BEUDAMED
    15 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 ×

    Merit 10mL Syringe

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583024950·CH60 NR, PS DB CHARM 60

    ZENITH PEDICLE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOPLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRADO™ Lumbar Interbody Fusion System

    FDA UDI
    Pt. Solutions, LLC·G616RAFS142636120·NON-STERILE PLANAR, PRADO A SYMMETRIC PEEK IBFD...

    PRADO™ Lumbar Interbody Fusion System

    FDA UDI
    Pt. Solutions, LLC·G616RAFS142636060·NON-STERILE PLANAR, PRADO A SYMMETRIC PEEK IBFD...

    PRADO™ Lumbar Interbody Fusion System

    FDA UDI
    Pt. Solutions, LLC·G616RAFS142636110·NON-STERILE PLANAR, PRADO A ASYMMETRIC PEEK IBF...

    VDW GOLD/SILVER CONTRA ANGLE

    FDA Adverse Event
    Malfunction ·DENTSPLY VDW GMBH·Product code EGS·September 30, 2019

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 3, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·September 26, 2014

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.,·Product code MMI·June 21, 2011

    Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD

    FDA Enforcement
    Class II ·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·January 5, 2023

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAR·January 5, 2023

    PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014