BEUDAMED
    8 results · 25ms · 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.

    KLEIN NEEDLE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MASTERGRAFT PUTTY

    FDA 510(k)
    FDA Class 2 ·Dental

    Spectra S3 Plus

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 27, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 11, 2010

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC·Product code DRM·November 7, 2012

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physician s directive.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·May 8, 2019

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024