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
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera 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)
easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.
EMD SERONO, INC.
U1222102
Not in Commercial Distribution

  • 04054839025860 ()


  • Empty self-injector, electronic
icotec Lumbar Cage, Implant Holder for Tamping
icotec AG
38-036
In Commercial Distribution

  • 07640164841830 ()
38-036

  • Bone graft packing block
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump
Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump
microTargeting™ Array Frame Platinum 6X Non Sterile
FHC, INC.
25335Z-00791
In Commercial Distribution

  • 10873263007911 ()
  • 00873263007914 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
25335Z

  • Depth electrode
microTargeting™ Array Electrodes 6x Non Sterile
FHC, INC.
22335Z-00789
In Commercial Distribution

  • 10873263007898 ()
  • 00873263007891 ()

  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
22335Z

  • Depth electrode
microTargeting™ Array Frame Platinum 5X Sterile
FHC, INC.
25375Z-00792
In Commercial Distribution

  • 10873263007928 ()
  • 00873263007921 ()

  • Length: 3 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
25375Z

  • Depth electrode
microTargeting™ Array Electrodes 5x Sterile
FHC, INC.
22375Z-00790
In Commercial Distribution

  • 10873263007904 ()
  • 00873263007907 ()

  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
22375Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, 1x, array, D.ZAP(Z) for use with Frame and STar or MT Drive
FHC, INC.
22675Z-00246
In Commercial Distribution

  • 10873263002466 ()
  • 00873263002469 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
22675Z

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWLN(AR)(DU1)-00707
In Commercial Distribution

  • 10873263007072 ()
  • 00873263007075 ()

  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.5 Millimeter
  • Length: 286.5 Millimeter
MTDWLN(AR)(DU1)

  • Depth electrode
microTargeting(TM) Electrode, 6x, differential, tungsten, DZAP(Z), nonsterile
FHC, INC.
MTDWZN(AR)(DU1)-00706
In Commercial Distribution

  • 10873263007065 ()
  • 00873263007068 ()

  • Length: 271.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 286.5 Millimeter
  • Impedance: Megaohms
MTDWZN(AR)(DU1)

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00748
In Commercial Distribution

  • 10873263007485 ()
  • 00873263007488 ()

  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00747
In Commercial Distribution

  • 10873263007478 ()
  • 00873263007471 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
FC1002

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00746
In Commercial Distribution

  • 10873263007461 ()
  • 00873263007464 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
34680

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Array, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
22670-00745
In Commercial Distribution

  • 10873263007454 ()
  • 00873263007457 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
22670

  • Depth electrode
microTargeting™ Electrode, differential, tungsten, nonsterile
FHC, INC.
MTDWXN(AR)(MP1)-00744
In Commercial Distribution

  • 10873263007447 ()
  • 00873263007440 ()

  • Lumen/Inner Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
MTDWXN(AR)(MP1)

  • Depth electrode
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