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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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MR 7700 - 00884838122239

Upgrade to workflow, and gradient performance of the MR 7700 for Ingenia 3.0T customers.
Philips Medical Systems Nederland B.V.
SmartPath to MR 7700
In Commercial Distribution

  • 00884838122239 ()
782178

  • Full-body MRI system, superconducting magnet

MR 5300, MR 7700 & Ingenia - 00884838108653

Upgrades dStream to R11
Philips Medical Systems Nederland B.V.
Upgrades dStream to R11
In Commercial Distribution

  • 00884838108653 ()
782142

  • Full-body MRI system, superconducting magnet

Ingenia, MR 5300 - 00884838101135

R5.7 brings software and application improvements. These include SmartExam enhancements with Quick Smart Survey. Other SW enhancements are including Prescan Redesign, Automated Analysis Software to generate data for American College of Radiology (ACR) Accreditation etc. R5.7 is also enabler for optional new clinical features like 4D FreeBreathing, MR Elastography Extension, MultiBand SENSE with dS Head coil and in 1.5T & Diffusion Excellence Pack
Philips Medical Systems Nederland B.V.
Upgrades dStream to R5.7
In Commercial Distribution

  • 00884838101135 ()
782111

  • Full-body MRI system, superconducting magnet

APOZA - 04719883751362

Light Guide 8mm to 2mm. Accessories for APOZA LED Light Curing Unit
APOZA ENTERPRISE CO., LTD.
LIGHT GUIDE-8mm to 2mm
In Commercial Distribution

  • 04719883751362 ()

  • Outer Diameter: 2 Millimeter


  • Dental/surgical polymerization lamp

GN Otometrics A/S - 05713315004599

No Description
Natus Medical Denmark ApS
"TO/TB monitoring system
In Commercial Distribution

  • 05713315004599 ()


  • Tone audiometer, semi-automated

GN Otometrics A/S - 05713315004582

No Description
Natus Medical Denmark ApS
"TO/TB monitoring system
In Commercial Distribution

  • 05713315004582 ()


  • Tone audiometer, semi-automated

GN Otometrics A/S - 05713315000683

No Description
Natus Medical Denmark ApS
TO/TB Sound Tube
Not in Commercial Distribution

  • 05713315000683 ()


  • Tone audiometer, semi-automated

Voluson - 00195278677587

Voluson Exp to BT24 UPG
GE Healthcare Austria GmbH & Co OG
Exp to BT24 UPG
In Commercial Distribution

  • 00195278677587 ()
5936797

  • General-purpose ultrasound imaging system

Voluson - 00195278560124

Voluson SWIFT to BT23 UPG
GE Ultrasound Korea Ltd.
SWIFT to BT23 UPG
In Commercial Distribution

  • 00195278560124 ()
5919153

  • General-purpose ultrasound imaging system

Voluson - 00195278473028

Voluson Signature to BT22 UPG
GE Ultrasound Korea Ltd.
Signature to BT22 UPG
In Commercial Distribution

  • 00195278473028 ()
Voluson-Signature-to-BT22-UPG

  • General-purpose ultrasound imaging system
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