BEUDAMED
    20 results · 23ms · 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 ×

    8ch T/R Knee Coil

    FDA 510(k)
    FDA Class 2 ·Radiology

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357232253·

    BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 27, 2022

    DURATA STS OPTIM ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·November 10, 2008

    UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011

    COULTER® LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 12, 2013

    HARMONIC SCALPEL CURVED SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 28, 2019

    CLOSUREFAST CATHETER

    FDA Adverse Event
    Injury ·COVIDIEN·Product code GEI·December 23, 2025

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·June 1, 2017

    HARMONIC SCALPEL CURVED SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·December 30, 2019

    RECOVERY FILTER

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS·Product code DTK·April 15, 2020

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·July 6, 2017

    COPAN WASP/COLIBRI

    FDA Adverse Event
    Other ·COPAN WASP·Product code QQV·July 25, 2024

    MRIdian Linac Radiation Therapy System, Model 20000.

    FDA Enforcement
    Class II ·Terminated·Viewray, Inc.·May 8, 2019

    MRIdian Linac Radiation Therapy System Model 10000 and 20000

    FDA Enforcement
    Class II ·Terminated·Viewray, Inc.·December 18, 2019

    Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.

    FDA Enforcement
    Class II ·Terminated·Leica Microsystems, Inc.·August 7, 2013

    dS Breast 16ch 3.0T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025