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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MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06100R
In Commercial Distribution

  • 54987350727546 ()
  • 04987350727541 ()

  • Lumen/Inner Diameter: 6 Millimeter
  • Catheter Usable Length: 200 centimeters
  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Length: 100 Millimeter
SX*FMA06X0RN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06080R
In Commercial Distribution

  • 54987350727522 ()
  • 04987350727527 ()

  • Length: 80 Millimeter
  • Catheter Usable Length: 200 centimeters
  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Lumen/Inner Diameter: 6 Millimeter
SX*FMA0680RN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06060R
In Commercial Distribution

  • 54987350727508 ()
  • 04987350727503 ()

  • Length: 60 Millimeter
  • Catheter Usable Length: 200 centimeters
  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Lumen/Inner Diameter: 6 Millimeter
SX*FMA0660RN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06040R
In Commercial Distribution

  • 54987350727485 ()
  • 04987350727480 ()

  • Lumen/Inner Diameter: 6 Millimeter
  • Catheter Usable Length: 200 centimeters
  • Length: 40 Millimeter
  • Distal Tip and Sheath are coated with Hydrophilic Polymer
SX*FMA0640RN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR08100L
In Commercial Distribution

  • 54987350722343 ()
  • 04987350722348 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 8 Millimeter
SX*FXA08X0LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR08080L
In Commercial Distribution

  • 54987350722329 ()
  • 04987350722324 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 80 Millimeter
  • Lumen/Inner Diameter: 8 Millimeter
SX*FXA0880LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR08060L
In Commercial Distribution

  • 54987350722305 ()
  • 04987350722300 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 60 Millimeter
  • Lumen/Inner Diameter: 8 Millimeter
SX*FXA0860LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR08040L
In Commercial Distribution

  • 54987350722282 ()
  • 04987350722287 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 8 Millimeter
SX*FXA0840LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07150L
In Commercial Distribution

  • 04987350722263 ()
  • 54987350722268 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 150 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA07X5LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07120L
In Commercial Distribution

  • 04987350722249 ()
  • 54987350722244 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 120 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA07X2LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07100L
In Commercial Distribution

  • 54987350722220 ()
  • 04987350722225 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 100 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA07X0LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07080L
In Commercial Distribution

  • 54987350722206 ()
  • 04987350722201 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 80 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0780LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07060L
In Commercial Distribution

  • 54987350722183 ()
  • 04987350722188 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 60 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0760LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR07040L
In Commercial Distribution

  • 54987350722169 ()
  • 04987350722164 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 40 Millimeter
  • Lumen/Inner Diameter: 7 Millimeter
SX*FXA0740LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06150L
In Commercial Distribution

  • 54987350722145 ()
  • 04987350722140 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 150 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
SX*FXA06X5LN

  • Peripheral artery stent, bare-metal
MISAGO RX Self-expanding Peripheral Stent
TERUMO CORPORATION
SXR06120L
In Commercial Distribution

  • 54987350722121 ()
  • 04987350722126 ()

  • Distal Tip and Sheath are coated with Hydrophilic Polymer
  • Catheter Usable Length: 135 centimeters
  • Length: 120 Millimeter
  • Lumen/Inner Diameter: 6 Millimeter
SX*FXA06X2LN

  • Peripheral artery stent, bare-metal
ANTI-NUCLEAR ANTIBODY ELISA TEST KIT, 40 TESTS OF 9 INDIVIDUAL ANTIGENS
THERA-TEST LABORATORIES, INC
104-005
In Commercial Distribution

  • 00854473003071 ()
104-005

  • Centromere protein antibody (anti-CENP) IVD, kit, enzyme immunoassay (EIA)
  • Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, enzyme immunoassay (EIA)
  • SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
  • Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
  • Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
  • Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA)
  • Single stranded DNA antibody (anti-ssDNA) IVD, kit, enzyme immunoassay (EIA)
No Description
Hasa Optix
HA-SET009
In Commercial Distribution

  • 05404027446592 ()
  • 05404027444574 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
The Global Reference Module 9 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 9
In Commercial Distribution

  • 00850011306598 ()
31-0604-0051

  • Electroencephalographic signal amplifier
No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006417 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00009
In Commercial Distribution

  • 00858395006073 ()
  • 00858395006141 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric
No Description
Bird & Cronin, LLC
99000583
In Commercial Distribution

  • 00610570121519 ()


  • Ankle/foot orthosis
No Description
Bird & Cronin, LLC
BC 0372
In Commercial Distribution

  • 00610570107285 ()


  • Abdominal binder, single-use
No Description
Bird & Cronin, LLC
BC 0362
In Commercial Distribution

  • 00610570107278 ()


  • Abdominal binder, single-use
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-201-509
In Commercial Distribution

  • 09348215073572 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
132-112-185
In Commercial Distribution

  • 09348215068356 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC709/S709
In Commercial Distribution

  • 00606509300384 ()
N/A

  • Assistive scooter, electric-motor-driven
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
SC609/S609
In Commercial Distribution

  • 00606509300377 ()
N/A

  • Assistive scooter, electric-motor-driven
No Description
ZIRKONZAHN SRL
ZRAE0501
In Commercial Distribution

  • D800ZRAE0501 ()


  • Dental bridge, ceramic
Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)
ZIRKONZAHN SRL
ZRAD0501
In Commercial Distribution

  • D800ZRAD0501 ()


  • Dental bridge, ceramic
No Description
HELENA LABORATORIES CORPORATION
552138
In Commercial Distribution

  • M5255521380 ()


  • Faecal occult blood IVD, kit, rapid colorimetric, clinical
ContrIL 9 Level 3
INSTRUMENTATION LABORATORY COMPANY
00024001421
In Commercial Distribution

  • 08426950087915 ()
  • 18426950087912 ()
00024001421

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
ContrIL 9 Level 2
INSTRUMENTATION LABORATORY COMPANY
00024001420
In Commercial Distribution

  • 08426950087908 ()
  • 18426950087905 ()
00024001420

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
ContrIL 9 Level 1
INSTRUMENTATION LABORATORY COMPANY
00024001419
In Commercial Distribution

  • 08426950087892 ()
  • 18426950087899 ()
00024001419

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Coil for G-scan Brio
ESAOTE SPA
131000400
In Commercial Distribution

  • 08056304452870 ()


  • MRI system coil, radio-frequency
No Description
HPF SRL
9095.11.302
In Commercial Distribution

  • 08055727374578 ()


  • Surgical depth gauge, reusable
No Description
HPF SRL
H0010354099
In Commercial Distribution

  • 08055727374561 ()


  • Surgical depth gauge, reusable
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 709
In Commercial Distribution

  • 00840118103411 ()

  • Height: 2.5 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 935
In Commercial Distribution

  • 00840118103602 ()

  • Height: 3.7 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Compatible with 2.7mm/3.5mm screws, implants for orthopedic bone fixation
FLOWER ORTHOPEDICS CORPORATION
FRP 909
In Commercial Distribution

  • 00840118103510 ()

  • Height: 3.2 Millimeter


  • Orthopaedic fixation plate, non-bioabsorbable
Sealing Caps attach to the Molar Procedure Instrument in order to properly setup the Procedure Instrument for teeth of different pulp chamber depths. The Sealing Caps include a color-coded surface to match the proper Sealing Cap to the proper Depth Gauge. Additionally, Sealing Caps feature a sealing element intended to keep air out of the root canal system and procedure fluid inside the tooth.
SONENDO, INC.
FG-001-00109
In Commercial Distribution

  • 10858395006513 ()
  • 00858395006516 ()
GW-MOL-SP09

  • Dental delivery system instrument unit, electric
Wheelchair cushion
Vicair B.V.
OCT9/6060
In Commercial Distribution

  • 08717261056678 ()

  • Width: 24 Inch
  • Depth: 24 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion
Wheelchair cushion
Vicair B.V.
OCT9/6058
In Commercial Distribution

  • 08717261056661 ()

  • Device Size Text, specify:
  • Width: 24 Inch
  • Depth: 23 Inch


  • Wheelchair seat cushion
Wheelchair cushion
Vicair B.V.
OCT9/6055
In Commercial Distribution

  • 08717261056654 ()

  • Depth: 22 Inch
  • Width: 24 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion
Wheelchair cushion
Vicair B.V.
OCT9/6053
In Commercial Distribution

  • 08717261056647 ()

  • Width: 24 Inch
  • Device Size Text, specify:
  • Depth: 21 Inch


  • Wheelchair seat cushion
Wheelchair cushion
Vicair B.V.
OCT9/6050
In Commercial Distribution

  • 08717261056630 ()

  • Depth: 20 Inch
  • Width: 24 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion
Wheelchair cushion
Vicair B.V.
OCT9/6048
In Commercial Distribution

  • 08717261056623 ()

  • Depth: 19 Inch
  • Device Size Text, specify:
  • Width: 24 Inch


  • Wheelchair seat cushion
Wheelchair cushion
Vicair B.V.
OCT9/6045
In Commercial Distribution

  • 08717261056616 ()

  • Width: 24 Inch
  • Depth: 18 Inch
  • Device Size Text, specify:


  • Wheelchair seat cushion
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