LogoFDA 510(k) Search
Search Filters

Search Results

Found 18746 results

510(k) Data Aggregation

    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 System**s **Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    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 Osteonic**s **Corp (dba Stryker Orthopaedics)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251322
    Device Name
    Venue; Venue Go; Venue Fit; Venue Sprint
    Manufacturer
    GE Medical Systems Ultrasound and Primary care Diagnostics,
    Date Cleared
    2025-07-25

    (87 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Medical System**s **Ultrasound and Primary care Diagnostics,

    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 Osteonic**s **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 Technologie**s **Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251455
    Device Name
    EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
    Manufacturer
    Philips Ultrasound LLC
    Date Cleared
    2025-07-24

    (73 days)

    Product Code
    IYN, ITX, IYO, OBJ, QIH
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Philip**s **Ultrasound LLC

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

    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) :

    Edward**s **Lifesciences

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251280
    Device Name
    DESS® Dental Implants
    Manufacturer
    Terrats Medical SL
    Date Cleared
    2025-07-23

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    Terrat**s **Medical SL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K243415
    Device Name
    Granudacyn® Wound Irrigation Solution
    Manufacturer
    P.G.F. Industry Solutions GmbH
    Date Cleared
    2025-07-22

    (263 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Industry Solution**s **GmbH

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

    Page 1 of 1875