BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    FLEXIBLE SILICONE GELIHORN

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

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110935·STERILIZING CASE NARROW

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110928·STERILIZING CASE SINGLE VR

    Medical Surgical Mask (Model: JM92, JM92B)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MULTI-MODALITY IMAGE FUSION

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 16, 2015

    STANDARD IM NAIL

    FDA Adverse Event
    Injury ·SIGN FRACTURE CARE INTERNATIONAL·Product code HSB·January 9, 2013

    OSCILLATING BONE SAW DOUBLE HOSE CONNECTOR

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·July 8, 2014

    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