ClearanceBrief
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)
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Top companies in ETB

Decided510(k)Device and applicantCode
Dec 23, 1991K915121TEF/WIRE PISTON
River Medical, Inc.
ETB
Dec 18, 1991K913287H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
River Medical, Inc.
ETB
Dec 18, 1991K913285PTFE PISTON
River Medical, Inc.
ETB
Dec 4, 1991K910685WEHRS INCUS AND INCUS-STAPES PROSTHESES
Smith & Nephew Richards, Inc.
ETB
Oct 15, 1991K913619CERAVITAL MIDDLE EAR IMPLANT
Friedrichsfeld Medizintechnik AG
ETB
Dec 26, 1989K895814MICROTEK PISTON & WIRE PROSTHESES
Microbio-Medics, Inc.
ETB
Aug 3, 1989K893134APACERAM OSSICULAR PROSTHESIS
Asahi Optical Co. C/O Rosati Associates, P.C.
ETB
Jan 13, 1989K883727BUCKET PROSTHESIS PORP
Treace Medical, Inc.
ETB
Jul 2, 1987K872112XOMED PLATINUM WIRE TEFLON PISTION
Xomed, Inc.
ETB
Apr 15, 1987K870766PROSTHESIS WIRE
Treace Medical, Inc.
ETB
Jul 14, 1986K861369INCUS/STAPES PROSTHESIS
Richards Medical Co., Inc.
ETB
Jul 11, 1986K860460MICROTEK STAINLESS STEEL PISTON
Microtek Medical, Inc.
ETB
Feb 26, 1985K844961INCUS PROSTHESIS
Richards Medical Co., Inc.
ETB
Jul 6, 1984K841353CAUSSE SPONGE BOAT
Treace Medical, Inc.
ETB
Jan 3, 1984K832540DRUMTO STAPES PROSTHESIS
Humboldt Products
ETB
Dec 9, 1982K823483STAINLESS STEEL PISTONS
Humboldt Products
ETB
Dec 3, 1982K823440MCGEE MODIFIED STAINLESS STEEL PISTON
Treace Medical, Inc.
ETB
Dec 3, 1982K823439CAUSSE TEF-PISTON
Treace Medical, Inc.
ETB
Dec 3, 1982K823429FISCH MODIFIED TEF-WIRE PISTON
Treace Medical, Inc.
ETB
Dec 19, 1980K802873SHEA LOCKING BAIL PROSTHESIS
Richard'S Medical Equip., Inc.
ETB
Nov 12, 1980K802431SCHURING OSSICLE CUP & COLUMELLA PROSTH.
Richard'S Medical Equip., Inc.
ETB
Oct 5, 1976K760437CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
Richard'S Medical Equip., Inc.
ETB
Oct 5, 1976K760434TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY
Richard'S Medical Equip., Inc.
ETB
Sep 27, 1976K760435PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
Richard'S Medical Equip., Inc.
ETB

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