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510(k) Data Aggregation
(149 days)
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(327 days)
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(178 days)
This product is intended to be used in combination with compatible colonoscopes to maintain the field of view during endoscopic procedures such as mucosal resection.
This product needs to be cut and connected to the endoscope tip of 9mm to 14mm, and medical tape needs to be prepared in advance to fix it into a cylindrical shape.
This product is intended to be attached to an endoscope.
The Disposable Distal End Tape Hood is installed at the tip of the endoscope to assist the endoscope in a clearer observation. It can push away the mucosa and keep a certain distance between the lens and the mucosa, thus maintaining the field of view.
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(60 days)
Model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
- The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.
- The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Model: INIA-ED001, INIA-ED002, INIA-BLD001, E1507:
Facial & Body Beauty Device is a hand-held device for over-the counter aesthetic purposes.
- The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation;
- The Photon mode: The red light is intended for the treatment of periorbital wrinkles.
Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging.
The device is for home environment use, which has electrodes for microcurrent stimulation (the microcurrent stimulation mode was cleared under K252553) and light emitting diodes for light therapy treatment. Especially, the light therapy function of the device equips both red light (for wrinkles treatment) and blue light (for acne treatment) for model INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, while equips only red light for model INIA-ED001, INIA-ED002, INIA-BLD001, E1507.
To use the device, user should place the treatment head on the face and body (only applicable for microcurrent stimulation mode). The device will automatically shut down after treatment time is over.
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(269 days)
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(70 days)
The Dual Stage Venous Return Cannula is indicated for single tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery for up to six hours.
Dual Stage Venous Return Cannulae are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.
The devices are composed of the cannula: an open lumen PVC polymer tube incorporating wire reinforcement in distal section. In some models is present a malleable obturator inserted into the cannula to allow the placement of the cannula along the vein. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the venous line.
The distal end of the cannula has a lighthouse-shaped tip, allowing the venous blood to flow from the vessel into the cannula, in addition the distal sections of the cannula are perforated with multiple holes at multiple stages to better allow the fluid flows from outside into the cannula body. The clear proximal section is not reinforced to allow clamping; the proximal end typically does not have any pre-mounted connector and can accommodate a barbed connector for standard cardiopulmonary bypass tubing (½" diameter). In some models a pre-mounted 1/2" barbed connector is present.
The following cannula models are available:
| Device trade name | Model | French size (Outside diameter) | Characteristics |
|---|---|---|---|
| Dual Stage Venous Cannulae | RDS-61040 | Proximal: 40 Fr Distal: 32 Fr. | Without connector |
| Dual Stage Venous Cannulae | RDS-61034 | Proximal: 46 Fr Distal: 34 Fr. | Without connector |
| Dual Stage Venous Cannulae | RDS-61046 | Proximal: 46 Fr Distal: 36 Fr. | Without connector |
| Dual Stage Venous Cannulae | RDS-61050 | Proximal: 50 Fr Distal: 36 Fr. | Without connector |
| Dual Stage Venous Cannulae | RDS-61140 | Proximal: 40 Fr Distal: 32 Fr. | With connector |
| Dual Stage Venous Cannulae | RDS-61134 | Proximal: 46 Fr Distal: 34 Fr. | With connector |
| Dual Stage Venous Cannulae | RDS-61146 | Proximal: 46 Fr Distal: 36 Fr. | With connector |
| Dual Stage Venous Cannulae | RDS-61150 | Proximal: 50 Fr Distal: 36 Fr. | With connector |
The Dual Stage Venous Return Cannulae are the modified version of the disposables currently marketed under K943934.
Both modified and unmodified cannulae models are recommended for use as Venous cannula during cardiopulmonary bypass up to six hours.
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