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    K Number
    K243403
    Device Name
    BD Nexiva™ Closed IV Catheter System
    Manufacturer
    Becton Dickinson Infusion Therapy Systems Inc.
    Date Cleared
    2025-07-25

    (267 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Becton Dickinson Infusion Therapy Systems Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250334
    Device Name
    Fusion Craniofacial Implant; Fusion Skull Implant
    Manufacturer
    Kelyniam Global Inc.
    Date Cleared
    2025-07-25

    (170 days)

    Product Code
    GWO
    Regulation Number
    882.5320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kelyniam Global Inc

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

    dba Stryker Orthopaedics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    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
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    K Number
    K250284
    Device Name
    TSK SELECT™ Needle
    Manufacturer
    TSK Laboratory, Japan
    Date Cleared
    2025-07-24

    (174 days)

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

    TSK Laboratory, Japan

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251984
    Device Name
    Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
    Manufacturer
    Shenzhen Ulike Smart Electronics Co.,Ltd.
    Date Cleared
    2025-07-24

    (27 days)

    Product Code
    OHT
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Ulike Smart Electronics Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K252010
    Device Name
    SPY Laparoscope
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2025-07-24

    (27 days)

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

    Stryker Endoscopy

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Takeda Pharmaceuticals

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beckman Coulter, Inc

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