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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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QLAB Quantification Software - 00884838070837

No Description
Philips Ultrasound LLC
Release 10.7
In Commercial Distribution

  • 00884838070837 ()


  • Radiological PACS software

QLAB Quantification Software - 00884838059788

No Description
Philips Ultrasound LLC
Release 10.5
In Commercial Distribution

  • 00884838059788 ()


  • Radiological PACS software

QLAB Quantification Software - 00884838086616

No Description
Philips Ultrasound LLC
Release 10.8.5
In Commercial Distribution

  • 00884838086616 ()


  • Radiological PACS software

Q-Station Application Software - 00884838083509

No Description
Philips Ultrasound LLC
Release 3.8
In Commercial Distribution

  • 00884838083509 ()


  • Radiological PACS software

Eonis Analysis software - 06438147373901

The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).
Wallac Oy
5020-1000
In Commercial Distribution

  • 06438147373901 ()
5020-1000

  • Human genomic analysis interpretive software IVD

sUSBA Software, VA25A - 04056869001067

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10855671
Not in Commercial Distribution

  • 04056869001067 ()


  • Radiological PACS software

syngo Application Software - 04056869262567

syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Siemens Healthcare GmbH
11328180
In Commercial Distribution

  • 04056869262567 ()


  • Basic diagnostic x-ray system application software

sUSBA Trial Software - 04056869006840

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149926
Not in Commercial Distribution

  • 04056869006840 ()


  • Radiological PACS software

neuromate - neuroinspire software - 03662724000482

No Description
RENISHAW MAYFIELD
neuroinspire SW Atlas Module
In Commercial Distribution

  • 03662724000482 ()
001.0123

  • Neurological stereotactic surgery system

neuromate neuroinspire software - 03662724000390

No Description
RENISHAW MAYFIELD
neuroinspire planning software
In Commercial Distribution

  • 03662724000390 ()
001.0142

  • Neurological stereotactic surgery system
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