BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    IM-9C MICROINJECTORS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    3i Certain

    FDA UDI
    Preat Corporation·00842092167243·Biomet 3i Certain®-compatible 6.0mm Engaging Pl...

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964015876·Endo Carry-On Procedure Kit

    SCANLAN® Easy-Tag™ Tracking System

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159025361·Easy-Tag, Orange, Spool of 250

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112366·CHUCK HANDLE #3K 10CM LONG

    ASCENT KNEE REVISION FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CRYSTAL-EEG MODEL 15

    FDA 510(k)
    FDA Class 2 ·Neurology

    CARDIOSAVE HYBRID, TYPE G PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·April 23, 2025

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·July 10, 2025

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·March 11, 2013

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-ASAHI·Product code DQX·February 27, 2011

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code MIH·February 21, 2008

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 14, 2011

    CR 40MM GLENOSPHERE +3MM COCR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·June 16, 2022

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024