BEUDAMED
    14 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 ×

    IPL Hair Removal Device

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

    HEALIX ADVANCE

    FDA UDI
    Medos International Sàrl·10886705022410·HEALIX ADVANCE Cortical Awl-Tap Package Contain...

    Philips

    FDA UDI
    Sbo Hearing A/S·05714464010998·HEARLINK 9030 MNR T R DG

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113607·PS-C Insert, Size 3 x 16mm

    ZAVATION CONNECTOR

    FDA UDI
    Zavation LLC·00197157021122·Open-Open/Large-Small 16mm Offset Connector

    AZUR DETACHABLE 35

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ambassador Cervical Plate System

    FDA UDI
    Choice Spine, LP·00840996161275·AMBASSADOR,DRILL,2.3x16

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 3, 2014

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 12, 2013

    4.75MM HEALIX ADVANCE KNOTLESS BR ANCHOR

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code MAI·September 21, 2017

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    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