Profile: Angiodynamics, Inc. provides medical devices for radiologists, surgeons, and other physicians. We offer medical devices for the minimally invasive diagnosis and treatment of cancer and peripheral vascular disease. Our product line includes market-leading radio frequency ablation systems, vascular access, angiographic products and accessories, dialysis, angioplasty products, drainage, thrombolytic, embolization and venous products. Our patented electro surgical delivery method, known as the RITA system uses deployable radio frequency electrode arrays to raise the temperature of cells above 45 to 50°C and cause cellular death. The RITA System includes radio frequency generators and a family of electro surgical devices that deliver controlled thermal energy to the targeted tissue.

The company was founded in 1990, has revenues of USD 25-50 Million, has ~150 employees and is ISO 9001, CE certified. NASDAQ:ANGO (SEC Filings)

FDA Registration Number: 1056436

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• Intravenous Administration Kit (FDA Code: FPA / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Irrigation Catheter (FDA Code: GBX / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Long-Term Indwelling Peritoneal Catheter (FDA Code: FJS / 876.5630) (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.

• Long-Term Vascular Catheter

• Low Energy Direct Current Thermal Ablation System (FDA Code: OAB / 878.4400)

• Lumbo-Peritoneal Catheter Kit

• Multiple Lumen Catheter (FDA Code: GBP / 878.4200)

• N-Fil hydrogel Beads

• Non-Implanted Hemodialysis Catheters (FDA Code: MPB / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Other Catheter

• Parallel Flow Dialyzer (FDA Code: FJG / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Pediatric Angiographic Catheters

• Percutaneous Catheter (FDA Code: DQY / 870.1250) A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

• Peripheral Transluminal Angioplasty Catheter (FDA Code: LIT / 870.1250)

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Peritoneal Catheter (FDA Code: GBW / 878.4200)

• Photodynamic Therapy Laser System (FDA Code: MVF)

• Powered Flotation Therapy Bed (FDA Code: IOQ / 890.5170) A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.

• Powered Surgical Laser Instrument (FDA Code: GEX / 878.4810) (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.

• Radiofrequency Lesion Generator (FDA Code: GXD / 882.4400) A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

• Semi-Flex RFA Devices

• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200) An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

• Shunt Adaptor (FDA Code: FKN / 876.5540)

• Shunt Connector (FDA Code: FJQ / 876.5540)

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Single Needle Dialysis Kit (FDA Code: LBW / 876.5540)

• Single-Needle Hemodialysis Catheter

• Sterile Single-Use Angiographic Catheter

• Subclavian Catheter (FDA Code: LFJ / 876.5540)

• Surgical Needle Guide (FDA Code: GDF / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Suture Retention Device (FDA Code: KGS / 878.4930) A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.

• T-Type Infusion Blood Tubing Connector (FDA Code: FKB / 876.5820)

• Tenckhoff Catheter

• Therapeutic Intravascular Catheter (FDA Code: LJS / 880.5970) A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

• Tip Angiographic Catheters

• Vascular Access Port

• Vessel Dilator (FDA Code: FKA / 876.5540)

• Vessel Tip (FDA Code: FKW / 876.5540)