The company was founded in 1999, has revenues of USD 500 Million to 1 Billion, has ~650 employees and is ISO 9001, CE certified. NASDAQ:XOMD (SEC Filings)
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|• (FDA Code: FSD / 880.5160)|
|• (FDA Code: GGC / 864.5425)|
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
|• (FDA Code: HWE / 878.4820)|
Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
|• (FDA Code: HQR / 886.4100)|
A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.
|• (FDA Code: GEY / 878.4820)|
|• (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: KBJ / 874.4420)|
|• (FDA Code: KBS / 874.4420)|
|• (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: FMA / 880.6230)|
A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.
|• (FDA Code: BSP / 868.5150)|
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
|• (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.
|• (FDA Code: DXT / 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: 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: KAT / 874.4420)|
|• (FDA Code: KAW / 874.4420)|
|• (FDA Code: ILI / 890.3640)|
An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
|• (FDA Code: DSI / 870.1025)|
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
|• (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: HRX / 888.1100)|
An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
|• (FDA Code: NBH / 888.1100)|
|• (FDA Code: JYX / 874.4420)|
|• (FDA Code: ETY / 874.1090)|
An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.
|• (FDA Code: GKN / 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: NIK)|
|• (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: HWJ / 888.4540)|
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
|• (FDA Code: MAV / 870.1650)|
|• (FDA Code: HOG / 886.4070)|
A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.
|• (FDA Code: KYT / 880.6350)|
A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
|• (FDA Code: HQQ / 886.4100)|
|• (FDA Code: HQP / 886.4115)|
A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.
|• (FDA Code: HRC / 886.5928)|
A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.
|• (FDA Code: HJN / 886.1945)|
A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.
|• (FDA Code: FPS / 880.6070)|
A bed board is a device intended for medical purposes that consists of a stiff board used to increase the firmness of a bed.
|• (FDA Code: HXW / 888.4540)|
|• (FDA Code: HXP / 888.4540)|
|• (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: HXD / 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.
|• (FDA Code: HRS / 888.3030)|
Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.
|• (FDA Code: HWC / 888.3040)|
A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
|• (FDA Code: JDR / 888.3030)|
|• (FDA Code: HXL / 878.4800)|
|• (FDA Code: LYS / 888.4540)|