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
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD
PDT-J
In Commercial Distribution

  • 06976264730035 ()


  • Blue/red/infrared phototherapy lamp
No Description
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO.,LTD
PDT-I
In Commercial Distribution

  • 06976264730028 ()


  • Blue/red/infrared phototherapy lamp
Performa Adjustable Paraffin Bath
Performance Health Supply, LLC
081706738
In Commercial Distribution

  • 00885914070932 ()


  • Physical therapy paraffin wax bath
LED Light Therapy Mask
SILKN BEAUTY LTD
FM-03
In Commercial Distribution

  • 27290019840057 ()
  • 17290019840050 ()
  • 07290019840053 ()
7290019840053

  • Blue/red/infrared phototherapy lamp
LED Light Therapy Mask
SILKN BEAUTY LTD
FM-02
In Commercial Distribution

  • 27290019840040 ()
  • 17290019840043 ()
  • 07290019840046 ()
7290019840046

  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne
Shenzhen Rainbow Technology Co.,Ltd
RB-081
In Commercial Distribution

  • 06978368600818 ()
  • 16978368600815 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-030
In Commercial Distribution

  • 06978368600306 ()
  • 16978368600303 ()


  • Blue/red/infrared phototherapy lamp
Red+Infrared light:Treatment of full-face wrinkles. Red light:Treatment of full-face wrinkles. Blue light:Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-008
In Commercial Distribution

  • 16978368600082 ()
  • 06978368600085 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-008
In Commercial Distribution

  • 06978368600054 ()
  • 16978368600051 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008JB
In Commercial Distribution

  • 06978368600047 ()
  • 16978368600044 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008J
In Commercial Distribution

  • 06978368600030 ()
  • 16978368600037 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008GB
In Commercial Distribution

  • 06978368600023 ()
  • 16978368600020 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008G
In Commercial Distribution

  • 06978368600016 ()
  • 16978368600013 ()


  • Blue/red/infrared phototherapy lamp
Led Mask/CD07S
Shenzhen Wells Optoelectronics Co.,Ltd.
CD07S
In Commercial Distribution

  • 16977182810073 ()


  • Blue/red/infrared phototherapy lamp
Plasma Thawer
Cardinal Health 200, LLC
CH-PT1000
In Commercial Distribution

  • 50885380024847 ()
CH-PT1000

  • Cryopreserved blood/tissue thawing unit
No Description
ICU MEDICAL, INC.
80-01-040
In Commercial Distribution

  • 50695085804008 ()


  • Heater/cooler system tester kit
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne
Shenzhen Rainbow Technology Co.,Ltd
RB-081
In Commercial Distribution

  • 06978368600818 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Blue light: Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-030
In Commercial Distribution

  • 06978368600306 ()


  • Blue/red/infrared phototherapy lamp
Red+Infrared light:Treatment of full-face wrinkles. Red light:Treatment of full-face wrinkles. Blue light:Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-008
In Commercial Distribution

  • 06978368600085 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne.
Shenzhen Rainbow Technology Co.,Ltd
RB-008
In Commercial Distribution

  • 06978368600054 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008JB
In Commercial Distribution

  • 06978368600047 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008J
In Commercial Distribution

  • 06978368600030 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008GB
In Commercial Distribution

  • 06978368600023 ()


  • Blue/red/infrared phototherapy lamp
- Red+Infrared light: Treatment of full-face wrinkles. - Red light: Treatment of full-face wrinkles - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne. The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.
Shenzhen Rainbow Technology Co.,Ltd
RB-008G
In Commercial Distribution

  • 06978368600016 ()
  • 26978368600010 ()


  • Blue/red/infrared phototherapy lamp
No Description
Hunan Guangye Biotechnology Co., Ltd.
KFB265
In Commercial Distribution

  • 06975587680010 ()


  • Blue/red/infrared phototherapy lamp
Plasma thawing device
FREMON SCIENTIFIC, INC.
202
In Commercial Distribution

  • 07290115270006 ()


  • Cryopreserved blood/tissue thawing unit
EXCHANGER 61399400964 1EA HT BIOTHERM
MEDTRONIC, INC.
61399400964
In Commercial Distribution

  • 30613994009648 ()
  • 50613994009642 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
EXCHANGER 61399400870 1EA EMOTHRMII HT
MEDTRONIC, INC.
61399400870
In Commercial Distribution

  • 30613994008702 ()
  • 50613994008706 ()


  • Cardiopulmonary bypass system heat exchanger, reusable
No Description
SPECTRUM MEDICAL SRL
HX32V-C0W
In Commercial Distribution

  • 18051160302267 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX55V-S0W
In Commercial Distribution

  • 18051160302205 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S2M
In Commercial Distribution

  • 18051160302175 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S1M
In Commercial Distribution

  • 18051160302168 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
No Description
SPECTRUM MEDICAL SRL
HX11W-S2
In Commercial Distribution

  • 18051160302151 ()


  • Cardiopulmonary bypass system heat exchanger, single-use
The LED Light Therapy Mask (Models: MK-04) is an over the counter device that is intended forthe use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK-04
In Commercial Distribution

  • 00856957008022 ()


  • Blue/red/infrared phototherapy lamp
The HlGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
MK66-L
In Commercial Distribution

  • 00850049532471 ()


  • Blue/red/infrared phototherapy lamp
The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
61043
In Commercial Distribution

  • 00810137610436 ()


  • Blue/red/infrared phototherapy lamp
The LED Eye Mask, model: EY-20N is an over-the-counter light-emiting diode (LEDdevice that emits energy for dermatology to treat wrinkles within the periorbital region. The device usesfour types of LEDs is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the mainunit, USB cable cord and velcro straps and removable eye protection. There is a total of 40 LEDs toprovide a power intensity of about 65 mW/cm?. The device has only one button to turn on/off.The user wears the device on their eye area for the treatment, and the device will shut down automatically
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-20N
In Commercial Distribution

  • 00810137610429 ()


  • Blue/red/infrared phototherapy lamp
The LED Eye Perfector (Model: EY-36B) is an Over-the-Counter (0TC) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-36B
In Commercial Distribution

  • 00695866567110 ()


  • Blue/red/infrared phototherapy lamp
Mi is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a non. invasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment offull-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for thepurpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness.minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporaryrelaxation of muscles.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
TY-01
In Commercial Distribution

  • 06970006971212 ()


  • Blue/red/infrared phototherapy lamp
The LED Eve Mask (Model: EY-20R) is an Over-the-Counter (OTc) device intended for use in treating wrinkles within the periorbital region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
EY-20R
In Commercial Distribution

  • 06970006971144 ()


  • Blue/red/infrared phototherapy lamp
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