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510(k) Data Aggregation

    K Number
    K252050

    Validate with FDA (Live)

    Device Name
    Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2026-03-20

    (262 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K251967

    Validate with FDA (Live)

    Device Name
    HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor
    Manufacturer
    O&M Halyard, Inc.
    Date Cleared
    2026-03-18

    (265 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253447

    Validate with FDA (Live)

    Device Name
    Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2026-03-16

    (165 days)

    Product Code
    GXR
    Regulation Number
    882.5250
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251848

    Validate with FDA (Live)

    Device Name
    Pentacam® Cornea OCT
    Manufacturer
    Oculus Optikgeräte GmbH
    Date Cleared
    2026-03-13

    (270 days)

    Product Code
    MXK
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253732

    Validate with FDA (Live)

    Device Name
    Permatage Flowable, Settable Bone Paste
    Manufacturer
    Orthocon, Inc.
    Date Cleared
    2026-03-13

    (109 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K253668

    Validate with FDA (Live)

    Device Name
    Onera SleepMap (SLEEPMAP)
    Manufacturer
    Onera B.V.
    Date Cleared
    2026-03-08

    (107 days)

    Product Code
    OLZ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K251807

    Validate with FDA (Live)

    Device Name
    Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2026-03-06

    (267 days)

    Product Code
    KGE
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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    K Number
    K252538

    Validate with FDA (Live)

    Device Name
    CEPHX3D
    Manufacturer
    Orca Dental AI , Ltd.
    Date Cleared
    2026-03-05

    (205 days)

    Product Code
    QIH
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K251434

    Validate with FDA (Live)

    Device Name
    Healing Abutment System
    Manufacturer
    Osstem Implant Co., Ltd.
    Date Cleared
    2026-03-04

    (300 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K253641

    Validate with FDA (Live)

    Device Name
    Owl Night Guard
    Manufacturer
    Owl Dental Lab, Inc.
    Date Cleared
    2026-02-26

    (99 days)

    Product Code
    OBR,MQC,OCO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Age Range
    18 - 120
    Reference & Predicate Devices
    K200125,K251778,K211158
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Owl 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.

    Device Description

    The Owl 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).

    AI/ML Overview

    N/A

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