BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    INJECTION NEEDLE

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

    NOVEOS Fluo Beads

    FDA UDI
    HYCOR BIOMEDICAL LLC·00816879028881·

    NOVEOS Fluo Beads

    FDA UDI
    HYCOR BIOMEDICAL LLC·00816879029642·

    NexxZr™ T / D-100-30-NT-B100-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112750·

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111245183·OP SCISS 6 1/2" CVD SH/SH

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019315020285·

    MEDLINE BAND BAGS AND EQUIPMENT COVERS

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

    SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 1, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021