BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    INOMAX DSIR (DELIVERY SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZAVATION F3D-Z CIF

    FDA UDI
    Zavation LLC·00197157020675·F3D-Z CIF 14mmx18mmx5mm - 6deg

    ALEUTIAN Interbody Systems

    FDA UDI
    VB Spine LLC·10888857560741·Disc Spreader Size 10 mm

    RAPID IMF

    FDA 510(k)
    FDA Class 2 ·Dental

    MIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRA WAVEWRITER?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 26, 2025

    PERMACOL 10X15 1.5MM

    FDA Adverse Event
    Death ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES, PLC·Product code FTL·September 3, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 24, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 30, 2014

    13 CM TRICUT BLADE

    FDA Adverse Event
    Malfunction ·MEDTRONIC ENT (JACKSONVILLE)·Product code HAW·July 23, 2015

    CURVED SINUS BURS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EQJ·June 2, 2014

    Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 5, 25 mm; Ref 96-2756.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

    Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

    FDA Enforcement
    Class II ·Terminated·Senseonics, Inc.·November 6, 2019

    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