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

Elastomer, Silicone Block

21 CFR 874.3620 / Ear, Nose, Throat
FDA source (opens on fda.gov)

MIB is the FDA product code for Elastomer, Silicone Block, a class II device type, regulated under 21 CFR 874.3620. As of , FDA records hold 45 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
MIB
Device name
Elastomer, Silicone Block
Regulation
21 CFR 874.3620
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
45
Ingested recalls
3

Clearances, product code MIB

By decision year
45 clearances under product code MIB with a decision year between 1992 and 2024, 1998 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code MIB by decision year
YearClearances
19921
19941
19954
19965
19975
19989
20024
20032
20042
20053
20171
20181
20191
20201
20223
20231
20241

Applicants with the most clearances

Product code MIB
Applicants holding the most 510(k) clearances under product code MIB
ApplicantClearances
Aesthetic and Reconstructive Technologies, Inc.4
Hanson Medical, Inc.4
International Medical Devices, Inc4
Silimed, LLC4
Allied Biomedical Corp.3
Specialty Surgical Products, Inc.3
Applied Biomaterial Technologies2
Implantech Associates Inc2
Rand Scientific Corp.2
Seare Biomedical Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code