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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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iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software
iSage Rx™ (iSage Rx Basal Insulin Titration)
Amalgam Rx Inc
Version 2.X
In Commercial Distribution

  • 00850006610006 ()


  • Home pharmaceutical management support software
No Description
KONAN MEDICAL, INC.
Cellchek
Not in Commercial Distribution

  • 04582275250428 ()


  • Eye anterior segment analyser software
No Description
HICLUB, INC.
/
In Commercial Distribution

  • 04595318292019 ()


  • Sleep disorder interpretive software, patient-use
No Description
EverEx
1.2.X
In Commercial Distribution

  • 08809970060005 ()


  • Biomechanical function analysis/rehabilitation software
No Description
BIOFOURMIS SINGAPORE PTE. LTD.
1.1
In Commercial Distribution

  • 08885018690014 ()


  • Cardiopulmonary physiological parameter analysis software
OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
OPTIMIZED ORTHO PTY LTD
1.2
In Commercial Distribution

  • 09351327000848 ()
1200-0000

  • Orthopaedic/craniofacial implantation planning software
No Description
DEXIS LLC
10
In Commercial Distribution

  • EKAV100879340 ()
1.008.7934

  • Radiology information system application software
No Description
mediCAD Hectec GmbH
7
In Commercial Distribution

  • 04260489720110 ()


  • Orthopaedic/craniofacial implantation planning software
No Description
ICU MEDICAL, INC.
22-3510-51
In Commercial Distribution

  • 00610586032335 ()


  • Infusion pump medication-dosage application software
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