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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No Description
I.C. MEDICAL, INC.
ICM-000-0014
In Commercial Distribution

  • 00817688021445 ()
  • 00817688021438 ()


  • Surgical plume evacuation system
UNIVERSAL BLUE™ RF Sensor
I.C. MEDICAL, INC.
ICM-000-0599
In Commercial Distribution

  • 00817688020363 ()
ICM-000-0599

  • Surgical plume evacuation system
No Description
Hydrafacial LLC
10000
In Commercial Distribution

  • 00850043007067 ()
10000

  • Surgical plume evacuation system
robotic neurorehabilitation device for gait training and additional therapy purposes
Healing Innovations, Inc.
RWC1000
In Commercial Distribution

  • 00860003483206 ()


  • Gait rehabilitation frame, electric
No Description
Hangwei GE Medical Systems Co., Ltd.
H2401DS
In Commercial Distribution

  • 00840682154338 ()


  • Stationary gamma camera system
  • Full-body CT system
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.
5376496-15
In Commercial Distribution

  • 00840682117869 ()


  • Stationary gamma camera 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 Kombi Motivation
In Commercial Distribution

  • 07640174660469 ()
63058

  • Treadmill/elliptical gait rehabilitation 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 AD Motivation
In Commercial Distribution

  • 07640174660476 ()
63059

  • 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
Not in Commercial Distribution

  • 07640174660254 ()
32001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660247 ()
32000

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Nanos V1.2
Not in Commercial Distribution

  • 07640174660223 ()
31002

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Nanos V1.2
Not in Commercial Distribution

  • 07640174660216 ()
31001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Nanos V1.2
Not in Commercial Distribution

  • 07640174660209 ()
31000

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660179 ()
30684

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660162 ()
30683

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660155 ()
30682

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660148 ()
30681

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660117 ()
30005

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660100 ()
30004

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660094 ()
30003

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660087 ()
30002

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660070 ()
30001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660063 ()
30000

  • Treadmill/elliptical gait rehabilitation system
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution

  • 00840682115292 ()


  • Stationary gamma camera system
UFC GANTRY FINAL ASSEMBLY
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906ER
In Commercial Distribution

  • 00840682146401 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906EF
In Commercial Distribution

  • 00840682145947 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3908AX
In Commercial Distribution

  • 00840682145930 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DX
In Commercial Distribution

  • 00840682145725 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AN
In Commercial Distribution

  • 00840682145527 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AR
In Commercial Distribution

  • 00840682145510 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3908AP
In Commercial Distribution

  • 00840682145497 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H308AK
In Commercial Distribution

  • 00840682145480 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3908AM
In Commercial Distribution

  • 00840682145473 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DT
In Commercial Distribution

  • 00840682145459 ()


  • Full-body CT system
  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3907AT
In Commercial Distribution

  • 00840682145442 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DE
In Commercial Distribution

  • 00840682141635 ()


  • Full-body CT system
  • Stationary gamma camera system
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