BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    I-QARE DS-W BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2

    FDA 510(k)
    FDA Class 2 ·Immunology

    AED RESECTOSCOPE

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

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·August 24, 2015

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 27, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·XUZHOU KERNEL MEDICAL INSTRUMENT EQUIPMENT CO.·Product code FTC·November 30, 2022

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 25, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 3, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 26, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·UNK·Product code FTC·January 29, 2021

    RELOAD FOR 60MM ECHELON

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

    UV PHOTOTHERAPY

    FDA Adverse Event
    Injury ·ANGEL KISS LLC·Product code FTC·February 2, 2021

    UV PHOTOTHERAPY LAMP

    FDA Adverse Event
    Injury ·ANGEL KISS LLC.·Product code FTC·February 4, 2021

    AVAULTA POSTERIOR SOLO SYNTHETIC SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·BARD SHANNON LIMITED·Product code OTP·May 16, 2013

    I-STAT CTNI CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·August 13, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·June 17, 2011

    AXOGUARD NERVE CONNECTOR AND PROTECTOR

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code JXI·October 24, 2019

    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