Search Results
Found 1383 results
510(k) Data Aggregation
(165 days)
Ask a specific question about this device
(256 days)
Ask a specific question about this device
(219 days)
SeptAlign is used to support and straighten deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.
The SeptAlign System consists of a bioabsorbable implant and single use delivery device. The polydioxanone implant is 190 mm long and 0.65 mm thick with bi-directional anchors which enable mechanical correction of cartilaginous nasal septal deviations without cartilage resection. The implant also includes a surgical needle to enable placement which is trimmed off after use. The implant supports the cartilage in the straightened positioned as the cartilage remodels and is fully resorbed within a 6-month period.
The implant is provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. SeptAlign is provided sterile and is intended for single-use only.
N/A
Ask a specific question about this device
(165 days)
The iotaSOFT® Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of array insertion. The iotaSOFT Insertion System is indicated for use in cochlear implant patients ages 4 years and older during cochlear implant procedures using either a round window or cochleostomy approach.
The iotaSOFT® Insertion System is designed to assist the surgeon during cochlear implantation by controlling the speed of electrode array insertion. The iotaSOFT Insertion System is designed to reduce electrode array insertion variability and forces. The system includes:
- Sterile single-use Drive Unit (IM-00 or IM-05)
- Reusable, nonsterile touch screen console and footpedal interface
The Drive Unit is mounted on a standard surgical equipment Rolling Stand and is compatible with commercially available cochlear implant arrays from each of the 3 CI manufacturers distributing product in the U.S.
N/A
Ask a specific question about this device
(266 days)
This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trachea, bronchus and lesions adjacent to these structures using ultrasonic images, at medical facilities under the management of physicians.
This product is not intended for use on children and infants.
EB-710US (referred to as 'the device') is a medical ultrasonic electronic endoscope. The device is inserted into a lumen, a coelom, body cavity, or inside of a body, and provides images for observation, diagnosis, photographing, or treatment. It is also used for ultrasonography by visualizing the shape, the characteristic, or the dynamics of the inside of the body.
This product is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion portion is flexible and contains glass fiber bundles, a channel, a complementary metal-oxide semiconductor (CMOS) image sensor and a ultrasonic transducer in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channel in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor.
This product is used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. And the device drives ultrasonic transducer installed in the distal end of the device by being connected with a ultrasonic processor.
The driven ultrasonic transducer emits ultrasound into the body, and receives the reflected ultrasonic signal from the body. The ultrasonic processor connected to the device performs image processing using the received signal. The electric signal of the image processing is converted into video signal, and it is output to the monitor as a ultrasonic image.
N/A
Ask a specific question about this device
(182 days)
The Flexible Intubation Video Endoscope – Sterile (FIVE-S) is intended for use by physicians for endotracheal intubation and diagnostic and therapeutic procedures in bronchoscopy. The Karl Storz Video Bronchoscope is intended to provide visualization via a video monitor.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
The videoscopes in the modified Flexible Intubation Video Endoscope – Sterile (FIVE-S) is sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor (when using the Image1 S CCU), where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into the compatible CCU (Camera Control Unit) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
N/A
Ask a specific question about this device
(161 days)
The Tuned Self-Fitting Mobile App is a software-only mobile medical application that is intended to be used with compatible wireless air-conduction hearing aids. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Tuned Self-Fitting Mobile App utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.
The Tuned Self-Fitting Mobile App is a software-only, over the counter (OTC) medical application designed to support adults (18+) with perceived mild to moderate hearing loss. Available on both iOS and Android platforms, the app allows users to independently tune and personalize the settings of compatible wireless air-conduction hearing aids without requiring assistance from a hearing healthcare professional.
The Tuned Self-Fitting Mobile App utilizes calibrated pure-tone audiometry to conduct a self-administered hearing test and computes individualized amplification targets based on the NAL-NL2 prescription algorithm. It automatically configures connected hearing aids according to the results and enables additional fine-tuning by the user through intuitive controls for volume, frequency bands (low/mid/high), and preset sound environments such as everyday use, speech enhancement, music, and outdoor noise reduction.
The reason for this submission is to expand the use of the Tuned Mobile App, which was previously cleared under K223848 for use with the Lumen155 hearing aids (Intricon, USA), to include an additional compatible wireless air-conduction hearing aid, the NoviOne (Novidan, USA).
N/A
Ask a specific question about this device
(95 days)
The sterile single-use flexible video bronchoscopes are designed to be used with the Himaging endoscopic video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Himaging bronchoscope system is applicable to hospital environment or medical office environment.
The Himaging bronchoscopes are sterile single-use devices designed for use in adults.
The subject device, Himaging Bronchoscope System, is consisting of a single-use flexible video Bronchoscope and an endoscopic video processor. The subject device has been designed to be used for endoscopy within the airways and tracheobronchial tree.
N/A
Ask a specific question about this device
(85 days)
Bipolar applicator CelonProBreath is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar Radiofrequency Induced Thermotherapy (RFITT).
Bipolar applicator CelonProBreath is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:
- Shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.
The product is intended to be used for patients from 2 years and up.
Bipolar applicator CelonProSleep plus is intended for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT).
Bipolar applicator CelonProSleep plus is indicated for ablation and coagulation of soft tissue in otorhinolaryngeal surgery, specifically:
- Shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.
The product is intended to be used for patients from 18 years up.
The devices subject to this submission are sterile, single-use devices: the bipolar applicator CelonProBreath (WB990210 and WB990310) and the bipolar applicator CelonProSleep plus (WB990211 and WB990311). The devices are for use with a compatible electrosurgical generator. This method of treatment is also called bipolar radiofrequency induced thermotherapy (RFITT). The devices are intended for the ablation and coagulation of soft tissue in otorhinolaryngeal surgery.
Bipolar applicator CelonProBreath (WB990210 and WB990310) is specifically used for shrinkage of submucosal tissue in nasal airway obstruction by reduction of hypertrophic nasal turbinates.
Bipolar applicator CelonProSleep plus (WB990211 and WB990311) is specifically used for shrinkage of submucosal tissue and tissue coagulation in the soft palate for the treatment of snoring.
N/A
Ask a specific question about this device
(85 days)
The Ion™ Endoluminal System (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion™ Endoluminal System enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.
The PlanPoint™ Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion™ Endoluminal System.
The Ion Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. It consists of a Planning Laptop with PlanPoint Software, a System Cart with System Software, a Controller, Instruments, and Accessories.
The IF1000 Instruments include the Ion Fully Articulating Catheter, the Ion™ Peripheral Vision Probe, and the Flexision Biopsy Needles.
The Planning Laptop is a separate computer from the System Cart and Controller. A 3D airway model is generated from the patient's chest CT scan using the PlanPoint Software.
The System Cart contains the Instrument Arm, electronics for the follower portion of the servomechanism, and two monitors. The System Cart allows the user to navigate the Catheter Instrument with the Controller, which represents the leader in the leader-follower relationship. For optimal viewing, the physician can position the monitors in both vertical and horizontal axes.
The Controller is the user input device on the Ion Endoluminal System. It provides the controls to command insertion, retraction, and articulation of the Catheter. The Controller also has buttons to operate the Catheter control states.
The Ion Endoluminal System integrates an optional Tomosynthesis feature, optimizes the existing Cone Beam CT workflow, improves the Navigation View, troubleshoots the airway tree, and enhances the control algorithm to provide an additional safety margin.
N/A
Ask a specific question about this device
Page 1 of 139