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

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    Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OSTAPEK VBR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PENUMBRA COIL 400

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code HCG·November 29, 2016

    PELVITEX POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTIONS·Product code FTL·April 12, 2013

    BONE SCREW, T10, 3.5X20MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HRS·June 23, 2011

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 18, 2008

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

    FDA Recall
    Open, Classified ·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code EOQ·September 25, 2023