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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PMK VIAL/SNAP CAP
DIAGNOSTIC HYBRIDS, INC.
15-308
In Commercial Distribution

  • 30014613331391 ()
15-308

  • Cell culture line IVD
RMK SV5/SV40 TUBE
DIAGNOSTIC HYBRIDS, INC.
14-309
In Commercial Distribution

  • 30014613331384 ()
14-309

  • Cell culture line IVD
RMK TUBE
DIAGNOSTIC HYBRIDS, INC.
14-308
In Commercial Distribution

  • 30014613331377 ()
14-308

  • Cell culture line IVD
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw
In Commercial Distribution

  • 07290114061407 ()
700-001330-00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP10X-000
In Commercial Distribution

  • 90841823103553 ()
  • 00841823103550 ()
FO06K-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO06K-SP05X-000
In Commercial Distribution

  • 90841823103546 ()
  • 00841823103543 ()
FO06K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO05K-SP05X-000
In Commercial Distribution

  • 90841823103539 ()
  • 00841823103536 ()
FO05K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP26X-A00
In Commercial Distribution

  • 00841823103529 ()
FO04K-SP26X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO04K-SP05X-000
In Commercial Distribution

  • 90841823103515 ()
  • 00841823103512 ()
FO04K-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
FO03K-SP05X-000
In Commercial Distribution

  • 90841823103508 ()
  • 00841823103505 ()
FO03K-SP05X-000

  • Depth electrode
No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • Surgical plume evacuation system
Caddy 8.5 Screws. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-850
In Commercial Distribution

  • 00810005664912 ()


  • Surgical instrument/implant rack
Caddy 7.5 Screws. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-750
In Commercial Distribution

  • 00810005664905 ()


  • Surgical instrument/implant rack
Caddy 6.5 Screws. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-650
In Commercial Distribution

  • 00810005664899 ()


  • Surgical instrument/implant rack
Caddy 5.5 Screws. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-550
In Commercial Distribution

  • 00810005662260 ()


  • Surgical instrument/implant rack
Caddy 4.75 Screws. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-475
In Commercial Distribution

  • 00810005662253 ()


  • Surgical instrument/implant rack
Caddy Set Screws. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-SS
In Commercial Distribution

  • 00810005662246 ()


  • Surgical instrument/implant rack
Caddy CrossLinks. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-CC
In Commercial Distribution

  • 00810005662239 ()


  • Surgical instrument/implant rack
Caddy Lordotic Rods. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-LR
In Commercial Distribution

  • 00810005662222 ()


  • Surgical instrument/implant rack
Caddy Straight Rods. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-SR
In Commercial Distribution

  • 00810005662215 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 4 INSERT 4 Instruments. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-106
In Commercial Distribution

  • 00810005662208 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 4 INSERT 3 Instruments. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-105
In Commercial Distribution

  • 00810005662192 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 3 INSERT 2 Instruments. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-104
In Commercial Distribution

  • 00810005662185 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 3 INSERT 1 Instruments. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-103
In Commercial Distribution

  • 00810005662178 ()


  • Surgical instrument/implant rack
Pedicle Screw Case, Instruments. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-102
In Commercial Distribution

  • 00810005662161 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 2 INSERT 3. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-204
In Commercial Distribution

  • 00810005662154 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 2 Base, Implants. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-211
In Commercial Distribution

  • 00810005662147 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 INSERT 2. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-202
In Commercial Distribution

  • 00810005662130 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 INSERT 1. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-203
In Commercial Distribution

  • 00810005662123 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 Lid. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-101
In Commercial Distribution

  • 00810005662116 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 Base, Implants. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-201
In Commercial Distribution

  • 00810005662109 ()


  • Surgical instrument/implant rack
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
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
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
921050FT
Not in Commercial Distribution

  • 05037881011035 ()

  • Dimension 10 x 50 mm
921050FT

  • Cardiovascular patch, animal-derived
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
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
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
920875FT
Not in Commercial Distribution

  • 05037881011028 ()

  • Dimension 8 x 75 mm
920875FT

  • 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
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0120
Not in Commercial Distribution

  • 00815381020147 ()
RFIT-ASY-0120

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
FUMOVAC 700 Complete Unit 220/240 V 50/60 Hz
Conmed Corporation
57525422
In Commercial Distribution

  • 30845854061415 ()
57525422

  • Surgical plume evacuation system
FUMOVAC 700 Complete Unit 220/240 V 50/60 Hz
Conmed Corporation
57525420
In Commercial Distribution

  • 30845854061408 ()
  • 10845854061404 ()
57525420

  • Surgical plume evacuation system
FREND™ TSH Linearity Kit is intended for use as an assayed linearity material for the thyroid stimulating hormone (TSH) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ TSH Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND Vitamin D Linearity Kit
In Commercial Distribution

  • 08809317540566 ()
FLK-VTD

  • Non-blood cell primer/calibrator/control material IVD, reagent
FREND™ Testosterone Linearity Kit is intended for use as an assayed linearity material for the testosterone on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ Testosterone Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution
NanoEnTek, Inc.
FREND Testosterone Linearity Kit
In Commercial Distribution

  • 08809317540542 ()
FLK-TES

  • Non-blood cell primer/calibrator/control material IVD, reagent
FREND™ Free T4 Linearity Kit is intended for use as an assayed linearity material for the free thyroxine (Free T4) on the FREND™ System. The Linearity Kit is for the FREND™ System only. FREND™ Free T4 Linearity Kit is provided at five levels to assist in the checking of analytical systems within the clinical range. The kit is horse serum-based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The kit is a ready-to-use liquid requiring no reconstitution.
NanoEnTek, Inc.
FREND Free T4 Linearity Kit
In Commercial Distribution

  • 08809317540528 ()
FLK-FT4

  • Non-blood cell primer/calibrator/control material IVD, reagent
FREND™ Blocking Reagent is provided in 15 tubes, the blocking reagent is buffer based containing constituents of human origin as well as purified chemicals. Preservatives and stabilizers have been added to maintain product integrity. The Blocking Reagent is provided in a dried solid state.
NanoEnTek, Inc.
FREND Blocking Reagent
In Commercial Distribution

  • 08809317540825 ()
FRBR 015

  • Immunohistochemistry endogenous protein blocking reagent IVD
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