Search Results

The InstaFAN device is intended for sampling targeted submucosal and extramural lesions within or adjacent to the gastrointestinal tract through the accessory channel of a curvilinear echo-endoscope. Use only with EUS endoscopes.

InstaFAN is an endoscopic ultrasound-guided fine needle aspiration/fine needle biopsy device that collects several samples from different locations in a single pass. The InstaFAN can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope and delivered to the gastrointestinal tract. The InstaFAN device is comprised of a central single 19-gauge needle and five peripheral 25-gauge needles. The device has a single handle design that contains two moving parts. The distal section of the handle controls the central needle, which can be activated first on its own or together with the proximal section of the handle to deploy all five needles simultaneously. The needles are used to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Aspiration/biopsy samples are obtained by penetrating the lesion with the needle(s) while applying suction with the syringe.

The Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The Resolve Anterior Cervical Plate (ACP) System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments designed to facilitate proper implantation/explantation of the plates and screws.

Onera STS 2 measures and records multiple physiological parameters from a patient during a sleep study, which are used by clinicians to decide on the diagnosis of sleep disorders. Onera STS 2 is intended to be used on a patient who has been prescribed a polysomnography study by a healthcare professional. The device is designed to be used under the direction of a physician or trained technician but applied by a layperson. The recorded data will be made available to the healthcare professional to assist in the diagnosis of sleep disorders. The device is intended to be used for adults. The device is not a life supporting physiological monitor.

Onera Sleep Test System 2 (Onera STS 2) is a hardware, wearable system for measuring physiological signals during a sleep study. The device can be used in the home (Home Healthcare Environment) as well as in Professional Healthcare Facilities. The device measures EEG, EOG, EMG, ECG, respiratory signals, cannula based respiratory flow, oxygen saturation, activity, position, ambient light level and sound pressure level. The ECG signal is not intended for diagnosis of cardiac disorders, except for the manual determination of arrhythmia during polysomnography studies. The Onera STS 2 does not provide any automated output like heart rate, assessments of arrhythmia, heart rate variability, or other related heart rate measurement functions. Onera STS 2 consists of five Sensors applied on the forehead, upper chest area, abdomen and lower leg area (both left and right leg). The Sensors should be placed on intact skin. During the night measurement it is not needed to inspect the application sites. The Sensors encrypt the recorded signals and upload the measurement data during the night to the Patient App installed on the patient's phone via Bluetooth. The Patient App securely transfers the data to the cloud interface for further processing once all data has been uploaded. The output of the system is represented by a file in EDF format which contains the recorded (physiological) signals. EDF files can be read by any application software that accepts such files as input. It is not possible to relocate the Sensors during a sleep study since the Sensor is single-use and for one sleep study only.

The Leone Orthodontic Implant TADs (Temporary Anchorage Devices) are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.

Leone TADs are miniscrews made of titanium for surgical use (ISO 5832-3/ASTM F136). These orthodontic miniscrews are self-drilling with right-hand thread and they are available in an 8mm length. These devices are supplied sterile and sterilized by gamma irradiation.

The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System. The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.

Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses. Bonvadis® is multiple use and supplied in a 15 g aluminum tube. The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing. Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs and fentanyl citrate per ASTM D6978-05 (Reapproved 2019) Standard Practices for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] are Class I patient examination gloves, bearing the product codes LZA, LZC, OPJ, QDO (21 CFR 880.6250). They meet all current specifications listed under the ASTM D6319-19 (2023), Standard Specification for Nitrile Examination Gloves for Medical Application and comply with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978-05. The powder-free gloves are made from Nitrile (NBR) latex and are green in color. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff, and single use only. The product is not manufactured using natural rubber latex. GLOVEONE™, Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for Use with Chemotherapy Drugs and Fentanyl] include glove sizes: X-Small, Small, Medium, Large, and X-Large.

FP3D is a dual cure resin indicated for the 3D printed fabrication of flexible partial dentures in dental laboratories.

The FP3D is designed for additive manufacturing on Carbon 3D printers (wavelength = 385 nm). FP3D is intended to be used within a computer-aided design and manufacturing (CAD/CAM) digital dentistry system that includes a 3D scanner, design software, 3D printer, post-cure unit (wavelength = 385-405 nm), and post-cure oven for the fabrication of flexible partial dentures for partially edentulous patients.

The Sovereign Posterior Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Sovereign Posterior Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system's Instructions for Use for a list of indications for use for each system.

The Met One Technologies Sovereign Posterior Cervical System is an implant device designed for the posterior stabilization of the cervical and upper thoracic spine. The system includes implants such as polyaxial screws, blocker screws, rods, crosslinks, lateral connectors, and rod to rod connectors to form a unique construct to match patient anatomy. Polyaxial screws are offered in a range of sizes in both standard and reduction tulips for ease of use. All screws are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). Straight, pre-bent, and transition rods are offered in 3.5mm and 4.0mm diameters and in two different materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-Cr28-Mo6 per ASTM F1537). Transition rods are fully compatible with Met One Technologies Xultan 5.5 Pedicle Screw System line of implants. A variety of connectors and crosslinks are offered for surgeons to create the desired construction. Rod to rod crosslinks improve the torsional stability of the construct. Lateral connectors are provided in open and closed configurations, 3.5mm and 4.0mm diameters, and in long and short lengths. Rod to rod connectors are offered in several configurations to join rods together. All connectors are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136).

The OsseOne Dental Implant System implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. OsseOne Dental implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseOne Dental implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

The OsseOne Dental Implant System contains 1 design of internal hex implant and a multipurpose indexed hex abutment as described below as well as 3 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from ASTM F136 Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments are intended to be modified by the user other than the multipurpose indexed abutments & tapered multipurpose abutments which can be reduced in height to a minimum of 6mm above the platform. Multipurpose indexed abutments & tapered multi-purpose abutments are not intended for angular correction and are not intended to be cast. OsseoMax Hex implants are tapered internal hex implants with evenly spaced large threads the length of the implant. OsseoMax Hex comes in 4.6, and 5.4 mm diameter with lengths of 8, 10mm. OsseoMax Hex are only restored using hex ball attachments or Denture Lock hex cleared in K182293. Tapered Multipurpose Indexed Hex Abutments have a 3.75mm platform diameter with a total height of 10.98mm. Height above the platform is 7.58mm. Tapered Multipurpose Indexed Hex Abutments are to be used with internal hex implant designs cleared in K182293 and are not to be used with OsseoMax Hex. OsseoCone implants are slightly tapered conical implants with evenly spaced sharp edge threads with microthreads in between them as well as microgrooves in the collar. OsseoCone comes in NP (3.5mm), and RP (4.3, 5.0, and 5.5mm) in lengths of 8.5, 10, 11.5, 13 and 15mm. OsseoCone Plus implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. OsseoCone Plus comes in 3.5 (NP), 4.3 (RP), 5.0 (RP) and, 5.5 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16 mm (no 5.5 x 16mm). OsseoMax Conical implants tapered conical implants with evenly spaced large threads the length of the implant. OsseoMax Conical comes in 4.6 and 5.4 RP diameter with lengths of 8, 10mm. OsseoMax Conical are only restored using Conical ball attachments or Conical Denture Lock. Conical healing caps come in NP and RP (3.75 and 4.5 mm diameter) with cuff heights (also height above gingiva) of 2,3,4,5 mm. Total heights are 7.32, 8.32, 9.32, 20.32 mm and 7.47, 8.47, 9.47, 10.47mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available. Conical straight abutments in 4.5mm diameter come in NP and RP with heights above gingiva of 7.7, 10.7 and 6.1, 8.3mm. Total heights are 11.85, 15.9mm and 10.6, 13mm. Conical anatomic abutments in 4.5mm diameter come in NP and RP with gingival heights of 1,2,3 mm. Height above the platform is 7.5mm. Total heights are 11.8, 12.6, 13.6mm for both NP and RP versions. Conical angled anatomic abutments in 5mm diameter come in 15° and 25° NP with shoulder cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm. Height above platform is 7.6mm. Conical angled anatomic abutments in 5mm diameter come in 15° and 25° RP with shoulder cuff heights of 1,2,3,4 mm and total heights of 11, 12, 13, 14 mm. Height above platform is 8.4mm. Multipurpose Indexed Conical abutment comes in NP, RP, and RP Wide with platform diameters of 4.2, 4.2 and 4.7 mm Total heights are 11.69, 11.33 and 11.33 mm. Height above platform is 8.29, 7.93, 7.93mm. Multipurpose Indexed Conical abutments are to be used with the conical implants listed above but are not to be used with OsseoMax Conical Implants. Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. Total heights are 9.5, 10.5, 11.5, 12.5, 13.5, 14.5mm and 9.45, 10.45, 11.45, 12.45, 13.45, 14.45mm. Height above the platform is 3.47, 4.47, 5.47, 6.47, 7.47, 8.47mm and 4, 5, 6, 7, 8, 9mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place. The housing and retention caps were cleared in K182293. Conical Denture Lock attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. Total heights are 8.95, 9.95, 10.95, 11.95mm and 8.7, 9.7, 10.7, 11.7mm. Height above the gingiva is 2.3, 3.3, 4.3, 5.3mm. The Denture Lock attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place. The housing and retention caps were cleared in K182293. Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm. Height above platform is 3.6, 4.6, 5.6, 6.6, 7.6mm. Total heights are 9.1, 10.1, 11.1, 12.1, 13.1mm and 9.25, 10.25, 11.25, 12.25, 13.25mm. Conical NP and RP Angled Multi-Units are 4.8mm in diameter and come in 17° and 30° with cuff heights of 1, or 2 mm. Cone height above platform 2.15mm. NP total heights are 6.35, 7.35mm and 6.85, 7.85mm. RP total heights are 6.75, 7.11mm and 7.15, 8.15mm. Conical abutment screws in NP & RP are used with conical abutments including angled multi-units.