BEUDAMED
    16 results · 26ms · 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 ×

    PENTRA 5D

    FDA 510(k)
    FDA Class 2 ·Hematology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964023468·The ENDO CARRY-ON Procedure Kit contains all of...

    Leksell Stereotactic System

    FDA UDI
    Elekta Instrument AB·07340048305747·ARM SECTION

    SCANLAN® Needle Holders

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159019445·Jacobson Needle Holder

    NorthStar

    FDA UDI
    Seaspine Orthopedics Corporation·10889981196059·Poly. Screw, 3.5mm x 34mm

    SILASTIC GEL-FILLED MAMMARY IMPLANT

    FDA Adverse Event
    DOW CORNING CORP.·Product code FTR·September 29, 1994

    COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II

    FDA 510(k)
    FDA Class 2 ·Immunology

    PINNACLE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·June 21, 2024

    DHS/DC COUPLING SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES JENNERSVILLE·Product code LXH·February 28, 2013

    PROTECT IV PLUS-W SAFETY CATHETER RADIOPAQUE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code FOZ·February 21, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIQ·February 26, 2008

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·January 16, 2019

    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·July 1, 2015

    smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025