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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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StealthStation® Cranial - 00763000253165

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000253165 ()


  • Neurological stereotactic surgery system

uWS - 06971576834020

CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-CT
In Commercial Distribution

  • 06971576834020 ()


  • Radiology DICOM image processing application software

uWS - 06971576834013

MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software

StealthStation® Cranial - 00763000095741

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000095741 ()


  • Neurological stereotactic surgery system

Software LENS Tablet Application - 00885556653876

SOFTWARE LENS TABLET APPLICATION
Smith & Nephew, Inc.
72204699
In Commercial Distribution

  • 00885556653876 ()
72204699

  • Endoscopic video imaging system

N/A - 00885074445465

SOFTWARE, 9732430, SPINE UNIFIED
MEDTRONIC NAVIGATION, INC.
9732430
In Commercial Distribution

  • 00885074445465 ()


  • Multi-purpose stereotactic surgery system

Welch Allyn, Inc. - 00732094308440

Q-Stress Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308440 ()
QSERV-6AA-XXXXX

  • Electrocardiographic lead set, reusable

Welch Allyn, Inc. - 00732094263978

HScribe Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263978 ()
HSERV-6AA-XXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Minuteful - kidney test - 17290017272471

The Minuteful - kidney test is an in-vitro diagnostic, home-use urine analysis test system for the semi-quantitative measurement of albumin and creatinine in urine, as well as the presentation of their ratio, the albumin-creatinine ratio (ACR), with results that are intended to be used in conjunction with clinical evaluation as an aid in the assessment of kidney health.
HEALTHY.IO LTD
MNT KDN.US.GEN
In Commercial Distribution

  • 17290017272471 ()


  • Self-testing data clinician presentation application software IVD

Alaris - 10885403897535

Alaris Systems Maintenance v12.3-v.12.5
CAREFUSION 303, INC.
8975
In Commercial Distribution

  • 10885403897535 ()


  • Infusion pump medication-dosage application software
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