BEUDAMED
    14 results · 20ms · 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 ×

    IPL Hair removal

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

    Needle aspiration and injection

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113592·PERIBULBAR NEEDLE 25GA 16MM

    UNIVERSAL NEURO 2

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613154750542·LOW PROFILE BHC PLATE,W/TAB, 10mm

    Responsive Respiratory

    FDA UDI
    RESPONSIVE RESPIRATORY, INC.·00851440007759·Adult Aerosol Mask

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113851·ARBISSER ANTERIOR CHAMBER CANNULA 30GA ANG 7MM

    TRUTEK SELECT MODEL TT-1001

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500

    FDA 510(k)
    FDA Class 2 ·Radiology

    IDRIVE ULTRA

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·August 31, 2017

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·October 17, 2008

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 2, 2013

    Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 020661 The AIA-Pack BHCG Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK BHCG assay

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·September 23, 2020

    Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·March 26, 2014

    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

    FDA Enforcement
    Class I ·Terminated·Oscor, Inc.·July 19, 2017