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

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    eCareManager 4.1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SR PIP

    FDA UDI
    Stryker GmbH·00886385019819·SIZE 3: PIP DISTAL TRIAL

    Symmetry Ultra®

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482039960·Ultra Instruments® Forceps, Overholt C Dissecti...

    POWDER FREE LATEX EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    JOINSOON ELECTRONICS MFG CO., LTD INFRARED EAR THERMOMETER, MODEL TT-001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 18, 2020

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 14, 2014

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 21, 2011

    REFURBISHED COLLEAGUE VOLUMETRIC INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 24, 2008

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·November 20, 2017

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

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

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 8, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 22, 2019

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·January 26, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·February 12, 2018

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code PNO·January 29, 2018

    EVEREST ® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·STRYKER-SPINE·Product code LXH·September 9, 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