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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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WVSM Wireless Vital Signs Monitor - B3943900004000

WVSM Management Suite - PC
ATHENA GTX, INC.
PC Software
In Commercial Distribution

  • B3943900004000 ()
390-0004-00

  • Centralized patient monitor

NovoTAL Software for Array Mapping - 07290107981729

No Description
Novocure GmbH
NovoTAL Software
In Commercial Distribution

  • 07290107981729 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator

NovoTAL Software for Array Mapping - 07290107981576

No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution

  • 07290107981576 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator

NovoTAL Software for Array Mapping - 07290107980715

No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution

  • 07290107980715 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator

Duet™ - 07290107653053

No Description
BIO-VIEW LTD
Solo Software
In Commercial Distribution

  • 07290107653053 ()


  • Fluorescence light microscope

Selenia Dimensions 3D System - 15420045500013

Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Hologic, Inc.
3D software
In Commercial Distribution

  • 15420045500013 ()
SW-01648

  • Stationary mammographic x-ray system, digital

NA - EPTWS0900020

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MultiSoft software
In Commercial Distribution

  • EPTWS0900020 ()
S090002

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0800520

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
PeakScan software
In Commercial Distribution

  • EPTWS0800520 ()
S080052

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0800380

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
FilmScan software
In Commercial Distribution

  • EPTWS0800380 ()
S080038

  • Multi-modality therapeutic radiation phantom, anthropomorphic

NA - EPTWS0800310

No Description
PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
MP1Control software
In Commercial Distribution

  • EPTWS0800310 ()
S080031

  • Multi-modality therapeutic radiation phantom, anthropomorphic
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