A substance containing a viable microorganism intended to be used to verify the performance of an assay or culture medium used in microbial testing for the identification of a microorganism isolated from a clinical specimen; it is not specific to any partic...
A prefabricated device intended to be used in the mouth during a prescribed period of time to stretch apart the oral opening to prevent and/or treat microstomia, typically acquired from facial burns, radiation treatment or surgical scarring. Also referred t...
A furniture-like device designed for the secure storage of many prepared laboratory specimen slides, e.g., histology microscope slides. The slides will typically be placed in dedicated trays. This device may be used, e.g., in the laboratory or a physician's...
A collection of sterile devices designed to drain small, superficial abscesses and/or fluid collections. It will typically include an introducer needle, a guidewire, and a flexible, single-lumen, micro-drainage catheter with attached dilator that allows for...
An electronic accessory to a surgical microscope designed to filter light to enable fluorescence excitation and visualization of tissues treated with an ultraviolet-excitable agent (e.g., aminolaevulinic acid) during open surgical procedures. It is typicall...
A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), or guidewire through its lumen(s), within the vascular syste...
A sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., thr...
A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitat...
A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand ...
A flexible tube with an electrode array its distal end designed to be used as part of a cardiac irreversible electroporation system to apply a series of microsecond electrical pulses to ablate endocardial tissues through irreversible electroporation, to tre...
A sterile, flexible, single-lumen tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system...
An electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient. It is typically used during...
A manually-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient. It is typically used during pati...
A manually-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient, in conjunction with a handpiece/...
An application software designed to provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth...
An application software designed to provide algorithms to assist a surgeon in performing calculations to help predict the amount of postoperative corneal astigmatism that needs to be corrected in order to optimize intraocular lens (IOL) model selection and ...
A sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. The distal end is micro-threaded which is intended to provide more controlled advancement of the device. It may be used to deliver anaesthetic or analgesic ...
A manually-operated surgical instrument (rotated by hand) designed to penetrate a fingernail, or toenail, to access the underlying tissue, typically to relieve pressure from a subungual haematoma (release of blood/fluid accumulated in the underlying nail be...
A mains electricity (AC-powered) device designed to heat factory-sealed prep pads (skin cleansing pads typically containing alcohol or povidone iodine), with a pre-set maximum temperature (e.g., 55?C) for the purpose of warming the pads prior to use on a pa...
A mains electricity (AC-powered) device designed to be connected between a physiological monitor and an off-the-shelf computer, containing dedicated application software, and intended to function as a data acquisition node for real-time sampling of neonatal...
A long, thin, non-powered, steerable wire intended to be percutaneously introduced into the neurovasculature anatomy to function as a guide for the introduction of interventional devices (e.g., microcatheter, embolization coil) for the treatment/management ...