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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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0006-0101
In Commercial Distribution

  • 04049016068785 ()


  • Laboratory instrument/analyser application software IVD
No Description
Philips North America LLC
Capsule Surveillance System
In Commercial Distribution

  • 03615041990332 ()


  • Clinical management support software
Bioserenity CLOUD is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals.
BIOSERENITY MEDICAL DEVICES GROUP
1012-21002-US
Not in Commercial Distribution

  • 03615220004270 ()


  • Bio-energy preliminary diagnosis system application software
BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD
U.S.IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, US, SW4.3_v5 12001443
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563922 ()

  • 1 Each
12001443

  • Laboratory instrument/analyser application software IVD
BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD
U.S. IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, SW 4.3_v5
BIO-RAD LABORATORIES, INC.
SW4.3_v5
In Commercial Distribution

  • 03610520178904 ()

  • 1 Each
12003844

  • Laboratory instrument/analyser application software IVD
Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.
BRIGHTHEART
V1.0.0
In Commercial Distribution

  • 03760415600000 ()


  • Ultrasound imaging system application software
iQ®200 Body Fluids Module (CD only)
BECKMAN COULTER IRELAND INC.
Body Fluids Module
In Commercial Distribution

  • 10837461002475 ()
800-3704

  • Laboratory instrument/analyser application software IVD
DRIVER HF UNIT KLS MARTIN
Richard Wolf GmbH
5592606
Not in Commercial Distribution

  • 04055207057537 ()
5592606

  • Operating room audiovisual data/device management system application software
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