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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR

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

    HELIX HYDRO-JET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMITH & NEPHEW OFF-CENTERED PORP

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 16, 2013

    SURGICEL ABSORBABLE HEMOSTAT

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code LMF·June 17, 2008

    IMPLANTIUM

    FDA Adverse Event
    Injury ·DENTIUM USA·Product code DZE·April 6, 2011

    ANGIODYNAMICS / SMART PORT

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code LJT·August 21, 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