Medical Device Manufacturer · US , Memphis , TN

Grace Medical, Inc.

14 submissions · 14 cleared · Since 1994
14
Total
14
Cleared
0
Denied

Grace Medical, Inc. — FDA 510(k) Submissions

Grace Medical, Inc. has submitted 14 FDA 510(k) premarket notifications since 1994, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Partial Ossicular Replacement, Tube, Tympanostomy, Replacement, Ossicular Prosthesis, Total, Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Tympanostomy Tubes
K232059 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Nov 2023 136d
DragonFly Surgical Drill System
K161376 · ERL Drill, Surgical, Ent... · Ear, Nose, Throat
Aug 2016 99d
GRACE DYNAMIC TORP
K091187 · ETA Replacement, Ossicular... · Ear, Nose, Throat
Sep 2009 144d
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K080070 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Apr 2008 98d
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE
K063374 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Dec 2006 28d
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
K062672 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Oct 2006 46d
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
K062385 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Sep 2006 43d
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES
K061853 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Aug 2006 49d
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
K060518 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Jun 2006 121d
STAPES PROSTHESES
K991394 · ETB Prosthesis, Partial... · Ear, Nose, Throat
May 1999 27d
TYMPANOSTOMY TUBE
K981575 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Jul 1998 72d
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K972815 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Oct 1997 72d
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K963752 · ETB Prosthesis, Partial... · Ear, Nose, Throat
Oct 1996 22d
TYMPANOSTOMY TUBE
K943325 · ETD Tube, Tympanostomy · Ear, Nose, Throat
Oct 1994 92d
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