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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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OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
18cc
In Commercial Distribution

  • 00816986020129 ()
OMP-18

  • Synthetic bone graft
OSTEOMATRIX+ is a bone graft substitute comprising biphasic mineral granules suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
9cc
In Commercial Distribution

  • 00816986020112 ()
OMP-09

  • Synthetic bone graft
The BioHealx Anal Fistula Device is indicated for closure of the internal opening of mature, cryptogenic, transsphincteric, non branching fistulas in ano via tissue apposition. BH201X1 is a single unit of the BioHealx Anal Fistula Device. Each single unti contains a single absorbable implant preloaded into a single use delivery system. It is provided sterile and is intended for single use. BH201X1 can be provided as a single unit or as a multipack of 5 units in a box.
SIGNUM SURGICAL LIMITED
BH201X1
In Commercial Distribution

  • 05391546930001 ()
  • 05391546930018 ()


  • Fistula-repair biomatrix implant
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
FIDIA FARMACEUTICI SPA
FID185704
Not in Commercial Distribution

  • M71389122049663SAM1 ()
  • M71389122049663SAM0 ()

  • Total Volume: 3 Milliliter
FID185704

  • Synovial fluid supplementation medium
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
FIDIA FARMACEUTICI SPA
89122-0496-63
Not in Commercial Distribution

  • M71389122049663A16 ()
  • M71389122049663 ()

  • Total Volume: 3 Milliliter
89122-0496-63

  • Synovial fluid supplementation medium
The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
PMB-SBX45-1
In Commercial Distribution

  • 05712821012890 ()
PMB-SBX45-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
CPMB-ZSV57-1
In Commercial Distribution

  • 05712821011985 ()
CPMB-ZSV57-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
CPMB-ZSV45-1
In Commercial Distribution

  • 05712821011978 ()
CPMB-ZSV45-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
CPMB-ZSV35-1
In Commercial Distribution

  • 05712821011961 ()
CPMB-ZSV35-1

  • Dental implant suprastructure, permanent, preformed
The Pre-Milled Blank is used in creation of a customized abutment. It has a pre-manufactured connection interface that fits directly to an endosseous dental implant. The customized shape of the abutment shall be manufactured by either an Elos Medtech approved milling facility or at point of use. The Pre-Milled abutment is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
Elos Medtech Pinol A/S
CPMB-SSY65-1
In Commercial Distribution

  • 05712821011954 ()
CPMB-SSY65-1

  • Dental implant suprastructure, permanent, preformed
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