BEUDAMED
    10 results · 80ms · 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.

    DISSECTING TWEEZER #283-72PCS. SS 410

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690192367·Apex Revision Knee Reamer - Zimmer 17mm

    FEATHER-FLEX ADULT ANESTHESIA CIRCUIT

    FDA Adverse Event
    Malfunction ·BOMIMED INC.·Product code BSJ·August 28, 2014

    GEMINI GXL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Tosama 100% Organic Cotton Menstrual Tampon

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

    SILICONE FOLEY CATHETER

    FDA Adverse Event
    Injury ·PRODUCTOS PARA EL CUIDAD DE LA SALUD·Product code MJC·May 23, 2014

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·November 29, 2012

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 30, 2010

    GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 26, 2009

    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