BEUDAMED
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    Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978948799·INSTRUMENT 8230928 DY CLSC 7.5MM TAP

    PENTAX Medical Video Bronchoscope EB11-J10

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Overjet Calculus Assist

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·July 20, 2011

    TARGET DEVICE GAMMA3 300X160MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·July 17, 2013

    VIDAS® ESTRADIOL II (E2II)

    FDA Adverse Event
    Injury ·BIOMÉRIEUX SA·Product code CHP·January 24, 2023

    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

    BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020