Company Name Brand Name GMDN Term 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.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


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

  • 00840682117869 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3100JY
In Commercial Distribution

  • 00840682115292 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000YT
In Commercial Distribution

  • 00840682121644 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3000SA
In Commercial Distribution

  • 00840682105286 ()


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

  • 00840682139267 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
830
In Commercial Distribution

  • 00840682140829 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
NM 630
In Commercial Distribution

  • 00840682139274 ()


  • Stationary gamma camera system
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H2401JF
In Commercial Distribution

  • 00840682123761 ()


  • Stationary gamma camera system
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
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
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
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
Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump
Xpert Flu kit; 10 test kit
CEPHEID
GXFLU-10A
In Commercial Distribution

  • 07332940001070 ()
GXFLU-10A

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16105
In Commercial Distribution

  • 27350025914590 ()
  • 17350025914593 ()
  • 07350025914596 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1400
In Commercial Distribution

  • M7161111814000 ()
111-18-1400

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1300
In Commercial Distribution

  • M7161111813000 ()
111-18-1300

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1100
In Commercial Distribution

  • M7161111811000 ()
111-18-1100

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 8, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0800
In Commercial Distribution

  • M7161111808000 ()
111-18-0800

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1500
In Commercial Distribution

  • M7161111815000 ()
111-18-1500

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1200
In Commercial Distribution

  • M7161111812000 ()
111-18-1200

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1000
In Commercial Distribution

  • M7161111810000 ()
111-18-1000

  • Press-fit femoral stem prosthesis
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