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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COMPACT MONITOR,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Compact Monitor
In Commercial Distribution

  • 10841522131455 ()
91390

  • Multiple vital physiological parameter monitoring system, clinical
MD EchoPAC Plug-In v210
GE Vingmed Ultrasound AS
Plug-In v210
In Commercial Distribution

  • 00195278951717 ()


  • Ultrasound imaging system application software
MD EchoPAC Software Only v210
GE Vingmed Ultrasound AS
Software Only v210
In Commercial Distribution

  • 00195278951700 ()


  • Ultrasound imaging system application software
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
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
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-04
In Commercial Distribution

  • 05415067053367 ()
ENSITE-R-SYS-04

  • Cardiac mapping system
X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-04
In Commercial Distribution

  • 05415067053350 ()
ENSITE-SYSTEM-04

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-04
In Commercial Distribution

  • 05415067051257 ()
ENSITE-DWS-04

  • Cardiac mapping system
X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-04
In Commercial Distribution

  • 05415067051226 ()
ENSITE-R-DWS-04

  • Cardiac mapping system
CIWS WRLS MAS SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094231014 ()
  • 00732094118865 ()
85MXVX

  • Multiple vital physiological parameter monitoring system, clinical
CIWS STD MAS SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230901 ()
  • 00732094058086 ()
84MXVE

  • Multiple vital physiological parameter monitoring system, clinical
CIWS STD NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230888 ()
  • 00732094057485 ()
84NXVE

  • Multiple vital physiological parameter monitoring system, clinical
CIWS WRLS NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230857 ()
  • 00732094118803 ()
85NXVX

  • Multiple vital physiological parameter monitoring system, clinical
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
Cortex, Inc.
FG0009
In Commercial Distribution

  • 00850064686029 ()
OPTI-MON

  • Cardiac mapping system
OptiMap Workstation
Cortex, Inc.
FG0008
In Commercial Distribution

  • 00850064686012 ()
OPTI-WS

  • Cardiac mapping system
CIWS STD NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230871 ()
  • 00732094119312 ()
84NXVX

  • Multiple vital physiological parameter monitoring system, clinical
CIWS WRLS NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230826 ()
  • 00732094055054 ()
85NXVE

  • Multiple vital physiological parameter monitoring system, clinical
HEAD BLOCK ATTACH HARDWARE SET: (4) SOCKET HEAD CAP SCREWS, (4) WASHERS, (2) ALLEN WRENCHES
PMT CORPORATION
1201-36
In Commercial Distribution

  • 00650551044840 ()
1201-36

  • Cervical spine immobilization system, single-use
4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369037 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5BR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369020 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLASC3x4BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369013 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368931 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368917 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLAS4x5BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368832 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLASC4x5BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368818 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLAS4x5BR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368733 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLASC4x5BL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368726 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLASC3x4BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368719 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLAS4x5BL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368702 ()

  • Width: 4 Inch
  • Length: 3 Inch
PBLAS3x4BL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368610 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLS4X5PBR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368603 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLS3X4PBR

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368559 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLS4X5PBL

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Left (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368542 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLS3X4PBL

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368498 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLS4X5PBP

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Pair (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368481 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLS3X4PBP

  • Wheelchair head/trunk support, prefabricated
4 x 5 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368436 ()

  • Length: 4 Inch
  • Width: 5 Inch
PBLS4X5PBR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads with Swing Away Mounting Hardware for BTX - Right (E0956,E1028)
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368429 ()

  • Length: 3 Inch
  • Width: 4 Inch
PBLS3X4PBR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Flat with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369006 ()

  • Width: 4 Inch
  • Length: 3 Inch
PLLAS3x4BR

  • Wheelchair head/trunk support, prefabricated
3 x 4 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Left
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368924 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLASC3x4BL

  • Wheelchair head/trunk support, prefabricated
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