BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    PEDIATRIC OXYGEN MASKS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    A-FIT®

    FDA UDI
    Gc Orthodontics America Inc.·E53581171100001·A-FIT® 2. MOLAR UPR RGT SZ 11

    JOURNEY II BCS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO EBI EFIX VISION FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JRNY BCS PAT RESRF RD 35 MM STD

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 15, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012

    ACCENT DR RF PACEMAKER

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code LWP·June 2, 2015

    JOURNEY POLY TIBIAL INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017

    PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024