Angiodynamics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
100
510(k) Clearances
90
Inspections
24
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-1862-2026Class IISoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: March 3, 2026
Z-1861-2026Class IISoft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog NMarch 3, 2026
Z-1874-2026Class IIAccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 03March 3, 2026
Z-1875-2026Class IIAccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NMarch 3, 2026
Z-1865-2026Class IISoft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog March 3, 2026
Z-1870-2026Class IISoft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog NMarch 3, 2026
Z-1856-2026Class IISoft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog NoMarch 3, 2026
Z-1873-2026Class IIAccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F XMarch 3, 2026
Z-1871-2026Class IISoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: March 3, 2026
Z-1864-2026Class IISoft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog March 3, 2026
Z-1863-2026Class IISoft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; CatalogMarch 3, 2026
Z-1867-2026Class IISoft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SMarch 3, 2026
Z-1859-2026Class IISoft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.March 3, 2026
Z-1872-2026Class IIAccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035March 3, 2026
Z-1857-2026Class IISoft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.:March 3, 2026
Z-1869-2026Class IISoft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; CaMarch 3, 2026
Z-1866-2026Class IISoft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.:March 3, 2026
Z-1858-2026Class IISoft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog NMarch 3, 2026
Z-1868-2026Class IISoft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; CatMarch 3, 2026
Z-1860-2026Class IISoft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog March 3, 2026

Recent 510(k) Clearances

K-NumberDeviceDate
K253198NanoKnife Generator (H78720300351US0)March 24, 2026
K252509AlphaVac Multipurpose Mechanical Aspiration System F1885November 24, 2025
K253106AngioVac CannulaOctober 24, 2025
K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H78720400December 6, 2024
K240397AlphaVac MMA F1885 System (H787253020)April 1, 2024
K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure KitsJuly 20, 2023
K223581Solero Microwave Tissue Ablation (MTA) System and AccessoriesMarch 27, 2023
K221883Solero Microwave Tissue Ablation (MTA) System and AccessoriesMarch 7, 2023
K213388AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 SystemApril 4, 2022
K213067Solero Microwave Tissue Ablation (MTA) System and AccessoriesDecember 3, 2021
K212386AngioVac F18 85September 30, 2021
K211081AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemJune 4, 2021
K202347UNIFUSE Infusion System with Cooper WireSeptember 15, 2020
K192864UNI*FUSE Infusion System with Cooper WireJune 1, 2020
K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsMay 22, 2020
K190594AngioVac C20, AngioVac C180July 5, 2019
K183385NanoKnife SystemJune 18, 2019
K182250Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero micFebruary 28, 2019
K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic CathetersJuly 18, 2018
K181044400um Perforator and Accessory Vein Ablation KitJuly 5, 2018