BEUDAMED
    10 results · 22ms · Sources: EU EUDAMED, US FDA

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    2710-000 OSCILLATING SAW, GENERAL ASSEMBLY

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111083884·

    STERI-CATH(TM)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BULLET SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·January 9, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 18, 2010

    COGNIS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWP·July 1, 2014

    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

    FDA Enforcement
    Class II ·Terminated·Mako Surgical Corporation·August 12, 2020

    Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; 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