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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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AUDIOMETER. Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and certain supra-threshold tests. Harp Plus with Printer has, in addtion, an integrated thermal printer.
INVENTIS SRL
HARP PLUS WITH PRINTER
In Commercial Distribution

  • 08054187380075 ()
10163

  • Tone audiometer
AUDIOMETER. Harp Plus is an advanced diagnostic audiometer, capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and certain supra-threshold tests.
INVENTIS SRL
HARP PLUS
In Commercial Distribution

  • 08054187380068 ()
10146

  • Tone audiometer
AUDIOMETER. Harp Basic is an advanced diagnostic audiometer, capable of performing speech and pure-tone audiometry, via air conduction, bone conduction, and free field. Harp Basic with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
HARP BASIC WITH PRINTER
In Commercial Distribution

  • 08054187380051 ()
10162

  • Tone audiometer
AUDIOMETER. Harp Basic is an advanced diagnostic audiometer, capable of performing speech and pure-tone audiometry, via air conduction, bone conduction, and free field.
INVENTIS SRL
HARP BASIC
In Commercial Distribution

  • 08054187380044 ()
10145

  • Tone audiometer
AUDIOMETER. Basic diagnostic audiometer, capable of performing fast and accurate air and bone conduction threshold examination.
INVENTIS SRL
BELL PLUS
In Commercial Distribution

  • 08054187380020 ()
10144

  • Tone audiometer
software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG)
MICROMED SPA
BRAIN QUICK SOFTWARE
In Commercial Distribution

  • 08033928120958 ()


  • Bioelectrical signal analysis software
software for acquisition, review, storage , process and measure of biologic signals (particularly EEG and PSG)
MICROMED SPA
SystemPlus EVOLUTION
In Commercial Distribution

  • 08033928120880 ()


  • Bioelectrical signal analysis software
Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant-Planner Practice service contract is obligatory for the duration of 12 months! Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Practice
ZIRKONZAHN SRL
SY1620
In Commercial Distribution

  • D800SY1620 ()


  • Dental treatment application software
Rights of use Zirkonzahn.Implant-Planner The conclusion of the Zirkonzahn.Implant-Planner service contract is obligatory for the duration of 12 months! Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner
ZIRKONZAHN SRL
SY1600
In Commercial Distribution

  • D800SY1600 ()


  • Dental treatment application software
MSOFT Dental Planning System
Swissmeda AG
2.22
In Commercial Distribution

  • 07649997938021 ()


  • Dental treatment application software
SMOP Dental Planning System 2.21.0
Swissmeda AG
2.21.0
In Commercial Distribution

  • 07649997938014 ()


  • Dental treatment application software
X-Guide Windows Planning Software 2.3.3
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020803 ()
P008296

  • Dental treatment application software
The device is a camera system specifically intended to examine the oral cavity. This system is designed to allow the dentist to more efficiently show and explain to patients all oral conditions and reasons for planned treatment.
CEFLA SOCIETA' COOPERATIVA
C-U2
In Commercial Distribution

  • 08033837930174 ()
70220000

  • Intraoral camera
Biopsy Digit SL is a medical device intended to be used for mamnmographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL
BIOPSY DIGIT SL
In Commercial Distribution

  • 18033837190209 ()
  • 08033837190202 ()

  • Height: 330 Millimeter
  • Depth: 303 Millimeter
  • Width: 358 Millimeter
9201-01

  • Mammographic stereotactic biopsy system
Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.
EB NEURO SPA
B8640053000
In Commercial Distribution

  • 08056446900642 ()


  • Bioelectrical signal analysis software
CareMaster,1 E-type attachment , 2 Highspeed Handpieces
Beyes Dental Canada Inc
EV2060
In Commercial Distribution

  • 00990010301658 ()
Canaview Intra Oral Camera, Direct-USB, Auto-Focus

  • Intraoral camera
OtoPad is a software based audiometer used by a practitioner to test the hearing of a patient.
AMPLIFON SPA
2.0
In Commercial Distribution

  • 08059300420010 ()


  • Tone audiometer
No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution

  • B348SHOEBOXAUDIOMETER0 ()


  • Tone audiometer
No Description
MEDTRAK VNG, INC.
M920520
In Commercial Distribution

  • B292M9205200 ()


  • Eye movement analysis system
No Description
MEDTRAK VNG, INC.
M920302
In Commercial Distribution

  • B292M9203020 ()


  • Eye movement analysis system
No Description
MEDTRAK VNG, INC.
M917415
In Commercial Distribution

  • B292M9174150 ()


  • Eye movement analysis system
No Description
MEDTRAK VNG, INC.
M917081
In Commercial Distribution

  • B292M9170810 ()


  • Eye movement analysis system
No Description
MEDTRAK VNG, INC.
40-9107
In Commercial Distribution

  • B2924091070 ()


  • Eye movement analysis system
No Description
MEDTRAK VNG, INC.
40-4010
In Commercial Distribution

  • B2924040100 ()


  • Eye movement analysis system
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.7.0
In Commercial Distribution

  • 00814901021558 ()
RS-0049

  • Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.6.1
In Commercial Distribution

  • 00814901021497 ()
RS-0049

  • Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.6.0
Not in Commercial Distribution

  • 00814901021466 ()
RS-0049

  • Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.5.2
Not in Commercial Distribution

  • 00814901021459 ()
RS-0049, RS-0152

  • Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.5.0
Not in Commercial Distribution

  • 00814901021428 ()
RS-0049

  • Bioelectrical signal analysis software
NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.0.4
Not in Commercial Distribution

  • 00814901020315 ()
RS-0115

  • Bioelectrical signal analysis software
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