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

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    M.U.S.T. Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023

    EarQ

    FDA UDI
    Oticon A/S·05707131341617·G20, BTE 13 2.4G 85 C092 EARQ

    Contrast Line

    FDA UDI
    ARGON MEDICAL DEVICES, INC.·00886333207497·Contrast Line 48"(122cm) Female/Rotating Adapte...

    INFANT ARRAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A

    FDA 510(k)
    FDA Class 2 ·Radiology

    GORILLA/BABY GORILLA PLATING SYSTEM

    FDA Adverse Event
    Injury ·PARAGON 28, INC·Product code HRS·September 17, 2020

    ELECSYS 2010 RACK

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 7, 2008

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 27, 2013

    CLARION

    FDA Adverse Event
    Injury ·ADVANCED BIONICS, LLC·Product code MCM·July 29, 2011

    COBAS E 411 ANALYZER (DISK SYSTEM)

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 15, 2026

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

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

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023