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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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Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution

  • 00850025688819 ()


  • Home pharmaceutical management support software
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution

  • 00850010298146 ()
ELEFT

  • Cardiopulmonary physiological parameter analysis software
No Description
Bigfoot Biomedical, Inc.
SW-300983
In Commercial Distribution

  • 00850003506517 ()
SW-300983

  • Self-care monitoring/reporting software
SYRINGE LABELER INK CARTRIDGE
BECTON, DICKINSON AND COMPANY
516803
In Commercial Distribution

  • 60382905168033 ()
  • 00382905168031 ()
  • 50382905168036 ()
516803

  • Intravenous injection automated detection/documentation system processor/transmitter
SYRINGE LABELER BARREL LABEL ROLL
BECTON, DICKINSON AND COMPANY
516802
In Commercial Distribution

  • 60382905168026 ()
  • 00382905168024 ()
  • 50382905168029 ()
516802

  • Intravenous injection automated detection/documentation system processor/transmitter
SYRINGE LABELER LUER LABEL CASSETTE
BECTON, DICKINSON AND COMPANY
516801
In Commercial Distribution

  • 50382905168012 ()
  • 00382905168017 ()
  • 60382905168019 ()
516801

  • Intravenous injection automated detection/documentation system processor/transmitter
OBM ROLL STAND KIT
XLTEK
OBM00003
In Commercial Distribution

  • 00382830008020 ()


  • Electroencephalograph
Neonatal Sensors
XLTEK
CZA00037
In Commercial Distribution

  • 00382830007443 ()
  • 00382830058506 ()


  • Analytical scalp electrode, single-use
The Ceramill M-Plant module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Ceramill M-Plant is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.1
In Commercial Distribution

  • 04260521363619 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
exocad GmbH
3.2
In Commercial Distribution

  • 04260521363534 ()


  • Dental milling system, CAD/CAM, chairside
  • CAD/CAM software
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