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Bioprosthesis definition: Prosthesis, usually heart valve, composed of biological material and whose durability depends upon the stability of the material after pretreatment, rather than regeneration by host cell ingrowth. Durability is achieved 1, mechanically by the interposition of a cloth, usually polytetrafluoroethylene, between the host and the graft, and 2, chemically by stabilization of the tissue by intermolecular linking, usually with glutaraldehyde, after removal of antigenic components, or the use of reconstituted and restructured biopolymers.
Contraceptive Devices definition: Devices that diminish the likelihood of or prevent conception. (From Dorland, 28th ed)
nondrug contraceptive definition: non-pharmacological method to diminish the likelihood of or to prevent conception.
Contraceptive Device definition: A device designed to prevent conception through local or systemic effect, such as a barrier contraceptive, an intrauterine device, or a means of preventing ovulation (e.g., birth control pill).
biomedical equipment definition: any instrument used in biomedical research or medical practice.
Medical Device definition: Any physical object that is useful for prevention, diagnosis, monitoring, or treatment of disease or other conditions.
Medical Device definition: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. (CFR Title 21, Chapter 9, Subchapter II, Section 321)
Self-Help Devices definition: Devices, not affixed to the body, designed to help persons having musculoskeletal or neuromuscular disabilities to perform activities involving movement.
catheter definition: (KATH-i-ter) A flexible tube used to deliver fluids into or withdraw fluids from the body.
Catheters definition: Tubes designed for insertion into canals, vessels, passageways, or body cavities to permit injection or withdrawal of fluids or other substances. Most catheters consist of long, flexible tubes with many different shapes and tip configurations; they can perform or permit a great variety of therapeutic (e.g., hemodialysis, urinary drainage) and diagnostic procedures (e.g., cardiac, biliary).
CLAMP definition: 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.
Clamps definition: Devices designed to compress a structure and/or to bring together several isolated objects and/or anatomic structures by pressing, fastening, or binding them firmly. Clamps are usually handheld, manual instruments with a working end that permits a large jaw opening and a handle and without a preferred resting state; dedicated clamps are available in a variety of shapes and sizes according to the procedure to be performed or the object to be held. Clamps are clinically used as dental, surgical, and postmortem instruments and/or to hold ancillary devices during those procedures; other clamps are intended to hold objects (e.g., test tubes, small instruments).
Analyzers definition: Instruments to separate or break up any whole into its parts, to find out their nature, proportion, function, or relationship. Most analyzers are used in the clinical field for in vitro analysis in the laboratory and/or at the point of care; some others are capable of physiologic or technical parameter analysis. These instruments are not designed to take continuous records (i.e., monitor) of the parameters that are measured or determined in their analysis.
Applicator definition: A pre-filled non-injectable pipette, syringe or tube.
Bag definition: A sac or pouch.
Balances definition: Measuring instruments designed to determine the mass of a body, using the force of gravity on the body (weight) as a basis for comparison. The result read from the balance is generally taken as a measure of the quantity weighed; corrective calculations are done only in exceptional cases. In practice, most balances measure in grams, although other units such as ounces and grains are also used. Balances are mostly used for clinical laboratory measurements; they are usually placed on a vibration-free workbench.
Binders definition: Bandages, typically constructed from a single piece of material, designed to fit and support a specific part of the body.
Bottle definition: A vessel with a narrow neck designed to accept a specific closure.
Brushes definition: Devices consisting of a handle and bristles, fibers, or spines that are usually mounted along a single plane at the distal end or radiate from a central shaft. The shaft handle may be flexible or rigid, and the bristles may be soft or stiff. Dedicated brushes are designed to be used to clean a surface, to gather tissue samples (i.e., cytology), for surgical purposes, for personal hygiene, or to apply materials to a surface or tissue. Most brushes are designed as manual, handheld devices; however, some brushes are designed to be used with a powered handpiece (e.g., attached to the revolving component of the handpiece).
Calibrators definition: Devices designed to determine and/or adjust the accuracy of a measuring instrument so that the instrument can be used to make measurements that are accurate to within a specified tolerance. Most calibrators assess the medical instrument measurements deviations from a standard; others are high-accuracy simulators used to calibrate instruments that are capable of adjustment. A calibrator should be several times (e.g., 4 to 10 times) more accurate than the instrument being calibrated. Calibrators are also used in nuclear medicine to assess the radiation dose of radionuclides before their administration to patients.
Cameras definition: Devices used to capture images. Cameras can be designed for many purposes, including to make permanent images of objects on films, electronic images to be displayed and/or transmitted, radiographic/fluoroscopic images, and images produced by the radiation generated by radiopharmaceuticals.
Cartridge definition: A container consisting of a cylinder with a septum at one end, and a seal at the other end, which is inserted into a device to form a syringe which contains a single dose of a parenteral drug product.
Carts definition: Storage devices equipped with wheels for transporting supplies from one area of a medical facility to another. They are typically constructed of metal or plastic and contain shelves or drawers. Some carts are designed specifically for use in magnetic resonance imaging [MRI] environments, i.e., MRI-compatible supply carts, MRI-compatible utility carts, MRI-compatible coil carts, MRI-compatible medication carts, etc., and are made from nonmagnetic materials so that they can be safely used in an MRI suite.
Centrifuges definition: Laboratory devices that apply centrifugal force to a specimen (e.g., suspended cells in a liquid), causing its separation according to component density. Centrifuge basic components are an electric motor, a shaft, and a rotor on which the centrifuge head turns. The two most common designs of rotors are fixed angle and horizontal or swinging bucket. Most centrifuges can operate with several interchangeable heads. Centrifugation of body fluids, commercial reagents, or mixtures of both with other additives is one of several sample preparation steps commonly required in the clinical laboratory before measuring analytes in a patient sample. The use of basket-style heads and draining-chamber inserts in some centrifuge models allows the continuous introduction of materials to be separated into the centrifuge until the basket is full (i.e., intermittent-flow mode); this mode is used to separate suspensions and emulsions.
Compresses definition: Soft pads, typically made of cloth, designed to be used to apply heat, cold, or medications to a body surface. These devices can also be applied to a wound to help control bleeding.
DERMATOME definition: 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.
Dermatomes definition: Surgical instruments designed to rapidly excise (harvest) and/or process large, uniform-thickness skin slices. These instruments may be a manually operated device (e.g., a handheld mechanical frame and cutting blade) or, more frequently, a powered (e.g., electrical, pneumatic) device with a cutting blade. Powered (e.g., Castroviejo, Reese, Padgett-Hood, Brown, Davol-Simon, Zimmer) dermatomes typically use a rapidly oscillating blade that is manually advanced over the skin. Dermatomes are used mainly to obtain skin grafts from donor sites, but they are sometimes used in other procedures (e.g., to remove tattoos). Dedicated instruments are available to expand the skin graft (i.e., expanded mesh dermatomes), increasing the area of damaged skin that can be covered with a given graft.
Device Approval definition: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.
Canister definition: A type of can for holding a drug product.
Bombs definition: A weapon designed to explode when deployed. It frequently refers to a hollow case filled with EXPLOSIVE AGENTS.
INSTRUMENT, BIOPSY definition: 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.
Cannulae definition: Short, hollow cylinders or tubes for insertion into a canal, vessel, passageway, body cavity, or duct. Cannulae usually consist of a small-length rigid or semirigid plastic or metal tube, a handle, and a valve. The valve regulates the pressure within the cavity. Most cannulae are fitted with a trocar or stylet during insertion. After insertion, the trocar is withdrawn, providing a rigid or semirigid structure that can be connected to an external tube, catheter, or connector for the injection or withdrawal of substances. Cannulae may also provide a port through which diagnostic or surgical instruments are passed to gain access to and operate on internal structures. They can be used in a great variety of therapeutic and diagnostic procedures.
Device definition: An object contrived for a specific purpose.
device definition:

A subtype of ManufacturedMaterial used in an activity, without being substantially changed through that activity. The kind of device is identified by the code attribute inherited from Entity.

Usage: This includes durable (reusable) medical equipment as well as disposable equipment.

Biomimetic Devices definition: Devices fabricated with materials from biological systems.
device definition: Something used in delivering the service without being substantially affected by the service (i.e. durable or inert with respect to that particular service). Examples are: monitoring equipment, tools, but also access/drainage lines, prostheses, pace maker, etc.
BlackBerry definition: A wireless handheld device from Research In Motion (RIM) that supports e-mail, mobile telephone, text messaging, web browsing and other wireless information services.
biosensor device definition: sensing devices that couple a biological system capable of responding to the stimuli of interest with a physical detector that converts that response to electrical signals.
Burn of device or device component definition: Issues associated with a discoloration or destruction as a result of thermal decomposition of the device or its components.
Clumping in device or device ingredient definition: Issue associated with the aggregation of particles into irregular masses.
Coagulation in device or device ingredient definition: Issue associated with the undesired characterization of congealing, solidifying, thickening, curdling.
Detachment of device or device component definition: Issue associated with the unintentional separation of the device and/or its components from something to which it is connected or attached.
Device-device incompatibility definition: Issue associated with the incompatibility of two or more devices while being operated in the same use environment thereby leading to a dysfunction of more than one device.
Entrapment of device or device component definition: Issue associated with the device and/or device accessories caught within patient vasculature or tissue.
Device or device component damaged by another device definition: Issue associated with one device and/or device component causing harm to another device and/or component.
Migration of device or device component definition: Issue associated with an undesired movement of device and/or device components, related to its movement away from or dislodging from a source.
Nonstandard device or device component definition: Issue associated with a material that does not meet the specifications or requirements for which it was manufactured, and has not been subjected to use or processing other than that required for its initial manufacture.
Overheating of device or device component definition: Issue associated with the device producing high temperatures, such that its operation is compromised (e.g. overheating that produces melting of components or automatic shutdown).
Precipitate in device or device ingredient definition: Issue associated with the separation of solid particles from a liquid as the result of a chemical or physical change.
device definition: Dispositif, appareil.
Gerät definition: [1] Oberbegriff für alle mögliche Werkzeuge und Hilfsmittel, mit denen etwas bewirkt werden kann
Mittel definition: [1] Methode oder Werkzeug [2] nur Plural: speziell finanzielle Mittel[1] [3] Kurzform von: Ergebnis der Mittelung
Vorrichtung definition: [1] ein Hilfsmittel zu einem bestimmten Zweck, eigens gefertigtes Werkzeug
appareil definition: Objet conçu par l’homme afin de faciliter un travail.
appareil definition: Mélange de plusieurs ingrédients servant à la préparation d’un mets.
appareil definition: Ensemble d’organes ayant une fonction particulière.
appareil definition: Manière dont les personnes ou les choses se montrent aux autres.
appareil definition: Dimension et disposition des pierres ou des briques d’un bâtiment.
appareil definition: Installation mobile posée au sol permettant de faire des exercices spécifiques (barres parallèles, cheval d’arçons, etc.). Les éléments suspendus sont appelés agrès.
appareil definition: Assemblage de choses disposées avec ordre, dans le dessein de donner à un cérémonial de l'éclat, de la pompe.
biais definition: Obliquité, ligne ou sens oblique.
biais definition: Différentes faces d’une chose, côtés d’un caractère.
biais definition: Moyens détournés qu’on emploie pour réussir.
biais definition: Défaut de mesure, d'échantillonnage, d'évaluation, induisant une valeur erronée.
biais definition: Bande qui est coupée en oblique (généralement à 45°) par rapport au droit-fil du tissu.
dispositif definition: Partie d’une loi, d’un édit, d’un jugement, d’une ordonnance, d’un décret, d’un arrêté, d’un arrêt, etc., qui en contient la décision et les dispositions pratiques, par opposition au préambule, aux motifs, etc.
dispositif definition: Toute manière de disposer les différentes parties d’un appareil ou des travaux exécutés en vue d’une exploitation de carrière, de mine, etc.