Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Gyrus Ent LLC

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K040996 RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEMNIX2004-08-20 View
510(k) K034004 DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLEERL2004-03-03 View
510(k) K033089 HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEMGEI2004-02-05 View
510(k) K033554 SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESISETB2003-11-24 View
510(k) K030343 DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACEHAW2003-05-02 View
510(k) K021595 GYRUS ENT NERVE STIMULATORETN2002-10-24 View
510(k) K021777 GYRUS ENT COGENT 2/G2 SYSTEM (GENERATOR,ACCESSORIES SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES)GEI2002-08-26 View
510(k) K020778 GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420GEI2002-05-28 View
510(k) K020067 GYRUS ENT SOMNOPLASTY GENERATORGEI2002-04-04 View
510(k) K020594 DIEGO POWERED DISSECTOR AND DRILL SYSTEMERL2002-03-08 View
510(k) K003214 SMITH & NEPHEW PISTONSETB2000-10-31 View
510(k) K002702 NEUROTOLOGY DRAPE, MODEL TBDKKX2000-10-26 View
510(k) K002737 SMITH & NEPHEW PORPS & TORPSETB2000-10-12 View
510(k) K002378 MODULAR PORP AND TORP MODEL TBDETA2000-08-29 View
510(k) K002464 SMITH & NEPHEW OFF-CENTERED PORPETB2000-08-29 View
510(k) K002021 HEMOSTATIX THERMAL SCALPEL SYSTEM - #12 BLADEGEI2000-08-24 View
510(k) K001902 BOJRAB UNIVERSAL LONG IMLANT, MODEL TBDETA2000-07-10 View
510(k) K000801 PC COATED FLUOROPLASTIC VENT TUBESETD2000-06-19 View
510(k) K000858 WEHRS INCUS-STAPESETB2000-04-03 View
510(k) K000256 CAP PORP, CAP TORPETB2000-02-11 View
↑