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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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Paradigm - 00850042604014

Paradigm System Cart, 120-volt
Proprio, Inc.
1100006
In Commercial Distribution

  • 00850042604014 ()
1100006

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

Paradigm - 00850042604007

Paradigm System Cart
Proprio, Inc.
1100001
Not in Commercial Distribution

  • 00850042604007 ()
  • 10850042604004 ()
1100003

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software

FACSCanto - 00382906641267

BD FACSCanto™ System Software
Becton, Dickinson And Company
664126
In Commercial Distribution

  • 00382906641267 ()
664126

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641229

BD FACSCanto™ System Software
Becton, Dickinson And Company
664122
In Commercial Distribution

  • 00382906641229 ()
664122

  • Laboratory analyser operation system software IVD

BD FACSDiva - 00382906641182

BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664118
In Commercial Distribution

  • 00382906641182 ()
664118

  • Laboratory analyser operation system software IVD

BD FACSDiva - 00382906641175

BD FACSDiva™ Software v9.0
Becton, Dickinson And Company
664117
In Commercial Distribution

  • 00382906641175 ()
664117

  • Laboratory instrument/analyser application software IVD

FACSCanto - 00382906641144

BD FACSCanto™ System Software
Becton, Dickinson And Company
664114
In Commercial Distribution

  • 00382906641144 ()
664114

  • Laboratory analyser operation system software IVD

FACSCanto - 00382906641120

BD FACSCanto™ System Software
Becton, Dickinson And Company
664112
In Commercial Distribution

  • 00382906641120 ()
664112

  • Laboratory analyser operation system software IVD

BD FACSCanto™ - 00382906466006

BD FACSCanto System Software V2.4
BECTON, DICKINSON AND COMPANY
646600
Not in Commercial Distribution

  • 00382906466006 ()
646600

  • Laboratory instrument/analyser application software IVD

N/A - 00382906434388

BD® HLA-B27 Software v5.1
BECTON, DICKINSON AND COMPANY
643438
Not in Commercial Distribution

  • 00382906434388 ()
643438

  • Laboratory instrument/analyser application software IVD

Xltek - 00382830059541

NeuroWorks/SleepWorks 9.3.1 Software (US)
XLTEK
034879
In Commercial Distribution

  • 00382830059541 ()


  • Electroencephalograph

Keypoint - 00382830050999

VIR SOFTWARE, EDX - EMG/ NCS
NATUS MANUFACTURING LIMITED
9033S0511
In Commercial Distribution

  • 00382830050999 ()
9033S0511

  • Electromyograph

Natus - 00382830062268

Natus Elite v2 Software Update
NATUS NEUROLOGY INCORPORATED
688-630000
In Commercial Distribution

  • 00382830062268 ()


  • Electromyograph

Natus - 00382830062244

Natus Elite v2 Software Upgrade
NATUS NEUROLOGY INCORPORATED
688-630100
In Commercial Distribution

  • 00382830062244 ()


  • Electromyograph

Natus - 00382830062237

Natus Elite v2 Reader Software
NATUS NEUROLOGY INCORPORATED
828-080000
In Commercial Distribution

  • 00382830062237 ()


  • Electromyograph

Natus - 00382830062213

Natus Elite v2 Software - Viking
NATUS NEUROLOGY INCORPORATED
828-080200
In Commercial Distribution

  • 00382830062213 ()


  • Electromyograph

Natus - 00382830062206

Natus Elite v2 Software - Synergy
NATUS NEUROLOGY INCORPORATED
828-080100
In Commercial Distribution

  • 00382830062206 ()


  • Electromyograph

Xltek - 00382830061742

NeuroWorks/SleepWorks 10.0.1 Software (US)
XLTEK
041904
In Commercial Distribution

  • 00382830061742 ()


  • Electroencephalograph

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

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 Flow - 04056869246628

mobile C-arm; software version VA30
Siemens Healthcare GmbH
11108110
In Commercial Distribution

  • 04056869246628 ()


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

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 Alpha - 04056869153490

mobile C-arm; software version VA30
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

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

HL7 - 00606959048942

Software, HL7 Sleepware G3, Web
Respironics, Inc.
Software, HL7 Sleepware G3, Web - 3
In Commercial Distribution

  • 00606959048942 ()
1117948

  • Clinical laboratory information system

Sleepware - 00606959046955

Software, Sleepware G3 (Japan Only)
Respironics, Inc.
Sleepware G3 Software, (Japan Only) - 3
Not in Commercial Distribution

  • 00606959046955 ()
1121998

  • Polysomnography analyser

EX-M1 - 04547410448214

A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system

Sleepware - 00606959004849

Sleepware G3 Software Package, English
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004849 ()
1082462

  • Polysomnography analyser

Cochlear - 09321502046503

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1593077
In Commercial Distribution

  • 09321502046503 ()
P1593077

  • Audiometric/hearing device software

Cochlear - 09321502044905

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1348428
In Commercial Distribution

  • 09321502044905 ()
P1348428

  • Audiometric/hearing device software

Cochlear - 09321502044899

Osia™ Fitting Software 2
COCHLEAR LIMITED
P1341442
In Commercial Distribution

  • 09321502044899 ()
P1341442

  • Audiometric/hearing device software

Compumedics Grael - 09342451001313

Grael PSG System, no software
COMPUMEDICS LIMITED
Grael PSG
In Commercial Distribution

  • 09342451001313 ()
9028-0009-01

  • Polysomnograph

Compumedics Grael - 09342451001290

Grael LT System, no software
COMPUMEDICS LIMITED
Grael LT
In Commercial Distribution

  • 09342451001290 ()
9028-0008-01

  • Electroencephalograph

Compumedics Grael - 09342451001276

Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph

Sleepware - 00606959045279

Software, Sleepware G3, Web download
Respironics, Inc.
Sleepware G3 Software, Web download - 3
In Commercial Distribution

  • 00606959045279 ()
1115720

  • Polysomnography analyser

Actiware - 00606959040366

Actiware Clinical Trial Software, English
Respironics, Inc.
Actiware Clinical Trial Software, English - 6
In Commercial Distribution

  • 00606959040366 ()
1103609

  • Kinesiology ambulatory recorder

Sleepware - 00606959038943

Sleepware G3 Software Package, Japan
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959038943 ()
1121998

  • Polysomnography analyser

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

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

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

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
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