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

Collector, Ostomy

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

EXB is the FDA product code for Collector, Ostomy, a class I device type, regulated under 21 CFR 876.5900. As of , FDA records hold 102 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
EXB
Device name
Collector, 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
102
Ingested recalls
5

Clearances, product code EXB

By decision year
102 clearances under product code EXB with a decision year between 1976 and 2025, 1984 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code EXB by decision year
YearClearances
19764
19773
19786
19798
198010
198113
19824
19835
198417
198510
19867
19878
19883
19931
20141
20181
20251

Applicants with the most clearances

Product code EXB
Applicants holding the most 510(k) clearances under product code EXB
ApplicantClearances
Hollister, Inc.14
MEDLINE INDUSTRIES, LP - Northfield12
E. R. Squibb & Sons, Inc.10
Convatec, A Division of E.R. Squibb & Sons9
Howmedica Corp.9
C.R. Bard Inc6
Johnson & Johnson Professionals, Inc.5
Dbt Medical, Ltd.3
John F. Greer Co., Inc.3
Arnold Technologies2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 79 companies shown, in name order