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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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The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
HIGI SH LLC
KMY-120630950-117
In Commercial Distribution

  • B416KMY8202F0 ()
n/a

  • Automatic-inflation electronic sphygmomanometer, non-portable
No Description
Csa Service Solutions
LC300WC
In Commercial Distribution

  • B468LC300WC0 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable
No Description
Csa Service Solutions
LC300
In Commercial Distribution

  • B468LC300 ()


  • Automatic-inflation electronic sphygmomanometer, non-portable
The AliveCor KardiaMobile Card System is a single-channel electrocardiogram (ECG) device that is intended to record, store, transfer, display, and analyze single-channel ECG rhythms.
Alivecor, Inc.
AC-021
In Commercial Distribution

  • B210AC0210 ()


  • Electrocardiograph, professional, single-channel
  • Electrocardiograph, home-use
No Description
Alivecor, Inc.
AC-019
In Commercial Distribution

  • B210AC0190 ()


  • Electrocardiograph, professional, single-channel
BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 4.7/5.2 mm, Bleach White
Prismatik Dentalcraft, Inc
70-1185-NOW0133
In Commercial Distribution

  • D745701185NOW01330 ()
70-1185-NOW0133

  • Dental implant suprastructure, permanent, preformed
BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 4.7/5.2 mm, Bleach3
Prismatik Dentalcraft, Inc
70-1185-NOW0132
In Commercial Distribution

  • D745701185NOW01320 ()
70-1185-NOW0132

  • Dental implant suprastructure, permanent, preformed
BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 4.7/5.2 mm, Bleach1
Prismatik Dentalcraft, Inc
70-1185-NOW0131
In Commercial Distribution

  • D745701185NOW01310 ()
70-1185-NOW0131

  • Dental implant suprastructure, permanent, preformed
BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 4.7/5.2 mm, D4
Prismatik Dentalcraft, Inc
70-1185-NOW0130
In Commercial Distribution

  • D745701185NOW01300 ()
70-1185-NOW0130

  • Dental implant suprastructure, permanent, preformed
BruxZir® NOW SRC for Inclusive® Tapered Implant System Ø 4.7/5.2 mm, D3
Prismatik Dentalcraft, Inc
70-1185-NOW0129
In Commercial Distribution

  • D745701185NOW01290 ()
70-1185-NOW0129

  • Dental implant suprastructure, permanent, preformed
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