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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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emPOWER, Ankle only, Black
BIONX MEDICAL TECHNOLOGIES, INC.
em1B
In Commercial Distribution

  • B155EM1B0 ()


  • Dynamic-response foot prosthesis
emPOWER Ankle System, Black
BIONX MEDICAL TECHNOLOGIES, INC.
em0B
In Commercial Distribution

  • B155EM0B0 ()


  • Dynamic-response foot prosthesis
emPOWER Battery Charger
BIONX MEDICAL TECHNOLOGIES, INC.
em3
In Commercial Distribution

  • B155EM30 ()


  • Noninvasive device battery charger
emPOWER, Ankle only, Gray
BIONX MEDICAL TECHNOLOGIES, INC.
em1G
In Commercial Distribution

  • B155EM1G0 ()


  • Dynamic-response foot prosthesis
emPOWER Ankle System, Gray
BIONX MEDICAL TECHNOLOGIES, INC.
em0G
In Commercial Distribution

  • B155EM0G0 ()


  • Dynamic-response foot prosthesis
ellacor System with Micro-Coring Technology includes: Console = EL-CON02 Handpiece = EL-HPC02 Footswitch = FTS01
Cytrellis Biosystems, Inc.
EL-SYS01
In Commercial Distribution

  • B933ELSYS01 ()
EL-SYS01

  • Cosmetic micro-needling electronic handpiece, professional
Consumables Kit includes the following items: Needle Cartridge (EL-03N01) Biofilter Suction Tube Cleaning Cover (EL-CCV01) Tube Clip (EL-CLP01)
Cytrellis Biosystems, Inc.
EL-KIT01
In Commercial Distribution

  • B933ELKIT010 ()
EL-KIT01

  • Cosmetic micro-needling electronic handpiece, professional
ellacor Console 1.1
Cytrellis Biosystems, Inc.
EL-CON02
In Commercial Distribution

  • B933ELCON02 ()
EL-CON02

  • Cosmetic micro-needling electronic handpiece, professional
Suction tubing clip
Cytrellis Biosystems, Inc.
EL-CLP01
In Commercial Distribution

  • B933ELCLP011 ()
  • B933ELCLP016 ()
EL-CLP01

  • Medical/surgical interventional tube/cable securement clip, reusable
physiological signal amplfier
eemagine Medical Imaging Solutions GmbH
EE-511
In Commercial Distribution

  • B195EE511 ()


  • Electroencephalographic signal amplifier
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