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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SW APP A810 TDD CLINICIAN PROG V2.X
MEDTRONIC, INC.
A810
In Commercial Distribution

  • 00763000632786 ()


  • Infusion pump programmer
PRGM 8835 PERSONAL THRPY MG2 SRVC US
MEDTRONIC, INC.
8835-SVC
In Commercial Distribution

  • 00763000875701 ()


  • Infusion pump programmer
PRGM 8835 PERSONAL THRPY MG2 RFRB US
MEDTRONIC, INC.
8835-RFB
In Commercial Distribution

  • 00763000875695 ()


  • Infusion pump programmer
No Description
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
ABUS Review Software
In Commercial Distribution

  • 00840682100090 ()


  • Breast ultrasound imaging system
Intelligent 2D™ is a software feature where a high-resolution digital mammography image is generated from data acquired during a high-resolution breast tomosynthesis scan. The high resolution tomosynthesis image and the Intelligent 2D image have a pixel resolution of 70 microns.
Hologic, Inc.
INTELLIGENT 2D SOFTWARE
In Commercial Distribution

  • 15420045507289 ()
SW-04882

  • Stationary mammographic x-ray system, digital
Hologic Clarity HD® (high resolution tomosynthesis) is a software driven digital breast tomosynthesis 3(D) imaging feature intended to improve image resolution on tomosynhesis slices and synthesized 2D images that will enhance image quality and user experience.
Hologic, Inc.
CLARITY HD SOFTWARE
In Commercial Distribution

  • 15420045507272 ()
SW-04756

  • Stationary mammographic x-ray system, digital
HeartStart Configure
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart Configure
In Commercial Distribution

  • 00884838041547 ()
861487

  • Emergency/ambulatory healthcare software
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution

  • M727SAVEREVOH013 ()
PAD-ACC-03

  • External defibrillator application software
Event Reporting and Administrative AED Configuration Software V.2.2.1.1 for Powerheart G5
Zoll Medical Corporation
40-00296-05
In Commercial Distribution

  • 00812394021505 ()
40-00296-05

  • External defibrillator application software
MDLink SW 12.0
Zoll Medical Corporation
40-00580-01
In Commercial Distribution

  • 00812394021499 ()
40-00580-01

  • External defibrillator application software
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