BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

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    SPIRASEAL(TM) FACE MASK (VARIOUS SIZES)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556709259·GC Initial™ PC Pellets Dentin D3, 5pcs. X 2

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228720151·GC Initial™ PC Pellets Dentin D3, 5pcs. X 2

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376680637·Proximity Drill, 15mm

    Epimed

    FDA UDI
    EPIMED INTERNATIONAL, INC·00818788022646·R-F™ Cannula Coudé® B-Bevel 20g x 15cm w/ 10mm ...

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867311749·Low Profile Screw, 2.0 x 15mm, Cortical

    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PATIENT HEATER SYSTEM, MODEL PH112

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·June 11, 2025

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·June 13, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 14, 2010

    NELLCOR OXIMAX N-65P

    FDA Adverse Event
    Malfunction ·SANMINA-SCI SYSTEM·Product code DQA·December 11, 2012

    SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

    FDA Enforcement
    Class II ·Completed·Townsend Design·January 17, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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