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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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Media Writer - 00850677007129

Media Writer Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007129 ()


  • Radiology DICOM image processing application software

Gearview QC - 00850677007051

Gearview QC Software
HYLAND LLC
2
In Commercial Distribution

  • 00850677007051 ()


  • Radiological PACS software

PACS Scan - 00850677007006

PACS Scan Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007006 ()


  • Radiography digital imaging scanner

Office Medic - 00857175006166

Office Medic Software
VECTRACOR INC
6.0
In Commercial Distribution

  • 00857175006166 ()


  • Cardiopulmonary physiological parameter analysis software

SureSmile Ortho Software - 00856379007092

SureSmile Ortho Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007092 ()
DIGI-500153

  • CAD/CAM software

SureSmile Advanced Software - 00856379007108

SureSmile Advanced Software
ORAMETRIX, INC.
7.6
In Commercial Distribution

  • 00856379007108 ()
DIGI-500159

  • CAD/CAM software

SPRINT - 00850022775291

Clinical Programmer Software
SPR THERAPEUTICS, INC.
50009
In Commercial Distribution

  • 00850022775291 ()
50009

  • Analgesic PENS system

REMI Robotic Navigation System - 00850026574364

Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software

AVEIR™ - 05415067049971

Patient Transmitter Software
ST. JUDE MEDICAL, INC.
LSRM1000
In Commercial Distribution

  • 05415067049971 ()
LSRM1000

  • Transtelephonic implantable pacemaker analysis system

WorkMate Claris™ - 05415067047212

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800022
In Commercial Distribution

  • 05415067047212 ()
H800022

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067042385

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800014
In Commercial Distribution

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067042378

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800013
In Commercial Distribution

  • 05415067042378 ()
H800013

  • Cardiac catheterization monitoring system

WorkMate™ Scribe™ - 05415067042361

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system

JointVue 3D Echo - 00850014885007

3D Echo Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885007 ()


  • Ultrasound imaging system operation software

VNS Therapy™ Programmer, Model 3100 v1.1.0 - 05425025750634

Programmer and Software
LIVANOVA USA, INC.
3100
In Commercial Distribution

  • 05425025750634 ()


  • Vagus nerve electrical stimulation system programmer

Abutment Design - 05902729752237

Dental CAD Software
3shape A/S
2017-1 (R1.1)
In Commercial Distribution

  • 05902729752237 ()


  • CAD/CAM software

Anatomy Design - 05902729752220

Dental CAD Software
3shape A/S
R1.1
In Commercial Distribution

  • 05902729752220 ()


  • CAD/CAM software

Nexstim NBT software - 06430063200156

NBT main software
NEXSTIM, INC.
2
In Commercial Distribution

  • 06430063200156 ()


  • Stereotactic neuronavigation/planning system

NexSpeech analyzer software - 06430063200033

NexSpeech Analyzer Software
NEXSTIM, INC.
2
In Commercial Distribution

  • 06430063200033 ()


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

NexSpeech main software - 06430063200026

NexSpeech Main Software
NEXSTIM, INC.
2
In Commercial Distribution

  • 06430063200026 ()


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

Nexstim NBS software - 06430063200002

NBS main software
NEXSTIM, INC.
5
In Commercial Distribution

  • 06430063200002 ()


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

Richmar EMG Software - 00092237626573

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

  • 00092237626573 ()


  • Electromyograph

RMS - 08031527021188

Remote Monitoring Software
MICROPORT CRM SRL
RMS
In Commercial Distribution

  • 08031527021188 ()
RMS

  • Cardiology information system application software

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

CRW® - 10381780252610

StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system

X-Guide FastMap - 00817421022852

FastMap Photogrammetry Software
XNAV TECHNOLOGIES LLC
P011942
In Commercial Distribution

  • 00817421022852 ()


  • Dental milling system, CAD/CAM, laboratory

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

N/A - 07613327622782

SC+ AI Software
STRYKER CORPORATION
0894000004
In Commercial Distribution

  • 07613327622782 ()
0894-000-004

  • Blood loss estimation application software

SurgiCount - 07613327622751

+ Sponge Counting Software
STRYKER CORPORATION
0894000003
In Commercial Distribution

  • 07613327622751 ()
0894-000-003

  • Electronic surgical sponge-counter

N/A - 07613327568998

QBL Software License
STRYKER CORPORATION
0794111090
In Commercial Distribution

  • 07613327568998 ()
0794-111-090

  • Electronic surgical sponge-counter

N/A - 07613327545883

Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system

Cranial Guidance Software - 07613327538298

Cranial Guidance Software
Stryker Leibinger GmbH & Co. KG
6000-670-000
In Commercial Distribution

  • 07613327538298 ()
6000-670-000

  • Electromagnetic/optical surgical navigation device tracking system

CuattroDR - B269SWR00069MD0

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

  • B269SWR00069MD0 ()


  • Stationary basic diagnostic x-ray system, digital

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

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

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

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

SleepImage - B315SLEEPIMAGECOM0

Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier

PROFESS - 07613327071948

PROFESS(TM) SOFTWARE
Stryker Leibinger GmbH & Co. KG
6001-400-000
In Commercial Distribution

  • 07613327071948 ()
6001-400-000

  • Robotic surgical navigation system application 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

CardioConfirm - 00812345024708

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-50    
In Commercial Distribution

  • 00812345024708 ()


  • Cardiology information system application software

ELI Edit - 00812345023459

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-50
In Commercial Distribution

  • 00812345023459 ()


  • Patient health record information system

ILUMIEN™ - 00812059021482

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1 Software
In Commercial Distribution

  • 00812059021482 ()
100074942

  • Coronary optical coherence tomography system

OPTIS™ - 00812059021390

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution

  • 00812059021390 ()
C408657

  • Coronary optical coherence tomography system
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