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

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    MODIFICATION TO ITI DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092102886·CAMLOG® Screw-Line-compatible 3.3mm Esthetic Ab...

    Alpha-Tec Systems

    FDA UDI
    Alpha-TEC Systems, Inc.·00816085023694·QC1 AFB Negative Slides

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)

    HARDYDISK, SULFA/TRIMETH

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SAMARCO SPIDER PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARDIOSAVE HYBRID, TYPE G PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 30, 2025

    OT PING METER

    FDA Adverse Event
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013

    6461500 INFUSOR PUMP (1 LABEL)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011

    ZENITH RENU CONVERTER AAA ANCILLARY GRAFT

    FDA Adverse Event
    Injury ·COOK INCORPORATED·Product code MIH·February 27, 2008

    TMJ SYSTEM CROSS DRIVE FOSSA SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 1, 2018

    TMJ SYSTEM CROSS DRIVE FOSSA SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 1, 2018

    INSORB 30 STAPLER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GAG·December 27, 2022

    TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code LZD·June 1, 2018

    "2.4MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 1, 2018

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024