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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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EncorePro2 - 00606959055001

EncorePro2 Software, web
Respironics, Inc.
EncorePro2 - 2
In Commercial Distribution

  • 00606959055001 ()
1099731

  • Medical equipment clinical data interfacing software

EncorePro2 - 00606959053786

EncorePro2 Software (Web)
Respironics, Inc.
2.23
In Commercial Distribution

  • 00606959053786 ()
1099731

  • Medical equipment clinical data interfacing software

EncorePro 2, Software - 00606959050778

EncorePro 2, Software
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959050778 ()
1054785

  • Medical equipment clinical data interfacing software

Software, EncorePro2, web - 00606959050761

Software, EncorePro2, web
Respironics, Inc.
2.22
In Commercial Distribution

  • 00606959050761 ()
1099731

  • Medical equipment clinical data interfacing software

EncorePro 2, Software - 00606959048348

EncorePro 2, Software
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048348 ()
1054785

  • Medical equipment clinical data interfacing software

EncorePro - 00606959048331

Software, EncorePro2, web
Respironics, Inc.
2.21
In Commercial Distribution

  • 00606959048331 ()
1099731

  • Medical equipment clinical data interfacing software

myQA iON - EIBAMQ100000

myQA iON software
IBA Dosimetry GmbH
MQ10-000
In Commercial Distribution

  • EIBAMQ100000 ()


  • Accelerator system quality assurance device

myQA®Daily (Software) - EIBADQ000000

myQA Daily Software
IBA Dosimetry GmbH
DQ00000
In Commercial Distribution

  • EIBADQ000000 ()
DQ00-000

  • Accelerator system quality assurance device

CubeVue - 00863152000379

3D visualization software
CURVEBEAM, LLC
3.7.0
In Commercial Distribution

  • 00863152000379 ()


  • Radiology DICOM image processing application software

CubeVue - 00863152000362

3D visualization software
CURVEBEAM, LLC
3.6.0
In Commercial Distribution

  • 00863152000362 ()


  • Radiology DICOM image processing application software

PMD Viewer - 00862726000326

PMD Viewer Software
Spencer Technologies
PMD Viewer
In Commercial Distribution

  • 00862726000326 ()
12143

  • Radiology DICOM image processing application software

DoseLab Pro - 00861334000339

Dosimetry QA Software
VARIAN MEDICAL SYSTEMS, INC.
6.8.0
Not in Commercial Distribution

  • 00861334000339 ()
DoseLab Pro

  • Accelerator system quality assurance device

WAVENET - 00380650004567

WAVENET PLANNING SOFTWARE
Alcon Laboratories, Inc.
8065000456
In Commercial Distribution

  • 00380650004567 ()


  • Laser application software

INSTRUMENT SELECTION - 04056481142018

Instrument selection software
Brainlab AG
1.5
In Commercial Distribution

  • 04056481142018 ()


  • Robotic surgical navigation system

Protura - 00841439102930

Protura Software Manual
MEDTEC, INC.
MT6XSM1.6.0
Not in Commercial Distribution

  • 00841439102930 ()

  • Width: 8.5 Inch
  • Length: 11 Inch
MT6XSM1.6.0

  • Indexed-immobilization patient positioning system

Smart-V-Link - 00894912002777

Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software

PAUS - 00894912002067

Modality Worklist Software
KOVEN TECHNOLOGY, INC.
2.0
In Commercial Distribution

  • 00894912002067 ()
PAUS2.0

  • Radiology information system application software

RMS - 08031527021188

Remote Monitoring Software
MICROPORT CRM SRL
RMS
In Commercial Distribution

  • 08031527021188 ()
RMS

  • Cardiology information system application software

XDR - D787XDRSW300

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software

XDR - D787XDRSW1

Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software

DCTclock - B626100410

DCTclock Uploader Software
Linus Health, Inc.
10041
In Commercial Distribution

  • B626100410 ()
10041

  • Drawing-test cognitive function analysis device

Polaroid DDS - 10667147001542

Polaroid DDS software
Synca Marketing Inc
V8
In Commercial Distribution

  • 10667147001542 ()
PDDS

  • Radiology information system application software

AESCULAP - 04046955206810

SOFTWARE MODULE DICOM
Aesculap AG
PV024
In Commercial Distribution

  • 04046955206810 ()
PV024

  • Neurosurgical microscope

AESCULAP - 04038653423316

ORTHOPILOT SOFTWARE ACL
Aesculap AG
FS215
Not in Commercial Distribution

  • 04038653423316 ()
FS215

  • Robotic surgical navigation system application software

not applicable - 00840682146845

Software Pristina Infinity
GE MEDICAL SYSTEMS
PRISTINA 2.0
In Commercial Distribution

  • 00840682146845 ()


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

IEM GmbH - 04041346102054

Hypertension Management Software
IEM GmbH
HMS CS 6.1.3 Medtronic 1.0.0
In Commercial Distribution

  • 04041346102054 ()


  • Medical equipment clinical data interfacing software

Vmax - 10846446032925

VMAX SOFTWARE UPGRADE
Carefusion Corporation
28528-001
Not in Commercial Distribution

  • 10846446032925 ()
28528-001

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

Dexcom Clarity - 00038270000451

Data Manager Software
Dexcom, Inc.
350-0011
Not in Commercial Distribution

  • 00038270000451 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

ELI Edit - 00817655022802

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system

ELI Edit - 00817655022796

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-50
In Commercial Distribution

  • 00817655022796 ()


  • Patient health record information system

CardioConfirm - 00817655022772

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-003-51
In Commercial Distribution

  • 00817655022772 ()


  • Cardiology information system application software

CardioConfirm - 00817655022765

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-003-50
In Commercial Distribution

  • 00817655022765 ()


  • Cardiology information system application software

CardioConfirm - 00817655020259

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-51    
In Commercial Distribution

  • 00817655020259 ()


  • Cardiology information system application software

CardioConfirm - 00817655020242

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-002-50    
In Commercial Distribution

  • 00817655020242 ()


  • Cardiology information system application software

X-Guide FastMap - 00817421022852

FastMap Photogrammetry Software
XNAV TECHNOLOGIES LLC
P011942
In Commercial Distribution

  • 00817421022852 ()


  • Dental milling system, CAD/CAM, laboratory

Richmar EMG Software - 00092237626573

Richmar EMG Software
COMPASS HEALTH BRANDS CORP.
EMG-SW
In Commercial Distribution

  • 00092237626573 ()


  • Electromyograph

SleepImage - B315SLEEPIMAGECOM0

Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier

CRW® - 10381780252610

StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system

UbiqVue - B353UA2550S1

Central Server Software
Lifesignals, Inc.
UA2550-S
In Commercial Distribution

  • B353UA2550S1 ()


  • Network server

UbiqVue - B353UA2550RB1

Relay Bridge Software
Lifesignals, Inc.
UA2550-RB
In Commercial Distribution

  • B353UA2550RB1 ()


  • Physiological measuring device wireless data capture/transfer unit

UbiqVue - B353UA2550BG1

Bluetooth Gateway Software
Lifesignals, Inc.
UA2550-BG
In Commercial Distribution

  • B353UA2550BG1 ()


  • Physiological measuring device wireless data capture/transfer unit

Arthrex® - 00888867100626

Synergy.net Management Software
ARTHREX, INC.
AR-3200-1030
In Commercial Distribution

  • 00888867100626 ()
AR-3200-1030

  • Operating room audiovisual data/device management system

MySpine Webplanner & MyBalance - 07630345725905

WebPlanner Spine Software
Medacta International SA
98.46.WEBPSPINE
In Commercial Distribution

  • 07630345725905 ()


  • Orthopaedic/craniofacial implantation planning software

StimRouter - 00815962020306

Clinician Programmer Software
BIONESS INC.
ST2-SW01
In Commercial Distribution

  • 00815962020306 ()


  • Transcutaneous electrical stimulation probe

H200 Wireless - 00815962020290

Clinician Programmer Software
BIONESS INC.
H2W-SW01
In Commercial Distribution

  • 00815962020290 ()


  • Hand orthosis

MyShoulder Planner - 07630542730153

MyShoulder Planner Software
Medacta International SA
5.3SSWPL
In Commercial Distribution

  • 07630542730153 ()


  • Orthopaedic/craniofacial implantation planning software

CuattroDR - B269SWR00069MD0

CuattroDR System Software
Cuattro Medical
SWR-00069-MD
In Commercial Distribution

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital

TrueFit Software v5.4 - 07613389644579

TrueFit Software v5.4
Sonova AG
058-5178-054
In Commercial Distribution

  • 07613389644579 ()
058-5178-054

  • Audiometric/hearing device software

ELI Edit - 00812345025217

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution

  • 00812345025217 ()


  • Patient health record information system

CardioConfirm - 00812345024715

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-51    
In Commercial Distribution

  • 00812345024715 ()


  • Cardiology information system application software
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