BEUDAMED
    23 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.

    ELECTRONIC HOUSE CALL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Coblation

    FDA UDI
    Smith & Nephew, Inc.·00817470001419·PERC DC (OLD)

    Bosma Enterprises

    FDA UDI
    Bosma Enterprises·00818634025005·FSSA PPE Kit; Each Kit Includes Large Nitrile E...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065708·INTRAORAL ELASTICS 4,5 oz 1/4" red

    PC COATED FLUOROPLASTIC VENT TUBES

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    T2 FEMORAL NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    100" 20 DROP Y-TYPE BLOOD SET

    FDA Adverse Event
    Malfunction ·ICU MEDICAL, INC.·Product code FPA·November 8, 2016

    INOGEN EL ICD DR

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·May 29, 2025

    OMNI MULTIUSE HANDPIECE WITH FIBER ASSEMBLY

    FDA Adverse Event
    Malfunction ·TRIMEDYNE, INC.·Product code GEX·May 2, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 15, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·April 26, 2011

    IODINE (I-125) SEEDS

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code KXK·September 9, 2011

    100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·August 15, 2018

    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

    THMCL SMTCH SF BID, TC, D-F

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·July 11, 2024

    INGEVITY MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NVN·January 2, 2021

    Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    NEEDLE HOLDER CEV738T5 DIA 5MM TUNGSTEN

    FDA Adverse Event
    Malfunction ·INTEGRA MICROFRANCE S.A.S.·Product code HET·November 13, 2019

    SELECTSECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO VILLALBA·Product code NVN·October 21, 2025

    CELSIUS¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code LPB·August 25, 2022