BEUDAMED
    15 results · 29ms · 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 ×

    DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517596772·CoRoent Large MP Ti, 8x9x23mm 4°

    PYRAMESH® Implant System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490844390·PYRAMESH 8 X 10 X 24MM

    Neo-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043508237·

    Neo-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043508473·

    PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPAZZ

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ALT HA CLR STD SZ 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·October 15, 2025

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009

    PINNACLE PELVIC FLOOR REPAIR KITS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 10, 2013

    0.8% RESOLVE PANEL A

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·April 12, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008

    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices

    FDA Enforcement
    Class II ·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014