BEUDAMED
    10 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 ×

    THE STERN ERA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO: ERBE APC CONNECTOR HOSE AND PROBES, MODELS 20132-158, 20132-155, 20132-156, 20132-157, 20132-166

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

    COUGAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 9, 2017

    Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGI·December 8, 2009

    TRILOGY O2

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·May 14, 2014

    MCK TIBIAL ONLAY INSERT- SZ 5- 8MM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code NPJ·July 14, 2015

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 14, 2013

    FISHER & PAYKEL HEALTHCARE

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 15, 2025

    REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 23, 2023