BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    GIBBONS STERILE TROCAR KITS

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

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197191319·Freeman Rake Retractor 4 pron...

    INSET II

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 22, 2026

    FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERILE POWDERED LATEX SURGEON GLOVES

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ST. JOSEPH HSP BALTIMORE MD1

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

    ONYX AVM

    FDA Adverse Event
    Injury ·COVIDIEN·Product code MFE·July 10, 2015

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 16, 2007

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 13, 2013

    VASOVIEW HEMOPRO EVH SYSTEM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·February 1, 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

    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

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024