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

Injector, Contrast Medium, Automatic

21 CFR 870.1650 / Cardiovascular
FDA source (opens on fda.gov)

IZQ is the FDA product code for Injector, Contrast Medium, Automatic, a class II device type, regulated under 21 CFR 870.1650. As of , FDA records hold 23 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
IZQ
Device name
Injector, Contrast Medium, Automatic
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
23
Ingested recalls
3

Clearances, product code IZQ

By decision year
23 clearances under product code IZQ with a decision year between 1976 and 2026, 2007 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IZQ by decision year
YearClearances
19762
19951
19992
20031
20061
20073
20101
20162
20171
20201
20211
20243
20253
20261

Applicants with the most clearances

Product code IZQ
Applicants holding the most 510(k) clearances under product code IZQ
ApplicantClearances
Ulrich GmbH & Co. KG7
Acist Medical Systems, Inc.2
BD Becton Dickinson Vacutainer Systems Preanalytic2
E-Z-EM, Inc2
Imaxeon Pty Ltd2
Bracco Injeneering S.A.1
Kenex, Ltd.1
Mallinckrodt, Inc.1
Mallinckrodt Inc., Liebel-Flarsheim Business1
Medrad, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 35 companies shown, in name order