BEUDAMED
    20 results · 27ms · 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.

    CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000

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

    ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX

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

    MODIFICATION TO EDI VERIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    C21617 DE LIFE SYSTEMS $PHISIO

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 4, 2025

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    APPLIED MEDICAL·Product code FZP·March 26, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·March 9, 2011

    LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·April 16, 2008

    CP82200 I MIRANDOLA

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 18965050S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    CP85341 FR PARIS

    FDA Adverse Event
    Other ·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011

    EMORY/CL/KNNSTN ATLANTA GA1

    FDA Adverse Event
    Other ·SORIN GROUP USA·Product code DWF·August 19, 2010

    DUKE UNIV DURHAM NC 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016

    COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA·Product code KFM·February 29, 2016

    REVOLUTION CENTRIFUGAL BLOOD PUMP

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code KFM·July 20, 2018

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA SRL·Product code KFM·October 6, 2016

    COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING

    FDA Adverse Event
    SORIN GROUP ITALIA SRL·Product code KFM·October 5, 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