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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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X-Guide 2.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020896 ()


  • Surgical planning/navigation-enhancement system
NeuroCatch Platform software NS20
NeuroCatch Inc
2.0
In Commercial Distribution

  • G134NS200 ()


  • Electroencephalograph
Blue Sky Plan Software
BLUE SKY BIO LLC
5.0
In Commercial Distribution

  • 00810060226346 ()
BSP

  • Dental treatment application software
VERSATILE HIP 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6007-616-000
In Commercial Distribution

  • 07613327004250 ()
6007-616-000

  • Robotic surgical navigation system application software
WinOMS Practice Management Software
CARESTREAM HEALTH, INC.
CS WinOMS
In Commercial Distribution

  • 60889978014576 ()
8014573

  • Physician-practice-management information system
CS OMS Imaging Software
CARESTREAM HEALTH, INC.
CS OMS Imaging Software
In Commercial Distribution

  • 60889971746849 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software
CS Orthodontic Imaging Software
CARESTREAM HEALTH, INC.
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60889971746832 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software
CS OMS Imaging Software
CARESTREAM HEALTH, INC.
CS OMS Imaging Software
In Commercial Distribution

  • 60889971546975 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software
VITA V3.2 LITE SOFTWARE
CARESTREAM HEALTH, INC.
Vita CR System
Not in Commercial Distribution

  • 60889971024084 ()
1024082

  • Computed radiography digital imaging scanner
CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851666 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software
CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851659 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software
CS Orthodontic Imaging Software
CARESTREAM DENTAL LLC
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60192156851642 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software
Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software
FLUOROSCOPY SOFTWARE 2.3 CD
Stryker Leibinger GmbH & Co. KG
81-80036
In Commercial Distribution

  • 07613327115048 ()
81-80036

  • Robotic surgical navigation system application software
SPINEMAP¿ 3D 3.0 - SOFTWARE
Stryker Leibinger GmbH & Co. KG
6002-670-000
In Commercial Distribution

  • 07613327114898 ()
6002-670-000

  • Robotic surgical navigation system application software
Multi Patient Relay Software
Lifesignals, Inc.
UA2550-MR
In Commercial Distribution

  • B353UA2550MR1 ()


  • Physiological measuring device wireless data capture/transfer unit
Holter Web Server Software
Lifesignals, Inc.
UA2251-W
In Commercial Distribution

  • B353UA2251W1 ()


  • Network server
Holter Central Server Software
Lifesignals, Inc.
UA2251-S
In Commercial Distribution

  • B353UA2251S1 ()


  • Network server
Medical Device Software Application
Airstrip Technologies, Inc.
2003
In Commercial Distribution

  • B15320030 ()


  • Bedside monitor remote-viewing software, physiological parameter
SYNERGY MATRIX SOFTWARE LICENSE
ARTHREX, INC.
AR-3200-1052
In Commercial Distribution

  • 00888867339941 ()
AR-3200-1052

  • Multidisciplinary medical image management software
Clinician’s Programmer with Software
BIONESS INC.
ST2-4000
In Commercial Distribution

  • 00815962020023 ()


  • Analgesic PENS system probe, single-use
Bioness Integrated Therapy Software
BIONESS INC.
2.0.5
In Commercial Distribution

  • 00815962020245 ()


  • Perceptual-coordination assistive training device
SOFTWARE E-SCRIBE WORKSTATION V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020686 ()
11012-016-51

  • Patient health record information system application software
SOFTWARE E-SCRIBE SERVER V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020679 ()
11012-016-50

  • Patient health record information system application software
Software Eli Edit Standard
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023267 ()
107420

  • Electrocardiograph, professional, multichannel
Software Eli Edit Pro
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655023250 ()
107422

  • Electrocardiograph, professional, multichannel
Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11100-005-50
In Commercial Distribution

  • 00817655022642 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11110-005-50
In Commercial Distribution

  • 00817655022635 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Synergy Matrix Management Software
ARTHREX, INC.
AR-3200-1036
In Commercial Distribution

  • 00888867253902 ()
AR-3200-1036

  • Operating room audiovisual data/device management system
Click2Correct/ Smart Correction software
Wishbone Medical, Inc.
C2C20210
Not in Commercial Distribution

  • B562C2C20210 ()


  • External orthopaedic fixation frame calculation software
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