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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S1030 Skin Conduction Probe
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130312 ()


  • Red-light phototherapy unit, professional
S2101 810nm 450mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130305 ()


  • Red-light phototherapy unit, professional
S1101 810nm 450mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130299 ()


  • Red-light phototherapy unit, professional
S1102 810nm 450mW Dental Probe
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130282 ()


  • Red-light phototherapy unit, professional
S2100 810nm 450mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130275 ()


  • Red-light phototherapy unit, professional
S1100 810nm 450mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130268 ()


  • Red-light phototherapy unit, professional
S1121 810nm 2W Cluster C (5x400mW)
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130251 ()


  • Red-light phototherapy unit, professional
S2120 810nm 2W Cluster (5x400mW)
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130244 ()


  • Red-light phototherapy unit, professional
S1120 810nm 2W Cluster (5x400mW)
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130237 ()


  • Red-light phototherapy unit, professional
S2092 810nm 200mW Standard Tip
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130220 ()


  • Red-light phototherapy unit, professional
S1092 810nm 200mW Standard Tip
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130213 ()


  • Red-light phototherapy unit, professional
S2091 810nm 200mW Dental Probe
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130206 ()


  • Red-light phototherapy unit, professional
S1091 810nm 200mW Dental Probe
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130190 ()


  • Red-light phototherapy unit, professional
S2090 810nm 200mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130183 ()


  • Red-light phototherapy unit, professional
S1090 810nm 200mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130176 ()


  • Red-light phototherapy unit, professional
S1160 810nm 1W Cluster (5x200mW)
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130145 ()


  • Red-light phototherapy unit, professional
S2110 69 LED Cluster Probe Wavelength = 660nm & 850nm Power
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130138 ()


  • Red-light phototherapy unit, professional
S1110 69 LED Cluster Probe 660nm & 850nm 1390mW
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130121 ()


  • Red-light phototherapy unit, professional
S2173 660nm 75mW Dental Probe
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130114 ()


  • Red-light phototherapy unit, professional
S1173 660nm 75mW Dental Probe
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130107 ()


  • Red-light phototherapy unit, professional
S2042 660nm 30mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130091 ()


  • Red-light phototherapy unit, professional
S1042 660nm 30mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130084 ()


  • Red-light phototherapy unit, professional
S2040 660nm 30mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130077 ()


  • Red-light phototherapy unit, professional
S1040 660nm 30mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130060 ()


  • Red-light phototherapy unit, professional
S2062 660nm 200mW Standard Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130053 ()


  • Red-light phototherapy unit, professional
S2060 660nm 200mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130046 ()


  • Red-light phototherapy unit, professional
S1175 660nm 100mW Acu Tip B/G
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130039 ()


  • Red-light phototherapy unit, professional
S1131 19 LED Cluster Probe 660nm & 850nm 370mW
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130022 ()


  • Red-light phototherapy unit, professional
S2140 104 LED Cluster Probe 660nm & 850nm 2W
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130015 ()


  • Red-light phototherapy unit, professional
S1140 104 LED Cluster Probe 660nm & 850nm 2W
THOR PHOTOMEDICINE LIMITED
2.0
In Commercial Distribution

  • 05060494130008 ()


  • Red-light phototherapy unit, professional
Sunset Fingertip Pulse Oximeter
SUNSET HEALTHCARE SOLUTIONS, INC.
RES5100
In Commercial Distribution

  • 10848530061163 ()
  • 00848530061166 ()
RES5100

  • Pulse oximeter
Fingertip Pulse Oximeter with 6-way Display
SUNSET HEALTHCARE SOLUTIONS, INC.
RES5101
In Commercial Distribution

  • 10848530061170 ()
  • 00848530061173 ()
RES5101

  • Pulse oximeter
Far Infrared Ray Healthful Lamp (or Medical FIR Radiator)
CHUNG CHENG ELECTRIC HEATING CO., LTD.
CH-8810
In Commercial Distribution

  • 04716171749018 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
BLUBLOX PTY LTD
Red Light Face Wand
In Commercial Distribution

  • 09361725000081 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Mini Red Light Therapy Device
In Commercial Distribution

  • 09361725000074 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Therapy Blanket
In Commercial Distribution

  • 09361725000067 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Neck and Chest Mask
In Commercial Distribution

  • 09361725000050 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Red Light Face Mask
In Commercial Distribution

  • 09361725000043 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Super Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000036 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Max Red Light Therapy Device
In Commercial Distribution

  • 09361725000029 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Demi Red Light Therapy Device
In Commercial Distribution

  • 09361725000012 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
BLUBLOX PTY LTD
Bullet Red Light Therapy Device
In Commercial Distribution

  • 09361725000005 ()


  • Cosmetic red-light phototherapy system, home-use
The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.
GOLDEN SMART HOME TECHNOLOGY CORP.
GSH601
In Commercial Distribution

  • 04719878124027 ()
  • 14719878124024 ()
  • 54719878124022 ()

  • Weight: 50 Gram
  • Height: 58 Millimeter
  • Width: 34 Millimeter
  • Depth: 30 Millimeter
Orange

  • Pulse oximeter
The pulse oximeter is a reusable device, and it’s intended for intermittent checks of oxygen saturation and pulse rate for adults in a home-use only. This device is not intended for continuous monitoring. The device is intended to use of Over-The-Counter.
GOLDEN SMART HOME TECHNOLOGY CORP.
GSH601
In Commercial Distribution

  • 04719878124010 ()
  • 14719878124017 ()
  • 54719878124015 ()

  • Weight: 50 Gram
  • Height: 58 Millimeter
  • Width: 34 Millimeter
  • Depth: 30 Millimeter
Gray

  • Pulse oximeter
a cosmetic outlook improved version if compare with the previous ABPT1003 device. so, this is a Mark II version with slight change to the machine outlook.
APPLIED BIOPHOTONICS LIMITED
ABPT1003-2
In Commercial Distribution

  • 04719873240029 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
APPLIED BIOPHOTONICS LIMITED
ABPT1003
In Commercial Distribution

  • 04719873240012 ()


  • Red-light phototherapy unit, professional
  • Musculoskeletal infrared phototherapy unit, non-wearable
The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 μm Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
KP-B210
In Commercial Distribution

  • 04719873220199 ()


  • Full-body radiant heating system
The WS Therapy Unit is an infrared heating system which emits topical heat to the human body for therapeutic applications. It consists of an IR emitter (Emission spectrum ranges from 3~25 microns.), a control box, a supporting arm to allow for adjustment of the emitter locations, and a protection net on the emitter to prevent fire or direct touch by the user. The entire unit is mounted on the base that is easy to move. The device uses 100V as the power source. It meets the related requirement of IEC60601-1 Electrical Safety.
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
TY-101F
In Commercial Distribution

  • 04719873220045 ()


  • Full-body radiant heating system
ChoiceMMed Pulse Oximeter OxyWatch C29C
Beijing Choice Electronic Technology Co., Ltd.
OxyWatch C29C
In Commercial Distribution

  • 00846841071645 ()


  • Pulse oximeter
mibest Fingtertip Pulse Oximeter MD300C55
Beijing Choice Electronic Technology Co., Ltd.
MD300C55
In Commercial Distribution

  • 00846841071638 ()


  • Pulse oximeter
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