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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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CardioLab - 00840682123549

SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

KBA3D - 03701313007935

Spinal surgery planning software
S.M.A.I.O
V2.0.0
In Commercial Distribution

  • 03701313007935 ()


  • Radiological PACS software

DYONICS POWER - 03596010622716

DYONICS II SOFTWARE UPGRADE
Smith & Nephew, Inc.
72202103
In Commercial Distribution

  • 03596010622716 ()
72202103

  • Arthroscopic shaver system, electrically-powered

INTEGRATION BROKER - 03596010589637

SOFTWARE INTEGRATION BROKER HL7
Smith & Nephew, Inc.
72201079
Not in Commercial Distribution

  • 03596010589637 ()
72201079

  • Robotic surgical navigation system application software

N/A - 03596010588371

INTEGRATION SOFTWARE BROKER, DICOM
Smith & Nephew, Inc.
72201081
In Commercial Distribution

  • 03596010588371 ()
72201081

  • Robotic surgical navigation system application software

Keypoint - 00382830050302

Review Software (Single User)
NATUS MANUFACTURING LIMITED
9033S0628
In Commercial Distribution

  • 00382830050302 ()
9033S0628

  • Electromyograph

FreeStyle Libre - 00357599000479

FreeSyle Libre Software CD
ABBOTT DIABETES CARE INC
71527
In Commercial Distribution

  • 30357599000470 ()
  • 00357599000479 ()
71527

  • Self-care monitoring/reporting software

Natus - 00382830019231

NEUROWORKS 8.1.1 SOFTWARE (US)
XLTEK
104196
In Commercial Distribution

  • 00382830019231 ()


  • Electroencephalograph

Embla - 00382830048484

RemLogic 4.0 Software (English)
Embla Systems Ltd
025406
In Commercial Distribution

  • 00382830048484 ()


  • Sleep disorder interpretive software

Xltek - 00382830043458

RemLogic 3.4.1 (ENU) Software
Embla Systems Ltd
013974
In Commercial Distribution

  • 00382830043458 ()


  • Sleep disorder interpretive software

Natus - 00382830039475

SYNERGY REVIEW SOFTWARE CD
NATUS NEUROLOGY INCORPORATED
031K040
In Commercial Distribution

  • 00382830039475 ()


  • Electromyograph

Natus - 00382830038034

Synergy Application Software v20.0
NATUS NEUROLOGY INCORPORATED
482-645500
In Commercial Distribution

  • 00382830038034 ()


  • Electromyograph

Natus - 00382830038003

Synergy Software v20 CD
NATUS NEUROLOGY INCORPORATED
482-647500
In Commercial Distribution

  • 00382830038003 ()


  • Electromyograph

AESCULAP - 04046963181901

ORTHOPILOT SOFTWARE THA PLUS
Aesculap AG
FS217
In Commercial Distribution

  • 04046963181901 ()
FS217

  • Robotic surgical navigation system application software

AESCULAP - 04046963989101

ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software

AESCULAP - 04046963492083

ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software

AEOS - 04046955206803

SOFTWARE MODULE DIR 800
Aesculap AG
PV023
In Commercial Distribution

  • 04046955206803 ()
PV023

  • Surgical microscope fluorescent angiography system

AESCULAP - 04046955206797

SOFTWARE MODULE DUV 400
Aesculap AG
PV022
In Commercial Distribution

  • 04046955206797 ()
PV022

  • Neurosurgical microscope

n.a. - 04048551392270

SCB control NEO Software
Karl Storz GmbH & Co. KG
20090001-47
In Commercial Distribution

  • 04048551392270 ()


  • Operating room audiovisual data/device management system application software

Alaris - 10885403516054

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

  • 10885403516054 ()


  • Carbon dioxide monitor
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