510(k) Report

FDA applicant

Angiodynamics, Div. E-Z-Em, Inc.

Queensbury, NY6 decisions1992–19966 recalls

FDA records 6 decisions for Angiodynamics, Div. E-Z-Em, Inc. (Queensbury, NY) from 1992 to 1996: 6 510(k) clearances. Most are in product codes QEY (Mechanical Thrombolysis Catheter) and DXT (Injector And Syringe, Angiographic). 6 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Angiodynamics, Div. E-Z-Em, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Angiodynamics, Div. E-Z-Em, Inc. since 2007.

Recalls per year

1in 2018

2011: 22014: 32018: 1
2007high 3 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Angiodynamics, Div. E-Z-Em, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Angiodynamics”

FDA records each applicant name separately; these may or may not be the same firm.