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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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 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
primaLOK SP 15mm 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 ack 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.
800-0115-00
In Commercial Distribution

  • 00813210021761 ()

  • Height: 15 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 12mm 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 ack 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.
800-0112-00
In Commercial Distribution

  • 00813210021754 ()

  • Height: 12 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 10mm 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 ack 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.
800-0110-00
In Commercial Distribution

  • 00813210021747 ()

  • Height: 10 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 8mm 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.
800-0108-00
In Commercial Distribution

  • 00813210021730 ()

  • Height: 8 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 6mm 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.
800-0106-00
In Commercial Distribution

  • 00813210021723 ()

  • Height: 6 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-13-24-00
In Commercial Distribution

  • 00813210020016 ()

  • Length: 24 Millimeter
  • Outer Diameter: 13 Millimeter


  • Metallic spinal interbody fusion cage
The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-11-24-00
In Commercial Distribution

  • 00813210020009 ()

  • Length: 24 Millimeter
  • Outer Diameter: 11 Millimeter


  • Metallic spinal interbody fusion cage
The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-15-24-00
In Commercial Distribution

  • 00813210020023 ()

  • Length: 24 Millimeter
  • Outer Diameter: 15 Millimeter


  • Metallic spinal interbody fusion cage
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump
Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920611FT
Not in Commercial Distribution

  • 05037881011080 ()

  • Dimension 6 x 110 mm
920611FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920875FT
Not in Commercial Distribution

  • 05037881011028 ()

  • Dimension 8 x 75 mm
920875FT

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
922512T
In Commercial Distribution

  • 05037881010892 ()

  • Dimension 25 x 120 mm
922512T

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921575T
In Commercial Distribution

  • 05037881010878 ()

  • Dimension 15 x 75 mm
921575T

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921010T
In Commercial Distribution

  • 05037881010854 ()

  • Dimension 10 x 100 mm
921010T

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921075T
In Commercial Distribution

  • 05037881010847 ()

  • Dimension 10 x 75 mm
921075T

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921050T
In Commercial Distribution

  • 05037881010830 ()

  • Dimension 10 x 50 mm
921050T

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920875T
In Commercial Distribution

  • 05037881010823 ()

  • Dimension 8 x 75 mm
920875T

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920675T
In Commercial Distribution

  • 05037881010816 ()

  • Dimension 6 x 75 mm
920675T

  • Cardiovascular patch, animal-derived
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961208
In Commercial Distribution

  • 05037881010700 ()

  • Dimensions 12 x 8 cm
961208

  • Cardiovascular patch, animal-derived
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960804
In Commercial Distribution

  • 05037881010687 ()

  • Dimensions 8 x 4 cm
960804

  • Cardiovascular patch, animal-derived
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961001S
In Commercial Distribution

  • 05037881010663 ()

  • Dimensions 10 x 1 cm
961001S

  • Cardiovascular patch, animal-derived
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960701S
In Commercial Distribution

  • 05037881010649 ()

  • Dimensions 7 x 1 cm
960701S

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
922512FT
Not in Commercial Distribution

  • 05037881011103 ()

  • Dimension 25 x 120 mm
922512FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921015FT
Not in Commercial Distribution

  • 05037881011097 ()

  • Dimension 10 x 150 mm
921015FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921575FT
Not in Commercial Distribution

  • 05037881011073 ()

  • Dimension 15 x 75 mm
921575FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921550FT
Not in Commercial Distribution

  • 05037881011066 ()

  • Dimension 15 x 50 mm
921550FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921010FT
Not in Commercial Distribution

  • 05037881011059 ()

  • Dimension 10 x 100 mm
921010FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921075FT
Not in Commercial Distribution

  • 05037881011042 ()

  • Dimension 10 x 75 mm
921075FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921050FT
Not in Commercial Distribution

  • 05037881011035 ()

  • Dimension 10 x 50 mm
921050FT

  • Cardiovascular patch, animal-derived
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920675FT
Not in Commercial Distribution

  • 05037881011011 ()

  • Dimension 6 x 75 mm
920675FT

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921015T
In Commercial Distribution

  • 05037881010885 ()

  • Dimension 10 x 150 mm
921015T

  • Cardiovascular patch, animal-derived
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921550T
In Commercial Distribution

  • 05037881010861 ()

  • Dimension 15 x 50 mm
921550T

  • Cardiovascular patch, animal-derived
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961204
In Commercial Distribution

  • 05037881010694 ()

  • Dimensions 12 x 4 cm
961204

  • Cardiovascular patch, animal-derived
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 Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960701
In Commercial Distribution

  • 05037881010656 ()

  • Dimensions 7 x 1.5 cm
960701

  • Cardiovascular patch, animal-derived
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960603
In Commercial Distribution

  • 05037881010632 ()

  • Dimensions 6 x 3 cm
960603

  • Cardiovascular patch, animal-derived
Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960501
In Commercial Distribution

  • 05037881010625 ()

  • Dimensions 5 x 1.5 cm
960501

  • Cardiovascular patch, animal-derived
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