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

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    TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH

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

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code DZL·September 6, 2017

    LIGASURE ATLAS HANDSWITCHING 37CM

    FDA Adverse Event
    Malfunction ·COVIDIEN LLC (SHANGHAI)·Product code GEI·March 28, 2013

    STERLING ES PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·April 19, 2011

    BD SPINAL NEEDLE

    FDA Adverse Event
    Injury ·Product code BSP·June 19, 2008

    TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015