LogoFDA 510(k) Search
Search Filters

Search Results

Found 6762 results

510(k) Data Aggregation

    K Number
    K250989
    Device Name
    Stryker and Serf hip devices
    Manufacturer
    Howmedica Osteonics Corp (dba Stryker Orthopaedics)
    Date Cleared
    2025-07-25

    (116 days)

    Product Code
    LPH, HWC, KWZ, LZO, MAY, MBL, MEH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    Howmedica Osteonics Corp (dba Stryker Orthopaedics)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251665
    Device Name
    Triathlon® Hinge Knee System
    Manufacturer
    Howmedica Osteonics Corp. dba Stryker Orthopaedics
    Date Cleared
    2025-07-25

    (56 days)

    Product Code
    KRO
    Regulation Number
    888.3510
    Why did this record match?
    Applicant Name (Manufacturer) :

    Howmedica Osteonics Corp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K243711
    Device Name
    Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);
    Manufacturer
    Wuxi Hisky Medical Technologies Co., Ltd.
    Date Cleared
    2025-07-24

    (234 days)

    Product Code
    OWN
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuxi Hisky Medical Technologies Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K243373
    Device Name
    Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
    Manufacturer
    Vitrolife Sweden AB
    Date Cleared
    2025-07-23

    (266 days)

    Product Code
    MQF
    Regulation Number
    884.6110
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vitrolife Sweden AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K243781
    Device Name
    HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)
    Manufacturer
    Edwards Lifesciences
    Date Cleared
    2025-07-23

    (226 days)

    Product Code
    DQK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Edwards Lifesciences

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K250716
    Device Name
    IMAGE ONE
    Manufacturer
    Infomed Software, S.L.
    Date Cleared
    2025-07-23

    (135 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Infomed Software, S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K244018
    Device Name
    Disposable Biopsy Needle
    Manufacturer
    Zhejiang CuraWay Medical Technology Co., Ltd.
    Date Cleared
    2025-07-22

    (207 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    Zhejiang CuraWay Medical Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    HeartFlow, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251151
    Device Name
    Rapid CTA 360
    Manufacturer
    iSchemaView
    Date Cleared
    2025-07-16

    (93 days)

    Product Code
    QAS
    Regulation Number
    892.2080
    Why did this record match?
    Applicant Name (Manufacturer) :

    iSchemaView

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251198
    Device Name
    HyperVue™ Software
    Manufacturer
    SpectraWAVE, Inc.
    Date Cleared
    2025-07-16

    (90 days)

    Product Code
    NQQ
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    SpectraWAVE, Inc

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

    Page 1 of 677