BEUDAMED
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    PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033314·Baltic Denture System BDLoad BDLoad Ln6 PLSEbi...

    OPIATES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MICROFIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BD CONNECTA¿ STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·January 10, 2022

    PHYSIOMESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·April 3, 2013

    D-FLEX TRIANGULAR RETRACTOR 60MM 5MM

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code GCJ·March 30, 2011

    MESH

    FDA Adverse Event
    Injury ·DAVOL, INC., SUB. C.R. BARD, INC.·Product code FTL·April 11, 2008

    3.0 mm Reaming Rod/950 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    BD CONNECTA¿ 3-WAY STOPCOCK

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·March 4, 2022

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021