Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- EPFHearing Aid, Group And Auditory Trainer2Product Code
- NEACement, Ear, Nose And Throat2Product Code
- ESDHearing Aid, Air Conduction1Product Code
- ESELarynx, Artificial (Battery-Powered)1Product Code
- ESHPolymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane2Product Code
- ESXTack, Sacculotomy (Cody Tack)2Product Code
- ESZTube, Shunt, Endolymphatic2Product Code
- ETAReplacement, Ossicular Prosthesis, Total2Product Code
- ETBProsthesis, Partial Ossicular Replacement2Product Code
- ETCMold, Middle-Ear2Product Code
- ETDTube, Tympanostomy2Product Code
- ETWCalibrator, Hearing Aid / Earphone And Analysis Systems2Product Code
- EWLProsthesis, Laryngeal (Taub)2Product Code
- FWNProsthesis, Larynx (Stents And Keels)2Product Code
- JAZProsthesis, Facial, Mandibular Implant2Product Code
- JOFPolymer, Ent Synthetic, Porous Polyethylene2Product Code
- JXSBlock, Cutting, Ent, Sterile1Product Code
- JXTCrimper, Wire, Ent, Sterile1Product Code
- JXWDie, Wire Bending, Ent, Sterile1Product Code
- JXXForceps, Wire Closure, Ent, Sterile1Product Code
- JXYJig, Piston Cutting, Ent, Sterile1Product Code
- JXZPunch, Gelfoam, Sterile1Product Code
- JYAScissors, Wire Cutting, Ent, Sterile1Product Code
- JYBVise, Ossicular Finger, Sterile1Product Code
- KHJPolymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)2Product Code
- K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)2Cleared 510(K)
- K161000Biodesign Otologic Repair Graft2Cleared 510(K)
- K150594Biodesign Otologic Repair Graft2Cleared 510(K)
- K132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI2Cleared 510(K)
- K121360BIODESIGN ENT REPAIR GRAFT2Cleared 510(K)
- K122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN2Cleared 510(K)
- K120220ADAPTAIN SOLUBLE IMPLANT MATERIAL2Cleared 510(K)
- K103047CERETENE SOLUBLE IMPLANT MATERIAL2Cleared 510(K)
- K080022GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP2Cleared 510(K)
- K082245AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV2Cleared 510(K)
- K081531AOC SOLUBLE IMPLANT MATERIAL2Cleared 510(K)
- K070093OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE2Cleared 510(K)
- K062280OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE AND ACTIPASTE2Cleared 510(K)
- K060561CLEARADEX GEL2Cleared 510(K)
- K060878GELITA-SPON ABSORBABLE GELATIN SPONGE, USP2Cleared 510(K)
- K051487DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE2Cleared 510(K)
- K051911GELITA-SPON2Cleared 510(K)
- K043035SEPRAGEL ENT BIORESORBABLE PACKING/STENT2Cleared 510(K)
- K033796KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS2Cleared 510(K)
- K013243COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-12Cleared 510(K)
- K003855HYALOMATRIX CO2Cleared 510(K)
- K002972MEROGEL CONTROL GEL ENT SURGICAL DRESSING2Cleared 510(K)
- K001148MEROGEL OTOLOGIC PACK2Cleared 510(K)
- K991324TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)2Cleared 510(K)
- K982870EPIFILM OTOLOGIC LAMINA2Cleared 510(K)
- K982294XOMED SILICONE PRE-FORM BLOCKS2Cleared 510(K)
- K972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)2Cleared 510(K)
- K974311VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT2Cleared 510(K)
- K970910XOMED SILICONE BLOCK/STRIP2Cleared 510(K)
- K964484KARTUSH TM PATCHER2Cleared 510(K)
- K953013MEROCEL REINFORCED SILICONE SHEETS2Cleared 510(K)
- K932176BIOSIL MEDICAL GRADE SILICONE SHEETING2Cleared 510(K)
- K911503EXMOOR SILICONE RUBBER SHEET2Cleared 510(K)
- KHLHearing Aid, Master2Product Code
- KLWMasker, Tinnitus2Product Code
- KLZTube, Shunt, Endolymphatic With Valve2Product Code
- KQLTube, Tympanostomy With Semi-Permeable Membrane2Product Code
- LBLTube, Tympanostomy, Porous Polyethylene2Product Code
- LBMPorous Polyethylene Ossicular Replacement2Product Code
- LBNReplacement, Total Ossicular, Prosthesis, Porous, Polyethylene2Product Code
- LBPReplacement, Ossicular (Stapes) Using Absorbable Gelatin Material2Product Code
- LDGKit, Earmold, Impression1Product Code
- LRBFace Plate Hearing Aid1Product Code
- LREInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Sterile1Product Code
- LWFDilator, Nasal1Product Code
- LXBHearing Aid, Bone Conduction2Product Code
- LZIDevice, Assistive Listening2Product Code
- MAHHearing Aid, Bone Conduction, Implanted2Product Code
- MCKDevice, Voice Amplification2Product Code
- MIXSystem, Vocal Cord Medialization2Product Code
- NHBPolymer, Ear, Nose And Throat, Synthetic, Absorbable2Product Code
- NIXHearing Aid, Air Conduction, Transcutaneous System2Product Code
- NNNCrimper, Wire, Ent, Non-Sterile1Product Code
- NNOJig, Piston Cutting, Ent, Non-Sterile1Product Code
- NNPDie, Wire Bending, Ent, Non-Sterile1Product Code
- NNQForceps, Wire Closure, Ent, Non-Sterile1Product Code
- NNRBlock, Cutting, Ent, Non-Sterile1Product Code
- NNSInstrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile1Product Code
- NNTPunch, Gelfoam, Non-Sterile1Product Code
- NNUScissors, Wire Cutting, Ent, Non-Sterile1Product Code
- NNVVise, Ossicular Finger, Non-Sterile1Product Code
- OGSMyringotomy Procedure Kit2Product Code
- OSMHearing Aid, Air Conduction With Wireless Technology2Product Code
- PFOActive Implantable Bone Conduction Hearing System2Product Code
- PLKTympanic Membrane Direct Contact Hearing Aid2Product Code
- QDDSelf-Fitting Air-Conduction Hearing Aid2Product Code
- QUFHearing Aid, Air-Conduction, Over The Counter1Product Code
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter2Product Code
- QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter2Product 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—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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- OphthalmicReview Panel
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COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K013243
- 510(k) Type
- Traditional
- Applicant
- BIOFORM, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/9/2002
- Days to Decision
- 103 days
- Submission Type
- Summary