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510(k) Data Aggregation
(260 days)
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(170 days)
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(134 days)
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(88 days)
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(269 days)
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(128 days)
The RELIEEV HSG Catheter (HSG7FA1) is for the delivery of contrast media or saline into the uterine cavity during hysterosalpingography or sonohysterography for examination of the uterus and fallopian tubes.
The RELIEEV HSG Catheter (HSG7FA1) is a 7 French (Fr) dual lumen polyurethane catheter with a working length of 30 cm. RELIEEV HSG Catheter (HSG7FA1) is available with a closed-end tip with two side ports. The catheter consists of two lumens: an open lumen used to inflate the balloon and an open lumen used to inject diagnostic media into the uterus. The silicone balloon is designed with a balloon volume of 3.5 mL. When the balloon is inflated inside the uterus, the subject device seals the cervix. The catheter features a proximal fitting of a double-lumen polyurethane hub with a polycarbonate stopcock attached. Both the hub and stopcock accept a standard Luer lock. A stopcock is provided at the proximal end of the device to allow inflation of the balloon with a syringe. The center lumen is open through the device to the distal end, and the device has a luer connector at the proximal end for injecting fluids. An introducing sheath is placed over the tube as a guide and into the endocervix to the level of the internal os (opening of the cervix) with no dilatation required; therefore, allowing the catheter to pass easily through the cervix and into the uterine cavity.
The RELIEEV HSG Catheter (HSG7FA1) consists of a balloon catheter and a 5 mL syringe. The subject device is supplied sterile and is single-use.
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(166 days)
RCT700 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway and ENT structure for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified heath care professionals
RCT700 provides 3D computed tomography for scanning hard tissues such as bone and teeth. By rotating the C-arm, which houses a high-voltage generator, an X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a cephalometric option for obtaining cephalometric images.
The software of RCT700 saves the patient and image data and offers an inquiry function, in addition, supports the image generate function intended to obtain images using the RCT700 equipment and various sensors for diagnosis.
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(199 days)
The ROSA Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray based surgical planning tools. It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.
The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System.
The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona® PPS® CR, Persona® PPS® PS, Persona SoluTion PPS, Persona IQ® The Smart Knee™, Vanguard® CR, and Vanguard PS.
The ROSA® Knee System for use with the ROSA® RECON platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.
The ROSA® Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries.
If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI system (X-PSI Knee System K171269) to create a 3D model of the patient's femur/tibia and allows the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.
The intraoperative workflow and surgical concepts implemented in the ROSA Knee System remain close to the conventional TKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) Determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.
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(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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