BEUDAMED
    10 results · 19ms · 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 ×

    TPN FLUID TRANSFER SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FLI Twin

    FDA UDI
    Rmo, Inc.·00885797562463·FLI(R) TWIN BIO .018 WITH HOOK ON CUSPID 5-5 20...

    FLOCARE N

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED

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

    CTA HUMERAL HEADS (COCRMO) DIA.54MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·June 24, 2020

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·May 28, 2014

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·January 9, 2013

    SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DQO·November 22, 2010

    Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020