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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Kaye Nephrostomy Tamponade Balloon Catheter Set
COOK INCORPORATED
G14343
In Commercial Distribution

  • 00827002143432 ()
086014

  • Intrauterine haemostatic balloon catheter
No Description
Summit Medical, Inc.
SP-78107
In Commercial Distribution

  • 10385640065228 ()
  • 00385640065221 ()
SP-78100

  • Intranasal splint, non-biodegradable
No Description
Summit Medical, Inc.
SP-78105
In Commercial Distribution

  • 10385640065211 ()
  • 00385640065214 ()
SP-78100

  • Intranasal splint, non-biodegradable
No Description
Summit Medical, Inc.
SP-78100
In Commercial Distribution

  • 10385640065204 ()
  • 00385640065207 ()
SP-78100

  • Intranasal splint, non-biodegradable
No Description
Summit Medical, Inc.
SP-78107
In Commercial Distribution

  • 00385640000024 ()
SP-78107

  • Intranasal splint, non-biodegradable
No Description
Summit Medical, Inc.
SP-78105
Not in Commercial Distribution

  • 00385640000017 ()
SP-78105

  • Intranasal splint, non-biodegradable
No Description
Summit Medical, Inc.
SP-78100
In Commercial Distribution

  • 00385640000000 ()
SP-78100

  • Intranasal splint, non-biodegradable
Electro Acupuncture Therapy Unit
ITO CO., LTD.
ES-130
In Commercial Distribution

  • 04983087008403 ()
  • 14983087008400 ()
  • 24983087008407 ()
ES-130

  • Acupuncture electrical stimulation system
No Description
INNO HEALTH TECHNOLOGY CO., LTD.
IDOC-01
In Commercial Distribution

  • 04719874910013 ()


  • Acupuncture electrical stimulation system
The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution

  • B327NSS202 ()
  • B327NSS2022 ()
  • B327NSS2021 ()
01-1011-NSS/MFS

  • Acupuncture electrical stimulation system
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