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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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No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.12_US
In Commercial Distribution

  • 04059237000594 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.10-US
In Commercial Distribution

  • 04059237000549 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Software with HEYEX 2 V6.14_US
In Commercial Distribution

  • 04059237000488 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.9.1-US
In Commercial Distribution

  • 04059237000341 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.8a-US
In Commercial Distribution

  • 04059237000310 ()


  • Ophthalmic spectral-domain optical coherence tomography system
  • Scanning-laser retinal imaging system
No Description
Heidelberg Engineering GmbH
Product Family SW V6.8-US
Not in Commercial Distribution

  • 04059237000303 ()


  • Scanning-laser retinal imaging system
  • Ophthalmic spectral-domain optical coherence tomography system
No Description
Heidelberg Engineering GmbH
SPEC-CAM-S2600
In Commercial Distribution

  • 04059237000280 ()


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