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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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Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×1 R2:6mL×1
In Commercial Distribution

  • 06971674860792 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:18mL×4 R2:6mL×4
In Commercial Distribution

  • 06971674860785 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent
No Description
Biobase Biodustry(Shandong)Co., Ltd.
R1:60mL×2 R2:20mL×2
In Commercial Distribution

  • 06971674860778 ()


  • Apolipoprotein A-I (Apo A1) IVD, reagent
CEREC AI Connect with Omnicam
SIRONA Dental Systems GmbH
6564707
In Commercial Distribution

  • E27665647070 ()


  • CAD/CAM software
CEREC AI without CEREC Omnicam
SIRONA Dental Systems GmbH
6542901
In Commercial Distribution

  • E27665429010 ()


  • CAD/CAM software
CEREC AI with CEREC Omnicam
SIRONA Dental Systems GmbH
6534791
In Commercial Distribution

  • E27665347910 ()


  • CAD/CAM software
AI SaMD for prostate cancer.
Avenda Health, Inc.
V0.1.4
In Commercial Distribution

  • 00850012642008 ()


  • MRI image interpretive software
Silastic Ring Applicator AI Style
Avalign Technologies, Inc.
72-52205501M
In Commercial Distribution

  • 00190776208462 ()


  • Rigid endoscopic tissue manipulation forceps, reusable
FiberOptic Adapter Storzympus to AI
Avalign Technologies, Inc.
72-9883
In Commercial Distribution

  • 00190776191504 ()


  • Fibreoptic retractor handle
SW ZA400 ACCURHYTHM AI POST-PROCESSING
MEDTRONIC, INC.
ZA400
In Commercial Distribution

  • 00763000504519 ()


  • Implantable cardiac device management application software
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