Panels › Ear, Nose, Throat › Product code ETA · Class 2
Replacement, Ossicular Prosthesis, Total
Regulation 874.3495
2510(k)s in 12 months (40 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in ETA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2026 | K260264 | Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) Shanghai Medi Astro Technology Co., Ltd., CN | ETA |
| Apr 3, 2026 | K260719 | mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58 MED-EL Elektromedizinische Geräte GmbH, AT | ETA |
| Jan 17, 2025 | K241269 | mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit MED-EL Elektromedizinische Geräte GmbH, AT | ETA |
| Sep 14, 2009 | K091187 | GRACE DYNAMIC TORP Grace Medical, Inc. | ETA |
| Mar 23, 2009 | 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., IT | ETA |
| Jan 24, 2005 | K043375 | FISCH TITANIUM MIDDLE EAR PROSTHESES Karl Storz Endoscopy | ETA |
| Oct 1, 2004 | K042503 | KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM Heinz Kurz GmbH Medizintechnik, NL | ETA |
| Mar 3, 2003 | K030492 | TITANIUM OSSICULAR REPLACMENT SYSTEM Invotec International, Inc. | ETA |
| Aug 29, 2000 | K002378 | MODULAR PORP AND TORP MODEL TBD Gyrus Ent LLC | ETA |
| Aug 8, 2000 | K001406 | HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES Mednet Locator, Inc. | ETA |
| Aug 8, 2000 | K001404 | GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON Mednet Locator, Inc. | ETA |
| Jul 10, 2000 | K001902 | BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD Gyrus Ent LLC | ETA |
| Nov 10, 1999 | K993583 | ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM Stryker Corp. | ETA |
| Aug 9, 1999 | K992138 | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES Micromedics, Inc. | ETA |
| Mar 31, 1999 | K990601 | BOJRAB MICRO-TORP, MODEL 7014-5845 Gyrus Ent LLC | ETA |
| Jun 5, 1998 | K981088 | MILLS COLUMELLA PROSTHESIS Exmoor Plastics , Ltd., GB | ETA |
| Sep 5, 1997 | K972735 | TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP) Mednet Locator, Inc. | ETA |
| Aug 22, 1997 | K963899 | CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1) Exmoor Plastics , Ltd., GB | ETA |
| Aug 4, 1997 | K972585 | AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN Heinz Kurz GmbH Medizintechnik, DE | ETA |
| Dec 22, 1995 | K955615 | MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS Misten Medical Corp. | ETA |
| Oct 27, 1995 | K954518 | TREBAY TOTAL RECTANGULAR HEAD Trebay Medical Corp. | ETA |
| Jul 3, 1995 | K952549 | RICHARDS TORP Smith & Nephew Richards, Inc. | ETA |
| Mar 21, 1995 | K950927 | HAPEX MALLEABLE TORP Smith & Nephew Richards, Inc. | ETA |
| Nov 22, 1994 | K945106 | MICROMED TOTAL REGULAR AND PARTIAL OFFSET Micromed Development Corp. | ETA |
| Jun 8, 1994 | K934107 | BLACK OVAL-TOP TORP/PORP Smith & Nephew Richards, Inc. | ETA |
| Dec 18, 1991 | K913286 | H/A TOTAL-REGULAR, H/A TOTAL-OFFSET River Medical, Inc. | ETA |
| Sep 9, 1991 | K911583 | IONOS(R) OSSICLE 5MM & 7MM Ionos GmbH & Co. KG, DE | ETA |
| Jun 21, 1991 | K904239 | SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES Microbio-Medics, Inc. | ETA |
| Dec 26, 1989 | K895815 | MICROTEK TOTAL OSSICULAR PROTHESIS Microbio-Medics, Inc. | ETA |
| Jun 16, 1989 | K884884 | OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL Porex Technologies Corp. of Georgia | ETA |
| Apr 19, 1989 | K885201 | OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT Microbio-Medics, Inc. | ETA |
| Feb 6, 1987 | K864444 | SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE Richards Medical Co., Inc. | ETA |
| Feb 2, 1987 | K864443 | EGG-TOP TORP AND EGG-TOP PORP Richards Medical Co., Inc. | ETA |
| Jan 9, 1985 | K843461 | BIOGLASS OSSICULAR RECONSTRUCTION PROSTH American Biomaterials Corp. | ETA |
| Jun 24, 1983 | K823919 | TOTAL OSSICULAR REPLACEMENT Treace Medical, Inc. | ETA |
| Jun 24, 1983 | K823918 | AUSTIN MODIFIED PARTIAL OSSICULAR RE- Treace Medical, Inc. | ETA |
| Jun 24, 1983 | K823917 | PARTIAL OSSICULAR REPLACEMENT Treace Medical, Inc. | ETA |
| Jun 24, 1983 | K823912 | AUSTIN MODIFIED TOTAL OSSICULAR REPLACE Treace Medical, Inc. | ETA |
| Jun 16, 1981 | K810707 | CERAVITAL CERAMIC OSSICULAR REPL. PROS. Xomed, Inc. | ETA |
| Oct 5, 1976 | K760433 | SHEA TORP, OTOLOGY IMPLANT Richard'S Medical Equip., Inc. | ETA |
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