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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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MedTrakVNG Goggle - B292M9205200

No Description
MEDTRAK VNG, INC.
M920520
In Commercial Distribution

  • B292M9205200 ()


  • Eye movement analysis system

MedTrakVNG Interface Controller - B292M9203020

No Description
MEDTRAK VNG, INC.
M920302
In Commercial Distribution

  • B292M9203020 ()


  • Eye movement analysis system

MobiTrakVNG Receiver - B292M9174150

No Description
MEDTRAK VNG, INC.
M917415
In Commercial Distribution

  • B292M9174150 ()


  • Eye movement analysis system

MobiTrak Software v3.00 - B292M9170810

No Description
MEDTRAK VNG, INC.
M917081
In Commercial Distribution

  • B292M9170810 ()


  • Eye movement analysis system

MedTrakVNG Footswitch - B2924091070

No Description
MEDTRAK VNG, INC.
40-9107
In Commercial Distribution

  • B2924091070 ()


  • Eye movement analysis system

MedTrakVNG MobiTrak System - B2924040100

No Description
MEDTRAK VNG, INC.
40-4010
In Commercial Distribution

  • B2924040100 ()


  • Eye movement analysis system

Blackrock NeuroPort Biopotential Signal Processing System - 00814901021558

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.7.0
In Commercial Distribution

  • 00814901021558 ()
RS-0049

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901021497

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.6.1
In Commercial Distribution

  • 00814901021497 ()
RS-0049

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901021466

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.6.0
Not in Commercial Distribution

  • 00814901021466 ()
RS-0049

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901021459

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.5.2
Not in Commercial Distribution

  • 00814901021459 ()
RS-0049, RS-0152

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901021428

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.5.0
Not in Commercial Distribution

  • 00814901021428 ()
RS-0049

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901020315

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.0.4
Not in Commercial Distribution

  • 00814901020315 ()
RS-0115

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901020308

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.0.3
Not in Commercial Distribution

  • 00814901020308 ()
RS-0101

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901020292

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.0.2
Not in Commercial Distribution

  • 00814901020292 ()
RS-0101

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901020278

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
7.0.0
Not in Commercial Distribution

  • 00814901020278 ()
RS-0049

  • Bioelectrical signal analysis software

Blackrock NeuroPort Biopotential Signal Processing System - 00814901020193

NeuroPort Central Suite
BLACKROCK MICROSYSTEMS, LLC
6.5.4
Not in Commercial Distribution

  • 00814901020193 ()
RS-0049

  • Bioelectrical signal analysis software

SHOEBOX AUDIOMETRY - B348SHOEBOXAUDIOMETER0

No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution

  • B348SHOEBOXAUDIOMETER0 ()


  • Tone audiometer

ZIRKONZAHN.Implant-Planner Practice - D800SY1620

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

ZIRKONZAHN.Implant-Planner - D800SY1600

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

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

MSOFT Dental Planning System - 07649997938021

MSOFT Dental Planning System
Swissmeda AG
2.22
In Commercial Distribution

  • 07649997938021 ()


  • Dental treatment application software

Swissmeda Dental Planning System - 07649997938014

SMOP Dental Planning System 2.21.0
Swissmeda AG
2.21.0
In Commercial Distribution

  • 07649997938014 ()


  • Dental treatment application software

GoCheck Audiometric Headphone Assembly - B43061000060

Audiometric Headphone Final Assembly
Gobiquity, Inc.
Sennheiser HD280 Pro
In Commercial Distribution

  • B43061000060 ()


  • Tone audiometer

GoCheck - B43056000011000

Mobile Application for Hearing Screening
Gobiquity, Inc.
Hearing Mobile App V1.0.0
In Commercial Distribution

  • B43056000011000 ()


  • Tone audiometer

CNS Envision - B485VIS100

Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
MOBERG RESEARCH INC
VIS-100
In Commercial Distribution

  • B485VIS100 ()


  • Bioelectrical signal analysis software

CNS Envision - B485CNSENV1000

Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
NATUS NEUROLOGY INCORPORATED
1.03.00
In Commercial Distribution

  • B485CNSENV1000 ()


  • Bioelectrical signal analysis software

X-Guide - 00817421020803

X-Guide Windows Planning Software 2.3.3
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020803 ()
P008296

  • Dental treatment application 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

SmartEP Software - 00817020020808

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811000
In Commercial Distribution

  • 00817020020808 ()


  • Bioelectrical signal analysis software

SoundField USBBox-to-Amp Cable (Mono Plugs) - 00817020020358

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M025701
In Commercial Distribution

  • 00817020020358 ()


  • Tone audiometer

SoundField USBBox-to-Amp Cable (RCA Plugs) - 00817020020365

No Description
INTELLIGENT HEARING SYSTEMS CORP.
M025704
In Commercial Distribution

  • 00817020020365 ()


  • Tone audiometer

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

NONE - B006EMGVIEW0

No Description
Neurovision Medical Products, Inc.
NONE
In Commercial Distribution

  • B006EMGVIEW0 ()


  • Bioelectrical signal analysis software

BC - B202BCSEG0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software) Segmental
In Commercial Distribution

  • B202BCSEG0 ()
BCSEG

  • Bioelectrical signal analysis software

BC - B202BC0

No Description
R.J.L. SCIENCES, INC.
BC (Body Composition Software)
In Commercial Distribution

  • B202BC0 ()
BC

  • Bioelectrical signal analysis software

PXL - 00813557020243

PXL Intraoral Camera
Digital Doc LLC
PXL-1000
In Commercial Distribution

  • 00813557020243 ()
PXL-1000

  • Intraoral camera

Iris - 00813557020205

IRIS X90 Intraoral Camera
Digital Doc LLC
X90
In Commercial Distribution

  • 00813557020205 ()
IRIS-X90

  • Intraoral camera

Iris - 00813557020144

IRIS X80 Intraoral Camera
Digital Doc LLC
X80
In Commercial Distribution

  • 00813557020144 ()
IRIS-X80

  • Intraoral camera
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