BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    CUSTOMED CYSTO PACK I

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

    3M™ Victory Series™

    FDA UDI
    3M UNITEK CORPORATION·00652221111890·3M™ Victory Series™ First Molar Bands, 902-274,...

    RANDOX BENZODIAZEPINE ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 4, 2024

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·June 30, 2014

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·January 8, 2013

    SYNCRHOMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MANUFACTURING·Product code LKK·November 15, 2010

    GS SALINE SOLUTION 12FL OZ, SKU 902274

    FDA Recall
    Open, Classified ·Family Dollar Stores, Llc.·Product code NGT·June 23, 2022

    GS SALINE SOLUTION 12FL OZ, SKU 902274

    FDA Enforcement
    Class II ·Ongoing·Family Dollar Stores, Llc.·August 24, 2022

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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