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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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NA - 00643169671553

SOFTWARE CD S0278-00 NOAH FITTING
MEDTRONIC XOMED, INC.
S0278-00
Not in Commercial Distribution

  • 00643169671553 ()


  • Audiometric/hearing device software

NA - 00643169693616

SOFTWARE 9735638 FUSION COMPACT ENT
MEDTRONIC NAVIGATION, INC.
9735638
In Commercial Distribution

  • 00643169693616 ()


  • ENT stereotactic surgery system

RTgo - 00884838092112

MR-RT RTgo software USB stick
Philips Oy
459801266633
In Commercial Distribution

  • 00884838092112 ()


  • MRI system application software

RTgo - 00884838084667

MR-RT RTgo software USB stick
Philips Oy
989603083082
In Commercial Distribution

  • 00884838084667 ()


  • MRI system application software

Nexstim NBS software GER - 06430063200064

Nexstim NBS German Main Software
Nexstim Oyj
5
In Commercial Distribution

  • 06430063200064 ()


  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph

Littmann® Telesteth™ - 00707387766597

TS1200CL TELESTETH SOFTWARE HOSTED LICENSE
3M COMPANY
TS1200CL
In Commercial Distribution

  • 00707387766597 ()
TS1200CL

  • Stethoscope application software

N/A - 00643169272583

SOFTWARE KIT 9735235 MICROSCOPE ROBOTICS
MEDTRONIC NAVIGATION, INC.
9735235
In Commercial Distribution

  • 00643169272583 ()


  • Neurological stereotactic surgery system

Delivery Analysis - M65810643150

Software, Delivery Analysis, Version 1.2.2
ACCURAY INCORPORATED
1064315
In Commercial Distribution

  • M65810643150 ()
NA

  • Linear accelerator system

Delivery Analysis - M65810622130

Software, Delivery Analysis, Version 1.2.1
ACCURAY INCORPORATED
1062213
In Commercial Distribution

  • M65810622130 ()
NA

  • Linear accelerator system

Delivery Analysis TM - M65810573750

Software, Delivery Analysis, Version 1.2
ACCURAY INCORPORATED
1057375
In Commercial Distribution

  • M65810573750 ()
NA

  • Linear accelerator system

Delivery Analysis TM - M65810525910

Software, Delivery Analysis, Version 1.1
ACCURAY INCORPORATED
1052591
In Commercial Distribution

  • M65810525910 ()
NA

  • Linear accelerator system

Neuro Cochlear Implant System - 03663227001532

Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit

CIOS SELECT - 04056869267197

mobile C-arm; software version VA21
Siemens Shanghai Medical Equipment Ltd.
11515055
In Commercial Distribution

  • 04056869267197 ()


  • Portable general-purpose fluoroscopic x-ray system, analogue

Cios Spin - 04056869153506

mobile C-arm; software version VA30
Siemens Healthcare GmbH
10308194
In Commercial Distribution

  • 04056869153506 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Cios Flow - 04056869246628

mobile C-arm; software version VA31A
Siemens Healthcare GmbH
11108110
In Commercial Distribution

  • 04056869246628 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Cios Alpha - 04056869153490

mobile C-arm; software version VA31A
Siemens Healthcare GmbH
11105200
In Commercial Distribution

  • 04056869153490 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Orthex - 00841731118844

Orthex P&C Software v1.2
VILEX IN TENNESSEE, INC.
ORTHEXRPS
In Commercial Distribution

  • 00841731118844 ()


  • External orthopaedic fixation frame calculation software

KARL STORZ SCB - 04048551060599

KARL STORZ SCB Software Upgrade
Karl Storz GmbH & Co. KG
20090001-28
In Commercial Distribution

  • 04048551060599 ()


  • Operating room audiovisual data/device management system application software

n.a. - 04048551325117

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001S432
In Commercial Distribution

  • 04048551325117 ()


  • Operating room audiovisual data/device management system

coDiagnostiX - D835CODX1

Dental surgery treatment planning software
Dental Wings GmbH
10
In Commercial Distribution

  • D835CODX200 ()
  • D835CODX1 ()
  • D835CODX201 ()
  • D835CODX202 ()


  • Diagnostic x-ray digital imaging system workstation

n.a. - 04048551329856

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001-44
In Commercial Distribution

  • 04048551329856 ()


  • Operating room audiovisual data/device management system application software

IH-Com V5.2 - 03610522123919

IH-Com V5.2, Software Version 5.2
Bio-Rad Medical Diagnostics GmbH
5.2
In Commercial Distribution

  • 03610522123919 ()
12010236

  • Laboratory instrument/analyser application software IVD

KneePlus - 03760297030469

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030469 ()
KNS170

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030322

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030322 ()
KNS160

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030315

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030315 ()
KNS002

  • Orthopaedic stereotactic surgery system

Portal - 03760297030148

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030148 ()
KNP001

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030124

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
In Commercial Distribution

  • 03760297030124 ()
KNS002

  • Orthopaedic stereotactic surgery system

KneePlus - 03760297030117

Software for Total Knee Arthroplasty
PIXEE MEDICAL
Knee+
Not in Commercial Distribution

  • 03760297030117 ()
KNS002

  • Orthopaedic stereotactic surgery system

Sonata® System Software - 10817929020357

Ultrasound-guided radio-frequency ablation system software
Gynesonics, Inc.
SW-001
Not in Commercial Distribution

  • 10817929020357 ()
SW-001

  • Ultrasound-guided radio-frequency ablation system software

NA - 00841983102219

SOFTWARE, EVENT POTENTIAL FOR MEB-2300
NIHON KOHDEN AMERICA, INC.
QP-260BK
In Commercial Distribution

  • 00841983102219 ()
QP-260BK

  • Evoked-potential graphic recording system

NA - 00841983103636

HL-7 INTERFACE FOR NEUROWORKBENCH SOFTWARE
NIHON KOHDEN AMERICA, INC.
A/NWB-HL7CS
In Commercial Distribution

  • 00841983103636 ()
A/NWB-HL7CS

  • Medical networking interface unit

not applicable - 00195278655141

Software Pristina 8.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.2
In Commercial Distribution

  • 00195278655141 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

not applicable - 00195278560049

Software Pristina 8.1 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8
In Commercial Distribution

  • 00195278560049 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

EchoPAC - 00195278504302

MD EchoPAC Software Only v206
GE Vingmed Ultrasound AS
Software Only v206
In Commercial Distribution

  • 00195278504302 ()


  • Ultrasound imaging system application software

not applicable - 00195278866899

Software Pristina 8.4 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.6
In Commercial Distribution

  • 00195278866899 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

Vital Sync - 10884521851559

VITAL SYNC Mobile V4 SOFTWARE
Covidien LP
VSMASW04
In Commercial Distribution

  • 10884521851559 ()


  • Multiparameter physiologic analysis workstation

PillCam - 10884521845916

PillCam (TM) Desktop Software v9.7
Given Imaging, Inc.
FGS-0802
In Commercial Distribution

  • 10884521845916 ()


  • Video capsule endoscopy system application software

Vital Sync - 10884521815810

Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use

PillCam - 10884521836181

PillCam Cloud reader Software V1.0
Given Imaging, Inc.
FGS-0707
In Commercial Distribution

  • 10884521836181 ()


  • Video capsule endoscopy system application software

not applicable - 00195278795724

Software Pristina 8.3 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.4
In Commercial Distribution

  • 00195278795724 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit

not applicable - 00195278716026

UDI Software Pristina ME 9.1
GE MEDICAL SYSTEMS
PRISTINA ME 9.1
In Commercial Distribution

  • 00195278716026 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

OMNIBotics - 00841690194712

ART Knee Software unitary component
Omni Life Science, Inc.
0770-2000
In Commercial Distribution

  • 00841690194712 ()
0770-2000

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194460

ART Knee Software Rev 2.4.0
Omni Life Science, Inc.
NS-27014
In Commercial Distribution

  • 00841690194460 ()
NS-27014

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194446

ART Knee Software Rev 2.5.0
Omni Life Science, Inc.
NS-27016
In Commercial Distribution

  • 00841690194446 ()
NS-27016

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194439

ART Knee Software Rev 2.6.0
Omni Life Science, Inc.
NS-27017
In Commercial Distribution

  • 00841690194439 ()
NS-27017

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194392

Software Package, ART Knee 2.7
Omni Life Science, Inc.
NS-27114
In Commercial Distribution

  • 00841690194392 ()
NS-27114

  • Robotic surgical navigation system application software

ORTHOMAP - 04546540717450

ORTHOMAP¿ EXPRESS KNEE 2.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-672-000
In Commercial Distribution

  • 04546540717450 ()
6003-672-000

  • Robotic surgical navigation system application software

ORTHOMAP - 04546540717443

ORTHOMAP¿ PRECISION KNEE 5.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6003-655-000
In Commercial Distribution

  • 04546540717443 ()
6003-655-000

  • Robotic surgical navigation system application software

N/A - 00613994467089

SOFTWARE 9733808 DICOM Q/R
MEDTRONIC NAVIGATION, INC.
9733808
In Commercial Distribution

  • 00613994467089 ()


  • Multi-purpose stereotactic surgery system

N/A - 00613994570369

SOFTWARE 9734150 UNIVERSAL ITHR S7
MEDTRONIC NAVIGATION, INC.
9734150
In Commercial Distribution

  • 00613994570369 ()


  • Orthopaedic stereotactic surgery system
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