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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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PGDx elio™ tissue complete - 00192721000770

PGDx elio™ tissue complete software
PERSONAL GENOME DIAGNOSTICS INC.
B01103200
In Commercial Distribution

  • 00192721000770 ()
B01103200

  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

Siemens - 04046355641976

Siemens UNITY 3 SOFTWARE (USB STICK)
Ws Audiology Usa, Inc.
UNITY 3 SOFTWARE (USB STICK)
Not in Commercial Distribution

  • 04046355641976 ()
10823966

  • Audiometric/hearing aid tester

Senolris - 00840682104395

SenoIris 1 SP2.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682104395 ()


  • Diagnostic x-ray digital imaging system workstation

GE Client Workstation - 00840682123594

SOFTWARE GE CLIENT WORKSTATION V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

SenoIris - 00840682147767

SenoIris 1 SP4.5 Software and Manuals
GE MEDICAL SYSTEMS
1
In Commercial Distribution

  • 00840682147767 ()


  • Diagnostic x-ray digital imaging system workstation

SenoIris - 00840682140614

SenoIris 1 SP3.2 Software and Manuals
GE Healthcare GmbH
1
Not in Commercial Distribution

  • 00840682140614 ()


  • Diagnostic x-ray digital imaging system workstation

FX Shoulder Positioning System - 03760297030209

Planning software for total shoulder arthroplasty
PIXEE MEDICAL
FXSPS001
Not in Commercial Distribution

  • 03760297030209 ()


  • Orthopaedic/craniofacial implantation planning software

PULSE - 00195377099013

PULSE Software Package including IOM, iG
Nuvasive, Inc.
8000104
In Commercial Distribution

  • 00195377099013 ()


  • Orthopaedic stereotactic surgery system

Lumax™ TS Pro - 00888937013382

Lumax™ TS Pro Advanced Software
Coopersurgical, Inc.
23485
In Commercial Distribution

  • 00888937013382 ()


  • Urodynamic measurement system

360CAS - B432360CAS3100

360CAS KNEE NAVIGATION SYSTEM SOFTWARE v3
KICO KNEE INNOVATION COMPANY PTY LIMITED
3.1.0
In Commercial Distribution

  • B432360CAS3100 ()


  • Robotic surgical navigation system application software
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