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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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AQUA+ N22 COIL 6CM
COCHLEAR LIMITED
Z465779
In Commercial Distribution

  • 09321502033336 ()
Z465779

  • Cochlear implant/auditory brainstem implant coil
CP900 SERIES N22 COIL INTEGRATED 6M (SMOKE)
COCHLEAR LIMITED
Z479539
In Commercial Distribution

  • 09321502032742 ()
Z479539

  • Cochlear implant/auditory brainstem implant coil
CP900 SERIES N22 COIL INTEGRATED 6M (MAIZE)
COCHLEAR LIMITED
Z479537
In Commercial Distribution

  • 09321502032728 ()
Z479537

  • Cochlear implant/auditory brainstem implant coil
CP900 SERIES N22 COIL INTEGRATED 6M (CARBON)
COCHLEAR LIMITED
Z479492
In Commercial Distribution

  • 09321502032711 ()
Z479492

  • Cochlear implant/auditory brainstem implant coil
CP900 SERIES N22 COIL (SMOKE)
COCHLEAR LIMITED
Z479488
In Commercial Distribution

  • 09321502032698 ()
Z479488

  • Cochlear implant/auditory brainstem implant coil
Cochlear Nucleus CI512 cochlear implant with Contour Advance electrode
COCHLEAR LIMITED
Z209051
In Commercial Distribution

  • 09321502014564 ()
Z209051

  • Cochlear implant system electrode array assembly
Cochlear Nucleus Hybrid L24 cochlear implant
COCHLEAR LIMITED
Z60988
In Commercial Distribution

  • 09321502012089 ()
Z60988

  • Cochlear implant system electrode array assembly
CI24RE Series Non-Magnetic Plug
COCHLEAR LIMITED
Z50100
In Commercial Distribution

  • 09321502002776 ()
Z50100

  • Cochlear implant dummy magnet
The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.
Pyrexar Medical Inc.
BSD-500
In Commercial Distribution



  • Microwave hyperthermia system
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic peripheral arteries.
Shockwave Medical, Inc.
825D
In Commercial Distribution

  • M732IVLGCCD0 ()
IVLGCCD

  • Ultrasound thrombolysis system control unit
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