BEUDAMED
    20 results · 25ms · 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 ×

    SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HORIZONS INTERNATIONAL POLYPECTOMY SNARES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025

    FIBULA COMP LOCK PLATE 10H STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·August 24, 2016

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025

    AVANCE

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA·Product code BSZ·September 11, 2013

    CORONOID PLATE RT STE

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code HRS·June 9, 2016

    COBAS E411 DISK SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code MMI·May 14, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 2, 2011

    ACCU-CHEK COMPACT PLUS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·August 13, 2008

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025

    S3 SHOULDER PLATE 4 HOLE RIGHT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LXT·March 4, 2013

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·May 26, 2026

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

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

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021