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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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AcQMap - 00857042007272

AcQMap 2mm Pin Jumper St
ACUTUS MEDICAL, INC.
800523
Not in Commercial Distribution

  • 00857042007272 ()
800523

  • Cardiac mapping system

AcQMap - 00857042007265

AcQMap ECG w/Snaps Cable
ACUTUS MEDICAL, INC.
800522
Not in Commercial Distribution

  • 00857042007265 ()
800522

  • Cardiac mapping system

AcQMap - 00857042007258

AcQMap ECG POST Cable
ACUTUS MEDICAL, INC.
800524
Not in Commercial Distribution

  • 00857042007258 ()
800524

  • Cardiac mapping system

AcQMap - 00857042007241

AcQMap ECG Input Cable
ACUTUS MEDICAL, INC.
800421
Not in Commercial Distribution

  • 00857042007241 ()
800421

  • Cardiac mapping system

AcQMap - 00857042007234

AcQMap ECG Output Cable
ACUTUS MEDICAL, INC.
800424
Not in Commercial Distribution

  • 00857042007234 ()
800424

  • Cardiac mapping system

AcQMap - 00857042007135

Ampere® Adapter Cable AcQMap® Ampere
ACUTUS MEDICAL, INC.
800431
Not in Commercial Distribution

  • 00857042007135 ()
800431

  • Cardiac mapping system

AcQMap - 00857042007128

AcQMap® Surface ECG Cable
ACUTUS MEDICAL, INC.
800407
Not in Commercial Distribution

  • 00857042007128 ()
800407

  • Cardiac mapping system

AcQMap - 00857042007111

AcQMap® Auxiliary Catheter Cable
ACUTUS MEDICAL, INC.
800109
Not in Commercial Distribution

  • 00857042007111 ()
800109

  • Cardiac mapping system

AcQMap - 00857042007104

AcQMap® Ablation Interface Unit Cable
ACUTUS MEDICAL, INC.
800112
Not in Commercial Distribution

  • 00857042007104 ()
800112

  • Cardiac mapping system

AcQMap - 00857042007098

AcQMap® Patient Interface Unit Cable
ACUTUS MEDICAL, INC.
800113
Not in Commercial Distribution

  • 00857042007098 ()
800113

  • Cardiac mapping system

AcQMap - 00857042007081

AcQMap® Patient Interface Unit
ACUTUS MEDICAL, INC.
800229
Not in Commercial Distribution

  • 00857042007081 ()
800229

  • Cardiac mapping system

AcQMap - 00857042007074

Ampere® Adapter Cable AcQMap® Ablation Catheter
ACUTUS MEDICAL, INC.
800430
Not in Commercial Distribution

  • 00857042007074 ()
800430

  • Cardiac mapping system

AcQMap - 00857042007067

AcQMap® Ablation Interface Unit
ACUTUS MEDICAL, INC.
800244-001
Not in Commercial Distribution

  • 00857042007067 ()
800244-001

  • Cardiac mapping system

AcQMap - 00857042007050

AcQMap® Workstation
ACUTUS MEDICAL, INC.
800254
Not in Commercial Distribution

  • 00857042007050 ()
800254

  • Cardiac mapping system

AcQMap - 00857042007043

AcQMap® Console
ACUTUS MEDICAL, INC.
800258
Not in Commercial Distribution

  • 00857042007043 ()
800258

  • Cardiac mapping system

AcQMap - 00857042007005

North America Power Cord
ACUTUS MEDICAL, INC.
800426
Not in Commercial Distribution

  • 00857042007005 ()
800426

  • Cardiac mapping system

Promaxo MRI System - 00860006901110

Magnetic Resonance Imaging System, Magnet Cart
Promaxo, Inc.
PR071-001-M
In Commercial Distribution

  • 00860006901110 ()
PR071-001-M

  • Full-body MRI system, permanent magnet

See-Mode Technologies - 00860006305727

Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution

  • 00860006305727 ()


  • Ultrasound imaging system application software

See-Mode Technologies - 00860006305703

Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution

  • 00860006305703 ()


  • Ultrasound imaging system application software

MediScout system - 00860006066307

MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution

  • 00860006066307 ()


  • Ultrasound imaging system application software
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