BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    CANDELA CRYOSYSTEM CS-5

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT

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

    CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PROTECTA XT CRT-D

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·February 9, 2013

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·AV-TEMECULA-CT·Product code NIQ·January 7, 2011

    RIATA ACTIVE FIXATION

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

    ev3 Pipeline Flex Embolization Device. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

    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