BEUDAMED
    13 results · 26ms · Sources: EU EUDAMED, US FDA

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    CIVCO STEPPER

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

    PANOVIEW

    FDA UDI
    Richard Wolf GmbH·04055207021422·TELESCOPE 30° Ø 2.4MM SL 98MM rigid, TL 156mm,...

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78714131·Mini Sprint Bracket Roth .018" mand. 3 left

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867303812·Low Profile Screw, 1.4x13mm, Cortical,Ti

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78714131001·Mini Sprint Bracket Roth .018" mand. 3 left

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78714130101·Mini Sprint Bracket Roth .018" mand. 3 left

    Mini-Sprint®

    FDA UDI
    Forestadent Bernhard Förster GmbH·EFOR78714130051·Mini Sprint Bracket Roth .018" mand. 3 left

    3871413

    FDA Adverse Event
    Malfunction ·May 14, 2014

    HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEMICAP PATELLO-FEMORAL RESURFACING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·October 15, 2010

    SPARC SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·December 5, 2012

    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