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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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ROSA® KNEE SOFTWARE - 00889024511330

No Description
Orthosoft Inc
20-8020-130-01
In Commercial Distribution

  • 00889024511330 ()
20-8020-130-01

  • Robotic surgical navigation system application software

MoMe® Software Platform - B690MS10

MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Signature ONE Software Package - 00889024585393

v. 1.0
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024585393 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024647046

v. 1.2
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647046 ()
302.4018

  • Radiology DICOM image processing application software

Signature ONE Software Package - 00889024647039

v. 1.1
Orthosoft Inc
302.4018
In Commercial Distribution

  • 00889024647039 ()
302.4018

  • Radiology DICOM image processing application software

e-Ortho Shoulder Software V1.1 - 03661489716270

No Description
FOURNITURES HOSPITALIERES INDUSTRIE
271627
In Commercial Distribution

  • 03661489716270 ()


  • Orthopaedic/craniofacial implantation planning software

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
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