BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    SOF-WICKLAP PAD

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

    Archon

    FDA UDI
    Nuvasive, Inc.·00887517499509·Archon Screw, Ø4.0x18mm SD Fixed

    PERISTALTIC INFUSION PUMP (2100,2101)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Dental

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Injury ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·April 22, 2014

    NEXGEN GSF LPS-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·October 5, 2012

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·May 19, 2015

    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