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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Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-31M
In Commercial Distribution

  • 05415067033093 ()
E200-31M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-29M
In Commercial Distribution

  • 05415067033086 ()
E200-29M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-29A
In Commercial Distribution

  • 05415067033079 ()
E200-29A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-27M
In Commercial Distribution

  • 05415067033062 ()
E200-27M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-27A
In Commercial Distribution

  • 05415067033055 ()
E200-27A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-25M
In Commercial Distribution

  • 05415067033048 ()
E200-25M

  • Mitral open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-25A
In Commercial Distribution

  • 05415067033031 ()
E200-25A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-23A
In Commercial Distribution

  • 05415067033024 ()
E200-23A

  • Aortic open-surgery heart valve bioprosthesis
Stented Tissue Valve
ST. JUDE MEDICAL, INC.
E200-21A
In Commercial Distribution

  • 05415067033017 ()
E200-21A

  • Aortic open-surgery heart valve bioprosthesis
HF Cardiac Resychronisation Therapy Defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CDHFA300Q
In Commercial Distribution

  • 05415067032850 ()
CDHFA300Q

  • Cardiac resynchronization therapy implantable defibrillator
DR Implantable Cardioverter Defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
CDDRA300Q
In Commercial Distribution

  • 05415067032843 ()
CDDRA300Q

  • Dual-chamber implantable defibrillator
VR Implantable Cardioverter Defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CDVRA300Q
In Commercial Distribution

  • 05415067032836 ()
CDVRA300Q

  • Single-chamber implantable defibrillator
Mobile application compatible to iOS operating system
ST. JUDE MEDICAL, INC.
APP1005
In Commercial Distribution

  • 05415067032829 ()
APP1005

  • Implantable cardiac device management application software
Mobile application compatible to Android operating system
ST. JUDE MEDICAL, INC.
APP1004
In Commercial Distribution

  • 05415067032812 ()
APP1004

  • Implantable cardiac device management application software
Stand Components
ST. JUDE MEDICAL, INC.
TENDV-SC
In Commercial Distribution

  • 05415067032720 ()
TENDV-SC

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Pad Positioning System
ST. JUDE MEDICAL, INC.
TENDV-PS
In Commercial Distribution

  • 05415067032713 ()
TENDV-PS

  • Mitral transcatheter heart valve bioprosthesis
Loading System
ST. JUDE MEDICAL, INC.
TENDV-LS
In Commercial Distribution

  • 05415067032706 ()
TENDV-LS

  • Self-expandable heart valve bioprosthesis collapsing tool, single-use
Delivery System
ST. JUDE MEDICAL, INC.
TENDV-DS
In Commercial Distribution

  • 05415067032690 ()
TENDV-DS

  • Mitral transcatheter heart valve bioprosthesis
Apical Pad - Large
ST. JUDE MEDICAL, INC.
TENDV-LPAD
In Commercial Distribution

  • 05415067032683 ()
TENDV-LPAD

  • Mitral transcatheter heart valve bioprosthesis
Apical Pad - Small
ST. JUDE MEDICAL, INC.
TENDV-SPAD
In Commercial Distribution

  • 05415067032676 ()
TENDV-SPAD

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-29L
In Commercial Distribution

  • 05415067032669 ()

  • Outer Diameter: 29.0000 Millimeter
TENDV-LP-29L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-29S
In Commercial Distribution

  • 05415067032652 ()

  • Outer Diameter: 29.0000 Millimeter
TENDV-LP-29S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-37M
In Commercial Distribution

  • 05415067032645 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-LP-37M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-37S
In Commercial Distribution

  • 05415067032638 ()
TENDV-LP-37S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-35M
In Commercial Distribution

  • 05415067032621 ()

  • Outer Diameter: 35.0000 Millimeter
TENDV-LP-35M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-35S
In Commercial Distribution

  • 05415067032614 ()
TENDV-LP-35S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-33M
In Commercial Distribution

  • 05415067032607 ()
TENDV-LP-33M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-LP-33S
In Commercial Distribution

  • 05415067032591 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-LP-33S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37L
In Commercial Distribution

  • 05415067032584 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35L
In Commercial Distribution

  • 05415067032577 ()
TENDV-SP-35L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33L
In Commercial Distribution

  • 05415067032560 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-SP-33L

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-41S
In Commercial Distribution

  • 05415067032553 ()
TENDV-SP-41S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-39M
In Commercial Distribution

  • 05415067032546 ()

  • Outer Diameter: 39.0000 Millimeter
TENDV-SP-39M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-39S
In Commercial Distribution

  • 05415067032539 ()
TENDV-SP-39S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37M
In Commercial Distribution

  • 05415067032522 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-37S
In Commercial Distribution

  • 05415067032515 ()

  • Outer Diameter: 37.0000 Millimeter
TENDV-SP-37S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35M
In Commercial Distribution

  • 05415067032508 ()

  • Outer Diameter: 35.0000 Millimeter
TENDV-SP-35M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-35S
In Commercial Distribution

  • 05415067032492 ()
TENDV-SP-35S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33M
In Commercial Distribution

  • 05415067032485 ()
TENDV-SP-33M

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33S
In Commercial Distribution

  • 05415067032478 ()

  • Outer Diameter: 33.0000 Millimeter
TENDV-SP-33S

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33C
In Commercial Distribution

  • 05415067032461 ()
TENDV-SP-33C

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33B
In Commercial Distribution

  • 05415067032454 ()
TENDV-SP-33B

  • Mitral transcatheter heart valve bioprosthesis
Mitral Valve
ST. JUDE MEDICAL, INC.
TENDV-SP-33A
In Commercial Distribution

  • 05415067032447 ()
TENDV-SP-33A

  • Mitral transcatheter heart valve bioprosthesis
X EP System Surface Electrode Kit
ST. JUDE MEDICAL, INC.
ENSITE-SEK-5-01
In Commercial Distribution

  • 05415067032379 ()
  • 15415067032376 ()
ENSITE-SEK-5-01

  • Cardiac mapping system reference patch
Surface Electrode Kit
ST. JUDE MEDICAL, INC.
PRCN-SEK-A
In Commercial Distribution

  • 05415067032355 ()
  • 15415067032352 ()
PRCN-SEK-A

  • Cardiac mapping system reference patch
Locating Electrodes
ST. JUDE MEDICAL, INC.
SURF-ELEC-2PRS
In Commercial Distribution

  • 05415067032300 ()
SURF-ELEC-2PRS

  • Cardiac mapping system reference patch
Steerable Catheter with Electrodes
ST. JUDE MEDICAL, INC.
DS3H010-38
In Commercial Distribution

  • 05415067032287 ()

  • Catheter Gauge: 10.5000 French
DS3H010-38

  • Vascular guide-catheter, single-use
Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-CF-01
In Commercial Distribution

  • 05415067032256 ()
ENSITE-D-CF-01

  • Cardiac mapping system application software
Contact Force Software License
ST. JUDE MEDICAL, INC.
ENSITE-CF-01
In Commercial Distribution

  • 05415067032249 ()
ENSITE-CF-01

  • Cardiac mapping system application software
Field Frame Cable
ST. JUDE MEDICAL, INC.
ENSITE-FF-4.5C-01
In Commercial Distribution

  • 05415067032232 ()
ENSITE-FF-4.5C-01

  • Electrical-only medical device connection cable, reusable
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