BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    ANA LATEX SLIDE TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    AcQMap

    FDA UDI
    ACUTUS MEDICAL, INC.·00857042007562·AcQMap Patient Electrode Kit

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756016179·STRAP ARM SLING

    ACUMED

    FDA UDI
    Acumed LLC·10806378043369·3.0mm Hex Impact Screw Extractor

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127026690·Shortened Dual Taper Broach, Size 5

    SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STACKHOUSE LENS HOOD, MODEL SA-700/F

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRULIANT TIB IMP PSC INSERT SZ 3, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·April 17, 2024

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMELRY NELLCOR·Product code CBK·February 11, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    SM104 MSERIES W5TH WHL

    FDA Adverse Event
    Malfunction ·STRYKER CORP, MEDICAL DIVISION·Product code FPO·August 3, 2010

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023