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

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    GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471123007·K-WIRE - SINGLE TROCAR 1.6mm DIA x 150mm

    Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NOBEL BIOCARE ENDOSSEOUS IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 4, 2013

    TRILOGY O2

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·March 5, 2014

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·PURITAN BENNETT CORP.·Product code CBK·December 10, 2010

    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