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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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Bravo - 10840935105473

No Description
SUNTECH MEDICAL, INC.
99-0013-70
In Commercial Distribution

  • 10840935105473 ()


  • Blood pressure ambulatory recorder

Agilis - 10840935105466

No Description
SUNTECH MEDICAL, INC.
99-0013-60
In Commercial Distribution

  • 10840935105466 ()


  • Blood pressure ambulatory recorder

Opti - 10840935105428

No Description
SUNTECH MEDICAL, INC.
99-0013-26
In Commercial Distribution

  • 10840935105428 ()


  • Blood pressure ambulatory recorder

PressureTrak - 10840935105411

No Description
SUNTECH MEDICAL, INC.
99-0013-20
In Commercial Distribution

  • 10840935105411 ()


  • Blood pressure ambulatory recorder

Oscar 2 - 10840935105374

No Description
SUNTECH MEDICAL, INC.
99-0012-41
In Commercial Distribution

  • 10840935105374 ()


  • Blood pressure ambulatory recorder

Oscar 2 - 10840935105367

No Description
SUNTECH MEDICAL, INC.
99-0012-29
In Commercial Distribution

  • 10840935105367 ()


  • Blood pressure ambulatory recorder

Oscar 2 - 10840935105343

No Description
SUNTECH MEDICAL, INC.
99-0012-09
In Commercial Distribution

  • 10840935105343 ()


  • Blood pressure ambulatory recorder

Oscar 2 - 10840935105336

No Description
SUNTECH MEDICAL, INC.
99-0012-00
In Commercial Distribution

  • 10840935105336 ()


  • Blood pressure ambulatory recorder

Tremetrics - 08584270041731

No Description
Diagnostic Group LLC
HT Wizard PC
Not in Commercial Distribution

  • 08584270041731 ()


  • Tone audiometer

Tremetrics - 08584270041724

No Description
Diagnostic Group LLC
RA650
Not in Commercial Distribution

  • 08584270041724 ()


  • Tone audiometer

Maico - 08584270041557

No Description
Diagnostic Group LLC
MA 41
Not in Commercial Distribution

  • 08584270041557 ()


  • Tone audiometer

Maico - 08584270041533

No Description
Diagnostic Group LLC
MA 25
Not in Commercial Distribution

  • 08584270041533 ()


  • Tone audiometer

Maico - 08584270041526

No Description
Diagnostic Group LLC
MA 1
Not in Commercial Distribution

  • 08584270041526 ()


  • Tone audiometer

Tremetrics - 08584270041328

No Description
Diagnostic Group LLC
HT Wizard Ultra
Not in Commercial Distribution

  • 08584270041328 ()


  • Tone audiometer

Tremetrics - 08584270041311

No Description
Diagnostic Group LLC
RA300
Not in Commercial Distribution

  • 08584270041311 ()


  • Tone audiometer

Maico - 08584270041298

No Description
Diagnostic Group LLC
Digital Pilot Test
Not in Commercial Distribution

  • 08584270041298 ()


  • Tone audiometer

Maico - 08584270041267

No Description
Diagnostic Group LLC
MA 27
Not in Commercial Distribution

  • 08584270041267 ()


  • Tone audiometer

Maico - 08584270041168

No Description
Diagnostic Group LLC
MA 52
Not in Commercial Distribution

  • 08584270041168 ()


  • Tone audiometer

Maico - 08584270041151

No Description
Diagnostic Group LLC
MA 42
Not in Commercial Distribution

  • 08584270041151 ()


  • Tone audiometer

Tremetrics - 08584270041106

No Description
Diagnostic Group LLC
RA800
Not in Commercial Distribution

  • 08584270041106 ()


  • Tone audiometer

Grason-Stadler - 08584270041069

No Description
Diagnostic Group LLC
GSI AudioStar Pro
Not in Commercial Distribution

  • 08584270041069 ()


  • Tone audiometer

Canaview - 00837699000000

Canaview Intra Oral Camera, Direct-USB, Auto-Focus
Beyes Dental Canada Inc
EV2060
In Commercial Distribution

  • 00837699000000 ()


  • Intraoral camera

Galileo NT Line Software - 08056446900642

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

MULTIFUNCTION TABLE - 08055715707074

Provides a large, ergonomic and functional support surface for manual activities or reading, adaptable to the position chosen by the user (sitting, standing / vertical or prone) and which allows the approach not only to normal chairs, but also to more specific seating systems. Intended for children and adults with moderate to complex motor or cognitive impairment and who need a reference plan for carrying out teaching, training and / or work activities, as a complement to other devices such as seats and / or high chairs.
ORMESA SRL
TAVOLO MULTIFUNZIONE MIS SMALL
In Commercial Distribution

  • 08055715707074 ()


  • Ergonomic workdesk, manual

MULTIFUNCTION TABLE - 08055715707067

Provides a large, ergonomic and functional support surface for manual activities or reading, adaptable to the position chosen by the user (sitting, standing / vertical or prone) and which allows the approach not only to normal chairs, but also to more specific seating systems. Intended for children and adults with moderate to complex motor or cognitive impairment and who need a reference plan for carrying out teaching, training and / or work activities, as a complement to other devices such as seats and / or high chairs.
ORMESA SRL
TAVOLO MULTIFUNZIONE MIS MEDIUM
In Commercial Distribution

  • 08055715707067 ()


  • Ergonomic workdesk, manual

MULTIFUNCTION TABLE - 08055715707050

Provides a large, ergonomic and functional support surface for manual activities or reading, adaptable to the position chosen by the user (sitting, standing / vertical or prone) and which allows the approach not only to normal chairs, but also to more specific seating systems. Intended for children and adults with moderate to complex motor or cognitive impairment and who need a reference plan for carrying out teaching, training and / or work activities, as a complement to other devices such as seats and / or high chairs.
ORMESA SRL
TAVOLO MULTIFUNZIONE MIS LARGE
In Commercial Distribution

  • 08055715707050 ()


  • Ergonomic workdesk, manual

TRIANGLE - 08054187380778

AUDIOMETER. Screening audiometer, capable of performing fast and accurate air and bone conduction threshold examination and screening test.
INVENTIS SRL
TRIANGLE
In Commercial Distribution

  • 08054187380778 ()
11689

  • Tone audiometer

TRUMPET - 08054187380600

The additional loudspeaker for Trumpet can be used as a second loudspeaker when performing a PTA or Speech Audiometry in Free Field.
INVENTIS SRL
ADDITIONAL LOUDSPEAKER FOR TRUMPET
In Commercial Distribution

  • 08054187380600 ()
11142

  • Tone audiometer

MAESTRO CONTROL PANEL - 08054187380914

ACCESSORY OF Maestro Control Panel is a physical keyboard to be used to control Inventis audiometers, through Maestro software while performing audiometric exams.
INVENTIS SRL
MAESTRO CONTROL PANEL
In Commercial Distribution

  • 08054187380914 ()
12080

  • Tone audiometer

BELL - 08054187380587

AUDIOMETER. Bell Plus S 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
BELL PLUS S
In Commercial Distribution

  • 08054187380587 ()
10547

  • Tone audiometer

TRUMPET - 08054187380563

Trumpet AUD is a diagnostic audiometer, capable of performing: pure tone and speech audiometry, in air, free field, and in bone conduction.
INVENTIS SRL
TRUMPET AUD
In Commercial Distribution

  • 08054187380563 ()
10967

  • Tone audiometer

CELLO - 08054187380518

AUDIOMETER. Cello is a portable audiometer that can be controlled from a Windows computer or an iPad. Available exams: pure tone and speech audiometry via air conduction, bone conduction and free field; supra-threshold tests,
INVENTIS SRL
CELLO AERO
In Commercial Distribution

  • 08054187380518 ()
10559

  • Tone audiometer

CELLO - 08054187380501

AUDIOMETER. Cello is a portable audiometer that can be controlled from a Windows computer. Available exams: pure tone and speech audiometry via air conduction, bone conduction and free field; supra-threshold tests,
INVENTIS SRL
CELLO
In Commercial Distribution

  • 08054187380501 ()
10558

  • Tone audiometer

PICCOLO - 08054187380396

AUDIOMETER. Piccolo Speech Aero is a portable audiometer that can be controlled from a Windows computer or iPad. Available exams: pure tone audiometry via air conduction and bone conduction; speech audiometry.
INVENTIS SRL
PICCOLO SPEECH AERO
In Commercial Distribution

  • 08054187380396 ()
10332

  • Tone audiometer

PICCOLO - 08054187380389

AUDIOMETER. Piccolo Speech is a portable audiometer that can be controlled from a Windows computer. Available exams: pure tone audiometry via air conduction and bone conduction; speech audiometry.
INVENTIS SRL
PICCOLO SPEECH
In Commercial Distribution

  • 08054187380389 ()
10331

  • Tone audiometer

PICCOLO - 08054187380372

AUDIOMETER. Piccolo Plus is a portable audiometer that can be controlled from a Windows computer. Available exams: pure tone audiometry via air conduction and bone conduction.
INVENTIS SRL
PICCOLO PLUS
In Commercial Distribution

  • 08054187380372 ()
10329

  • Tone audiometer

PICCOLO - 08054187380365

AUDIOMETER. Piccolo Plus Aero is a portable audiometer that can be controlled from a Windows computer or iPad. Available exams: pure tone audiometry via air conduction and bone conduction.
INVENTIS SRL
PICCOLO PLUS AERO
In Commercial Distribution

  • 08054187380365 ()
10330

  • Tone audiometer

PIANO - 08054187380112

AUDIOMETER. Piano Plus is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry, Bekesy and MLD tests. Piano Plus with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
PIANO PLUS WITH PRINTER
In Commercial Distribution

  • 08054187380112 ()
10165

  • Tone audiometer

PIANO - 08054187380105

AUDIOMETER. Piano Plus is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; supra-threshold tests; High Frequency and Multi-frequency audiometry, Bekesy and MLD tests.
INVENTIS SRL
PIANO PLUS
In Commercial Distribution

  • 08054187380105 ()
10148

  • Tone audiometer

PIANO - 08054187380099

AUDIOMETER. Piano Basic is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and supra-threshold tests. Piano Basic with Printer has, in addition, an integrated thermal printer.
INVENTIS SRL
PIANO BASIC WITH PRINTER
In Commercial Distribution

  • 08054187380099 ()
10164

  • Tone audiometer

PIANO - 08054187380082

AUDIOMETER. Piano Basic is an advanced clinical audiometer with two separate and independent channels. It is capable of performing: speech and pure-tone audiometry via air conduction, bone conduction, and free field; and supra-threshold tests.
INVENTIS SRL
PIANO BASIC
In Commercial Distribution

  • 08054187380082 ()
10147

  • Tone audiometer

HARP - 08054187380075

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

HARP - 08054187380068

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

HARP - 08054187380051

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

HARP - 08054187380044

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

BELL - 08054187380020

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

Micromed - 08033928120958

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

micromed - 08033928120880

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

myray - 08033837930174

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 - 08033837190202

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
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