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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No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 24560189210282 ()
  • 14560189210285 ()
  • 04560189210288 ()


  • Free triiodothyronine (FT3) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210261 ()
  • 04560189210264 ()


  • Beta-2-microglobulin IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210230 ()
  • 04560189210233 ()


  • Alpha-fetoprotein (AFP) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210179 ()
  • 04560189210172 ()


  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210155 ()
  • 04560189210158 ()


  • Total immunoglobulin E (IgE total) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210094 ()
  • 04560189210097 ()


  • Myoglobin IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210063 ()
  • 04560189210066 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, enzyme immunoassay (EIA)
No Description
TOSOH CORPORATION
N/A
In Commercial Distribution

  • 14560189210032 ()
  • 04560189210035 ()


  • Total testosterone IVD, kit, enzyme immunoassay (EIA)
70cm 8 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-70E
In Commercial Distribution

  • 08714729820741 ()

  • 70 cm Length


  • Implantable electrical stimulation system intraoperative test lead
30cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-30
In Commercial Distribution

  • 08714729771180 ()

  • 30 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
70cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-70
In Commercial Distribution

  • 08714729767749 ()

  • 70 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
50cm 8 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-50
In Commercial Distribution

  • 08714729767725 ()

  • 50 cm Length


  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
50cm 8 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2218-50E
In Commercial Distribution

  • 08714729784067 ()

  • 50 cm Length


  • Implantable electrical stimulation system intraoperative test lead
Ablation Catheter
BOSTON SCIENTIFIC CORPORATION
M004R5031TH0
In Commercial Distribution

  • 08714729963974 ()

  • 7 F Diameter
  • 2.33 mm Diameter
  • 4 mm Length
M004R5031TH0

  • Cardiac radio-frequency ablation system catheter
Ablation Catheter
BOSTON SCIENTIFIC CORPORATION
M004R5031THK20
In Commercial Distribution

  • 08714729963950 ()

  • 2.33 mm Diameter
  • 7 F Diameter
  • 4 mm Length
M004R5031THK20

  • Cardiac radio-frequency ablation system catheter
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200100
Not in Commercial Distribution

  • 08714729877851 ()

  • 7 F Diameter
  • 2.33 mm Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200090
Not in Commercial Distribution

  • 08714729877844 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200080
Not in Commercial Distribution

  • 08714729877837 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200070
Not in Commercial Distribution

  • 08714729877820 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200060
Not in Commercial Distribution

  • 08714729877813 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200050
Not in Commercial Distribution

  • 08714729877806 ()

  • 7 F Diameter
  • 2.33 mm Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200030
Not in Commercial Distribution

  • 08714729877783 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200020
Not in Commercial Distribution

  • 08714729877776 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
Bidirectional Steerable Diagnostic Catheter
BOSTON SCIENTIFIC CORPORATION
M0043200010
Not in Commercial Distribution

  • 08714729877769 ()

  • 2.33 mm Diameter
  • 7 F Diameter


  • Cardiac mapping catheter, percutaneous, single-use
CUSTOM ADAPTER-BARD/ST.JUDE 10 LD
GRAPHIC CONTROLS ACQUISITION CORP
St Jude Medical
In Commercial Distribution

  • 03700506307104 ()
IPC73745

  • Patient monitoring system module, electrocardiographic
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST250
In Commercial Distribution

  • 00892064002089 ()

  • Area/Surface Area: 250 Square millimeter
10-0609

  • Glaucoma shunt, tubular, non-animal-derived
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST350
In Commercial Distribution

  • 00892064002096 ()

  • Area/Surface Area: 350 Square millimeter
10-0610

  • Glaucoma shunt, tubular, non-animal-derived
No Description
DIAGNOSTICA STAGO
58230
In Commercial Distribution

  • 03607450582307 ()


  • Coagulation analyser IVD, laboratory, semi-automated
No Description
BIOTRONIK SE & Co. KG
346367
Not in Commercial Distribution

  • 04035479077853 ()

  • Length: 60 cm
  • Max. Diameter: 2.2 mm
346367

  • Endocardial/interventricular septal pacing lead
No Description
BIOTRONIK SE & Co. KG
346366
Not in Commercial Distribution

  • 04035479077846 ()

  • Length: 53 cm
  • Max. Diameter: 2.2 mm
346366

  • Endocardial/interventricular septal pacing lead
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 8 LOWER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865012834 ()
  • 28056865012838 ()
0120083

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 8 UPPER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865012827 ()
  • 28056865012821 ()
0120082

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 6 LOWER
Not in Commercial Distribution

  • 28056865012906 ()
  • 08056865012810 ()
  • 18056865012817 ()
0120081

  • Resin artificial teeth
No Description
DENTAL MANUFACTURING SPA
EVO 2 ST 6 UPPER
Not in Commercial Distribution

  • 08056865012803 ()
  • 28056865012906 ()
  • 18056865012800 ()
0120080

  • Resin artificial teeth
St. Jude Medical Probe Covers Clear Polyethylene Non-Sterile 9in x 96in x 1in 100 per Case
TIDI PRODUCTS, LLC
33431
Not in Commercial Distribution

  • 01618125183882 ()


  • Medical equipment/instrument drape, single-use
St. Jude Medical Probe Covers Clear Polyethylene Sterile 9in x 96in x 1in 100 per Case
TIDI PRODUCTS, LLC
30965
Not in Commercial Distribution

  • 00618125167883 ()
  • 01618125167882 ()


  • Medical equipment/instrument drape, single-use
Analog Crystaline ST Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
6102SD
In Commercial Distribution

  • 20815236020302 ()
  • 10815236020305 ()
  • 00815236020308 ()
6102SD

  • Liquid-crystal patient thermometer, single-use
Analog Crystaline ST Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
6102SB
In Commercial Distribution

  • 10815236020299 ()
  • 00815236020292 ()
6102SB

  • Liquid-crystal patient thermometer, single-use
Analog Crystaline ST Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
6102H
In Commercial Distribution

  • 20815236020289 ()
  • 10815236020282 ()
  • 00815236020285 ()
6102H

  • Liquid-crystal patient thermometer, single-use
Analog Crystaline ST Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
6102F
In Commercial Distribution

  • 20815236020272 ()
  • 10815236020275 ()
  • 00815236020278 ()
6102F

  • Liquid-crystal patient thermometer, single-use
Analog Crystaline ST Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
6102C
In Commercial Distribution

  • 20815236020265 ()
  • 10815236020268 ()
  • 00815236020261 ()
6102C

  • Liquid-crystal patient thermometer, single-use
Analog Crystaline ST Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
6102B
In Commercial Distribution

  • 10815236020251 ()
  • 00815236020254 ()
6102B

  • Liquid-crystal patient thermometer, single-use
Analog Crystaline ST Liquid Crystal Temperature Trend Indicator
LCR HALLCREST, LLC.
6102
In Commercial Distribution

  • 30815236020248 ()
  • 20815236020241 ()
  • 10815236020244 ()
6102

  • Liquid-crystal patient thermometer, single-use
Short Tip Microwave Antenna Kit (20 cm, 1 per Tray)
VARIAN MEDICAL SYSTEMS, INC.
22-17025-320
In Commercial Distribution

  • 00810563021042 ()
SWST-1420

  • Microwave ablation system probe, non-powered
Short Tip Microwave Antenna Kit (15 cm, 1 per Tray)
VARIAN MEDICAL SYSTEMS, INC.
22-17025-315
In Commercial Distribution

  • 00810563021035 ()
SWST-1415

  • Microwave ablation system probe, non-powered
The St. Louis Band is a patient specific cranial orthosis that redirects the head growth to improve proportion and symmetry. It is intended for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional head shape deformities, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. This device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads. The St. Louis Band is made with an outer copolymer plastic shell and an inner liner made of Aliplast foam (closed cell polyethylene). It utilizes an overlapping bi-valve design with a sliding rivet mechanism and is held in place by a Velcro® strap.
ORTHOMERICA PRODUCTS, INC.
704.08A
In Commercial Distribution

  • B15170408A0 ()
704.08A

  • Cranial orthosis
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114247 ()

  • 16x10x32mm
TST20161032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114230 ()

  • 15x10x32mm
TST20151032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114162 ()

  • 18x10x32mm
TST20181032

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, angled
In Commercial Distribution

  • 04047844114094 ()

  • 18x10x32mm
TST12181032

  • Metallic spinal interbody fusion cage
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