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

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    FASTPACK TOTAL PSA METHOD VERIFICATION KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TOWEL DRAPE, MODELS 4409, 4410

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

    SOLAR SPO2 MODULE WITH MASIMO SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD LUER-LOK¿ SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·November 22, 2021

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 16, 2017

    30 ML BD LUER-LOK TIP SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·July 22, 2021

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 17, 2013

    ISYMM ASPHERIC INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·HOYA SURGICAL OPTICS, INC.·Product code HQL·March 21, 2011

    ULTRAFLEX PRECISION COLONIC STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC IRELAND, LTD·Product code MQR·June 19, 2008

    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