BEUDAMED
    42 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 ×

    ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SleepWeaver Advance - Mask Only - Blue

    FDA UDI
    CIRCADIANCE, LLC·B036100289·SleepWeaver Advance Cloth Nasal CPAP Mask Only ...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450173435·

    SCIMEDX PHASE II MPO IGG ANTIBODY EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    SYNTHES T-PAL SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHYSICA KR TIB. LINER RIGHT #5

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code MBH·December 21, 2022

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2013

    ABBOTT M2000SP

    FDA Adverse Event
    Malfunction ·ABBOTT MOLECULAR, INC.·Product code JJH·September 18, 2014

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 16, 2011

    SURSHIELD PUR SAFETY I.V. CATHETER

    FDA Adverse Event
    Injury ·TERUMO CORPORATION - KOFU·Product code FOZ·December 22, 2017

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

    SOMATOM Confidence -Computed tomography systems Model 10590100

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 19, 2022

    SOMATOM Confidence with software syngo.CT VB20 Model #10590100

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 17, 2016

    Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    TherMax Blood Warmer Unit

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024