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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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VISUCONSULT 500 - 04250668606618

N/A
Carl Zeiss Vision GmbH
000000-2265-586
In Commercial Distribution

  • 04250668606618 ()
000000-2265-586

  • Multidisciplinary medical image management software

ELMED - 00842180191426

CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
ST13CG0823
In Commercial Distribution

  • 00842180191426 ()
ST13CG0823

  • Robotic surgical system application software

MonitAir - 00198715136333

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.7
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

ELMED - 00842180177390

CATHETER GUIDE, STAINLESS STEEL, AUTOCLAVABLE, 4.75MM ROUND (.1870"), KNURLED HANDLE/STOP, 90 DEGREE BEND AT DISTAL END.
ELMED INCORPORATED
13-CG0823
In Commercial Distribution

  • 00842180177390 ()
13-CG0823

  • Robotic surgical system application software

ELMED - 00198506058103

CYSTO GRID MARKER STAINLESS STEEL
ELMED INCORPORATED
83-31000-CC
In Commercial Distribution

  • 00198506058103 ()
83-31000-CC

  • Robotic surgical system application software

ELMED - 00198506001659

GUYON Catheter Guide GUYON cm, 15-1/2"
ELMED INCORPORATED
ST310703939
In Commercial Distribution

  • 00198506001659 ()
ST310703939

  • Robotic surgical system application software

MonitAir - 00198168370179

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.6
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00198168299500

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.4
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

MonitAir - 00198168116760

MonitAir is a HIPAA compliant, FDA registered MDDS combining remote data monitoring and telemedicine features to support patients on PAP/NIV therapy for chronic sleep and respiratory conditions.
Monitair LLC
1.2.5
In Commercial Distribution



  • Vulnerable patient home-monitoring software, professional-only

TDHisto/Cyto - 03770027519010

TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities. .
TECHNIDATA
TDHisto/Cyto
In Commercial Distribution

  • 03770027519010 ()


  • Pathology information system application software
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