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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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LOGIQ - 00195278835789

LOGIQ E10s R2/R3 to R4 Upgrade with Hardware including Wireless
GE Ultrasound Korea Ltd.
E10s R2R3 to R4 HW Upgrade W
In Commercial Distribution

  • 00195278835789 ()
5946724

  • General-purpose ultrasound imaging system

E2 Heavy-Duty EasySet Removable Mounting Hardware - 07540147001216

E2 Heavy-Duty EasySet Removable Mounting Hardware (pair); includes E2 EasySet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design.
Motion Concepts Inc
E2HDMH
In Commercial Distribution

  • 07540147001216 ()
E2HDMH

  • Wheelchair back rest positioner

E2 Heavy-Duty MiniSet Removable Mounting Hardware - 07540147001209

E2 Heavy-Duty MiniSet Removable Mounting Hardware (pair); includes E2 MiniSet Mounting Pin Interface Brackets. Optional mounting hardware for Matrx E2 Backs (18H/20H). Quick-release design.
Motion Concepts Inc
E2MSHD
In Commercial Distribution

  • 07540147001209 ()
E2MSHD

  • Wheelchair back rest positioner

GammaPod™ Treatment Planning System - 00850002615029

TPS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615029 ()
XMSGP030A09.07-001

  • Stereotactic system application software

GammaPod™ Treatment Control System - 00850002615012

TCS Software
XCISION MEDICAL SYSTEMS, LLC
Model A
In Commercial Distribution

  • 00850002615012 ()
XMSGP030A09.06-101

  • Stereotactic system application software

StealthConnect - 00643169705432

SFTW KIT 9735696 STEALTHCONNECT SYS
MEDTRONIC NAVIGATION, INC.
9735696
In Commercial Distribution

  • 00643169705432 ()


  • Stereotactic system application software

CGMS® Solutions™ - 00613994675293

SOFTWARE MMT-7310 SOLNS EA CGMS V3.0C EN
MEDTRONIC MINIMED, INC.
MMT-7310
In Commercial Distribution

  • 00613994675293 ()


  • Home healthcare information system

ClarifEye - 00884838104570

Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.
Philips Medical Systems Nederland B.V.
ClarifEye - 1
In Commercial Distribution

  • 00884838104570 ()
002120

  • Stereotactic system application software

IntelliSpace Perinatal - 00884838084483

IntelliSpace Perinatal Large Architecture is a software-only offering and includes three separate versions of IntelliSpace Perinatal.
Philips Medical Systems Hsg
IntelliSpace Perinatal K Large Arch.
In Commercial Distribution

  • 00884838084483 ()
867061

  • Obstetrics information system

Invivo - 00884838083592

UroNAV Fusion Biopsy System
Philips DS North America LLC
784001
In Commercial Distribution

  • 00884838083592 ()


  • Stereotactic system application software
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