BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

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    HL888HA

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEWISE BLOOD PRESSURE MONITOR

    FDA Adverse Event
    Injury ·RADIOSHACK·Product code DXN·October 20, 2004

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120304981·Diamond, cone flat, medium grit

    NAIL HOLDING SCREW

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·January 6, 2012

    FRESENIUS OPTIFLUX 200A

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

    COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 2, 2013

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 9, 2011

    PRECISION

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC NEUROMODULATION CORP·Product code LGW·April 17, 2008

    BAXJECT II HI-FLOW NEEDLESS TRANSFER DEVICE

    FDA Adverse Event
    Malfunction ·TAKEDA PHARMACEUTICALS U.S.A., INC.·Product code LHI·May 4, 2026

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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