BEUDAMED
    20 results · 22ms · 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 ×

    CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45

    FDA 510(k)
    FDA Class 2 ·Radiology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607528·SKYTRON 6700, 6701 3" DELUXE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450182796·

    REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HBS HEADLESS BONE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 8, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DIO·October 4, 2019

    AMISTEM H FEMORAL STEM

    FDA Adverse Event
    Injury ·MEDACTA INTL SA·Product code LZO·April 15, 2013

    MONOJECT STANDARD HYPODERMIC NEEDLE

    FDA Adverse Event
    Injury ·COVIDIEN·Product code FMI·September 7, 2014

    AU681-02E CLINICAL CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·August 8, 2025

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 4, 2025

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·August 3, 2022

    ABBOTT TUBE EDTA PLH 13X75 2.0 PNK

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·September 17, 2019

    ARCHITECT CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MKW·September 30, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014