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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|• (FDA Code: JWI / 888.3800)|
A wrist joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a wrist joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have either a one-part radial component made of alloys, such as cobalt-chromium-molybdenum, with an ultra-high molecular weight polyethylene bearing surface, or a two-part radial component made of alloys and an ultra-high molecular weight polyethylene ball that is mounted on the radial component with a trunnion bearing. The metallic portion of the two-part radial component is inserted into the radius. These devices have a metacarpal component(s) made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).
|• (FDA Code: JWJ / 888.3800)|
|• (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: HQO / 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: KBJ / 874.4420)|
|• (FDA Code: KBS / 874.4420)|
|• (FDA Code: KBH / 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: HGE / 884.4530)|
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:
|• (FDA Code: GDN / 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: CAZ / 868.5140)|
An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.
|• (FDA Code: BRY / 868.6100)|
An anesthetic cabinet, table, or tray is a device intended to store anesthetic equipment and drugs. The device is usually constructed to eliminate build-up of static electrical charges.
|• (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: HCH / 882.5200)|
An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.
|• (FDA Code: HCI / 882.4175)|
An aneurysm clip applier is a device used by the surgeon for holding and applying intracranial aneurysm clips.
|• (FDA Code: FER / 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.
|• (FDA Code: DXC / 870.4450)|
A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.
|• (FDA Code: NBH / 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: 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: 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: HXW / 888.4540)|
|• (FDA Code: FRC / 880.2800)|
A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.
|• (FDA Code: HXD / 878.4800)|
|• (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: KIK / 878.4800)|
|• (FDA Code: HXL / 878.4800)|
|• (FDA Code: LYS / 888.4540)|
|• (FDA Code: HTR / 878.4800)|
|• (FDA Code: HWD / 888.4540)|
|• (FDA Code: HWO / 888.4540)|
|• (FDA Code: HXJ / 888.4540)|
|• (FDA Code: HWX / 888.4540)|
|• (FDA Code: HWK / 888.4540)|
|• (FDA Code: JAY / 868.5280)|
A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).
|• (FDA Code: MQV / 888.3045)|
A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
|• (FDA Code: KTZ / 888.4150)|
A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.
|• (FDA Code: FKC / 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.
|• (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: HCE / 882.5175)|
A carotid artery clamp is a device that is surgically placed around a patient's carotid artery (the principal artery in the neck that supplies blood to the brain) and has a removable adjusting mechanism that protrudes through the skin of the patient's neck. The clamp is used to occlude the patient's carotid artery to treat intracranial aneurysms (balloonlike sacs formed on blood vessels) or other intracranial vascular malformations that are difficult to attach directly by reducing the blood pressure and blood flow to the aneurysm or malformation.
|• (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.
|• (FDA Code: KIH / 888.4200)|
A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.
|• (FDA Code: LZN / 878.3300)|
Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.
|• (FDA Code: JDK / 878.3300)|
|• (FDA Code: JXG / 882.5550)|
A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.
|• (FDA Code: KDG / 878.4820)|
|• (FDA Code: HBR / 882.4215)|
A clip rack is a device used to hold or store surgical clips during surgery.