Profile: Edwards Lifesciences Corporation delivers acute hemodynamic monitoring & heart valves. Our new perimount magna heart valve (bioprosthesis), with its supra-annular design, offers optimal hemodynamics and flow characteristics for treatment of aortic heart valve diseases. Our embolectomy catheters are indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The company was founded in 1958, has revenues of USD 1-5 Million, has ~5600 employees and is ISO 9001, CE certified. NYSE:EW (SEC Filings)

FDA Registration Number: 2015691

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• Advanced Portable CW Dopplers

• Angiography Catheters

• Angioscope (FDA Code: LYK / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Annuloplasty Devices

• Annuloplasty Rings (FDA Code: KRH / 870.3800) An annuloplasty ring is a rigid or flexible ring implanted around the mitral or tricuspid heart valve for reconstructive treatment of valvular insufficiency.

• Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK / 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.

• Antimicrobial Central Venous Catheter

• Aortic Root Bioprostheses

• Aortic Root Bioprostheses, Bioprosthetic Aortic Valves

• Aortic Root Bioprostheses, Bioprosthetic Valved Conduits

• Aortic Valve

• Arterial Blood Sampling Kit (FDA Code: CBT / 868.1100) An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.

• Arterial Embolectomy Catheter

• Arterial Line Cardiopulmonary Bypass Blood Filter (FDA Code: DTM / 870.4260) A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

• Artery Vascular Clamp (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Atherectomy Peripheral Catheter (FDA Code: MCW / 870.4875) An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

• Balloon Catheters

• Biological Cardiac Valve Prosthesis (FDA Code: DYE / 870.3925) A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.

• Bioprosthetic Aortic Valves

• Bioprosthetic Mitral Valves

• Cardiac Catheters

• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290) A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Cardiopulmonary Bypass Pump Tube (FDA Code: DWE / 870.4390) A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.

• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210) A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

• Cardiovascular Catheters

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Cardiovascular Trocar (FDA Code: DRC / 870.1390) A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

• Catheter Cannula (FDA Code: DQR / 870.1300) A catheter cannula is a hollow tube which is inserted into a vessel or cavity; this device provides a rigid or semirigid structure which can be connected to a tube or connector.

• Catheter Introducers (FDA Code: DYB / 870.1340) A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

• Catheter Tip Blood Pressure Transducer (FDA Code: DXO / 870.2870) A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.

• Cholangiography Catheters (FDA Code: GBZ / 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.

• Continuous Flush Catheter (FDA Code: KRA / 870.1210) A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010) A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Disposable Ophthalmic Cannulae

• Dopplers

• Embolectomy Catheters (FDA Code: DXE / 870.5150) An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

• Endomyocardial Biopsy Device (FDA Code: DWZ / 870.4075) An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.

• Extravascular Blood Pressure Transducer (FDA Code: DRS / 870.2850) An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

• Fetal and Vascular Dopplers

• Fiberoptic Oximeter Catheter (FDA Code: DQE / 870.1230) A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.

• Flow Directed Catheter (FDA Code: DYG / 870.1240) A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 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.

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General Diagnostics

• General Medical Supplies

• General Surgery Supplies

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• Hand-Held Dopplers

• Heart Stabilizer (FDA Code: MWS / 870.4500)