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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
Edwards Lifesciences LLC
4200
In Commercial Distribution

  • 00690103166514 ()

  • SURFACE OF THE ANTERIOR LEAFLET, 28 MM
4200M28

  • Mitral annuloplasty ring
No Description
Edwards Lifesciences LLC
4200
In Commercial Distribution

  • 00690103166507 ()

  • SURFACE OF THE ANTERIOR LEAFLET, 26 MM
4200M26

  • Mitral annuloplasty ring
EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING
Edwards Lifesciences LLC
EXXLD
In Commercial Distribution

  • 00690103166378 ()

  • ID 35-40 mm (Minimum Aortic Inner Diameter - Maximum Aortic Inner Diameter)
EXXLD

  • Embolic protection filtering guidewire
CleanFlow Device used with the GentleWave System to treat root canals (Posterior teeth).
SONENDO, INC.
FG-013-00004
In Commercial Distribution

  • 00858395006783 ()
GW-PST-PI01

  • Dental delivery system instrument unit, electric
The Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-014-00003
In Commercial Distribution

  • 00858395006684 ()
GW-PRE-XF01

  • Dental delivery system instrument unit, electric
Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on the premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site.
SONENDO, INC.
FG-014-00001
In Commercial Distribution

  • 00858395006646 ()
  • 00858395006653 ()
GW-PRE-XF10

  • Dental delivery system instrument unit, electric
Hemolung® Cartridge with Blood Tubing
Alung Technologies, Inc.
40400
Not in Commercial Distribution

  • 00850046004254 ()


  • Mobile extracorporeal gas exchange system
No Description
Smith & Nephew, Inc.
2503-A
In Commercial Distribution

  • 00854501006173 ()
2503-A

  • Arthroscopic surgical procedure kit, non-medicated, single-use
  • Tendon/ligament bone anchor, non-bioabsorbable
Regulating Set 1-6 with MultiBolus, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Ambu A/S
418000511
In Commercial Distribution

  • 05707480119387 ()
  • 05707480119370 ()


  • Elastomeric infusion pump kit
Compression Unit Upto 650ml, stand alone, complementary accessory (to be used with ACTion Block and ACTion Fuser ONLY)
Ambu A/S
418000650
In Commercial Distribution

  • 05707480121793 ()
  • 05707480121755 ()

  • Total Volume: 650 Milliliter


  • Elastomeric infusion pump kit
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