BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    MIS Solution

    FDA 510(k)
    FDA Unclassified ·Unknown

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551001554·Suction Tube, conical, dia. 3.5 mm

    Ophthalmic Spatulas

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114322·RUBENSTEIN CORNEAL ROLLER (BX/3)

    ValueStim

    FDA UDI
    COMPASS HEALTH BRANDS CORP.·10850958007470·2"x 2" Cloth 2 pk, Case of 10

    ValueStim

    FDA UDI
    COMPASS HEALTH BRANDS CORP.·00850958007473·2"x 2" Cloth 2 pk

    DEVEX MESH SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JAS MAGNESIUM REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INTELLIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·December 12, 2018

    ACCELERATOR APS

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JQP·December 28, 2015

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 19, 2014

    ACCELERATOR APS

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JQP·July 21, 2014

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 27, 2014

    PROTECTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 11, 2011

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 3, 2013

    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

    FDA Enforcement
    Class II ·Ongoing·Abbott·April 27, 2022

    MULTI HOLE WIRE GUIDE

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FZX·May 23, 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

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021