FDA Product Code
FDA Product Code ETA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3495
510(k) Clearances — 39 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 | MED-EL Elektromedizinische Geräte GmbH | 2026-04-03 | Special | PDF ↗ |
| K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit | MED-EL Elektromedizinische Geräte GmbH | 2025-01-17 | Traditional | PDF ↗ |
| K091187 | GRACE DYNAMIC TORP | Grace Medical, Inc. | 2009-09-14 | Traditional | PDF ↗ |
| K083780 | SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 | Audio Technologies S.R.L. | 2009-03-23 | Traditional | PDF ↗ |
| K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES | Karl Storz Endoscopy | 2005-01-24 | Traditional | PDF ↗ |
| K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM | Heinz Kurz GmbH Medizintechnik | 2004-10-01 | Traditional | PDF ↗ |
| K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM | Invotec International, Inc. | 2003-03-03 | Traditional | PDF ↗ |
| K002378 | MODULAR PORP AND TORP MODEL TBD | Gyrus Ent LLC | 2000-08-29 | Traditional | PDF ↗ |
| K001404 | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON | Mednet Locator, Inc. | 2000-08-08 | Traditional | PDF ↗ |
| K001406 | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES | Mednet Locator, Inc. | 2000-08-08 | Traditional | PDF ↗ |
| K001902 | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD | Gyrus Ent LLC | 2000-07-10 | Traditional | PDF ↗ |
| K993583 | ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM | Stryker Corp. | 1999-11-10 | Traditional | PDF ↗ |
| K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES | Micromedics, Inc. | 1999-08-09 | Traditional | PDF ↗ |
| K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 | Gyrus Ent LLC | 1999-03-31 | Traditional | PDF ↗ |
| K981088 | MILLS COLUMELLA PROSTHESIS | Exmoor Plastics , Ltd. | 1998-06-05 | Traditional | PDF ↗ |
| K972735 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) | Mednet Locator, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K963899 | CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) | Exmoor Plastics , Ltd. | 1997-08-22 | Traditional | PDF ↗ |
| K972585 | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN | Heinz Kurz GmbH Medizintechnik | 1997-08-04 | Traditional | PDF ↗ |
| K955615 | MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS | Misten Medical Corp. | 1995-12-22 | Traditional | PDF ↗ |
| K954518 | TREBAY TOTAL RECTANGULAR HEAD | Trebay Medical Corp. | 1995-10-27 | Traditional | PDF ↗ |
| K952549 | RICHARDS TORP | Smith & Nephew Richards, Inc. | 1995-07-03 | Traditional | PDF ↗ |
| K950927 | HAPEX MALLEABLE TORP | Smith & Nephew Richards, Inc. | 1995-03-21 | Traditional | PDF ↗ |
| K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET | Micromed Development Corp. | 1994-11-22 | Traditional | PDF ↗ |
| K934107 | BLACK OVAL-TOP TORP/PORP | Smith & Nephew Richards, Inc. | 1994-06-08 | Traditional | PDF ↗ |
| K913286 | H/A TOTAL-REGULAR, H/A TOTAL-OFFSET | River Medical, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K911583 | IONOS(R) OSSICLE 5MM & 7MM | Ionos GmbH & Co. KG | 1991-09-09 | Traditional | PDF ↗ |
| K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES | Microbio-Medics, Inc. | 1991-06-21 | Traditional | PDF ↗ |
| K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS | Microbio-Medics, Inc. | 1989-12-26 | Traditional | PDF ↗ |
| K884884 | OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL | Porex Technologies Corp. of Georgia | 1989-06-16 | Traditional | PDF ↗ |
| K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT | Microbio-Medics, Inc. | 1989-04-19 | Traditional | PDF ↗ |
| K864444 | SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE | Richards Medical Co., Inc. | 1987-02-06 | Traditional | PDF ↗ |
| K864443 | EGG-TOP TORP AND EGG-TOP PORP | Richards Medical Co., Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K843461 | BIOGLASS OSSICULAR RECONSTRUCTION PROSTH | American Biomaterials Corp. | 1985-01-09 | Traditional | PDF ↗ |
| K823918 | AUSTIN MODIFIED PARTIAL OSSICULAR RE- | Treace Medical, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K823919 | TOTAL OSSICULAR REPLACEMENT | Treace Medical, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K823917 | PARTIAL OSSICULAR REPLACEMENT | Treace Medical, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K823912 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE | Treace Medical, Inc. | 1983-06-24 | Traditional | PDF ↗ |
| K810707 | CERAVITAL CERAMIC OSSICULAR REPL. PROS. | Xomed, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K760433 | SHEA TORP, OTOLOGY IMPLANT | Richard'S Medical Equip., Inc. | 1976-10-05 | Traditional | PDF ↗ |
Product code ETA · Class II · Ear, Nose, Throat. Data: openFDA.