BEUDAMED
    34 results · 24ms · 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 ×

    DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Bur PM2-70 50K Carb Xcut Ø6.0

    FDA UDI
    Bien-Air Surgery SA·07630055503985·

    Digital Analogue STD

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074727·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450172506·

    Indus®

    FDA UDI
    SPINEFRONTIER, INC.·00190361001140·Invue Max, Two Level ACP, 43mm

    Tibial Trial PS Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215042004·

    Bicon Impression Component

    FDA UDI
    BICON, LLC·00813110027405·2.5mm Impression Post and Sleeve (Extended)

    REMOTE FETAL MEDICINE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 7

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·April 25, 2022

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 8, 2013

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·May 17, 2011

    DA VINCI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code GCJ·July 25, 2008

    EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 30, 2026

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 29, 2019

    Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012

    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    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

    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

    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025