BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Tritanium C Anterior Cervical Cage

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICATH, STERILESURE

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

    CABLECAP MODEL: WLF, STZ, ACM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·December 19, 2017

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 14, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013

    PROLENE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GAT·July 20, 2011

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code FCG·December 26, 2017

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·October 1, 2018

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

    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