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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    ROADRUNNER WIRE GUIDE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE

    FDA Adverse Event
    Injury ·COOK INC·Product code DQX·January 26, 2018

    Publix Regular Needle Insulin Syringe

    FDA UDI
    PUBLIX SUPER MARKETS, INC.·10041415021782·Publix 3/10cc, 1/2 inch x 30 gauge insulin syri...

    VITEK 2 GRAM NEGATIVE MEROPENEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    IMPROVED TRY-IN GEL

    FDA 510(k)
    FDA Class 2 ·Dental

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 3, 2024

    POSTERIOR CHAMBER LENS

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 12, 2010

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 21, 2012

    POWERED WHEELCHAIR

    FDA Adverse Event
    Injury ·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014

    HUMAPEN LUXURA HALF-DOSE PEN

    FDA Adverse Event
    Injury ·ELI LILLY AND COMPANY·Product code NSC·November 3, 2011

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 8, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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