Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Grace Medical, Inc. with 15 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Aug 18, 2026: Tympendi™ (810).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 18, 2026 | Tympendi™ (810)K260266 · KHJ | 510(k) clearances |
| Apr 3, 2026 | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes ProsthesisClass II · Due to incorrect functional length on device labeling. | Device recalls |
| Nov 24, 2023 | Tympanostomy TubesK232059 · ETD | 510(k) clearances |
| Aug 25, 2016 | DragonFly Surgical Drill SystemK161376 · ERL | 510(k) clearances |
| Sep 14, 2009 | GRACE DYNAMIC TORPK091187 · ETA | 510(k) clearances |
| Apr 17, 2008 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESESK080070 · ETB | 510(k) clearances |
| Dec 6, 2006 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOEK063374 · ETB | 510(k) clearances |
| Oct 24, 2006 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBESK062672 · ETD | 510(k) clearances |
| Sep 27, 2006 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBESK062385 · ETD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
