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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MDCK SV/CS
DIAGNOSTIC HYBRIDS, INC.
83-0102
In Commercial Distribution

  • 30014613333975 ()
83-0102

  • Cell culture line IVD
MDCK FRZER VIAL
DIAGNOSTIC HYBRIDS, INC.
83-00050
In Commercial Distribution

  • 30014613333968 ()
83-00050

  • Cell culture line IVD
L-929 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
78-T150
In Commercial Distribution

  • 30014613333890 ()
78-T150

  • Cell culture line IVD
L-929 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
78-T075
In Commercial Distribution

  • 30014613333883 ()
78-T075

  • Cell culture line IVD
L-929 25ML FLASK- NO ANTIBIOTI
DIAGNOSTIC HYBRIDS, INC.
78-T025AF
In Commercial Distribution

  • 30014613333876 ()
78-T025AF

  • Cell culture line IVD
RD FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
76-T075
In Commercial Distribution

  • 30014613333869 ()
76-T075

  • Cell culture line IVD
RD FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
76-T025
In Commercial Distribution

  • 30014613333852 ()
76-T025

  • Cell culture line IVD
RD CELLS TUBE CULT REG DENS
DIAGNOSTIC HYBRIDS, INC.
76-0600R
In Commercial Distribution

  • 30014613333845 ()
76-0600R

  • Cell culture line IVD
RD CELLS TUBE CULT LIGHT DENS
DIAGNOSTIC HYBRIDS, INC.
76-0600L
In Commercial Distribution

  • 30014613333838 ()
76-0600L

  • Cell culture line IVD
RD FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
76-00050
In Commercial Distribution

  • 30014613333821 ()
76-00050

  • Cell culture line IVD
HELA-229 FLASK 225 SQ CM
DIAGNOSTIC HYBRIDS, INC.
75-T225
In Commercial Distribution

  • 30014613333814 ()
75-T225

  • Cell culture line IVD
HELA-229 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
75-T150
In Commercial Distribution

  • 30014613333807 ()
75-T150

  • Cell culture line IVD
HELA-229 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
75-T075
In Commercial Distribution

  • 30014613333791 ()
75-T075

  • Cell culture line IVD
HELA229 SV/CS
DIAGNOSTIC HYBRIDS, INC.
75-0102
In Commercial Distribution

  • 30014613333784 ()
75-0102

  • Cell culture line IVD
HEK 96W88F - 12 COLUMN EMPTY
DIAGNOSTIC HYBRIDS, INC.
74-9688PR
In Commercial Distribution

  • 30014613333777 ()
74-9688PR

  • Cell culture line IVD
HELA FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
72-T075
In Commercial Distribution

  • 30014613333760 ()
72-T075

  • Cell culture line IVD
HELA MWP W96/96F
DIAGNOSTIC HYBRIDS, INC.
72-9696
In Commercial Distribution

  • 30014613333753 ()
72-9696

  • Cell culture line IVD
HELA TUBE
DIAGNOSTIC HYBRIDS, INC.
72-0600
In Commercial Distribution

  • 30014613333746 ()
72-0600

  • Cell culture line IVD
HELA 50 MER SUSP.
DIAGNOSTIC HYBRIDS, INC.
72-00050
In Commercial Distribution

  • 30014613333739 ()
72-00050

  • Cell culture line IVD
VERO-76 FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
67-T150
In Commercial Distribution

  • 30014613333722 ()
67-T150

  • Cell culture line IVD
VERO-76 FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
67-T075
In Commercial Distribution

  • 30014613333715 ()
67-T075

  • Cell culture line IVD
VERO-76 FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
67-T025
In Commercial Distribution

  • 30014613333708 ()
67-T025

  • Cell culture line IVD
VERO-76 MWP W96/96F
DIAGNOSTIC HYBRIDS, INC.
67-9696
In Commercial Distribution

  • 30014613333692 ()
67-9696

  • Cell culture line IVD
VERO-76 MWP W24/24F
DIAGNOSTIC HYBRIDS, INC.
67-2424
In Commercial Distribution

  • 30014613333685 ()
67-2424

  • Cell culture line IVD
VERO76MWP W12/12F 80%CONFL
DIAGNOSTIC HYBRIDS, INC.
67-1212B
In Commercial Distribution

  • 30014613333678 ()
67-1212B

  • Cell culture line IVD
VERO 76. 6-WELL PLATES~80% CON
DIAGNOSTIC HYBRIDS, INC.
67-0606L
In Commercial Distribution

  • 30014613333661 ()
67-0606L

  • Cell culture line IVD
VERO 76 MWP W6/6F CUST
DIAGNOSTIC HYBRIDS, INC.
67-0606B
In Commercial Distribution

  • 30014613333654 ()
67-0606B

  • Cell culture line IVD
VERO76 MWP W6/6F
DIAGNOSTIC HYBRIDS, INC.
67-0606
In Commercial Distribution

  • 30014613333647 ()
67-0606

  • Cell culture line IVD
VERO-76 CELLS TUBE CULT
DIAGNOSTIC HYBRIDS, INC.
67-0600
In Commercial Distribution

  • 30014613333630 ()
67-0600

  • Cell culture line IVD
HUMAN FETAL LUNG FLK 75 SQCM
DIAGNOSTIC HYBRIDS, INC.
64-T075
In Commercial Distribution

  • 30014613333623 ()
64-T075

  • Cell culture line IVD
MNA FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
62-T150
In Commercial Distribution

  • 30014613333616 ()
62-T150

  • Cell culture line IVD
MNA FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
62-T075
In Commercial Distribution

  • 30014613333609 ()
62-T075

  • Cell culture line IVD
MNA FLASK 25 SQ CM
DIAGNOSTIC HYBRIDS, INC.
62-T025
In Commercial Distribution

  • 30014613333593 ()
62-T025

  • Cell culture line IVD
MNA SV/CS
DIAGNOSTIC HYBRIDS, INC.
62-0102
In Commercial Distribution

  • 30014613333586 ()
62-0102

  • Cell culture line IVD
MNA FROZEN SUSP. 50 MER
DIAGNOSTIC HYBRIDS, INC.
62-00050
In Commercial Distribution

  • 30014613333579 ()
62-00050

  • Cell culture line IVD
NCI-H292 FLK 75 SQCM
DIAGNOSTIC HYBRIDS, INC.
59-T075
In Commercial Distribution

  • 30014613333562 ()
59-T075

  • 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
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