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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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SeeMore Software 4.2.1 Urology
INTERSON CORP
4.2.1 URO
In Commercial Distribution

  • 00850921007165 ()
98-3528-03

  • Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 4.2.1 Generic
INTERSON CORP
4.2.1 GEN
In Commercial Distribution

  • 00850921007158 ()
98-3528-02

  • Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 4.2.1 OB GYN
INTERSON CORP
4.2.1 OB GYN
In Commercial Distribution

  • 00850921007141 ()
98-3528-01

  • Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 2.0.03 OB GYN
INTERSON CORP
2.0.03 OB GYN
In Commercial Distribution

  • 00850921007110 ()
98-3517-03

  • Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 2.0.03 Generic
INTERSON CORP
2.0.03 GEN
In Commercial Distribution

  • 00850921007103 ()
98-3517-00

  • Extracorporeal ultrasound imaging transducer, hand-held
Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution

  • 00850154007086 ()
RS-0003

  • Electroencephalography telemetric monitoring system
  • Bioelectrical signal analysis software
No Description
ECENTIAL ROBOTICS
L00016
In Commercial Distribution

  • 03701311500445 ()


  • Robotic surgical navigation system application software
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M815000
In Commercial Distribution

  • 00817020020884 ()


  • Visual-reinforcement audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution

  • 00817020020877 ()


  • Tone audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution

  • 00817020020860 ()


  • Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution

  • 00817020020853 ()


  • Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811007
In Commercial Distribution

  • 00817020020815 ()


  • Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811000
In Commercial Distribution

  • 00817020020808 ()


  • Bioelectrical signal analysis software
No Description
Haag-Streit AG
i9.0
In Commercial Distribution

  • 07640132987256 ()


  • Medical image management system
No Description
Haag-Streit AG
i8.2
In Commercial Distribution

  • 07640132986105 ()


  • Medical image management system
No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • Electrocardiographic ambulatory recorder
Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838094895 ()
860292

  • Electrocardiographic long-term ambulatory recording analyser application software
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution

  • 07290114064071 ()
407-000024-00

  • Brain-responsive electrical stimulation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution

  • 07290114064545 ()
407-000024-00

  • Depth electrode
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