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    K Number
    K250970
    Device Name
    Marie
    Manufacturer
    Leo Cancer Care
    Date Cleared
    2025-07-25

    (116 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Le**o **Cancer Care

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242615
    Device Name
    Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
    Manufacturer
    Xiamen Taotao Technology Co.,Ltd.
    Date Cleared
    2025-07-23

    (323 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Xiamen Taota**o **Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K252218
    Device Name
    MF SC GEN2 Facial Toning System
    Manufacturer
    Micro Current Technology, Inc.
    Date Cleared
    2025-07-18

    (3 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Micr**o **Current Technology, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243324
    Device Name
    Masimo O3 Regional Oximeter
    Manufacturer
    Masimo Corporation
    Date Cleared
    2025-07-17

    (267 days)

    Product Code
    MUD
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Masim**o **Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250751
    Device Name
    DualView Catheter
    Manufacturer
    Terumo Corporation
    Date Cleared
    2025-07-17

    (127 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Terum**o **Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243412
    Device Name
    ARCHIMEDES Biodegradable Pancreatic Stent
    Manufacturer
    Q3 Medical USA, LLC (c/o Q3 Medical Devices Ltd.)
    Date Cleared
    2025-07-16

    (257 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Q3 Medical USA, LLC (c/**o **Q3 Medical Devices Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251102
    Device Name
    Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)
    Manufacturer
    Cemho Medical Technology (Guangdong) Co., Ltd.
    Date Cleared
    2025-07-16

    (96 days)

    Product Code
    DXN
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cemh**o **Medical Technology (Guangdong) Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251447
    Device Name
    K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)
    Manufacturer
    Terumo Europe N.V.
    Date Cleared
    2025-07-08

    (60 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Terum**o **Europe N

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250496
    Device Name
    Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)
    Manufacturer
    Zibo Shengkun Chemical Industry Co., Ltd
    Date Cleared
    2025-07-07

    (137 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zib**o **Shengkun Chemical Industry Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251390
    Device Name
    MTA vpt
    Manufacturer
    VOCO GmbH
    Date Cleared
    2025-07-03

    (59 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    VOC**O **GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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