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510(k) Data Aggregation
(189 days)
The Recana Thrombectomy Catheter System is indicated for:
- The non-surgical removal of thrombi and emboli from veins.
- Injection, infusion, and/or aspiration of contrast media and other fluids into or from a vein.
The Recana Thrombectomy Catheter System is indicated for use in peripheral venous vasculature.
The Recana Thrombectomy Catheter System is designed to remove thrombus and emboli from native vessels or stented veins. The system is comprised of the debulking catheter, collection basket(s) with delivery sheaths, and a family of sheaths. Together, the Recana Thrombectomy Catheter System functions to capture and remove obstructive / occlusive thrombus from the venous vasculature.
The debulking catheter utilizes an adjustable diameter stainless steel coring element to remove thrombus from the venous vasculature. Handle controls enable expansion and collapse of the coring element to achieve the desired working diameter. The debulking catheter is 0.035" guidewire and 0.060" basket shaft compatible and provides a working length of 80cm.
18mm and 30mm Collection basket(s) are self-expanding nitinol wire-form and braided structures designed to ensure capture and removal of thrombi and emboli. The basket shaft has a 0.035" guidewire compatible lumen for over the wire delivery through a 9Fr Delivery Sheath with a working length of 95cm.
Sheaths for introduction of the debulking catheter and collection baskets into the vasculature and for the recapture and removal of thrombi and emboli via the collection basket(s) are offered in four (4) size configurations (13Fr x 30cm, 13Fr x 90cm, 16Fr x 30cm, and 16Fr x 90cm) providing optionality based on access vessel size and location.
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(129 days)
The Remi Custom Night Guard is Indicated for protection of teeth and restorations against grinding and clenching, and as an aid in the reduction of medically diagnosed migraine pain associated with jaw clenching and bruxing.
The Remi Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
Remi Night Guards are manufactured using impressions and/or scans.
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(317 days)
The Re:Balans is intended for use under the direction of a physician, for the non-invasive monitoring of patients with fluid management-related health conditions. The device measures thoracic bioimpedance in patients to assist the physician in fluid management assessment.
The device is indicated for adult patients with fluid overload such as end-stage renal disease, and patients at risk of dehydration.
The device does not generate any real-time alarms for consideration by the user at home or by a healthcare professional. Data from the device should be used in the context of all clinical data to make determinations of a patient's fluid status.
The Re:Balans is a non-invasive wearable device measuring impedance in patients with fluid management-related health conditions.
The device has the form factor of an adhesive patch, with four integrated electrodes, which is applied on the back of the patient. The impedance signal is obtained by applying a small, safe battery-generated current and measuring the resulting electrical impedance.
The impedance signal reflects the electrical resistance of the tissue and is modulated by the changes in fluid levels. The impedance signal is captured at multiple unique frequencies to enable the calculation of base impedance, extracellular and total resistance values. The Impedance decreases when fluid increases and increases when fluid decreases in the thorax. Normal upper body base impedance range is between 35– 65 Ohms. However, every person has their own baseline values. Fluid status changes should be noted and shared with professional medical clinicians when impedance readings vary from typical daily values.
Once the device is successfully placed and activated on the patient, the Re:Balans will collect impedance data over a period of up to 7 days. Re:Balans is a medical electrical equipment, non-sterile, and single-use device for intact skin only. Re:Balans is designed for use in clinic and home settings.
The data readout is performed on the Re:Balans software application compatible with iOS iPad.
The Re:Balans device is an assessment tool. It is not intended to be a medical diagnostic device. This monitor is intended to be operated by technically qualified medical personnel.
The physician or designated healthcare provider is responsible for interpreting what assessment, intervention, or action is required as a result of changing impedance values.
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(192 days)
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(284 days)
The Revolve Surgical System is intended to assist in the control of Revolve Surgical laparoscopic instrument for endoscopic manipulation of tissue, including approximation, ligation, and suturing, during laparoscopic general surgery. It is intended to be used by trained physicians in an operating room environment, in accordance with its Instructions for Use.
The Revolve Surgical System is an electromechanically controlled laparoscopic surgery platform used for minimally invasive surgery in the abdomen comprised of a reusable system arm which mounts to the operating table and several sterile, single-use disposable accessories – instrument, instrument handle, and drape. The device operates under the direct control of the surgeon to manipulate tissues during surgery. Surgeon control is achieved by grasping the instrument handle and moving it to the desired position. The device compensates for gravitational forces applied to the instrument and maintains the instrument position when the surgeon's hand is removed from the device.
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(14 days)
These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps should not be used for any purpose other than their intended function.
The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) is a sterile, single-use device. The RJ4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8 mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0 mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length, and are offered in Box 5 and Box 20 packaging configurations.
To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.
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(91 days)
The Stryker Robotic Precision System (RPS) Primary TKA Software application, when used with the Stryker Guidance Systems, is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to rigid anatomical structures during orthopedic procedures.
The RPS Primary TKA Software application is indicated for use in total knee arthroplasty (TKA) procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified.
RPS is a total joint bone preparation system to support total knee arthroplasty (TKA) consisting of functionality for intraoperative planning, kinematic analysis, boundary control, and guided resection. The Complete Workflow allows for the placement of Stryker Triathlon CR/PS Total Knee Implants (cemented or cementless), and plans/resects all 6 primary femoral/tibial resections. The Quick-Cut Workflow allows for placement of implants with implant-specific cut guides requiring primary distal femoral and proximal tibial cuts.
A handheld robotic saw is guided via camera visualization in relation to patient anatomy and the surgical plan established intraoperatively. The robotic saw movement is partially controlled by the RPS Console which determines, based on surgical plan and localization data, how the saw actuators need to move within three degrees of freedom (elevation, pitch, roll) to maintain the planned cut plane. The surgeon controls the remaining degrees of freedom.
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(135 days)
Root canal repair materials (nRoot BP) is developed for permanent root canal sealer and repair and surgical applications.
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
The root canal repair material is a pre mixed paste material containing an inorganic powder system and an organic mixed liquid. Can solidify in a bodily fluid environment and effectively repair root canals; Has excellent X-ray blocking properties, stable curing time, and does not stain teeth. nRoot BP is packaged in a preloaded syringe.
The performance of the Root canal repair materials conforms to ISO 6876:2012 Dentistry- Root canal sealing materials.
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(75 days)
Resitu Slider 09 is intended to provide breast tissue for diagnostic analysis of imaged abnormalities.
Resitu Slider 09 (RESL09) is a minimally invasive, vacuum assisted device, intended to provide large intact breast tissue samples for histologic examination of imaged abnormalities. The device is provided sterile and is for single-use. Resitu Slider 09 is hand-held (vacuum is created in the handle) and is part of a monopolar high frequency electrosurgical system.
The intended sample site is reached via a skin incision followed by blunt penetration under ultrasound guidance. The sample capture relies on a combination of vacuum that fixates the sample and cutting with a circular knife. While cutting around the sample area, the vacuum allows the whole tissue sample to enter into the tube of the device. An electrosurgical electrode, designed to mimic a mechanical cutting blade, severs the top base of the breast tissue sample from surrounding area. The device is withdrawn with the intact breast tissue sample inside the tube.
The device functions as an active accessory by passing energy that is controlled by the electrosurgical generator to the tissue, similar to other electrosurgical tools.
The Resitu Slider 09 electrosurgical system consists of the following:
- Active Accessory (Monopolar)
- Electrosurgical Unit
- Active Accessory Cord
- Neutral Electrode
- Neutral Electrode Connection Cord
- Foot Switch (Pedal)
The device consists of a plastic handle, to which a transparent tube with a circular stainless steel knife at the end is attached. Inside the tube is a rod that creates a blunt end when in its outer position. The rod can be pulled back to expose the circular knife and create a vacuum, which will assist in excising the tissue, inside the tube.
In the center of the tube is an electrode, a diathermic knife, which can be pushed forward, backwards, and also turn 360 degrees, thereby enabling a radial cutting from the center.
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(279 days)
For the temporary displacement of the marginal gingiva and drying of the gingival sulcus, e.g. for
- conventional or digital impressions,
- cementation of temporary and permanent restorations
- and the creation of Class II and V fillings.
RetraXil belongs to the group of dental retraction material, mainly as cords (threads) with astringent agents. The retraction material is also marketed in form of a paste as alternative to the cords. RetraXil is a retraction paste containing aluminium chloride as astringent agent, which serves as hemostatic agent.
RetraXil is marketed as a gingival retraction paste with no hints of performance or safety issues for patients and users.
Retraxil is a retraction paste stored in a 1g syringe with a cannula and twisting aid.
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