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
Tita-Link BVBA
B-UL-21
In Commercial Distribution

  • 05430000515016 ()


  • Subperiosteal dental implant material
Single Use Spirotome 8G 60mm
Medinvents NV
SS0806
In Commercial Distribution

  • 05430000459020 ()


  • Soft-tissue biopsy procedure kit, non-medicated
Non Sterilized
Bedal
bedal flex XS
In Commercial Distribution

  • 05430000258968 ()

  • Length: 93.9 Millimeter
  • Width: 38.8 Millimeter
  • Height: 6.3 Millimeter
UN-FLEX-NS-XS

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal flex M
In Commercial Distribution

  • 05430000258920 ()

  • Length: 94.1 Millimeter
  • Width: 38.8 Millimeter
  • Height: 9.6 Millimeter
UN-FLEX-M

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal flex S
In Commercial Distribution

  • 05430000258883 ()

  • Length: 87.6 Millimeter
  • Width: 38.8 Millimeter
  • Height: 7.2 Millimeter
UN-FLEX-S

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal flex M
In Commercial Distribution

  • 05430000258814 ()
  • 05430000258807 ()
  • 05430000258821 ()

  • Length: 94.1 Millimeter
  • Width: 38.8 Millimeter
  • Height: 9.6 Millimeter
UN-FLEX-M

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal flex S
In Commercial Distribution

  • 05430000258777 ()
  • 05430000258760 ()
  • 05430000258784 ()

  • Length: 87.6 Millimeter
  • Width: 38.8 Millimeter
  • Height: 7.2 Millimeter
UN-FLEX-S

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal flex XS
In Commercial Distribution

  • 05430000258739 ()
  • 05430000258722 ()
  • 05430000258746 ()

  • Length: 93.9 Millimeter
  • Width: 38.8 Millimeter
  • Height: 6.3 Millimeter
UN-FLEX-XS

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
Bedal air M
In Commercial Distribution

  • 05430000258685 ()
  • 05430000258692 ()
  • 05430000258708 ()

  • Length: 120 Millimeter
  • Width: 83.2 Millimeter
  • Height: 14.4 Millimeter
DP01

  • Synthetic polymer semi-permeable film dressing, adhesive
Non Sterilized
Bedal
bedal flex epi/pnb
In Commercial Distribution

  • 05430000258609 ()

  • Length: 95 Millimeter
  • Width: 60 Millimeter
  • Height: 6.4 Millimeter
EPNS02

  • Synthetic polymer semi-permeable film dressing, adhesive
Non Sterilized
Bedal
bedal pivc
In Commercial Distribution

  • 05430000258562 ()

  • Length: 70 Millimeter
  • Width: 44.8 Millimeter
  • Height: 15 Millimeter
PVNS02

  • Synthetic polymer semi-permeable film dressing, adhesive
Non Sterilized
Bedal
bedal picc/cvc
In Commercial Distribution

  • 05430000258531 ()
  • 05430000258524 ()

  • Length: 78 Millimeter
  • Width: 38.8 Millimeter
  • Height: 10.2 Millimeter
PCNS02

  • Synthetic polymer semi-permeable film dressing, adhesive
Non Sterilized
Bedal
Bedal air M
In Commercial Distribution

  • 05430000258487 ()

  • Length: 120 Millimeter
  • Width: 83.2 Millimeter
  • Height: 14.4 Millimeter
DPNS01

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal air S
In Commercial Distribution

  • 05430000258418 ()
  • 05430000258401 ()
  • 05430000258425 ()

  • Length: 78 Millimeter
  • Width: 38.8 Millimeter
  • Height: 11.1 Millimeter
UN02

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal flex, epi/pnb
In Commercial Distribution

  • 05430000258371 ()
  • 05430000258364 ()
  • 05430000258388 ()

  • Length: 95 Millimeter
  • Width: 60 Millimeter
  • Height: 6.4 Millimeter
EP02

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal pivc
In Commercial Distribution

  • 05430000258333 ()
  • 05430000258326 ()
  • 05430000258340 ()

  • Length: 70 Millimeter
  • Width: 44.8 Millimeter
  • Height: 15 Millimeter
PV02

  • Synthetic polymer semi-permeable film dressing, adhesive
Sterilized
Bedal
bedal picc/cvc
In Commercial Distribution

  • 05430000258210 ()
  • 05430000258203 ()
  • 05430000258234 ()

  • Length: 78 Millimeter
  • Width: 38.8 Millimeter
  • Height: 10.2 Millimeter
PC02

  • Synthetic polymer semi-permeable film dressing, adhesive
No Description
Immunodiagnostic Systems SA
IS-6010
In Commercial Distribution

  • 05425030426012 ()


  • Immunoassay instrument/analyser general performance control kit IVD
No Description
Immunodiagnostic Systems SA
IS-CW100
In Commercial Distribution

  • 05425030421031 ()


  • Wash/cleaning solution IVD, automated/semi-automated system
No Description
Immunodiagnostic Systems SA
IS-CT100
In Commercial Distribution

  • 05425030421024 ()


  • Chemiluminescent immunoassay oxidizing reagent IVD
No Description
Immunodiagnostic Systems SA
IS-CS100
In Commercial Distribution

  • 05425030421017 ()


  • Wash/cleaning solution IVD, automated/semi-automated system
TAPES primary packaging (x1)
Endo Tools Therapeutics
TAPES
In Commercial Distribution

  • 05425029282698 ()
  • 05425029282094 ()
  • 05425029282391 ()
  • 05425029282995 ()
  • 05425029282919 ()
  • 05425029282988 ()
  • 05425029282933 ()
  • 05425029282964 ()


  • Suturing unit, single-use
endomina system is composed of 1 endomina platform and 6 TAPES
Endo Tools Therapeutics
endomina system
In Commercial Distribution

  • 05425029282070 ()
  • 05425029282971 ()


  • Endoscopic overtube, single-use
  • Suturing unit, single-use
endomina platform primary packaging (x1)
Endo Tools Therapeutics
endomina platform
In Commercial Distribution

  • 05425029282117 ()
  • 05425029282018 ()
  • 05425029282339 ()
  • 05425029282940 ()
  • 05425029282957 ()
  • 05425029282926 ()


  • Endoscopic overtube, single-use
Programmer and Software
LIVANOVA USA, INC.
3100
In Commercial Distribution

  • 05425025750634 ()


  • Vagus nerve electrical stimulation system programmer
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750535 ()


  • Vagus nerve electrical stimulation system programmer
Implantable Pulse Generator
LIVANOVA USA, INC.
1000-D
In Commercial Distribution

  • 05425025750528 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
VNS Therapy Kit
LIVANOVA USA, INC.
98142
In Commercial Distribution

  • 05425025750511 ()

  • Length: 2 Millimeter


  • Vascular graft tunneller
  • Vagus nerve electrical stimulation system lead
  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Implantable Pulse Generator
LIVANOVA USA, INC.
8103
In Commercial Distribution

  • 05425025750504 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750481 ()


  • Vagus nerve electrical stimulation system programmer
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750443 ()


  • Vagus nerve electrical stimulation system programmer
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750429 ()


  • Vagus nerve electrical stimulation system programmer
Implantable Pulse Generator
LIVANOVA USA, INC.
1000
In Commercial Distribution

  • 05425025750405 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Programmer
LIVANOVA USA, INC.
3000
In Commercial Distribution

  • 05425025750399 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750382 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750375 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v11.0
In Commercial Distribution

  • 05425025750368 ()


  • Vagus nerve electrical stimulation system programmer
Patient Magnet
LIVANOVA USA, INC.
7220
In Commercial Distribution

  • 05425025750313 ()


  • Active implantable device control magnet
Patient Magnet
LIVANOVA USA, INC.
220
In Commercial Distribution

  • 05425025750252 ()


  • Active implantable device control magnet
Accessory Pack
LIVANOVA USA, INC.
502
In Commercial Distribution

  • 05425025750245 ()


  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Tunneler
LIVANOVA USA, INC.
402
In Commercial Distribution

  • 05425025750238 ()


  • Vascular graft tunneller
Programming Software
LIVANOVA USA, INC.
250 v10.0
In Commercial Distribution

  • 05425025750214 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X5)
In Commercial Distribution

  • 05425025750191 ()


  • Vagus nerve electrical stimulation system programmer
Programming Software
LIVANOVA USA, INC.
250 v8.1 (X50)
In Commercial Distribution

  • 05425025750184 ()


  • Vagus nerve electrical stimulation system programmer
Programming Wand
LIVANOVA USA, INC.
2000
In Commercial Distribution

  • 05425025750177 ()


  • Vagus nerve electrical stimulation system programmer
Programming Wand
LIVANOVA USA, INC.
201
In Commercial Distribution

  • 05425025750160 ()


  • Vagus nerve electrical stimulation system programmer
Implantable Lead
LIVANOVA USA, INC.
304-30
In Commercial Distribution

  • 05425025750153 ()

  • Outer Diameter: 3.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
304-20
In Commercial Distribution

  • 05425025750139 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
303-30
In Commercial Distribution

  • 05425025750122 ()

  • Outer Diameter: 3.0 Millimeter


  • Vagus nerve electrical stimulation system lead
Implantable Lead
LIVANOVA USA, INC.
303-20
In Commercial Distribution

  • 05425025750115 ()

  • Outer Diameter: 2.0 Millimeter


  • Vagus nerve electrical stimulation system lead
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