BEUDAMED
    15 results · 31ms · 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 ×

    ASCEND SHOULDER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Arx

    FDA UDI
    Life Spine, Inc.·00190837035402·ARX Counter Torque, Short

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134130·Trial, TLIF, 27L OB STR 7Deg, 13mm

    POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MICROMARK II TISSUE MARKER,MODEL C1535

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

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026

    BENCHMARK GX, STAINER MODULE

    FDA Adverse Event
    Injury ·VENTANA MEDICAL SYSTEMS INC.·Product code KPA·June 18, 2024

    TRUWAVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

    11.0MM TI HELICAL BLADE 110MM

    FDA Adverse Event
    Injury ·SYNTHES ELMIRA·Product code HSB·May 15, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014

    I-STAT 1 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code JJE·May 25, 2011

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021