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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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SCB control NEO Software
Karl Storz GmbH & Co. KG
20090001-47
In Commercial Distribution

  • 04048551392270 ()


  • Operating room audiovisual data/device management system application software
SOFTWARE, AUTO NERV, MEB-9400
NIHON KOHDEN CORPORATION
QP-948BK
In Commercial Distribution

  • 04931921104842 ()
QP-948BK

  • Evoked-potential graphic recording system
SOFTWARE, SINGLE FIBER, MEB-9400
NIHON KOHDEN CORPORATION
QP-947BK
In Commercial Distribution

  • 04931921104835 ()
QP-947BK

  • Evoked-potential graphic recording system
SOFTWARE, QUANT EMG , MEB-9400
NIHON KOHDEN CORPORATION
QP-946BK
In Commercial Distribution

  • 04931921104828 ()
QP-946BK

  • Evoked-potential graphic recording system
EEG examination support software
NIHON KOHDEN CORPORATION
QP-150AK
In Commercial Distribution

  • 04931921100783 ()
QP-150AK

  • Electroencephalograph
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333247417 ()


  • Speech assistive training device
COMPUTERIZED SPEECH LAB (SOFTWARE)
PENTAX OF AMERICA, INC.
4500B
In Commercial Distribution

  • 04961333236589 ()


  • Speech assistive training device
PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)
PENTAX OF AMERICA, INC.
6600
In Commercial Distribution

  • 04961333236565 ()


  • Electroglottograph
CAPE V SOFTWARE MODULE
PENTAX OF AMERICA, INC.
5168
In Commercial Distribution

  • 04961333235421 ()


  • Electroglottograph
Educational Bundle, Speech Software
PENTAX OF AMERICA, INC.
5157
Not in Commercial Distribution

  • 04961333230051 ()


  • Electroglottograph
Signal Enhancement Program, Software
PENTAX OF AMERICA, INC.
5142
Not in Commercial Distribution

  • 04961333230044 ()


  • Electroglottograph
Real-Time EGG Analysis Software
PENTAX OF AMERICA, INC.
5138
In Commercial Distribution

  • 04961333229796 ()


  • Electroglottograph
Analysis-Synthesis Laboratory (ASL) Software
PENTAX OF AMERICA, INC.
5104
Not in Commercial Distribution

  • 04961333229734 ()


  • Electroglottograph
Palatometer Database Program, Software
PENTAX OF AMERICA, INC.
4333
Not in Commercial Distribution

  • 04961333229697 ()


  • Electroglottograph
Phonetic Database Program, Software
PENTAX OF AMERICA, INC.
4332
Not in Commercial Distribution

  • 04961333229680 ()


  • Electroglottograph
Auditory Feedback Tools, Software
PENTAX OF AMERICA, INC.
3506
In Commercial Distribution

  • 04961333229628 ()
N/A

  • Electroglottograph
SOFTWARE KEY, USB HASP-4
PENTAX OF AMERICA, INC.
1111-1322
In Commercial Distribution

  • 04961333231157 ()


  • Electroglottograph
Motor Speech Products, Software
PENTAX OF AMERICA, INC.
5141
In Commercial Distribution

  • 04961333229802 ()


  • Electroglottograph
Software Package, AS 2.3
Omni Life Science, Inc.
NS-27111
In Commercial Distribution

  • 00841690194422 ()
NS-27111

  • Robotic surgical navigation system application software
NEUROWORKS 8.1.1 SOFTWARE (US)
XLTEK
104196
In Commercial Distribution

  • 00382830019231 ()


  • Electroencephalograph
syngo Dynamics VA40 Software
Siemens Healthcare GmbH
10745960
In Commercial Distribution

  • 04056869253244 ()


  • Radiological PACS software
syngo Application Software VE2
Siemens Healthcare GmbH
11327667
In Commercial Distribution

  • 04056869124162 ()


  • Basic diagnostic x-ray system application software
syngo Application Software VD2
Siemens Healthcare GmbH
10849231
In Commercial Distribution

  • 04056869050874 ()


  • Basic diagnostic x-ray system application software
Software for spine navigation
Brainlab AG
1,5
In Commercial Distribution

  • 04056481142025 ()


  • Robotic surgical navigation system
X-ray system application software
MIDMARK CORPORATION
60-A0007
In Commercial Distribution

  • 00841709101410 ()
60-A0007

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0004
In Commercial Distribution

  • 00841709101403 ()
60-A0004

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
60-A0003
In Commercial Distribution

  • 00841709101397 ()
60-A0003

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
45-A0023
In Commercial Distribution

  • 00841709101380 ()
45-A0023

  • General-purpose dental x-ray system application software
X-ray system application software
MIDMARK CORPORATION
30-A0027
In Commercial Distribution

  • 00841709101373 ()
30-A0027

  • General-purpose dental x-ray system application software
syngo Application Software VE3
Siemens Healthcare GmbH
30000266
In Commercial Distribution

  • 04056869964546 ()


  • Basic diagnostic x-ray system application software
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