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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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Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-005-70
In Commercial Distribution

  • 00817655021430 ()


  • Electrocardiography telemetric monitoring system
Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-001-70
In Commercial Distribution

  • 00817655020105 ()


  • Electrocardiography telemetric monitoring system
Clinical Laboratory Information System application software
ASPYRA, LLC
7.3.1
In Commercial Distribution

  • B433CL0 ()
CL731

  • Clinical laboratory information system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.1
In Commercial Distribution

  • B432360CAS3110 ()


  • Robotic surgical navigation system application software
360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.0
In Commercial Distribution

  • B432360CAS3100 ()


  • Robotic surgical navigation system application software
Stand-alone software for GoCheck Kids Nokia.
Gobiquity, Inc.
Nokia 4.4.29
In Commercial Distribution

  • B430GCKNOK44290L ()


  • External ocular measurement camera
Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system
Lumax™ TS Pro Advanced Software
Coopersurgical, Inc.
23485
In Commercial Distribution

  • 00888937013382 ()


  • Urodynamic measurement system
TrueFit v3.7 DVD Software Package USA
Unitron Hearing Division
058-5229
In Commercial Distribution

  • 07613389221589 ()
058-5229

  • Audiometric/hearing device software
TrueFit Fitting Software v3.7 USB USA
Unitron Hearing Division
058-5228
In Commercial Distribution

  • 07613389221572 ()
058-5228

  • Audiometric/hearing device software
USB V3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5227
In Commercial Distribution

  • 07613389143232 ()
058-5227

  • Audiometric/hearing device software
DVD v3.6.1 Fitting Software Hansaton Scout
Hansaton Akustik GmbH
058-5226
In Commercial Distribution

  • 07613389143225 ()
058-5226

  • Audiometric/hearing device software
CAPILLAROSCOPE HIGH RESOLUTION WITH PROFESSIONAL SOFTWARE
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-318
Not in Commercial Distribution

  • B1623181 ()
FEDMEDMICFIP5MSWC_US

  • Otoscope, direct
OB Legacy System iOS Software System
Airstrip Technologies, Inc.
1001
In Commercial Distribution

  • B15310010 ()


  • Bedside monitor remote-viewing software, physiological parameter
OB Legacy System Server Software System
Airstrip Technologies, Inc.
1000
In Commercial Distribution

  • B15310000 ()


  • Bedside monitor remote-viewing software, physiological parameter
ARCS ABP Analysis & Reporting Software & Dongle
VASOMEDICAL, INC.
ARCS Series S/W
In Commercial Distribution

  • 00817980020283 ()
A10-0118-50

  • Electrocardiographic long-term ambulatory recording analyser application software
IMAGE PROCESSING SOFTWARE / FOR VITA CR
CARESTREAM HEALTH, INC.
Vita CR System
In Commercial Distribution

  • 60889971919878 ()
1919877

  • Computed radiography digital imaging scanner
KARL STORZ SCB Software Upgrade "VOICE1"
Karl Storz GmbH & Co. KG
20090001-40
In Commercial Distribution

  • 04048551228517 ()


  • Operating room audiovisual data/device management system application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498313020 ()
31302

  • Ventilator application software
Patient data management software (web version)
RESMED PTY LTD
31302
In Commercial Distribution

  • 00619498000722 ()
31302

  • Ventilator application software
Respiration, Phonation and Prosody Simulation, Software
PENTAX OF AMERICA, INC.
5152
Not in Commercial Distribution

  • 04961333229833 ()


  • Electroglottograph
Applied Speech Science for Dysarthrias, Software
PENTAX OF AMERICA, INC.
5153
Not in Commercial Distribution

  • 04961333229840 ()


  • Electroglottograph
Knee Software Package, ART 2.0.1 Add-on
Omni Life Science, Inc.
NS-27007
In Commercial Distribution

  • 00841690194538 ()
NS-27007

  • Instrument tray, reusable
Knee Software Package, ART 2.1 Add-on
Omni Life Science, Inc.
NS-27008
In Commercial Distribution

  • 00841690194521 ()
NS-27008

  • Instrument tray, reusable
Knee Software Package, ART 2.2 Add-on
Omni Life Science, Inc.
NS-27009
In Commercial Distribution

  • 00841690194514 ()
NS-27009

  • Instrument tray, reusable
Knee Software Package, ART 2.3 Add-on
Omni Life Science, Inc.
NS-27010
In Commercial Distribution

  • 00841690194507 ()
NS-27010

  • Instrument tray, reusable
Sandman Codec Software V.2.0 CD-Elite
Embla Systems Ltd
4120082
In Commercial Distribution

  • 00382830023924 ()


  • Sleep disorder interpretive software
BD FACSCanto II System Software V2.4
BECTON, DICKINSON AND COMPANY
646601
Not in Commercial Distribution

  • 00382906466013 ()
646601

  • Laboratory instrument/analyser application software IVD
BD BBL Crystal™ MIND Software
BECTON, DICKINSON AND COMPANY
441010
Not in Commercial Distribution

  • 00382904410100 ()
441010

  • Human infectome analysis interpretive software IVD
BD FACSCanto™ II System Software
Becton, Dickinson And Company
664124
In Commercial Distribution

  • 00382906641243 ()
664124

  • Laboratory analyser operation system software IVD
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