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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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E-Scribe ECG Data Management Workstation - Enterprise system, floating; English system language; 110V power; Tower workstation computer hardware (no keyboard, mouse, or display);
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094265057 ()
ESWKST-DAA-AXXXX

  • Patient health record information system application software
Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0300
In Commercial Distribution

  • 00858184006062 ()


  • Gait-enhancement electrical stimulation system, external
Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.
INNOVATIVE NEUROTRONICS, INC.
20-0310
In Commercial Distribution

  • 00858184006055 ()


  • Gait-enhancement electrical stimulation system, external
Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions
Sensimed SA
V3
In Commercial Distribution

  • 07640153470157 ()
ST8000

  • Ocular volume ambulatory recording system software
Voicepro NOAH is fitting software with a NOAH Database used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss. The Noah software system is designed specifically for the hearing care industry, providing hearing care professionals with a unified system for performing client-related tasks.
Persona Medical
Voicepro Fitting Software NOAH
In Commercial Distribution

  • 00851362008049 ()


  • Hearing aid wireless-fitting computer-aided set
  • Air-conduction hearing aid, behind-the-ear
Voicepro is fitting software used in conjunction with Persona Medical hearing instruments as a tool by Audiologists/Hearing Instrument Specialists to mitigate hearing loss.
Persona Medical
Voicepro Fitting Software
In Commercial Distribution

  • 00851362008032 ()


  • Hearing aid wireless-fitting computer-aided set
  • Air-conduction hearing aid, behind-the-ear
The Nidek Mirante Scanning Laser Ophthalmoscope is an ophthalmic imaging device that allows non invasive and non-contact observation of the shape and the disease state of the fundus, anterior segment, and retina using a scanning laser ophthalmoscope (hereafter referred to as “SLO”) and/or optical coherence tomography (hereafter referred to as “OCT”).
NIDEK CO.,LTD.
Mirante
In Commercial Distribution

  • 04987669101568 ()


  • Scanning-laser retinal imaging system
  • Retinal optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software V.7.2-US with Heidelberg Eye Explorer
In Commercial Distribution

  • 04059237001034 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software V.7.2-US
In Commercial Distribution

  • 04059237001027 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
S2002
In Commercial Distribution

  • 04059237000891 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
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