BEUDAMED
    17 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 ×

    FERRIS HYDROPHILIC DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011880330180·dentaform® Snap Band, tooth 46,size 30/Roth 18

    dentaform®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011880330220·dentaform® Snap, tooth 46,size 30/Roth 22

    NA

    FDA UDI
    STRYKER CORPORATION·07613327063493·6.9/10 Fr. SRU-6, Semi-Rigid Ureteroscope, Auto...

    Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EPIDURAL CATHETERIZATION KIT

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL·Product code CAZ·June 13, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 20, 2010

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·December 19, 2012

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 13, 2017

    M2A-MAGNUM 42-50MM TPR INSRT-6

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 13, 2017

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 13, 2017

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·August 29, 2019

    regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Enforcement
    Class II ·Terminated·Resource Optimization & Innovation Llc·October 14, 2015

    regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

    FDA Recall
    Terminated ·Resource Optimization & Innovation Llc·Product code FSY·April 22, 2015

    a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025

    Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019