BEUDAMED
    16 results · 24ms · Sources: EU EUDAMED, US FDA

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    Tina-quant Transferrin ver.2 (urine application)

    FDA 510(k)
    FDA Class 2 ·Immunology

    SSW CARBIDE GREAT WHITE

    FDA UDI
    Ss White Burs, Inc.·D6901820952·GREAT WHITE GOLD CARBIDE GW2 PEAR - 5 PACK

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704513066·

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026711·Crile Retractor, sz 1, 4 1/4"

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019

    ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROMUS PREMIER?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·October 17, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code OUT·June 21, 2013

    L9000 LIGHT SOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·June 23, 2011

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Injury ·COOK ENDOSCOPY·Product code PID·June 17, 2021

    STRATA®

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·September 14, 2022

    STRATA®

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·September 14, 2022

    WILSON-COOK ACHALASIA BALLOON

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code PID·October 6, 2020

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023

    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