BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    EEG MONITOR WITH BIS, MODEL A-2000

    FDA 510(k)
    FDA Class 2 ·Neurology

    Holder, Needle, Micro, Streamline/catch round-handle 23cm tip 1.2mm

    FDA UDI
    Geister Medizintechnik GmbH·04057034006498·Holder, Needle, Micro, Streamline/catch round-...

    ELECTRODE LEADS 030-267 & 030-268

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    TriVerse Femoral Component CR

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215100308·

    PALFIQUE ESTELITE LV CLEAR

    FDA 510(k)
    FDA Class 2 ·Dental

    SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A

    FDA 510(k)
    FDA Class 2 ·Hematology

    FLOWTRON/UNIVERSAL PUMPS

    FDA Adverse Event
    Injury ·GETINGE SUZHOU CO. LTD.·Product code JOW·March 28, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 21, 2011

    ENDO CLINCH II 5MM INSTRUMENT

    FDA Adverse Event
    Malfunction ·PONCE - USS·Product code GCJ·April 15, 2008

    8.0MM/3.2MM DRILL SLEEVE 200MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·October 13, 2016

    3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HTW·October 13, 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

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (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