BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    OPHTIMPLANT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFANT REFLUX SLING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MULTI SPECT 2 [510(K) K913630]

    FDA Adverse Event
    Other ·SIEMENS MEDICAL SYSTEMS·Product code IYX·April 13, 2001

    ULTRASCAN B

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECH CTR·Product code IYO·June 11, 2014

    8CM ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·January 10, 2013

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·December 6, 2010

    The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL 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. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. 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 double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).

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