BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK ACTIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

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

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 7, 2010

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Malfunction ·DAVOL INC.·Product code FTL·September 1, 2011

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·March 26, 2013

    LIGAMAX-5MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·March 17, 2011

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·March 19, 2008

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·June 27, 2013

    DHF 06 HEMOCONCENTRATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALY·Product code KDI·May 22, 2025

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·May 25, 2016

    PERCEPT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·May 9, 2022

    MODIFIED KUGEL PATCH

    FDA Adverse Event
    Injury ·DAVOL INC·Product code FTL·August 2, 2011

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·January 31, 2022

    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

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014