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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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Blue Sky Bio, LLC. - 00810060226063

Blue Sky Plan Software
BLUE SKY BIO LLC
4.13
In Commercial Distribution

  • 00810060226063 ()
BSP

  • Dental treatment application software

CS OMS Imaging Software - 60192156851666

CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851666 ()
1746841

  • Diagnostic x-ray digital imaging system workstation application software

CS OMS Imaging Software - 60192156851659

CS OMS Imaging Software
CARESTREAM DENTAL LLC
CS OMS Imaging Software
In Commercial Distribution

  • 60192156851659 ()
1546977

  • Diagnostic x-ray digital imaging system workstation application software

CS Orthodontic Imaging Software - 60192156851642

CS Orthodontic Imaging Software
CARESTREAM DENTAL LLC
CS Orthodontic Imaging Software
In Commercial Distribution

  • 60192156851642 ()
1746833

  • Diagnostic x-ray digital imaging system workstation application software

Welch Allyn, Inc. - 00817655020686

SOFTWARE E-SCRIBE WORKSTATION V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020686 ()
11012-016-51

  • Patient health record information system application software

Welch Allyn, Inc. - 00817655020679

SOFTWARE E-SCRIBE SERVER V9.0.0
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00817655020679 ()
11012-016-50

  • Patient health record information system application software

Vision - 00817655022642

Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11100-005-50
In Commercial Distribution

  • 00817655022642 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

HScribe - 00817655022635

Holter Analysis System Software
MORTARA INSTRUMENT, INC.
11110-005-50
In Commercial Distribution

  • 00817655022635 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Arthrex® - 00888867253902

Synergy Matrix Management Software
ARTHREX, INC.
AR-3200-1036
In Commercial Distribution

  • 00888867253902 ()
AR-3200-1036

  • Operating room audiovisual data/device management system

CD TrueFit Software v5.3 - 07613389638875

CD TrueFit Software v5.3
Sonova AG
058-5178-053
In Commercial Distribution

  • 07613389638875 ()
058-5178-053

  • Audiometric/hearing device software

Unitron - 07613389483895

Aura:fit Software v 5.0
Unitron Hearing Division
058-5260
In Commercial Distribution

  • 07613389483895 ()
058-5260

  • Audiometric/hearing device software

Unitron - 07613389483888

TrueFit Software v 5.0
Unitron Hearing Division
058-5259
In Commercial Distribution

  • 07613389483888 ()
058-5259

  • Audiometric/hearing device software

ARIA - 00885556803868

ARIA HOME PT SOFTWARE
Smith & Nephew, Inc.
SSK1
In Commercial Distribution

  • 00885556803868 ()
SSK1

  • Virtual-display rehabilitation system, non-supportive, clinical

REAL INTELLIGENCE - 00885556798027

R.I.KNEE 2.1 SOFTWARE KIT
Smith & Nephew, Inc.
ROB10405
In Commercial Distribution

  • 00885556798027 ()
ROB10405

  • Robotic surgical arm system

TriageHF™ - 00763000351656

SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software

Ascom - 17350088671396

TELLIGENCE BRIDGE SOFTWARE V7.0
Ascom (Sweden) AB
NGTELL70-S
In Commercial Distribution

  • 17350088671396 ()


  • Nurse call system

Ascom - 17350088671372

TELLIGENCE BRIDGE SOFTWARE V6.4
Ascom (Sweden) AB
NGTELL64-S
In Commercial Distribution

  • 17350088671372 ()


  • Nurse call system

Ascom - 17350088671297

TELLIGENCE BRIDGE SOFTWARE V6.3
Ascom (Sweden) AB
NGTELL63-S
In Commercial Distribution

  • 17350088671297 ()


  • Nurse call system

Ascom - 17350088671266

TELLIGENCE BRIDGE SOFTWARE V5.2
Ascom (Sweden) AB
NGTELL52-S
In Commercial Distribution

  • 17350088671266 ()


  • Nurse call system

Ascom - 17350088671259

TELLIGENCE BRIDGE SOFTWARE V6.2
Ascom (Sweden) AB
NGTELL62-S
In Commercial Distribution

  • 17350088671259 ()


  • Nurse call system

ASCOM - 17350088671167

TELLIGENCE BRIDGE SOFTWARE V6.1
Ascom (Sweden) AB
NGTELL61-S
In Commercial Distribution

  • 17350088671167 ()


  • Nurse call system

Ascom - 17350088670887

TELLIGENCE BRIDGE SOFTWARE V5.3
Ascom (Sweden) AB
NGTELL53-S
In Commercial Distribution

  • 17350088670887 ()


  • Nurse call system

Ascom - 17350088670870

TELLIGENCE BRIDGE SOFTWARE V6.9
Ascom (Sweden) AB
NGTELL69-S
In Commercial Distribution

  • 17350088670870 ()


  • Nurse call system

Ascom - 17350088670825

TELLIGENCE BRIDGE SOFTWARE V6.10
Ascom (Sweden) AB
NGTELL610-S
In Commercial Distribution

  • 17350088670825 ()


  • Nurse call system

Ascom - 17350088670740

TELLIGENCE BRIDGE SOFTWARE V6.8
Ascom (Sweden) AB
NGTELL68-S
In Commercial Distribution

  • 17350088670740 ()


  • Nurse call system

Ascom - 17350088670726

TELLIGENCE BRIDGE SOFTWARE V6.6
Ascom (Sweden) AB
NGTELL66-S
In Commercial Distribution

  • 17350088670726 ()


  • Nurse call system

Ascom - 17350088670719

TELLIGENCE BRIDGE SOFTWARE V6.5
Ascom (Sweden) AB
NGTELL65-S
In Commercial Distribution

  • 17350088670719 ()


  • Nurse call system

Ascom - 17350088670610

TELLIGENCE BRIDGE SOFTWARE V5.1
Ascom (Sweden) AB
NGTELL51-S
Not in Commercial Distribution

  • 17350088670610 ()


  • Nurse call system

Ascom - 17350088670603

TELLIGENCE BRIDGE SOFTWARE V5.0
Ascom (Sweden) AB
NGTELL50-S
Not in Commercial Distribution



  • Nurse call system

Ascom - 17350088670597

TELLIGENCE BRIDGE SOFTWARE V4.1
Ascom (Sweden) AB
NGTELL41-S
In Commercial Distribution



  • Nurse call system

ASCOM - 17350088670368

TELLIGENCE BRIDGE SOFTWARE V4.0
Ascom (Sweden) AB
NGTELL40-S
In Commercial Distribution

  • 17350088670368 ()


  • Nurse call system

OrthoNext™ Platform System Software - 18059015375831

ORTHONEXT SOFTWARE VERSION 2.1
ORTHOFIX SRL
2.1
In Commercial Distribution

  • 18059015375831 ()
ORTHONEXTSW2.1

  • Radiological PACS software

CareLink™ Software - 00763000242787

PRODUCT SOFTWARE MMT-7350 V2.2A
MEDTRONIC MINIMED, INC.
MMT-7350
In Commercial Distribution

  • 00763000242787 ()


  • Patient health record information system application software

StealthStation® Cranial - 00763000253165

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000253165 ()


  • Neurological stereotactic surgery system

uWS - 06971576834020

CT Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-CT
In Commercial Distribution

  • 06971576834020 ()


  • Radiology DICOM image processing application software

uWS - 06971576834013

MR Image Post-Processing Software
Shanghai United Imaging Healthcare Co., Ltd.
uWS-MR
In Commercial Distribution

  • 06971576834013 ()


  • MRI system application software

N/A - 00885556607497

SOFTWARE STILLIFE V2.4 DIG
Smith & Nephew, Inc.
7205006U
Not in Commercial Distribution

  • 00885556607497 ()
7205006U

  • Electrical-only medical device connection cable, reusable

N/A - 00885556607480

SERVICE REP SOFTWARE V2.4
Smith & Nephew, Inc.
7205006S
Not in Commercial Distribution

  • 00885556607480 ()
7205006S

  • Electrical-only medical device connection cable, reusable

StealthStation® Cranial - 00763000095741

SOFTWARE 9735585 STEALTHSTATION CRANIAL
MEDTRONIC NAVIGATION, INC.
9735585
In Commercial Distribution

  • 00763000095741 ()


  • Neurological stereotactic surgery system

Software LENS Tablet Application - 00885556653876

SOFTWARE LENS TABLET APPLICATION
Smith & Nephew, Inc.
72204699
In Commercial Distribution

  • 00885556653876 ()
72204699

  • Endoscopic video imaging system
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