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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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Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
ST. JUDE MEDICAL, INC.
TFGT-19A
In Commercial Distribution

  • 05415067018205 ()

  • Outer Diameter: 19 Millimeter
TFGT-19A

  • Aortic open-surgery heart valve bioprosthesis
MONITOR 24955 FRU USA 2BD
MEDTRONIC, INC.
24955
Not in Commercial Distribution

  • 00643169469891 ()


  • Cardiac pulse generator reader, home-use
MONITOR 24955 FRU US CAN ANZ EUR 1 BD
MEDTRONIC, INC.
24955
Not in Commercial Distribution

  • 00643169469884 ()


  • Cardiac pulse generator reader, home-use
MON 24950D MYCARELINK US M2.0
MEDTRONIC, INC.
24950D
Not in Commercial Distribution

  • 00643169441101 ()


  • Cardiac pulse generator reader, home-use
MON 24950E MYCARELINK/SVC USA
MEDTRONIC, INC.
24950E
In Commercial Distribution

  • 00643169452060 ()


  • Cardiac pulse generator reader, home-use
MON 24950D1 MYCARELINK/SVC MKT USA
MEDTRONIC, INC.
24950D1
Not in Commercial Distribution

  • 00643169486744 ()


  • Cardiac pulse generator reader, home-use
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 450P
In Commercial Distribution

  • M727SAM450P ()


  • Non-rechargeable public semi-automated external defibrillator
Fully Automatic Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • M727SAM360P0 ()


  • Non-rechargeable public automated external defibrillator
Semi-Automatic External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • M727SAM350P ()


  • Non-rechargeable public semi-automated external defibrillator
8.5 FR VARIPULSE™ Bi-Directional Catheter
Biosense Webster Inc
D141201
In Commercial Distribution

  • 10846835025460 ()
D141201

  • Cardiac irreversible electroporation system catheter
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