BEUDAMED
    9 results · 28ms · Sources: EU EUDAMED, US FDA

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    DIASTAT VASCULAR ACCESS GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221116802·3M™ Victory Series™ First Molar Bands, 953-287,...

    OSTEOTOME

    FDA UDI
    KLS-Martin L.P.·00888118118172·BURTON, 7 MM TIP

    HUBOUT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·February 9, 2013

    365 MICRON FIBER WITH FLAT TIP

    FDA Adverse Event
    Malfunction ·TRIMEDYNE, INC.·Product code GEX·January 7, 2011

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 23, 2014

    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