BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    HISTOFREEZER

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

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK114201·DD tempMED are pre-colored dental milling blank...

    Reusable SpO2 Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MM-87 MOTOR-DRIVE MANIPULATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BIVONA

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 19, 2021

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·January 11, 2013

    UMBILI-CATH

    FDA Adverse Event
    Malfunction ·UTAH MEDICAL PRODUCTS, INC·Product code FOS·November 17, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014

    SILICONE - BIVONA TUBES NEO/PED

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·October 19, 2021

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN030; c) 3.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN035; d) 4.0 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN040; e) 2.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP025; f) 3.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP030; g) 3.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP035; h) 4.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP040; i) 4.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP045; j) 5.0 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP050; k) 5.5 UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SP055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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