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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
AUGMEDICS LTD
ACC00001
In Commercial Distribution

  • 07290113780262 ()


  • Multi-purpose stereotactic surgery system
No Description
AUGMEDICS LTD
ACC00008
In Commercial Distribution

  • 07290113780231 ()


  • Multi-purpose stereotactic surgery system
Selenia® Dimensions® C-View Software is a software feature where a standard digital mammography image is generated from data acquired during a standard resolution breast tomosynthesis scan.
Hologic, Inc.
C-View
In Commercial Distribution

  • 15420045500020 ()
SW-03052

  • Basic diagnostic x-ray system application software
No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • X-ray image interpretive software
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.
iWEECARE Co., Ltd.
STP-MB01-1
In Commercial Distribution

  • 04712977931060 ()
  • 14712977931067 ()


  • Wireless patient thermometer, reusable
The wireless Enfasmart FeverSense Continuous Monitoring Thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV220
In Commercial Distribution

  • 00865064000164 ()


  • Wireless patient thermometer, reusable
The wireless Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
VIVALNK, INC.
VV200
In Commercial Distribution

  • 00865064000119 ()


  • Wireless patient thermometer, reusable
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module. This model includes a well counter with 2 inch of lead shielding.
Mirion Technologies (capintec), Inc.
5430-30154
In Commercial Distribution

  • 00859942006423 ()
5430-30154

  • Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System
In Commercial Distribution

  • 00859942006096 ()
5430-30151

  • Thyroid-uptake nuclear medicine system
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, Bioassay module, Wipe Test Module, and Lab Tests.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid System with Well
In Commercial Distribution

  • 00859942006102 ()
5430-30152

  • Thyroid-uptake nuclear medicine system
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