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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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Navigation Software Trauma 2D - 04056481000745

No Description
Brainlab AG
3.1
Not in Commercial Distribution

  • 04056481000745 ()
22082

  • Robotic surgical navigation system

Navigation Software Fluoro Express - 04056481000738

No Description
Brainlab AG
3.2
Not in Commercial Distribution

  • 04056481000738 ()
22084

  • Robotic surgical navigation system

Navigation Software Fluoro Express - 04056481000509

No Description
Brainlab AG
3.2
Not in Commercial Distribution

  • 04056481000509 ()
22082-01A

  • Robotic surgical navigation system

Avatar Medical Software V1 - 03770026095003

AVATAR MEDICAL Software V1 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images. AVATAR MEDICAL Software V1 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.
AVATAR MEDICAL
AMS V1
Not in Commercial Distribution

  • 03770026095003 ()


  • Radiology picture archiving and communication system workstation

QuickScan Touch Software & Key - M52516910000

No Description
HELENA LABORATORIES CORPORATION
1691000
In Commercial Distribution

  • M52516910000 ()


  • Densitometry analyser IVD

VersiHD with GuideMe software - M535NX100016F0

No Description
NXSTAGE MEDICAL, INC.
NX1000-16-F
In Commercial Distribution

  • M535NX100016F0 ()


  • Haemodialysis system, institutional/home-use

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
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