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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-812B
Not in Commercial Distribution

  • 06976415770170 ()


  • Transcutaneous electrical stimulation probe
  • Blue/red/infrared phototherapy lamp
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
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-812W
Not in Commercial Distribution

  • 06976415770187 ()


  • 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-810W
Not in Commercial Distribution

  • 06976415770163 ()


  • Blue/red/infrared phototherapy lamp
  • Transcutaneous electrical stimulation probe
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
Omnilux Men's Facemask Device (Red & NIR).
I-SMART DEVELOPMENTS LIMITED
TN2227
In Commercial Distribution

  • 05060534510524 ()


  • Cosmetic red-light phototherapy system, home-use
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZC-05
In Commercial Distribution

  • 00655729008426 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
B&M SRL MARKETING NEL BENESSERE
T-SHAPE 2
In Commercial Distribution

  • 08053782383283 ()


  • Multi-modality skin/body contouring system
3100A DISPOSABLES SHIP KIT (MR850 FLEX CIRCUIT)
VYAIRE MEDICAL, INC.
770630-103
Not in Commercial Distribution

  • 10190752155411 ()
770630-103

  • Breathing circuit condensate trap, single-use
  • Respiratory gas heating wire, adult
  • Microbial medical gas filter, single-use
  • Ventilator breathing circuit, single-use
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