Search Results
Found 4197 results
510(k) Data Aggregation
(268 days)
Ask a specific question about this device
(107 days)
Ask a specific question about this device
(197 days)
Ask a specific question about this device
(167 days)
Ask a specific question about this device
(141 days)
Ask a specific question about this device
(168 days)
Ask a specific question about this device
(270 days)
The Sophy Mini Monopressure Valve is designed for the treatment of hydrocephalus by shunting cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.
The Sophy® Mini Monopressure Valve is intended for the treatment of hydrocephalus by shunting the cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.
The complete CSF shunting system provides shunting of CSF from the ventricular cavities in the brain to another part of the body where the CSF can be absorbed in blood.
At the minimum, a complete CSF shunt consists of:
- A proximal catheter to drain CSF from either lateral brain ventricles;
- A distal catheter to drain CSF to a body cavity where it can be absorbed in blood (most often, the peritoneal cavity or the right atrium of the heart so respectively called peritoneal or atrial catheter also);
- Between the two, a valve which regulates the flow of CSF.
N/A
Ask a specific question about this device
(61 days)
The 0.014" Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.
N/A
Ask a specific question about this device
(188 days)
NX01 is intended for use in healthcare or home settings to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes in the ears of patients. It acquires, records and transmits one channel of electroencephalogram (EEG) data. The medical use of data acquired by NX01 is to be performed under the direction and interpretation of a licensed medical professional. NX01 does not provide any diagnostic conclusions about the patient's condition.
The NX01 is intended for use with adult and pediatric patients (6+).
NX01 is a wearable device for continuous recording of non-invasive EEG signals in healthcare and home settings. NX01 is intended to be prescribed by a trained healthcare professional. It consists of a pair of earbuds (one per ear) integrating a pair of active, dry electrodes, connected by a cable to a command panel. This command panel houses the battery, the internal memory to store the data, the main acquisition unit with function buttons and LEDs which display the device's status.
The NX01 solution is composed of:
- Two earbuds (1) connected by 45 cm cables, to a command panel (5). This command panel houses the battery, the internal memory to store the data, the main acquisition unit with function buttons (2 - Left button and 3 - Right button) and LEDs (4) which display the device's status.
- A set of eartips, to be placed on the earbuds for the recording. Eartips are single use consumable that should be discarded and replaced for every recording that takes place.
- A medical grade PSU with the following specifications: Input AC 100-240V, 50/60Hz; Output USB-C DC 5.0V, min 1.0A; Compliance IEC 60601-1, IEC 62368-1 or IEC 60950-1.
N/A
Ask a specific question about this device
(90 days)
Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.
Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 14 programs (11 standard programs and 3 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K213879). Size: 50*50mm.
N/A
Ask a specific question about this device
Page 1 of 420