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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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Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-810W
Not in Commercial Distribution

  • 06976415770163 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild tomoderate inflammatory acne.(cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic useincluding facial and neck stimulation.
Shenzhen Aozemei Technology Co., Ltd.
AM-810B
Not in Commercial Distribution

  • 06976415770156 ()


  • Transcutaneous electrical stimulation probe
  • Blue/red/infrared phototherapy lamp
No Description
DIASORIN MOLECULAR LLC
MOL3560
In Commercial Distribution

  • 20816101025651 ()
MOL3560

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL3550
In Commercial Distribution

  • 20816101025644 ()
MOL5290

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
QUEST MEDICAL INC
5001029
In Commercial Distribution

  • 20634624510290 ()


  • Electrical mains power cable
  • Cardiopulmonary bypass system heat exchanger, reusable
Refill/accessory for power supply for Gemini EVO
AZENA MEDICAL, LLC
9125
In Commercial Distribution

  • 00850010501116 ()
G2-5-004

  • Dental diode laser system
Gemini EVO Demo Laser Unit
AZENA MEDICAL, LLC
9122
In Commercial Distribution

  • 00850010501086 ()


  • Dental diode laser system
Gemini EVO Domestic Laser
AZENA MEDICAL, LLC
9120
In Commercial Distribution

  • 00850010501062 ()


  • Dental diode laser system
Refill/accessory for Gemini EVO laser handpiece shell
AZENA MEDICAL, LLC
9127
In Commercial Distribution

  • 00850010501130 ()
G2-5-006

  • Dental diode laser system
Refill/accessory for International Power supply for Gemini EVO
AZENA MEDICAL, LLC
9126
In Commercial Distribution

  • 00850010501123 ()
G2-5-005

  • Dental diode laser system
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