BEUDAMED
    17 results · 39ms · Sources: EU EUDAMED, US FDA

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    MANUKA IG

    FDA 510(k)
    FDA Unclassified ·Unknown

    NOVO Health Services, LLC

    FDA UDI
    NOVO HEALTH SERVICES, LLC·00812564031686·Vaginal Pack

    LuxaCrown

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1209760·Self-curing Composite for the fabrication of se...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450314043·

    T2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·December 11, 2018

    POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    T2 XVBR 1.5 SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HISTOACRYL FLEXIBLE PACK 5

    FDA Adverse Event
    Injury ·B.BRAUN SURGICAL SA·Product code MPN·July 23, 2019

    TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2

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

    TM ANKLE TIBIAL INSERT COMPONENT SIZE 4

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018

    SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code NPT·May 20, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    COBAS INTEGRA 800

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·June 13, 2011

    TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

    TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018

    TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSN·April 5, 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 Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021