510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ETBClass II

Prosthesis, Partial Ossicular Replacement

21 CFR 874.3450 / Ear, Nose, Throat
FDA source (opens on fda.gov)

ETB is the FDA product code for Prosthesis, Partial Ossicular Replacement, a class II device type, regulated under 21 CFR 874.3450. As of , FDA records hold 74 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
ETB
Device name
Prosthesis, Partial Ossicular Replacement
Regulation
21 CFR 874.3450
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
74
Ingested recalls
3

Clearances, product code ETB

By decision year
74 clearances under product code ETB with a decision year between 1976 and 2026, 1997 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code ETB by decision year
YearClearances
19763
19802
19824
19842
19851
19862
19872
19893
19916
19931
19943
19957
19962
19978
19982
19994
20008
20012
20021
20031
20063
20081
20132
20252
20262

Applicants with the most clearances

Product code ETB
Applicants holding the most 510(k) clearances under product code ETB
ApplicantClearances
Grace Medical, Inc.7
Gyrus Ent LLC7
Smith & Nephew Richards, Inc.7
Heinz Kurz GmbH Medizintechnik6
Treace Medical, Inc.6
Richard'S Medical Equip., Inc.5
Heinz Kurz4
MED-EL Elektromedizinische Geräte GmbH4
Micromed Development Corp.4
River Medical, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order