BEUDAMED
    11 results · 19ms · 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.

    SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VascuTrak®

    FDA UDI
    Bard Peripheral Vascular, Inc.·00801741061400·VascuTrak® PTA Dilatation Catheter 3.5 mm x 20 ...

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707012160·CALIBRA 1ST MOL BANDS W/G8025-03 n.UL 20

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1430200·Rod Template, 250mm

    EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 3, 2013

    QUADRA H FEMORAL STEM SIZE 3 LATERALIZED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·September 5, 2014

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·June 2, 2011

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.

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

    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