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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Software for Code Blue Annunciator, Version 1.8.8
AMPLION CLINICAL COMMUNICATIONS, INC.
S-CBA-188-1
Not in Commercial Distribution

  • 00850016398758 ()
S-CBA-188-1

  • Nurse call system
Software Kit FACSDiva 9.4 RUO w/Dongle
BECTON, DICKINSON AND COMPANY
664286
Not in Commercial Distribution

  • 00382906642868 ()
664286

  • Laboratory instrument/analyser application software IVD
BD FACSCount System Users Guide and Software
Becton, Dickinson And Company
344619
In Commercial Distribution

  • 00382903446193 ()
344619

  • Laboratory instrument/analyser application software IVD
NeuroWorks TrexHD Monitoring Software Installation Media (US)
XLTEK
021764
In Commercial Distribution

  • 00382830043380 ()


  • Electroencephalograph
Natus Elite - Synergy & Viking Combo Master Software
NATUS NEUROLOGY INCORPORATED
828-069500
In Commercial Distribution

  • 00382830035019 ()


  • Electromyograph
Natus Elite v2 Software - Synergy & Viking Combo
NATUS NEUROLOGY INCORPORATED
828-080300
In Commercial Distribution

  • 00382830062220 ()


  • Electromyograph
EMG Software Upgrade with New System Order
NATUS NEUROLOGY INCORPORATED
017806
In Commercial Distribution

  • 00382830061933 ()


  • Electromyograph
Leica Biosystems CytoVision Karyotype & FISH Software Update
Leica Biosystems Richmond, Inc.
23SWR002KFL001
Not in Commercial Distribution

  • 00849832003687 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica CytoVision Karyotyping review software (incl. dongle)
Leica Biosystems Richmond, Inc.
23SWR000KXX001
Not in Commercial Distribution

  • 00849832003656 ()

  • Device Size Text, specify:


  • Laboratory analyser operation system software IVD
Leica Biosystems CytoVision Karyotyping Software License Activation
Leica Biosystems Richmond, Inc.
23SWR000KLX001
Not in Commercial Distribution

  • 00849832003649 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping & FISH Review software
Leica Biosystems Richmond, Inc.
23SWR000KFX001
Not in Commercial Distribution

  • 00849832003632 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
SOFTWARE 9734472 SONONAV CAL APP FOR SC
MEDTRONIC NAVIGATION, INC.
9734472
In Commercial Distribution

  • 00643169183407 ()


  • Multi-purpose stereotactic surgery system
Speech Articulation: Animation of Muscle Vectors, Software
PENTAX OF AMERICA, INC.
5154
Not in Commercial Distribution

  • 04961333229857 ()


  • Electroglottograph
Grael EEG v2 System with EEG software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001825 ()
9028-0004-02

  • Electroencephalograph
VA version of Baha Fitting Software 7
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075527 ()
P2121915

  • Hearing aid wireless-fitting computer-aided set
Task Force Monitor Software inkl. Kunden-CD (multilingual)
CNSystems Medizintechnik AG
V2.3
Not in Commercial Distribution

  • 09120073931009 ()


  • Noninvasive haemodynamic monitoring system
KOSMOS OTS iOS SOFTWARE PACKAGE [2.X]
ECHONOUS, INC.
P007944
In Commercial Distribution

  • 09353278000762 ()


  • Ultrasound imaging system application software
EchoNous (Uscan) Samsung S8 Tablet with Software
ECHONOUS, INC.
P007635
In Commercial Distribution

  • 09353278000663 ()


  • Hand-held ultrasound imaging system, body-surface
EncoreAnywhere Data Management Software (North American Instance)
Respironics, Inc.
2.32
In Commercial Distribution

  • 00606959042902 ()
1119756

  • Medical equipment clinical data interfacing software
Encore Pro 2, Patient Management Software (DVD)
Respironics, Inc.
Encore Pro Patient Management Software - 2
In Commercial Distribution

  • 00606959053793 ()
1054785

  • Medical equipment clinical data interfacing software
EncoreAnywhere Data Management Software (U.S. - North America)
Respironics, Inc.
2.35
In Commercial Distribution

  • 00606959047228 ()
1119756

  • Medical equipment clinical data interfacing software
G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system
Dental imaging capture, enhance and display software.
APTERYX INC
3
In Commercial Distribution

  • 00685031000023 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
APTERYX INC
3
Not in Commercial Distribution

  • 00685031000016 ()


  • General-purpose dental x-ray system application software
Dental imaging capture, enhance and display software.
APTERYX INC
4
Not in Commercial Distribution

  • 00685031000009 ()


  • General-purpose dental x-ray system application software
Guideline™ 4000 5.0 Software, Version 2.2.0
FHC, INC.
C0217-00864
In Commercial Distribution

  • 00873263008645 ()
C0217

  • Neurophysiologic monitoring system
  • Electroencephalograph
microTargeting WayPoint Navigato, Laptop and Software, 1x
FHC, INC.
66-WP-NV(4.2)-00433
Not in Commercial Distribution

  • 00873263004333 ()
66-WP-NV(4.2)

  • Neurological stereotactic surgery system
3CPM EGGSAS Research/Waterload Interface (Software Only)
3CPM CO., INC.
2.09g
In Commercial Distribution

  • 00864359000292 ()


  • Myoelectric gastrointestinal motility analysis system
Aurora Xi Plasmapheresis System Software Version 1.2
Fresenius Kabi AG
1.2
In Commercial Distribution

  • 04086000101967 ()


  • Apheresis system
SOFTWARE KIT,VMAX ENCORE VERSION 20-5B CD
Carefusion Corporation
63654
Not in Commercial Distribution

  • 10846446027600 ()
63654

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
In Commercial Distribution

  • 30093815708453 ()
  • 00093815708452 ()
  • 00093815000839 ()
70845

  • Electrical-only medical device connection cable, reusable
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution

  • 30093815000830 ()
  • 00093815000839 ()
  • 57599-0845-1 ()
70845

  • Electrical-only medical device connection cable, reusable
Resting ECG connectivity gateway software v.5.0.0
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655021058 ()
11027-024-50

  • Electrocardiograph, professional, multichannel
USB Stick containing Mag Log Converter Software
Thoratec Switzerland GmbH
201-52213
In Commercial Distribution

  • 07640135140566 ()
201-52213

  • Circulatory assist system application software
GoCheck Kids Native Software Application for Nokia.
Gobiquity, Inc.
Nokia 4.6.3
In Commercial Distribution

GCKNOK463

  • External ocular measurement camera
Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system
Clinician Programmer Software for L300 Go system
BIONESS INC.
LG4-SW01
In Commercial Distribution

  • 00815962020061 ()


  • Gait-enhancement electrical stimulation system, external
Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system
Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Software Version 9.0
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020429 ()
004652-005

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system
Lumax™ TS Pro Advanced • Software Kit
Coopersurgical, Inc.
23486
In Commercial Distribution

  • 60888937013391 ()


  • Urodynamic measurement system
Scopis ENT Software with Target Guided Surgery
Stryker Leibinger GmbH & Co. KG
8000-020-002
In Commercial Distribution

  • 07613327413199 ()
8000-020-002

  • Stereotactic system application software
Clinician Programmer Software for H200 Wireless System
Bioness Medical, Inc.
H2W-SW01
In Commercial Distribution



  • Hand orthosis
Clinician Programmer Software for L300 Go System
Bioness Medical, Inc.
LG4-SW01
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
Site~Rite 9 Ultrasound Software v.1.2.0
Bard Access Systems, Inc.
SR9v1.2.0
In Commercial Distribution

  • 00801741231186 ()
SR9v1.2.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system
Site Rite 8 Ultrasound System Application Software
Bard Access Systems, Inc.
SR8v2.4.0
In Commercial Distribution

  • 00801741219405 ()
SR8v2.4.0

  • General-purpose ultrasound imaging system
Site~Rite 8 Ultrasound System Host Software
Bard Access Systems, Inc.
SR8 USv2.1.0
In Commercial Distribution

  • 00801741161094 ()
SR8 USv2.1.0

  • General-purpose ultrasound imaging system
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