BEUDAMED
    22 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.
    Filters Regulation: Us FDA ×

    DENTAL, MEDICAL INSTRUMENT CASES & CASSETTE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sklar Instruments

    FDA UDI
    SKLAR CORPORATION·10649111056185·ECONO STERILE ROCH PEAN FCP STR STER 61/4 25

    HEARING AID (ALL-IN-EAR)

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    RMI LCD ALCOHOL DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 15, 2023

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 14, 2013

    MALE SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 7, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 29, 2014

    CONTOUR ACETABULAR RECONSTRUCTION RING

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025

    MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026

    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·June 29, 2022

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·July 26, 2024

    NSK

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EFB·September 17, 2025

    BA102

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 31, 2016

    BA105

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 28, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·August 29, 2017

    Newport Coast Basic Pack, part number 007484-1

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EFB·February 18, 2019