BEUDAMED
    11 results · 33ms · Sources: EU EUDAMED, US FDA

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    AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF7

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690197430·AK3 PS-R Insert Trial Size 3, 10mm

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756632744·RHODE ISLAND GENERAL MAJOR

    MURINE MONOCLONAL ANTI-ADENOVIRUS IGG

    FDA 510(k)
    FDA Class 1 ·Microbiology

    RETICULOCYTE STAIN

    FDA 510(k)
    FDA Class 1 ·Hematology

    REALSEAL SE

    FDA Adverse Event
    Injury ·SYBRONENDO·Product code KIF·June 25, 2014

    ARTICULEZE M HEAD 36MM +1.5

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD.·Product code JDI·January 3, 2013

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·November 2, 2010

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    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