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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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Welch Allyn, Inc. - 00732094230888

CIWS STD NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230888 ()
  • 00732094057485 ()
84NXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230857

CIWS WRLS NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230857 ()
  • 00732094118803 ()
85NXVX

  • Multiple vital physiological parameter monitoring system, clinical

OptiMap™ System - NA - 00850064686135

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias.
Cortex, Inc.
FG0001-NA
In Commercial Distribution

  • 00850064686135 ()
OPTI-SYS-NA

  • Cardiac mapping system

OptiMap Monitor - 00850064686029

OptiMap Monitor
Cortex, Inc.
FG0009
In Commercial Distribution

  • 00850064686029 ()
OPTI-MON

  • Cardiac mapping system

OptiMap™ Workstation - 00850064686012

OptiMap Workstation
Cortex, Inc.
FG0008
In Commercial Distribution

  • 00850064686012 ()
OPTI-WS

  • Cardiac mapping system

Welch Allyn, Inc. - 00732094230871

CIWS STD NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230871 ()
  • 00732094119312 ()
84NXVX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230826

CIWS WRLS NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230826 ()
  • 00732094055054 ()
85NXVE

  • Multiple vital physiological parameter monitoring system, clinical

HnX-PB - 08800070400166

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-PB
In Commercial Distribution

  • 08800070400166 ()


  • Portable basic diagnostic x-ray system, digital

HnX-P1 - 08800070400074

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-P1
In Commercial Distribution

  • 08800070400074 ()


  • Portable basic diagnostic x-ray system, digital

Ion - 00886874116234

System Cart
INTUITIVE SURGICAL, INC.
380748
In Commercial Distribution

  • 00886874116234 ()


  • Surgical planning/navigation-enhancement system
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