BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Transit-Pellets

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RSVP PHANTOM PELVIS, MODEL TLP260

    FDA 510(k)
    FDA Class 2 ·Radiology

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code LXH·February 10, 2020

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 21, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011

    KINETRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code MHY·September 30, 2008

    INTRAUTERINE ACCESS BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LKF·December 10, 2020

    SELECTIVE SALPINGOGRAPHY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LKF·November 19, 2021

    Inserter for Titanium Elastic Nails (TEN), orthopedic device

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·October 21, 2015

    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 Enforcement
    Class II ·Terminated·Synthes, Inc.·March 18, 2015