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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Ø4.5/ L=15
Megagen Implant Co. Ltd
ST4515
In Commercial Distribution

  • 08806388236893 ()
ST4515C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=13
Megagen Implant Co. Ltd
ST4513
In Commercial Distribution

  • 08806388236886 ()
ST4513C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=11.5
Megagen Implant Co. Ltd
ST4511
In Commercial Distribution

  • 08806388236879 ()
ST4511C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=10
Megagen Implant Co. Ltd
ST4510
In Commercial Distribution

  • 08806388236862 ()
ST4510C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=8.5
Megagen Implant Co. Ltd
ST4508
In Commercial Distribution

  • 08806388236855 ()
ST4508C

  • Screw endosteal dental implant, two-piece
Ø4.5/ L=7
Megagen Implant Co. Ltd
ST4507
In Commercial Distribution

  • 08806388236848 ()
ST4507C

  • Screw endosteal dental implant, two-piece
Ø4/ L=15
Megagen Implant Co. Ltd
ST4015
In Commercial Distribution

  • 08806388236831 ()
ST4015C

  • Screw endosteal dental implant, two-piece
Ø4/ L=13
Megagen Implant Co. Ltd
ST4013
In Commercial Distribution

  • 08806388236824 ()
ST4013C

  • Screw endosteal dental implant, two-piece
Ø4/ L=11.5
Megagen Implant Co. Ltd
ST4011
In Commercial Distribution

  • 08806388236817 ()
ST4011C

  • Screw endosteal dental implant, two-piece
Ø4/ L=10
Megagen Implant Co. Ltd
ST4010
In Commercial Distribution

  • 08806388236800 ()
ST4010C

  • Screw endosteal dental implant, two-piece
Ø4/ L=8.5
Megagen Implant Co. Ltd
ST4008
In Commercial Distribution

  • 08806388236794 ()
ST4008C

  • Screw endosteal dental implant, two-piece
Ø4/ L=7
Megagen Implant Co. Ltd
ST4007
In Commercial Distribution

  • 08806388236787 ()
ST4007C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=15
Megagen Implant Co. Ltd
ST3515
In Commercial Distribution

  • 08806388236770 ()
ST3515C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=13
Megagen Implant Co. Ltd
ST3513
In Commercial Distribution

  • 08806388236763 ()
ST3513C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=11.5
Megagen Implant Co. Ltd
ST3511
In Commercial Distribution

  • 08806388236756 ()
ST3511C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=10
Megagen Implant Co. Ltd
ST3510
In Commercial Distribution

  • 08806388236749 ()
ST3510C

  • Screw endosteal dental implant, two-piece
Ø3.5/ L=8.5
Megagen Implant Co. Ltd
ST3508
In Commercial Distribution

  • 08806388236732 ()
ST3508C

  • Screw endosteal dental implant, two-piece
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST350
In Commercial Distribution

  • 00892064002096 ()

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

  • Glaucoma shunt
Glaucoma shunt
NEW WORLD MEDICAL, INCORPORATED
ST250
In Commercial Distribution

  • 00892064002089 ()

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

  • Glaucoma shunt
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.
709.08PA
In Commercial Distribution

  • B15170908PA0 ()
709.08PA

  • Cranial orthosis
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.
709.08A
In Commercial Distribution

  • B15170908A0 ()
709.08A

  • Cranial orthosis
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 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.
763.08PA
In Commercial Distribution

  • B15176308PA0 ()
763.08PA

  • Cranial orthosis
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.
763.08A
In Commercial Distribution

  • B15176308A0 ()
763.08A

  • Cranial orthosis
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.
704.08PA
In Commercial Distribution

  • B15170408PA0 ()
704.08PA

  • Cranial orthosis
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
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
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
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
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
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
No Description
DIAGNOSTICA STAGO
58230
In Commercial Distribution

  • 03607450582307 ()


  • Coagulation analyser IVD, laboratory, semi-automated
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
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