BEUDAMED
    14 results · 35ms · Sources: EU EUDAMED, US FDA

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    PAINBUSTER INFUSION KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Invacare TDX SP2-HD with Captain's Seat

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MORTARA ELI 350 ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    PINN CAN BONE SCREW 6.5MMX30MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·March 15, 2013

    PINN CAN BONE SCREW 6.5MMX35MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NDJ·March 15, 2013

    RENEW RECEIVER KIT, 16-CHANNEL

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 4, 2015

    PINN MULTIHOLE W/GRIPTION 52MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·March 15, 2013

    PWRD ECH FLEX 60MM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 28, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION TIPLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 9, 2011

    OSFERION

    FDA Adverse Event
    Other ·OLYMPUS TERUMO BIOMATERIALS CORP. MISHIMA FACTORY·Product code MQV·July 14, 2014

    ASPHERE M SPEC 12/14 36 +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 11, 2012

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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