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

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    HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810

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

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607726·STERIS-AMSCO 1080, 2080 5.25" DELUXE GEL

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450600726·

    UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COPELAND MB/HA RESURFACING HUMERAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VANGUARD PFR FEMORAL LT SM

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRR·May 17, 2018

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

    TENODESIS SCREW WITH HANDLED INSERTER

    FDA Adverse Event
    Injury ·ARTHREX·Product code HXX·September 4, 2014

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·July 21, 2008

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018