BEUDAMED
    17 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 ×

    MLX™ - Medial Lateral Expandable Lumbar Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Poly Per-Q-Cath Catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741034794·Poly Per-Q-Cath Catheter 3F Single-Lumen Basic ...

    Poly Per-Q-Cath Catheter

    FDA UDI
    Bard Access Systems, Inc.·00801741035456·Poly Per-Q-Cath Catheter with Sherlock Tip Loca...

    New Image

    FDA UDI
    HOLLISTER INCORPORATED·00610075078608·2-Piece Ostomy Skin Barrier, Convex, CeraPlus

    Kirwan

    FDA UDI
    KIRWAN SURGICAL PRODUCTS LLC·00841019103869·Titanium Bipolar Coagulation Forceps 4 3/4" (12...

    ORTHODONTIC SCREW

    FDA 510(k)
    FDA Class 2 ·Dental

    SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2012

    HI-TORQUE WHISPER LS GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·June 8, 2013

    UNICEL DXC 800 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGA·June 17, 2011

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008

    Linvatec LS 7500, 300 Watt Xenon Light Source Catalog Numbers: LS7500, LS7500L (loaner), LS7500R (refurbished)

    FDA Recall
    Terminated ·Linvatec Imaging·Product code GCT·August 1, 2005

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.

    FDA Enforcement
    Class III ·Terminated·Invivo Corporation·October 28, 2020