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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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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

MSOFT Dental Planning System - 07629999685093

No Description
Swissmeda AG
2.16
Not in Commercial Distribution

  • 07629999685093 ()


  • Dental treatment application software

MSOFT Dental Planning System - 07629999628410

No Description
Swissmeda AG
2.19.0
In Commercial Distribution

  • 07629999628410 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999614178

No Description
Swissmeda AG
2.17.1
In Commercial Distribution

  • 07629999614178 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999065512

No Description
Swissmeda AG
2.15.4
In Commercial Distribution

  • 07629999065512 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999062177

No Description
Swissmeda AG
2.20.0
In Commercial Distribution

  • 07629999062177 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999061569

No Description
Swissmeda AG
2.15.3
Not in Commercial Distribution

  • 07629999061569 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999057654

No Description
Swissmeda AG
2.15.2
Not in Commercial Distribution

  • 07629999057654 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999056985

No Description
Swissmeda AG
2.15.1
Not in Commercial Distribution

  • 07629999056985 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999056220

No Description
Swissmeda AG
2.15
Not in Commercial Distribution

  • 07629999056220 ()


  • Dental treatment application software

MSOFT Dental Planning System - 07629999054356

No Description
Swissmeda AG
2.14.3
Not in Commercial Distribution

  • 07629999054356 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999052505

No Description
Swissmeda AG
2.14.2
Not in Commercial Distribution

  • 07629999052505 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999052109

No Description
Swissmeda AG
2.14.1
Not in Commercial Distribution

  • 07629999052109 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07629999048713

No Description
Swissmeda AG
2.14
Not in Commercial Distribution

  • 07629999048713 ()


  • Dental treatment application software

Custom Healthcare Systems Inc. - 00811870035227

No Description
Manus Medical, LLC
B9-18339
In Commercial Distribution

  • 20811870035221 ()
  • 00811870035227 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870033360

No Description
Manus Medical, LLC
B9-17972A
In Commercial Distribution

  • 20811870033364 ()
  • 00811870033360 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870033254

No Description
Manus Medical, LLC
B9-17972
In Commercial Distribution

  • 20811870033258 ()
  • 00811870033254 ()


  • Mammographic stereotactic biopsy system

CUSTOM HEALTHCARE SYSTEMS INC - 00811870031830

No Description
Manus Medical, LLC
B9-16261
In Commercial Distribution

  • 00811870031830 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870031649

No Description
Manus Medical, LLC
B9-15263A
In Commercial Distribution

  • 00811870031649 ()


  • Mammographic stereotactic biopsy system

Custom Healthcare Systems Inc. - 00811870031137

No Description
Manus Medical, LLC
B446MM-B
In Commercial Distribution

  • 20811870031131 ()
  • 00811870031137 ()


  • Mammographic stereotactic biopsy system

CUSTOM HEALTHCARE SYSTEMS INC - 00811870030710

No Description
Manus Medical, LLC
B9-18339B
In Commercial Distribution

  • 20811870030714 ()
  • 00811870030710 ()


  • Mammographic stereotactic biopsy system

Coapt Evaluation Kit - B618Q1

The Coapt Evaluation Kit is a handheld clinical tool created with technology from the Coapt COMPLETE CONTROL System Gen2. It is an accessory intended to be used during the planning and alignment of myoelectric control contact locations for an upper limb prosthetic socket.
COAPT LLC
1
In Commercial Distribution

  • B618Q1 ()


  • Bioelectrical signal analysis software

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

SmartAudiometer Software - 00817020020877

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution

  • 00817020020877 ()


  • Tone audiometer

SmartTrOAE Software - 00817020020860

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution

  • 00817020020860 ()


  • Bioelectrical signal analysis software

SmartDPOAE Software - 00817020020853

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution

  • 00817020020853 ()


  • Bioelectrical signal analysis software

SmartScreener-Plus2 OAE Module - 00817020020846

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813010
In Commercial Distribution

  • 00817020020846 ()


  • Bioelectrical signal analysis software

SmartScreener-Plus2 AEP Module - 00817020020839

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M812001
In Commercial Distribution

  • 00817020020839 ()


  • Bioelectrical signal analysis software

SmartScreener-Plus2 Screener Launch - 00817020020822

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M812002
In Commercial Distribution

  • 00817020020822 ()


  • Bioelectrical signal analysis software

SmartEP-ASSR Software - 00817020020815

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811007
In Commercial Distribution

  • 00817020020815 ()


  • Bioelectrical signal analysis software
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