BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    CARDIOPLEGIA COOLING SYST. CCAS-2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KETAC-CEM IN REF. TO K802048

    FDA 510(k)
    FDA Class 2 ·Dental

    SPO2 WRAP SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NUBIC AND RABEA DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTISTAR LE INJECTOR SYSTEM

    FDA Adverse Event
    Malfunction ·LIEBEL FLARSHEIM·Product code DXT·July 30, 2015

    OPTISTAR LE INJECTOR SYSTEM

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code DXT·May 14, 2013

    OPTISTAR LE INJECTOR SYSTEM

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code DXT·May 14, 2013

    TEMPERATURE SENSING 14F CATHETER

    FDA Adverse Event
    Injury ·MEDLINE INDUSTRIES, INC.·Product code NWR·May 2, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 24, 2012

    VERSA DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·August 17, 2010

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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