FDA.reportPublic FDA data

Search

167 matching records for SMART.

NDC#

Mitchum Smart Solid

Revlon Consumer Products Corp

Aluminum Zirconium Tetrachlorohydrex Gly liquid

Mitchum Smart Solid

Revlon Consumer Products Corp

Aluminum Zirconium Tetrachlorohydrex Gly liquid

DailyMed#

alcohol

Shenzhen Lantern Scicence Co.,Ltd. | Shenzhen Lantern Science Co.,Ltd.

20260525

alcohol

Shenzhen Lantern Scicence Co.,Ltd. | Shenzhen Lantern Science Co.,Ltd.

20260524

GMDN Terms#

Smartphone camera ophthalmic imaging lens

3 GUDID devices

An optical device intended to be attached over the camera lens of an off-the-shelf smartphone by a healthcare professional to enable imaging of the eye, including anterior segment and/or fundus, using the existing camera/video capabilities of the smartphone...

Video intubation laryngoscope imaging system

18 GUDID devices

An assembly of video-imaging devices intended to be user-installed in a video intubation laryngoscope blade/handle shell (not included) to make functional a video intubation laryngoscope, enabling video imaging of the trachea during insertion of an endotrac...

Home uroflowmetry software

2 GUDID devices

An application software program intended to be installed in a smartphone/tablet to enable the measurement/display of urine flow parameters (e.g., flow and volume of urine during urination, time of urination) by a patient/layperson in the home. It may receiv...

Loss-of-pulse emergency alert software

1 GUDID devices

A software program intended to be installed on a wearable off-the-shelf smart device with photoplethysmography (PPG) capacities [e.g., smart watch] to recognise the absence of a pulse and notify the wearer with audio, visual or haptic alerts; in the absence...

Audiometric/hearing device software

737 GUDID devices

A software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-s...

Rectal/vaginal ultrasound imaging transducer

365 GUDID devices

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...

Audiometric/hearing device software

324 GUDID devices

A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the h...

Hand-held ultrasound imaging system, body-surface

188 GUDID devices

A battery-powered, hand-held device/device assembly designed to be placed over the external body surface for collection, display, and analysis of ultrasound information during a variety of ultrasound imaging procedures (i.e., non-dedicated); it may in addit...

Central venous catheter navigation system, electrocardiographic

132 GUDID devices

An assembly of noninvasive devices intended to use electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC), central venous catheter (CVC), haemodialysis catheter]. ...

Migraine-therapy peripheral nerve electrical stimulator

87 GUDID devices

A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator contr...

Audiometric/hearing device software

84 GUDID devices

A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the h...

Cerebrospinal fluid shunt valve programmer

80 GUDID devices

A device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted hydrocephalic valve that will be part of a hydrocephalic shunt system. It is used in neurosurgery for intra- and postoperative treatment of hydrocephal...

Inhaler dose sensor

74 GUDID devices

A small, non-sterile, battery-powered device intended to be attached to a portable inhaler [e.g., metered dose inhaler (MDI), dry powder inhaler (DPI), soft mist inhaler (SMI)] to detect when a dose of inhaled medication has been taken, and to transmit this...

Wearable multiple physiological parameter recorder, reusable

72 GUDID devices

An electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), ha...

Implantable cardiac device management application software

67 GUDID devices

An application software program intended to be used in the management of an implantable cardiac device (e.g., monitor, pulse generator, pacemaker, defibrillator) by enabling computer-assisted functionality typically in one or more of the following areas: de...

Red/blue light phototherapy unit

57 GUDID devices

A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to ...

Cognitive assessment software

49 GUDID devices

A software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic da...

Channelled video intubation laryngoscope

47 GUDID devices

A hand-held device intended to enable clear view of the trachea via video imaging to facilitate positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation, passing the ET tube through an integrated ET tube ch...

Pressure monitoring insole

42 GUDID devices

A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure...

Wearable multiple vital physiological parameter monitoring system

34 GUDID devices

A portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters ...

Wireless patient thermometer, single-use

33 GUDID devices

A battery-powered electronic device intended to continuously measure body temperature and wirelessly transmit data to a computing device, typically a smartphone or tablet with dedicated software, for data display, recording and analysis. It is in the form o...

Biomechanical function analysis system, force-testing, portable

29 GUDID devices

A portable computerized device assembly with multiple force-sensing hardware designed for analysis of biomechanical/neuromuscular function by enabling performance of: 1) multiple functional strength tests using a variety of hardware (e.g., dynamometers, pin...

Cognitive therapy software

17 GUDID devices

A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen inte...

Portable computer

17 GUDID devices

A portable, non-dedicated, and commonly hand-held computing device intended for the download/running of medical software to input, process and/or display data. It typically includes a microprocessor [central processing unit (CPU)], a display screen, and a k...

Assistive object-fixation holder

15 GUDID devices

A non-powered device designed to be used by a patient with a disability, typically in the home, to hold an object (e.g., toothbrush, book, smartphone) in a fixed position. It may be in the form of a clip, clamp, non-slip pad, or static magnet, and may be us...

Cognitive therapy software

14 GUDID devices

A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help improve a cognitive function (e.g., attention/concentration, memory, eye movement training to improve reading ability) by providing a patient with on-screen inte...

Video otoscope/audiometer

14 GUDID devices

An electrically-powered portable device intended for the visual examination of the outer ear canal/tympanic membrane by video otology, and basic evaluation of hearing function. It consists of a speculum with integrated video camera, light source, pitch gene...

Wireless patient monitor/sensor reporting software

14 GUDID devices

A software program intended to wirelessly receive data from a noninvasive, patient-worn, wireless monitor/sensor to display, record, and assist in analysis and healthcare provider reporting reporting of the collected clinical data, typically for continuous ...

Video intubation laryngoscope blade/handle shell

13 GUDID devices

A non-electronic, hand-held component of a video intubation laryngoscope intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an en...

Insect bite/sting hyperthermia device

12 GUDID devices

A portable, electrically-powered device intended to be used for the external surface treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the topical application of concentrated heat. The heat (around...