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

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    QUIK-BRUSH

    FDA 510(k)
    FDA Class 1 ·Dental

    GAMBRO CARTRIDGE BLOOD SETS

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

    Arthrex Univers Revers Apex Humeral Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    12/14 ARTICUL 40MM M SPEC-2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·January 16, 2026

    CARTRIDGE

    FDA Adverse Event
    Injury ·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·July 8, 2015

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 2, 2014

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 12, 2012

    "3.5"TRIFURCATED EXTENSION SET WITH ROTATING MALE LUER LOCKS

    FDA Adverse Event
    Malfunction ·CHURCHILL MEDICAL SYSTEMS·Product code FPA·September 28, 2010

    PROTAPER ULTIMATE SEQUENCE 25MM X5

    FDA Adverse Event
    Malfunction ·MAILLEFER INSTRUMENTS HOLDING SARL·Product code EKS·April 23, 2025

    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

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020