Grace Medical, Inc. is one of 16333 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Grace Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Tympendi™ (810), Tympanostomy Tubes, DragonFly Surgical Drill System
15
Total
15
Cleared
0
Denied
Grace Medical, Inc. has 15 FDA 510(k) cleared ear, nose, throat devices. Based in Memphis, US.
Latest FDA clearance: Aug 2026. Active since 1994.
Browse the complete list of FDA 510(k) cleared ear, nose, throat devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Third Party Review Group, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Grace Medical, Inc.
15 devices
Cleared
Aug 18, 2026
Tympendi™ (810)
Ear, Nose, Throat
202d
Cleared
Nov 24, 2023
Tympanostomy Tubes
Ear, Nose, Throat
136d
Cleared
Aug 25, 2016
DragonFly Surgical Drill System
Ear, Nose, Throat
99d
Cleared
Sep 14, 2009
GRACE DYNAMIC TORP
Ear, Nose, Throat
144d
Cleared
Apr 17, 2008
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES
Ear, Nose, Throat
98d
Cleared
Dec 06, 2006
NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS...
Ear, Nose, Throat
28d
Cleared
Oct 24, 2006
GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
Ear, Nose, Throat
46d
Cleared
Sep 27, 2006
BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES
Ear, Nose, Throat
43d
Cleared
Aug 18, 2006
GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR...
Ear, Nose, Throat
49d
Cleared
Jun 28, 2006
PARTIAL OSSICULAR REPLACEMENT PROSTHESES
Ear, Nose, Throat
121d
Cleared
May 18, 1999
STAPES PROSTHESES
Ear, Nose, Throat
27d
Cleared
Jul 15, 1998
TYMPANOSTOMY TUBE
Ear, Nose, Throat
72d
Cleared
Oct 08, 1997
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
Ear, Nose, Throat
72d
Cleared
Oct 10, 1996
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
Ear, Nose, Throat
22d
Cleared
Oct 11, 1994
TYMPANOSTOMY TUBE
Ear, Nose, Throat
92d