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

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    FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Neo-Tee T-Piece Resuscitator

    FDA UDI
    MERCURY ENTERPRISES, INC.·10641043508268·

    PRODIGY LATERAL VIEW SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRECISET DAT AMPHETAMINE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UNKNOWN MAXERA CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·October 14, 2022

    UNK MAXERA 58MM ACETABULUM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 17, 2022

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·April 10, 2013

    RESIDENT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 4, 2011

    RIATA ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    UNKNOWN MAXERA 58MM CUP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·October 14, 2022

    UNKNOWN MAXERA ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 13, 2022

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·July 12, 2012

    UNK MAXERA 58MM ACETABULUM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·October 17, 2022

    UNKNOWN BIOLOX DELTA TAPER LINER

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·October 20, 2022

    UNKNOWN BIOLOX DELTA TAPER LINER

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·October 20, 2022

    Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing less than 10kg (22 lb). The T-piece resuscitator circuit is a component used in conjunction with the T-piece resuscitator devices

    FDA Enforcement
    Class II ·Terminated·Mercury Enterprises, Inc. dba Mercury Medical·January 20, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012