Search Filters

Search Results

Found 3406 results

510(k) Data Aggregation

    K Number
    K253489
    Manufacturer
    Date Cleared
    2025-12-12

    (49 days)

    Product Code
    Regulation Number
    892.1000
    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
    K252997
    Manufacturer
    Date Cleared
    2025-12-11

    (84 days)

    Product Code
    Regulation Number
    888.3030
    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
    K252497
    Device Name
    SANSA HSAT
    Manufacturer
    Date Cleared
    2025-12-10

    (124 days)

    Product Code
    Regulation Number
    868.2375
    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
    K250258
    Manufacturer
    Date Cleared
    2025-12-08

    (314 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
    K243438
    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
    K251881
    Device Name
    HippoMind (v1.0)
    Manufacturer
    Date Cleared
    2025-12-03

    (168 days)

    Product Code
    Regulation Number
    882.1400
    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
    K253105
    Manufacturer
    Date Cleared
    2025-11-20

    (57 days)

    Product Code
    Regulation Number
    866.1620
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HardyDisk AST disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacterales, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Candida spp., Haemophilus spp., Neisseria gonorrhoeae, Neisseria meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

    Use of HardyDisk AST Cefiderocol 30μg (FDC30) for in vitro agar diffusion susceptibility testing is indicated when there is the need to determine the susceptibility of Enterobacterales, Pseudomonas aeruginosa, Acinetobacter baumannii complex and Stenotrophomonas maltophilia to cefiderocol, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

    HardyDisk AST Cefiderocol at concentration 30μg demonstrated acceptable performance to determine the zone diameter (mm) of cefiderocol against the following microorganisms:

    • Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, and Serratia marcescens)
    • Pseudomonas aeruginosa
    • Acinetobacter baumannii complex
    • Stenotrophomonas maltophilia
    Device Description

    Not Found

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K250643
    Date Cleared
    2025-11-20

    (261 days)

    Product Code
    Regulation Number
    878.4300
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Disposable Polymer Ligation Clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

    Device Description

    The Disposable polymer ligation clips includes Polymer Clips and Multiple polymer clips. The devices are sterilized by EO, single-use, non-absorbable, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The Disposable polymer ligation clips are compatible with the reusable, non-sterile Clip appliers which are made by Kangji. The clips are placed around the tissue and closed with the grip of a clip applier. These clips are made of medical grade acetyl homopolymer and supplied in different sizes and packaged in different clip quantity.

    Polymer Clips are housed in a colored cartridge which is consist of base and platen. The clips shall be placed and fired in clip applier one by one. Polymer Clips are available in four sizes: M, ML, L, XL.

    Multiple polymer clips (model: KJ-JZJDML, KJ-JZJDL, KJ-JZJDXL) are available in 3 sizes (ML, L, XL), housed in a colored cartridge and has 3 clips which can be placed in clip applier in one time and fired constantly totally 3 times.

    Multiple polymer clips (except model: KJ-JZJDML, KJ-JZJDL, KJ-JZJDXL) are available in ML and L size, housed in a striped cartridge. The cartridge which contains 5-15 clips will be placed in clip applier. The clips will be delivered individually advance after each firing.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K250642
    Date Cleared
    2025-11-19

    (260 days)

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

    Prescription Use:
    LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.

    OTC Use:
    LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

    Device Description

    LUOFUCON® Skin and Wound Cleanser is a clear, colorless solution with a mild odor. It helps in the mechanical removal of debris and foreign materials from the skin, wounds, or application sites. This product contains 0.1% w/w polyhexamethylene biguanide (PHMB) as a preservative, which helps inhibit the growth of microorganisms in the solution.

    LUOFUCON® Skin and Wound Cleanser is available in various packaging forms, such as Spray, Mist, Squeeze, and Bottle models. They can be suited for different clinical situations.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    K Number
    K252271
    Device Name
    Hemoclip
    Date Cleared
    2025-11-12

    (114 days)

    Product Code
    Regulation Number
    876.4400
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

    1. Endoscopic marking,
    2. Hemostasis for:
      • Mucosal/sub-mucosal defects <3cm
      • Bleeding ulcers
      • Arteries<2mm
      • Polyps<1.5cm in diameter
      • Diverticula in the colon
    3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.
    4. As a supplementary method, closure of GI tract luminal perforations<20mm that can be treated conservatively.
    Device Description

    Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube and Handle assembly. EO Sterilization and use for single use only.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 341