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

Catheter, Straight

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EZD is the FDA product code for Catheter, Straight, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 86 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
EZD
Device name
Catheter, Straight
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
87
Ingested recalls
13

Clearances, product code EZD

By decision year
87 clearances under product code EZD with a decision year between 1978 and 2026, 2026 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code EZD by decision year
YearClearances
19781
19945
19972
19991
20032
20042
20052
20074
20081
20092
20102
20114
20122
20134
20145
20151
20163
20172
20183
20201
202210
20236
20245
20256
202611

Applicants with the most clearances

Product code EZD
Applicants holding the most 510(k) clearances under product code EZD
ApplicantClearances
MEDLINE INDUSTRIES, LP - Northfield16
ConvaTec Limited6
C.R. Bard Inc5
Hollister Incorporated5
Compactcath, Inc3
Cure Medical, LLC3
Well Lead Medical Co. Ltd3
Wellspect Inc.3
Adapta Medical, Inc.2
Amsino International, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 74 companies shown, in name order