BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    AMEDICA DRUG SCREEN TEST CUP

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CURON CONTROL MODULE ELECTROSURGICAL GENERATOR AND ACCESSORIES, MODEL S500-ST

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

    MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GRAFTYS HBS (510K NUMBER: K082498)

    FDA Adverse Event
    Injury ·GRAFTYS·Product code MQV·July 11, 2013

    ST. JOSEPH HSP BALTIMORE MD1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWF·October 1, 2010

    URETEX SUPPORT PP KIT X1

    FDA Adverse Event
    Injury ·SOFRADIM PRODUCTION·Product code OTN·April 22, 2013

    GLOBAL ADVANTAGE ECC HD 44X18

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWS·May 3, 2011

    ELITE PASS SHUTTLE NEEDLE, BOX OF 5

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIV.·Product code FMI·July 25, 2008

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·December 23, 2020

    CHILDRENS MERCY KS CITY MO1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

    SMART, PERFUSION PACKS, CONNECTORS, TUBING

    FDA Adverse Event
    Malfunction ·LIVANOVA USA·Product code DWE·August 1, 2023

    CSC14 CARDIOLOGIA HEAT EXCHANGER

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·April 20, 2023

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTR·March 10, 2016

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTR·November 20, 2015

    CSC14 BLOOD CARDIOPLEGIA SYSTEM

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTR·October 18, 2019

    CHILDRENS MERCY KS CITY MO1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·August 10, 2010

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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