Data / Medical devices / United States / Angiodynamics, Inc
Angiodynamics, Inc: FDA-registered device maker in Glens Falls, NY, United States, 11 510(k) clearances
Angiodynamics, Inc is registered with the FDA (registration 3017892510) in Glens Falls, NY, United States. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 6, 2024. 41 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017892510
- Address
- 8 Glens Falls Technical Park, Glens Falls, NY, United States, 12801
- Owner or operator
- ANGIODYNAMICS, INC (9028212)
- Roles
- Manufacturer
- First device listed
- June 15, 2006
- Registered through
- 2026
- Brand names listed
- Generator Accessories (Foot Switch, Power Cords), Habib 4X, Habib 4X Laparoscopic, Habib Cable, IntelliFlow Pump, IntelliFlow Pump Communication Cable, MRI Extention Cable, NanoKnife 3 Generator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Manufacturer | accessdata.fda.gov |
| Low Energy Direct Current Thermal Ablation System | OAB | 2 | Manufacturer | accessdata.fda.gov |
| System, Ablation, Microwave And Accessories | NEY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 6, 2024 | K242687 | NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) | OAB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 27, 2023 | K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| March 7, 2023 | K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| December 3, 2021 | K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 18, 2019 | K183385 | NanoKnife System | OAB | Substantially Equivalent | Angiodynamics | accessdata.fda.gov |
| February 28, 2019 | K182250 | Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| May 5, 2017 | K162449 | Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) | NEY | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| June 18, 2015 | K150089 | NanoKnife System | OAB | Substantially Equivalent | AngioDynamics, Inc. | accessdata.fda.gov |
| October 13, 2006 | K062935 | HABIB 4X LAPAROSCOPIC | GEI | Substantially Equivalent | Rita Medical Systems | accessdata.fda.gov |
| August 15, 2005 | K051420 | HABIB 4X | GEI | Substantially Equivalent | Emcision , Ltd. | accessdata.fda.gov |
| April 28, 2004 | K040989 | RITA SYSTEMS | GEI | Substantially Equivalent | Rita Medical Systems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 22, 2021 | 87567 | Class II | Terminated | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number | accessdata.fda.gov |
| October 2, 2019 | 84072 | Class II | Terminated | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 | The devices are not labelled correctly. End users impacted by this issue may experience a procedural delay. | accessdata.fda.gov |
| September 18, 2019 | 83907 | Class II | Terminated | BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chem | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure. | accessdata.fda.gov |
| April 17, 2019 | 82743 | Class II | Terminated | AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generat | Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure | accessdata.fda.gov |
| October 16, 2018 | 81477 | Class II | Terminated | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 | Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use | accessdata.fda.gov |
| July 24, 2018 | 80913 | Class II | Terminated | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous syste | BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled | accessdata.fda.gov |
| May 10, 2018 | 80169 | Class II | Terminated | XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | accessdata.fda.gov |
| January 18, 2018 | 79558 | Class II | Terminated | Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems. | NAMIC Fluid Management Convenience Kits contains a Fluid Delivery Set that was not assembled in accordance with specification, and prevents the device from being used, resulting in a minor delay in procedure. | accessdata.fda.gov |
| October 17, 2017 | 88596 | Class II | Terminated | Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, th | Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec). | accessdata.fda.gov |
| January 13, 2017 | 76347 | Class II | Terminated | NAMIC Fluid Delivery Set - 72" (183cm) UPN H965913000051, Catalog 91300005 | The product has the potential to be non-sterile as it was not packaged in accordance to specification. | accessdata.fda.gov |
| November 28, 2016 | 76570 | Class II | Terminated | Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO a | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Not | accessdata.fda.gov |
| September 7, 2016 | 75226 | Class II | Terminated | Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls | The Celerity ECG Cable Accessory Pack has the potential to contain an ECG Clip Cable that was not properly manufactured. The affected product is not soldered per specification, and may result in the device not properly conducting the ECG signal. | accessdata.fda.gov |
| August 29, 2016 | 75322 | Class II | Terminated | Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short o | Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have be | accessdata.fda.gov |
| June 8, 2016 | 74948 | Class II | Terminated | Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Tec | There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016. | accessdata.fda.gov |
| March 21, 2016 | 73815 | Class II | Terminated | Vortex MEDICAL AngioVac Circuit, REF/UPN VTX3100, STERILE, Rx Only, Single Use Only -- The AngioVac Circuit and AngioVac Circuit Pack are designed to be used with the AngioVac Cannula. | Maquet Cardiopulmonary, the manufacturer of the RotaFlow Centrifugal Pump, determined that the products may possess levels of endotoxin that exceed regulatory limits. AngioDynamics confirmed that the affected RotaFlow Centrifugal Pumps were included in packaged AngioVac Circuit Packs. | accessdata.fda.gov |
| March 14, 2016 | 73598 | Class II | Terminated | Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishi | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. | accessdata.fda.gov |
| November 3, 2015 | 72957 | Class II | Terminated | NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the | Procedure Products initiated the recall due to the inner lumen of the needles not meeting the intended specification. Specifically, at least a portion of the affected lot is unable to accept a 0.038" guidewire as intended. In some cases the inner lumen was found to be 0.036". | accessdata.fda.gov |
| January 9, 2015 | 70322 | Class II | Terminated | NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used | The labelled expiration dating of the affected product is not fully supported by shelf life verification testing, which may result in a sterility breach. Use of a Fluid Management Convenience Kit, where sterility has been breached, may result in an increased risk of infection. | accessdata.fda.gov |
| December 19, 2014 | 70388 | Class II | Terminated | Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product | Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle. | accessdata.fda.gov |
| August 25, 2014 | 69085 | Class II | Terminated | BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for | NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the | accessdata.fda.gov |
| June 11, 2013 | 65439 | Class II | Terminated | AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices. | The RITA Main Cable product contains the incorrect Instructions for Use. | accessdata.fda.gov |
| December 19, 2011 | 60729 | Not yet classified | Terminated | NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit label contains the cu | Navilyst Medical has received reports of damaged manifolds contained in certain NAMIC Convenience Kits which may result in air injection during certain procedures. | accessdata.fda.gov |
| August 1, 2011 | 59526 | Not yet classified | Terminated | 8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure. | The product may contain an incorrect size catheter and introducer. | accessdata.fda.gov |
| February 4, 2011 | 60775 | Not yet classified | Terminated | Exodus(TM) 8F (2.7 mm)/ 35 cm Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5 eaches --- Made in USA: 2301 Cen | Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated. | accessdata.fda.gov |
| September 27, 2010 | 56876 | Not yet classified | Terminated | Vortex VX Port, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816 | Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set. | accessdata.fda.gov |
| August 30, 2010 | 59680 | Not yet classified | Terminated | Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, AngioDynamics, Inc., One Horizon Way, Manchester, GA 30816 Indicated for central venous placement (either peripheral or chest placement) when pat | The labeling contains errors which result in the products being misbranded | accessdata.fda.gov |
| May 24, 2010 | 56219 | Not yet classified | Terminated | Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jefferson | One box containing five catheters did not complete the sterilization process prior to distribution. | accessdata.fda.gov |
| May 13, 2010 | 55786 | Not yet classified | Terminated | Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 6F Polyurethane Catheter (1.1 mm/1.9 mm), REF Catalog No. 45-213, UPN Product No. M001452130, STERILE, Rx ONLY, For Single Use | FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury. | accessdata.fda.gov |
| July 16, 2009 | 52762 | Not yet classified | Terminated | SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected bod | The product may contain an incorrect size catheter and introducer. | accessdata.fda.gov |
| August 6, 2008 | 49571 | Not yet classified | Terminated | NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, label | Firm became aware that a specific batch of the product may contain loose plastic particulates in the fluid pathway. | accessdata.fda.gov |
| October 3, 2007 | 45404 | Not yet classified | Terminated | Vortex VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816 | Incorrect Size Catheter: The product may contain an incorrect size catheter. | accessdata.fda.gov |
| April 3, 2007 | 37742 | Not yet classified | Terminated | RITA Starburst XL (3-5 cm Diameter/25cm Length), Electro-surgical Device, Manufactured by: RITA Medical Systems, Inc., One Horizon Way, Manchester, GA 31816 | The product may have a cracked tray which can compromise the sterility of the product. | accessdata.fda.gov |
| September 27, 2006 | 37442 | Not yet classified | Terminated | Vaxcel Implantable Vascular Access System - Titanium Mini-Port with PASV Valve and 8F Polyurethane Catheter, REF/Catalog No. 45-215, UPN/Material No. M001452150 | Sterile barrier may have been compromised. Firm received one complaint which demonstrated that the inner and outer seals of the port tray packaging had been compromised. | accessdata.fda.gov |
| June 13, 2006 | 37427 | Not yet classified | Terminated | Vaxcel Implantable Vascular Access System -Titanium Standard Port With 9F Polyurethane Catheter, Catalog/REF No. 45-315, UPN/Material No. M001453150, Single Use Only, STERILE, EO. Boston Scientific MEDI-TECH, /, 480 Plea | Mispackaging: some kits of peelable sheaths/dilators may contain a 10F sheath instead of a 9F sheath--(Recalling Firm was notified by supplier B. Braun Medical of the error) | accessdata.fda.gov |
| May 2, 2006 | 35342 | Not yet classified | Terminated | Talon Straight, 25 cm--Electrosurgical Device--RITA * Medical Systems, Inc. * StarBurst Talon * * REF: 700-102846 * 4 cm Diameter * 25 cm Length * Sterile/R * Catalog # 700-102846-RITA * Manufactured by: Rita Medical Sys | Misbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker. | accessdata.fda.gov |
| October 21, 2004 | 30489 | Not yet classified | Terminated | NAMIC Custom Angiographic Kit, Left Heart Kit -. Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls, NY 12801. | The kits contain defective Magellan Monoject Safety Needles. The needle shaft may separate from the hub. Tyco Healthcare has recalled the needles. | accessdata.fda.gov |
| September 20, 2004 | 30048 | Not yet classified | Terminated | LifePort, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices | The product has an incorrectly sized introducer included in the kit. The kit contains a 12 French introducer instead of a 7 French introducer. | accessdata.fda.gov |
| June 24, 2004 | 32286 | Not yet classified | Terminated | EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual labeled pouches, 10 units per box, 40 boxes per case. Firm on label: Schneider/NAMIC, Glens Falls, New York 12801 | Product labeled to contain Emcee Obturators contained Emcee Dilators. | accessdata.fda.gov |
| May 28, 2004 | 29253 | Not yet classified | Terminated | Circle C Dual Lumen Acute Hemodialysis/Apheresis Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm, Sterile, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816,. The pr | The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile. | accessdata.fda.gov |
| May 5, 2004 | 32288 | Not yet classified | Terminated | ''NAMIC Custom Angiographic Kit'' sold under the following labels: (1) Medical University of South Carolina. Pouch Catalog # 60131481; (2) Covenant Medical Center, Pouch Catalog #60131603; (3) St. Joseph Hospital, Pouch | Molded handles used in Angiographic Manifolds may be occluded. | accessdata.fda.gov |
| March 18, 2004 | 28669 | Not yet classified | Terminated | Product in clear plastic pouch labeled: Boston Scientific MEDI-TECH *** VASCULAR DILATOR *** Order No./REF: 48-151 M001481510, 5 Fr. Firm on the label: Boston Scientific Corporation, 480 Pleasant Street, Watertown, MA 02 | Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr. | accessdata.fda.gov |
Compare with other makers
- All makers of Low Energy Direct Current Thermal Ablation System
- All makers of System, Ablation, Microwave And Accessories
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
Updated December 6, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.