Panels › Ear, Nose, Throat › Product code ETB · Class 2
Prosthesis, Partial Ossicular Replacement
Regulation 874.3450
2510(k)s in 12 months (74 all time)
1recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in ETB
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2026 | K260720 | mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesi MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
| Apr 3, 2026 | K260718 | mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
| Jan 17, 2025 | K241261 | mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
| Jan 17, 2025 | K241142 | mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis MED-EL Elektromedizinische Geräte GmbH, AT | ETB |
| Dec 2, 2013 | K130512 | NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS Heinz Kurz GmbH Medizintechnik, DE | ETB |
| Feb 8, 2013 | K112616 | NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS Heinz Kurz GmbH Medizintechnik, NL | ETB |
| Apr 17, 2008 | K080070 | K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. | ETB |
| Dec 6, 2006 | K063374 | NITINOL LOCKING INCUDO-STAPEDIAL JOINT, ANGULAR PISTON, PISTON, MALLEUS PISTON, PORP AND FOOTPLATE SHOE Grace Medical, Inc. | ETB |
| Aug 18, 2006 | K061853 | GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. | ETB |
| Jun 28, 2006 | K060518 | PARTIAL OSSICULAR REPLACEMENT PROSTHESES Grace Medical, Inc. | ETB |
| Nov 24, 2003 | K033554 | SMART OFFSET STAPES PISTON; SMART ISJ PROSTHESIS Gyrus Ent LLC | ETB |
| May 21, 2002 | K021479 | CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861 Heinz Kurz GmbH Medizintechnik, NL | ETB |
| Nov 9, 2001 | K013573 | CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 Heinz Kurz GmbH Medizintechnik, NL | ETB |
| Mar 8, 2001 | K010442 | KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 Heinz Kurz, NL | ETB |
| Oct 31, 2000 | K003214 | SMITH & NEPHEW PISTONS Gyrus Ent LLC | ETB |
| Oct 12, 2000 | K002737 | SMITH & NEPHEW PORPS & TORPS Gyrus Ent LLC | ETB |
| Oct 11, 2000 | K002897 | TITANIUM MIDDLE EAR PROSTHESES Xomed, Inc. | ETB |
| Aug 29, 2000 | K002464 | SMITH & NEPHEW OFF-CENTERED PORP Gyrus Ent LLC | ETB |
| Aug 9, 2000 | K002221 | KURKZ K-PISTON TITANIUM STAPEDIAL PROSTHESIS, MODEL 1006 103-1006 170 Heinz Kurz GmbH Medizintechnik, NL | ETB |
| Jun 23, 2000 | K001142 | AUDIO TECHNOLOGIES S:R.1 Audio Technologies S.R.L., IT | ETB |
| Apr 3, 2000 | K000858 | WEHRS INCUS-STAPES Gyrus Ent LLC | ETB |
| Feb 11, 2000 | K000256 | CAP PORP, CAP TORP Gyrus Ent LLC | ETB |
| Nov 10, 1999 | K993234 | MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Micromedics, Inc. | ETB |
| Sep 16, 1999 | K992839 | SOCKET STAPES PISTON W/O LOOP, SCHOBEL, SCHOBEL-CAUSSE Heinz Kurz GmbH Medizintechnik, NL | ETB |
| May 18, 1999 | K991394 | STAPES PROSTHESES Grace Medical, Inc. | ETB |
| Mar 31, 1999 | K990923 | TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 Heinz Kurz, DE | ETB |
| May 20, 1998 | K981045 | EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS Exmoor Plastics , Ltd., GB | ETB |
| Jan 22, 1998 | K974365 | MILLS INCUS HA SLEEVE Exmoor Plastics , Ltd., GB | ETB |
| Nov 21, 1997 | K973356 | K-PISTON WITH BAND HOOK /ANGULAR PISTON Heinz Kurz, DE | ETB |
| Oct 8, 1997 | K972815 | PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT Grace Medical, Inc. | ETB |
| Sep 5, 1997 | K972737 | CAUSSE PISTON Mednet Locator, Inc. | ETB |
| Sep 5, 1997 | K972734 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) Mednet Locator, Inc. | ETB |
| Aug 4, 1997 | K972492 | BELL PROSTHESIS (PARTIAL) Heinz Kurz, DE | ETB |
| Mar 10, 1997 | K964909 | ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS Xomed, Inc. | ETB |
| Jan 22, 1997 | K962564 | RICHARDS TOTAL/PARTIAL PROSTHESIS Gyrus Ent LLC | ETB |
| Jan 2, 1997 | K964798 | PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Anthony D. Prescott | ETB |
| Oct 10, 1996 | K963752 | PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS Grace Medical, Inc. | ETB |
| May 14, 1996 | K945105 | POLY/PLATINUM WIRE PISTON Micromed Development Corp. | ETB |
| Dec 22, 1995 | K955613 | MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS Misten Medical Corp. | ETB |
| Oct 27, 1995 | K954517 | TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT & STRAIGHT INCUS STRUT Trebay Medical Corp. | ETB |
| Jun 16, 1995 | K952481 | RICHARDS PORP Smith & Nephew Richards, Inc. | ETB |
| Mar 15, 1995 | K950984 | HAPES MALLEABLE INCUS STAPES Smith & Nephew Richards, Inc. | ETB |
| Mar 15, 1995 | K950887 | HAPEX INCUS Smith & Nephew Richards, Inc. | ETB |
| Mar 15, 1995 | K950886 | HAPEX PORP Smith & Nephew Richards, Inc. | ETB |
| Mar 15, 1995 | K950885 | HAPEX MALLEABLE PORP Smith & Nephew Richards, Inc. | ETB |
| Nov 22, 1994 | K945108 | POLY PISTON Micromed Development Corp. | ETB |
| Nov 22, 1994 | K945107 | POLY-WIRE PISTON Micromed Development Corp. | ETB |
| Nov 22, 1994 | K945104 | MICROMED PARTIAL REGULAR AND PARTIAL OFFSET Micromed Development Corp. | ETB |
| Mar 8, 1993 | K925443 | INCUDOSTAPEDIAL JOINT Smith & Nephew Richards, Inc. | ETB |
| Dec 27, 1991 | K915120 | TEF/PLATINUM PISTON River Medical, Inc. | ETB |
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