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

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    SD360 DIGITAL RECORDER/SD360 HOLTER DIGITAL RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Phonak

    FDA UDI
    Phonak AG·07612847943544·Phonak Solana 10 Petite

    Optimotion Blue CR HCCR Total Knee System

    FDA UDI
    OPTIMOTION IMPLANTS LLC·B6961014P0419010·CR Tibial Insert, UHMWPE + Vitamin E, Size 4, ...

    FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·June 28, 2021

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·October 31, 2023

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 8, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 29, 2011

    VITALITY AVT FAST-CHARGE

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·September 22, 2016

    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

    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

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