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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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Astra Tech Implant System® - 07392532182488

Small Tray EV Storage overlay
Dentsply Implants Manufacturing GmbH
25845
In Commercial Distribution

  • 07392532182488 ()
25845

  • Surgical instrument/implant rack

Astra Tech Implant System® - 07392532169373

Overlay, Streamline
Dentsply Implants Manufacturing GmbH
26099
In Commercial Distribution

  • 07392532169373 ()
26099

  • Surgical instrument/implant rack

Astra Tech Implant System® - 07392532169366

Overlay, Proline
Dentsply Implants Manufacturing GmbH
26098
In Commercial Distribution

  • 07392532169366 ()
26098

  • Surgical instrument/implant rack

Astra Tech Implant System® - 07392532151675

Large Tray EV
Dentsply Implants Manufacturing GmbH
25769
In Commercial Distribution

  • 07392532151675 ()
25769

  • Surgical instrument/implant rack

Astra Tech Implant System® - 07392532151668

Large Tray EV Overlay 3
Dentsply Implants Manufacturing GmbH
25723
In Commercial Distribution

  • 07392532151668 ()
25723

  • Surgical instrument/implant rack

Astra Tech Implant System® - 07392532151651

Large Tray EV Overlay 2
Dentsply Implants Manufacturing GmbH
25722
In Commercial Distribution

  • 07392532151651 ()
25722

  • Surgical instrument/implant rack

Astra Tech Implant System® - 07392532151644

Large Tray EV Overlay 1
Dentsply Implants Manufacturing GmbH
25721
In Commercial Distribution

  • 07392532151644 ()
25721

  • Surgical instrument/implant rack

Case - 00810136430028

Graphic Case
Forma Medical, Inc.
6100.0001
In Commercial Distribution

  • 00810136430028 ()
6100.0001

  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135961103

EARP RETRACTOR TRAY. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-TRAY02-XXX
In Commercial Distribution

  • 00810135961103 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135961035

EARP, IMPLANT CADDIE 22X45. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_2245
In Commercial Distribution

  • 00810135961035 ()


  • Surgical instrument/implant rack
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