Phospholine Iodide
echothiophate iodide for ophthalmic solution
echothiophate iodide for ophthalmic solution
Device - Hand-held Rubber Bulb Nebulizer
Saline
racepinephrine hydrochloride
echothiophate iodide
Ear Wax Drops
ISOPROPYL ALCOHOL
Benzalkonium chloride
CHLOROXYLENOL
GLYCERIN, ALLANTOIN
20250707
20200522
20200521
20200520
2026-05-28
2026-05-28
2026-05-11
2026-05-11
2025-05-08
2024-02-23
2024-02-16
2023-02-25
An electrically-powered, body-worn device intended to be used as a mobility aid for a patient with a visual impairment by providing feedback on their local environment using ultrasound-based echolocation. It includes an ultrasound transceiver designed to de...
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple Echovirus antigens from serotypes EV1-EV33 in a clinical specimen, using an enzyme immunoassay (EIA) method.
A hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes ...
An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound pro...
A hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ul...
An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) imaging procedures involving the heart and blood vessels. Included are software packages that support a variety of static ...
A battery-powered device designed to provide high-definition digital wireless audio transmission from an external telecommunication audio source [e.g., television (TV), radio/stereo equipment, mobile phone (cell phone)] to a hearing aid, to enhance the soun...
An ultrasound imaging transducer assembly specifically designed to be positioned within the rectum either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric vol...
An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related t...
A sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy...
A mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. Typically foetal heart rate is measured, but heart valve movement can also be assessed. The device operates noninvasively by:...
An assembly of portable, battery-powered devices designed for the extracorporeal ultrasound measurement of the male or female urinary bladder volume. It typically consists of an electronic measuring and imaging display unit with a connected ultrasound trans...
A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac ...
A steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and possibly great vessel (e.g., pulmonary artery) visualization for the assessment of cardiac ...
An implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous clip deli...
An ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's eye during imaging applications involving the examination of the lens. It may include single or multiple element transducer assembly configurations that...
A sterile balloon-like cap made of a synthetic-polymer (e.g., silicone) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endos...
An assembly of devices used to produce bone density measurements and other calculations based on data obtained from transmitted and reflected ultrasound (US) waves. Also called a bone densitometer, it has an integrated ultrasound transducer to deliver an ul...
An ultrasound imaging transducer assembly specifically designed to be positioned within the bladder either manually or under endoscopic guidance. Included is a variety of single or multiple element transducer assembly configurations that convert electric vo...
An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the abil...
A sterile implantable device intended for the reconstruction of an insufficient mitral and/or tricuspid heart valve and reduction of valve regurgitation through the fixed approximation of the valve leaflets. It is typically implanted using a percutaneous cl...
An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to giv...
An ultrasound imaging transducer assembly that is either located within the housing of an ultrasound based scanner system, e.g., a breast scanning system, Doppler flow system, ultrasound based bone absorptiometry or densitometry system; or is mounted on a f...
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to one or multiple virus serotypes from within the enterovirus family, in a clinical sp...
A vessel designed to protect the part of a device that cannot be exposed to liquid cleaning agents or disinfectant [e.g., the electrical connector of a transoesophageal echocardiography (TOE) probe] in a water-tight vault that may be air-pressurized, so the...
An assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) obstetrical and gynaecological (OB/GYN) imaging procedures. It includes software packages to support a variety of static a...
A sterile, steerable, flexible tube with an ultrasonic phased-array imaging transducer at its distal tip designed for intracardiac echocardiography to enable intracardiac and/or intraluminal visualization to assess cardiac anatomy and physiology, as well as...
One or multiple immunoglobulins with the capability of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of the viral protein 1 (VP1) antigen from one or multiple enteroviruses (e.g., poliov...
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus serotypes from within the enterovirus family, in a clinical specimen. Enteroviruses intended...
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 detection of immunoglobulin G (IgG) antibodies to one or multiple virus serotypes from wit...