BEUDAMED
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    TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110980·STERILIZING CASE PLASTIC LARGE

    Continuum® Trilogy® IT Allofit® IT Acetabular Systems

    FDA UDI
    Zimmer, Inc.·00889024153011·

    ELATION MB METAL REINFORCED PLASTIC BRACKET

    FDA 510(k)
    FDA Class 2 ·Dental

    RS80 EVO Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXPLOR 8X28MM IMPL STEM W/SCR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWI·February 19, 2018

    COMP RVSR SHLDR GLNSP +3 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·February 12, 2021

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 14, 2014

    EON

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 12, 2012

    RENEGADE HI-FLO MICROCATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code KRA·August 10, 2010

    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 60010741-707; CD1211-36/100006983, 100012542, 100016679, 100031495, 100035634, 100035635, 100042587, 100047090; CD1211-36Q/100004079, 100004081, 100019783, 100035607, 100042591, 100047191; CD1215-36/100006990, 100010230, 100010241, 100010242, 100010244, 100012563, 100012564, 100034631, 100046574, 100046786; CD1215-36Q/100006768, 100006769, 100006770, 100023300, 100030306, 100033794, 100042402, 100046720, 100046904; CD1217-36/100011824; CD1219-36/100002160, 100002864, 100011826; CD1219-36Q/100004071, 100023301; CD2211-36/100006982, 100012536, 100016678, 100031440, 100035629, 100035636, 100042520, 100047192; CD2211-36Q/100004085, 100004087, 100019782, 100035587, 100042575, 100047193; CD2215-36/100006992, 100010224, 100010226, 100010227, 100010228, 100012515, 100012516, 100036606, 100046676, 100046792, 60019063; CD2215-36Q/100006762, 100006763, 100006764, 100023302, 100029180, 100033793, 100042404, 100046789, 100046905; CD2217-36/100011828, 100046991, 60016124-401; CD2219-36/100002139, 100002140, 100002862, 100011830; CD2219-36Q/100023303

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018