BEUDAMED
    9 results · 20ms · 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.

    HEALTHPHONE TOCO MODEL

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

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228746311·GC Initial™ Ti Shoulder Transparent ST-31, 50g

    ASSERT EO BIOLOGICAL TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERIFLUX PF-2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·April 24, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 19, 2010

    TI LOW PROFILE TRANSCONNECTOR 56MM-83MM FOR 6.0MM RODS

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWP·December 15, 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

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024