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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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FAQ™ 200 Plus is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Black
In Commercial Distribution

  • 07640260120662 ()


  • Blue/red/infrared phototherapy lamp
FAQ™ 202 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Black
In Commercial Distribution

  • 07640260120174 ()


  • Blue/red/infrared phototherapy lamp
FAQ™ 201 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
Foreo AB
Pink Ruby
In Commercial Distribution

  • 07640260120167 ()


  • 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
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
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
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