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Withings BeamO is intended to record, display (when prescribed or used under the care of a physician), store, and transfer single-channel electrocardiogram (ECG) rhythms. It is indicated for use with individuals 22 years and older.

Withings BeamO is a non-sterile, contactless, reusable clinical thermometer intended for the intermittent determination of human body temperature over the temporal artery as the measurement site on people of all ages.

Withings BeamO is also an electronic stethoscope that enables the recording and transmission of auscultation sound data. Withings BeamO is intended to be used by professional users in a clinical environment or by lay users in a non-clinical environment on people of all ages. The electronic stethoscope is for medical diagnostics purposes only. The device is not intended for self-diagnosis.

Withings BeamO, model name SCT02, is a multi-function handheld battery powered device with ECG, stethoscope, temperature capabilities. Withings BeamO can record a 1-lead ECG using two stainless steel electrodes. It analyzes the data collected by the integrated two stainless steel electrodes to generate an one-lead ECG waveform and provides the ECG recording to the user for a given 30 second measurement.

Withings BeamO is also a contactless thermometer that can measure body temperature in adjusted mode.

Withings BeamO is also a digital stethoscope that can be used to auscultate heart and lung sounds. The sensor generates an electric charge when subjected to mechanical vibrations. The charge variations are amplified and digitized by an audio codec. Sound filters are applied to the resulting sound wave in order to listen to the patient's heart and lung sounds with clarity.

Withings BeamO consists of hardware and embedded software. Withings BeamO works in conjunction with a companion software on the Withings App. Withings BeamO communicates with the companion software via Bluetooth Low Energy (BLE). The device measurement results and recordings are synchronized with the companion software using Wi-Fi/Cellular data via the Withings servers.

Withings BeamO does not include ECG analysis or ECG-derived heart rate functionalities.

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The Lunderquist Extra Stiff Wire Guides are intended to facilitate catheterization and/or placement of devices during vascular interventional procedures.

The Lunderquist Extra Stiff Wire Guides are intended for use in the aorta, including its access vessels and major adjacent vessels.

The Lunderquist Extra Stiff Wire Guides are auxiliary devices and hence not primary interventional devices themselves. Instead, they are intended to facilitate vascular access and/or delivery of over-the-wire medical devices during endovascular procedures, including TEVAR/EVAR procedures.

The Lunderquist Extra Stiff Wire Guides are both long and stiff; features that make them suitable for facilitating endovascular procedures that involve placement of large devices e.g., stent grafts in the aorta. The wire guides are not intended for coronary or neurovascular use.

The Lunderquist® Extra Stiff Wire Guides are 0.035 inch PTFE coated stainless steel wire guides consisting of a mandril and a 15 cm or 18 cm long coil. The mandril has a tapered end with a length of 11 cm and an additional 4 or 7 cm flexible tip. The Lunderquist wire guides are available in the following configurations:

Straight Lunderquist wire guides (TSMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil.

Curved Lunderquist wire guides (TSCMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.

Double Curved Lunderquist wire guides (TSCMG-/-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Double Curved Lunderquist wire guides have a large curve/J-curve radius of 75/15 mm.

Extended Double Curved Lunderquist wire guides (TSCMG-/-E-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Extended Double Curved Lunderquist wire guides have an extended large curve/J-curve radius of 55/15 mm.

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The Allure Hip Stems are intended to be used in total and partial (hemi-) hip arthroplasty to treat mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures. The Allure Hip Stems are intended for uncemented use only.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision surgeries

The Intramedullary Plugs are intended for use with cemented hip stem prostheses to prevent uncontrolled diffusion of bone cement within the medullary canal.

This submission includes the Allure Hip Stems for cementless use and Intramedullary (IM) Plugs for use with cemented hip stem prostheses. Therefore, they are not meant to be used together, but the Allure Stems and the IM Plugs (when used with LINK cemented hip stems) are both used with the same previously cleared LINK systems (Prosthesis Heads and Vario Cups, BiMobile Dual Mobility System, MobileLink Acetabular Cup System) to create hemi-hip or total hip arthroplasty constructs.

The Allure Hip Stem is forged out of a Tilastan-S (Ti6Al4V) alloy. The Prosthesis Stems are proximally equipped with a TiCaP (Titanium-plasma + Calcium Phosphate) coating while the distal tip features a microporous surface with a HX (Calcium Phosphate) coating. The implants are available in different sizes and neck designs, standard or lateralized version and collared or collarless neck, allowing an accurate anatomical match for each patient.

The Allure Hip Stem is part of a mechanical reconstruction of the hip joint. The Allure Hip Stem forms a total hip arthroplasty (THA) when combined with a prosthesis head and an acetabular cup. Alternatively, a hemiarthroplasty (HA) is formed, when combined with the Vario-Cup System. The Hip Stem is intended for uncemented use.

The Intramedullary Plugs are used in combination with cemented implant components.

The Intramedullary Plugs are manufactured from ultrahigh molecular weight polyethylene (UHMWPE), and in sizes from 8 mm to 20 mm.

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Synchfix™ EVT is intended for soft tissue and bone fixation for ankle syndesmosis disruptions with or without ankle fractures and as an adjunct in connection with hardware for ankle fractures such as Weber B, Weber C and Maisonneuve in adult and adolescent patient populations.

The subject device, Synchfix™ EVT, is a sterile, single-use, suture-button system intended to stabilize syndesmotic disruptions in the ankle. The subject system consists of a UHMWPE suture tensioned between two titanium alloy buttons and single use instruments to assist in implantation, including a pre-loaded inserter.

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The intended use of the VenAir Sequential Compression System (hereby referenced as "VenAir system") is to help prevent Deep Vein Thrombosis (DVT) and pulmonary embolism. The garments are single patient use - do not reuse. The VenAir system is intended for use only in professional healthcare facility environment by trained medical staff. It is not for use in the home healthcare environment. The VenAir system should be used as part of a prescribed plan of care.

The VenAir system is a sequential pneumatic compression system by applying sequential and gradient pressure to increase venous blood flow and circulation in at-risk patients to help prevent deep vein thrombosis and pulmonary embolism. The product consists of the pump, tubing sets, and disposable (single patient use) garments (thigh, calf, and foot optional purchase) and focuses on compressing the limbs to enhance better blood circulation.

The VenAir system has digital sensors to check the garment connections, pressure output and power supply. On the other hand, operator can follow this manual to check the error code and action as advised.

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Atalante X is intended to perform ambulatory functions and mobility exercises, hands‐free, in rehabilitation institutions under the supervision of a trained operator for the following populations:

• Individuals with hemiplegia due to cerebrovascular accident (CVA)
• Individuals with spinal cord injuries at levels C4 to L5 (SCI)
• Individuals with multiple sclerosis (MS)

The operator must complete a training program prior to use of the device.

Atalante X is intended to be used on adolescents of 18 years and older and adults, able to tolerate a stand‐up position.

The device is not intended for sports or stair climbing.

Atalante X is a completely self‐balancing walking system for people with mobility disabilities. It is a fully powered hip‐knee‐ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self‐balancing and includes dynamic‐walking control. Dynamic‐walking allows the Atalante X to consume significantly less power and have a more natural gait.

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Indications for Use (Describe)

Prescription Use

Collagen Wound Dressing is indicated for the management of exuding wounds including:

• Full thickness and partial thickness wounds
• Pressure and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Diabetic ulcers
• Partial thickness burns
• Donor sites and other bleeding surface wounds
• Abrasions
• Traumatic wound healing by secondary intention
• Dehisced surgical incisions

Over-The-Counter Use

Intended for the management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.

Collagen Wound Dressing is a wound care device composed of pure freeze-dried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing that can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound healing situation.

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Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device, is intended to provide 50 Hz shear wave speed measurements and estimates of tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body.

Shear Wave Quantificational Ultrasound Diagnostic System, Transient Elastography based device is intended to provide 100Hz shear wave speed measurements and estimates of tissue stiffness in spleen.

Shear Wave Quantificational Ultrasound Diagnostic System is indicated as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease, as part of an overall assessment of the liver. Results in the pediatric population should be interpreted while considering the clinical condition and the overall patient profile.

Shear Wave Quantificational Ultrasound Diagnostic System is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis in the human body (including abdominal applications) in B, M, CFM, PWD, B/B, 4B, B+M, B+CFM, B+PWD, and B+CFM+PWD modes.

The system must be operated by qualified and appropriately trained medical professionals in a professional healthcare facility environment.

The subject system is a general purpose, software-controlled, diagnostic ultrasound system. It is composed of a complex probe, an imaging probe, a main unit, a power cord, a foot switch, two fuses and a protective earth wire. The complex probe is a convex array probe used for elasticity measurement and ultrasound imaging, and the imaging probe is also a convex array probe used for ultrasound imaging. The system uses transient elastography to measure shear wave speed non-invasively and estimate tissue stiffness as well as Ultrasound Attenuation Parameter (UAP) in internal structures of the body. A mechanical vibrator in the complex probe produces low-frequency shear waves at 50 Hz or 100HZ that travel through the skin and intercostal space into the liver or spleen respectively. The propagation speed of the shear wave is captured by complex probe using ultrasound at 2.5 MHz. Under imaging mode, the system acquires and displays ultrasound images in B, M, CFM, PWD modes. The system uses imaging probe and complex probe with a frequency range of 2.5MHz to 5.0 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. The ultrasonic imaging also helps to find a proper location for the Transient Elastography examination.

There are a total of 6 models in this product, all of which share the same intended use, physical design and principle of technology. The only differences among these models are software functions configuration and availability of imaging probe.

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