Angiodynamics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
80
510(k) Clearances
89
Inspections
24
Compliance Actions
3

Recent Recalls

NumberClassProductDate
Z-1391-2025Class IIIsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-6February 4, 2025
Z-0770-2025Class IIAURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100November 25, 2024
Z-2453-2024Class IISOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732June 18, 2024
Z-2454-2024Class IISOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732June 18, 2024
Z-2267-2024Class IIIsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100May 21, 2024
Z-1774-2024Class IIBioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term March 18, 2024
Z-1773-2024Class IIDURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascMarch 18, 2024
Z-1771-2024Class IIDURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vasMarch 18, 2024
Z-1768-2024Class IIDURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular March 18, 2024
Z-1770-2024Class IIDURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular March 18, 2024
Z-1766-2024Class IIDURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031March 18, 2024
Z-1767-2024Class IIDURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular March 18, 2024
Z-1760-2024Class IIDURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for HeMarch 18, 2024
Z-1769-2024Class IIDURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular March 18, 2024
Z-1765-2024Class IIDURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access foMarch 18, 2024
Z-1772-2024Class IIDURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascMarch 18, 2024
Z-1764-2024Class IIDURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access foMarch 18, 2024
Z-1762-2024Class IIDURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access foMarch 18, 2024
Z-1761-2024Class IIDURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascularMarch 18, 2024
Z-1763-2024Class IIDURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access fMarch 18, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
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
K171921VenaCure EVLT NeverTouch Procedure KitAugust 24, 2017