Search Filters

Search Results

Found 1755 results

510(k) Data Aggregation

    K Number
    K250314

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (318 days)

    Product Code
    Regulation Number
    870.1340
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K250914

    Validate with FDA (Live)

    Device Name
    MediAI-BA
    Manufacturer
    Date Cleared
    2025-12-18

    (266 days)

    Product Code
    Regulation Number
    892.2050
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K243438

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-05

    (394 days)

    Product Code
    Regulation Number
    870.2920
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K252658

    Validate with FDA (Live)

    Date Cleared
    2025-11-28

    (98 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.

    Device Description

    The Medical Diode Laser Systems generate a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coagulation of the target tissue.

    The Medical Diode Laser Systems generate a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

    The Medical Laser Family has following characteristics:

    • Dual wavelengths
    • Temperature monitoring system
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K242976

    Validate with FDA (Live)

    Date Cleared
    2025-11-26

    (426 days)

    Product Code
    Regulation Number
    866.2390
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is intended to preserve the viability and infectivity of fecal specimens after their collection and during transport from the collection site to the testing laboratory. The product can be used to collect stool specimen directly from the patient, using the swab as a rectal swab. Alternatively, the swab can be used to take material from a previously collected stool specimen. Fecal Transwab® specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.

    Device Description

    Each Fecal Transwab® Liquid Cary Blair Medium Collection and Transport Device comprises a sterile peel pouch containing a plastic screw-cap self standing tube with conical shaped bottom filled with 2 ml of Liquid Cary Blair transport medium and a specimen collection swab with a polyurethane foam coated tip. After sampling the swab applicator is placed in the tube where the bud is bathed in the liquid medium. The swab shaft is broken to allow the swab to fit in the tube, with the screw-cap being replaced.

    Fecal Transwab can also be supplied as a medium only device without a swab, in which case the specimen can be inoculated into the medium using a sterile swab, or scoop, or inoculating loop.

    The Liquid Cary Blair transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium chloride and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability without overgrowth of enteric bacteria during transit to the testing laboratory.
    The foam-tipped collection swab provided with the Medical Wire Fecal Transwab® Collection and Transport System has a plastic shaft with a defined breakpoint site. A bold red marker line indicates the limit of insertion if the swab is used to take a rectal specimen.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K252405

    Validate with FDA (Live)

    Date Cleared
    2025-11-26

    (118 days)

    Product Code
    Regulation Number
    870.1220
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.

    Device Description

    The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic Tip Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K252555

    Validate with FDA (Live)

    Date Cleared
    2025-11-25

    (104 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medusa Orthopedics Boa External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects.

    The Medusa Orthopedics Boa External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

    Device Description

    The Medusa Orthopedics Boa External Fixation System is a ring fixator device used to stabilize and maintain alignment of complicated bone fractures, soft tissue and/or congenital deformity repairs of an extremity. The fixator consists of two rings connected by four (4) struts that are lengthened and shortened independently. It is a modular system and facilitates a multitude of frame configurations to provide a wide variety of patient needs. The independent motion of the struts allows the surgeon to adjust the position of the proximal and distal rings. By utilizing the body's natural ability of osteogenesis to grow new bone tissue, the system guides the orientation and position of the new bone to the desired corrected location in a steady controlled manner.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K251659

    Validate with FDA (Live)

    Date Cleared
    2025-11-14

    (168 days)

    Product Code
    Regulation Number
    868.5630
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (> 4 years of age) and adult patients in the home, hospital and sub-acute care settings.

    It is not intended for use with Pentamidine.

    Device Description

    The Mesh Nebulizer H6 is a portable handheld device that uses micromesh vibration technology to generate aerosols for inhalation by patients. The H6 consists of a main unit, a nebulizer cup and optional accessories, including inhalation masks (available in child and adult sizes), a mouthpiece and a power cord. The main unit housing is made of ABS material, the nebulizer cup is made of PC material, the inhalation mask is made of PP&TPE&silicone material, and the mouthpiece is made of PP&silicone material. It can be powered by an internal lithium battery or by an adapter that complies with the IEC 60601-1 standard.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K252564

    Validate with FDA (Live)

    Date Cleared
    2025-11-07

    (85 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The "VeinCure" is indicated for use in the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

    Device Description

    Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.The diode laser for this unit is GaAlAs (Gallium-aluminum-arsenic) diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K250853

    Validate with FDA (Live)

    Device Name
    Merit Syringe
    Date Cleared
    2025-11-04

    (228 days)

    Product Code
    Regulation Number
    880.5860
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Merit Syringe is used to inject fluids into, and withdraw fluids from, the body.

    Device Description

    The Merit Syringe a standard three-piece piston syringe intended for general purpose injection and aspiration by a qualified clinician. The syringe is constructed of a calibrated, hollow, clear polycarbonate barrel into which is inserted a closely fitted movable ABS plunger with black silicone rubber piston seal (tip). The barrel is marked with standard graduations per ISO 7886-1 requirements and contains an ISO 80369-7 compliant fixed male luer, small-bore connector. The subject device is single use and is available in either an ethylene oxide (EO) or gamma-sterile configuration.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 176