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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Adstation Oto+-X/Coax+Oph-X,429,Clock Aner/Spec Disp,EU,WB
AMERICAN DIAGNOSTIC CORP
56802X-347EUW
In Commercial Distribution

  • 00634782089870 ()
56802X-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-L/Coax+Oph-L,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
56802L-347W
In Commercial Distribution

  • 00634782089382 ()
56802L-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-L/Coax+Oph-L,429,Clock Aner/Spec Disp,EU,WB
AMERICAN DIAGNOSTIC CORP
56802L-347EUW
In Commercial Distribution

  • 00634782089375 ()
56802L-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-X/Coax+Oph-L,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
56802B-347W
In Commercial Distribution

  • 00634782088880 ()
56802B-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-X/Coax+Oph-L,429, Clk Aner/Spec Disp, WB, EU
AMERICAN DIAGNOSTIC CORP
56802B-347EUW
In Commercial Distribution

  • 00634782088873 ()
56802B-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-L/Coax+Oph-X,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
56802A-347W
In Commercial Distribution

  • 00634782088385 ()
56802A-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-L/Coax+Oph-X,429, Clk Aner/Spec Disp, WB,EU
AMERICAN DIAGNOSTIC CORP
56802A-347EUW
In Commercial Distribution

  • 00634782088378 ()
56802A-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-L/Throat-X,429,Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5611L-346X7W
In Commercial Distribution

  • 00634782088040 ()
5611L-346X7W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-L/Throat-X,429,Clock Aner/Spec Disp, EU, WB
AMERICAN DIAGNOSTIC CORP
5611L-346X7EUW
In Commercial Distribution

  • 00634782088033 ()
5611L-346X7EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-L/Throat-L,429,Clock Aner/Spec Disp,WB
AMERICAN DIAGNOSTIC CORP
5611L-346L7W
In Commercial Distribution

  • 00634782088026 ()
5611L-346L7W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-L/Throat-L,429,Clock Aner/Spec Disp, EU, WB
AMERICAN DIAGNOSTIC CORP
5611L-346L7EUW
In Commercial Distribution

  • 00634782088019 ()
5611L-346L7EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-X/Coax Oph-X,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5610X-347W
In Commercial Distribution

  • 00634782087968 ()
5610X-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-X/Coax Oph-X,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5610X-347EUW
In Commercial Distribution

  • 00634782087951 ()
5610X-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-L/Coax Oph-L,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5610L-347W
In Commercial Distribution

  • 00634782087920 ()
5610L-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-L/Coax Oph-L,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5610L-347EUW
In Commercial Distribution

  • 00634782087913 ()
5610L-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-X/Coax Oph-L,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5610B-347W
In Commercial Distribution

  • 00634782087883 ()
5610B-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-X/Coax Oph-L,429, Clk Aner/Spec Disp,EU,WB
AMERICAN DIAGNOSTIC CORP
5610B-347EUW
In Commercial Distribution

  • 00634782087876 ()
5610B-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-L/Coax Oph-X,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5610A-347W
In Commercial Distribution

  • 00634782087845 ()
5610A-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-L/Coax Oph-X,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5610A-347EUW
In Commercial Distribution

  • 00634782087838 ()
5610A-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-X/Coax+Oph-X,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
56102X-347W
In Commercial Distribution

  • 00634782087807 ()
56102X-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-X/Coax+Oph-X,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
56102X-347EUW
In Commercial Distribution

  • 00634782087791 ()
56102X-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-L/Coax+Oph-L,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
56102L-347W
In Commercial Distribution

  • 00634782087760 ()
56102L-347W

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-L/Coax+Oph-L,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
56102L-347EUW
In Commercial Distribution

  • 00634782087753 ()
56102L-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-X/Coax+Oph-L,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
56102B-347W
In Commercial Distribution

  • 00634782087722 ()
56102B-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-X/Coax+Oph-L,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
56102B-347EUW
In Commercial Distribution

  • 00634782087715 ()
56102B-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto-L/Coax+Oph-X,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
56102A-347W
In Commercial Distribution

  • 00634782087685 ()
56102A-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto-L/Coax+Oph-X,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
56102A-347EUW
In Commercial Distribution

  • 00634782087678 ()
56102A-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-X/Throat-X,429, Clk Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5681X-346X7W
In Commercial Distribution

  • 00634782093129 ()
5681X-346X7W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-X/Throat-X,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5681X-346X7EUW
In Commercial Distribution

  • 00634782093112 ()
5681X-346X7EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-X/Throat-L,429,Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5681X-346LW
In Commercial Distribution

  • 00634782093105 ()
5681X-346LW

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-X/Throat-L,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5681X-346LEUW
In Commercial Distribution

  • 00634782093099 ()
5681X-346LEUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-X/Derm ,429,Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5681X-3457W
In Commercial Distribution

  • 00634782093082 ()
5681X-3457W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-X/Derm,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5681X-3457EUW
In Commercial Distribution

  • 00634782093075 ()
5681X-3457EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-L/Throat-X,429,Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5681L-346X7W
In Commercial Distribution

  • 00634782092429 ()
5681L-346X7W

  • Ophthalmic/otologic diagnostic set
  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
Adstation Oto+-L/Throat-X,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5681L-346X7EUW
In Commercial Distribution

  • 00634782092412 ()
5681L-346X7EUW

  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-L/Throat-L,429,Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5681L-346L7W
In Commercial Distribution

  • 00634782092405 ()
5681L-346L7W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-L/Throat-L,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5681L-346L7EUW
In Commercial Distribution

  • 00634782092399 ()
5681L-346L7EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-L/Derm,429,Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5681L-3457W
In Commercial Distribution

  • 00634782092382 ()
5681L-3457W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-L/Derm,429, Clk Aner/Spec Disp,EU, WB
AMERICAN DIAGNOSTIC CORP
5681L-3457EUW
In Commercial Distribution

  • 00634782092375 ()
5681L-3457EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-X/Coax Oph-X,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5680X-347W
In Commercial Distribution

  • 00634782091880 ()
5680X-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-X/Coax Oph-X,429, Clk Aner/Spec Disp, EU,WB
AMERICAN DIAGNOSTIC CORP
5680X-347EUW
In Commercial Distribution

  • 00634782091873 ()
5680X-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
Adstation Oto+-L/Coax Oph-L,429, Clock Aner/Spec Disp, WB
AMERICAN DIAGNOSTIC CORP
5680L-347W
In Commercial Distribution

  • 00634782091385 ()
5680L-347W

  • Ophthalmic/otologic diagnostic set
  • Infrared patient thermometer, skin
  • Aneroid manual sphygmomanometer
Adstation Oto+-L/Coax Oph-L,429,Clk Aner/Spec Disp, EU, WB
AMERICAN DIAGNOSTIC CORP
5680L-347EUW
In Commercial Distribution

  • 00634782091378 ()
5680L-347EUW

  • Aneroid manual sphygmomanometer
  • Infrared patient thermometer, skin
  • Ophthalmic/otologic diagnostic set
The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user’s examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data. The N9 device measure, record, and transmit data of auscultation sound of human body (lung, hear, abdomen), temperature, oxygen saturation (SpO2) and pulse rate, and can be used to send images of an examined body part. In addition, the device includes otoscope where images of the ear can be transmitted to the healthcare provider.
NONAGON LTD
N9
In Commercial Distribution

  • 07290018446102 ()
  • 17290018446109 ()
MHD-100-02-001

  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 27290018446151 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
No Description
NONAGON LTD
N9+
In Commercial Distribution

  • 17290018446154 ()


  • Pulse oximeter
  • Electronic acoustic stethoscope
  • Otoscope, direct
  • Infrared patient thermometer, skin
Adstation Oto PMV-Xen/Throat-Xen, 429, ,9003W/Spec Disp, WB, EU
AMERICAN DIAGNOSTIC CORP
5681X-346X8EUW
In Commercial Distribution

  • 00634782097899 ()
5681X-346X8EUW

  • Ophthalmic/otologic diagnostic set
  • Automatic-inflation electronic sphygmomanometer, non-portable
  • Infrared patient thermometer, skin
Adstation Oto PMV-Xen/Throat-LED, 429, ,9003W/Spec Disp, WB, EU
AMERICAN DIAGNOSTIC CORP
5681X-346L8EUW
In Commercial Distribution

  • 00634782097882 ()
5681X-346L8EUW

  • Ophthalmic/otologic diagnostic set
  • Automatic-inflation electronic sphygmomanometer, non-portable
  • Infrared patient thermometer, skin
Adstation Oto PMV-LED/Throat-Xen, 429, ,9003W/Spec Disp, WB, EU
AMERICAN DIAGNOSTIC CORP
5681L-346X8EUW
In Commercial Distribution

  • 00634782097837 ()
5681L-346X8EUW

  • Ophthalmic/otologic diagnostic set
  • Automatic-inflation electronic sphygmomanometer, non-portable
  • Infrared patient thermometer, skin
Adstation Oto PMV-LED/Throat-LED, 429, ,9003W/Spec Disp, WB, EU
AMERICAN DIAGNOSTIC CORP
5681L-346L8EUW
In Commercial Distribution

  • 00634782097820 ()
5681L-346L8EUW

  • Ophthalmic/otologic diagnostic set
  • Automatic-inflation electronic sphygmomanometer, non-portable
  • Infrared patient thermometer, skin
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