Profile: Luxtec produces medical illumination systems. We develop lighting and visualization systems for the operating room. Our products include headlights, ultralite, halogen, camera, surgical loupes, monitors, printers, and light sources. Our ultralite consists of ergonomic designs that use the head's natural contours to hold the light in place without uncomfortable pressure. Our MicroLux® DLX headlight camera system gives an entirely new way to visualize, edit, share and store surgical cases. Our adjustable surgical loupes make fitting easy and simplify the customization procedure to a minor movement of the loupe body. It requires neither time-consuming multiple fittings nor intrusive Pupillary Distance (PD) measurements. The frames can be fitted with prescription lenses and adjusted to fit the surgeon's PD on the spot. Our light source brings the brilliance of surgical lighting with the breakthrough CLX system, which is the first Xenon light source designed specifically for private practice, surgical centers and community hospitals. We develop lighting and visualization systems for the operating room.

The company was founded in 1981, has revenues of USD 10-25 Million, has ~140 employees and is ISO 9001, CE certified. NASDAQ:IART (SEC Filings)

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• Manual Cast Application and Removal Instrument (FDA Code: LGG / 888.5980) A manual cast application and removal instrument is a nonpowered hand-held device intended to be used in applying or removing a cast. This generic type of device includes the cast knife, cast spreader, plaster saw, plaster dispenser, and casting stand.

• Manual Operating Room Table (FDA Code: FSE / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Manual Osteotome (FDA Code: GFI / 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.

• Manual Rongeur (FDA Code: HAE / 882.4840) A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

• Manual Saw & Accessories (FDA Code: GDR / 878.4800)

• Manual Stethoscope (FDA Code: LDE / 870.1875) A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Manual Tonometer (FDA Code: HKY / 886.1930) A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

• Manual Trephines & Accessories (FDA Code: HBG / 882.4300) Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

• Mastoid Chisel (FDA Code: JYD / 878.4800)

• Mastoid Rongeurs (FDA Code: JZA / 874.4420)

• Measuring Gauge (FDA Code: JYJ / 874.4420)

• Medical Instrument Ultrasonic Cleaner (FDA Code: FLG / 880.6150) An ultrasonic cleaner for medical instruments is a device intended for cleaning medical instruments by the emission of high frequency soundwaves.

• Medical Linear Accelerator (FDA Code: IYE / 892.5050) A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

• Medical Probes (FDA Code: HXB / 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.

• Medical Rasps (FDA Code: HTR / 878.4800)

• Metal Vaginal Speculum (FDA Code: HDF / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Metal/Plastic Urethral Sound (FDA Code: FBX / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

• Metal/Polymer Semi-Constrained Ankle Prosthesis (FDA Code: HSN / 888.3110) An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).

• Micro Video Camera Systems for Endoscopy

• Micro Video Camera Systems for Microscopy

• Microsurgical Ear Hook (FDA Code: JYL / 874.4420)

• Microsurgical Ear Pick (FDA Code: JYT / 874.4420)

• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Middle Ear Chisel (FDA Code: JYE / 874.4420)

• Monocrome Video Camera

• Mouth Gags (FDA Code: KBN / 874.4420)

• Myringotomy Knife (FDA Code: JYP / 874.4420)

• Nail Extractors (FDA Code: HWB / 888.4540)

• Nail/Blade/Plate Component Fixation Appliance (FDA Code: LXT / 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.

• Nasal Chisel (FDA Code: KAN / 878.4800)

• Nasal Curette (FDA Code: KAP / 874.4420)

• Nasal Knife (FDA Code: KAS / 874.4420)

• Nasal Rongeur (FDA Code: KBB / 874.4420)

• Nasal Saw (FDA Code: KBC / 874.4420)

• Nasal Scissors (FDA Code: KBD / 874.4420)

• Nasal Scissors Straight (FDA Code: KBD / 874.4420)

• Nasal Snare (FDA Code: KBE / 874.4420)

• Nasal Splints (FDA Code: EPP / 874.5800) An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

• Natural Absorbable Suture (FDA Code: GAL / 878.4830) An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.

• Nerve Cuff (FDA Code: JXI / 882.5275) A nerve cuff is a tubular silicone rubber sheath used to encase a nerve for aid in repairing the nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the nerve to prevent the formation of neuroma (tumors).

• Neurological Camera Systems, Endoscopy Recording Systems

• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560) A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

• Neurology Self-Retaining Retractor (FDA Code: GZT / 882.4800) A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.

• Neurosurgical Fragmentation and Aspiration Device (FDA Code: LBK)

• Neurosurgical Head Holder (FDA Code: HBL / 882.4460) A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

• Neurosurgical Head Rest (FDA Code: HBM / 882.4440) A neurosurgical headrest is a device used to support the patient's head during a surgical procedure.

• No Adhesive External Aesthetic Restoration Material (FDA Code: NOK / 878.3800) An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non-Alterable Preformed Skull Bone Plate (FDA Code: GXN / 882.5330) A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.