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

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    EndoFLIP System

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

    Vanguard® Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304270725·

    REVERE SACRAL PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TINA-QUANT ALBUMIN GEN.2

    FDA 510(k)
    FDA Class 2 ·Immunology

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6+ R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 7, 2021

    MULTI-LINK 8

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·June 21, 2013

    PROXIMATE** SKIN STAPLER 35 WIDE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDT·July 28, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    VANGUARD DCM CR TIBIAL BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·February 8, 2018

    BMET REGENX PRI TIB TRAY 79MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·March 22, 2017

    REGENEREX PRIMARY TIBIAL TRAY

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·August 10, 2017

    BIOMET MODULAR FINNED STEM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JWH·August 10, 2017

    REGENEREX PRIMARY PATELLA

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·August 10, 2017

    VANGUARD TIBIAL BEARING

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code MBH·August 10, 2017

    REGENEREX SERIES A PATELLA 3 PEG DCM ARCOM POROUS TITANIUM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 14, 2018

    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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