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

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    CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack

    FDA 510(k)
    FDA Class 2 ·Dental

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304461437·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036153·30°/35° Fusion Recess Reamer, Quick Release

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137572·Trial, 42 X 32, 19mm Height 16° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137558·Trial, 42 X 32, 15mm Height 16° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137565·Trial, 42 X 32, 17mm Height 16° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137589·Trial, 42 X 32, 21mm Height 16° Hyperlordotic

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523137541·Trial, 42 X 32, 13mm Height 16° Hyperlordotic

    BLADEVIEW

    FDA 510(k)
    FDA Class 2 ·Radiology

    LINGLOCK

    FDA 510(k)
    FDA Class 2 ·Dental

    SYRINGE 20ML LL S/C 50

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·May 13, 2021

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 10, 2014

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    ALLEGRETTO WAVE

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code LZS·June 17, 2011

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    CHROMID STREPTO B AGAR

    FDA Adverse Event
    Malfunction ·BIOMERIEUX SA·Product code PQZ·November 1, 2017

    OSS MOD EXPANDABLE SZ20 SEG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 14, 2019

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 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