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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System One Heated Humidifier, Japan
Respironics, Inc.
System One Heated Humidifier, JP
Not in Commercial Distribution

  • 00606959029248 ()
JP6H

  • Heated respiratory humidifier
Trilogy 200 Ventilator, Bluetooth, Japan
Respironics, Inc.
Trilogy 200 Ventilator, Bluetooth, Japan
Not in Commercial Distribution

  • 00606959052352 ()
1032804B

  • Portable electric ventilator
Allen Advanced Arm Support - Japan
HILL-ROM, INC.
107002
In Commercial Distribution

  • 00615521002671 ()
A-70615-JP

  • Arm procedure positioner, reusable
Japan Clamp, Shoulder Suspension System
ALLEN MEDICAL SYSTEMS, INC.
AR-1650-11
In Commercial Distribution

  • 00615521004620 ()


  • Operating table traction frame
ASSY, LTV1150, W/ ACCESS, JAPAN
Carefusion Corporation
18984-006
Not in Commercial Distribution

  • 00845873002740 ()


  • Transport electric ventilator
ASSY, LTV1200, W/ ACCESS, JAPAN
Carefusion Corporation
18888-006
Not in Commercial Distribution

  • 00845873002641 ()


  • Transport electric ventilator
DreamStation Auto CPAP, 12mm, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959061316 ()
JPX501S16

  • Home CPAP unit
System, Med4 Elite, Japan, Japanese
Avanos Medical, Inc.
650500-JA12
In Commercial Distribution

  • 00812120002785 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
RESTORATION CYLINDRICAL DISTAL EXTENSION JAPAN
Howmedica Osteonics Corp.
1217-3135
In Commercial Distribution

  • 07613327211375 ()

  • Length: 175.0 Millimeter
  • Diameter: 13.5 Millimeter
1217-3135

  • Orthopaedic prosthesis implantation positioning instrument, reusable
RESTORATION CYLINDRICAL DISTAL EXTENSION JAPAN
Howmedica Osteonics Corp.
1217-3175
In Commercial Distribution

  • 07613327211245 ()

  • Length: 175.0 Millimeter
  • Diameter: 17.5 Millimeter
1217-3175

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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