BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    NEITZ HALOGEN OPHTHALMOSCOPE BXA-12

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL

    FDA 510(k)
    FDA Class 1 ·Dental

    ON-BOARD IMAGER DEVICE

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FPA·December 30, 2010

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·AQUATEC OPERATIONS GMBH·Product code IKX·February 4, 2013

    SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·July 17, 2014

    The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).

    FDA Enforcement
    Class II ·Terminated·Peters Surgical·October 1, 2014