Search Results

Ask a specific question about this device

Ask a specific question about this device

The Oxygen Concentrator provide supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air, by way of a molecular sieve, it can be used in the home or health care facility. It is not intended to sustain or support life.

The Oxygen Concentrator is a portable concentrator which could utilize a molecular sieve and pressure swing adsorption to produce the oxygen. The device could separate nitrogen by absorbing through the molecular sieve when the room air enters the device, and allows the enriched oxygen to be collected. The device could provide approximately 90~96% of oxygen to patients on a continuous flow basis at a rate of 1L/min to 10L/min. The nasal cannula is not sold with the device, users need to purchase the accessories by themselves that are legally marketed. The products have not undergone biocompatibility assessment of condensate precipitates according to ISO18562-4, and it is not recommended to use humidification bottles. The maximum altitude the subject device can operate without degradation of concentration is 2000m.

N/A

Ask a specific question about this device

Ask a specific question about this device

The OsteoRemedies Hip Spacer System consists of modular heads and stems, and optional acetabular cups. The REMEDY® components of the OsteoRemedies Hip Spacer System include gentamicin and the REMEDY SPECTRUM® GV components include gentamicin and vancomycin.

The OsteoRemedies Hip Spacer System is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin or gentamicin/vancomycin are the most appropriate antibiotics based on the susceptibility pattern of the infecting micro-organism(s).

Following removal of the existing femoral and acetabular components and radical debridement, the head and stem components are inserted into the femoral medullary canal and can mate directly with the native acetabulum or an acetabular component which is placed in the acetabular cavity. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The OsteoRemedies Hip Spacer System is not intended for use for more than 180 days, at which time all components must be explanted, and a permanent device implanted or another appropriate treatment performed (e.g., resection arthroplasty, fusion, etc.).

The OsteoRemedies' REMEDY Hip Spacer and REMEDY SPECTRUM GV Hip Spacer families (K112470, K172906, K191981, K192995) are legally marketed devices that are used in skeletally mature patients undergoing a two-stage procedure due to a septic process.

The 510(k)-cleared Hip Spacer is a temporary hip spacer device consisting of independent components (femoral stem, head, and cup components). All hip spacer constructs include component(s) manufactured from PMMA with gentamicin (REMEDY Hip Spacers) or PMMA with gentamicin and vancomycin (REMEDY SPECTRUM GV Hip Spacers); the stems are structurally reinforced with a stainless steel core.

The subject REMEDY POLY+PLUS Acetabular Cup and REMEDY CoCr Modular Femoral Head Components are intended to be a line extension to the REMEDY Hip Spacer and REMEDY SPECTRUM GV Hip Spacer families (K112470, K172906, K191981, K192995).

N/A

Ask a specific question about this device

The oxygen concentrator P2-O5E is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. This device is for adults only.

The oxygen concentrator P2-O5E is intended to provide supplemental low flow oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities. The oxygen concentrator consists of two parts: an oxygen concentrator and accessories. The oxygen concentrator is composed of compressor, fans, solenoid valves, molecular sieve beds, circuit control system, heat dissipation system, and a flow control device. Accessories include power cord, air intake filter box, air intake filter cotton.

N/A

Ask a specific question about this device

This product is intended for delivery of respiratory gases to adult patients in hospitals.

This product is indicated for the delivery of nasal high flow (NHF) and low-flow oxygen by appropriately qualified healthcare professionals.

Qualitative carbon dioxide (CO2) sampling can be used at nasal cannula flow rates from 5 to 50 L/min in operating and procedure rooms.

This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation, by individuals who perform anesthesia care or airway management.

This product is not intended for apneic ventilation.

This product is not indicated for use during CPR.

The Optiflow™ Switch+ Filtered Nasal Interface with CO2 Sampling interface is intended to deliver respiratory gases to the patient.

The subject device includes a CO2 sampling tube that provides a sample of the patient's exhaled respiratory gases through the CO2 sampling accessory to a CO2 sampling line and CO2 analyzer.

The subject device has been designed to allow for mask ventilation without the need to remove the nasal interface from the patient during therapy. To support this function, a Flow Diverter (K234053) is required.

The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.

This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).

It is intended to be used in combination with a compatible respiratory humidifier, Optiflow Oxygen Kit and the Optiflow Flow Diverter (K234053).

N/A

Ask a specific question about this device

• Instrument for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions. Marking of lesions.
• The OTSCneo clip is indicated for clip placement within the GI tract for the purpose of:
  • Endoscopic marking
• Hemostasis for:
  • Mucosal/submucosal defects < 3 cm
  • Bleeding ulcers
  • Arteries < 2 mm
  • Polyps < 1.5 cm in diameter
  • Diverticuli in the colon
• Closure of GI tract luminal perforations < 20 mm that can be treated conservatively.

NOTE: The OTSCneo System Set is not indicated for stent fixation. For stent fixation, use the stentfix OTSC® System Set.

The subject device constitutes an over-the-scope clip application device used within the context of flexible endoscopy in the gastrointestinal tract. The clip application capabilities center around a memory-shape alloy clip mounted on a transparent plastic cap. Cap (and clip) are mounted on the distal end of an endoscope. Endoscopic instruments or suction are used via endoscope working channels for mobilization and retraction of target tissue into the cap lumen. With the target tissue inside the cap lumen, the memory-shape alloy clip is applied onto the target tissue using a manual thread mechanism.

Contents of the OTSCneo System Set are:

• Application cap (with spout, application ring, thread, clip mounted on the cap)
• Hand Wheel
• Thread Retriever

In line with cleared indications, clip application with the subject device can be used for hemostasis, treatment of lesions, or marking of lesions in the GI tract.

N/A

Ask a specific question about this device

The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device, along with a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.

The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device designed to contain FDA cleared bone void filler within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

The OptiMesh implants are available with and without HAnano Surface®, a 20 – 40 nanometer thin hydroxyapatite (HA) surfaces treatment.

N/A

Ask a specific question about this device

OncoPatch is indicated for the surface treatment of localized tumors. It is designed to deliver radiation therapy for the treatment of superficial lesions. It can be used either as primary treatment or as treatment for residual disease after excision of primary or recurrent tumors.

The OncoPatch device is engineered for the surface treatment of skin cancers, such as basal and squamous cell carcinoma, as well as for other skin conditions, including keloids. Using yttrium-90 (Y-90) as the radioactive source, this device delivers low-energy beta radiation directly to the skin surface, targeting cancerous or abnormal tissue while sparing underlying healthy tissue. The OncoPatch device makes use of radioactive patches constructed from thin, polymer-coated foils containing Y-90. These foils are adhered to the underside of a plastic or metal composite shield, which ensures safety for both the patient and healthcare providers during treatment. The patch and shield are coupled with an applicator. The applicator uses collimators with predetermined shapes and sizes that assume a flat patient geometry. The OncoPatch is secured temporarily to the patient surface for single or multiple treatment fractions, typically with short (< 60 min) treatment durations.

N/A

Ask a specific question about this device