BEUDAMED
    8 results · 36ms · 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.

    TULA Tube Delivery System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    VIEWFLEX PLUS ICE CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TOTAL PROTEIN URINE/CSF GEN.3

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 14, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 14, 2013

    COULTER ACT DIFF 2 ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 36MM

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code HWC·July 26, 2017

    TI Single Vector Distractor Body with Right Foot/20mm; Catalog ID 487.962 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·August 24, 2016