BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    qXR-LN

    FDA 510(k)
    FDA Class 2 ·Radiology

    MILAGRO

    FDA UDI
    DEPUY MITEK, LLC·10886705010738·MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLG...

    INPULSE LASER

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

    BLU-U, MODEL 4170

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

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·November 4, 2014

    ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 1, 2011

    HT70 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·July 15, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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