BEUDAMED
    18 results · 23ms · 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 ×

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017712·K-Wire, Double Ended, Trocar Point, Diameter Si...

    NexxZr™ T / D-100-30-NT-A400-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112644·

    V200 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

    FDA 510(k)
    FDA Class 2 ·Neurology

    V200 / ESPRIT

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 16, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·March 28, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·May 19, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code CBK·May 20, 2021

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 7, 2021

    V200 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code CBK·December 9, 2020

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, LLC·Product code MNT·June 21, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ASKU

    FDA Adverse Event
    Malfunction ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    SCORPIO-FLEX PS X3 TIB INSERT

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code HSH·August 21, 2008

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, 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