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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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i.Terminal 2 - 04250668606717

N/A
Carl Zeiss Vision GmbH
000000-2408-310
In Commercial Distribution

  • 04250668606717 ()
000000-2408-310

  • Vision corrective spectacles centration image analysis software

VISUFIT 1000 - 04250668606687

N/A
Carl Zeiss Vision GmbH
000000-2351-293
In Commercial Distribution

  • 04250668606687 ()
000000-2351-293

  • Vision corrective spectacles centration image analysis software

i.Terminal mobile - 04250668606649

N/A
Carl Zeiss Vision GmbH
000000-2120-340
In Commercial Distribution

  • 04250668606649 ()
000000-2120-340

  • Vision corrective spectacles centration image analysis software

STELLAR Knee - 00850046497131

STELLAR Knee Application, V2
POLARISAR, INC.
Software Version 2.0.107
In Commercial Distribution

  • 00850046497131 ()
70-0003

  • Orthopaedic stereotactic surgery system

STELLAR Knee - 00850046497100

STELLAR Knee Application
POLARISAR, INC.
Software Version 1.2.2
In Commercial Distribution

  • 00850046497100 ()
70-0001

  • Orthopaedic stereotactic surgery system

SAINT - 00860011072515

No Description
Magnus Medical, Inc.
Magnus Neuromodulation Software
In Commercial Distribution

  • 00860011072515 ()


  • Stereotactic neuronavigation/planning system

SAINT - 00860011072508

A software for personalizing and optimizing magnetic brain stimulation treatment.
Magnus Medical, Inc.
Magnus Cloud Software
In Commercial Distribution

  • 00860011072508 ()


  • Magnetic neural stimulation system

Bernoulli - 00854709006029

No Description
Philips North America LLC
Bernoulli One Software
In Commercial Distribution

  • 00854709006029 ()


  • Centralized patient monitor

Persona Medical - 00851362008032

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

ESSENZ - 04033817903161

No Description
LivaNova Deutschland GmbH
Patient Monitor Software
In Commercial Distribution

  • 04033817903161 ()


  • Patient health record information system
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