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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Audio Processor AudioStream Adapter
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
44786
In Commercial Distribution

  • 09008737447861 ()


  • Hearing aid/implant system functionality-enhancing device
Audio Processor Adapter
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
44785
In Commercial Distribution

  • 09008737447854 ()


  • Hearing aid/implant system functionality-enhancing device
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter. Indications for Use: The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: • Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; • Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and • Mixed astigmatism with cylinder from >1.00 D up to 4.00 D; in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution

  • 04049471095074 ()

  • Weight: 295 Kilogram
  • x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m


  • Ophthalmic excimer laser system
The Plasmat® Futura System
B.Braun Avitum AG
706210A
Not in Commercial Distribution

  • 04046964337017 ()
706210A

  • Apheresis system
Kit upgrade HW Single PC Infinity
GE MEDICAL SYSTEMS
ATA2
In Commercial Distribution

  • 00195278194039 ()


  • Stationary mammographic x-ray system, digital
Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system
Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer
Analog Output Cable
ST. JUDE MEDICAL, INC.
PN-001427
In Commercial Distribution

  • 07640157990217 ()
PN-001427

  • Electrical-only medical device connection cable, reusable
RF Cable
ST. JUDE MEDICAL, INC.
PN-004515
In Commercial Distribution

  • 07640157990064 ()
PN-004515

  • Electrical-only medical device connection cable, reusable
RF Cable
ST. JUDE MEDICAL, INC.
PN-004514
In Commercial Distribution

  • 07640157990057 ()
PN-004514

  • Electrical-only medical device connection cable, reusable
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