BEUDAMED
    16 results · 26ms · 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 ×

    Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Injury ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021

    G-CATH TISSUE ANCHOR DELIVERY CATHETER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HRB-127-32 HIGH RESOLUTION BRAIN COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    FUJIFILM ENDOSCOPE MODELS EC-760R-V/M

    FDA Adverse Event
    Malfunction ·FUJIFILM CORPORATION·Product code FDF·March 25, 2024

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2013

    COMPACT EXCHANGE DEVICE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code KDJ·July 28, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023

    COMPR NANO HMRL PPS 34MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024

    COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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