ClearanceBrief
Company · US

Angiodynamics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2026. Name variants (Inc, Corp, punctuation) are merged.

90510(k) clearances (2 in 12 months)
135recalls (20 in 12 months)
114recalls that name a 510(k)

Product codes

CodeDeviceRecords
MSDCatheter, Hemodialysis, Implanted38
DQOCatheter, Intravascular, Diagnostic34
GEXPowered Laser Surgical Instrument19
DREDilator, Vessel, For Percutaneous Catheterization15
NEYSystem, Ablation, Microwave And Accessories15
DYBIntroducer, Catheter13
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days12
OABLow Energy Direct Current Thermal Ablation System8
KRACatheter, Continuous Flush7
LJTPort & Catheter, Implanted, Subcutaneous, Intravascular7
FRNPump, Infusion6
GEIElectrosurgical, Cutting & Coagulation & Accessories6
QEYMechanical Thrombolysis Catheter6
FGEStents, Drains And Dilators For The Biliary Ducts5
NZTDosimeter, Ionizing Radiation, Implanted5
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass4
OEZCardiovascular Procedure Kit4
QEZAspiration Thrombectomy Catheter4
DQRCannula, Catheter3
DQYCatheter, Percutaneous3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 24, 2026K253198NanoKnife Generator (H78720300351US0)
Angiodynamics
OAB
Nov 24, 2025K252509AlphaVac Multipurpose Mechanical Aspiration System F1885
AngioDynamics, Inc.
QEZ
Oct 24, 2025K253106AngioVac Cannula
AngioDynamics, Inc.
DWF
Dec 6, 2024K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Sin
AngioDynamics, Inc.
OAB
Apr 1, 2024K240397AlphaVac MMA F1885 System (H787253020)
AngioDynamics, Inc.
QEZ
Jul 20, 2023K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
AngioDynamics, Inc.
GEX
Mar 27, 2023K223581Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc.
NEY
Mar 7, 2023K221883Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc.
NEY
Apr 4, 2022K213388AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
AngioDynamics, Inc.
QEZ
Dec 3, 2021K213067Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc.
NEY
Sep 30, 2021K212386AngioVac F18 85
AngioDynamics, Inc.
DWF
Jun 4, 2021K211081AlphaVac Multipurpose Mechanical Aspiration (MMA) System
AngioDynamics, Inc.
QEZ
Sep 15, 2020K202347UNIFUSE Infusion System with Cooper Wire
AngioDynamics, Inc.
QEY
Jun 1, 2020K192864UNI*FUSE Infusion System with Cooper Wire
AngioDynamics, Inc.
QEY
May 22, 2020K190559SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
AngioDynamics, Inc.
LJT
Jul 5, 2019K190594AngioVac C20, AngioVac C180
AngioDynamics, Inc.
DWF
Jun 18, 2019K183385NanoKnife System
Angiodynamics
OAB
Feb 28, 2019K182250Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablati
AngioDynamics, Inc.
NEY
Jul 18, 2018K173762AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
AngioDynamics, Inc.
DQO
Jul 5, 2018K181044400um Perforator and Accessory Vein Ablation Kit
AngioDynamics, Inc.
GEX
Aug 24, 2017K171921VenaCure EVLT NeverTouch Procedure Kit
AngioDynamics, Inc.
GEX
Jul 19, 2017K170775Mini Stick ENVI Non-Vascular Introducer Kit
AngioDynamics, Inc.
DYB
May 30, 2017K170695VenaCure EVLT NeverTouch Direct Introducer Sheath
AngioDynamics, Inc.
DYB
May 30, 2017K163356Pulse* Spray Infusion System, Uni*Fuse Infusion System
AngioDynamics, Inc.
QEY
May 5, 2017K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm
AngioDynamics, Inc.
NEY
Apr 28, 2017K161596Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters
AngioDynamics, Inc.
DQO
Mar 30, 2017K170743AngioDynamics Total Abscession Biliary Drainage Catheter
AngioDynamics, Inc.
FGE
Feb 21, 2017K170258SpeedLyser Infusion Catheter Kit
AngioDynamics, Inc.
QEY
Jan 6, 2017K163141NAMIC ClearaCIL Contrast Injection Lines
AngioDynamics, Inc.
DQO
Nov 16, 2016K162914VenaCure EVLT NeverTouch Procedure Kit
AngioDynamics, Inc.
GEX
Oct 14, 2015K151724AngioDynamics Mariner Angiographic Catheters
AngioDynamics, Inc.
DQO
Jun 18, 2015K150089NanoKnife System
AngioDynamics, Inc.
OAB
Jan 27, 2015K142889Celerity PICC Tip Confirmation System
AngioDynamics, Inc.
LJS
Dec 11, 2014K142607AngioVac Circuit
Angiodynamics
DWE
Nov 12, 2014K142593AngioVac Cannula
AngioDynamics, Inc.
DWF
Oct 10, 2014K142614AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits
AngioDynamics, Inc.
GEX
Dec 19, 2013K133561VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
AngioDynamics, Inc.
GEX
Mar 26, 2013K130671VENACURE EVLT NEVERTOUCH PROCEDURE KIT
AngioDynamics, Inc.
GEX
Mar 30, 2012K112452ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS
AngioDynamics, Inc.
DQO
Jan 30, 2012K112600ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
AngioDynamics, Inc.
GEX
Oct 24, 2011K102329NANOKNIFE SYSTEM
AngioDynamics, Inc.
OAB
Jun 10, 2011K110936DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
AngioDynamics, Inc.
MSD
May 13, 2011K110225ANGIODYNAMICS, INC. VENACURE 1470 LASER
AngioDynamics, Inc.
GEX
Dec 15, 2010K102796ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
AngioDynamics, Inc.
GEX
Nov 26, 2010K100199ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
AngioDynamics, Inc.
GEX
Oct 20, 2010K101843DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
AngioDynamics, Inc.
MSD
Jun 17, 2010K101017ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
AngioDynamics, Inc.
LJT
Mar 25, 2010K093406MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
AngioDynamics, Inc.
LJS
Sep 23, 2008K081472SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
AngioDynamics, Inc.
LJT
Jul 3, 2008K080451UNIBLATE ELECTROSURGICAL DEVICE
AngioDynamics, Inc.
GEI

Newest 50 of 90.

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 17, 2026Angiodynamics, Inc.
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch)
Open, Classified
DQOK112452
K161596
Apr 17, 2026Angiodynamics, Inc.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouc
Open, Classified
DQOK112452
K161596
Apr 17, 2026Angiodynamics, Inc.
AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box), H7
Open, Classified
DQOK112452
K161596
Apr 17, 2026Angiodynamics, Inc.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pouch)
Open, Classified
DQOK112452
K161596
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouc
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 pouch
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity:
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: 10714021; Product/UPN No.: H787107140215 (Box), H787107140210 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145 (Box), H787107140140 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;
Open, Classified
DQOK112452
K161596 +1
Apr 17, 2026Angiodynamics, Inc.
Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;
Open, Classified
DQOK161596
K173762
Apr 17, 2026Angiodynamics, Inc.
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;
Open, Classified
DQOK112452
K161596 +1
Mar 18, 2025Angiodynamics, Inc.
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Open, Classified
PCTNone listed
Dec 27, 2024Angiodynamics, Inc.
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Open, Classified
MCWK241553
Jul 31, 2024Angiodynamics, Inc.
SOFT-VU KUMPE 5F X 65CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732701
Open, Classified
DQOK173762
Jul 31, 2024Angiodynamics, Inc.
SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Open, Classified
DQOK173762
Jul 3, 2024Angiodynamics, Inc.
IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
Open, Classified
PCTNone listed
May 3, 2024Angiodynamics, Inc.
BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
Open, Classified
MSDK131260
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
Open, Classified
MSDK101843
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
Open, Classified
MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
Open, Classified
MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
Open, Classified
MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
Open, Classified
MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
Open, Classified
MSDK110936
May 3, 2024Angiodynamics, Inc.
DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
Open, Classified
MSDK110936
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758
Open, Classified
DREK132713
Mar 21, 2024Angiodynamics, Inc.
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Open, Classified
DREK132713

Newest 50 of 135.

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