

  • 00858935006440 ()
602017

  • Musculoskeletal infrared phototherapy unit, non-wearable
Six Port CAREController - Phototherapy Control Device for up to 6 separate phototherapy emitters
HEALTHLIGHT LLC
CL-C6
In Commercial Distribution

  • 00858935006433 ()
602016, 602025, 602031

  • Musculoskeletal infrared phototherapy unit, non-wearable
Foot & Calf Red/IR CAREPad - Infrared Phototherapy Device
HEALTHLIGHT LLC
CL-NP
In Commercial Distribution

  • 00858935006426 ()
602015

  • Musculoskeletal infrared phototherapy unit, non-wearable
Lumen MD Foot and Hand Pad System
HEALTHLIGHT LLC
LM-CP-S
In Commercial Distribution

  • 00858935006372 ()
602009

  • Musculoskeletal infrared phototherapy unit, non-wearable
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