BEUDAMED
    12 results · 19ms · Sources: EU EUDAMED, US FDA

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    DSM Biomedical DPR Cable

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526550216·GENUMEDI PT KNEE SUP SILVER R EW VI

    Headless Compression Screw

    FDA UDI
    I.T.S. GmbH·09120047299005·Headless Compression Screw, Cannulated, D=4.3mm...

    ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    POWERHEART G5 AUTOMATIC AED

    FDA Adverse Event
    Malfunction ·CARDIAC SCIENCE CORPORATION·Product code MKJ·October 18, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 6, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 3, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·June 3, 2011

    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·July 2, 2014

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use.

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015