BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    GUILD MAXOX GENERATOR (MAXOX)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083016944·STR, 4 electrode, MPD-SL, 2mm electrode spacing

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981142025·Counter Torque Short

    Maestro® Buccal Tube Direct Bond

    FDA UDI
    Ortho Organizers, Inc.·00190707070076·.022 UL7 NC Std -10T 0A 10DO DB

    ENDOVASCULAR LAER VEIN SYSTEM KIT

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

    3D ACTIVETRAC

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LASER SURGERY

    FDA Adverse Event
    Injury ·Product code LZS·June 23, 2014

    IMPLANT PDS3000M 6PK PILLAR PALATAL

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code LRK·January 8, 2013

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MMI·November 17, 2010

    LOGIC PSC TIB INS SZ 5 17MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·June 14, 2023

    THREE PEG PATELLA 38MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·November 22, 2024

    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