Grace Medical, Inc. - FDA 510(k) Cleared Devices

Cleared Aug 18, 2026

Tympendi™ (810)

K260266 · KHJ

Ear, Nose, Throat · 202d

Cleared Nov 24, 2023

Tympanostomy Tubes

K232059 · ETD

Ear, Nose, Throat · 136d

Cleared Aug 25, 2016

DragonFly Surgical Drill System

K161376 · ERL

Ear, Nose, Throat · 99d

Cleared Sep 14, 2009

GRACE DYNAMIC TORP

K091187 · ETA

Ear, Nose, Throat · 144d

Cleared Apr 17, 2008

K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K080070 · ETB

Ear, Nose, Throat · 98d

Cleared Dec 06, 2006

NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS...

K063374 · ETB

Ear, Nose, Throat · 28d

Cleared Oct 24, 2006

GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES

K062672 · ETD

Ear, Nose, Throat · 46d

Cleared Sep 27, 2006

BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES

K062385 · ETD

Ear, Nose, Throat · 43d

Cleared Aug 18, 2006

GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR...

K061853 · ETB

Ear, Nose, Throat · 49d

Cleared Jun 28, 2006

PARTIAL OSSICULAR REPLACEMENT PROSTHESES

K060518 · ETB

Ear, Nose, Throat · 121d

Cleared May 18, 1999

STAPES PROSTHESES

K991394 · ETB

Ear, Nose, Throat · 27d

Cleared Jul 15, 1998

TYMPANOSTOMY TUBE

K981575 · ETD

Ear, Nose, Throat · 72d

Cleared Oct 08, 1997

PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT

K972815 · ETB

Ear, Nose, Throat · 72d

Cleared Oct 10, 1996

PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS

K963752 · ETB

Ear, Nose, Throat · 22d

Cleared Oct 11, 1994

TYMPANOSTOMY TUBE

K943325 · ETD

Ear, Nose, Throat · 92d