BEUDAMED
    13 results · 37ms · 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 ×

    RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spine Innovation Interbody System

    FDA UDI
    SPINE INNOVATION, LLC·00817722020007·Expandable Implant 0° x 8mm W x 8mm H x 26mm L

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 25, 2025

    GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INVAC

    FDA 510(k)
    FDA Class 2 ·Radiology

    HAHN TAPERED IMPLANT Ø3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·February 12, 2026

    HT70 PLUS VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 23, 2013

    VISTA BRITE TIP GUIDING CATHETERS

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQY·May 10, 2011

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL·Product code HQL·July 23, 2008

    HAHN TAPERED IMPLANT 3.5 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 3, 2022

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024