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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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VersiHD with GuideMe software - M535NX100010G0

No Description
NXSTAGE MEDICAL, INC.
NX1000-10-G
In Commercial Distribution

  • M535NX100010G0 ()


  • Haemodialysis system, institutional/home-use

VersiHD with GuideMe software - M535NX100010F0

No Description
NXSTAGE MEDICAL, INC.
NX1000-10-F
In Commercial Distribution

  • M535NX100010F0 ()


  • Haemodialysis system, institutional/home-use

VersiHD with GuideMe software - M535NX100010E0

No Description
NXSTAGE MEDICAL, INC.
NX1000-10-E
In Commercial Distribution

  • M535NX100010E0 ()


  • Haemodialysis system, institutional/home-use

e-Ortho Shoulder Software V1.1 - 03661489716270

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
271627
In Commercial Distribution

  • 03661489716270 ()


  • Orthopaedic/craniofacial implantation planning software

Galileo NT Line Software - 08056446900642

Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.
EB NEURO SPA
B8640053000
In Commercial Distribution

  • 08056446900642 ()


  • Bioelectrical signal analysis software

THD Procto Software System - 08033737713037

The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for: - Endoanal ultrasound (trans-rectal ultrasound / echography) - Anoscopy exams - Manometry exams
THD SPA
THD Procto Software
In Commercial Distribution

  • 08033737713037 ()
760004

  • Ultrasound imaging system application software

B-scan Plus: Software Package - 00897826002178

No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002178 ()


  • Ophthalmic ultrasound imaging system

UBM Plus: Software Package - 00897826002161

No Description
ACCUTOME, INC.
4.07.02-U
In Commercial Distribution

  • 00897826002161 ()


  • Ophthalmic ultrasound imaging system

B-scan Pro: Software Package - 00897826002154

No Description
ACCUTOME, INC.
1.03.03-U
In Commercial Distribution

  • 00897826002154 ()


  • Ophthalmic ultrasound imaging system

EMAG® SOFTWARE V1.4 - 03573026635046

EMAG software (virtual) version 1.4 also called SP4
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026635046 ()


  • Nucleic acid sample preparation instrument IVD
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