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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 Software - 00643169878204

SFW 9735910 STEALTH S8 DBS
MEDTRONIC NAVIGATION, INC.
9735910
In Commercial Distribution

  • 00643169878204 ()


  • Neurological stereotactic surgery system

StealthStation Cranial Software - 00643169865341

SW APP 9735762 STEALTH S8 APP
MEDTRONIC NAVIGATION, INC.
9735762
In Commercial Distribution

  • 00643169865341 ()


  • Multi-purpose stereotactic surgery system

Care Orchestrator Software - 00606959050730

Care Orchestrator Clinical Management Data Software
Respironics, Inc.
1.13
In Commercial Distribution

  • 00606959050730 ()
1126366

  • Medical equipment clinical data interfacing 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

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

Qlab Quantification Software - 00884838098220

Version 15.0
Philips Ultrasound LLC
989606710071
In Commercial Distribution

  • 00884838098220 ()


  • Radiological PACS software

MOVE FORWARD SOFTWARE - 00880304992863

No Description
Biomet Orthopedics, LLC
CG100
Not in Commercial Distribution

  • 00880304992863 ()
CG100

  • Orthopaedic/craniofacial implantation planning software

VMA DataLink Software - 00868579000223

VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site
ORTHO KINEMATICS, INC.
3
In Commercial Distribution

  • 00868579000223 ()


  • Radiological PACS software

VMA DataLink Software - 00868579000216

No Description
ORTHO KINEMATICS, INC.
2.3
In Commercial Distribution

  • 00868579000216 ()


  • Radiological PACS software
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