BEUDAMED
    16 results · 22ms · Sources: EU EUDAMED, US FDA

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    C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge

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

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113615·PERIBULBAR NEEDLE 23GA 32MM

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113608·PERIBULBAR NEEDLE 25GA 22MM

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113622·PERIBULBAR NEEDLE 25GA 32MM

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203024150·20mm H x 30mm W x 24mm L x 15 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A20302480·20mm H x 30mm W x 24mm L x 8 degrees ALIF

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587A203024120·20mm H x 30mm W x 24mm L x 12 degrees ALIF

    uMR 570

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCU-CHEK ® FLEXLINK PLUS INFUSION SET

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE, INC.·Product code FPA·April 26, 2018

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

    SJM EPIC STENTED PORCINE HEART VALVE

    FDA Adverse Event
    Death ·ST JUDE MEDICAL BRASIL LTDA.·Product code LWR·October 17, 2008

    VITROS 5600 INTEGRATED SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·July 2, 2013

    BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.

    FDA Enforcement
    Class II ·Ongoing·Becton, Dickinson and Company, BD Biosciences·November 9, 2022

    Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

    FDA Enforcement
    Class II ·Ongoing·Medtronic Neurosurgery·July 26, 2023

    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