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

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    SINTEA BIOTECH PLS MULTI-AXIAL SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ISA-21 INTERVENTIONAL SPINE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    CORTEX METAMAX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AVALIGN

    FDA Adverse Event
    Malfunction ·AVALIGN GERMAN SPECIALTY INSTRUMENTS·Product code HAE·June 17, 2019

    VERTEBRAL BODY RETAINER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·April 29, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 13, 2011

    CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·July 22, 2008

    BD ECLIPSE NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·September 26, 2020

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    WHITE STAR HIGH SPEED VIT CUTTER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL OPTICS·Product code MLZ·March 24, 2017

    Ankle Arthrodesis Nail, right T2 Ankle ¿11x300mm, Product Number 18191130S

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·July 18, 2018

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024