BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAXILLARY DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    CP840442 DE LEIPZIG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 12, 2010

    LIBERTY CYCLER

    FDA Adverse Event
    Malfunction ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·August 23, 2011

    CP025369 DE LEIPZIG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·August 3, 2011

    CP85315 IT MODENA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·January 14, 2013

    CP84050 FR LA REUNION

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·May 17, 2012

    CP84042 DE LEIPZIG %

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DWE·April 20, 2011

    D905 DIDECO EOS SINGLE HVR

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·September 25, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 28, 2011

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·August 27, 2014

    FLEXTEND IS-1 BI POSITIVE FIX

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 1, 2016

    D905 EOS OXYGENATOR (PHISIO TREATED)

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·July 13, 2018

    D905 EOS PHISIO OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTZ·August 8, 2017

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    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

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017