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

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    XIA 4.5 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517636508·CoRoent Ant TLIF PEEK, 12x11x34mm 12°

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973714·

    NORMED BI-DIRECTIONAL/MULTIDIRECTIONAL JAW DISTRACTOR

    FDA 510(k)
    FDA Class 2 ·Dental

    OSIRIX MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    ALT HA S CLR EXT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·November 14, 2023

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    ACRYSOF IQ TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD/HUNTINGTON·Product code HQL·September 22, 2014

    NI

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HRS·June 6, 2011

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·May 31, 2024

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·August 12, 2024

    FLEXI SEAL SIGNAL (FMS)

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code KNT·October 11, 2016

    BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 3, 2024

    NV GXL LINER LIPPED 36MM ID GROUP 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·November 1, 2022

    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·November 21, 2018

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Recall
    Open, Classified ·Exactech, Inc.·Product code JWH·August 30, 2021