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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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microTargeting WayPoint Planner Software, single license
FHC, INC.
66-WP-PL-00437
In Commercial Distribution

  • 00873263004371 ()
66-WP-PL

  • Neurological stereotactic surgery system
SOFTWARE COMP GPS 4.8 USB PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256772 ()
21041975

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.8 DVD PACK
Widex A/S
Compass GPS 4.8
In Commercial Distribution

  • 05714880256765 ()
21041974

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.7 USB PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239140 ()
21038004

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.7 DVD PACKAGE
Widex A/S
Compass GPS 4.7
In Commercial Distribution

  • 05714880239133 ()
21038003

  • Audiometric/hearing device software
SOFTWARE COMP GPS 4.5 DVD PACKAGE
Widex A/S
Compass GPS 4.5
In Commercial Distribution

  • 05714880204070 ()
21027791

  • Audiometric/hearing device software
3CPM EGGSAS Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000285 ()


  • Myoelectric gastrointestinal motility analysis system
3CPM EGGSAS Research Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000247 ()


  • Myoelectric gastrointestinal motility analysis system
IMAGEXL XRAY SOFTWARE VERSION 4 BASE
PROFESSIONAL ECONOMICS BUREAU OF AMERICA INC
4
In Commercial Distribution

  • 00861787000306 ()


  • General-purpose dental x-ray system application software
RETINAVUE NETWORK SOFTWARE VERSION 3.X
WELCH ALLYN, INC.
901108
In Commercial Distribution

  • 00732094223910 ()
411215

  • Retinal image analysis software
ASSY DVD CPWS SOFTWARE 1.6.6 - D
WELCH ALLYN, INC.
901047
Not in Commercial Distribution

  • 00732094301212 ()
413294

  • Ophthalmic/otologic diagnostic set
CCW Software Viewing License (per computer)
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094043488 ()
SW-CCW-LIC

  • Electrocardiograph, professional, multichannel
CardioPerfect Workstation Software Update (latest version)
WELCH ALLYN, INC.
901047
In Commercial Distribution

  • 00732094041033 ()
UPDT-WACPW-CD

  • Electrocardiograph, professional, multichannel
PCH2OO Stand Alone Software, Expert Holter
WELCH ALLYN, INC.
901052
Not in Commercial Distribution

  • 00732094128444 ()
704527

  • Electrocardiograph, professional, multichannel
Medical equipment clinical data interfacing software
ACCELERATED CARE PLUS CORP
100ACPLUS
In Commercial Distribution

  • 00858703006368 ()


  • Medical equipment clinical data interfacing software
prolaio Personalized Physiology Analytics Engine Software
Prolaio, Inc.
1.0
In Commercial Distribution

  • 00850071330038 ()


  • Electrocardiography monitoring system receiver
OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system
Smartphone stethoscope software application for iPhones
Sparrow Acoustics Inc.
2.x.x
In Commercial Distribution

  • 00860011561705 ()


  • Electronic acoustic stethoscope
Kinesia Web Application/Portal 2 Software
Great Lakes Neurotechnologies Inc.
360-2011, Kinesia Web App/Portal 2
In Commercial Distribution

  • 00859584006164 ()


  • Tremor transducer
Kinesia Web Application/Portal 1 Software
Great Lakes Neurotechnologies Inc.
360-2005, Web Portal Software Application
In Commercial Distribution

  • 00859584006133 ()


  • Tremor transducer
SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation
PAV+ SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122271
Not in Commercial Distribution

  • 10884521641013 ()


  • Ventilator application software
MR Applications Software for MP24 R03
GENERAL ELECTRIC COMPANY
MP24 R03
Not in Commercial Distribution

  • 00840682124591 ()


  • MRI system application software
SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
Win 11 PC - Arial Software Client
Securitas Healthcare LLC
0850-222
In Commercial Distribution

  • 00840948102738 ()
0850-222

  • Fixed call button
SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation
SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation
Lilivis CAD L-CAD (Chairside CAD Software)
Huvitz Co., Ltd.
L-CAD
In Commercial Distribution

  • 08800019600909 ()
LS-100

  • CAD/CAM software
Monarch™ Laptop P16 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811527 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.1
AURIS HEALTH, INC.
Version 4.1.1
In Commercial Distribution

  • 10810068811510 ()


  • Robotic surgical system application software
Monarch™ Laptop P16 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810612 ()


  • Robotic surgical system application software
Monarch™ Laptop P17 Software v4.1.0
AURIS HEALTH, INC.
Version 4.1.0
In Commercial Distribution

  • 10810068810605 ()


  • Robotic surgical system application software
Planning software for total shoulder arthroplasty
PIXEE MEDICAL
FXSPS001
Not in Commercial Distribution

  • 03760297030209 ()


  • Orthopaedic/craniofacial implantation planning software
Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system
OptiBolus, Bolus Shaping Software, Domestic (Accessory)
Liebel-Flarsheim Company LLC
844200
In Commercial Distribution

  • 10746190004806 ()


  • CT contrast medium injection system, line-powered, stationary
OptiBolus, Bolus Shaping Software, International (Accessory)
Liebel-Flarsheim Company LLC
844210
In Commercial Distribution

  • 10746190004813 ()


  • CT contrast medium injection system, line-powered, stationary
BD Pyxis CIISafe (Software v9.X)
CAREFUSION 303, INC.
SW-CII-SAFE-V9
In Commercial Distribution

  • 10885403513725 ()


  • Anaesthesia cabinet
PillCam (TM) Desktop Software v9.7 Upgrade
Given Imaging, Inc.
FGS-0803
In Commercial Distribution

  • 10884521845923 ()


  • Video capsule endoscopy system application software
PCMCIA CARD SOFTWARE VERSION 3.71 VULC
Smith & Nephew, Inc.
72201356
In Commercial Distribution

  • 03596010612793 ()
72201356

  • Radio-frequency ablation system
CD 660IMS SOFTWARE UPGRADE VER 1.5
Smith & Nephew, Inc.
72201078
In Commercial Distribution

  • 03596010579591 ()
72201078

  • Endoscopic video imaging system
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