BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027445·

    ERO SCAN OAE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LUX 1440

    FDA Adverse Event
    Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

    ASR 300 SPIKED CUP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·September 15, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015