The company was founded in 1976, has revenues of USD 1-5 Million, has ~50 employees and is CE certified.
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|• (FDA Code: JBP / 864.7140)|
An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.
|• (FDA Code: KGX / 880.5240)|
A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.
|• (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.
|• (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.
|• (FDA Code: GKP / 864.5400)|
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
|• (FDA Code: JOX / 864.5680)|
An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.
|• (FDA Code: LWS)|
|• (FDA Code: CAC / 868.5830)|
An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
|• (FDA Code: MAV / 870.1650)|
An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
|• (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.
|• (FDA Code: KNW / 876.1075)|
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
|• (FDA Code: KNW / 876.1075)|
|• (FDA Code: JCA / 864.6100)|
A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.
|• (FDA Code: KSR / 864.9100)|
An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.
|• (FDA Code: LPB)|
|• (FDA Code: KRI / 870.4200)|
Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.
|• (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.
|• (FDA Code: DTN / 870.4400)|
A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.
|• (FDA Code: DTS / 870.4420)|
A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.
|• (FDA Code: DTQ / 870.4220)|
A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.
|• (FDA Code: DTR / 870.4240)|
A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.
|• (FDA Code: DTZ / 870.4350)|
A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.
|• (FDA Code: JOR / 870.4320)|
A cardiopulmonary bypass pulsatile flow generator is an electrically and pneumatically operated device used to create pulsatile blood flow. The device is placed in a cardiopulmonary bypass circuit downstream from the oxygenator.
|• (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.
|• (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.
|• (FDA Code: KRJ / 870.4280)|
A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood.
|• (FDA Code: DWO / 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.