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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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No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2381
In Commercial Distribution

  • 04953170431883 ()
N6157330

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2304
Not in Commercial Distribution

  • 04953170424724 ()


  • Software upgrade/unlocking key
Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
P803254
In Commercial Distribution

  • 09321502036023 ()
P803254

  • Hearing aid wireless-fitting computer-aided set
Baha® Fitting Software
Cochlear Bone Anchored Solutions AB
95430
In Commercial Distribution

  • 09321502032834 ()
95430

  • Hearing aid wireless-fitting computer-aided set
Baha Fitting Software 4.0
Cochlear Bone Anchored Solutions AB
94223
In Commercial Distribution

  • 09321502026383 ()
94223

  • Hearing aid wireless-fitting computer-aided set
Akunah Reflect Planning Software
AKUNAH PTY LTD
REFLECT
In Commercial Distribution

  • 09309002093005 ()


  • Orthopaedic/craniofacial implantation planning software
ARVIS Surgical Planning Software
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-27300
In Commercial Distribution

  • 09309001071011 ()


  • Orthopaedic/craniofacial implantation planning software
Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser
SenSmart Data Management software
NONIN MEDICAL, INC.
SenSmart Download Software
In Commercial Distribution

  • 00849686074796 ()
  • 00849686072617 ()


  • Medical equipment clinical data interfacing software
Cytolink 1.0 Software DVD
Leica Biosystems Richmond, Inc.
23SW0001LNK
Not in Commercial Distribution

  • 00849832011569 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
SOFTWARE 9732811 MICROCAL PLUS
MEDTRONIC NAVIGATION, INC.
9732811
In Commercial Distribution

  • 00613994099488 ()


  • Multi-purpose stereotactic surgery system
ORTHOMAP¿ 3D 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6005-660-000
In Commercial Distribution

  • 04546540651600 ()
6005-660-000

  • Robotic surgical navigation system application software
Charger Software Upgrade Kit
STRYKER CORPORATION
0408655200
In Commercial Distribution

  • 04546540591630 ()
0408655200

  • Surgical helmet system
Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software
SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00643169625532 ()


  • Neurological stereotactic surgery system
IMPAX Software 6.X
Agfa HealthCare NV
6
In Commercial Distribution



  • Radiological PACS software
SOFTWARE CD S0278-00 FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169719972 ()


  • Audiometric/hearing device software
SOFTWARE 9733877 STEALTHVIZ LINUX
MEDTRONIC NAVIGATION, INC.
9733877
In Commercial Distribution

  • 00613994446060 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733878 STEALTHVIZ WIN32
MEDTRONIC NAVIGATION, INC.
9733878
In Commercial Distribution

  • 00613994446053 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733760 CRANIAL S7
MEDTRONIC NAVIGATION, INC.
9733760
In Commercial Distribution

  • 00613994445988 ()


  • Neurological stereotactic surgery system
SOFTWARE 9734220 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734220
In Commercial Distribution

  • 00613994596826 ()


  • Neurological stereotactic surgery system
SOFTWARE 9734620 MACH POLESTAR
MEDTRONIC NAVIGATION, INC.
9734620
In Commercial Distribution

  • 00613994776730 ()


  • Stereotactic surgery system probe, reusable
Radiation therapy QA software.
SUN NUCLEAR CORP.
1216028
In Commercial Distribution

1216028

  • Radiation therapy software
SOFTWARE 9734383XOM STEALTHMERGE ENT
MEDTRONIC NAVIGATION, INC.
9734383XOM
Not in Commercial Distribution

  • 00643169491830 ()


  • Multi-purpose stereotactic surgery system
SOFTWARE 9733986 FRAMELINK S7
MEDTRONIC NAVIGATION, INC.
9733986
In Commercial Distribution

  • 00643169363540 ()


  • Multi-purpose stereotactic surgery system
Respiratory Module software module.
VISION RT LIMITED
Respiratory Module
Not in Commercial Distribution

  • 05056190500733 ()
Respiratory Module

  • Radiological video camera patient positioning/tracking system
ClearPoint - Software Version 3.0
Clearpoint Neuro, Inc.
CP-SFW-11-30
In Commercial Distribution

  • 00850047354099 ()
CP-SFW-11-30

  • Neurological stereotactic surgery system
SOFTWARE 8870AAV01 N'VISION US
MEDTRONIC, INC.
8870AAV01
In Commercial Distribution

  • 00643169955653 ()


  • Multiple active implantable device programmer
Software Upgrade Kit v.F
ST. JUDE MEDICAL, INC.
H701809
In Commercial Distribution

  • 05415067018090 ()
H701809

  • Cardiac catheterization monitoring system
Software Installation, v.1.0.1
ST. JUDE MEDICAL, INC.
H702503
In Commercial Distribution

  • 05415067026279 ()
H702503

  • Cardiac mapping system application software
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