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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)

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Top companies in ETA

Company	510(k)s	Recalls
Treace Medical, Inc.	4	0
Gyrus Ent LLC	3	0
Heinz Kurz GmbH Medizintechnik	2	1
Mednet Locator, Inc.	3	0
Microbio-Medics, Inc.	3	0
Smith & Nephew Richards, Inc.	3	0
Exmoor Plastics , Ltd.	2	0
MED-EL Elektromedizinische Geräte GmbH	2	0
Richards Medical Co., Inc.	2	0
American Biomaterials Corp.	1	0

Date	Firm and product	Code	Linked 510(k)
Sep 26, 2013	Medtronic Xomed, Inc. Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss. Terminated	ETA	K002897
Jun 30, 2011	Heinz Kurz GmbH Medizintechnik Kurz, Heinz Kurz Gmb, Medizintecnik, Tuebinger Strasse 3, 7214 Dusslingen, Germany, Surgical Implant, Clip - Piston MVP Titanium, REF: 1006 711, Lot 2 09 13 06. Product is designed for ossicular repl Terminated	ETA	None listed

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