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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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CEREC Ortho Software - E27666111690

CEREC Ortho Software Version 1.2.0
SIRONA Dental Systems GmbH
6611169
Not in Commercial Distribution

  • E27666111690 ()


  • CAD/CAM software

iChiropro Surgery APP - J00714000520521

iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad).
Bien-Air Dental SA
1400052
In Commercial Distribution

  • J00714000520521 ()
1400052

  • Surgical power tool system control unit, line-powered
  • Dental treatment application software

DEXIS™ Software - EKAV101244750

Software
DEXIS LLC
11
In Commercial Distribution

  • EKAV101244750 ()
1.012.4475

  • Radiology information system application software

DEXIS™ Software - EKAV101135330

Software
DEXIS LLC
11
In Commercial Distribution

  • EKAV101135330 ()
10124479

  • Radiology information system application software

iSy® Re-Set - E219P590010001

iSy® Re-Set Removal tools set
ALTATEC GmbH
P5900.1000
In Commercial Distribution

  • E219P590010001 ()
P5900.1000

  • Dental implant extractor

ANS1 Software - B322G0011

"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath (Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management. The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."
LD TECHNOLOGY, LLC
G001
In Commercial Distribution

  • B322G0011 ()


  • Manual-inflation electronic sphygmomanometer, non-portable
  • Skin electrical conductance meter

eCardiostation Software - B147EC0

Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution

  • B147EC0 ()


  • Electrocardiography telemetric monitoring system

Millennia Software - B146C4MA020

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-02
In Commercial Distribution

  • B146C4MA020 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C4MA000

No Description
BRAEMAR MANUFACTURING, LLC
900-0621-00
In Commercial Distribution

  • B146C4MA000 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Millennia Software - B146C3MA080

No Description
BRAEMAR MANUFACTURING, LLC
900-0620-08
In Commercial Distribution

  • B146C3MA080 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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