BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SINGLE AXLE TOTAL ELBOW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Polystar Selection EDITION HD

    FDA UDI
    Merz Dental GmbH·D7091983036·posteriors; shade A4; size M; upper jaw

    PROXIMATE ILS CIRCULAR STAPLES

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006

    Dilator Sets

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOCO PROFLUORID L

    FDA 510(k)
    FDA Class 2 ·Dental

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024218178·

    PROXIMATE ILS CIRCULAR STAPLERS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.·Product code GAG·June 7, 2006

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWY·February 28, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·February 7, 2011

    SYSTEM 6 NON STERILE BATTERY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HWE·August 6, 2014

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·October 22, 2019

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·August 13, 2021

    DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 27, 2022

    COONS DILATOR

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DRE·July 28, 2022

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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