BEUDAMED
    19 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 ×

    Ora-GUARD Dental Grind Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II

    OSS™ Orthopedic Salvage System

    FDA UDI
    Biomet Orthopedics, LLC·00880304240087·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM

    K2 MEDICAL VASCULAR CLAMPS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTEGRA BONE FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 19, 2025

    NEXIVA 18 GA X 1.25IN SP WITH MAXZERO

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·November 13, 2025

    AXIOS

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 17, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·February 20, 2025

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 5, 2008

    PROTACK 5MM INSTRUMENT

    FDA Adverse Event
    Injury ·USSC PUERTO RICO·Product code GDW·June 22, 2011

    AXIOS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·December 18, 2024

    AXIOS

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KNS·November 27, 2024

    Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part of a replacement knee joint.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KRO·May 15, 2008

    Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019