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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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Upgrades dStream to R12
Philips Medical Systems Nederland B.V.
Upgrades dStream to R12
In Commercial Distribution

  • 00884838115729 ()
782161

  • Full-body MRI system, superconducting magnet
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
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
No Description
Natus Medical Denmark ApS
"TO/TB monitoring system
In Commercial Distribution

  • 05713315004599 ()


  • Tone audiometer, semi-automated
No Description
Natus Medical Denmark ApS
"TO/TB monitoring system
In Commercial Distribution

  • 05713315004582 ()


  • Tone audiometer, semi-automated
No Description
Natus Medical Denmark ApS
TO/TB Sound Tube
Not in Commercial Distribution

  • 05713315000683 ()


  • Tone audiometer, semi-automated
Rod to rod clamp.
CITIEFFE SRL
Rod to rod clamp
In Commercial Distribution

  • 08052990972333 ()
DF200030

  • External orthopaedic fixation system, single-use, sterile
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution

  • 08055060110185 ()
FS01

  • Foot-switch, electrical
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution

  • 08055060110178 ()
UKS01

  • Foot-switch, electrical
Rod to rod clamp.
CITIEFFE SRL
Rod to rod clamp
Not in Commercial Distribution

  • 08032909624904 ()
DF200030

  • External orthopaedic fixation system, single-use, sterile
The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.
DOMINO SRL
GLOBUS REVO TO GO
In Commercial Distribution

  • 08032625829812 ()
G5598

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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 SWIFT to BT23 UPG
GE Ultrasound Korea Ltd.
SWIFT to BT23 UPG
In Commercial Distribution

  • 00195278560124 ()
5919153

  • General-purpose ultrasound imaging system
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
Voluson Performance to BT22 UPG
GE Ultrasound Korea Ltd.
Performance to BT22 UPG
In Commercial Distribution

  • 00195278473011 ()
Voluson-Performance-to-BT22-UPG

  • General-purpose ultrasound imaging system
Tempo Foot, Right, Tan, Endo IP, 30cm, Category 5
COLLEGE PARK INDUSTRIES, INC.
TO RTEN 30 D5
In Commercial Distribution

  • 00195411060443 ()


  • Mechanical-resistance external ankle-foot prosthesis
Tempo Foot, Right, Tan, Endo IP, 30cm, Category 4
COLLEGE PARK INDUSTRIES, INC.
TO RTEN 30 D4
In Commercial Distribution

  • 00195411060436 ()


  • Mechanical-resistance external ankle-foot prosthesis
Tempo Foot, Right, Tan, Endo IP, 30cm, Category 3
COLLEGE PARK INDUSTRIES, INC.
TO RTEN 30 D3
In Commercial Distribution

  • 00195411060429 ()


  • Mechanical-resistance external ankle-foot prosthesis
Tempo Foot, Right, Tan, Endo IP, 30cm, Category 2
COLLEGE PARK INDUSTRIES, INC.
TO RTEN 30 D2
In Commercial Distribution

  • 00195411060412 ()


  • Mechanical-resistance external ankle-foot prosthesis
Tempo Foot, Right, Tan, Endo IP, 30cm, Category 1
COLLEGE PARK INDUSTRIES, INC.
TO RTEN 30 D1
In Commercial Distribution

  • 00195411060405 ()


  • Mechanical-resistance external ankle-foot prosthesis
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