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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Nautilus Assembly CA, Ø6.5 x 55 Long x 5 Lead
Life Spine, Inc.
365-55-5
In Commercial Distribution

  • 00190837057022 ()
365-55-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø6.5 x 50 Long x 5 Lead
Life Spine, Inc.
365-50-5
In Commercial Distribution

  • 00190837057008 ()
365-50-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø6.5 x 45 Long x 5 Lead
Life Spine, Inc.
365-45-5
In Commercial Distribution

  • 00190837056988 ()
365-45-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø6.5 x 40 Long x 5 Lead
Life Spine, Inc.
365-40-5
In Commercial Distribution

  • 00190837056964 ()
365-40-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø6.5 x 35 Long x 5 Lead
Life Spine, Inc.
365-35-5
In Commercial Distribution

  • 00190837056940 ()
365-35-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø6.5 x 30 Long x 5 Lead
Life Spine, Inc.
365-30-5
In Commercial Distribution

  • 00190837056926 ()
365-30-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 55 Long x 5 Lead
Life Spine, Inc.
355-55-5
In Commercial Distribution

  • 00190837056896 ()
355-55-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 50 Long x 5 Lead
Life Spine, Inc.
355-50-5
In Commercial Distribution

  • 00190837056872 ()
355-50-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 45 Long x 5 Lead
Life Spine, Inc.
355-45-5
In Commercial Distribution

  • 00190837056858 ()
355-45-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 40 Long x 5 Lead
Life Spine, Inc.
355-40-5
In Commercial Distribution

  • 00190837056834 ()
355-40-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 35 Long x 5 Lead
Life Spine, Inc.
355-35-5
In Commercial Distribution

  • 00190837056810 ()
355-35-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø5.5 x 30 Long x 5 Lead
Life Spine, Inc.
355-30-5
In Commercial Distribution

  • 00190837056797 ()
355-30-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø4.5 x 55 Long x 5 Lead
Life Spine, Inc.
345-55-5
In Commercial Distribution

  • 00190837056780 ()
345-55-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø4.5 x 50 Long x 5 Lead
Life Spine, Inc.
345-50-5
In Commercial Distribution

  • 00190837056773 ()
345-50-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø4.5 x 45 Long x 5 Lead
Life Spine, Inc.
345-45-5
In Commercial Distribution

  • 00190837056766 ()
345-45-5

  • Bone-screw internal spinal fixation system, non-sterile
Nautilus Assembly CA, Ø4.5 x 40 Long x 5 Lead
Life Spine, Inc.
345-40-5
In Commercial Distribution

  • 00190837056759 ()
345-40-5

  • Bone-screw internal spinal fixation system, non-sterile
Series 1, 700 DT, Single CA, 1000mm, GEN2 4K CAM
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009392 ()
C17S3W

  • Operating room light
No Description
Roche Diagnostics GmbH
07026986190
In Commercial Distribution

  • 04015630939633 ()
07026986190

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
No Description
Roche Diagnostics GmbH
11776215122
In Commercial Distribution

  • 04015630904310 ()
11776215122

  • Cancer antigen 19-9 (CA19-9) IVD, calibrator
No Description
Roche Diagnostics GmbH
07027001190
In Commercial Distribution

  • 04015630939961 ()
07027001190

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Diagnostics GmbH
11776193122
In Commercial Distribution

  • 04015630904297 ()
11776193122

  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.
Bien-Air Dental SA
1601267-001
In Commercial Distribution

  • J00716012670011 ()


  • Dental laboratory drilling system handpiece
Bien-Air Dental contra-angle and straight handpieces are designed to transmit and apply the mechanical energy produced by an electric or air micromotor.
Bien-Air Dental SA
1601235-001
In Commercial Distribution

  • J00716012350011 ()


  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601163-001
In Commercial Distribution

  • J00716011630011 ()
1601163-001

  • Dental laboratory drilling system handpiece
CA & HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor’s speed.
Bien-Air Dental SA
1601139-001
In Commercial Distribution

  • J00716011390011 ()
1601139-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1601012-001
In Commercial Distribution

  • J00716010120011 ()
1601012-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600873-001
In Commercial Distribution

  • J00716008730011 ()
1600873-001

  • Dental laboratory drilling system handpiece
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600655-UNIV
In Commercial Distribution

  • J0071600655NIV1 ()
1600655-UNIV

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600598-001
In Commercial Distribution

  • J00716005980011 ()
1600598-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600386-001
In Commercial Distribution

  • J00716003860011 ()
1600386-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600385-001
In Commercial Distribution

  • J00716003850011 ()
1600385-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600384-001
In Commercial Distribution

  • J00716003840011 ()
1600384-001

  • Dental power tool system handpiece, remotely-driven
CA and HP are intended to transmit and apply the mechanical energy produced by a dental air or electric micromotor. They contain the gearing necessary for maintaining, increasing or reducing the micromotor's speed
Bien-Air Dental SA
1600290-001
In Commercial Distribution

  • J00716002900011 ()
1600290-001

  • Dental power tool system handpiece, remotely-driven
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210209 ()
  • 04560189210202 ()


  • Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)
For coagulation tests and as a rinsing solution for the sample needles of the Sysmex® CA Systems
Siemens Healthcare Diagnostics Products GmbH
10873915
In Commercial Distribution

  • 00842768019845 ()
  • 00630414639901 ()
10873915

  • Buffered sample diluent IVD
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210216 ()
  • 04560189210219 ()


  • Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA)
Biotyper system for clinical use in the USA, with smartbeam laser.
Bruker Daltonik GmbH
8604784
In Commercial Distribution

  • 04251204325734 ()
8604784

  • Microbial identification mass spectrometry system IVD
Biotyper system for clinical use in the USA.
Bruker Daltonik GmbH
8603464
In Commercial Distribution

  • 04251204300014 ()
8603464

  • Microbial identification mass spectrometry system IVD
Dental bur holder
HAGER WORLDWIDE, INC.
355245
In Commercial Distribution

  • D2483552450 ()


  • Device sterilization/disinfection container, reusable
Dental bur holder
HAGER WORLDWIDE, INC.
355244
In Commercial Distribution

  • D2483552440 ()


  • Device sterilization/disinfection container, reusable
Dental bur holder
HAGER WORLDWIDE, INC.
355243
In Commercial Distribution

  • D2483552430 ()


  • Device sterilization/disinfection container, reusable
Dental bur holder
HAGER WORLDWIDE, INC.
355242
In Commercial Distribution

  • D2483552420 ()


  • Device sterilization/disinfection container, reusable
No Description
Drägerwerk AG & Co. KGaA
8418582
Not in Commercial Distribution

  • 04048675027997 ()
  • 04048675429104 ()


  • Nasal oxygen cannula, CPAP
Biotyper system for clinical use in the USA.
Bruker Scientific LLC
8603464
Not in Commercial Distribution

  • 00841594100024 ()
8603464

  • Microbial identification mass spectrometry system IVD
Biotyper system for clinical use in the USA, with smart laser.
Bruker Scientific LLC
8604784
Not in Commercial Distribution

  • 00841594100031 ()
8604784

  • Microbial identification mass spectrometry system IVD
Central Axis Single 3pole for ceiling tube 70mm
S.I.M.E.O.N. Medical GmbH & Co. KG
111-0004490
In Commercial Distribution

  • 04250613814617 ()


  • Operating room light
No Description
Epocal Inc
HH-1009-CA-00
In Commercial Distribution

  • 00809708069117 ()
HH-1009-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0R03-CA-00
In Commercial Distribution

  • 00809708064068 ()
HH-0R03-CA-00

  • Metabolic profile clinical chemistry analyser IVD
No Description
Epocal Inc
HH-0005-CA-00
In Commercial Distribution

  • 00809708064044 ()
HH-0005-CA-00

  • Metabolic profile clinical chemistry analyser IVD
Contains DIs: E23506580; E23506650; E23506700; E23506630; E23506680; E23506730; E23506610; E23506660; E23506710
SHOFU DENTAL CORPORATION
0333B
In Commercial Distribution

  • E2350333B0 ()
0333B

  • Dental abrasive point, reusable
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