Search Results

The Difiney Advanced Anti Snoring Device 4.0 is intended to help reduce snoring in people 18 years of age or older.

The Difiney Advanced Anti Snoring Device 4.0 is designed to reduce snoring by gently repositioning the lower jaw forward, which opens the airway and allows for smoother airflow during sleep. By adjusting the position of the lower jaw, the device helps prevent the throat tissues from collapsing and blocking airflow, which is a common cause of snoring.

The 4.0 version is customizable, allowing users to set the lower jaw advancement up to 6mm, providing a personalized fit for maximum comfort and effectiveness. This forward positioning also reduces vibrations in the airway, which are often responsible for the snoring sound.

N/A

Ask a specific question about this device

The prostheses from FH Industrie are designed for specific indications such as:

SIMPLE HUMERAL PROSTHESIS

• Humeral head necrosis without injury to the glenoid cavity.
• Extensive humeral head cartilage damage without injury to the glenoid cavity
• Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
• Rheumatoid polyarthritis with thin rotator cuff.
• Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH PEGS)

• Centred glenohumeral osteoarthritis with functional rotator cuff
• Rheumatoid polyarthritis with functional rotator cuff
• Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

• Centred glenohumeral osteoarthritis
• Rheumatoid polyarthritis
• Post-traumatic sequela with glenoid injury
• Revision for glenoid loosening
• Glenoid bone loss, where bone graft is needed

A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW and JARVIS Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

For all types of prosthesis, the glenoid baseplate (porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem and diaphyseal stem) is intended for cementless use.

At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

The JARVIS Diaphyseal Stem Standard is an extension of humeral stem range of the Arrow prosthesis. The JARVIS Diaphyseal Stem Standard is intended to be used with the Metaphyseal component of the modular ARROW Short Stem device (K202024). The JARVIS Diaphyseal Stem Standard is offered in various sizes to accommodate patient anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3.

N/A

Ask a specific question about this device

The Electric Breast Pump (Models HL-3058, F5112) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3058, F5112) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
Electric Breast Pump (Models HL-3058, F5112) also has a hot function which provides hear to the users neck for warmth. It does not affect the intended use of the product.

N/A

Ask a specific question about this device

The Electric Breast Pump (Models HL-3060, F5113) is intended to express milk from lactating women and collect milk from their breast. The device is intended for single user.

The Electric Breast Pump (Models HL-3060, F5113) is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.

N/A

Ask a specific question about this device

The VereSee Optical Veres Needle and Endoscopic Camera is intended for:

• Percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic surgery

• Use as an endoscopic video camera to provide visible light imaging in a variety of endoscopic and laparoscopic diagnostic and surgical procedures

The VereSee Optical Veres Needle and Endoscopic Camera System consists of two components: 1) VereSee Optical Veres Needle and Endoscopic Camera, and 2) VereSee Camera Control Unit.

The VereSee Optical Veres Needle and Endoscopic Camera consists of a series of three concentric stainless steel cannulas with a handle and an umbilical cable to connect it to the VereSee Camera Control Unit. It is provided sterile, for single patient use. The three concentric stainless steel cannulas include: 1) an Outer Cannula (or Insufflation Cannula), 2) a Central Cannula (or Access Cannula) with a clear, pointed tip for penetration and visualization during body cavity entry, and 3) Inner Cannula (or Camera Cannula) with a CMOS camera surrounded by light fibers at its tip.

The VereSee Camera Control Unit connects the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to HDMI compatible monitors to provide an image for endoscopic procedures. The VereSee Camera Control Unit (CCU) includes an LED driver to power the LED. The CCU connects to the Optical Veres Needle and Endoscopic Camera via an umbilical cable. The CCU converts signals from the CMOS camera in the VereSee Optical Veres Needle and Endoscopic Camera to a format compatible with HDMI display input requirements.

N/A

Ask a specific question about this device

The Miracu™ Absorbable Polydioxanone Suture with Needle (MONO) is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location( s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

Miracu™ synthetic absorbable PDO suture with needle is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The Miracu™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.

Each dyed (violet) suture has no barbs along the long axis of the suture monofilament with needle attachment. The Miracu™ Synthetic Absorbable PDO suture with needle (No Barb) approximates tissue is equivalent in form and function to the predicate device DemeDIOX (K181582).

The proposed suture is available in 4-0, 5-0, 6-0 suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia, and is equivalent to sizes available in the PDREX reference device (K173779).

The formation of barbs in the Miracu™ reduces the tensile strength relative to non-barbed suture material of the same size. Therefore, the suture tensile strength for the Non Barbed is not compromised and is equal or stronger than the barbed reference configuration. The Miracu™ non-barbed suture is made from the same material, sterilized in the same manner, and packaged as the barbed reference device Miracu™ (K172602).

The strength of the Miracu™ (non Barbed) can be compared with, and is substantially equivalent to, the publicly available information for the PDS Plus (K212380).

N/A

Ask a specific question about this device

The V-Soft Line™ barbed device comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.

The V-Soft Line™ synthetic absorbable PDO suture with needle is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. The V-Soft Line™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The barbed sutures are pre-loaded and are not attached to the needle.

Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament with needle attachment. The V-Soft Line™ Synthetic Absorbable PDO suture with needle approximates tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues.

The proposed suture is available in 2, 2-0, and 3-0 suture sizes, which are the sizes identified in the currently recognized Unites States Pharmacopeia.

The V-Soft Line™ is barbed to two sections on suture and the barbs on each section are opposite direction each other. The reason that this suture has each opposite barb direction is not to slide and move to forth and back and to fix well. Therefore, the effectiveness of suture for treatment can be improved.

N/A

Ask a specific question about this device

IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

IPL Home Use Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

IPL Home Use Hair Removal Device includes five models, JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032. The five models adopt identical intended use, similar performance, operation and structure, with main differences in appearance, dimensions and weight, and light output parameters. Models JD-TM016, JD-TM023 are single pulse devices while models JD-TM027, JD-TM028 and JD-TM032 are double pulses devices. The device is only powered by the external power adapter. This device adopts sapphire flash outlet that is suitable for multiple hair removal areas.

The device is fitted with a skin sensor to detect appropriate skin contact, if the flash outlet of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by manual finger switch or auto light emission. The device has a cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

N/A

Ask a specific question about this device

The DIASAFE®plusUS is intended for the preparation of ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system). The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care hemodialysis machines fitted for use with the DIASAFE®plusUS.

The DIASAFE®plusUS is a non-sterile dialysis fluid filter that produces ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) for use in chronic and acute hemodialysis and hemodiafiltration. The DIASAFE®plusUS reduces microbial contaminants including endotoxin in the dialysate during treatments. The DIASAFE®plusUS is available in one (1) configuration and is compatible for use with 2008 series and 5008X hemodialysis machines. It is installed on the hemodialysis machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on the hemodialysis machines and is installed during machine production.

The 2008 series hemodialysis machines use 1 DIASAFE®plusUS. Mixed dialysis fluid is forced through an open filter port across the fibers of the DIASAFE®plusUS. A closed bypass valve at the other end forces the dialysis fluid across the fiber membrane. Dialysis fluid passes through the porous membrane and into the filtrate compartment where it is allowed to flow through the uncapped side ports and into the hemodialyzer. Microorganisms and molecules too large to pass through the membrane are trapped in the fibers until they are flushed out, and/or disinfected during a routine cleaning cycle.

The 5008X hemodialysis system uses two (2) DIASAFE®plusUS for preparation of the dialysis and substitution fluid which can be used for up to 100 on-line HDF treatments. The dialysis fluid is filtered by the first DIASAFE®plusUS. A second DIASAFE®plusUS is used to filter the ultrafiltered dialysis fluid a second time to prepare the substitution fluid. The substitution fluid can be infused in the post-dilution mode (i.e., after the blood has passed through the dialyzer), in the pre-dilution mode (i.e., before the blood enters the dialyzer), or combined.

N/A

Ask a specific question about this device

FEHLING Biopsy Forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach.

The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components:

1. an actuating handle ergonomically designed for comfortable use,
2. a flexible shaft,
3. and surgical stainless steel cutting jaws.

At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device.

The product is provided single for use and sterile.

N/A

Ask a specific question about this device