BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

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    413A NEONATAL MONITOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Preat

    FDA UDI
    Preat Corporation·00842092172582·2.5mm Retention Caps--Yellow (6-Pack)

    Convaid

    FDA UDI
    CONVAID PRODUCTS, INC.·10840117400914·

    Convaid

    FDA UDI
    CONVAID PRODUCTS, INC.·00840117408531·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306809712·Twist Lock 10cc BD

    COMPLETE BRAND COMFORTPLUS MULTI-PURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ZIMMER PATIENT-SPECIFIC CERAMIC ABUTMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 8, 2014

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012

    22G BD INSYTE AUTOGUARD WINGED ; 22GX1 INCH

    FDA Adverse Event
    Malfunction ·BD MEDICAL·Product code FOZ·July 28, 2010

    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.

    FDA Recall
    Terminated ·Medtronic MiniMed Inc.·Product code MDS·July 22, 2015

    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