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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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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

X-Guide FastMap - 00817421022852

FastMap Photogrammetry Software
XNAV TECHNOLOGIES LLC
P011942
In Commercial Distribution

  • 00817421022852 ()


  • Dental milling system, CAD/CAM, laboratory

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

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

MySpine Webplanner & MyBalance - 07630345725905

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

  • 07630345725905 ()


  • Orthopaedic/craniofacial implantation planning software

MyShoulder Planner - 07630542730153

MyShoulder Planner Software
Medacta International SA
5.3SSWPL
In Commercial Distribution

  • 07630542730153 ()


  • Orthopaedic/craniofacial implantation planning software

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

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

C7-XR™ - 00812059021536

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
C.0.4 Software Upgrade
In Commercial Distribution

  • 00812059021536 ()
15211-01

  • Coronary optical coherence tomography 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

ILUMIEN™ - 00812059021383

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
OPTIS™ E.2 Software
In Commercial Distribution

  • 00812059021383 ()
C408656

  • Coronary optical coherence tomography system

ILUMIEN™ - 00812059020560

Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1.1 Software
In Commercial Distribution

  • 00812059020560 ()
100111860

  • Coronary optical coherence tomography 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

MicroMedical - 34250892901603

Spirometry PC Software
Jaeger Medical GmbH
2.5
Not in Commercial Distribution

  • 34250892901603 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

SmartPill - 07290110360481

SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system

Reflux - 07290110360429

Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution

  • 07290110360429 ()


  • Gastrointestinal telemetric monitoring system

True Lok System - 18054242511847

TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution

  • 18054242511847 ()
TLHEXSW

  • External orthopaedic fixation frame calculation software

Spirometry PC Software - 34250892980233

Spirometry PC Software
CAREFUSION U.K. 232 LIMITED
2.5
Not in Commercial Distribution

  • 34250892980233 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Vyaire - 34250892904161

Spirometry PC Software
Jaeger Medical GmbH
2.5
In Commercial Distribution

  • 34250892904161 ()
36-SPC1000-STK

  • Pulmonary function analysis system, adult

Clarity® - 07540180000221

Clarity® Software
Elekta Solutions AB
9310-00044
In Commercial Distribution

  • 07540180000221 ()


  • Ultrasound patient positioning system

Clarity® - 07540180000207

Clarity® Software
Elekta Ltd
9310-00043
In Commercial Distribution

  • 07540180000207 ()


  • Ultrasound patient positioning system
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