Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- HPZImplant, Eye Sphere2Product Code
- HQHEye, Artificial, Non-Custom1Product Code
- HQJImplant, Absorbable, (Scleral Buckling Methods)2Product Code
- HQLIntraocular Lens3Product Code
- HQMKeratoprosthesis, Permanent Implant2Product Code
- HQNConformer, Ophthalmic2Product Code
- HQTShell, Scleral2Product Code
- HQWClip, Tantalum, Ophthalmic2Product Code
- HQXImplant, Orbital, Extra-Ocular2Product Code
- K023481MICROVISION SCLERAL BUCKLING COMPONENTS2Cleared 510(K)
- K983581OCU-GUARD AND OCU-GUARD SUPPLE2Cleared 510(K)
- K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES2Cleared 510(K)
- K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES2Cleared 510(K)
- K950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS2Cleared 510(K)
- K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)2Cleared 510(K)
- K945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS2Cleared 510(K)
- K902308TAMCENAN OCULAR EXPLANTS AND BANDS2Cleared 510(K)
- K901002O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES2Cleared 510(K)
- K900929PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL2Cleared 510(K)
Show All 16 Submissions
- KYFImplant, Eye Valve2Product Code
- MFKLens, Multifocal Intraocular3Product Code
- MJPLens, Intraocular, Toric Optics3Product Code
- MLPKeratoprosthesis, Temporary Implant, Surgical Use2Product Code
- MQUOcular Peg2Product Code
- MTZWrap, Implant, Orbital2Product Code
- NAALens, Intraocular, Accommodative3Product Code
- NCKButton, Iris, Eye, Artificial1Product Code
- NFMExpander, Tissue, Orbital2Product Code
- NIZLens, Iris Reconstruction3Product Code
- NQBConformer, Ophthalmic, Biological Tissue2Product Code
- NXMProsthesis, Eyelid Spacer/Graft, Biologic2Product Code
- POEExtended Depth Of Focus Intraocular Lens3Product Code
- PUFOcular Peg, Exempt2Product Code
- PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)3Product Code
- QCBPhakic Toric Intraocular Lens3Product Code
- QWUProsthesis, Eyelid Spacer/Graft, Polymer2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K980816
- 510(k) Type
- Traditional
- Applicant
- FCI OPHTHALMICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/18/1998
- Days to Decision
- 199 days
- Submission Type
- Statement