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

Company510(k)sRecalls
Grace Medical, Inc.71
Gyrus Ent LLC70
Smith & Nephew Richards, Inc.70
Heinz Kurz GmbH Medizintechnik60
Treace Medical, Inc.60
Richard'S Medical Equip., Inc.50
Heinz Kurz40
MED-EL Elektromedizinische Geräte GmbH40
Micromed Development Corp.40
River Medical, Inc.40
DateFirm and productCodeLinked 510(k)
Jun 4, 2026Grace Medical, Inc.
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Open, Classified		 ETBK060518
Jul 14, 2020Olympus Corporation of the Americas
Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement Catalog Number: 70143662
Terminated		 ETBK003214
Jul 14, 2020Olympus Corporation of the Americas
Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168
Terminated		 ETBK003214

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