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

Cement, Stomal Appliance, Ostomy

21 CFR 876.5900 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EZR is the FDA product code for Cement, Stomal Appliance, Ostomy, a class I device type, regulated under 21 CFR 876.5900. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EZR
Device name
Cement, Stomal Appliance, Ostomy
Regulation
21 CFR 876.5900
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code EZR

By decision year
6 clearances under product code EZR with a decision year between 1977 and 1985, 1977 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code EZR by decision year
YearClearances
19773
19791
19811
19851

Applicants with the most clearances

Product code EZR
Applicants holding the most 510(k) clearances under product code EZR
ApplicantClearances
Howmedica Corp.3
Atlantic Surgical1
E. R. Squibb & Sons, Inc.1
Suburban Ostomy Supply Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order