BEUDAMED
    13 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 ×

    GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857531529·Trial Size 15°

    MULTICONSTITUENT CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TRI-FIX SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRONTO SPOT CHECK PULSE CO-OXIMETER

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·July 9, 2018

    LD304 MATERNITY BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code HDD·May 15, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·June 3, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·June 9, 2008

    AVANTA FLUID MANAGEMENT SYSTEM

    FDA Adverse Event
    Injury ·MEDRAD·Product code DXT·January 20, 2012

    96-8366 Drip Chambers, Convertible with Pierce Pin .138 Assembly; Abbott, Ashland, Ohio 44805; 650 drip chambers per case; Abbott Commodity 968366, Ashland Product #85-55960

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code FPA·June 9, 2003

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    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