BEUDAMED
    11 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 ×

    SILVERLON CA (CALCIUM ALGINATE)

    FDA 510(k)
    FDA Unclassified ·Unknown

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496053590·MICROMASSAGE ARMBANDS CCL1, SIZE XL, NERO, GRAD...

    GRAMS POLYESTER NONABSORBABLE SUTURE

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

    POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FLEXTEND II

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVN·April 11, 2013

    TOTAL CARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 17, 2011

    SMART CONTROL NITINOL STENT SYSTEM

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code FGE·May 22, 2008

    MediBeads King Pad, Item Numbers: 34120, 34120PM, 34125R

    FDA Enforcement
    Class II ·Ongoing·Bruder Healthcare Company, LLC·April 3, 2024

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 29, 2011

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    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