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510(k) Data Aggregation

    K Number
    K250913
    Device Name
    TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
    Manufacturer
    Jiangsu Tingsn Technology Co., Ltd.
    Date Cleared
    2025-07-19

    (114 days)

    Product Code
    IYN, IYO, OBJ
    Regulation Number
    892.1550
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K231562
    Device Name
    ELEC ENGINE (Model: ISE-170L)
    Manufacturer
    Micro-NX Co., Ltd.
    Date Cleared
    2025-07-18

    (779 days)

    Product Code
    EBW
    Regulation Number
    872.4200
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243404
    Device Name
    HyHub™ and HyHub™ Duo Vial Access Devices
    Manufacturer
    Takeda Pharmaceuticals
    Date Cleared
    2025-07-18

    (259 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243775
    Device Name
    True Non-Surgical Spinal Decompression System (DRX9000-SL)
    Manufacturer
    Excite Medical of Tampa Bay, LLC
    Date Cleared
    2025-07-18

    (221 days)

    Product Code
    ITH
    Regulation Number
    890.5900
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250084
    Device Name
    MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
    Manufacturer
    Beckman Coulter, Inc.
    Date Cleared
    2025-07-18

    (186 days)

    Product Code
    LTT, JWY, LRG, LTW
    Regulation Number
    866.1640
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250553
    Device Name
    Tomey Cornea/Anterior Segment OCT (CASIA2)
    Manufacturer
    TOMEY Corporation
    Date Cleared
    2025-07-18

    (143 days)

    Product Code
    OBO
    Regulation Number
    886.1570
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250750
    Device Name
    INNOVISION-P5
    Manufacturer
    DK Medical Systems Co., Ltd
    Date Cleared
    2025-07-18

    (128 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250902
    Device Name
    HeartFlow Analysis
    Manufacturer
    HeartFlow, Inc.
    Date Cleared
    2025-07-18

    (114 days)

    Product Code
    PJA, LLZ, QIH
    Regulation Number
    870.1415
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250952
    Device Name
    Baby Gorilla®/Gorilla® Plating System
    Manufacturer
    Paragon 28 Inc
    Date Cleared
    2025-07-18

    (112 days)

    Product Code
    N/A
    Regulation Number
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250999
    Device Name
    V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System
    Manufacturer
    Samsung Medison Co., Ltd.
    Date Cleared
    2025-07-18

    (108 days)

    Product Code
    IYN, ITX, IYO, LLZ, QIH
    Regulation Number
    892.1550
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251542
    Device Name
    InstaFAN
    Manufacturer
    OnePass Medical Ltd.
    Date Cleared
    2025-07-18

    (59 days)

    Product Code
    ODG
    Regulation Number
    876.1500
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251585
    Device Name
    Profoject™ Enteral Feeding Syringe
    Manufacturer
    CMT Health PTE. Ltd.
    Date Cleared
    2025-07-18

    (56 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251655
    Device Name
    VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)
    Manufacturer
    Alafair Biosciences
    Date Cleared
    2025-07-18

    (49 days)

    Product Code
    N/A
    Regulation Number
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251809
    Device Name
    Arthrex FiberTak Suture Anchor
    Manufacturer
    Arthrex, Inc.
    Date Cleared
    2025-07-18

    (36 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251906
    Device Name
    Z1 Hip System
    Manufacturer
    Zimmer, Inc.
    Date Cleared
    2025-07-18

    (28 days)

    Product Code
    LZO, KWY, KWZ, LWJ, MEH
    Regulation Number
    888.3353
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K252012
    Device Name
    SPY Cystoscope/Hysteroscope
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2025-07-18

    (21 days)

    Product Code
    HIH, FAJ, NWB
    Regulation Number
    884.1690
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K242505
    Device Name
    Elecsys Cortisol III
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2025-07-17

    (329 days)

    Product Code
    JFT
    Regulation Number
    862.1205
    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
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K243420
    Device Name
    HESTIA
    Manufacturer
    GENORAY Co., Ltd.
    Date Cleared
    2025-07-17

    (255 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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