BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    REPLICA PLATER

    FDA 510(k)
    FDA Class 1 ·Microbiology

    POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ORIGIN ZIRCONIA

    FDA 510(k)
    FDA Class 2 ·Dental

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 9, 2014

    SPRINT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 31, 2012

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·February 29, 2008

    Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code LXH·February 3, 2015