Grace Medical, Inc.
FDA Regulatory Profile
Grace Medical, Inc. appears in FDA public data with 1 recall, 15 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2308-2026, Class II) was initiated on April 3, 2026. Its most recent 510(k) clearance was granted on August 18, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2308-2026 | Class II | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Des | April 3, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260266 | Tympendi (810) | August 18, 2026 |
| K232059 | Tympanostomy Tubes | November 24, 2023 |
| K161376 | DragonFly Surgical Drill System | August 25, 2016 |
| K091187 | GRACE DYNAMIC TORP | September 14, 2009 |
| K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES | April 17, 2008 |
| K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE S | December 6, 2006 |
| K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | October 24, 2006 |
| K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | September 27, 2006 |
| K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES | August 18, 2006 |
| K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES | June 28, 2006 |
| K991394 | STAPES PROSTHESES | May 18, 1999 |
| K981575 | TYMPANOSTOMY TUBE | July 15, 1998 |
| K972815 | PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT | October 8, 1997 |
| K963752 | PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS | October 10, 1996 |
| K943325 | TYMPANOSTOMY TUBE | October 11, 1994 |