A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of multiple analytes of the insulin synthesis pathway (i.e., proinsulin, insulin, and C-peptide) in a clinical specimen.
An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of p...
A hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and h...
An assembly of mains electricity (AC-powered) devices designed to monitor and provide electrical stimuli to spinal nerves or other neural pathways (may include the brain) during intraoperative surgery or intensive care, typically to reduce the incidence of ...
A sterile, steerable, flexible tube containing electrodes intended to be introduced percutaneously into the heart chambers in order to provide a pathway for the controlled delivery and support of a selective infusion of fluids or transvenous devices to the ...
An assembly of mains electricity (AC-powered) devices designed to locate a nerve by applying an electrical stimulus with a probe and comparing muscle responses as the probe is moved. Once the pathways are located, their transmission capabilities can be asse...
An multicomponent assembly of electrically-powered devices designed to locate a nerve by applying an electrical stimulus with a probe and observing muscle responses. Once the pathways are located, their transmission capabilities can be assessed by comparing...
An assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from t...
A collection of sterile devices and materials designed to perform percutaneous laser treatment of varicose veins and varicosities associated with reflux in the superficial veins of the leg. It typically contains an entry needle, a laser fibre, an introducer...
A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or ...
An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. It consists of a capsule, containing the bat...
A battery-powered assembly of devices intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, to the middle ear. It primarily consists of an external microphone and a vibrator implanted in the middle ear that is ...
A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial?s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the ...
A body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways ...
The non-sterile external portion of a partially-implantable middle ear implant system that typically consists of a battery-powered microphone, signal analysis and filtering unit, radio-frequency (RF) modulator and amplifier, and an RF transmitter and antenn...
An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care...
A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or ...
A sterile, hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduct...
A manually-powered instrument intended to be used to create a pathway through an occluded blood vessel to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [especially a chronic total occlusion (CTO) of a coronary ar...
A sterile device used to encompass the distal end of a dedicated ultrasonic surgical system handpiece and tip to provide a pathway for the delivery of irrigation fluid. The device helps to concentrate the fluid at the tip of the handpiece, remove some of th...
A sterile device designed to protect a haemodialysis system pressure monitor and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plast...
A prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted ch...
A sterile device designed to be securely attached to the septum end of a vial to create a channel, by spiking through the vial’s sealed stopper, to allow access to the contents of the vial. This device is intended to reduce risk of unwanted exposure to the ...
An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed indirect contact with the TM and to convert signals into vibrations, which are then passed alongthe normal sound conduction pathway in the middle ear. The TM trans...
A body-worn electronic device intended for vagus nerve stimulation (VNS) applied close to auricular peripheral nerves to achieve remote pain relief mediated by central nervous system (CNS) pathways and structures [e.g., brainstem activation]; it may be used...
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative measurement of complement factor B of the alternative pathway in a clinical specimen, using a precipitation/immunodiffusion method. Elevated ...
A device designed to protect a haemodialysis system pressure monitor from contamination and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consis...
A body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways ...
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative measurement of complement factor B of the alternative pathway in a clinical specimen.
An electronic component of a tympanic membrane (TM) contact hearing aid intended to be placed in direct contact with the TM and to convert signals into vibrations, which are then passed along the normal sound conduction pathway in the middle ear. The TM tra...