Data / Medical devices / United States / Grace Medical, Inc.
Grace Medical, Inc.: FDA-registered device maker in Memphis, TN, United States, 17 510(k) clearances
Grace Medical, Inc. is registered with the FDA (registration 1057421) in Memphis, TN, United States. It lists 25 device types. The FDA files 17 510(k) clearances under its listings, the newest dated August 18, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1057421
- FEI number
- 1000022662
- Address
- 8500 Wolf Lake DR. Suite 110, Memphis, TN, United States, 38133
- Owner or operator
- GRACE MEDICAL GROUP, INC. (9067138)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- July 24, 2006
- Registered through
- 2026
- Brand names listed
- 2 IN 1 ALTO, ACCUTIP AND DRAPE, ALTO CUTTER, ALTO CUTTER W/O RING, ALTO TOTAL, ARMSTONG R VENT TUBE, ARMSTRONG BEVELED STRAIGHT VENT TUBE, ARMSTRONG R VENT TUBE and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 18, 2026 | K260266 | Tympendi (810) | KHJ | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| November 24, 2023 | K232059 | Tympanostomy Tubes | ETD | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| August 25, 2016 | K161376 | DragonFly Surgical Drill System | ERL | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| March 13, 2014 | K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | KCT | Substantially Equivalent | Summit Medical, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131455 | RESTORE MODULAR STERILIZATION TRAY SYSTEM | KCT | Substantially Equivalent | Restore Medical Solutions, Inc. | accessdata.fda.gov |
| April 17, 2008 | K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES | ETB | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| December 6, 2006 | K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE | ETB | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| October 24, 2006 | K062672 | GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES | ETD | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| September 27, 2006 | K062385 | BLUE PTFE (FLUOROPLASTIC) VENTILATION TUBES | ETD | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| August 18, 2006 | K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES | ETB | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| June 28, 2006 | K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES | ETB | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| August 13, 1998 | K981751 | SINUSCOPE AND ACCESSORIES | EOB | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| July 15, 1998 | K981575 | TYMPANOSTOMY TUBE | ETD | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| October 8, 1997 | K972815 | PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT | ETB | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| October 10, 1996 | K963752 | PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS | ETB | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| October 11, 1994 | K943325 | TYMPANOSTOMY TUBE | ETD | Substantially Equivalent | Grace Medical, Inc. | accessdata.fda.gov |
| March 7, 1983 | K830228 | OTOLOGICAL VENTILATION TUBES-VARIOUS | ETD | Substantially Equivalent | Micromedics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 3, 2026 | 98773 | Class II | Ongoing | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: Product Description: Stapes Prosthesis | Due to incorrect functional length on device labeling. | accessdata.fda.gov |
| April 12, 2006 | 35214 | Not yet classified | Terminated | Krupin Eye Valve, P/N 6003 | Product may have deformed valves which would cause the valve not to operate properly. | accessdata.fda.gov |
Compare with other makers
- All makers of Tube, Tympanostomy
- All makers of Dressing, Compression
- All makers of Tray, Surgical, Ent
- All makers of Retractor, Ent
- All makers of Applicator, Ent
- All makers of Nasopharyngoscope (Flexible Or Rigid)
Updated August 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.