Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- ESFPolymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent2Product Code
- EZXMesh, Surgical, Metal2Product Code
- MIBElastomer, Silicone Block2Product Code
- MICImplant, Muscle, Pectoralis2Product Code
- BTXBoard, Arm (With Cover), Sterile1Product Code
- FTLMesh, Surgical, Polymeric2Product Code
- FTMMesh, Surgical2Product Code
- FTNPlastic Surgery And Accessories Kit1Product Code
- FTRProsthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled3Product Code
- FWMProsthesis, Breast, Inflatable, Internal, Saline3Product Code
- FWPProsthesis, Chin, Internal2Product Code
- FYIAppliance, Facial Fracture, External1Product Code
- FZDProsthesis, Ear, Internal2Product Code
- FZEProsthesis, Nose, Internal2Product Code
- K161548Osseointegrated Fixtures2Cleared 510(K)
- K090803HANSON MEDICAL FACIAL IMPLANTS2Cleared 510(K)
- K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)2Cleared 510(K)
- K071018MONARCH NASAL IMPLANT2Cleared 510(K)
- K041690MONARCH NASAL IMPLANT2Cleared 510(K)
- K021418AART NASAL IMPLANT2Cleared 510(K)
- K992242PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS2Cleared 510(K)
- K983755NASAL DORSAL SERIES2Cleared 510(K)
- K982753SEARE BIOMEDICAL NASAL IMPLANTS2Cleared 510(K)
- K981833SILIMED NASAL L SHAPED IMPLANT2Cleared 510(K)
- K973573DURALASTIC ANATOMICAL NASAL IMPLANTS2Cleared 510(K)
- K971481DURALASTIC ANATOMICAL NASAL IMPLANTS2Cleared 510(K)
- K962824IMPLANTECH JEJ PERI-PYRIFORM IMPLANT2Cleared 510(K)
- K961124THE NAUTILUS2Cleared 510(K)
- K952705SPIRIT RIDGE NASAL IMPLANT2Cleared 510(K)
- K952706SPIRIT RIDGE SILICONE CARVING BLOCK2Cleared 510(K)
- K952707SILICONE ELASTOMER MALAR IMPLANT2Cleared 510(K)
- K952708PECTORALIS IMPLANT2Cleared 510(K)
- K952709PROTHESIS, CHIN, INTERNAL2Cleared 510(K)
- K945154BA-CPAS2Cleared 510(K)
- K941960IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II2Cleared 510(K)
- K942876IMPLANTECH DORSAL NASAL IMPLANT2Cleared 510(K)
- K925743NASAL DORSUM2Cleared 510(K)
- K925426RIZZO NASAL IMPLANT2Cleared 510(K)
- K921580BRINK PRE-MAXILLARY IMPLANT2Cleared 510(K)
- K904656FLOWERS NASAL IMPLANT2Cleared 510(K)
- K904657FLOWERS DORSAL COLUMELLA IMPLANT2Cleared 510(K)
- K904350CUI DORSAL COLUMELLA PROSTHESIS2Cleared 510(K)
- K903328CUI PREMAXILLARY IMPLANT2Cleared 510(K)
- K902283THE NAUTILUS NASAL IMPLANT2Cleared 510(K)
- K880405SILASTIC NASAL IMPLANT S-TYPE2Cleared 510(K)
- K871071OMEGA DORSAL COLUMELLA IMPLANTS2Cleared 510(K)
- K863942POREX(TM) NOSE PROSTHESIS2Cleared 510(K)
- K863430BYRON BIVALVE NASAL SPLINTS2Cleared 510(K)
- K863398BYRON NASAL SEPTAL BUTTON2Cleared 510(K)
- K863399BYRON DORSAL COLUMELLA IMPLANT2Cleared 510(K)
- K853945CUI RHINOPLASTY IMPLANTS2Cleared 510(K)
- K822130FRANCIS NASAL TUBE2Cleared 510(K)
- K801074STRAITH NASAL IMPLANT2Cleared 510(K)
- K782104PASTE, PRO CARE PROPHYLAXIS2Cleared 510(K)
- K781574PLASTI-PORE SEPTAL BUTTON2Cleared 510(K)
- FZFSplint, Extremity, Inflatable, External1Product Code
- GBIMaterial, External Aesthetic Restoration, Used With Adhesive1Product Code
- GBJProsthesis, Adhesive, External1Product Code
- JCQProsthesis, Esophagus2Product Code
- KCZProsthesis, Breast, External, Used With Adhesive1Product Code
- KDAProsthesis, Ptfe/Carbon-Fiber2Product Code
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2Product Code
- LZKImplant, Malar2Product Code
- MCATape, Surgical, Internal2Product Code
- MNFImplant, Temporal2Product Code
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile1Product Code
- NODBoard, Arm (With Cover), Non-Sterile1Product Code
- NOJProsthesis, Breast, External, No Adhesive1Product Code
- NOKMaterial, External Aesthetic Restoration, No Adhesive1Product Code
- NWAProsthesis, Tracheal, Preformed/Molded2Product Code
- NYTProsthesis, Tracheal, Expandable, Polymeric2Product Code
- ODUFacial Implant2Product Code
- OXGMesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery2Product Code
- OODSurgical Film2Product Code
- OQLMesh, Surgical, Deployment Balloon2Product Code
- ORQMesh, Surgical, Deployer2Product Code
- OWRMesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery2Product Code
- OWSMesh, Surgical, Collagen, Plastics, Facial Implants2Product Code
- OWTMesh, Surgical, Absorbable, Abdominal Hernia2Product Code
- OWUMesh, Surgical, Non-Absorbable, Diaphragmatic Hernia2Product Code
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia2Product Code
- OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWXMesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon2Product Code
- OWZMesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXAMesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction2Product Code
- OXBMesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction2Product Code
- OXCMesh, Surgical, Absorbable, Staple Line Reinforcement2Product Code
- OXDMesh, Surgical, Non-Absorbable, Staple Line Reinforcement2Product Code
- OXEMesh, Surgical, Collagen, Staple Line Reinforcement2Product Code
- OXFMesh, Surgical, Absorbable, Plastic And Reconstructive Surgery2Product Code
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery2Product Code
- OXIMesh, Surgical, Absorbable, Large Abdominal Wall Defects2Product Code
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects2Product Code
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects2Product Code
- OXLMesh, Surgical, Absorbable, Organ Support2Product Code
- OXMMesh, Surgical, Absorbable, Fistula2Product Code
- OXNMesh, Surgical, Collagen, Fistula2Product Code
- PIJCollagen Surgical Mesh Containing Drugs2Product Code
- PQNCarbon Dioxide Gas Controlled Tissue Expander2Product Code
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
BA-CPAS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K945154
- 510(k) Type
- Traditional
- Applicant
- NOBELPHARMA USA, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/13/1995
- Days to Decision
- 84 days
- Submission Type
- Summary