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

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    BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964074677·Endo Carry-On Procedure Kit

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957000554·UIMS Viewing Station

    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

    ST. JOSEPH HSP BALTIMORE MD1

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

    ARIS TRANS-OBTURATOR KIT

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FTL·May 9, 2013

    BIPOL LEAD MODEL 300

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code MUZ·September 19, 2014

    LC PCA III INFUSER

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code MEA·May 4, 2011

    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

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021