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Grace Medical, Inc.

FDA 510(k) & PMA Approved Devices — 15 products

Total Devices15
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K260266 Tympendi™ (810)KHJ2026-08-18 View
510(k) K232059 Tympanostomy TubesETD2023-11-24 View
510(k) K161376 DragonFly Surgical Drill SystemERL2016-08-25 View
510(k) K091187 GRACE DYNAMIC TORPETA2009-09-14 View
510(k) K080070 K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESESETB2008-04-17 View
510(k) K063374 NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOEETB2006-12-06 View
510(k) K062672 GRACE MEDICAL PC COATED TYMPANOSTOMY TUBESETD2006-10-24 View
510(k) K062385 BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBESETD2006-09-27 View
510(k) K061853 GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESESETB2006-08-18 View
510(k) K060518 PARTIAL OSSICULAR REPLACEMENT PROSTHESESETB2006-06-28 View
510(k) K991394 STAPES PROSTHESESETB1999-05-18 View
510(k) K981575 TYMPANOSTOMY TUBEETD1998-07-15 View
510(k) K972815 PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENTETB1997-10-08 View
510(k) K963752 PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESISETB1996-10-10 View
510(k) K943325 TYMPANOSTOMY TUBEETD1994-10-11 View
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