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

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    PNEUMATIC WIRE TENSIONER

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

    Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PEFAKIT APC-R FACTOR V LEIDEN CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    BIVONA MID-RANGE TRACHEOSTOMY TUBE WITH AIRE-CUF

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.,·Product code JOH·December 20, 2010

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·February 4, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·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