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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
SYNCARDIA SYSTEMS, LLC
295025-001
In Commercial Distribution

  • 00858000003084 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
570500-001
In Commercial Distribution

  • 00858000003053 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
500177-001
In Commercial Distribution

  • 00858000003046 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
500101-001
In Commercial Distribution

  • 00858000003008 ()

  • Total Volume: 70 Cubic Centimeter


  • Ventricular prosthesis system, pneumatically-powered
ReActiv8 Implantable Pulse Generator
MAINSTAY MEDICAL LIMITED
7M5100-002
In Commercial Distribution

  • 05391527770015 ()
5100

  • Implantable lumbar neuromuscular electrical stimulation system pulse generator
WAVELIGHT TOPOLYZER VARIO: The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990767
In Commercial Distribution

  • 00380659907678 ()

  • Weight: 70.4 Pound


  • Corneal topography system
N/A
COCHLEAR LIMITED
Z246604
In Commercial Distribution

  • 09321502020404 ()
Z246604

  • Auditory brainstem implant system electrode array assembly
ALLEGRO ANALYZER. The WaveLight® Topolyzer™ VARIO and WaveLight® Analyzer II diagnostic devices are measuring instruments intended for use in eye examinations to measure corneal topography. Data from these systems may be exported and used to support refractive surgical procedures with the WaveLight® laser systems.
Alcon Laboratories, Inc.
8065990606
Not in Commercial Distribution

  • 00380659906060 ()

  • Weight: 188 Pound


  • Corneal topography system
No Description
SALUDA MEDICAL PTY LIMITED
3035
In Commercial Distribution

  • 09352307000339 ()
3035

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
Patient Trial Belt
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-6360-72
In Commercial Distribution

  • 08714729997283 ()


  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
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