BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    EPIPHANY INJECTION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036027414·

    SUPERBOND

    FDA 510(k)
    FDA Class 2 ·Dental

    AGILTRAC .018 PERIPHERAL DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·May 4, 2007

    SONA PILLOW

    FDA Adverse Event
    Other ·SLEEP DEVICES, INC.·Product code MYB·June 18, 2007

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·May 2, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 15, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·May 5, 2011

    Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 6, 2013

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016