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Found 1866 results
510(k) Data Aggregation
(2 days)
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(255 days)
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(182 days)
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(239 days)
The KARL STORZ Cholangiography Set consists of manually operated reusable surgical devices intended for use by qualified surgeons in minimally invasive intraoperative cholangiography in adults and pediatric patients ≥ 13 years of age.
The KARL STORZ Cholangiography Set are manually operated reusable surgical devices consisting of: Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet. The KARL STORZ Cholangiography Set includes devices which are used to facilitate the execution of cholangiograms (x-ray pictures of the bile ducts) during endoscopic surgery.
The Cholangiography Fixation Clamp, Guide Tube for Cholangiocatheter, and BERCI Plastic Stylet work together to ensure accurate and clear cholangiography during minimally invasive procedures.
- The Cholangiography Fixation Clamp secures the catheter in place after insertion, preventing movement and ensuring proper positioning.
- The Guide Tube provides a smooth, controlled pathway for the catheter during insertion.
- The BERCI Plastic Stylet eliminates metal shadows by remaining in place when the metal trocar sheath is removed, preserving clear X-ray imaging of the biliary system.
The devices facilitate precise catheter placement, reduce interference in imaging, and maintain optimal procedure conditions for successful cholangiography.
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(49 days)
For telescope (27033AA)
The endoscopes when used with sheaths and obturators are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.
The Miniature Telescope for Urology (27033AA) is a semi-rigid telescope that utilizes fiber optic technology. The shaft of the endoscope consists of phynox or stainless steel. An optical fiber bundle runs through a central lumen in the shaft and transmits the image received at the distal end to the eyepiece. Other fibers illuminate the operative site by transmitting light. The Miniature Telescope for Urology (27033AA) is just an optic, without a working or irrigation channel. It is always used in combination (e.g. with sheath (or working element and sheath). Thus providing instruments access to the operative site.
The Miniature Telescope for Urology (27033AA) is available in the following:
Direction of View: 0°
Field of View: 72.5°
Diameter: 3.5Fr
Working Length: 21cm
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(238 days)
The KLS Martin IPS Forearm System is indicated for use in forearm fractures, osteotomies, and arthrodeses. It is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or will not be crossed by fixation.
The KLS Martin Individual Patient Solutions (IPS) Forearm System is comprised of additively manufactured, patient-specific models, guides and metallic bone plates. The plates will be used in conjunction with previously cleared metallic bone screws and locking pins for internal fixation, alignment, stabilization, reconstruction, and/or corrective osteotomies of the radius and/or ulna. The devices are designed and manufactured to be patient-specific based on the electronic medical image of the patient's anatomy; with input from the physician during virtual planning, prior to finalization, and prior to production of the device. The physician provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an appropriate fit.
Implants are provided non-sterile and are manufactured using additive methods from Ti-6Al-4V. The system also includes the necessary fixation devices and instruments to facilitate placement of the implants.
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(88 days)
KLS-Martin Micro Osteosynthesis System (1.5MM): The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.
KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use:
- The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
- The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
- The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference
- The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
- The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
Individual Patient Solutions - Ti (IPS-Ti)*: Individual Patient Solutions - Ti (IPS-Ti) is intended to replace bony voids in the mandibular, maxillofacial or craniofacial skeleton.
Individual Patient Solutions - PEEK (IPS-PEEK)*: Individual Patient Solutions - PEEK (IPS-PEEK) is intended to replace bony voids in the cranial and/or craniofacial skeleton.
Individual Patient Solutions - (IPS-PEEK):** The Individual Patient Solutions - (IPS-PEEK) is intended to replace bony voids in the cranial skeleton.
KLS-Martin Micro Osteosynthesis System (1.5mm): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the bones of the skeletal system after a facial fracture or surgery. The bone plate system is composed of bone plates and screws of various shapes and sizes for use in oral-maxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 1.0mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.5mm - 1.8mm.
KLS Martin Centre-Drive Drill-Free Screw: The KLS Martin Centre-Drive Drill-Free Screws are designed to eliminate the need for pre-drilled pilot holes. They are self-tapping with one step insertion. They are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates where are contoured to fit the bony surface and stabilize the bone fragments. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 2.0mm.
KLS Martin Rigid Fixation - Sterile: The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging. The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's previously cleared osteosynthesis products in sterile packaging.
Individual Patient Solutions - Ti (IPS-Ti)*: The Individual Patient Solutions - Ti (IPS-Ti) is a preformed implant manufactured from Titanium material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
Individual Patient Solutions - PEEK (IPS-PEEK)*: The Individual Patient Solutions - PEEK (IPS-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
Individual Patient Solutions - (IPS-PEEK)**: The Individual Patient Solutions - (IPS-PEEK) is a preformed implant manufactured from PEEK material offered to the end-user as a sterile product. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
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(250 days)
Flexx Junior manual wheelchair is intended to provide mobility to pediatrics limited to a seating position.
The Flexx Junior is a pediatric manual wheelchair designed to provide mobility, comfort, and postural support for children with mobility limitations. Available in self-propelled (Model FLX-J00 with fixed backrest, Model FLX-J50 with foldable backrest) and transit configurations, it is primarily intended for indoor use with limited outdoor capability on smooth surfaces. The wheelchair offers both self-propulsion with 20" or 22" quick-release rear wheels and transit propulsion with 14" quick-release rear wheels. The device supports users weighing up to (165 lbs) 75 kg and is engineered for growth and incorporates adjustable features to accommodate growth.
The Flexx Junior is constructed with a lightweight aluminum folding frame, ensuring durability and ease of transport. Its compact folded dimensions facilitate storage and transport in vehicles. The device offers adjustable seat width, seat depth, and backrest height to ensure a customized fit as the child grows. The wheelchair's front caster wheel allows better maneuverability, while larger rear wheels improve stability and ease of movement, ensuring the device's structural integrity and safety. The wheelchair's compact design ensures maneuverability in tight spaces. The total width allows for easy navigation through doorways and confined spaces, and the overall height offers appropriate support and comfort. Easy to Transport and Its folding frame is built from aluminum, making it lightweight yet durable ensuring longevity. Despite its robust design, it remains lightweight and can be folded into a compact size for easy transport.
The handrim offers optimal leverage for self-propulsion. The wheelchair's turning radius ensures easy movement in confined spaces, with the pivot width supporting safe turning. Static stability defines the wheelchair's ability to maintain balance on slopes, ensuring safety on inclines and uneven terrains. The angular ranges are consistent with predicate devices and do not raise new questions of safety or effectiveness
The seat and backrest angles provide ergonomic support, promoting good posture and comfort. Adjustable seat depth and width cater to various body types, while the seat surface height facilitates ease of transfer. The wheelchair includes adjustable footrest and armrest distances, enhancing user comfort and posture.
Primarily designed for indoor environments but is not suitable for rough terrains.
The Flexx Junior is tested and compliant with ISO 7176-19 standards, making it suitable as a seat in a motor vehicle. Safety features include push-to-lock brakes, standard anti-tippers, and optional accessories such as a table tray, IV pole holder, and oxygen tank holder. Flip-up, height-adjustable armrests and quick-release axles enhance usability. Engineered to support children throughout their formative years, it provides the perfect balance of flexibility, safety, and comfort as they grow.
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(55 days)
The Community Container (Flap and Daisy) are intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.
The Community Containers (Flap and Daisy) are portable molded polypropylene syringe collectors that provide an alternate to re-sheathing a needle with its original protective cover and are designed to safely hold small low volume sharps such as blood needles, lancets, and small syringes.
The Community Containers (Flap and Daisy) are single use, non-sterile disposable, transportable sharps collectors intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.
The Community Containers (Flap and Daisy) are rectangular, with a conical taper and a temporary closure capability, which can be reopened for the storage of additional sharps prior to terminal disposal.
The Community Containers (Flap and Daisy) are approximately 8.7cm (L) x 4.3cm (W) x 15.1cm (H). The cap is opaque plastic with a hinged cap, which can be snapped closed to contain the biohazardous sharps. Each Community Container is individually embossed with a biohazard symbol.
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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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