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

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    POWER SUPPLY / BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code IYN·March 28, 2011

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·July 30, 2010

    POWER SUPPLY/BATTERY CHARGER

    FDA Adverse Event
    Malfunction ·ELPAC·Product code ITX·June 25, 2010

    SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)

    FDA 510(k)
    FDA Class 2 ·Radiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844788·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE EXTRA LA...

    BIOSPEED

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

    ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    PALL TRANSFER/FREEZING BAG SET

    FDA Adverse Event
    Malfunction ·ENSATEC, S.A. DE C.V.·Product code KSR·November 11, 2010

    OSTEORAPTOR 2.3 W/ 1UB WHITE

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC MANSFIELD MANUFACTURING SITE·Product code MAI·April 11, 2013

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM HYDRO

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·May 23, 2008

    FLEXTEND

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 13, 2011

    PORTEX® ULTRAPERC® SINGLE DILATOR TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD; INC.·Product code JOH·October 17, 2019

    PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 14, 2019

    Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Recall
    Terminated ·Carefusion 211 Inc dba Carefusion·Product code CBK·September 5, 2013

    Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

    FDA Enforcement
    Class I ·Terminated·Carefusion 211 Inc dba Carefusion·October 9, 2013

    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