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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CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0612
In Commercial Distribution

  • 00850023375001 ()

  • Length: 6 Centimeter
  • Width: 12 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0612

  • Cardiovascular patch, animal-derived
robotic neurorehabilitation device for gait training and additional therapy purposes
Healing Innovations, Inc.
RWC1000
In Commercial Distribution

  • 00860003483206 ()


  • Gait rehabilitation frame, electric
B615 to D630 upgrade kits option with new ROTOR
Hangwei GE Medical Systems Co., Ltd.
H2401XF
In Commercial Distribution

  • 00840682145503 ()
H2401XF

  • Stationary gamma camera system
No Description
Hangwei GE Medical Systems Co., Ltd.
NM 615
In Commercial Distribution

  • 00840682139267 ()


  • Stationary gamma camera system
No Description
Hangwei GE Medical Systems Co., Ltd.
H2401DS
In Commercial Distribution

  • 00840682154338 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
Hangwei GE Medical Systems Co., Ltd.
5376496-15
In Commercial Distribution

  • 00840682117869 ()


  • Stationary gamma camera system
No Description
HOCOMA AG
Nanos 1.3
In Commercial Distribution

  • 07640174660490 ()
63061

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 PE Motivation
In Commercial Distribution

  • 07640174660483 ()
63060

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 AD Motivation
In Commercial Distribution

  • 07640174660476 ()
63059

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 Kombi Motivation
In Commercial Distribution

  • 07640174660469 ()
63058

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 PE
In Commercial Distribution

  • 07640174660452 ()
63057

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 AD
In Commercial Distribution

  • 07640174660445 ()
63056

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 Kombi
In Commercial Distribution

  • 07640174660438 ()
63055

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD PE
In Commercial Distribution

  • 07640174660421 ()
63054

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD AD
In Commercial Distribution

  • 07640174660414 ()
63053

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD Kombi
In Commercial Distribution

  • 07640174660407 ()
63052

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660254 ()
32001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660247 ()
32000

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
V2.0
In Commercial Distribution

  • 07640174660230 ()
31585

  • Mobile gait rehabilitation system, harness-support
No Description
HOCOMA AG
Nanos V1.2
In Commercial Distribution

  • 07640174660223 ()
31002

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Nanos V1.2
In Commercial Distribution

  • 07640174660216 ()
31001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Nanos V1.2
In Commercial Distribution

  • 07640174660209 ()
31000

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660179 ()
30684

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660162 ()
30683

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660155 ()
30682

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660148 ()
30681

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660117 ()
30005

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660100 ()
30004

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660094 ()
30003

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
In Commercial Distribution

  • 07640174660087 ()
30002

  • Treadmill/elliptical gait rehabilitation system
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