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

Media, Coupling, Ultrasound

21 CFR 892.1570 / Radiology
FDA source (opens on fda.gov)

MUI is the FDA product code for Media, Coupling, Ultrasound, a class II device type, regulated under 21 CFR 892.1570. As of , FDA records hold 34 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
MUI
Device name
Media, Coupling, Ultrasound
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
34
Ingested recalls
6

Clearances, product code MUI

By decision year
34 clearances under product code MUI with a decision year between 1982 and 2026, 2018 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code MUI by decision year
YearClearances
19821
20023
20034
20042
20071
20091
20112
20122
20132
20141
20161
20171
20185
20191
20211
20221
20231
20242
20262

Applicants with the most clearances

Product code MUI
Applicants holding the most 510(k) clearances under product code MUI
ApplicantClearances
Pharmaceutical Innovations, Inc.4
Sonotech, Inc.4
Hony Medical Co., Ltd2
Sheathing Technologies Inc2
Advance Medical Designs Inc1
Anhui Deepblue Medical Technology Co., Ltd.1
Bluemtech1
Cloverline International Pharma Services GmbH1
Dynarex Corp.1
Edgecare Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order