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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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moorFLPI2- Measurement PC Software - 15060484490126

moorFLPI2- Measurement PC Software V2
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490126 ()


  • Cutaneous microcirculation laser Doppler imaging device

moorVMS-VASC PC Software - 15060484490102

Clinical software for micro vascular assessments in physiological research and clinical applications.
MOOR INSTRUMENTS LIMITED
2
In Commercial Distribution

  • 15060484490102 ()


  • Laser Doppler blood flowmeter

EVA System - 17290016976004

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The EVA System is a mobile colposcope in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, a mobile app for image capture, and online portal for image transfer and remote viewing. The device is intended for use in hospitals, doctor's offices and remote and rural clinics.
MOBILEODT LTD
2
In Commercial Distribution

  • 17290016976004 ()


  • Colposcope

Directa Temporary Polycarbonate Crowns - 17310236092091

No Description
Directa AB
2
In Commercial Distribution

  • 17310236092091 ()
609209

  • Preformed dental crown, temporary

NexFrame Mechanical Set Kit - 27290114061159

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061159 ()
700-021507-03

  • Depth electrode

Starfix frame Mechanical Set Kit - 27290114061142

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061142 ()
700-021508-00

  • Depth electrode

Leibinger RM frame Mechanical Set Kit - 27290114061135

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061135 ()
700-020874-00

  • Depth electrode

Leksell Non-XY frame Mechanical Set KIT - 27290114061111

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061111 ()
700-020832-00

  • Depth electrode

CRW Non-XY frame Mechanical Set KIT - 27290114061104

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061104 ()
700-020834-00

  • Depth electrode

Oxevision Sleep system - 50607514500023

Sleep disorder interpretive software, professional-only
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500023 ()


  • Sleep disorder interpretive software, professional-only
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