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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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BD FACSDiva - 00382906595287

BD FACSDiva™ Software
Becton, Dickinson And Company
659528
In Commercial Distribution

  • 00382906595287 ()
659528

  • Laboratory instrument/analyser application software IVD

BD FACSDiva - 00382906595232

BD FACSDiva™ Software
BECTON, DICKINSON AND COMPANY
659523
Not in Commercial Distribution

  • 00382906595232 ()
659523

  • Laboratory instrument/analyser application software IVD

Natus - 00382830061957

Natus Elite Software - Viking
NATUS NEUROLOGY INCORPORATED
033416
In Commercial Distribution

  • 00382830061957 ()


  • Electromyograph

Natus - 00382830061940

Natus Elite Software - Synergy
NATUS NEUROLOGY INCORPORATED
033415
In Commercial Distribution

  • 00382830061940 ()


  • Electromyograph

Care Orchestrator - 00606959052239

Care Orchestrator Software, Netherlands
Respironics, Inc.
1.14
In Commercial Distribution

  • 00606959052239 ()
1136535

  • Medical equipment clinical data interfacing software

AESCULAP - 04046963989101

ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software

AESCULAP - 04046963977979

ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software

Alaris - 10885403516054

Alaris EtCO2 V12.3 Software
CAREFUSION 303, INC.
8300
In Commercial Distribution

  • 10885403516054 ()


  • Carbon dioxide monitor

coDiagnostiX - D835CDX1

Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation

AESCULAP - 04046963895853

ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software

Spine & Trauma 3D Navigation - 04056481142025

Software for spine navigation
Brainlab AG
1,5
In Commercial Distribution

  • 04056481142025 ()


  • Robotic surgical navigation system

PORTRAIT HSWXB - 00195278697165

Portrait HSWXB Medical Software
GE Healthcare Finland Oy
HSWXB
In Commercial Distribution

  • 00195278697165 ()
5700219-11

  • Physiologic monitor-installed software

CloudCath Connect - Patient Monitoring Software - 00860006810238

Patient Monitoring Software/System
Gastroklenz Inc.
04PD001
In Commercial Distribution

  • 00860006810238 ()


  • Peritoneal dialysis system

Messenger - 00860011811961

Messenger 6.1.1 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811961 ()


  • Alarm application software

Messenger - 00860011811954

Messenger 5.18.4 Software Release
SPOK INC.
5.18.4
In Commercial Distribution

  • 00860011811954 ()


  • Alarm application software

Messenger - 00860011811947

Messenger 5.17.17 Software Release
SPOK INC.
5.17.17
In Commercial Distribution

  • 00860011811947 ()


  • Alarm application software

Messenger - 00860011811930

Messenger 5.18.3 Software Release
SPOK INC.
5.18.3
In Commercial Distribution

  • 00860011811930 ()


  • Alarm application software

Messenger - 00860011811923

Messenger 6.1.0 Software Release
SPOK INC.
6.1.0
In Commercial Distribution

  • 00860011811923 ()


  • Alarm application software

Messenger - 00860011811916

Messenger 5.18.2 Software Release
SPOK INC.
5.18.2
In Commercial Distribution

  • 00860011811916 ()


  • Alarm application software

Messenger - 00860011811909

Messenger 5.17.16 Software Release
SPOK INC.
5.17.16
In Commercial Distribution

  • 00860011811909 ()


  • Alarm application software
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