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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
OSADA ELECTRIC CO.,LTD.
Plugger set#20
In Commercial Distribution

  • 04582227397089 ()
81913

  • Ultrasonic dental scaling/debridement system handpiece tip, endodontic
The Vibrant Capsule is a small dimension, easy to swallow capsule, bearing pre-programed stimulations specifically designed for individuals with chronic constipation. Each box contains 2 blisters with capsules. Each blister contains 10 capsules.
VIBRANT LTD
1
In Commercial Distribution

  • 00860009189805 ()


  • Internal gastrointestinal vibratory-stimulation system capsule
20 Minute Biological Indicator, 25 Count
HU-FRIEDY MFG. CO., LLC
RR20BI
In Commercial Distribution

  • 10889950139889 ()


  • Biological sterilization indicator
20 Minute Reader Incubator
HU-FRIEDY MFG. CO., LLC
RR20READER
In Commercial Distribution

  • 10889950139872 ()


  • Test tube heater
SUPERSONIC MACH 20
Supersonic Imagine, Inc.
SSIP95020-HOLX
In Commercial Distribution

  • 03760193600230 ()
SSIP95020-HOLX

  • General-purpose ultrasound imaging system
Synthetic Bone Substitute Granules
BIOMATLANTE
RT0701M+GS50
In Commercial Distribution

  • 03700501812870 ()

  • Total Volume: 0.5 Milliliter
RT0701M+GS50

  • Bone matrix implant, synthetic, non-antimicrobial
No Description
G21 SRL
900199
In Commercial Distribution

  • 08058964727596 ()


  • Balloon kyphoplasty kit
Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NB5820
In Commercial Distribution

  • 00813909012919 ()

  • 8x9.4x25mm
NB5820

  • Bone matrix implant, synthetic, non-antimicrobial
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114247 ()

  • 16x10x32mm
TST20161032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114230 ()

  • 15x10x32mm
TST20151032

  • Metallic spinal interbody fusion cage
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