Company · US
Grace Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (1 in 12 months)
1recalls (1 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2026 | K260266 | Tympendi (810) Grace Medical, Inc. | KHJ |
| Nov 24, 2023 | K232059 | Tympanostomy Tubes Grace Medical, Inc. | ETD |
| Aug 25, 2016 | K161376 | DragonFly Surgical Drill System Grace Medical, Inc. | ERL |
| Sep 14, 2009 | K091187 | GRACE DYNAMIC TORP Grace Medical, Inc. | ETA |
| Apr 17, 2008 | K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. | ETB |
| Dec 6, 2006 | K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE Grace Medical, Inc. | ETB |
| Oct 24, 2006 | K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES Grace Medical, Inc. | ETD |
| Sep 27, 2006 | K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES Grace Medical, Inc. | ETD |
| Aug 18, 2006 | K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. | ETB |
| Jun 28, 2006 | K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. | ETB |
| May 18, 1999 | K991394 | STAPES PROSTHESES Grace Medical, Inc. | ETB |
| Jul 15, 1998 | K981575 | TYMPANOSTOMY TUBE Grace Medical, Inc. | ETD |
| Oct 8, 1997 | K972815 | PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT Grace Medical, Inc. | ETB |
| Oct 10, 1996 | K963752 | PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS Grace Medical, Inc. | ETB |
| Oct 11, 1994 | K943325 | TYMPANOSTOMY TUBE Grace Medical, Inc. | ETD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2026 | Grace Medical, Inc. TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L
Model/Catalog Number: 409-375
Product Description: Stapes Prosthesis Open, Classified |
ETB | K060518 |