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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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Gelsoft™ Cardiovascular Patch - 05037881010670

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961001
In Commercial Distribution

  • 05037881010670 ()

  • Dimensions 10 x 1.5 cm
961001

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010663

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961001S
In Commercial Distribution

  • 05037881010663 ()

  • Dimensions 10 x 1 cm
961001S

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010656

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960701
In Commercial Distribution

  • 05037881010656 ()

  • Dimensions 7 x 1.5 cm
960701

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010649

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960701S
In Commercial Distribution

  • 05037881010649 ()

  • Dimensions 7 x 1 cm
960701S

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010632

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960603
In Commercial Distribution

  • 05037881010632 ()

  • Dimensions 6 x 3 cm
960603

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010625

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960501
In Commercial Distribution

  • 05037881010625 ()

  • Dimensions 5 x 1.5 cm
960501

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010618

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960501S
In Commercial Distribution

  • 05037881010618 ()

  • Dimensions 5 x 1 cm
960501S

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010465

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951220
In Commercial Distribution

  • 05037881010465 ()

  • Dimensions 12 x 20 cm
951220

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010458

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951208
In Commercial Distribution

  • 05037881010458 ()

  • Dimensions 12 x 8 cm
951208

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010441

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951204
In Commercial Distribution

  • 05037881010441 ()

  • Dimensions 12 x 4 cm
951204

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010434

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951020
In Commercial Distribution

  • 05037881010434 ()

  • Dimensions 10 x 20 cm
951020

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010427

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951010
In Commercial Distribution

  • 05037881010427 ()

  • Dimensions 10 x 10 cm
951010

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010410

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
950804
In Commercial Distribution

  • 05037881010410 ()

  • Dimensions 8 x 4 cm
950804

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881003238

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch VS125 TAPERED PATCH
VASCUTEK LTD
921020FTS
Not in Commercial Distribution

  • 05037881003238 ()

  • Dimension 10 x 200 mm
921020FTS

  • Cardiovascular patch, animal-derived

Thinwall - 05037881999227

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED NO BLACK LINE
VASCUTEK LTD
920675TS
In Commercial Distribution

  • 05037881999227 ()

  • Dimension 6 x 75 mm
920675TS

  • Cardiovascular patch, animal-derived

Activator - 08625630003010

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003010 ()
403507

  • Intraurethral valve/pump

Activator - 08625630003001

Magnetic remote control for operation of inFlow urinary prosthesis. With base station and recharger.
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003001 ()
403507

  • Intraurethral valve/pump

Magnetic Shield - 00862563003191

Magnetic shield for the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003191 ()
403350

  • Intraurethral valve/pump

Activator Kit - 00862563003184

Magnetic remote control for the inFlow Device - with base station and medical charger
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003184 ()
403507K

  • Intraurethral valve/pump

Medical Charger - 00862563003177

Recharger for inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003177 ()
403320

  • Intraurethral valve/pump

Base Station - 00862563003160

Unit for storing and recharging the inFlow Activator
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003160 ()
403310

  • Intraurethral valve/pump

Activator - 00862563003153

Magnetic remote control for the inFlow Device
VESIFLO INC
August 2021
In Commercial Distribution

  • 00862563003153 ()
403300

  • Intraurethral valve/pump

Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

primaLOK FF - 00813210021990

primaLOK FF 45mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1145-00
In Commercial Distribution

  • 00813210021990 ()

  • Length: 45 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile

primaLOK FF - 00813210021983

primaLOK FF 40mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1140-00
In Commercial Distribution

  • 00813210021983 ()

  • Length: 40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile

primaLOK FF - 00813210021976

primaLOK FF 35mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1135-00
In Commercial Distribution

  • 00813210021976 ()

  • Length: 35 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile

primaLOK FF - 00813210021969

primaLOK FF 30mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1130-00
In Commercial Distribution

  • 00813210021969 ()

  • Length: 30 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile

primaLOK FF - 00813210021952

primaLOK FF 25mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1125-00
In Commercial Distribution

  • 00813210021952 ()

  • Length: 25 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile

primaLOK SP - 00813210021785

primaLOK SP 28mm Medium Boxless Implant, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0828-00
In Commercial Distribution

  • 00813210021785 ()

  • Width: 28 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

primaLOK SP - 00813210021778

primaLOK SP 18mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0118-00
In Commercial Distribution

  • 00813210021778 ()

  • Height: 18 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
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